IN THE CIRCUIT COUlEd'iga? KNOX COUNTY, TENNESSEE SIXTH JUDICI ?d?T KNOX 0mm?? STATE OF TENNESSEE, ex rel. HERBERT H. SLATERY ATTORNEY GENERAL and REPORTER, JURY DEMAND Plaintiff, v. Case No. ?23? /63 PURDUE PHARMA, L.P., a foreign limited partnership, Defendant. CONIPLAINT TO MOTION TO TEMPORARILY SEAL TABLE OF CONTENTS I. GENERAL FACTUAL ALLEGATIONS 1 PARTIES 3 STATE COURT JURISDICTION 3 SUBJECT MATTER JURISDICTION 4 PERSONAL JURISDICTION 4 VENUE 5 PRE-SUIT NOTICE . 5 TIME PERIOD -. 5 II. SPECIFIC FACTUAL ALLEGATIONS 6 Purdue?s Opioid Products 6 Purdue?s Reliance on Continued Users and High-Dose Opioids 6 Purdue?s Sales Model 7 Purdue?s Branded and Unbranded Marketing 13 Sales Calls 16 A. DECEPTIVE SAFETY CLAIMS AND MATERIAL OMISSIONS 19 Safety Claims: Unquali?ed No Dose Ceiling C1a1ms20 Safety Claims: Pseudoaddiction 24 Safety Claims: Overstating the Ef?cacy of Tools to Mitigate Addiction 29 Safety Claims: Misrepresentations as to ?Peaks and Valleys? 35 Safety Claims: Abuse-Deterrence Misrepresentations 38 Safety Claims: Understating the Risk of Addiction 40 Failing to Disclose Increased Risk of Addiction at Higher Doses 42 Failing to Disclose Lack of Evidence for Long?Term Use of Opioids 51 Safety Claims: General Safety Claims 55 B. DECEPTIVE COMPARATIVE CLAIMS 57 Comparative Claims: OxyContin?s General Superiority over Other Products 59 Comparative Claims: OxyContin v. Other ER Opioids 60 Comparative Claims: OxyContin v. Immediate Release Opioids 73 Comparative Claims: OxyContin v. Non-?Opioids 95 ii Comparative Claims: Butrans v. Immediate Release Opioids 96 Comparative Claims: Ryzolt v. Immediate Release Opioids 103 Comparative Claims: Ryzolt v. Other Tramadol Products 104 Comparative Claims: Hysingla ER v. Acetaminophen Products and Hydrocodone Combinations 106 C. DECEPTIVE BENEFIT CLAIMS 107 Bene?t Claims: Quality of Life 107 Bene?t Claims: Improved Function 110 Bene?t Claims: Sleep Aid 113 D. DECEPTIVE CLAIMS ABOUT OPIOID USE IN THE ELDERLY 116 E. OMISSIONS OF MATERIAL 121 F. VIOLATIONS OF 2007 AGREED FINAL JUDGMENT 129 Dr. Michael A. Rhodes, Sr. 139 Dr. James Pogue 153 Dr. Allen Foster 161 Dr. Robert Cochran 164 Drs. Mireille Lalanne and Visuvalingam Vilvarajah 167 Dr. Frank McNiel and Dr. 172 Pain Clinic A 181 Breakthrough Pain Therapy Center 191 Buffy Kirkland, APRN 199 Jamie Cordes, APRN 206 Pain Clinic 210 Brandy Burchell, APRN 211 Christina Collins, APRN . 213 Nurse Practitioner II 215 Teodora Neagu, APRN 21 8 Dr. Abdelrahman Mohamed 221 Dr. TT 225 Physician Assistant 228 David Brickhouse, PA 231 Dr. 235 Pain Clinic 238 Alan PecorellaPURDUE IS SUBSTANTIALLY RESPONSIBLE 246 FOR THE OPIOID EPIDEMIC IN TENNESSEE 246 VIOLATIONS OF THE LAW 261 COUNT I: TENNESSEE CONSUMER PROTECTION ACT 261 COUNT II: VIOLATIONS OF 2007 AGREED FINAL JUDGMENT 267 COUNT COMMON LAW NUISANCE 267 IV. PRAYER FOR RELIEF .7 270 iv 1. This civil law enforcement action is brought in the name of the State of Tennessee in its sovereign capacity by Herbert H. Slatery Attorney General and Reporter (State or Attorney General), pursuant to Tenn. Code Ann. 47-18?108 of the Tennessee Consumer Protection Act of 1977, Term. Code Ann. 47-18-401 to ~13l (TCPA), against Purdue Pharma, L.P. (Purdue) to protect consumers and the integrity of the commercial marketplace in Tennessee. The State also brings suit to remedy Purdue?s violations of the 2007 Agreed Final Judgment (Judgment or 2007 Judgment) and pursuant to the Attorney General?s common law police power to abate and remedy the statewide public nuisance created by Purdue?s interference with the commercial marketplace and endangerment of the public health. 0 I. GENERAL FACTUAL ALLEGATIONS 2. Opioids are or drugs derived from opium. Historically, Opioids were prescribed in limited circumstances because of long-standing and well-founded fears about their addictiVe potential and safety. Then came Purdue. Through unprecedented marketing for a narcotic, Purdue created a false narrative to reverse these attitudes among the public, health care providers, and other stakeholders in order to increase sales of its opioid products and its own market share. Time and again, Purdue placed pro?ts over people. 3. Purdue violated the TCPA by making a series of unlawful safety, comparative, and bene?t claims about its opioid products, failing to disclose its material connection to third?party pain advocacy groups it substantially funded, and unfairly targeting vulnerable populations like the elderly. Purdue advanced the deceptive narrative that its opioid products were safer than they actually were, its competitors? products were more dangerous or less effective than they actually were, its opioid products had certain qualities or bene?ts for which it lacked adequate substantiation, and its Opioid products were safer for elderly patients than they actually were. .4. ?The. Statenalso brings suit ,based Purdue?s .failure to .suf?ciently implement and follow an abuse and diversion detection (ADD) program as required by the 2007 Judgment. Purdue failed to take appropriate action in spite of knowing about unambiguous, credible signs of abuse or diversion. Instead, Purdue continued to direct its sales force to target the highest prescribers, many of whom had no or limited background or training in pain management. 5. For example, Purdue called on two providers 48 times after it had been told directly by law enforcement officials that the pair was responsible for signi?cant interstate diversion of OxyContin and called on another provider 31 times after the provider?s license was placed on restrictive probation because of issues related to his high prescribing of controlled substances. Purdue continued to make sales calls in spite of credible reports of patient overdoses, indictments, adverse licensure actions, a provider admitting he was addicted to heroin, a knife ?ght outside a provider?s of?ce, muggings over controlled substances outside of a pharmacy linked to a speci?c provider, a clinic that had no examination tables or equipment, an admission by a provider that he was running a pill mill, a provider changing the name of his practice shortly after he was noti?ed of a state investigation into his practice, a patient being coached in the waiting room about how to ?ll out intake forms, armed guards in provider waiting rooms, high numbers of patients who purchased OxyContin in cash, high numbers of out?of-?state or out?of?county tags in providers? parking lots, accusations of insurance fraud, choreographed urine screenings and. pill counts, standing-room-only waiting rooms, and additional signs of problematic high volume practices. 6. Purdue?s actions and omissions concerning its highly addictive narcotics have created and fueled a public nuisance in Tennessee by signi?cantly interfering with the commercial marketplace and endangering the life and health of the state?s residents. PARTIES 7. The Plaintiff, State of Tennessee ex rel. Herbert H. Slatery Ill, Attorney General and Reporter, is charged with enforcing the TCPA. Pursuant to Tenn. Code Ann. 47?18?108 actions for violations of the TCPA may be brought only by the Attorney General with approval from the Division of Consumer Affairs in courts of competent jurisdiction to restrain violations, to secure equitable and other relief, and to otherwise enforce the provisions of the TCPA. The Attorney General has all common law powers except as restricted by statute, State v. Heath, 806 535, 537 (Tenn. Ct. App. 1990), and is expressly authorized to utilize and refer to the common law in the exercise of his duties pursuant to Tenn. Code Ann. 8. Defendant Purdue Pharma, LP. is a limited partnership organized under the laws of Delaware with its principal place of business in Connecticut. STATE COURT JURISDICTION 9. The causes of action asserted and the remedies sought in this Complaint are based exclusively on Tennessee statutory, common, or decisional law. 10. The Complaint does not confer diversity jurisdiction upon federal courts pursuant to 28 U.S.C. 1332, as the State is not a citizen of any state and this action is not subject to the jurisdictional provisions of the Class Action Fairness Act of 2005, 28 U.S.C. 1332(d). Federal question subject matter jurisdiction under 28 U.S.C. 1331 is not invoked by the Complaint. Nowhere does the State plead, expressly or implicitly, any cause of action or request any remedy that arises under federal law. The issues presented in the allegations of this Complaint do not implicate any substantial federal issues and do not turn on the necessary interpretation of federal law. There is no federal issue important to the federal system, as a whole as set forth in Gunn v. Minton, 568 US. 251, 258 (2013). 11. In this Complaint, the State occasionally references federal statutes, regulations, or actions, but does so only to establish the Defendant?s knowledge or to explain how the Defendant?s conduct has not been approved by federal regulatory agencies. SUBJECT MATTER JURISDICTION 12. As a court of general jurisdiction, the circuit court is authorized to hear this matter, based on the TCPA and nuisance claims, the amount at issue, and the relief sought pursuant to Tenn. Code Ann. 16-10-101 and -110. PERSONAL JURISDICTION 13. As set forth below, this Court has personal jurisdiction over Purdue based on its contacts in Tennessee. Among other things, Purdue has employed at least 87 sales representatives;1 district managers, and regional managers from 2006 to 2017 to make or oversee sales calls to health care providers in Tennessee; has made numerous sales calls to health care providers in Tennessee between 2007 and 2017 for the purpose of promoting Purdue?s opioid products;2 mailed, delivered, or otherwise made marketing or promotional materials for Purdue?s opioid products available to health care providers or the public in Tennessee; convened regional sales meetings in Tennesseeg?? hosted numerous speaker events in Tennessee; and participated in several conferences hosted in Tennessee for the purpose of promoting Purdue?s opioid products.4 1 PWG004284992. 2 3 5500. 4 PTN000119294 ID28660 (9/5/2008) (?Gave saving card she is attending the [American Pain Society] in Nashville encouraged to stop by our booth for VENUE 14. Venue is proper in Knox County pursuant to the speci?c state enforcement venue provision, Tenn. Code Ann. because it is a county where the alleged violations took place and is also the county in which Purdue has conducted or transacted business. 15. Among other conduct, Purdue marketed its opioids in Knox County including to health care providers in Knox County through numerous in?person visits from its sales representatives. PRE-SUIT NOTICE 16. The Director of the Division of Consumer Affairs of the Tennessee Department of Commerce and Insurance requested that the State file a civil law enforcement action against Purdue for violations of the Consistent with Tenn. Code Ann. the State has provided Purdue with 10 days? advance notice of its intention to initiate legal proceedings against it. Consistent with the 2007 Judgment, the State provided Purdue with detailed notice of violations of the Judgment at least 30 business days in advance. TIME PERIOD 17. This enforcement action concerns violations of law that occurred after May 6, date the Judgment was entered. References in the Complaint to conduct that occurred before this date are mentioned to establish Purdue?s knowledge, a pattern of behavior, or other facts that are relevant to conduct occurring after May 6, 2007. Similarly, the State?s claim for violations of the 2007 Judgment Concerns conduct between June 15, 2007 and May 6, 2017, the period in which the Judgment mandated that Purdue follow an ADD program. II. SPECIFIC FACTUAL ALLEGATIONS Purdue?s Opioid Products 18. Purdue has marketed several different extended release opioid products in Tennessee that it owns and manufactures. These products include OxyContin, Butrans, and Hysingla ER, among others. As the name suggests, extended release opioids differ from immediate release opioids in that they have a concentrated active ingredient that is supposed to be released over a longer period of time. 19. OxyContin, Purdue?s highest selling and most pro?table drug, is the brand name for oxycodone hydrochloride, a potent extended release opioid delivered in tablet form in 10, 15, 20, 30, 40, 60, 80, and, at one time, 160 mg doses. Butrans is the brand name for Purdue?s buprenorphine skin patch available in ?ve different 5, 7.5, 10, 15, and 20 meg/hour doses. Hysingla ER is the brand name for Purdue?s hydrocodone bitartrate, an extended release opioid delivered in 20, 30, 40, 60, 80, 100, and 120 mg ?lm-coated tablets. Ryzolt, which Purdue no longer sells, was the brand name for tramadol hydrochloride, an opioid that had both immediate and extended release characteristics and was available in 100 mg dosing increments. Purdue?s Reliance on Continued Users and High-Dose Opioids 20. Purdue?s sales model relied substantially on both continued users and high-dose opioids. For OxyContin, over 80% of Purdue?s business consistently came from continued users.5 Out of the 104,340,382 total OxyContin tablets prescribed in Tennessee from 2008 to 2017, 53. 7% of them were 40 mg or higher.6 If 40 mg OxyContin is taken twice a day as directed, that amount 5 PWG00043 5505. 6 PWG003984543. equals 120 morphine milligram equivalents (MMEs) per day, which exceeds the 90 MMEs daily amount of opioids the CDC warns against by over 33%.7 Purdue?s Sales Model 21. Purdue created a sales structure that led to and fostered the proliferation of unlawful marketing claims, which was compounded by trainings in which Purdue instructed sales representatives to make select prohibited claims, lax compliance enforcement, a heavy emphasis on sales performance for compensation, and otherwise inadequate instruction. 22. Purdue employed a large sales force to market its opioid products to health care providers, pharmacies, and health care institutions in Tennessee. Purdue directed the marketing efforts of its sales representatives through detailed action plans, trainings, tests, scripts, role-plays, supervisor tag?alongs, and feedback on sales representatives? ?call notes? from sales Visits. 23. Purdue spent signi?cant sums to call on providers to promote its opioid products because, unsurprisingly, it had evidence that increased sales calls were ?highly correlated? with more prescriptions for its productss?particularly among the top prescribers of those products.9 24. Purdue summarized the marketing for its opioid products with the tagline ?We sell hope in a bottle,?10 shown below, in one of the company?s hiring guides for incoming marketing employees. 7 3 See, 9 ?0 mm Hm? 9pm LP. 0081:5854! mamas: mm: mm Wmhezmm ?a 1" tell Wmmaamu 25. Purdue trained its sales representatives to be aggressive in sales calls with providers. Purdue?s Tennessee sales representatives were expressly trained to ?Always be closing,? a well-known phrase from Glengarry Glen Ross, a play and movie about highly- aggressive salesmen who use deceptive tactics to sell undesirable real estate at in?ated prices. Both the phrase ?Always be closing? or the movie/play?s name itself appear in at least three places in training notebooks: from two different Purdue Tennessee sales representatives in 2009 and 201211 and from a Tennessee district manager in 2009.12 26. Similarly, a Purdue district manager in Tennessee in a sales training book made a 9913 note to ?follow the money, as shown below. ?1 ST000491 (2009 Notebook); PTN000100919 (2012 Notebook). 12 PWG004285522. 13 PWG004285554. f. 27. Among other things, Purdue expressly trained its Tennessee sales representatives to ?expand the physician?s de?nition of ?appropriate patient,? ?[d]evelop a speci?c plan for systematically moving physicians to move to the next level of prescribing behavior,?14 and ?never give someone more info than they need to act.?15 28. Purdue also trained its Tennessee sales representatives to focus on providers who had more patients, were less likely to have pain management expertise, and were less likely to have time to appropriately monitor patients on opioids. Purdue trained its sales representatives about how to overcome a provider?s objections, such as a provider expressing concern about the abuse of opioids or a provider stating he or she does not treat chronic paian?pushing these providers to write more Purdue prescriptions. 29. Many of Purdue?s Tennessee sales representatives devoted half of their sales calls in a given scheduling period to visit primary care physicians, family doctors, nurse practitioners, or physician assistants.? Purdue knew or should have known that these prescribers frequently had limited resources or time to scrutinize the company?s claims or conduct the necessary research 14 PWG000346233. ?5 ST000618 (2010 Notebook). ?5 1. *7 (2011 Notebook); PWG000071980. about the ef?cacy and risks of high doses of extended release opioids themselves. Yet Purdue targeted them anyway. The below chart illustrates that Purdue?s sales representatives focused at least 183,764 of at least 295,517 sales visits or 62% of sales visits to Tennessee providers to primary care physicians, internists, family doctors, nurse practitioners, and physician assistants over the last 10 years: '3 Purdue Sales Calls by Specialty - Family Practice - Internal Medicine Nursel?ractilinna' Physician Assistant - Pain Medicine - Other Specialties (cg, Anesthuiology, Oncology) 30. Purdue targeted nurse practitioners and physician assistants speci?cally to increase prescribing of its opioid products. In a 2015-2016 OxyContin Brand Strategy training session, Purdue instructed that [are] critical to our success; contributing to both volume and Likewise, in a sales and marketing PowerPoint focusing on strategies for 2012, Purdue included as a ?Strategic Imperative? that the company should ?[ijncrease/mainrain volume with high value [oxycodone extended release] prescribers These high value OxyConrin prescribers '3 PTN000119294. ?9 PWG000435504. l0 - will include-NBs and [i]dentify &.engage next .tierof frising stars? ,to .expand roster.?21 As part of its 2013 Annual Marketing Plan for OxyContin, Purdue analyzed marketing data and concluded that ?[t]he only specialties still growing are NPs and PAs, which make up the fastest- growing group in both the [extended release opioid] market and the industry in general.?22 Likewise, Purdue instructed a ?market insight? that and PAS desperately seek information, typically from sales representatives? in the same 2013 plan.23 31. Purdue?s marketing strategies to target generalists as well as nurse practitioners and physician assistants worked. Between January 2007 and August 2017, these providers prescribed 65% of all OxyContin tablets in Tennessee.24 7 32. Purdue was aware at least by 2014 that prescribers often relied upon the company as ?someone [sic] they can look to for the information they need to make prescribing decisions.?25 Similarly, Purdue taught its sales representatives in 2009 to assume that the ?Dr does not know how to rx [prescribe] 33. Purdue compensated its sales representatives through a salary and bonus structure that incentivized its sales representatives to make ?frequent sales calls to the highest volume prescribers of its opioid products, which it termed ?super core? and ?core? prescribers.27 These prescribers were also more likely to be the most problematic concerning the abuse and diversion of its opioid products.28 2? PWG000062476 (emphasis added); PWG000437024. See also PWG0000625 80. 2? PWG000062490. 22 PWG003 874196; see also PWG000062580. 23 PWG000062560. Z4 PWG003984543. 25 PWG003810482. 2?5 ST000556 (2009 Notebook) 27 ST000561 (2009 Notebook). 23 PWG003 874461. 11 . . .34. the number of prescriptions generated. Further, Purdue expressly told its sales representatives to focus on physicians who would give the best return on investment29 and high potential prescribers.3O Purdue subjected its sales representatives whose numbers lagged to disciplinary actions which included further sales training and strict managerial oversight, while disciplinary actions for noncompliant sales calls were rarer. 35. Predictably, this sales structure resulted in the dissemination of unlawful claims by Purdue as set forth below. 36. Purdue?s sales representatives misrepresented the safety, ef?cacy, and bene?ts of its opioid products and those of its competitors to providers in Tennessee, did not provide adequate warnings to these providers, and marketed the company?s opioid products to providers who were not experienced in prescribing them. 37. Unfortunately, Purdue?s material misrepresentations and omissions were then passed on from these deceived prescribers to patients. For instance, patients in substance abuse treatment whose addiction began with prescriptions fOr opioids to treat chronic pain often have reported that they were not warned of the risk they might become addicted. A 2015 survey of more than 1,000 opioid patients found that 4 out of 10 were not told opioids were potentially addictive.3 1? F39 ST000461 (2009 Notebook). 30 See also PTN000116388 (describing 80/20 rule that 20% of clinicians will write 80% of the business). 31 HAZELDEN BETTY FORD FOUNDATION, Missed Questions, Missed Opportunities, (Jan. 27, 2016), available at prevent?opioid~addiction. l2 Purdue?s Branded and Unbranded Marketing 38. Purdue created, used, and widely?disseminated a signi?cant number of written marketing materials for its opioid products in Tennessee. 39. Purdue required its sales representatives to use sales aids, which were reviewed, approved, and supplied by the company, during sales calls with prescribers. These sales aids included both branded materials?those that referred to one of Purdue?s opioid products by namewand unbranded materials?~those that referred to opioids generally or a class of opioids, such as extended release opioids for which Purdue was the branded market leader. 40. Purdue?s unbranded advertising was also designed to in?uence the prescription writing habits of providers, to increase sales of its branded opioid products, to restore ?Purdue?s ?32 and, in some cases, to make claims diminished reputation as the leader in pain management, about the safety or risks of opioids in general that would generate less scrutiny from the FDA than if made about a speci?c branded product. 41. Unbranded sales aids were integral to Purdue?s overall marketing strategy. Purdue created its own speci?c marketing plans for its unbranded campaigns, like Partners Against Pain,33 kept track of advertising metrics for these campaigns,34 evaluated its unbranded campaigns versus those of its com etitors,35 and had its marketing team play a ke role in creatin unbranded content, including Partners Against Pain,36 which ran in various forms from 1993 to 2016.37 32 PWG000209984. 33 PWG000209977. 34 PWG000209980. 35 PWG000209986. 36 PWG000209965. 37 PWG000098224. l3 42. As one Purdue Tennessee sales representative noted about health care providers (HCPS), ?Do HCPs believe in me on info? buy?in, believe?ability, value~ abilitYL] HCP buys me ls?t!?33 M/?/iaiit?mi/V/Mi/?r 16416357 trm?mg?p Mi swarm? 43. Unbranded marketing pieces, including Providing Relief Preventing Abuse,39 Partners Against Pain,40 and In the Face of Pain41 were handed out or promoted by Purdue?s Tennessee sales representatives as part of sales calls for speci?c branded products. Purdue?s unbranded materials also acted as a point-of-entry for sales representatives to make contact with a provider for a sales call for a branded product. 44. Unbranded materials such as Purdue?s Partners Against Pain and Providing Relief Preventing Abuse were supposed to be left behind or referenced in sales calls?~sometimes with the sales representative?s business card.42 Some unbranded materials were also designed to reach the general public. For example, Purdue?s Partners Against Pain campaign featured celebrities such as Naomi Judd and Jennifer Grey to generate more attention for Purdue?s opioid messaging.43 38 PWGOO4285326. 39 PTN000119294 ID34621 (2/27/2009). 40 41 PTN000082213. 42 PTN000031964. 43 PVT0054030. l4 45. Purdue referred to unbranded materials as a ?key tactic? to ?driv[e] brand differentiation while re?energizing [the extended release opioid] market,?44 ?unbranded HCP ?45 promotion to dispel the misperception of [extended release opioids], and part of Purdue?s Sales and Marketing Department?s focus to ?bring Value to customers.?46 46. Purdue even expressly characterized its ?Patient education material,? ?Patient Savings Coupon Program,? and ?Non?branded material ([Continuing Medical Education], abuse diversion, etc)? as part of its overall sales and marketing plan dating back to October 2007, mere months after Purdue entered into the May 200-7 Judgment regarding deceptive marketing for 0xyContin..47 The company described unbranded advocacy pieces it created such as Partners Against Pain and In the Face of Pain as part of Purdue?s primary marketing strategy whose ?overarching objective? was to get health care providers to ?View Purdue as the leading pain management resource/company?48 and to allow ?[p]ain patients and healthcare professionals [to] have a resource to obtain information regarding proper pain management.?49 Purdue referred to unbranded campaigns, such as Partners Against Pain, in marketing trainings for sales representatives regarding speci?c branded products like OxyContin.50 47. Purdue also created and offered materials for providers that were disguised as ?educational,? but were in reality vehicles for more subtle marketing to providers.51 Purdue expressly referenced some of these offerings in sales calls for speci?c branded products52 and even 44 PWG000062804. 45 PWG000062007. 46 PWG000063003. 47 PWG000063 003. 43 PVT0044940. 49 PVT0044940. 5? PVT0044939. 5? PTN000005311. 52 PTN000119294 ID27756 (8/14/2008). 15 instructed compensated physician speakers about speci?c marketing terms that would bene?t the company. In one example, Purdue trained its speaker as follows: Interaction: In order to create a sense of urgency for appropriately assessing and managing low back pain [(which happened to be one of the types of chronic pain Purdue heavily targeted and for which its opioid products were most often prescribed)], the speaker may use this discussion opportunity to further describe the impact of unrelieved pain or have participants provide their perspective on the impact of unrelieved pain on the patient, healthcare provider and healthcare system.53 48. Another example of Purdue using educational pieces to advance its marketing message was the Complexities of Caring for People in Pain brochure, which overstated the dangers of non-steroidal anti-in?ammatory drugs (N SAIDS) that contain acetaminophen and minimized the dangers of single?entity opioids, like OxyContin. 49. Thus, Purdue?s unbranded pieces were designed to increase both a health care provider?s receptiveness to its sales messages for its branded products and to advocate for pain management policies that were most bene?cial for sales of Purdue?s opioid products. 50. Purdue also funded third party pain advocacy groups like the American Pain Society (APS), the American Pain Foundation (APF), and the American Academy of Pain Medicine (AAPM) as well as speci?c advocacy pieces these groups published that were consistent with Purdue?s marketing objectives. Sales Calls 51. One of the primary ways that Purdue marketed its opioid products in Tennessee was through in?person sales calls with health care providers, pharmacies, managed care companies, and others. Purdue required its sales representatives to document each interaction through call 53 PTN00005998 (emphasis added). 16 .i-notesm?ithecontentsland accuracy .of whichPurdue. relied .onandusedasa key partof. its business. Purdue?s Tennessee sales representatives engaged in approximately 300,000 sales calls to Tennessee health care providers between May 7, 2007 and December that Purdue?s sales representatives averaged well over 100 sales calls to Tennessee providers per day to promote its opioid products. Notably, Purdue increased its primary marketing tool in recent years in Tennessee even after receiving civil investigative demands and subpoenas from Tennessee and other Attorneys General, being sued in litigation across the country, and as the devastating effects of the opioid epidemic became better known. Purdue increased the volume of sales calls dramatically in Tennessee over the last 10 yearsmparticularly after the reformulation of OxyContin. The number of sales calls by Purdue sales representatives in Tennessee steadily increased from 11,322 in 2007 to a high of 52,782 in 2016 as shown in the chart below:55 Purdue Sales Calls in Tennessee 50.6% 59.0% smear} reset} 54 PTN000119294. 55 PTN000119294. l7 ?52. Purdue tra'ine?d'i'ts? Tennessee? compo se cal l?note properly, which it told sales representatives was important because the call note was ?[t]he only record we have of your interaction with Healthcare Professionals 53. Purdue trained its sales representatives to ?[p]repare a concise call note that ?57 ?ensure that captures the key points of the dialogue between the Representative and Customer, call reporting clearly re?ects the sales presentation,?58 every word of your call report to make sure that it is clear and accurate,?59 ?[a]lways review a call note before saving the record to ensure that it accurately re?ects the important events that took place during the call,?60 and complete the call note shortly after the sales call to ensure accuracy.61 54. Purdue also required its sales representative managers, known as district managers, for a time to ?review the call notes for every call recorded during the previous week.?62 In addition, Purdue required its district managers to certify that they had carefully reviewed call notes from sales representatives,63 and use a software program to track the number and percentage of sales representative call notes that were reviewed.64 55. Purdue reprimanded only eight Tennessee sales representatives despite many other sales representatives in Tennessee entering numerous call notes referencing noncompliant and- misleading conduct. Sales Representative 1 was reprimanded on June 17, 2011;?55 Sales 56 PWG000035029. 57' PWG000035025. 53 59 60 PWG000035041. 6! PTN000001729. 62 PTN000010631 (emphasis omitted). 63 PTN000063 827. 64 PTN000035907. ?35 PTN000045516. 18 Representative 5 on October 27, 2011;66 Sales Representative 6 on November 4, 2013;67 Sales Representative 12 on December 22, 2008;68 Sales Representative 17 on September 26, 2011;69 Sales Representative 4 on September 30, 2010;770 Sales Representative 18 on September 2, 2011;771 and Sales Representative 16 on December 7, 2012.72 56. The call notes referenced in this Complaint are word-for-word excerpts. Some call notes are referenced in multiple locations in the Complaint if multiple actionable claims were made in one sales call. Because of the sheer volume of call notes Purdue produced from its Tennessee sales representatives, only an illustrative sample of call notes are included in this Complaint. A. DECEPTIVE SAFETY CLAIMS AND MATERIAL OMISSIONS 57. In its marketing in Tennessee, Purdue misrepresented the safety and potential adverse health risks of its opioid products?especially the increased risk of addiction, which it sought to minimize or failed to disclose entirely. Purdue did this in numerous ways, namely by: (1) representing without quali?cation that OxyContin did not have a dose ceiling; (2) advancing the concept of pseudoaddiction; (3) overstating the efficacy of addiction mitigation tools; (4) representing that its opioid products produced fewer peaks and valleys than short acting Opioids leading to less euphoria or more effective pain relief; (5) misrepresenting the abuse-deterrence properties of OxyContin and Hysingla (6) understating the risk of addiction; (7) failing to disclose the increased risk of addiction at higher doses of its opioid products; (8) failing to disclose 6?5 PTN00004552OM21. 67 PTN000045527428. 63 PTN000045 529. 69 7? 7? 72 19 - the, effectiveness. oflongrterm..use. of ,opioids; and sweeping, unquali?ed safety claims about its opioid products. Safety Claims: Unquali?ed No Dose Ceiling Claims 5 8. Purdue represented without quali?cation that OxyContin did not have a dose ceiling when those claims were false, deceptive, and/or unsubstantiated at the time they were made. 59. OxyContin has a dose ceiling that is imposed by adverse reactions to patients taking increased doses of the drug, including overdose, respiratory depression, somnolence, addiction, and other serious adverse effects. 60. While the FDA approved a limited statement on OxyContin?s Full Prescribing Information making clear that OxyContin?s dose ceiling was imposed by adverse reactions, Purdue?s Tennessee sales representatives routinely asserted that OxyContin had no dose ceiling at all. Further, Purdue failed to discipline or correct sales representatives who made such claims. 61. While not an exhaustive list, illustrative examples of these claims are set forth below. 62. Sales Representative 3 documented his sales call with a Morristown?based family doctor on August 15, 2007, as follows: has pt pancreatic ca - med can?t remb whgich plan - not sure if going to cover - woman is in lot of pain and 20 12 not touching her - went to 40 mg 12 just today - gave PI rev assymetric dosing - asked me what top dose is - rev in PI that 120 max dose as is pure opiodL]73 63. On March 31, 2008, Sales Representative 2 called on a Knoxville?area nurse practitioner and recorded his interaction as follows: 73 PTN000119294 ID 1 5 510 5/2007) (emphasis added). 20 64. Reviewed line of new strength she said that she had written for a 60 and was comfortable prescribing OxyContin discussed no ceiling with single enity Sales Representative 2 documented his sales call with a Knoxville?based neurologist on November 5, 2008, as follows: 65. He said that he does not start pt on morphine that he did not believe pt responded as well to morphine as compared to Duragesic or OxyContin. He asked about maximum dosing said he had a pt at 160mg a day of Oxycontin. Discussed bene?t of is there is no dosing limit said he would be uncomfortable going over 240 mg a day. 75 Likewise, Sales Representative 3 made a sales call to a Lenoir City?area family physician on March 3, 2009, and wrote the following about his interaction: 66. establishing a pain of?ce in the area - nurse anes for procedures, he to medical manage - no deisre for huge pain practice just trying to ?ll what need in community - doesnt see many willing to prescribe - asked me what max dose discussed no ceiling limit Likewise, Sales Representative 1 made a sales call to a McKenzie?area family physician on January 21, 2010, and wrote the following about her interaction: 67. ?dr said he likes oxycontin tablet options because it usually takes 2?3 months to get patient adjusted to therapeutic dose. dr said most patients are on lower but has a few on 80mg. said he would never write over 80mg for a patient. discussed that oxycontin is [single entity opioid] and that there is no max dose if he ever needed higher strength for a patient. discussed that oxycontin is not for everyone and importance of writing for appropriate Sales Representative 1 documented his sales call with a Lexington~based family physician on February 3, 2010, as follows: 74 19294 ID23107 (3/31/2008) (emphasis added). 75 PTN000119294 ID31257 (11/5/2008) (emphasis added). 76 PTN000119294 ID34696 (3/3/2009) (emphasis added). 77 19294 ID47892 (1/21/2010) (emphasis added). 21 dr said insurance plans won?t approve oxycontin over the max dose. i asked ?what-he ?meant?by'm?ax 'dose'an?c?l'hesaid ?80mg ?q?l 2h. explained "that there "is no max dose with oxycontin since it is [single entity opioid]. he said he recognizes that but insurance plans still won?t approve. he said they also won't approve q8h.asked if he has many patients dosed q8h. he said no that he only prescribes q12h but he has seen the 68. Likewise, Sales Representative 1 made a sales call to a Bolivar-area nurse practitioner on February 16, 2010, and wrote the following about his interaction: discussed tablet options. he said he has more people at the higher doses because patients don?t usually stay at the low end because everyone builds up tolerance eventually. said if patient is using breakthru meds more than 20 days per month then he will increase the dose. talked about no max dose because [single entity opioid]. asked him if patients build up tolerance to SA opioids too. he said yes. discussed indication which includes mod to severe chronic pain and asked him to write oxycontin for those patients who he trusts and meets indication.79 69. Sales Representative 1 documented her sales call with a Paris-based family physician on April 26, 2010, as follows: dr said he re?lls hydrocodone many times per day. asked him if any of those patients are persistent pain patients who can bene?t from q12h dosing. he said yes. dr said he does not have a cut off time or dose where he converts. dr said he is torn between getting a patient off SA to LA early but then has concerns about what to do with that patient when they have been on oxycontin for years??then where does he go. discussed that there is no max dose for oxycontin and that there is no apap. dr askekd how many copays is it for patient taking 160mg if the patient has to take 2 80mg. told him i thought one but would check with pharmacist and con?rm with him. we also discussed difference between physical dependence and addiction.80 70. Likewise, on May 13, 2013, Sales Representative 6 called on a Knoxville?area family doctor and recorded his interaction as follows: Discussed OxyContin and he asked if there was a maximum dose for OxyContin. I told him there has been no maximum dose established in our 78 PTN000119294 ID48505 (2/3/2010) (emphasis added). 79 PTN000119294 ID49024 16/2010) (emphasis added). 30 PTN000119294 ID52449 (4/26/2010) (emphasis added). 22 clinical trials. He says he has one patient taking ?ve of the 80 mg tablets a day. Acknowledgedthat?s an exception and is a high?dose compared to the other patients he has on OxyContin. We discused the dosing conversion chart from Percocet and I asked him to consider in any patient who's not comfortable with Q6 dosing or having to get up in the middle the night to take their medication.81 71. On July 2, 2015, Sales Representative 1 called on a Jackson~based nurse practitioner and stated the following: [Provider] said high doses of meds. One pt is on 60mg morphine q12 and also takes 40mg percocet for breakthru. She said she told pt after her pain blocks she would be eliminating the breakthru meds. I asked why not consolidate her to an oxycontin q12 dose. Explained tablet options and that 80mg is highest tablet dose but there is no max dose of oxycontin for tolerant pts. Reminded her she can titrate down as pain improves with procedures. [Provider] asked if oxycontin can be dosed tid. I told her q12 is the only approved dose and that if pt needs more than 2 breakthru doses then the oxycontin dose should be increased. [Provider] said she goes with the lower of the 2 total daily doses: 40mg q12 over 30mg tid.82 72. Substantially similar claims were made by Sales Representative 7 to a Johnson? City-based anesthesiologist on November 20, 2009;??3 Sales Representative 2 to a Knoxville-area pharmacy on April 30, 2010;84 Sales Representative 1 to a ackson-area hematologist on June 28, 2010,85 a Jackson-area oncologist on! September 29, 2010,86 and a Dyersburg?based nurse practitioner on October 26, 2010;87 Sales Representative 3 to a Lenoir City-area internist on 31 PTN000119294 113130004 (5/13/2013) (emphasis added). 32 PTN000119294 113201790 (7/2/2015) (emphasis added). 33 PTN000119294 11345510 (11/20/2009) (emphasis added). 3? PTN000119294 ID52728 (4/30/2010). 35 PTN000119294 11355446 (6/28/2010). 35 PTN000119294 11360562 (9/29/2010). 3" PTN000119294 11361732 (10/26/2010). 23 October 25, 2011;88 Sales Representative 6 to a Knoxville?area family doCtor on September 27, 2013.89 73. Elsewhere, Purdue?s Tennessee sales representatives routinely questioned health care providers who had set low dose ceilings for OxyContin.90 For example, in response to a Tennessee health care provider who stated that he did not go past the 20 mg OxyContin dose and did not prescribe OxyContin unless he had to, Sales Representative 4 planned to ?discuss further his reasoning for placing a ceiling on his oxycontin doses.?91 74. Likewise, in response to a nurse practitioner who was hesitant to prescribe OxyContin beyond 20 mg a day, Sales Representative 4 planned to ?[g]et into why she has ceiling limits on the dosing for oxycontin.?92 Safety Claims: Pseudoaddiction 75. Purdue downplayed the problem of addiction by simply re-labeling it as ?pseudoaddiction.? Purdue promoted this concept as part of its marketing for itsopioid products in Tennessee when it was false, deceptive, and/ or unsubstantiated at the time the claims were made. 76. The term pseudoaddiction was coined by Dr. David Haddox, who later became Purdue?s vice president of health policy, and was popularized for opioid treatment by Purdue. It referred to patients who exhibited drug-seeking behaviOr due to undertreated or uncontrolled pain, as Opposed to addiction. Purdue consistently used this concept in sales calls and written educational materials to teach providers in Tennessee to actually prescribe more or higher doses of Opioids for 38 PTN000119294 ID87656 (10/25/2011). 39 PTN000119294 ID142806 (9/27/2013). 90 See, PTN000031807 ID25899 (4/15/2009); PTN000031807 ID27888 (4/21/2009); PTN000031807 ID29235 (2/10/2009) (?Once again asked doc why he has established a ceiling dose for 9? PTN000031807 ID22897 (4/15/2009). 92 PTN000031807 ID27888 (4/21/2009). 24 purportedly ?pseudoaddicted? patients, who would then allegedly cease drug-seeking behavior once their pain was controlled. 77. Some of Purdue?s Key Opinion Leaders (KOLs), doctors hired by Purdue to help spread Purdue?s marketing messages to other providers, concede that pseudoaddiction is not a valid concept. Purdue KOL Dr. Webster later acknowledged: ?[Pseudoaddiction] obviously became too much of an excuse to give patients more medication. It led us down a path that caused harm. It is already something we are debunking as a concept.?93 Likewise, Dr. Russell Portenoy, a pain specialist with close ties to Purdue, later admitted that the concept of pseudoaddiction in chronic pain was not supported by the evidence. He stated, ?The term has taken on a bit of life of its own. That?s a mistake.?94 78. Purdue sent annual ?Dear Healthcare ProVider? letters to Tennessee health care providers who prescribed opioids and enclosed copies of the Providing Relief: Preventing Abuse brochure Purdue drafted, which had four versions.95 79. The ?rst edition of Purdue?s Providing Relief Preventing Abuse, which was ?rst disseminated in 2007-following entry of the 2007 Judgment, states: Pseudoaddiction: describes the misinterpretation by members of the health care team of relief?seeking behaviors in a person whose pain is inadequately treated as though they were drug?seeking behaviors as would be common in the setting of abuse. The lack of appropriate response to the behaviors can result in an escalation of them by the patient, in an attempt to get adequate analgesia. Patients with unrelieved pain may: Become focused on obtaining medications ?Clock watch? 93 John Fauber Ellen Gabler, Networking Fuels Painkiller Boom, MILWAUKEE WISC. J. SENTINEL (Feb. 19, 2012). 94 Id. 95 and 25 Display behaviors (eg, doctor shopping, deception) to obtain relief Pseudoaddiction can be distinguished from addiction in that the behaviors resolve when pain is effectively treated.96 80. Purdue asserts in the second edition of Providing Relief Preventing Abuse: Some patients may exhibit behaviors aimed at obtaining pain medication because their pain treatment is inadequate. The term pseudoaddiction has emerged in the literature to describe the inaccurate interpretation of these behaviors in patients who have pain that has not been effectively treated. Pseudoaddiction can be distinguished from addiction by the fact that, when adequate analgesia is achieved, the patient who is seeking pain relief demonstrates improved function, uses the medications as prescribed, and does not use drugs in a manner that persistently causes sedation or euphoria. Such behaviors may occur occasionally even with successful opioid therapy for pain; a pattern of persistent occurrences should prompt concern and further assessment.97 81. The third edition of Purdue?s Providing Relief Preventing Abuse, while no longer using the term pseudoaddiction by name, states: [s]ome patients may exhibit behaviors aimed at obtaining pain medication because their pain treatment is inadequate. Such behaviors may occur occasionally even with successful Opioid therapy for pain; a pattern of persistent occurrences should prompt concern and further assessment.98 82. Purdue widely disseminated Providing Relief Preventing Abuse in Tennessee. Purdue sent the brochure in a letter form to the following number of health care providers in Tennessee in each of the years indicated: 1,984 in 2007, 1,424 in 2008, 1,130 in 2009, 952 in 2010, 808 in 2011, 799 in 2012, 1,055 in 2013, 956 in 2014, 715 in 2015, and 458 in 2016.99 Purdue distributed at least 10,281 copies of Providing Relief Preventing Abuse by mail to providers in Tennessee. 96 PTN000003 807 (emphasis in original). 97 PTN00003 542 (emphasis in original). 98 PTN000003632. 99 see also 26 83. Purdue?s sales representatives also distributed and referred to the document in sales calls for its branded products.100 Purdue provided over 7,000 copies of Providing Relief Preventing Abuse to Tennessee sales representatives and district managers to distribute in person.101 84. In fact, the de?nitions Purdue included in Providing Relief, Preventing Abuse were so ingrained in Purdue marketing that Sales Representative 5, who had been retired for over a year when interviewed, immediately authenticated the Providing Relief, Preventing Abuse brochure, stated that he regularly used the de?nitions in the brochure in sales calls, and ?ipped without prompting to page 13 of the brochure to identify the de?nitions of pseudoaddiction and addiction during his investigative sworn testimony. Sales Representative 5 testi?ed that the brochure had been extremely helpful in educating Tennessee providers, many of whom were inexperienced in pain management. 85. Purdue advanced the notion of pseudoaddiction in numerous other ways. In 2013, Purdue, through its partnersagainstpaincom website, linked to materials including a consensus document created by the American Academy of Pain Medicine (AAPM), the American Pain Society (APS), and the American Society of Addiction Medicine (ASAM), that de?ned pseudoaddiction as: term which has been used to describe patient behaviors that may occur when pain is undertreated. Patients with unrelieved pain may become focused on obtaining medications, may ?clock watch,? and may otherwise seem inappropriately ?drug seeking.? Even such behaviors as illicit drug use and deception can occur in the patient?s efforts to obtain relief. Pseudoaddiction can be distinguished from true addiction in that the behaviors resolve when pain is effectively treated.102 100 See, PTN00031807 ID12887 (5/17/2007); PTN00031807 ID15483 (11/5/2007); PTN000031807 ID22842 (10/21/2008); PTN000031807 ID13035 (10/16/2007). 10? PWG004285193MA. ?02 PWG000085183. 27 86. Call notes from Purdue?s Tennessee sales representatives likewise show that the concept of pseudoaddiction and the distribution of the Providing Relief Preventing Abuse brochure were frequently used in sales calls with providers regarding Purdue?s opioid products. 87. While not an exhaustive list, illustrative examples of these claims are set forth below. 88. Sales Representative 5 made a sales call to a Nashville-area internist on May 17, 2007, and wrote the following about his interaction: discussed the di?erences between pseudoaddiction and addicti0n~~doc agreed that abuse of medication in susceptible patients can lead to addiction. will consider oxycontin for persistent pain patients.103 89. On October 16, 2007, Sales Representative 17 called on a Clarksville?area orthopedic surgeon and recorded his interaction as follows: Conversions and titration with OxyContin 20 mg tablet, OxyContin Savings Cards #30096, doctor said the new TN inng program works great, and tells patients upfront he will be monitoring their Rx?s. His long term OxyContin patients come in and they are no problems. Talked about pseudo- addiction.104 0 90. Likewise, Sales Representative 3 documented his sales call with a Crossville?based hematologist on November 5, 2007, as follows: is signed up for program talked with [providers] discussed pseudoaddiction and how may reveal some that are simply undertreatetd [.]105 91. On October 21, 2008, Sales Representative 5 called on a Nashville-area family doctor and recorded his interaction as follows: 103 PTN000119294 ID12683 (5/17/2007) (emphasis added). 104 PTN000119294 11917410 (10/16/2007) (emphasis added). 105 PTN000119294 ID18181 (11/5/2007) (emphasis added). 28 doc said that going over pain management de?nitions helps to clarify what "issues are,really, gOing on; ie, physical dependence, addiction pseudoaddiction. appreciated information.106 3 92. Sales Representative 14 called on a Brighton-area family physician on December 9, 2008, and recorded his interaction as follows: Is it pain? in-service with Doc. [Provider] listened to the presentation and commented that it is very di?icult at times to distinguish between addicted and pseudoaddicted patients. He asked if there is any magic strategy for identifying drug seekers. I explained that other physicians have found pain treatment agreements, regular assessment, and regular urine drug screening to be helpful in ensuring patient compliance. He agreed and added that the TN. prescription drug monitoring tool has been helpful as well. I asked doc about his current oxyconitn treated patients. He said that everyone he is currently treating is stable on the current dose. He added that he is making more of an effort to use the coupon cards. I reminded him about the 10mg q12H dose being a reasonable starting dose for appropriate opioid naiive patients. He said he will keep this dose in mind.107 Safety Claims: Overstating the Ef?cacy of Tools to Mitigate Addiction 93. In order to make health care providers more willing to prescribe its addictive opioid products, Purdue overstated the ef?cacy of abuse and diversion mitigation tools like patient contracts, urine drug testing, pill counts, and similar strategies. 108 These statements were false, deceptive, and/or unsubstantiated at the time they were made. 94. These claims were especially harmful because Purdue made them to nurse practitioners, physician assistants, general practitioners, internists, and family doctors who, generally speaking, lack the time and expertise to closely manage higher-risk patients on opioids. ?06 PTN0001 19294 ID30606 (10/21/2008) (emphasis added). ?07 PTN0001 19294 ID32318 (12/9/2008) (emphasis added). 103 ST000435. 29 95. Moreover, these misrepresentations by Purdue were critical to assure health care providers, who were beginning to see or hear about the rising tide of opioid addiction, that they could safely prescribe opioids in their own practices and that addiction was avoidablewthe result of the failure of other providers to rigorously manage and weed out problem patients. 96. The 2016 Center for Disease Control (CDC) Guideline for Prescribing Opioids for Chronic Pain109 (2016 CDC Guideline) con?rms the lack of adequate substantiation to support Purdue?s claims regarding the utility of screening tools and patient management strategies in managing addiction risk. The 2016 CDC Guideline notes that there are no studies assessing the effectiveness of risk mitigation strategies such as screening tools, patient agreements, urine drug testing, or pill counts?~?for improving outcomes related to overdose, addiction, abuse, or misuse.?110 As a result, the 2016 CDC Guideline recognizes that available risk screening tools ?show insuf?cient accuracy for classi?cation of patients at low or high risk for [opioid] abuse or misuse? and instructs that doctors ?should not overestimate the ability of these tools to rule out risks from long-term opioid therapy.?111 97. As recently as 2016, Purdue created sales training content for its sales representatives, including a piece called ?General Objection Handler,? that was supposed to help representatives respond to common objections from health care providers, ease these providers? concerns about prescribing potent opioids, and make them more likely to prescribe Purdue?s opioid products. 1 12 ?09 McDowell, Deborah MD, CDC Guideline for Prescribing Opioidsfor Chronic Pain United States, 2016, CENTERS FOR DISEASE CONTROL AND PREVENTION, 65(1), available at (hereinafter 2016 CDC Guideline). ?0 2016 CDC Guideline, at 11. ?1 2016 CDC Guideline, at 28. ?2 . 30 98. Purdue also created content that overstated the efficacy of opioid abuse and diversion tools that were used as part of sales calls for its opioids products and made publicly available. One example of this content was Purdue?s unbranded Partners Against Pain campaign. 1 Purdue highlighted the use of mitigation tools including pain diaries, 13 a pain management log, a daily pain diary, and an ?opioid risk tool? in this campaign through a Partners Against Pain Pain 11 33115 Management Kit, a dedicated website at partnersagainstpaincom, 4 a magazine titled ?Pain, and other materials. 99. The opioid risk tool was a five question, one?minute screening tool created by Purdue KOL Dr. Webster that relies on patient self?reports to purportedly allow health care providers to manage the risk that their patients will become addicted to or abuse opioids. Because of the very nature of addiction, self?reporting facts indicative of addiction are not effective. 100. In national trainings, Purdue instructed sales representatives to use a ?selling message? for the Partners Against Pain Pain Management Kit, which Purdue then distributed to providers. Purdue?s overarching purpose for the Pain Management Kit was educate HCPs [health care providers] and gain clinical practice implementation of the tools contained in the Kit.?116 The Pain Management Kit was so central to Purdue?s marketing that it was part of materials automatically shipped to sales representatives, at least as of 2009.117 In sales calls for Purdue?s opioid products, Purdue?s Tennessee sales representatives handed out the Pain Management Kit and other materials containing mitigation tools and used it as an integral part of Purdue?s sales messaging. ?3 PWG000320723. ?4 See PWG000014427. ?5 54 54. ?6 ?7 942. 31 101. Purdue also claimed in multiple presentations given to providers that mitigation tools, including controlled substance agreements, pill counts, and urine drug testing, could be used effectively by providers to mitigate the risk of abuse and diversion.118 102. While not an exhaustive list, illustrative examples of call notes deceptively referencing mitigation tools are set forth below. 103. On May 15, 2007, Sales Representative 4 called on a McKenzie?area family physician and recorded his interaction as follows: Reviewed pain toolkit with him and comparison to his current pain contract. Said ours had a lot of surefire wording to help protect him and he would implement these into his own contract.119 104. Sales Representative 4 documented his sales call with a Germantown-based family physician on May 23, 2007, as follOws: Continued discussion of having a ?sound? pain contract and reviewed conversion table with him. Had questions about patients on methadone and why? Explained that oxycontin provides better compliance and with 3rd party payers it is 105. Likewise, Sales Representative 4 made a sales call to a McKenzie?area family doctor on May 31, 2007, and wrote the following about his interaction: Reviewed the Purdue patient pain toolkit and revieWed some changes he could make in his contract. Said he needs to to try having patients sticking with the same pharmacist to help eliminate patients going everywhere to re?ll and help him keep better reigns on his patients that are on oxycontin and other long acting ?8 PTN000006794. ?9 PTN000119294 ID12583 (5/15/2007) (emphasis added). *20 PTN000119294 ID12856 (5/23/2007) (emphasis added). PTN000119297 ID13071 (5/31/2007) (emphasis added). 32 106. Following a June 7, 2007 sales call with a Nashville?based physician assistant, Sales Representative 5 made a note to ?focus on urine drug screen information? the next time he called on this provider.122 107. Similarly, Sales Representative 3 made a sales call to a Lafollette-area internist on July 30, 2007, and wrote the following about his interaction: stated tries not to write oxycontin hears that brand is worth more on the street asked if pro?t margin of someone that would misuse really mattered - replied no - discussed UDT, pill counts ways that doc kit can in addressing some issues gave doc kit cd 108. On July 18, 2007, Sales Representative 4 called on a Memphis-area family physician and recorded his interaction as follows: Pain documentation kit and using the pain contracts e?ectively. Said that her and her husband document but they don?t have an of?cial pain contract that they 109. Likewise, Sales Representative 4 made a sales call to a Memphis?area internist on September 12, 2007, and wrote the following about his interaction: Followed up with him on documenting pain. Reviewed the documentation kit and sample of contract. Said he documents but never felt the need to have patients sign a contract. Said he has good control of his patients and never felt the need to do this. Said it shows initial mistrust. Discussed preventing abuse and the insurance of having the contract on 110. Sales Representative 4 documented his sales call with a Savannah?based internist on September 13, 2007, as follows: Said most of her patients on oxycontin come from the hospital ER. Said that physicians in the are really have to focus on documentation because abuse ?2 PTN000031807 ID13334 (6/7/2007). 123 l9294 11314934 (7/30/2007) (emphasis added). 124 PTN000119294 ID14530 (7/18/2007) (emphasis added). ?25 PTN000119294 ID16378 (9/12/2007) (emphasis added). 33 "0f narcOticsin the area"is"'huge. Reviewed documentation material from Purdue and pain contract to put in place in her practice.126 1 11. Likewise, Sales Representative 14 documented his interaction with a Brighton?area family doctor on December 9, 2008 as follows: Is it pain? in?service with Doc. [Doctor] listened to the presentation and commented that it is very dif?cult at times to distinguish between addicted and pseudoaddicted patients. He asked if there is any magic strategy for identifying drug seekers. I explained that other physicians have found pain treatment agreements, regular assesSment, and regular urine drug screening to be helpful in ensuring patient compliance. He agreed and added that the TN. prescription drug monitoring tool has been helpful as well. I asked doc about his current oxyconitn treated patients. He said that everyone he is currently treating is stable on the current dose. He added that he is making more of an effort to use the coupon cards. I reminded him about the 10mg q12H dose being a reasonable starting dose for appropriate opioid naiive patients. He said he will keep this dose in mind.127 112. On March 22, 2013, Sales Representative 3 documented his encounter with a Knoxville-based internist as follows: [d]elivered communication insight message - delivered PAP web key and showed tools that were avavilable such as pt diaries, pain agreements, consent forms and how they were customizable to their individual practice [Doctor] looked up and asked me to repeat what it was (rare that he even speaks in setting) - I explained brie?y again and all seemed interested 128 113. Substantially similar claims were made by: Sales Representative 4 to a Germantown-?area internist on August 27, 2007;129 Sales Representative 12 to a Manchester-area family doctor on October 24, 2007;130 Sales Representative 5 to a Madison-based internist on 126 PTN000119294 ID16399 (9/13/2007) (emphasis added). 127 PTN000119294 ID32318 (12/9/2008) (emphasis added). 128 PTN000119294 ID125222 (3/22/2013) (emphasis added). 129 PTN000119294 ID15869 (8/27/2007) (emphasis added). 130 PTN000119294 11317711 (10/24/2007) (emphasis added). 34 November 27, 2007, 131 a Nashville?based physician assistant on November 27, 2007,132 and to a Springfield-based internist on December 7, 2007;133 Sales Representative 14 to a Cordova?area internist on May 8, 2008;134 Sales Representative 13 to a Livingston?area family doctor on October 28, 2008135 and a Spring?eld~area family doctor on October 30, 2008;136 Sales Representative 1 to a Dyersburg-area internist on May 4, 2010137 and a Jackson?area nurse practitioner on May 7, 2010.138 Safety Claims: Misrepresentations as to ?Peaks and Valleys? 114. Purdue sought to minimize the true addictive potential of its opioid products by representing its products provide a slow-onset, stable dose without the ?peaks and valleys?? encouraging health care providers to infer that these opioids are safer because they do not produce the euphoric high that fosters addiction. Further, Purdue used the term ?peaks and valleys? or similar words to overstate a limited ?nding about OxyContin?s steady?state in blood levels into a claim about the purported continuous pain relief and reduced euphoric effect of its opioid products or the converse in competing products. These statements were false, deceptive, and/or unsubstantiated at the time they were made. 115. In its 2012 and 2013 Promotional Guidelines, which were supposed to be followed by Purdue?s sales representatives, Purdue stated that these claims were prohibited.139 In spite of 331 PTN000119294 11318858 (11/27/2007). ?32 PTN000031807 11312398 (11/27/2007). *33 PTN000119294 11319269 (12/7/2007). 134 PTN000119294 11324432 (5/8/2008). 135 PTN000119294 11330876 (10/28/2008). 136 19294 11331016 (10/30/2008). *37 PTN000119294 11352847 (5/4/2010). 138 PW000119294 11353146 (5/7/2010). 139 41 0f7l); (36 Of 64). 35 this, Purdue?salesrepresentatives in slow?onset, stable dose without euphoric ?peaks and valleys.? 1 16. Sales Representative 14 documented his sales call with a Bartlett?based internist on June 5, 2008, as follows: Asked doc if he has any patients taking percocet 5mg doses either q4 or q6H atc month after month. He said yes. I talked to him about the bene?ts of Oxycontin, if appropriate, over Percocet for these patients. He agreed, but said that the biggest challenge is that people get used to the Euphoria they feel with [short acting] meds and as a result feel that LA agents don?t work as well b/c they don?t cause euphoria I acknowledged his concern, but pointed out that the spike in blood plasma levels that occurs with SA agents is many times what causes the euphoria, but that these agents then subsequently dip back out of the therapeutic window and the cycle must be repeated every 4-6H. I explained that a LA agent like Oxycontin is better b/c the patient gets pain relief with a more steady blood plasma level and -a more convenient dose. He agreed and said that he will continue trying to convince his SA patients to give Oxycontin a shot. Reminder for coupon cards.140 1 17. On August 14, 2008, Sales Representative 7 called on a group of ?ve Johnson City- area health care providers and recorded his interaction as follows: [H]is ?rst question was about a 30% dose dump and the euphoric feeling the patient feels when takeing the medicine. I wnet off of the PI showing steady state and explaining that if the patient is taking the product correctly, they should not have this feeling all the time. Which led into daily titration and the fact that there are 3 new that they were not aware of that would provide an apprOpriate daily titration which the competitors could not provide. Went over Med. Edu. Resource Catalog. All prescribers were interested in these.141 118. On November 24, 2008, Sales Representative 5 called on a Nashville-area internist and recorded his interaction as follows: discussed barry cole?s ten tips to prescribing opioids. residents felt all points were pertinent to what they are doing. they 'said short acting meds are used 14? PTN000119294 ID25283 (6/5/2008) (emphasis added). 141 PTN000119294 ID27756 (8/14/2008) (emphasis added). 36 ?rst, for patients in clinic. switch to long acting, like oxycontin, when in pain clinic. I mentioned peaks and troughs of short acting meds could pose a challenge for patients with persistent pain. appreciated package insert.I42 119. Sales Representative 18 documented his sales call with a Knoxville-based internist on April 12, 2011, as follows: reminded him of our previous conversations of the peaks and valleys he stated that happen with short actings and for the patients with chronic pain. He stated that he has not used Butrans yet. He stated that he will he just gets usy and tends to forget. I asked if I need to come in more often and he chuckled.143 120. On April 21, 2011, Sales Representative 18 called on a Knoxville?area internist and recorded his interaction as follows: Reminded him ofthe peaks and valleys he discussed with the [short actings]. He stated that he remembered our conversation and stated that he will use Butrans. I asked when. He stated he will and told me to be patient. I stated I bet he will see a patients that will ?t Butrans and he stated probabley I asked for that patient.144 121. Sales Representative 15 documented her sales call with a Memphis?based internist on February 21, 2013, as follows: Discussed ?discontinuation insight?. Doctor said he did see a high rate but he blames it on patients seeking the euphoric feeling. I asked him if his goal in treating pain was euphoria or pain relie? Doctor said he needs to remind patients of this goal. Discussed lack of ef?cacy and ?determining appropriate dose? marketing piece. Reminded doc that butrans is a CHI which needs to be monitored for abuse. Discussed dosing, 72~hour steady state, supplemental analgesia and titration. Discussed patient education which he wanted me to put in the waiting room.145 ?2 PTN000119294 ID31896 (11/24/2008) (emphasis added). ?3 PTN000119294 ID72356 (4/12/2011) (emphasis added). ?44 PTN000119294 ID72985 (4/21/2011) (emphasis added). ?45 19294 ID122481 (2/21/2013) (emphasis added). 37 122. I In another Purdue unbranded marketing piece titled In the Face of Pain, which was referenced during sales calls with Tennessee providers, Purdue told pain sufferers the following: Knowledge is power. Many people living with pain and even some health care providers believe that opioid medications are addictive. The truth is that when properly prescribed by a health care professional and taken as directed, these medications give relief not a ?high. ?146 Safety Claims: Abuse?Deterrence Misrepresentations 123. Opioid abuse takes several forms, the most common of which is oral abuse, which includes not only using drugs without a prescription, but also swallowing higher or more frequent doses than prescribed. Other forms of opioid abuse include crushing or liquefying the drug in order to snort or inject it. 124. Purdue falsely represented that OxyContin could not be abused in certain ways. 125. As one example, on March 25, 2008, Sales Representative 2 called on a Knoxville- area family doctor and recorded his interaction as follows: Doctor asked about OxyContin and if it could be crushed and put in gtube told docotr it could not but that he could check with pharmacist to see if another product could be used He is using oxycodone liquid pt cannot 126. In 2010, Purdue received approval from the FDA for a new formulation of OxyContin that had certain abuse-deterrent properties (ADPs) that resisted abuse from snorting or injecting. In its medical review of Purdue?s application, however, the FDA found that ?the tamper? resistant properties will have no effect on abuse by the oral route (the most common mode of ?46 PVTOO37244 (emphasis added). ?47 PTN000119294 ID22883 (3/25/2008) (emphasis added). 38 abuse)? and that ?[w]hile the reformulation is harder to crush or chew, possibly mitigating some accidental misuse, oxycodone is still relatively easily extracted.?148 127. After OxyContin and Hysingla ER were reformulated to include limited abuse- deterrent properties, Purdue used these features as a primary selling point, but failed to disclose that the abuse?deterrent properties of its opioids do not impact or prevent the most common form of abuse?oral ingestion. 128. In 2013, Purdue persuaded the FDA to permit a reference to some of the abuse? deterrent properties in the OxyContin label. When Hysingla ER launched in 2015, Purdue included similar references in the product label. 129. In sales calls with Tennessee health care providers, Purdue misrepresented the extent of the abuse-deterrent properties of its opioids that went beyond a limited acknowledgment on the 2013 revised OxyContin Full Prescribing Information approved by the FDA.149 130. Purdue even documented that Tennessee sales representatives in sales calls for both Hysingla ER and OxyContin did not ?convey that ADPs do not prevent or reduce the risk of addiction of OxyContin and that abuse is still possible by intravenous, intranasal, and oral routes.?150 131. Purdue failed to disclose that the ADPs of OxyContin and Hysingla ER did not impact oral abuse despite knowledge that its consultant conducted interviews in which some prescribers voiced concerns that the ?technology does not address oral abuse.?151 ?3 New Drug Application 22?272, OxyContin, Division Director Summary Review for Regulatory Action, at 7 (Dec. 30, 2009), available at 149 PWG003788164. ?50 See, ?51 (document is referenced both as a ?nal report and working draft). 39 132. In 2011, Purdue published a version of Providing Reliejf Preventing Abuse that it distributed in sales calls for its opioid products and to at least 808 individuals by mail.152 Purdue?s pamphlet deceptively depicted the signs of addiction by emphasizing the signs of injecting or snorting opioids?skin popping, track marks, and perforated nasal septamwithout clearly disclosing that the most common way to abuse opioids is through oral use.153 Safety Claims: Understating the Risk of Addiction 133. The vast majority of the ?source of business? for OxyContin came from patients who continued to use the product. For example, from August 2009 to March 2011, over 80% of Purdue?s business for OxyContin came from continued users.154 During a six-month period later in 201 1, 86.3% of Purdue?s business from OxyContin sales came from continuing prescriptions.155 During an eight-month period in 2015, 87% of Purdue?s business for OxyContin sales came from patients who continued to use the product.156 134. In order to sell more of its opioid products and keep continued users on its products, Purdue sought to change the narrative about the addictive potential of its opioids in ways that would generate less scrutiny from the FDA. On a website that Purdue controlled, Purdue promoted 1 material from a third-party pain advocacy group to which Purdue signi?cantly contributed ?nancially through projects it speci?cally funded that grossly misrepresented the risks of addiction from opioids. These statements were false, deceptive, and/or unsubstantiated at the time they were made. 152 see also PWG004285193WA. ?53 PTN000003544. ?54 PWG000324280. 155 PWG00004088. ?56 PWG000435505. 40 135. Exit Wounds was a publication, which Purdue speci?cally funded,157 that was targeted to. veterans seeking pain relief. The publication could be directly accessed through a Purdue website, and was attributed to the American Pain Foundation (APP), which Purdue also substantially funded.159 APP submitted grant proposals to Purdue for media responses in priority markets, including Nashville and Memphis, ?with a high incidence of negative news coverage, as identified by Purdue? that utilized Exit Wounds as well as other APP materials. 160 136. On Purdue held Exit Wounds out as an authoritative resource for veterans seeking pain relief. Purdue promoted its In the Face of Pain campaign and website on written material that contained express references to Purdue?s opioid products including OxyContin and Butrans.161 Purdue also promoted In the Face of Pain and linked to the website, on Purdue?s more comprehensive corporate website, WWtharmacom,162 and its mobile?friendly version,163 both of which also contained marketing for Purdue?s opioid products, such as OxyContin, by brand name. 137. Exit Wounds contained numerous misrepresentations about the addictive potential of opioid products. As an example, Exit Wounds states: The pain-relieving properties of opioids are unsurpassed; they are today considered the ?gold standard? of pain medications, and so are often the main medications used in the treatment of chronic pain. Yet, despite their great bene?ts, opioids are often underused. For a number of reasons, healthcare providers may be afraid to prescribe them, and patients may be ?57 PWG000048316. 153 PWG000190216, ?305. 159 PWG00096255. ?60 PTN000026567 (emphasis added). 16? 162 PWG000126647. 163 PWG000131841. 41 afraid to take them. At the core of this wariness is the fear of addiction, so I want to tackle this issue head-on. If your body adjusts to a drug or medication, it may become less effective over time. This is called tolerance. This is simply a physiological process that doesn?t occur for all people or with all medications. Many people with persistent pain, for example, don develop tolerance and stay on the same dose of opioids for a long time. Opioid medications can, however, be abused or used as recreational drugs, and some people who use these drugs this way will become addicted. Long experience with opioids shows that people who are not predisposed to addiction are unlikely to become addicted to opioid pain medications. When used correctly, opioid pain medications increase a person?s level of functioning; conversely, when a drug is used by somebody who is addicted, his or her function decreases.164 Failing to Disclose Increased Risk of Addiction at Higher Doses 138. As recognized by the CDC, taking opioids for longer periods of time or in higher doses increases the risk of addiction, among other serious risks and side effects.165 139. Aside from express representations, Purdue also downplayed the increased risk of addiction from higher doses of its opioid products through material omissions, which the company has recognized are actionable in sales trainings.166 140. In its marketing, including branded materials, unbranded materials, and sales calls with providers and others in Tennessee, Purdue failed to disclose the material fact that there is an increased risk of addiction at higher doses of its opioid products. ?64 PTN000023114 (emphasis in original). ?65 Opioid Prescribing: Where You Live Matters, CENTERS FOR DISEASE CONTROL AND PREVENTION, available at ?66 PW6000190154 (stating ?Promotion includes written materials, what is said and even what is NOT said. [District Managers] Pause for a moment to consider the last statement with your team. When could it be that there is an omission of material fact? Not including the risks statements, Not providing fair balance, Not correcting a misstatement or misimpression of a customer (and remember. ..describe the discussion in your call 42 141. The ability to escalate doses was critical to Purdue?s efforts to market opioids for long-term use to treat chronic pain. Unless health care providers felt comfortable prescribing increasingly higher doses of opioids to counter their patients? building of tolerance to the drugs? effects, they may not have chosen to initiate opioid therapy at all. Moreover, without disclosing the increased risk of addiction, Purdue regularly encouraged providers in Tennessee to increase the dose of its opioids, or ?titrate up,? products like OxyContin rather than prescribe them more frequently. 142. High dose opioids have continuously been a signi?cant part of Purdue?s business in Tennessee?particularly for OxyContin. While Purdue instructed sales representatives to emphasize low-dose starts, Purdue sold disproportionately high amounts of its 40 mg and above tablets of OxyContin. 143. To put this in context, one OxyContin 40 mg tablet taken every 12 hours equates to 120 MMEs per day, a standardized unit of opioid potency.167 120 MMEs is 30 MMEs over the 90 MME and above daily threshold that the CDC states providers should avoid or carefully justify.168 144. Of the 104,340,382 total tablets of OxyContin prescribed in Tennessee from 2008 to 2017, 56,058,315 or 53. 7% ofthese units were 40 mg or higher.169 145. Of the approximately 1,471,006 prescriptions written for Purdue?s OxyContin in Tennessee from 2008 to 2017, 708,315 or 48.15% of these prescriptions were for doses of OxyContin 40 mg or higher.?0 ?67 ?63 169 PWG003984543. 17o PWG003984537. 43 146. Purdue made the escalating dosing a centerpiece of its marketing for OxyContin, stating, ?OxyContin is the only ER oxycodone available in 7 tablet Purdue stated in internal marketing presentations that OxyContin?s availability in seven tablet was a key selling message.172 147. Numerous Purdue written marketing materials that were widely disseminated in Tennessee depict the seven OxyContin tablet a line or a series of upward steps?and instruct health care providers that they can increase the dose by titrating upwards without disclosing the increased risk of addiction at higher doses.173 148. As an example, Purdue?s Conversion and Titration Guide for OxyContin, which was widely disseminated in Tennessee,174 contains references to titrating with OxyContin?s seven dosage a statement to ?[t]itrate to the appropriate q12h dose increase 25% to 50% of the total daily dose as clinical needs dictates,? the statement patients who require titration 171 PTN000072961. ?2 PWG000435171. ?3 PWG000290890. ?4 PWG000077224. 44 above 80 mg q12h, follow titration guidelines, which recommend increasing the total daily dose between 25% and and graphics featuring stain?step depiction of titrating only upwards to higher doses of OxyContin?all without disclosing the increased risk of addiction from higher doses. 149. Another version of Purdue?s Conversion and Titration Guide for OxyContin also claims the ?7 tablet [of OxyContin] offer dosing flexibility,? features a stair?step titration graphic going only upwards, and contains a reference to titration above 80 mg every 12 hours?~w without disclosing the increased risk of addiction from higher doses of OxyContin (excerpt below).175 7 offer dosing ?exibility a? 282;?. 'mjaq?wq Wm! 01$??me 5 EM dmmduwamm minimum I ?*Mm?lwg 150. Purdue?s Conversion and Titration Guide was such a central part of the company?s marketing for OxyContin that each sales representative was automatically shipped 50 copies to distribute to providers in Tennessee.?6 175 5. ?76 PTN000031942, ?57 (referring to Lit Code: (version 45 Purdue ?also ?usedvisual" aids, "li?ke"?0PO479, in ?Sales calls With providers in Tennessee that depicted a modi?ed titration stair?step for Purdue?s ?rst 5 doses that also did not disclose the increased risk of addiction at higher doses.177 152. Purdue had similar titrating up messaging in other marketing materials. For example, Purdue again referenced the seven dosing of OxyContin and featured a similar stair-step titration graphic in a publication titled ?Chronic Pain Has Many Faces Maggie?s Story,? which likewise did not disclose the increased risk of addiction at high doses of OxyContin.178 153. Purdue?s titrationrprinciples were based on cancer pain management guidelines that Purdue conceded were no longer current as of 2011. In a 2011 training document for. sales representatives, Purdue stated: How were the Titration Principles initially established? Purdue developed them based on the AHRQ (Agency for Health Research Quality) Cancer Pain Management Guidelines. However, AHRQ guidelines are no longer considered current.179 '154. Purdue?s Tennessee sales representatives frequently referred to high doses of OxyContin or other opioids without disclosing the increased risk of addiction at higher doses. 155. Purdue taught Tennessee sales representatives at national meetings to ?close? with questions to providers about the bene?t of OxyContin at higher doses. For instance, at one training workshop Purdue?s sales representatives were taught: ?Doctor, you see the bene?t of OxyContin for the patient who requires 40 mg a day and higher??180 156.? Similarly, Purdue instructed its sales representatives: ?7 109649. ?8 ?79 PWG000042615. 18? 109650. 46 The second objective is to continue getting appropriate patient starts on mg tablets, as well as conversion tablets from other opioids, when appropriate.181 157. While not an exhaustive list, illustrative examples of call notes in which Purdue?s Tennessee sales representatives recorded making these claims to providers are set f01th below. 158. Sales Representative 4 documented his sales calls with a Memphis~based family doctor on May 23, 2007, in which he discussed the safety of OxyContin at higher doses without disclosing the increased risk of addiction. The call note reads as follows: Said that he will only go to 40mg of oxycontin unless absolutely necessary. Reviewed APS guidelines and safety at the higher doses of 159. Sales Representative 4 documented his sales call with a Germantown?based internist on August 13, 2007, in which he discussed the titration of OxyContin from a low dose to 40 mg or 80 mg every 12 hours and did not disclose the increase risk of addiction at higher doses. The call note states as follows: Reviewed of titration guide and principles. Asked about when to go from 10mgq12h to a higher dose and if it was ok to jump from low dose to 40 or 80mgq12h. Reviewed the 3/2 principle and make sure she is evaluating the 160. On December 5, 2007, Sales Representative 5 called on a Gallatin-area family physician in which the sales representative discussed titrating patients to higher doses of OxyContin without disclosing that there is an increased risk of addiction at higher doses. of opioids. The call note reads as follows: ?31 PTN000031939 (emphasis added). ?32 PTN000119294 ID12888 (5/23/2007) (emphasis added). ?33 PTN000119294 ID15378 13/2007) (emphasis added). 47 doc sdid?h?has no problem?in titra?t'ing ?tohigher bfoxyCOnt'in'if it is warrented in his chronic pain patients.184 161. Likewise, Sales Representative 5 made a sales call to a Nashville?area family physician on December 10, 2007, in which he discussed higher doses of OxyContin without disclosing the increased risk of addiction at higher opioid doses. The call note reads as follows: doc said he reserves oxycontin for those that need 40/80mg probably would not write lower for osteoarthritis.185 162. Likewise, Sales Representative 4 made a sales call to a Memphis?area internist on March 12, 2008, and had the following discussion with the provider without disclosing the increased risk of addiction at higher doses. The call note reads as follows: [S]aid he doesn?t see any real benefit in the new Said that oxycontin is not a tru 12 hr drug and he will typically add two breakthrough meds if necessary on a patient that is taking oxycontin tid and still having some pain through the night. Said that a lot of formularies don?t accept oxycontin in his practice. Told him a lot has to do with how he is writing it. Said he wrote one patient 80mgbid plus two short acting and Windsor healthcare told him it was too much. Asked why he didn ?t just write for 1601715; and he said that was a bad thought and I should really stop telling physicians that oxycontin is a q12h 163. Sales Representative 14 documented his sales call with a Cordova?based internist on July 24, 2008, in which the sales representative discussed a patient for a 60 mg OxyContin dose without disclosing the increased risk of addiction at higher doses. The call note reads as follows: Doc badly behind, so time was limited. Reminded him about the added ?exibility that the extended line o?ers. He echoed what he said on last call when he mentioned a patient of his that may be a candidate for the 60mg dose. Also, reminded him about the coupon cards.187 184 PTN000119294 11319180 (12/5/2007) (emphasis added). 185 19294 ID 19322 (12/10/2007) (emphasis added). ?36 PTN000119294 ID22397 (3/12/2008) (emphasis added). ?37 PTN000119294 ID26972 (7/24/2008) (emphasis added). 48 164. On August 14, 2008, Sales Representative 7 called on a group of ?ve Johnson City? area health care providers and referenced three new of OxyContin and daily titration without disclosing the increased risk of addiction at higher doses. The call note reads as follows: Lunch? I am going to use the same note for this of?ce as all providers came in at the same time and st at the table. This was a very good lunch and I feel we are going to see some results. His ?rst question was about a 30% dose dump and the euphoric feeling the patient feels when takeing the medicine. I wnet off of the Pl showing steady state and explaining that if the patient is taking the product correctly, they should not have this feeling all the time. Which led into daily titration and the fact that there are 3 new that they were not aware of that would provide an appropriate daily titration which the competitors could not provide. Went over Med. Edu. Resource Catalog. All prescribers were interested in these.188 165. On January 27, 2009, Sales Representative 12 called on a Chattanooga?area nurse practitioner and referenced titrating upwards without disclosing the increased risk of addiction at higher doses. The call note reads as follows: Reviewed and discussed how she could/would use the lower doses of 10 and 15 for appropriate patients. She still said most patients come in on higher doses. Asked if she ever wanted to develop a trust with lower doses and titrate up. She said she did and might be a good idea. Reminded of the savings cards and the Seno for patients on pain medication.189 166. Sales Representative 1 called on a Paris-area family doctor on April 26, 2010 and recorded the following about her discussion: [d]iscussed that there is no max dose for oxycontin and that there is no apap. dr askekd how many copays is it for patient taking 160mg if the patient has to take 2 80mg. told him i thought one but would check with pharmacist and con?rm with him. we also discussed difference between physical dependence and addiction. discussed ryzolt positioning statement and coverage[.] 188 PTN000119294 ID27756 (8/14/2008) (emphasis added). 139 PTN000119294 ID33429 (1/27/2009) (emphasis added). 49 167. On May 13, 2013, Sales Representative 6 made a sales call to a Knoxville~area family doctor and recorded his interaction as follows: Discussed OxyContin and he asked if there was a maximum dose for OxyContin. I told him there has been no maximum dose established in our clinical trials. He says he has one patient taking ?ve of the 80 mg tablets a day. Acknowledgedthat?s an exception and is a high?dose compared to the other patients he has on OxyContz'n. We discused the dosing conversion chart from Percocet and I asked him to consider in any patient who's not comfortable with Q6 dosing or having to get up in the middle the night to take their medication 168. Substantially similar claims were made by: Sales Representative 7 to a Mountain Home-area pharmacy on June 1, 2009;191 Sales Representative 5 to a Ashland City~based internist on December 12, 2007,192 a Hendersonville?area emergency medicine provider on December 21 2007,193 and a Nashville-area internist on July 15, 2009;194 Sales Representative 11 to a Lebanon? area physical medicine and rehabilitation specialist on September 3, 2009195 and to three Hermitage?based providers on September 3, 2009;196 Sales Representative 2 to a Knoxville-based 8197 and a Knoxville?area neurologist on November 5, physician assistant on September 22, 200 2008;198 Sales Representative 1 to a Lebanon-area internist on October 5, 2009,199 a Gordonsville- based family doctor on October 5, 2009,200 and a Lebanon?area physical medicine and rehabilitation specialist on October 5, 2009;201 Sales Representative 4 to a Memphis?area 190 PTN000119294 113130004 (5/13/2013) (emphasis added). 191 PTN000119294 ID38263 (6/1/2009). 192 PTN000119294 ID19416 (12/12/2007). 193 PTN000119294 113 19690 (12/21/2007). 194 PTN000119294 ID39709 (7/15/2009). 195 PTN000119294 11341710 (9/3/2009). 196 PTN000119294 1D41712 (9/3/2009). 197 PTN000119294 113293 83 (9/22/2008). 198 PTN000119294 11331257 (11/5/2008). ?99 PTN000119294 11343232 (10/5/2009). 20? PTN000119294 1D43233 (10/5/2009). 201 PTN000119294 11343235 (10/5/2009). 50 anesthesiologist on October 23, 2009 902 Sales Representative 1 to a Dyersburg?based nurse practitioner on November 20, 2009,203 and a Dyersburg-area pulmonary specialist on November 20, 2009;204 and Sales Representative 7 to a Bristol?area nurse practitioner on March 3, 2014.205 169. Purdue?s district managers told sales representatives in Tennessee to focus on the seven dosing of OxyContin and titration. For example, on May 27, 2016, District Manager 1 e?mailed sales representatives from the entire Nashville District and told the representatives, among other things, to ?[?ocus on product attributes, 7 dosing and the ability to titrate up and down as necessary,? without any indication that sales representatives were supposed to disclose the increased risk of addiction at higher doses.206 Failing to Disclose Lack of Evidence for Long?Term Use of Opioids 170. To convince Tennessee prescribers and patients that Opioids should be used to treat chronic pain, despite therunavoidable risk of addiction, Purdue had to persuade them that there is a signi?cant upside to long?term opioid use. But as the 2016 CDC Guideline makes clear, there is ?insuf?cient evidence to determine the long?term bene?ts of opioid therapy for chronic pain.? In fact, the CDC found that evidence shows a long-term bene?t of Opioids in pain and function versus no opioids for chronic pain with outcomes examined at least 1 year later (with most placebo? controlled randomized trials 5 6 weeks in duration)? and that other treatments were more or equally 202 PTN000119294 1D44097 (10/23/2009). 203 PTN000119294 ID45493 (1 1/20/2009). 204 PTN000119294 1D45494 (11/20/2009). 205 PTN0001192941D155137 (3/3/2014). 206 (emphasis added). 51 bene?cial?and less=harmful than-'long-terrnropioid "the FDA stated in 201 3 that?it was ?not aware of adequate and well-controlled studies of opioid use longer than 12 weeks.?208 171. Similarly, the US. Health and Human Services Agency for Healthcare Research and Quality, in an Evidence Report that assessed the current evidence on effectiveness and harms of opioid therapy for chronic pain focusing on long?term (21 year) outcomes, concluded that the evidence regarding long?term opioid therapy for chronic pain is ?very limited but suggests an increased risk of serious harms that appears to be dose?dependent.?209 172. Purdue has long been aware of the disconnect between the academic literature, which assesses ef?cacy of extended release opioids only as far out as 12 weeks, and the reality-m? which it helped create?that many patients use OxyContin and other opioids for months or years. For example, a 201 1 internal email among Purdue researchers discussed the need for ?new research studies of not less than 12 months duration to determine the long?term effectiveness of opioids for ?MO?an acknowledgment that such evidence did not exist. chronic non-cancer pain 173. Nevertheless, building on its earlier marketing, Purdue has continued to tout the purported bene?ts of long?term opioid use, while falsely and misleadingly implying that these benefits are supported by scienti?c evidence. In their sales conversations with Tennessee providers, Purdue sales representatives do not disclose the lack of evidence supporting long-term 207 2016 CDC Guideline at 15, 19. 203 Ltr. from US. Food and Drug Administration to Andrew Kolodny, M.D., Physicians for Responsible Opioid Prescribing, 10 (Sept. 10, 2013), available at content/uploads/20 ion_Approva1__andWDenia1.pdf. 209 Roger Chou, M.D., F.A.C.P., The E??ectiveness and Risks of Long?Term Opioid Treatment of Chronic Pain, AGENCY FOR HEALTHCARE RESEARCH AND US. DEPARTMENT OF HEALTH AND HUMANS SERVICES, abstract available at 21? PTN000022184. 52 use. And Purdue promotional materials likewise promote long?term use without disclosing the absence of long?term studies. 174. For example, the OxyContin Conversion and Titration Guide, which sales representatives widely disseminated in Tennessee, implies that Opioid use can continue safely for years. One version of the Guide that was widely?disseminated in Tennessee states, ?The need for ATC opioid therapy should be reassessed periodically every 6 to 12 months) as appropriate for patients on chronic therapy?211 without disclosing the lack of evidence for long-term use. A later 2014 version of the Guide omits the parenthetical every 6 to 12 months),? but states that prescribers should ?periodically reassess the continued need for the use of opioid analgesics.?212 This 2014 version still conveys, however, that chronic opioid therapy is appropriate without. disclosing the lack of evidence for use beyond 12 weeks. 175. Purdue?s Tennessee sales representatives frequently referred to long?term use of Purdue?s opioid products without disclosing the increased risk of addiction at higher doses. While not an exhaustive list, representative examples of these call notes are set forth below. 176. On August 4, 2010, Sales Representative 7 called on a Johnson City-area physical medicine and rehabilitation specialist and discussed the long?term use of Purdue?s opioids without disclosing the lack of scienti?c evidence for long-term use. The call note states: The providers in this practice are very conservative. They have a less is better philosophy. I said i understand and asked how many patients they have on pain medicine ?long?term They admitted that they do have quite a few on continuing therapy. I went over ir/sa therapy vs q24hr therapy and the possibilities er therapy can o?fer.213 2? PWG0001275 880 (?The need for around-the-clock opioid therapy should be reassessed periodically (eg, every 6 to 12 months) as appropriate for patients on chronic therapy?). 212 PWG00005273 8. 213 PTN000119294 ID57473 (8/4/2010) (emphasis added). 53 177. Sales Representative 15 documented her sales call with a Bartlett-based internist on September 4, 2012, in which she discussed the use of Purdue?s opioids for patients with long? term around the clock pain without disclosing the lack of scienti?c evidence for long?term use. The call note states: I Introduced myself as Butrans/OxyContin rep. Asked physician what his treatment algorithm was for patients with long-term AT pain. He said that he did not have any algorithm because everyone was different. Dr said that he uses IR in some patients and ER in other patients. I asked what triggers him to switch from to ER. Dr said ?when it feels right.?214 178. Likewise, Sales Representative 15 made a sales call to a Germantown?area orthopedic surgeon on October 23, 2012, in which she discussed the long-term use of Butrans without disclosing the lack of scienti?c evidence about long-term use. The call note reads: Asked Dr how he had Butrans and OxyContin positioned. Dr said he doesn?t use much long-acting for fear of abuse. Reminded Dr that Butrans is a 7? day transdermal patch, with potential for abuse, indicated for moderate to severe ATC pain. Asked him to keep Butrans in mind for his total hip/total knee patients that still present with pain after surgery. He said he had not thought of using it there until now. Also discussed hydrocodone patients that are not controlled at 1?2 tablets/day. He said he uses hydrocodone but tries to wean patients off of it and not use it long?term for fear of patients getting addicted. Showed him a placebo patch and reminded him it is matrix technology. Asked him to give patients the option of Butrans and give trial cards so patient can try it for free.215 179. On April 9, 2013, Sales Representative 6 called on a Knoxville-area family doctor and discussed the long?term use of Purdue?s opioids without disclosing the lack of scienti?c evidence for long?term use. The call note states: Good discussion around Butrans~he likes concept and feels it makes most sense with opioid?naive pts. We discussed dosing for those and reinforced savings card for commercial pts. I offered the Scott pro?le and not controlled on Tramadol. He said that he would consider that. He 2?4 PTN000119294 ID109956 (9/4/2012) (emphasis added). ?5 PTN000119294 ID113996 (10/23/2012) (emphasis added). 54 ended discussion by committing to prescribing Butrans for a couple of his pts. He likes oxycontin and does treat longmterm pain when appropriate. Reinforced the dose availability and he mentioned the 30 mg dose as helpful.216 Safety Claims: General Safety Claims 180. Purdue made a series of unquali?ed safety claims in Tennessee that represented that the company?s opioid products were safer than they actually were. These claims were false, deceptive, and/or unsubstantiated at the time they were made. While not an exhaustive list, representative examples of these claims are set forth below. 181. On May 7, 2007, Sales Representative 2 called on a Knoxville-area pain medicine Specialist and recorded his interaction as follows: [Provider] said he preffered to not use OxyContin ?rst line because he feels once a pt is put on Oxycontin they never will try anything else becuase they like the drug . i aks?ed if that was a bad thing he siad that the hard part was to ifgure out if it was due to releif or a 182. Sales Representative 4 documented his sales call with a Cordova?based internist on May 10, 2007, as follows: discussion involving todays settlement announcements. Reassuring oxycontin ?5 safety and her success with 183. Likewise, Sales Representative 5 made a sales call to a Dickson?area pharmacy on February 20, 2008, and wrote the following about his interaction: pharmacy tech was riding me about oxycontin being a bad drug. corrected her by saying good drug, bad peOple abusing it. pharmacist said he sees 20/ 10mg written to get 30mg. will order 30 and 60mg.219 216 19294 ID126688 (4/9/2013) (emphasis added). 2?7 PTN000119294 ID12181 (5/7/2007) (emphasis added). 213 PTN000119294 ID12407 (5/10/2007) (emphasis added). 259 PTN000119294 ID21584 (2/20/2008) (emphasis added). 55 .184. On January 8, 2009, Sales Representative 11 called on a Lebanon-area physical medicine and rehabilitation specialist and recorded his interaction as follows: asked if he was aware that oxycodone was 100 years old and the fact we only improved on the delivery system with oxycontin. he said he agreed and said if the pt is on oxycodone he will use oxycontin. he said he is using more now that the media is not saying it was a bad drug. he said his problem is when the pt wont take becasue what they heard on the news. he also asked about the generic situation. he said some did not like the different colors and sizes. he also said for workmans comp he is using the mail order. comp make up 80 percent of his practice.220 185. Sales Representative 11 made a sales call to a Brentwood-area anesthesiologist on March 26, 2009, and wrote the following about his interaction: in of?ce today i talked about taking lortab or percocet 10mg with apap 500mg. discussed apap use over a year and they were concerned with that much apap over a year. discussed to then titrate per indication over to oxycontin 186. Sales Representative 1 documented her sales call with a Jackson?based anesthesiologist on November 8, 2010, as follows: went over state board of medical examiners leave behind piece and discussed importance of proper documentation. also discussed that there is not a ?bad drug? list, that they are all good when properly prescribedd?: administered he said when the state talks about bad drugs they use oxycontin synonymously for all bad drugs. he then said someone told him about an article that stated which drugs are most likely to cause overdose. he asked me to ?nd that article and then we could discuss statistics. i told him i am not allowed to talk about anything that has not been approved by purdue and the fda but that he could complete a yellow card if he wanted any data specifically related to overdose and oxycontin. he signed the yellow card and his NP worded the question. then he told me that he bet 90% of the patients mentioned in that article were oxycontin deaths. i asked him why he thought that and if he has seen those statistics in his practice. he said no. he said he had a colleague.222 22? PTN000119294 ID33023 (1/8/2009) (emphasis added). 22? PTN0001 19294 ID35491 (3/26/2009) (emphasis added). 222 PTN000119294 ID62441 (11/8/2010) (emphasis added). 56 187. Sales Representatives 7 and 20 documented their sales call with a Nashville?based anesthesiologist on May 20, 2014, as follows: Discussed Oxycontin and Butrans. Dr said he likes to use Butrans on his patients he does not trust. Explained Burrans is not just for his train wrecks. Dr said he likes fentanyl. Does not like to use high doses for his patients, most patients taking lortab 5 mg q8h. Asked if Butrans patch will stay on, left him placebo patches?? 188. Purdue also promoted OxyContin?s time on the market as an implied safety claim. For example, at an OxyContin Brand Strategy meeting in Nashville on September 16, 2015, Purdue stated that OxyContin should be positioned ?For HCPs who treat chronic pain, make OxyContin? the preferred brand and extended?release oxycodone because it offers powerful ef?cacy, 20 years of clinical experience, abuse?deterrent properties and claims, and excellent managed care access? and that emphasizing OxyContin?s 20 year experience was a strategic imperative for the brand.224 B. DECEPTIVE COMPARATIVE CLAIMS 189. Purdue has admitted on multiple occasions that it does'not possess substantiated data, comparative trials, or head-to?head studies evaluating its products versus other products including in training documents from 2010,225 2011,226 2012,227 and 2013.228 190. For example, in 2011 Purdue indicated to sales representatives that ?Statements cannot represent or suggest that a drug is safer/more effective (or make any other sort of 223 PTN000119294 ID1625 82 (5/20/2014) (emphasis added). 22? PWG00043 5507. 225 PTN0000905 02 (emphasis in original) (stating ?Remind you that Purdue has no comparative trials or substantiated data~ thus no comparisons to other products are 226 PWG000190160. 227 PVT0058319 (emphasis in original) (stating ?Comparisons cannot represent or suggest a drug is safer/more effective unless there is substantial evidence/clinical trials. We have no drugs that satisfy this standard?). 228 PWG00008056 (stating ?Comparisons cannot represent or suggest a drug is safer/more effective unless there is substantial evidence/clinical trials. Purdue Products'do not have any comparative data that satisfy this standard?). 57 comparative elain?i) unless there ?is substantial e'vildence/clinicaltrials supporting" 'the statement We have no drugs that satisfy this 191. In Spite of this, Purdue made claims that competing products were more dangerous than they actually were, less effective than they actually were, or that its products were equivalent to or superior to competing opioids and non-opioids when these claims were false, deceptive, and/or unsubstantiated at the time they were made. 192. Purdue did this in eight main ways, namely: (1) broadly representing that its own products were superior to competing opioid products; (2) representing that OxyContin was safer, more effective, as effective, or superior to other extended release opioids such as Opana, Duragesic, methadone, and Avinza; (3) representing that OxyContin was safer, more effective, as effective, or superior to immediate release opioids generally as well as Dilaudid, hydrocodone, immediate release opioids containing acetaminophen, hydrocodone combinations, Lortab and Vicodin, and Percocet; (4) representing that OxyContin was safer, more effective, as effective, or superior to non-opioids; (5) representing that Butrans was safer, more effective, as effective, or superior to immediate release opioids such as hydrocodone, hydrocodone combinations, Darvocet, tramadol, and Lortab; (6) representing that Ryzolt was safer, more effective, as effective, or superior to immediate release opioids generally, as well as Percocet and Lortab speci?cally; (7) representing that Ryzolt was safer, more effective, as effective, or superior to other tramadol products including tramadol and Ultram and (8) representing that Hysingla ER was safer, more effective, as effective, or superior to immediate release opioids including hydrocodone combinations and those containing acetaminophen. 229 (emphasis in original). 58 Comparative Claims: O-xyContin?s General Superiority over Other Products 193. Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to other products when those claims were false, deceptive, and/or unsubstantiated at the time they were made. While not an exhaustive list, illustrative examples of these claims are set forth below. 194. Sales Representative 3 documented his sales call promoting OxyContin with a Greeneville-based family doctor on May 7, 2007, as follows: stated hates it because of name asked what was safer - didn;t have an answer - waved me 195. Sales Representative 4 documented his sales calls with a Collierville-based family doctor on?May 22, 2007, as follows: Discussed the athlete and the use of oxycontin being bene?cial. Better compliance, improved rehab time and don?t have to worry about heat being a factor as you would with patient on the patch. Said that was a valid point and there is a lag sometimes in pain control when it comes to the 196. Sales Representative 4 documented his sales call with a Huntingdon?based family doctor on May 30, 2007, as follows: Discussed dosing and lag time with fentanyl and cost difference disadvantages vs. oxycontin. Review of oxycontin PI safety and indications.232 197. Sales Representative 4 documented his sales call with a Huntingdon?based family doctor on August 10, 2007, as follows: Told me he was tired of me getting on him about paying attention to the patient?s insurance and utilizing the savings card. Explained that he can treat patients with chronic pain more e?ectively by ensuring brand with 23? 19294 ID12240 (5/7/2007) (emphasis added). 231 PTN000119294 ID12844 (5/22/2007) (emphasis added). 232 PTN000119294 ID12989 (5/30/2007) (emphasis added). 59 - Wand-making sure it+happens atzthe-pharmacy: by. giving outthe-savings cards.233 198. Likewise, Sales Representative 5 made a sales call to a Nashville?area oncologist on September 6, 2007, and wrote the following about his interaction: doc asked me why he should prescribe oxycontin. Told him most e?ective and well tolerated. doc agreed. will write.234 199. On November 13, 2007, Sales Representative 5 called on a Nashville~area hematologist and recorded his interaction as follows: doc shot passed me in the hallway??asked him what is more e??ective and better tolerated than oxycontin for moderate to severe pain. could not respond.235 200. Purdue Representative 3 documented his sales call with a Knoxville-based pain medicine specialist on April 17, 2008, as follows: re? intro call feels that name oxycontin keeps him from prescribing it more often - feels too many people divrt or abuse - stated continues to prescribe for those who are alrady on it asked how concludes other long acting opiods are safer - says matrix (delivery) system makes it easier to abuse than other such as ?any? - others harder to crush or have gel like matrix that makes it harder to abuse - agreed but asked if has gone on line and looked at how-to websites - I made the point that a is a Comparative Claims: OxyContin v. Other ER Opioids OxyContin v. Opana 201. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to Opana ER, an extended release opioid analgesic 233 PTN0001 19294 ID15356 (8/10/2007) (emphasis added). 234 PTN000119294 ID16158 (9/6/2007) (emphasis added). 235 PTN0001 19294 ID18436 (11/13/2007) (emphasis added). 236 PTN0001 19294 ID23662 (4/17/2008) (emphasis added). 60 tablet containing oxymorphone hydrochloride when those claims were false, deceptive, and/or unsubstantiated at the time they were made. 202. Purdue?s Tennessee sales representatives were taught to differentiate OxyContin from Opana ER in sales calls to providers based on (1) the warning on Opana label for the consumption of alcohol; (2) the effect of food on Opana and (3) the 3?7 day titration period for Opana ER compared with the l~?2 day period for OxyContin.237 While not an exhaustive list, illustrative examples of these claims are set forth below. 203. Sales Representative 11 made a sales call concerning OxyContin to an Hermitage- area physical medicine specialist on May 22, 2007, and wrote the following about his interaction: he had another quesion about the case discussed per email. then he asked me about opana and if the drug is doing well. i said no because of the alcohol issue on the delivery system and the food a?ectL]238 204. Likewise, Sales Representative 2 made a sales call to a Lebanon?area hematologist regarding OxyContin on June 11, 2007, and wrote the following about his interaction: saw doctor brei?y, and did discuss morphine vs oxycontin, and also had questions about opano. did not know about thee alcohol and the food 205. Sales Representative 2 documented his sales call with a Lebanonnbased internist on June 21, 2007, as follows: asked me how oxycontin compared to opana. discussed alcohol and the food affect issues. did not know about them. reminded of new 237 (2009). 23? PTN000119294 ID12830 (5/22/2007) (emphasis added). 239 PTN000119294 ID13426 (6/1 1/2007) (emphasis added). 240 PTN000119294 ID13466 (6/11/2007) (emphasis added). 61 206. Likewise, Sales Representative 4 made a sales call to a Cordova~area anesthesiologist on June 21, 2007, and wrote the following about his interaction: Discussed and reviewed the opana PI vs. oxycontin and disadvantages of bioavailability and issues with food and alcohol. Said he was unaware of this and the representative didn ?t make mention of the issues 207. On June 22, 2007, Sales Representative 4 called on a Memphis?area anesthesiologist and recorded his interaction as follows: PI review for opana. Said the reps didn?t tell him about the concerns for alcohol and food effect. Pointed out to him that oxycontin is a much more effective drug for treating pain and with the methadone he writes he doesn ?t need another drug that he has to 208. Sales Representative 11 documented his sales call with a Franklin?based anesthesiologist on June 26, 2007, as follows: called me today. said he could not ?nd the savings cards and wondered where they were. i went to of?ce and found them for him. did discuss opana vs oxycontin. he said the rep is really trying discussed comparisons. he did not know about the alcohol or food issue.243 209. On July 3, 2007, Sales Representative 4 called on a Germantown-area obstetrician] gynecologist and recorded his interaction as follows: Asked about his use of opana. Said that he has tried some of it and for the most part patients either don?t want to take it because they never heard of it or they started feeling funny on it. Said he is now going to it when oxycontin or another long acting doesn?t work. Reminded him that the bioavailability of opana is much lower and there should be concerns of food and alcohol consumption when taking opana. Said he still hasn?t given out any savings cards. Reminded him that they are bene?cial for existing patients and not just new starts and to have nurses place in chart upon patient follow 241 PTN000119294 ID13816 (6/21/2007) (emphasis added). 242 PTN000119294 11313910 (6/22/2007) (emphasis added). 243 PTN000119294 11314004 (6/26/2007) (emphasis added). 244 PTN000119294 11314131 (7/3/2007) (emphasis added). 62 210. Sales Representative 4 documented his sales call with a Cordova?based internist on July 5, 2007, as follows: 211. Not much time with her. Tried to get into discussion concerning Opana and asked about food alcohol effect. Said she was somewhat aware, but rep didn?t make mention Likewise, Sales Representative 14 made a sales call to a Millington-area family physician on July 12, 2007, and wrote the following about his interaction: 212. Talked to doc about the food e?ects on Oxycontin vs. the food e?ects on Opana. Stressed that food has no effect on Oxycontin while food has to be considered with Opana. Doc agreed that compliance is a big issue and that a medicine that is not affected by food is easier to stay compliant with than one that it is. I asked if he would keep this in mind when making decisions on which LA agent to choose. He agreed.I also made him aware of the recent forrnulary win with Tricare. He said that was good news b/c he sees a lot of Tricare patients. Also, reminded him about the coupon cards. He said that he had been using them and hadn't heard from anyone that the cards didn?t work.246 Sales Representative 4 documented his sales call with a Jackson?based family doctor on July 12, 2007, as follows: 213. based pharmacist on July 13, 2007,248 a Cordova?area internist on July 16, 200 Discussion on opana and awareness. oxycontin pi review/indications and safety section. Said she waited on opana and has tried it a few times. Said that patients haven?t called or been back to see if they are doing any Substantially similar claims were made by: Sales Representative 4 to a Knoxville? 7,249 a Memphis- area anesthesiologist on July 19, 2007,250 and a ackson-area family doctor on July 24, 2007;251 245 PTN000119294 1D14164 (7/5/2007) (emphasis added). 246 PTN0001 19294 ID14394 (7/12/2007) (emphasis added). PTN000119294 ID14370 (7/12/2007) (emphasis added). 248 PTN000119294 ID14418 (7/13/2007). 249 PTN000119294 ID14439 (7/16/2007). 250 PTN000119294 1D14612 (7/19/2007). 251 PTN000119294 ID14745 (7/24/2007). 63 "Sales"Representativel?l ?to"a?P1ermi?tage?area physical medicine'and rehabilitative doctor on July 24, 2007;252 Sales Representative 14 to a Millington?area family doctor on July 25, 2007;253 Sales Representative 11 to a Lebanon?based physical medicine and rehabilitation specialist on July 27, 2007;254 Sales Representative 4 to a Germantown?area internist on July 30, 2007;255 Sales Representative 2 to a Knoxville-based nurse practitioner on August 6, 2007;256 Sales Representative 11 to a Franklin-based anesthesiologist on August 10, 2007;257 Sales Representative 14 to a Millington?area family doctor on September 18, 2007;258 Sales Representative 11 to an Antioch-based internist on October 19, 2007;259 Sales Representative 5 to a Hendersonville-area internist on October 23, 2007;260 Sales Representative 11 to an Antioch- based physician assistant on October 26, 2007;261 Sales Representative 4 to a Memphis-area internist on December 7, 2007;262 Sales Representative 11 to a Murfreesboro?area oncologist on July 21, 2008;263 Sales Representative 2 to a NeWport?area internist on November 10, 2008;264 8265 Sales Representative 7 to a Knoxville-area family doctor on November 13, 200 and a Johnson City?based anesthesiologist on December 3, 2009.266 252 PTN000119294 ID14718 (7/24/2007). 253 PTN000119294 ID14788 (7/25/2007). 254 PTN000119294 ID14896 (7/27/2007). 255 PTN000119294 11914927 (7/30/2007). 256 PTN000119294 ID15177 (8/6/2007). 257 PTN000119294 ID15362 (8/10/2007). 258 PTN000119294 65 57 (9/18/2007). 259 19294 ID17553 (10/19/2007). 260 ID17688 (10/23/2007). 261 (10/26/2007). 262 PTN000119294 1D19278 (12/7/2007). 263 PTN000119294 ID15843 (8/27/2007). 264 PTN0001 19294 ID31409 (1 1/10/2008). 265 PTN000119294 1D31565 (11/13/2008). 266 PTN000119294 1D45510 (12/3/2008). 64 OxyContin v. Duragesic 214. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to Duragesic, the brand name for an extended release fentanyl skin patch, when those claims were false, deceptive, and/or unsubstantiated at the time they were made. 215. While not an exhaustive list, illustrative examples of call notes in which Purdue?s Tennessee sales representative compared OxyContin and Duragesic are set forth below. 216. On June 7, 2007, Sales Representative 11 called on a Franklin-area family physician and recorded his interaction as follows: looked through my sample box, and he wanted to discuss laxative. and the slow mag. and colace. only was able to discuss duragesic vs oxycontin. said he uses duragesic if pt has a hard time remembering to take med or likes the patch. showed aps oral route prefered because of convenience, ?exability, and steady blood level. 217. Sales Representative 11 called on a Murfreesboro?area anesthesiologist on June 12, 2007, and recorded his interaction as follows: saw in surgery center. he was going out did get in a good discussion of duragesic . he had a question about the patch. after he agreed with the aps oral is the better route.268 218. Likewise, Sales Representative 4 documented his sales call with a McKenzie?based family physician on June 26, 2007, as follows: Closing down for a half day today. said that he is starting to see some issues with patients being able to or not getting their oxycontin. Starting to pay attention to what they are getting substituted with and in the past has resorted to going to fentanyl. Explained the occurrence of lag time with 267 PTN000119294 ID13346 (6/7/2007) (emphasis added). 263 19294 ID13510 (6/12/2007) (emphasis added). 65 fentanyl and ease or oral dosing from APS and encouraging use of oxycontin more 219. Sales Representative 4 documented his sales call with a Memphis?based internist on July 5, 2007, as follows: Said that he uses duragesic when the patient asks for it or if oxycontin doesn?t work. Explained to him the importance of recommending what is best even when the patient request something else. Convenience of oral dosing vs. fentanyl/Lag time and adhesion in the summer problems and 220. Likewise, Sales Representative 11 made a sales call concerning OxyContin to a physical medicine specialist on September 4, 2007, and wrote the following about his interaction: discussed moprhine and duragesic and oxycontinshe said she uses morphine for that have to get because of insurance and she has been using less duragesic. said dont like taking a patch vs oral. i said that is what the aps says that oral is the best route becuase of convenience steady blood levels, and easy to titrate. she 221. Sales Representative 14 documented his sales call with a Memphis-based family physician on October 31, 2007, as follows: Continued discussion on doc?s preference for Duragesic. I gave doc a copy of the APS guidelines for treating acute and cancer pain and stated that the guidelines speak to the oral route of administration being the preferred route when e?ective and available. He agreed to review the guidelinesl also reminded him about the coupon cards. He thanked me for the reminder and said he would try to remember to use the cards.272 222. Sales Representative 11 documented his sales call with a Hermitage?based nurse practitioner on November 28, 2007, as follows: 269 PTN000119294 ID13996 (6/26/2007) (emphasis added). 270 PTN000119294 ID14161 (7/5/2007) (emphasis added). 27? PTN000119294 ID16086 (9/4/2007) (emphasis added). 272 PTN000119294 ID17993 (10/31/2007) (emphasis added). 66 223. had a discussion of the substance data base . discussed comparisons to duragesic morphine and oxcontin. she said she is using more oxycontin lately. she does have more side effects with morphine, and seem to not like the patch compared to oral. i mentioned that oral is the preferred route because of On February 11, 2008, Sales Representative 5 called on a Hendersonville-area family physician and recorded his interaction as follows: 224. doc feels duragesic is a safer opioid than oxycontin. told him it would not be I 1 if it were safer.274 In a July 31, 2008 sales call, Sales Representative 4 recorded the following discussion with a general practitioner in Erwin, which is excerpted below: 225. [I]asked about duragesic. Hesaid low rate of constipation and easy for elderly patients to use. Also said long acting. I said I understood, but duragesic has a 3day titration period vs I and with oxycontin there is no patch to abuse.2775 Sales Representative 5 made a sales call to a Nashville?area internist on June 16, 2008, and wrote the following about his interaction: 226. doc said he likes duragesic because he feels it is safer. told him it holds C- scheduling. all opioids in that category have same potential for abuse and diversion. told him patient selection is very important.276 On July 31, 2008, Sales Representative 7 documented the following discussion with a general practitioner based in Erwin as follows: Is the medical director for 5 nursing homes and 2 hospices. Suggested that I talk to the hospice administration in Stoney Creek. Said that he tries not to write for chronic pain in his practice but uses more in hospice or nursing home setting. [asked about duragesic. Hesaid low rate of constipation and easy for elderly patients to use. Also said long acting. [said] understood, 273 PTN000119294 ID18893 (11/28/2007) (emphasis added). 27? PTN000119294 ID21191 (2/11/2008) (emphasis added). 275 PTN000119294 ID27254 (7/31/2008) (emphasis added). 276 PTN000119294 ID25639 (6/16/2008) (emphasis added). 67 but duragesic has a 3day titration period vs 1 and with oxycontin there is no patch to abuse.277 227. Likewise, Sales Representative 11 made a sales call to a Hendersonville-area pain medicine specialist, an anesthesiologist, and a nurse practitioner on August 28, 2008, and wrote the following about his interaction with each: today in clinic my objective was to discuss duragesic and oxycontin. each said they use duragesic for those that need a patch instead of a pill . did discuss the that would be in practice . they said between 20 to 30 percent. i said well than well for the other 70 to 80 percent use oxycontin because of the convenience of many mg options and the best delivery system. they said they have been using more oxycontin with good results. did close on the 15mg pt. [Providers] both said they used this week closed on senokot and 228. Substantially similar claims were made by: Sales Representative 11 to a Shelbyville-area family doctor on May 14, 2007;279 Sales Representative 4 to a Germantown~area nurse practitioner on August 15, 2007;280 Sales Representative 14 to a Bartlett?based internist on October 31, 2007281 and a Memphis?area internist on December 14, 2007;232 Sales Representative 7 to an Erwin?based family doctor on January 27, 2009.283 OxyContin V. Methadone 229. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to methadone, another Schedule 11 extended release 277 PTN000119294 ID27254 (7/31/2008) (emphasis added). 273 PTN000119294 ID28393 (8/28/2008) (emphasis added). 279 PTN000119294 ID12540 (5/14/2007) (?discussed duragesic vs oxycontin. Agreed the bene?t of oral is better . .said I do use oxxycontin . easier to titrate, convenience and better blood levels per 280 PTN000119294 11315515 (8/15/2007). PTN000119294 ID18005 (10/31/2007). 282 PTN000119294 ID19519 (12/14/2007). 283 PTN000119294 ID33465 (1/27/2009). 68 opi'Oid used primarily for opioid addiction treatment, but also prescribed to treat pain, When those claims were false, deceptive, and/or unsubstantiated at the time they were made. 230. While not an exhaustive list, illustrative examples of call notes in which Purdue?s Tennessee sales representative compared OxyContin and methadone are set forth below. 231. Sales Representative 5 documented his sales call with a Gallatin~based family doctor on May 11, 2007, as follows: discussed bene?ts of oxycontin as opposed to methadone. long half?life of drug with frequent dosing poses a problem for some patients. doc said good points were made.284 232. Sales Representative 4 documented his sales calls with a Memphis-based pain doctor on May 11, 2007, as follows: Asked about the advantages of oxycontin vs. methadone. Discussed steady state achieved quicker, less metabolism time, cleaner side e?ect pro?le, and ease of use for the patient. Reviewed oxycontin safety pro?le from 233. On July 24, 2007, Sales Representative 11 called on an Hermitage?area physical medicine and rehabilitative doctor and recorded his interaction as follows: had a discussion of methodone, morphine, opana, and oxycontin. said he does still think oxycontin is the best tolerated and the one that works great. said to start to use as his opioid of choice. said he will now that he knows that oxycontin has better insurance 234. On August 2, 2007, Sales Representative 4 called on a Memphis?area anesthesiologist and recorded his interaction as follows: Reviewed preventing abuse guide and equivalent chances of abuse with both oxycontin and methadone. Said he just likes methadone and it is guranteed to work in his opinion and often better than 23? PTN000119294 ID12429 (5/1 1/2007) (emphasis added). 235 PTN000119294 ID12432 (5/11/2007) (emphasis added). 236 PTN000119294 ID14718 (7/24/2007) (emphasis added). 237 PTN000119294 ID15120 (8/2/2007) (emphasis added). 69 235. Sales Representative 4 documented his sales call with a Memphis-based pain medicine doctor on August 29, 2007, as follows: Inquired about the difference and bene?ts of oxycontin vs. methadone. Just discussed the fact of the black box warning with methadone and the disadvantage of long half life and tapering a patient o? of methadone vs. safety of OxyContin v. Avinza 236. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to Avinza, the brand name for an extended release morphine sulfate drug that was discontinued in 2015, when those claims were false, deceptive, and/or unsubstantiated at the time they were made. 237. While not an exhaustive list, illustrative examples of call notes in which Purdue?s Tennessee sales representatives compared OxyContin to Avinza are set forth below. 238. On May 31, 2007, Sales Representative 4 called on a general practitioner based in McKenzie and recorded the following: Senokot sampling and recommendation. Review/compare of Avinza to oxycontin and better formulary access of oxycontin. Said he has a lot of United Healthcare. Pointed out to him tier status and copays and using the savings 239. For his next call objective, Sales Representative 4 wrote, ?Continue with cost savings message and PI comparisons of 240. Sales Representative 11 documented his sales call with a Lebanon?based physical medicine and rehab specialist on July 27, 2007, as follows: 288 PTN000119294 ID15962 (8/29/2007) (emphasis added). 289 PTN000119294 ID13073 (5/31/2007) (emphasis added). 2901i 70 taskedaboutcase again. discussedperaemail. asked .aboutopana. discussed food and alcohol a?ect. said rep said that alcohol does not affect delivery system, and showed a study. he then looked up in package insert and looked at the black box warning for himself. then he asked about avinza and i said they too have the same black box warning. did discuss avinza, va patch, vs oxycontin. did say he does think oxycontin is very well tolerated and when he uses does very well. did review formulary grid and changes savings cards too. said he will daw and start to use the 241. On August 27, 2007, Sales Representative 11 called on a Murfreesboro-area oncologist and recorded his interaction as follows: discussed avinza, vs opana vs oxycontin. discussed the alcohol and food a?ect with avinza and opana ?s delivery system. he did not know about that info. discussed generic situation daw and savings cards. he said he will daw and use the cards. discussed formulary changes too. ie aetna, and 242. Likewise, following a September 7, 2007 call on a Lebanon-based physical medicine and rehabilitation specialist and his nurse practitioner, Sales Representative 11 recorded the following: discussed savings cards with [Provider] and his [Nurse Practitioner]. went over comparisons to avinza, opana, and methadone. both said the felt oxycontin was the best of all the opioids, and have been using ?rst if insurance covers. asked both to start to daw and use savings cards where approprate.293 243. Sales Representative 4 called on a Memphis?based addiction specialist on September 26, 2007, and recorded his interaction as follows: Asked me about the Action study comparing avinza to oxycontin. Said that the study is flawed and doesn?t cover a good patient population and variety to make an even comparison to oxycontin. Said the study is garbage. 291 PTN000119294 ID14896 (7/27/2007) (emphasis added). 292 PTN000119294 ID15843 (8/27/2007) (emphasis added). 293 PTN000119294, (9/7/2007) (emphasis added). 71 Reminded him again of areas he can write oxycontin such as part (1 plans for Cigna, Human, in his 244. On June 19, 2008, Sales Representative 11 called on a Hermitage?based family physician and recorded the following: discussed avinza. and opana because doc asked about if it was true concerning the black box of the alcohol warning. said he will use kadian and oxycontin. said he is using more oxycontin lately and doing great on controlin'g the pain and being well tolerated. did go over the pt info sheet on oxycontin and the generics going away. closed with the 15mg that would have pain per pi and be on 40mg of hydrocodone. said he is using that 245. On July 17, 2008, Sales Representative 7 called on a family physician in Johnson City and recorded the following: Gave patient savings cards and explained how they work and the bene?ts they can provide certain patient populations. Also discussed abuse and diversion with oxycontin vs kadian and avinza. Stated that he knows the same abuse is there and there is no way to stop it completely. Reminded of new 246. Likewise, on a July 24, 2008 sales call with a Kingsport physician assistant, Sales Representative 7 recorded his interaction as follows: Said that their corporation will not allow him to write oxycontin. Talked to him for awhile and ?nally asked what he does write. He said morphine, opana, kadian and avinza or whatever. Went over all of them and he ?nally agreed that oxycontin is a more ?exible and convenient opioid This practice is owned by a physician out of Franklin, TN 247. Sales Representative 11 called on a pain doctor in Nashville on August 6, 2008, and recorded the following: was able to sit down with [Provider] a and go thru the pain managment resouce guide. liked several and said how do i order. i went thru the ordering 294 PTN000119294 ID16916 (9/26/2007) (emphasis added). 295 PTN000119294 ID25743 (6/19/2008) (emphasis added). 296 PTN000119294 (7/17/2008) (emphasis added). 29? PTN000119294 ID26934 (7/24/2008) (emphasis added). 72 process. did discuss the tn board guidelines. did not see before. discussed all the steps and the pt consent form. did go over the new doses and bene?t to pt and doc. he said they will now be doing medical managment for pts. did say he has several on oxycontin, but did say some he would not put on oxycontin. did not elaborate or answer my question. he did bring up our old palladone and said he did not like to use medications that alcohol affects the delivery system. then i said well then avinza and opana have similar black box warnings. he did not know this. he then got paged and asked if i could set up a follow up meeting. did say he was going to the scotland meeting. i said we will be there Comparative Claims: OxyContin v. Immediate Release Opioids 248. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to immediate release, also known as short?acting, opioids when those claims were false, deceptive, and/0r unsubstantiated at the time they were made. 249. Substantiation aside, comparing OxyContin to immediate release opioids made ?nancial sense. As of 2008, 93.4% of switches to oxycodone extended release from other products came from immediate release Opioids.299 Purdue closely tracked and monitored those providers in Tennessee who were most likely to switch a patient from an immediate release opioid to an extended release opioid.300 250. At a national sales meeting attended by Tennessee sales representatives, Purdue trained its sales staff to ask the following question of a provider: 0 ?Doctor, do you realize (or are you aware) that initiating 10 mg q12h of OxyContin is comparable to initiating a 5 mg hydrocodone/oxycodone q4?6h after trying tramadol, while also giving the patient all the bene?ts of less frequent dosing and providing a single entity opioid? 298 19294 ID27453 (3/6/2003) (emphasis added). 299 PWG000109609. 300 See, PTN000108184. 73 251. 0 You will be providing a more convenient q12h dosing regimen. since?these are established opi'Oid patients ?With persistent ATC moderate to severe pain doesn?t this make sense?301 While not an exhaustive list, illustrative examples of call notes in which Purdue?s Tennessee sales representatives compared OxyContin and immediate release opioids are set forth below. 252. Sales Representative 4 documented his sales call with a Memphis?based family doctor on June 6, 2007, as follows: 253. Said she has had much chronic pain come through outside of the patients she already has on oxycontin. Reviewed oxycontin indications and P1 with her again and pointed out patients with back pain that are maxing out on their short acting or NSAID that they may be on as Likewise, Sales Representative 11 made a sales call to a Nashville?area rheumatologist on October 18, 2007, and wrote the following about his interaction: 254. discussed elderly and pain per oxycontin pi. said he is concerned with falls of the elderly. discussed advantages of long acting over short acting. showed pi and the elderly data. said he liked the info and said he should use more oxycontinn for his with aps book. sealed. he did say oxycontin has its bad publicity. i said look at the science of the drug for legitamat pts. he said your right.303 On November 14, 2007, Sales Representative 14 documented his sales call with a Covington-based family doctor as follows: Discussed appropriate patient types for 10mg Oxycontin dose. Asked doc speci?cally if he sees any diabetic peripheral neuropathy, severe OA, or post herpetic nearalgia. He said he does. I followed up from last call and stressed the advantages of Oxycontin over SA combos for appropriate patients with these ailments whose pain is in line with the Oxycontin indication. He said he would keep it in mind. Followed on TN prescription monitoring database and he said that the state had started promoting the 30? (emphasis added). 302 PTN000119294 ID13313 (6/6/2007) (emphasis added). 303 19294 ID17522 (10/18/2007) (emphasis added). 74 database. He said he is using it. Reminder for coupon cards and informed him about extension. Thanked me for update.304 255. Likewise, Sales Representative 14 made a sales call to a Brighton?area family. doctor on April 21, 2008, and wrote the following about his interaction: Discussed the advantages of converting appropriate chronic pain patients from SA combos to Oxycontin. Shared visual from conversion guide. Doc agreed in the signi?cant different in the number of pills b/t SA combos and Oxycontin in some cases. Asked him to keep this in mind when he sees patients back that have continually been getting re?lls on the SA medicine. He agreed. Reminded him about the coupon cards. He said that he had given a coupon card out today. Thanked him for making the effort and asked that he continue. He agreed.305 256. Sales Representative 11 made a sales call to a Lebanon-area nurse practitioner on June 21, 2008, and wrote the following about his interaction: discussed adv of long acting vs short acting. she made comment of switching 2 patients that were taking too much lortab/apap. i then asked if she does see alot of elderly. she said yes. asked about oa ra pts. she said many. discussed those taking a few lortab and not functioning . said she would start low dose 10mg or 15mg for those . she remembered our last call on conversions. she said yes the coversion multiplier is .9. discussed coverage for those medicare part pts. liked coverage and said she would use oxycontin for those oa ra and taking too much lortab/apap.306 257. On November 24, 2008, Sales Representative 5 called on a Nashville?area practice group and recorded his interaction as follows: discussed barry cole?s ten tips to prescribing opioids. residents felt all points were pertinent to what they are doing. they said short acting meds are used ?rst, for patients in clinic. switch to long acting, like oxycontin, when in pain clinic. I mentioned peaks and troughs of short acting meds could pose a challenge for patients with persistent pain. appreciated package insert.307 304 19294 ID18454 (11/14/2007) (emphasis added). 305 PTN000119294 11323745 (4/21/2008) (emphasis added). 306 PTN000119294 ID26748 (7/21/2008) (emphasis added). 307 PTN000119294 11331905 (11/24/2008) (emphasis added). 75 "2'58. On "December "StilesRepresentative"1'4 called on physician assistant and recorded his interaction as follows: Followed up on appropriate patients for the lower doses of Oxycontin. [Provider] said that she isn?t taking any new pain patients, but has no problem treating pain in her current patient population. She agreed that low dose oxycontin makes more sense than SA combos for appropriate patients suffering from chronic pain. She added that she believes tolerance many times results when chasing the pain with a SA combo. I asked if she would keep this in mind and initiate therapy with the 10mg ql2H dose instead of ?rst going to a SA combo atc for appropriate patients with pain indicative of oxycontin ?s indication. She 259. On January 29, 2009, Sales Representative 7 called on a Johnson City?area family doctor and recorded his interaction as follows: Went over converting to long acting at an earlier time. Presented patients on 7.5 short acting taking 3 times /day. converting to oxycontin. No apap, leaving meds at home, etc. I think he liked it, but we will see. Reminded of snokot?s for med induced constipation.309 260. Sales Representative 7 documented his sales call with a Johnson City?based neurologist on January 30, 2009, as follows: Went over lowdose conversion comparisons from short acting combos to q12h oxycontin. He agreed that it is best to have the patient take fewer doses and eliminate the apap as well [.]310 261. Sales Representative 18 documented his sales call with a Knoxville-based internist on April 12, 2011, as follows: reminded him of our previous conversations of the peaks and valleys he stated that happen with short actings and for the patients with chronic pain. He stated that he has not used Butrans yet. He stated that he will he 303 PTN000119294 ID32317 (12/9/2008) (emphasis added). 309 PTN000119294 ID33548 (1/29/2009) (emphasis added). 310 PTN000119294 ID33599 (1/30/2009) (emphasis added). 76 just gets usy and tends to forget. I asked if I need to come in more often and he chuckled:3 11 262. On April 21, 2011, Sales Representative 18 called on a Knoxville-area internist and recorded his interaction as follows: Reminded him of the peaks and valleys he discussed with the sa. He stated that he remembered our conversation and stated that he will use Butrans. I asked when. He stated he will and told me to be patient. I stated I bet he will see a patients that will ?t Butrans and he stated probabley I asked for that patient.312 263. Likewise, on July 2, 2014, Sales Representative 6 called on a Knoxville?based physician assistant and documented his call as follows: [quick reminder of OxyContin as an option for appropriate on 3?4 doses of a short-acting oxycodone. We talked about the opportunity to use the 10/15 mg doses that will maintain well under the morphine equivalency level .313 264. Substantially similar claims were made by: Sales Representative 14 to a Covington? area family doctor on November 26, 2007;314 and Sales Representative 6 to a Knoxville?area family doctor on June 18, 2014,315 a Knoxville-based nurse practitioner on June 23, 2014,316 and a Knoxville-area internist on June 30, 2014.317 OxyContin v. Dilaudid 265. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to Dilaudid, the brand name of an immediate 3? PTN000119294 ID72356 (4/12/2011) (emphasis added). 312 PTN000119294 ID72985 (4/21/2011) (emphasis added). 3?3 PTN000119294 ID166132 (7/2/2014) (emphasis added). 314 PTN000119294 ID18775 (11/26/2007). 315 PTN000119294 ID165173 (6/18/2014). 316 PTN000119294 ID165541 (6/23/2014). 317 PTN000119294 1D165972 (6/30/2014). 77 release opioid ConSiSti'n?g oi'f?hy'dromorphone? that is "manu'factured""'by Purdue'am'on'g "?others'? and which has been on the market since 1984, when those claims were false, deceptive, and/or unsubstantiated at the time they were made. 266. Substantiation aside, comparing OxyContin to an immediate release opioid Purdue also owned made financial sense because it encouraged the use of more expensive opioid products that would have to be taken over a longer time period. 267. While not exhaustive, an illustrative example of a call note in which Purdue?s Tennessee sales representative compared OxyContin and Dilaudid is set forth below. i 268. Sales Representative 14 documented his sales call with a Memphis-based physical medicine and rehabilitation doctor on August 23, 2007, as follows: Talked to doc today about the advantages of Oxycontin over SA meds like Dilaudid for appropriate patients. Walked doc through conversions from Dilaudid per the conversion guide. Doc nodded in OxyContin v. Hydrocodone 269. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to immediate release hydrocodone when those claims were false, deceptive, and/or unsubstantiated at the time they were made. 270. While not an exhaustive list, illustrative examples of call notes in which Purdue?s Tennessee sales representative compared OxyContin and hydrocodone are set forth below. 271. Sales Representative 2 documented his sales call about OxyContin with a Knoxville?based general practitioner on June 6, 2007, as follows: Discussed feature of 9112 and bene?t over hydrococone pt who has a pain crisis while 3'13 PTN000119294 ID15773 (8/23/2007) (emphasis added). 3?9 PTN000119294 ID13276 (6/6/2007) (emphasis added). 78 272. Sales Representative 4 documented his sales call with a Savannah?based family physician on June 8, 2007, as follows: 273. On his way out for the day. Reviewed titration and conversion principles with him and switching patients earlier to oxycontin once they have maxed out on Sales Representative 5 documented his sales call with a Nashville?based physical medicine and rehabilitative doctor on December 19, 2007, as follows: 274. doc asked about conversion of hydrocodone to oxycontin. agreed some patients can have a better quality of life by taking something ql2h as opposed to On October 20, 2008, Sales Representative 19 called on a Lexington?area physician assistant and recorded her interaction as follows: 275. She said she just had a patient she saw. of [Another Provider] on Oxycontin 30mg today. She told me she is new to treating chronic pain. She was not aware of the 15mg or the 60mg of the new so I told her about them. She asked me when she would prescribe hydrocodone vs another agent. I reminded her of Oxycontin?s indication. I showed her the page in the sales aid that shows a patient taking 240 tabs of hydrocodone vs. 60 of Oxycontin 15mg ql2h. I reinforced Oxycontin ?s convenience of fewer tablets than immediate release for the patients with q12h dosing. She said she would prescribe the 15mg for the elderly, osteoarthritic patients. She said she has not had enough opportunity yet to prescribe long acting agents. I also talked to her about the savings cards for Oxycontin. She told me she would try to use them. I left Colace samples and asked her to recommend OTCs for constipation.322 Sales Representative 19 documented her sales call with a Germantown-based pain management specialist on February 23, 2009, as follows: Doctor said he has taking hydrocodone q4?6h that could benefit from Oxycontin?s q12h dosing and the possible convenience of fewer tablets. 32? PTN000119294 ID13398 (6/8/2007) (emphasis added). 321 PTN000119294 ID19637 (12/19/2007) (emphasis added). 322 PTN000119294 11330499 (10/20/2008) (emphasis added). 79 Said thatthesecpts. meet. .the indication of . having moderate .to. severe, pain and who require ATC analgesic. Said he has taking hydrocodone 5mg q6h that are appropriate for conversions to Oxycontin 10mgq12h when their pain becomes persistent instead of titrating them to hydrocodone 7. 5mg tablets. Reminded him of the intermediate and he said he will prescribe them when appropriate. Savings cards reminder and preferred forrnulary status for Oxycontin. Transitioned to medicine induced constipation and asked him to recommend Senokot S. Also discussed Colace for straining due to constipation from postoperative conditions.323 276. Likewise, Sales Representative 19 made a sales call concerning OxyContin to a Decaturvi11e~area general practitioner on March 30, 2009, and wrote the following about her interaction: Asked doctor when are taking hydrocodone 5mgq4?6h and their pain becomes persistent if he will convert appropriate to Oxycontin 10mgq12h instead of titrating hydrocodone to 7. 5mg and 10mg tablets. Said he will convert sooner to Oxycontin 10mgq12h when they meet the indication. Said many of his are taking higher doses of hydrocodone so the conversions to Oxycontin are usually higher than Oxycontin 10mgq12h. Savings cards reminder. Said cards are bene?cial for third party pts. Transitioned to medicine induced constipation and asked him to recommend Senokot S. Also asked him to recommend Senokot for occasional constipation. Said many of his suffer from both and will recommend to his pts.324 277. Sales Representative 11 documented his sales call with four providers from a Lebanon?based physical medicine and rehabilitation practice group on July 9, 2009, as follows: talked to [practice group]. only [one of the providers] has used ryzollt and has had used on two with good results. everyone else said they forgot about ryzolt. did get committments to use ryzolt. did go over 321, positioning of ryzolt, dual matrix, and formulary changes. did close on the oxycontin savings cards with each clinician and ask for new with the oxycontin 15mg in needing more than 40mg and pt has pain per oxycontin pi with atc chronic mod to severe pain.325 323 PTN000119294 ID34399 (2/23/2009) (emphasis added). 32? PTN000119294 ID35605 (3/30/2009) (emphasis added). 325 PTN000119294 (7/9/2009) (emphasis added). 80 278. On July 9, 2009, Sales Representative 11 called on a Lebanon?area nurse practitioner and recorded his interaction as follows: second call on ryzolt. she said She will use ryzolt and liked our positioning of ryzolt and for oxycontin discussed 07: 40mg taking ate for pain per oxycontin pi.326 279. Likewise, Sales Representative 11 made a sales call concerning OxyContin to a Lebanon?area family physician on August 25, 2009, and wrote the following about his interaction: did discuss those 011 40mg that are taking ate for a persistent problem. to convert per pi to oxycontin 15mg q12. closed with 280. Sales Representative .11 documented his sales call with 4 providers from a Lebanon?based physical medicine and rehabilitation practice group on September 24, 2009, as follows: so far in this clinic 2 of the 5 clinicians have tryed ryzolt. [The] PA, and [the] NP. said he has not seen the pt back yet. said his was a pt that ryzolt was not covered. did go over ryzolt detail piece with all and discussed dual matrix, 231, formulary status.all said they would trail ryzolt. gave and discussed oxycontin conversion and titration guide. asked for new that are on 40mg taking ate and pain per oxycontin pi to use oxycontin 15mg q12. closed with OxyContin v. Products Containing Acetaminophen 281. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to other pain?relieving products containing acetaminophen when those claims were false, deceptive, and/0r unsubstantiated at the time they were made. 326 PTN000119294 11339507 (7/9/2009) (emphasis added). 327 PTN000119294 ID41218 (8/25/2009) (emphasis added). 328 19294 ID42679 (9/24/2009) (emphasis added). 81 '282. "studies comparin?g'the'safety? of its opioid products with those containing acetaminOphen, Purdue emphasized the dangers of excessive levels of acetaminOphen in the context of promoting its opioid products despite repeatedly recognizing that such claims were unsubstantiated comparative claims. 283. Purdue admitted in its Guidelines on Product Promotion that referring to OxyContin?s De?ned Maximum Dose? or ?Single Entity Opioid Status? ?could imply superiority of OxyContin? to non opioid/opioid combination products?329 despite having a marketing piece titled ?OxyContin Single-Entity Opioid Flashcard,? which was created help communicate to prescribers that OxyContin? is a single?entity opioid that does not contain acetaminophen, aspirin, or 284. Similarly, on July 20, 2009, Purdue?s Product Manager sent a bulletin to the company?s entire sales force that stated among other things: ?You must also remember never to discuss the maximum daily doses of APAP [acetaminophen] or ASA [aspirin] as this may lead to claims of implied superiority.?331 Elsewhere Purdue?s 2013 Guidelines on Product Promotion stated, ?Any discussion or reference to dosing limitations of another agent may lead to a claim of implied superiority.?332 285. In its 2013 Guidelines on Product Promotion, Purdue speci?cally listed unsubstantiated superiority claims as including: Asking the HCP if they could think of 1?2 Percocet? around?the-clock patients who could benefit from no acetaminophen. Stating to an HCP that they should start a patient on Butrans? or OxyContin? when they want to get patients off of acetaminophen. 3?29 PVTOOS 8322. 330 PWG000099907. 33? PTN000032056. 332 PWG000008057. 82 Discussing the bene?ts of no acetaminophen and q12h dosing with OxyContin? or 7 day dosing with Butrans?.333 286. Yet, Purdue?s marketing materials widely disseminated these same unsubstantiated claims in Tennessee. 287. Purdue created and/or distributed several written materials to warn providers and managed care companies about the dangers of too much acetaminophen. These included the following Purdue documents (identi?ed by Purdue?s coding): OMC103, PAP058, A5530R, P0400, and 288. One of these unbranded marketing pieces distributed by Purdue, titled ?Maximum Recommended Daily Doses of Opioid Analgesics Containing APAP (acetaminophen) or ASA (aspirin),? listed the maximum dosage of competing opioid productsz'35 and was often used by Purdue sales representatives to emphasize, directly and implicitly, that OxyContin had no- maximum dosage. 289. On websites that it controlled, Purdue linked to materials that misrepresented the potential dangers between both non-opioid and opioid products containing acetaminOphen and opioid products like OxyContin that do not contain acetaminophen. For example, on Purdue?s In the Face of Pain website, it linked to the APF guide for veterans, Exit Wounds, which misrepresented these potential dangers. 290. Exit Wounds stated in relevant part: 7 [A]ceteminophen can relieve mild to moderate pain and treat fever; but it is not an NSAID and will not reduce swelling. It produces few, if any, side 333 PWG000008059. 33? see also, PWG000325457 (Mgd Care Tab Showing OMC103 approved 1/14/2008); PWG00-0320843 (Spreadsheet Showing cease distribution attached to e-mail dated May 13, 2009). 335 PWG000089678. 83 ?effects at the doses-that can relieve pain,- butwitcanrd-amage the liver [when used in large doses, especially if used with alcohol. [A]cetaminophen is often combined with an opioid medication?usually, in the same pill or capsulewto treat moderate to severe pain. Be sure to check the amount with your doctor or pharmacist. Don?t decide on your own to take extra acetaminophen if a combination pain medicine is not controlling your pain, because you could end up using too much acetaminophen, and that could cause liver damage. Currently, there is concern in the medical community about the growing rate of liver damage associated with large doses of acetaminophen. Possible side effects of acetaminophen include: Possible liver damage at high doses[;] Liver damage and stomach bleeding if used in combination with alcohol[.] The pain-relieving properties of opioids are unsurpassed; they are today considered the ?gold standard? of pain medications, and so are often the main medications used in the treatment of chronic pain. Yet, deSpite their great bene?ts, opioids are often underused. For a number of reasons, healthcare providers may be afraid to take them. At the core of this wariness is the fear of addiction, so I want to tackle this issue head-on. Opioid medications can, however, be abused or used as recreational drugs, and some people who use these drugs this way will become addicted. Addiction is a disease state in which people can no longer control their use of a drug that is causing harm. They continue to crave and use the drug despite the harm it may be causing to their health, their relationships, or their ability to function in other spheres of life. Long experience with opioids shows that people who are not predisposed to addiction are unlikely to become addicted to opioid medications. When used correctly, opioid pain medications increase a person?s level of functioning; conversely, when a drug is used by somebody who is addicted, his or her function decreases.336 291. Purdue?s Tennessee sales representatives likewise made claims comparing OxyContin and other products containing acetaminophen. While not an exhaustive list, illustrative 336 PTN0000023114 (bold emphasis added, italicized emphasis in original). 84 examples of call notes in which Purdue?s Tennessee sales representative compared OxyContin and products containing acetaminophen are set forth below. 292. Sales Representative 5 documented his sales call with a Nashville-based family physician on May 10, 2007, as follows: doc agreed that many patients are taking too much apap and with oxycontin that would be one less concern. wants to discuss titration on next visit.337 293. Sales Representative 5 documented his sales call with a Nashville?based orthopedic surgeon on September 10, 2007, as follows: doc agreed that many patients are taking too much apap with prescription drugs and over the counter analgesics. one less concern with oxycontin.338 294. Sales Representative 5 documented his sales call with a Portland-based internist on October 11, 2007, as follows: doc said too much acetaminophen is being consumed by OTC and prescription pain medication. agreed that was one advantage of prescribing oxycontin. 339 295. Sales Representative 5 documented his sales call with a Nashville-based orthopedic surgeon on August 22, 2008, as follows: doc agreed that some postop pain could be severe for a few weeks. said 15mg oxycontin could help some of those patients without the concern of receiving too much acetaminophen. will consider.340 296. Likewise, Sales Representative 4 made a sales call to a Memphis-area internist on October 20, 2008, and wrote the following about his interaction: Me and Dr. discussedreducing pill burden and reducing APAP limits by going to long acting oxycontin sooner. Said that he had a patient that was 337 PTN000119294 ID12383 (5/10/2007) (emphasis added). 338 PTN000119294 ID16300 (9/10/2007) (emphasis added). 339 PTN000119294 ID17262 (10/11/2007) (emphasis added). 34? 1023151 (8/22/2008) (emphasis added). 85 ?taking vi?codin/percocet?q?h? and? wasn?t seeing ?any aid ='at'f1rst*he thought it was drug seeking because the patient was going throug them so fast. Said he moved the patient to 60mg of oxycontin and the patient was finallyseeing some pain control and stopped taking the both of the short 297. Likewise, Sales Representative 1 made a sales call to a Bolivar-area nurse practitioner on April 7, 2010, and wrote the following about her interaction: discussed oxycontin q12h dosing and fewer pills per day than SA meds. also discussed seo for patients on maximum levels of apap. discussed ryzolt positioning statement; OxyContin v. Hydrocodone Combinations 298. As the name suggests, hydrocodone combinations are opioids containing hydrocodone and other active ingredients including acetaminophen, aspirin, or other compounds. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to hydrocodone combinations when those claims were false, deceptive, and/or unsubstantiated at the time they were made. 299. Purdue instructed its Tennessee sales representatives to ask/providers, ?Last time [you] wrote script of hydrocodone did APAP toxicity come [to] mind??343 341 PTN000119294 ID30536 (10/20/2008) (emphasis added). 342 PTN000119294 ID51666 (4/7/2010) (emphasis added). 343 PWG004285362. 86 300. While not an exhaustive list, illustrative examples of call notes in which Purdue?s Tennessee sales representative compared OxyContin and hydrocodone combinations are set forth below. 301. On November 19, 2007, Sales Representative '4 called on a Memphis?area rheumatologist and recorded his interaction as follows: Discussion of short acting hyrdocodone and dangers of maxing out the APAP. review of safety in elderly from oxycontin 302. Sales Representative 14 documented his sales call with a Brighton?based family medicine physician on April 21, 2008, as follows: Quick hit reminder on the bene?ts of the extended line and introduced the new conversion guide to him. Asked him to keep patients continually getting re?lls on hydrocodone combos in mind as potentially being more e??ectively treated with Oxycontin. He said okay. Remidner for coupon cards.345 303. Sales Representative 1 documented her sales call with a Savannah-based internist on May 3, 2010, as follows: asked her what an oxycontin new start would be like. she said a patient with severe pain whom she trusts and can prove legitimate pain. asked her how many mg of hydrocodone she would be converting from. she said they would be maxed out at 10mg 4x per day. showed her conversion to 15mg q12h. discussed fewer tablets with oxycontin and treating without apap. asked was apap a concern for her. she said yes in some patients. also showed her indication which includes moderate atc pain so not limited to just severe 304. Likewise, Sales Representative 1 documented her sales call with a McKenzieubased internist on May 6, 2010, as follows: dr said he considers a patient to be chronic when they are taking 3 or more hydrocodone per month. discussed q] 2h dosing and treating without apap. PTN000119294 (11/19/2007) (emphasis added). 345 PTN000119294 ID23746 (4/21/2008) (emphasis added). 346 PTN000119294 ID52772 (5/3/2010) (emphasis added). 87 asked him. if he - would convert appropriate. patients who are: at thatw max number of pills who have chronic, arc pain. showed conversion ratio and that patients taking 30mg or less will convert to 10mg q12h. dr said he had a new ryzolt start yesterday.347 305. On June 4, 2010, Sales Representative 1 called on a Jackson~area internist and recorded her interaction as follows: showed dr that 5 of his 6 top plans have oxycontin covered at 2T which means the lowest branded copay for patients and no pa for his staff. asked him why would he treat a chronic pain patient with hydrocodone when patients can get oxycontin affordably and take fewer pills with no apap. he said he didn?t know coverage was so good. said he would look for appropriate conversions. discussed ryzolt coverage as 306. Sales Representative 1 called on a Jackson?area family physician on June 6, 2010, and recorded her interaction as follows: dr said he is currently starting oxycontin for low back, oa pain patients when they are maxed at 40mg hydrocodone or if he can tell that going from 7.5mg to 10mg isn?t going to make much difference. dr said he really likes lower doses of oxycontin. showed him 30mg and 40mg conversions. discussed fewer pills and no apap. showed dr coverage and explained top 3 of 4 plans have oxycontin at lowest branded copay. discussed ryzolt for cigna patients.349 OxyContin v. Lortab 0r Vicodin 307. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to Lortab or Vicodin, two brand name examples of hydrocodone combination products, when those claims were false, deceptive, and/or unsubstantiated at the time they were made. While not an exhaustive list, illustrative examples of 347 PTN000119294 ID53021 (5/6/2010) (emphasis added). 348 l9294 ID54433 (6/4/2010) (emphasis added). 349 PTN000119294 ID54617 (6/9/2010) (emphasis added). 88 call notes in which Purdue?s Tennessee sales representative compared OxyContin to Lortab or Vicodin speci?cally are set forth below. 308. On May 8, 2007, Sales Representative 4 called on a Collierville~area internist and recorded his interaction as follows: Asked him about how many patients have imprv.oed pain scores at least 4 points using lortab. Said many perceive it is working because they are taking it more often. Doesn?t hear much back from some patients and if he does its to request him to raise the dose. Explained the bene?t of better e?icacy and less dosing of oxycontin. Said he would give it a try 309. Sales Representative 11 called on an Antioch?based pain specialist on June 13, 2007, in which the sales representative recorded his interaction as follows: objective of day was to get them to go to long acting when approprate. discusseedpts on high dose short acting ie I 0mg lortab taking 4 to 5 a day. showed [American Pain Society Guidelines] on long acting. less end of dose pain and sleep better . all did say that would be using a pm for a persistent pain problem. will start to review one at a time to see if long acting is a appropriate per oxycontin 310. Sales Representative 14 documented his sales call with a Memphis-based internist on August 8, 2007, as follows: Discussed language from the PI that speaks to reasonable starting doses for opioid naiive patients. Also, walked doc through various conversions using the conversion guide. Emphasized indication and the similarities in analgesia b/t Vicodin 5/500 q4?6H and Oxycontin 10mg ql2H and asked doc to give strong consideration to Oxycontin over SA combos when the pain require-s ATC therapy for a continuous, extended period of time. Doc agreed.Also reminded doc about the coupon cards.352 3'50 PTN0001 19294 ID12300 (5/8/2007) (emphasis added). 351 19294 ID13549 (6/13/2007) (emphasis added). 3'52 PTN000119294 ID15249 (8/8/2007) (emphasis added) 89 311. Likewise, Sales "Representative ?11 made a sales call to a?BrentWoOd?area anesthesiologist and his nurse practitioner on March 26, 2009, and wrote the following about his interaction: in office today i talked about taking lortab or percocet 0mg with apap 500mg. discussed apap use over a year and they were concerned with that much apap over a year. discussed to then titrate per indication over to oxycontin 312. Sales Representative 4 documented his sales call with a Memphis-based family doctor on January 15, 2010, as follows: Doc said that she doesn?t have many new starts on oxycontin. I reviewed with her conversion formula and relayed the basis 1 to 1 conversion for her hydrocodone patients. When asked doc said that she doesn?t really know how long she has patients on a lortab or vicodin and ?gures that many are on either 5 or 7.5 mg dose. Told doc these are new oxycontin patients and to focus on cutting down the amount of pills these patients are taking and more e?ective pain control with switching to 10 or 5 mg dose for oxycontin. Doc didn?t commit but said that is interesting and she never looked at it that OxyContin v. Percocet 313. In its marketing in Tennessee, Purdue represented that OxyContin was safer than, more effective than, as effective as, or superior to Percocet, the brand name for a combination short-acting opioid product containing oxycodone and acetaminophen, when those claims were false, deceptive, and/or unsubstantiated at the time they were made. While not an exhaustive list, illustrative examples of call notes in which Purdue?s Tennessee sales representatives compared OxyContin and Percocet are set forth below. 353 PTN000119294 (3/26/2009) (emphasis added). 35" PTN000119294 11347548 (1/15/2010) (emphasis added). 90 314. On May 21, 2007, Sales Representative 4 called on a Germantownmarea obstetrician/gynecologist and recorded his interaction as follows: Said the cards are coming in handy f0r the patients she has on oxycontin. Said she has a few that pay cash for theirs and the $50 is still bene?cial even for them. Discussed the patients on percocet and upgrading to oxycontin when they are reaching APAP lin?zitationsL]355 315. Sales Representative 2 documented his sales call with a Knoxville-based physical medicine and rehabilitation doctor on August 6, 2007, as follows: asked for pt taking percoet around the clock that needed dose increase and problem sleeping he said that was one place he uses Oxycontin reminded of Saving Card 316. Sales Representative 2 documented his sales call with a Knoxville~based oncologist on August 20, 2007, as follows: Said he thought OxyCOntin was a good drug unfortunately it has received bad press discussed using for pt who can no longer tolerate morphine and pt ?rst line who are doing well with percocet and need to be on long acting for pain 317. Sales Representative 7 documented his sales call with a Rogersville-based family medicine physician on February 18, 2009, as follows: Had a new doc that is going to be starting there when done with residency [Provider]. We went over low dose conversions from lortab and percocets. Went over the fewer tablets, atc pain control and no apap. Both agreed. I also pointed out appropriate starting dose for opiate naive patient. He asked how much oxycontin cost, I said did you know that it is available on most insurance plans for a 2nd tier 355 PTN000119294 11312773 (5/21/2007) (emphasis added). 356 PTN000119294 11315174 (8/6/2007) (emphasis added). 357 PTN000119294 ID15675 (8/20/2007) (emphasis added). 353 PTN000119294 11334223 (2/18/2009) (emphasis added). 91 318. Sales Representative 4 documented his sales call with a Memphis?based anesthesiologist on March 10, 2010, as follows: Reviewed with him and nurse [Provider] what the actual copay scenario would be for a patiennt and making sure that for these patients he is writing oxycontin .Doc reminded me again that he is not writing any new oxycontin prescriptions. Pointed out that even though they are not new patients he is still re?lling and has plenty patients that are candidates for switching to oxycontin sooner because of the high doses of percocet they are taking and apap 319. On July 14, 2010, Sales Representative 1 made a sales call to a Jackson?area nurse practitioner and wrote the following about her interaction: [Wje discussed that oxycontin o?ers the ejj?icacy of oxycodone but allows him to treat with fewer pills than with percocet and without apap. showed him conversion formula and .9 conversion ratio from hydrocodone. asked him if there are patients in the jackson clinic with commercial and med insurance and he said lots. we looked at formulary grids and explained coverage. asked him if he would write oxycontin instead of percocet for patients with those plans we discussed. he said certainly.360 320. Sales Representative 6 made a sales call to a Knoxville-area family doctor on May 13, 2013, and wrote the following about his interaction: Discussed OxyContin and he asked if there was a maximum dose for OxyContin. I told him there has been no maximum dose established in our clinical trials. He says he has one patient taking ?ve of the 80 mg tablets a day. Acknowledgedthat?s an exception and is a high?dose compared to the other patients he has on OxyContin. We discused the dosing conversion chart from Percocet and I asked him to consider in any patient who?s not comfortable with Q6 dosing or having to get up in the middle the night to take their medication.361 359 PTN000119294 ID50182 (3/10/2010) (emphasis added). 36? PTN000119294 ID56266 (7/14/2010) (emphasis added). 361 PTN000119294 ID130004 (5/13/2013) (emphasis added). 92 321. Likewise, Sales Representative 6 made a sales call to a Knoxville?area family physician on June 18, 2014, and wrote the following about his interaction: also reminded [Provider] of the opportunity in patients with declining hepatic function who may not be appropriate for a hydrocodone formulation containing acetaminophen. He agreed and thought that was a good point. Quick reminder of OxyContin and the opportunity to convert appropriate patients on three or more doses a day of the short?acting oxycodone. [Provider] agreed an extended release is appropriate in that situation but they tend to refer many of those patients out to a pain clinic. I asked them to consider in elderly patients who they?re not comfortable sending to a pain clinic and he agreed to consider.362 322. On June 23, 2014, Sales Representative 6 called on a Knoxville-area emergency medicine physician and recorded his interaction as follows, along with comments from his district manager two-and-one-half weeks later: Discussed OxyContin use in appropriate patients. Reviewed the Percocet conversion chart and discussed opportunities inappropriate patients on three or more doses a day of the short-acting oxycodone. [Provider] agreed that getting patients on an extended release makes sense and will consider in his patients. I reminded him of the formulary coverage and savings card discount for cash pay pts. He said he?s not taking any new pain patients so any use of OxyContin or Butrans will have to come from his current patient population. iPhone up on his newest patient on Butrans. [Provider] said he?s not heard from patient and doesn?t know if they?re still taking the Butrans or not. We talked about the updated and expanded coverage for Medicare and appropriate elderly patients who might be candidates for Butrans. I mentioned speci?cally patients with declining hepatic function who may not be appropriate for an opioid with acetaminophen. [Provider] thought that was a good idea and Butrans would be a consideration. Left him the Butrans Tear?off sheets for application guidelines.20mcg 416. Substantially similar claims were made by: Sales Representative 11 to a Lebanon? based nurse practitioner on July 16, 2007;438 Sales Representative 7 and District Manager 3 to a Johnson City-based pharmacist on July 8, 2008;4g9 Sales Representative 2 to a Knoxville-based 436 PTN000119294 ID69677 (3/8/2011) (emphasis added). 48" 19294 ID72610 (4/18/2011) (emphasis added). 438 PTN000119294 ID14473 (7/16/2007). 439 PTN000119294 ID26270 (7/8/2008). 120 family doctor on November 8, 2007;490 Sales Representative 4 to a Collierville?area family physician on August 28, 2007;491 Sales Representative 14 to a Bartlett?based internist on September 16, 2008;492 Sales Representative 7 to a Johnson City~area institutional client on September 26, 2008;493 Sales Representative 12 to a Cleveland~based supplier on May 21, 2009;494 Sales Representative 1 to a Lexington-based pharmacist on November 4, 2009;495 Sales Representative 3 to a Tazewell-based health care institution on December 1, 2009;496 Sales Representative 13 to a Columbia-based internist on September 14, 2010;497 Sales Representative 24 to a Memphis?based geriatric medicine specialist on November 4, 2010;498 Sales Representative 1 to a Humboldt?based pharmacist on November 11, 2010;499 and Sales Representative 25 to a Columbia-area family physician on May 10, 2011.500 E. OMISSIONS OF MATERIAL CONNECTIONS 417. Purdue routinely referred to positions that third party pain advocacy groups would take with respect to a health care issue without clearly and conspicuously disclosing the material fact that Purdue was a substantial ?nancial contributor to the third party group. 418. This material omission had the effect of making the third party pain advocacy group?s position appear more credible or more neutral than it otherwise would had the material fact of Purdue?s substantial monetary contribution been disclosed. 49? PTN000119294 11918326 (11/8/2007). 49] PTN000119294 11915907 (8/28/2007). 492 PTN000119294 11929114 (9/16/2008). 493 PTN000119294 11929712 (9/26/2008). 494 PTN000119294 11937885 (5/21/2009). 495 PTN000119294 11944685 (11/4/2009). 4% PTN000119294 1D45908 (12/1/2009). 497 PTN000119294 ID59806 (9/14/2010). 498 PTN000119294 11962232 (11/4/2010). 499 PTN000119294 ID62706 (11/11/2010). 500 PTN00011929-4 11974421 (5/10/2011). 121 419.- Purduegwasrthe to theAmerican Pain. Society (APS). Between 2012 and 2017, Purdue gave APS 56% of its total funding, providing $542,259.52, compared with $420,465 combined from four other opioid manufacturers.501 From 2006 to 2016, Purdue gave APS at least $628,925 in educational grants.502 Between 1997 and 2012, Purdue gave APS $3,091,264.503 420. Purdue was also the predominant financial contributor of the American Academy for Pain Medicine (AAPM). Between 2012 and 2017, Purdue provided 60% of total funding, providing $725,584.95 compared with just $473,825 from four other large branded~opioid manufacturers.504 421. Purdue also signi?cantly funded the American Pain Foundation (APF), which was highly dependent on phamiaceutical company funding and produced numerous publications touting the use of opioids to treat chronic pain. Between 2006 and 2016, Purdue gave APF $1,356,000.505 Between 1999 and 2012, Purdue was one of biggest donors, with donations totaling $3 .6 million.506 422. With Purdue?s ?nancial backing, APF created several documents that advanced messages that were favorable to Purdue. For example, APF published Treatment Options: A Guide Senate Report available at: 502 PWG000096255. 503 PTN000017361. . 50? Senate Report available at: 505 PWG00096255. 506 PTN000017361. 122 for People Living with Paih507 that downplayed and omitted the serious risks of opioids while overstating the risks of non-steroidal anti-in?ammatory drugs (NSAIDS) and acetaminophen.508 423. Unsurprisingly, APF took actions that were directly in Purdue?s interest. As shown in' internal emails, Purdue even worried that APF would be perceived as acting too much on its behalf where position was consistent with branded manufacturers, as opposed to positions more consistent with general pain patient advocacy.509 424. APF took action that directly bene?ted Purdue. For example, APF responded to an article titled ?Grieving Mother Pushing Oxy Ban -- 18?year?old son died of overdose? in a Florida newspaper.510 425. APF and Purdue were so connected that Dr. Richard who was one of the principal owners of Purdue, even e-mailed Dr. David Haddox, Purdue?s Vice President of Health 9 Policy, upon learning that APF shut down in May 2012 after a Congressional investigation launched, stating, ?What is the story here? We were founding funders.?5 11 From: Sadder, Dr Richard To: Haddox, Dr. J. David Sent: 5I8i2012 1 1:44:42 PM Subject: FW important Announcement What is the story here? We were founding funders. 507 PWG009243 973. 503 1 . 509 PTN000024706. 510 PTN000023984. 5? PTN000023246 (emphasis added). 123 426. Purdue referred to third party groups in its marketing materials without disclosing its ?nancial connection to the groups alongside authoritative, unbiased sources. OJ 2? - ?le arsouncss ?lm. RELIEF .. PREVENTING .t ??55 Edition I: r4 h? 42?. Providing Relief Preventing Abuse brochures, as shown in the excerpt above, that were handed out to the general public in Tennessee, included APS and the AAPM along with references to federal regulatory and law enforcement agencies such as the DEA and FDA without disclosing Purdue?s funding connection to APS or thlil?iI.?2 428. SimiIarly, Purdue?s website referenced APS and AAPM as authoritative resources without disclosing Purdue?s ?nancial connection to the groups.?3 429. In standardized presentations Purdue created to give to health care providers and other groups, Purdue held out APS and among others as ?Resources for Appropriate Pain 5'3 ?6l. 5'3 PWGDOGGSS 82. l24 Management and Responsible Prescribing Practices? without disclosing Purdue?s funding connection to these groups.514 430. Purdue also linked to deceptive APF materials like Exit Wounds on its pain advocacy website, without disclosing Purdue?s signi?cant funding of the group.515 431. Purdue?s Tennessee sales representatives frequently referenced recommendations from other pain advocacy groups that Purdue signi?cantly funded without clearly and conspicuously disclosing this material fact. 432. For example, Purdue instructed its sales representatives to use the APS guidelines to advance its own branded marketing message. As with materials published by other pain advocacy groups, the APS guidelines advanced Purdue?s position by emphasizing the superiority of delivery of the opioid by oral use and attempting to legitimize high doses of opioids, de?ning a ?high? dose to be 200 MME per day.516 433. On May 8, 2007, Sales Representative 4 called on a Collierville?area internist and recorded an interaction in which the sales representative discussed the APS Guidelines without disclosing Purdue?s funding connection to APS. The call note from the interaction states as follows: Discussed the limitations again with using so much tylenol Said that is just has less of a bad perception with many patients, however she realizes the dosing limitations and will go to oxycontin next once the patient is exceeding the APS 514 PWG000290879. 515 516 PWG000225448. 5? PTN000119294 ID12301 (5/8/2007) (emphasis added). 125 434. On May "21, "Representative? 4' *called**on a - Germantown?area gynecologist and documented an interaction in which the sales representative discussed APS recommendations concerning fentanyl, a competing opioid product, without disclosing Purdue?s funding connection to APS. The call note from the interaction states as follows: Recommendation of senokotns for pain med patients and patients that are pregnant because of gentleness and speci?c delivery system. Never thought about it as a preference but said good point because of the stool softner on board. Discussed from APS lag time of fentanyl . Mentioned that he has some problems with this with patients saying it doesn?t last as long and adhesion issues.518 435. Sales Representative 4 documented his sales calls with a Memphis-based family doctor on May 23, 2007, as follows: Said that he will only go to 40mg of oxycontin unless absolutely necessary. Reviewed APS guidelines and safety at the higher doses 436. On June 7, 2007, Sales Representative 11 called on a Franklin-area family physician in which the sales representative told the provider that APS recommended oral ingestion of opioids without disclosing Purdue?s funding connection to APS. The call note reads as follows: looked through my sample box, and he wanted to discuss laxative. and the slow mag. and colace. only was able to discuss duragesie vs oxycontiri. said he uses duragesic if pt has a hard time remembering to take med or likes the patch. showed ops oral route prefered because of convenience, ?exability, and steady blood level. 437. On June 12, 2007, Sales Representative 11 called on a Murfreesboro?area anesthesiologist in which the sales representative told the provider that APS recommended oral 518 PTN000119294 ID12771 (5/21/2007) (emphasis added). 5'19 PTN000119294 ID12888 (5/23/2007) (emphasis added). 520 PIN000119294 ID13346 (6/7/2007) (emphasis added). 126 ingestion of Opioids without disclosing Purdue?s funding connection to APS. The call note reads as follows: 438. saw in surgery center. he was going out did get in a good discussion of duragesic . he had a question about the patch. after he agreed with the aps oral is the better route.521 On June 13, 2007, Sales Representative 11 called on an Antioch~based pain doctor and his physician assistant in which the sales representative showed the providers APS materials concerning longwacting opioids when discussing patients on high dose short acting such as Lortab taken multiple times a day without disclosing Purdue?s connection to APS. The call note reads as follows: 439. objective of day was to get them to go to long acting when approprate. discusseed on high dose short acting ie 10mg lortab taking 4 to 5 a day. showed aps on long acting. less end of dose pain and sleep better . all did say that would be using a pm for a persistent pain problem. will start to review one at a time to see if long acting is a appropriate per oxycontin On June 13, 2007, Sales Representative 14 called on a Memphis-based internist and showed the provider APS materials that referred to the potential bene?ts of OxyContin for patients who failed on NSAIDS without disclosing Purdue?s connection to APS. The call note reads as follows: Quick hit reminder 0n the APS guidelines for treating 0A pain. Stressed the language that speaks to the potential bene?ts of low dose oxycontin for patients that have previously not responded to NSAIDs. He said he would keep it in mind.523 521 PTN000119294 ID13510 (6/12/2007) (emphasis added). 522 19294 11313549 (6/13/2007) (emphasis added). 523 PTN000119294 ID13580 (6/13/2007) (emphasis added). 127 440. Similarly, on June 14, 2007, Sales Representative 14 called on another Memphis- based internist and showed the provider APS materials that referred to the potential bene?ts of OxyContin for patients who failed on without disclosing Purdue?s connection to APS. The call note reads as follows: Covered the APS guidelines for treating 0A pain. Stressed the language that speaks to the potential bene?ts that can be seen when NSAID failures are treated with 1 0mg Oxycontin q12H. Doc thanked me for the information and said that he continues to use Oxycontin where appropriate.524 441. On June 21, 2007, Representative 11 called on a Nashville?based internist and referenced APS materials that purportedly showed that long-acting opioids produce less end of dose pain and allow patients to sleep better at night, without disclosing Purdue?s connection to APS. The call note reads as follows: discussed new starts and when to go to long acting. showed aps less end of dose pain and sleep better at night. said if you see pain is persistent and per oxycontin pi then long acting. discussed 10mg usage in some of those patients. said he did not know we had a 442. On June 22, 2007, Sales Representative 5 called on a Hendersonville-based family physician in which the sales representative referred to APS materials supporting the use of OxyContin for patients going to bed in pain without disclosing Purdue?s connection to APS. The call note reads as follows: APS 5th edition-~supports use of oxycontin for patients going to bed in pain. doc said he would inquire, more, of his patients on how pain disrupts getting a good nights rest.526 524 PTN000119294 ID13584 (6/14/2007) (emphasis added). 525 PTN000119294 ID13833 (6/21/2007) (emphasis added). 526 PTN000119294 ID13905 (6/22/2007) (emphasis added). 128 443. Substantially similar claims without disclosures were made "by: sales Representative 5 to a Gallatinuarea family physician on June 25, 2007;527 Sales Representative 4 7528 to a Germantown~area nurse practitioner on August 15, 200 and a Collierville?area family physician on August 28, 2007;529 and Sales Representative 11 to a physical medicine and rehabilitation specialist on September 4, 2007.530 F. VIOLATIONS OF 2007 AGREED FINAL JUDGMENT 444. Under the 2007 Judgment that Purdue entered into with the State of Tennessee, Purdue was supposed to establish, implement, and follow an Abuse and Diversion Detection (ADD) program in which it would identify and act upon facts received from the ?eld that were indicative of abuse or diversion from June 15, 2007 to May 6, 2017. 445. The nonnexclusive facts referenced in the 2007 Judgment include: 0 an apparent pattern of an excessive number of patients for the practice type, such as long lines of patients waiting to be seen, waiting rooms ?lled to standing-room-only capacity, or patient prescriber interactions that are exceedingly brief or non?existent; - an atypical pattern of prescribing techniques or locations, such as repeated prescribing from an automobile, or repeated prescribing at atypical times, such as after usual of?ce hours when the Health Care Professional is not on call; 0 information from a highly?credible source or several sources pharmacists, law enforcement, other health care workers) that a Health Care Professional or their patients are abusing or diverting medications; sudden unexplained changes in prescribing or dispensing patterns that are not accounted for by changes in patient numbers or practice type; 0 a Health Care Professional who has a disproportionate number of patients who pay for of?ce visits and dispensed medications with cash; 527 PTN000119294 ID13918 (6/25/2007). 523 PTN000119294 ID15515 (8/15/2007). 529 PTN000119294 ID15907 (8/28/2007). 530 PTN000119294 ID16086 (9/4/2007). 129 0 multiple allegations that individuals from aylparticular praCtice have overdosed; or unauthorized individuals signing prescriptions or dispensing controlled substances. 446. Purdue also identi?ed the following speci?c examples of suspicious conduct for abuse and diversion in a training document describing its ADD program: 0 On a consistent basis, a long line of patients waiting to get prescriptions; A waiting room ?lled to capacity or standing room only; 0 Patient contact with a prescriber that is exceedingly brief or non- existent; . A volume of prescriptions that seems to signi?cantly exceed what you would expect from geographical data and the type of . . . practice; 0 Repeated prescribing at atypical times, such as after usual of?ce hours when the Prescriber is not on call; 0 Very restricted of?ce hours yet signi?cant volume of prescriptions; Practices heavily populated with young patients (teens and early 20?s); 0 Practices in which more than 35% of the patients pay for their prescription with cash; 0 A pediatrician, dentist, podiatrist (or other unusual specialty for a prescriber of opioid analgesics) who starts writing prescriptions for OxyContin? Tablets; 0 A prescriber with no history of writing OxyContin or other Schedule II controlled substances begins writing multiple 80 mg OxyContin prescriptions; A sudden increase in OxyContin prescriptions where no new HCP or Prescriber joined the practice; a A credible allegation that a Prescriber . .. staff member or patient has abused or is actively abusing substances, such as alcohol, illicit drugs or prescription medications; A Prescriber?s practice with a large number of patients who travel signi?cant distances, for example, across state lines, to obtain and/or ?ll their prescriptions without a rational explanation; 0 Numerous out?of-state license plates on cars in the parking lot; 130 0 Patients traveling from areas where there are pain management or other trained ?'healthcare' "professiOnal's to visit 'a practiCe that "lacks an outstanding reputation; A prescriber?s practice where there are reports that patients make frequent early requests for new prescriptions signi?cantly in advance of the time the initial prescription would normally be completed; 0 A credible allegation that a law enforcement or regulatory authorities are conducting an active investigation regarding a Prescriber related to their prescribing activities, diversion or substance abuse; 0 A Prescriber that moves his or her practice from one city or state to another on more than one occasion within a couple of years without obvious explanation; A Prescriber with an atypical patient population based on Prescriber?s location and other attendant circumstances; 0 A Prescriber with an atypical patient p0pulation based on Prescriber?s location and other attendant circumstances; and A disproportionate number of younger patients for the nature of the practice; among others.531 447. The 2007 Judgment required Purdue to take appropriate steps based on these facts; including the cessation of promotion of Purdue products to a speci?c health care provider if Purdue had knowledge of this suspicious conduct. 448. Purdue stated in a training document that the purpose of this ADD program was ?to enhance the likelihood that the Company does not promote its opioid products to a Prescriber about whom Purdue has a concern relating to the prescribing or dispensing of controlled 449. As part of its ADD program; Purdue required its sales representatives to submit reports of concern (ROCs) if they witnessed any of the above?listed factors and prohibited them from calling on providers they reported until they received further instruction from Purdue. Purdue 53] 532 PWGOO381617 (emphasis added). 131 then madewthe either ?fcease .calling?.? designation in which Purdue?s Law Department directed its sales representatives not to call on a speci?c provider, or keep the provider in ?continue calling? status. 450. Overall, Purdue routinely did not place a provider into cease calling status despite credible information indicative of abuse or diversion. Instead, Purdue usually did so only a?er a provider was subject to adverse licensure action, a criminal charge, conviction, or guilty plea, ifar all. Notably, Purdue requested the provider?s sales data as part of its decision process.534 451. Purdue?s ADD program had inherent structural de?ciencies. In establishing, implementing, and following its ADD program, Purdue: 0 failed to take appropriate action based on unambiguous, credible signs of abuse or diversion; 0 failed to consistently implement a cease calling directive once issued; 0 systematically placed a speci?c health care provider in cease calling status and not the provider?s clinic or supervisees who also prescribed opioids?aside from rare exceptions; 0 failed to respond or make decisions in a timely manner to reports or questions from sales representatives and district managers about suspicious providers; 0 created disincentives for sales representatives to report suspicious provider activity to Purdue?s Law Department; and I structured sales representative bonuses to heavily incentivize calls on high-volume prescribers of Purdue?s opioids. 452. As illustrated below, Purdue had knowledge of credible information that various providers and practices were engaging in the abuse or diversion of OxyContin or other opioids and 533 See PTN000031810. 534 See, PTN000042234 (cease call directive); PTN000042243 (continue call directive). 132 failed to act on this information. Purdue?s lack of action under the ADD program was especially true for Purdue?s highest volume prescribers of OxyContin. 453. At various times, Purdue?s Phoenix database, which Purdue?s sales representatives used to identify health care providers to target, still included providers who had been placed in cease calling status as potential targets.535 454. Purdue?s sales representatives repeatedly called on health care providers a?er they had been placed in cease calling status.536 Purdue sales representatives called on one provider who was previously identi?ed by law enforcement as being one of the most problematic prescribers in the area at least 13 times while he was in cease calling .S?I?az?as.537 455. According to internal Purdue documents, Purdue only reprimanded one sales representative in Tennessee for calling on prescribers in cease call status orafter a report of concern was submitted.538 456. In addition, except for isolated examples, Purdue merely made recommendations to cease calling on suspicious health care providers, not to cease calling on speci?c clinics, of?ces, or even any of the provider?s supervisees who also prescribed opioids.539 This practice allowed a Purdue sales representative to continue calling on the provider?s supervisees or the provider?s 535 See, PTN000040179. 536 See, PTN000031807 ID111986 (10/1/2013); PTN000119294 ID159232 (4/16/2014); and PTN000039271. See also, PTN000119294 ID137939 (8/8/2013) (noti?cation that doctor was supervising physician at Pain Clinic PTN000119294 ID168024 (7/25/2014) (report that doctor was still the supervising physician at Pain Clinic PTN000119294 ID142209 (9/23/2013); PTN000119294 ID144696 (10/17/2013); PTN000119294 ID146491 (11/6/2013); PTN000119294 ID147280 (11/13/2013); PTN000119294 1D150180 (12/18/2013); PTN000119294 ID151387 (1/13/2014); PTN000119294 ID154177 (2/19/2014); PTN000119294 ID155218 (3/4/2014); PTN000119294 ID158660 (4/8/2014); PTN000119294 ID161081 (5/5/2014); PTN000119294 ID163625 (6/2/2014); PTN000119294 1D166526 (7/8/2014); and PTN000119294 ID169020 (8/6/2014). 537 See PTN000119294. 5?38 1. 539 see also, PTN000036379. 133 clinic even when the entire Clinic was Suspected of abuse or? diversion Ur?the're'were?other'red ?ags I that were not limited to a single provider. 0n numerous occasions, Purdue kept calling on a provider?s supervisees when the supervisor had been placed in cease calling status or on other providers from a clinic when there were red ?ags that were not limited to a single provider.?0 457. Purdue?s home office frequently failed to timely reSpond to reports and questions about suspicious providers from sales representatives and district managers even after repeated prompts.541 458. In one example, Purdue had direct reports from a Sheriff and a narcotics detective on July 18, 2007 that two providers had questionable prescribing practices542 and had been disciplined by the Tennessee Board of Medical Examiners,543 as well as reports from sales representatives that contained classic red ?ags such as high numbers of cash paying patients, crowded waiting rooms, and reports of patients dying from overdoses.544 Despite these reports, Purdue waited one and one-half years before making a decision to cease calling on these two providers. Even then, Purdue only made the decision the day after news broke on February 4, 2009 of the providers? arrests and indictments for illegally supplying large quantities of prescriptions to hundreds of people, including a visibly pregnant woman whose child was later born with neonatal abstinence 459. Similarly, on October 30, 2008, Purdue received both a report that a provider was being investigated by the Tennessee Board of Medical Examiners546 and a report that local 540 See, PTN000031807 11986 (10/1/2013); PTN000031807 1D194150 (4/16/2014). 541 See, PTN000038338 and PTN000031810 (48 days until cease calling Status). 542 543 PTN0003 8268; PTN00003 8275. 544 PTN000038298. 545 PTN00003831 1?12. 546 PTN000042203M04. 134 pharmacists were seriously questioning the prescribing practices of the same provider.547 Purdue waited a full year and a half to make a decision until April 5, 2010. In the meantime, that provider had at least one patient die from an overdose of OxyContin548 and the provider was disciplined by the Tennessee Board of Medical Examiners for his inappropriate prescribing of controlled substances.549 460. Likewise, in 2013, Purdue waited 48 days to make a cease calling decision after receiving a ?rsthand report from one of its sales representatives that a 40 year-old patient was being closely coached on how to ?ll out intake forms by a much younger woman the patient came in with, both the patient and the younger woman were visibly nervous, and the clinic had a new sign stating that it provided MRIs 'for $270 cash.550 461. All of these providers mentioned above were among the top prescribers of OxyContin in Tennessee and were speci?cally and continuously targeted by Purdue sales representatives. 462. Purdue?s ADD program in many instances con?icted with Purdue?s primary focus: sales. Purdue?s Marketing Department attributed declines in its market share in part due to Region 0, a term often used interchangeably with Purdue? 3 ADD program. In its Data and Market Insights for 2011, Purdue stated its OxyContin brand share declined 0.6 points and attributed Region 0 as i one of the factors?-51 547 PTN000042206. 543 139?4 1. 549 PTN000042074. 55? PTN000038338. 55? PW6000324230. 135 .1 463 . In. addition to Purdue is .salesrepresentative . compensation program .that always. had prescription sales from targeted providers as a primary component, Purdue also created internal policies to actually dis?incentivize sales representatives from reporting suspicious providers. 464. For example, Purdue?s Incentive Bonus Program, which was effective January 1, 2013, made clear that sales representatives would not receive a bonus based on sales from providers whom the sales representatives reported to Purdue?s Law Department that were placed in cease calling status. However, under this Program, Purdue sales representatives would potentially still receive a bonus based on prescribers? sales data that sales representatives did not initially report but who were later placed in cease calling status by the Law Department.552 The Incentive Bonus Program stated: 5.1.3.2 Where the Sales Representative reports a prescriber pursuant to RSOP 1.7.1 and the Law Department ultimately determines that the Sales Representative should cease calling on that prescriber, the sales and sales history attributable to that prescriber will remain removed from the Sales Representative?s bonus calculations. 5.1.3.3 Conversely, where the Law Department determines that a Sales Representative should cease calling on a prescriber who was not initially reported by the Sales Representative, the sales history attributable to that prescriber may be manually added back into the Sales Representative?s bonus calculations at the company?s discretion following a review of the circumstances.553 465. While some Purdue sales representatives provided superiors with reports about suspicious prescribers, they did so in spite of the Incentive Bonus Program or their general compensation structure and far less often than they engaged in activity that undermined Purdue?s ADD duties. 552 PWG003 874628. 553 PWG003 874628. 136 466. As an illustrative example, Sales Representative 3 made a sales call to a Kingston? area family doctor on July 20, 2007, and wrote the following about his interaction: very interested in pain told me prescribes a lot of oxycontin but not brand due to street value asked him why it mattered if thought was going to end on street - point well received - interested in itmes to assist in pt 467. As an additional part of the bonus system, Purdue held a yearly national sales contest in which members of the sales force competed to be in the ?TOpper?s Club,? by either ?nishing the contest year as a district leader or in the top 10% of all representatives in the nation, generally based on the number of opioid prescriptions attributed to that representative. Sales personnel who were in the Purdue Topper?s Club won trips as well as money. 468. Purdue also structured bonuses for its sales staff to focus on its highest volume prescribers, which it termed ?super core? and ?core? prescribers.555 Purdue used a point system to allocate bonuses that rewarded sales representatives who had the highest percentage of total sales calls with super core or core prescribers, who were also more likely to be the most problematic sprescribers.556 Purdue repeatedly emphasized in memoranda to its sales representatives, ?It is extremely important that all Sales Force colleagues maintain a high energy level, and continue the focus solely on Core and Super Core selected prescribers.?557 469. Sales Representative 11?s career with Purdue demonstrates this perverse incentive. He was a member of the Purdue Topper?s Club558 for at least six years'and earned a total of $35,238 in related bonuses. Sales Representative 11 was also ranked ?rst nationally as the ?OxyContin 554 PTN000119294 ID14658 (7/20/2007) (emphasis added). 555 See, e. g, PWG003 874461 (?District Manager Incentive Program?). 556 PWGOO3 874461. 557 See, e. g, PTN000033091 (emphasis added). 558 PTN000056968. 137 Product?Leader? ianurdue? ?contest based on OxyContin prescription number-s, . for several. years running.559 Purdue rewarded his success in selling its Opioids. In 2010, Sales Representative 11?s base salary was $110,743.11, yet he earned and additional $128,592 in bonuses.560 In 2014, Sales Representative 11 participated as a member of Purdue?s Sales and Marketing Advisory Council.561 470. Sales Representative 11 called on a large number of highly problematic providers who ended up in cease calling status, criminally indicted, and/or had adverse licensure action taken against them, including many of the ones discussed below. For example, he called on Dr. Michael Rhodes, Dr. James Pogue, Dr. Mireille Lalarme, Dr. Visuvalingam Vilvarajah, Dr. Donald Boatright, among many others, as well as problematic pain clinics, such as Pain Clinic F, and pharmacies. Sales Representative 11 also ranked as high as second among all Purdue sales representatives for redemptions of OxyContin savings cards by patients of prescribers he called upon.562 The savings cards provided up to a $90563 discount off the purchase of OxyContin, could be used repeatedly, and were closely associated with cash-paying patients and high volume practices. 471. Other Purdue sales representatives who called on these same problematic providers ?led some ROCs to Purdue. Yet Sales Representative 11, despite calling on some of these providers for years and having access to other sales representatives? call notes for these providers, almost never reported them to Purdue. Purdue never disciplined Sales Representative 1 for failing to report abuse and diversion, despite ample evidence of it. Instead, they rewarded his blind eye. 559 See, PTN000032549. 560 PTN000036126. 561PTN000033821. 562 PWG000046398. 553 138 472. In other cases, Purdue ignored suspicious behavior. For example, in 2016 after a sales representative reported that a large health insurance company was ?pulling credentials for prescribing patterns? for a pain clinic, Purdue?s Law Department responded: This appears to be an insurance-related issue, not an SOP 1.7.1 issue, therefore we will not be Opening an ADD inquiry and you can continue calling on this practice. If you do learn of or observe any SOP 1.7.1 concerns, please be sure to report them immediately.564 Purdue employees used the term SOP 1.7.1 or 1.7.1 to refer to the section in Purdue?s Standard Operating Procedures that established circumstancesin which sales representatives were not supposed to make a sales call on a provider. During the time the ADD program was in effect, 1.7.1 was used interchangeably to describe the ADD program itself. 473. The inadequacy of Purdue?s ADD program and its failure to take appropriate steps is set forth in the following illustrative examples with speci?c health care providers and practices in Tennessee. Dr. Michael A. Rhodes, Sr. Cease Calling Status Date: November 3, 2015 474. Dr. Michael Rhodes was a family doctor in Spring?eld and one of Purdue?s top prescribers of OxyContin in Tennessee. From 2006 to 2015, Dr. Rhodes prescribed 102,166 tablets of 80 mg OxyContin?one of Purdue?s highest doses.565 From 2006 to 2015, Dr. Rhodes prescribed 319,560 total tablets of OxyContin.S66 Purdue had knowledge that at least 217 of Dr. Rhodes?s patients paid with cash for OxyContin in 2008.567 554 PTN000079780-8 1. 565 PTN000031809. 566 PTN000031809. 567 PTN000056674. 139 475. Dr. Rhodes wrote 297 prescriptions for OxyContin in 2007; 1,082 in 2008; 1,204 in 2009; and 1,307 in 2010. Between 2006 and August 2016, he wrote a total of 4,921 prescriptions for OxyContin, 3,593 of which were written in a three-year span.568 476. Purdue ?rst called on Dr. Rhodes on February 10, 2004,569 and would call on him at least 126 additional times between January 30, 2006 and August 27, 2015570 though there are indications that Purdue called on him more often than re?ected in the call notes.571 477. Purdue even called on Dr. Rhodes 3] times a?er the Tennessee Board of Medical Examiners placed his license on restrictive probation on May 22, 2013.572 478. Purdue reviewed ROCs ?led by sales representatives and af?rmatively decided to keep Dr. Rhodes in continue calling status on April 5, 2010, November 14, 2012, and August 26, 2013?the last of which occurred after his license was placed on probation.573 479. As outlined below, before Purdue ?nally moved Dr. Rhodes to cease calling status on November 3, 2015,574 it had knowledge of reports of patient overdose deaths from Dr. Rhodes?s prescription of OxyContin, a knife ?ght outside his of?ce, choreographed urine screenings, several relevant investigations by the Tennessee Board of Medical Examiners that led to disciplinary actions and ultimately the revocation of his medical license, an accusation of insurance fraud, his high patient volume, and that Dr. Rhodes was contemplating a business name change after discovering he was being investigated by the State. 568 PTN000052837. 559 PTN000042047. 57? PTN000031807. 57? See PTN00042221 (ROC Sales Representative 5 ?led on 10/23/15 saying Dr. Rhodes informed him that his license was suspended); PTN000031807 (listing last call note for Dr. Rhodes on 8/27/15). 572 573 PTN000031810. 57? PTN000031810. 140 480. While other Purdue sales representatives had been calling onhim for years, "Sales Representative 13 began calling on Dr. Rhodes on April 14, 2008.575 Sales Representative 13?s notes indicate that during this ?rst meeting, Dr. Rhodes told her that ?he heard Oxycontin is 80 dollars a pill on the street [d]id not reveal source,? and she ?[r]eminded him of the appropriate patient and the indications for Oxycontin.?576 481. That same day, Sales Representative 13 also called on a pharmacy, where she and the pharmacist ?[d]iscussed the [prescription] writers in town and she con?rmed I was going to the right places. Said Dr. Rhodes uses much TNcare and she is usally having to be on the phone for long periods of time for his patients.?577 482. On May 8, 2008, District Manager 1 accompanied Sales Representative 13 on her call with Dr. Rhodes and he stated: ?Documentation resources presented, doctor agreed to implement and have sta? print, new presented, agreement for 30mg and 60mg, Snokot samples and dosing.?578 483. A month later on June 26, 2008, Sales Representative 13 submitted an ROC about Dr. Rhodes which stated: Had lunch today and went over the new savings cards and ordered cme?s for Dr. Rhodes, as I was sitting in his o?ice, there were two patients in a knife ?ght outside the o?ice?s front door, I overheard one of the patients saying he wanted his ID. Many patients were lottery the o?ice as they have the past two times I was in there. Concerned the doctor is being taken advantage of by some drug seekers. Dr. Rhodes said he does urine drug screens but tells the patient when he will do the next drug screen. Said he was trying to get the pain management forms together. Said he has many patients saying that their doctors are referring patients to him because they can?t write any narcotics but he can, he asked me why they cannot write it. 575 PTN000042087. 576 PTN000042087. 577 PTN000119294. 573 PTN000035268 (emphasis added). 141 Said his patient load that morning was 40 people for the morning that someone oV?erbooke'd himks?79 484. Purdue?s Sales and Marketing Department forwarded this ROC to Purdue?s Risk Management the next day on June 27, 2008.580 485. Sales Representative 13 submitted another ROC about Dr. Rhodes to Purdue on July 2, 2008, which stated: On Monday evening, I was in the back yard with my sister~in?law in Clarksville, TN. Her neighbor a Nurse Practitioners, told me that she has been sending many of her patients, who are asking for pain medication to Dr. Boatwright?s o?ice, where Dr. A has been prescribing narcotics for them. She said she had heard that if you o?er enough money Dr. A will write whatever you ask forterritory but his partner Dr. Boatwright has several other locations with Dr. Rhodes from Spring?eld TN. Dr. Boatwright and Dr. Rhodes are in my territory. A report was made last week, by me. I have heard that Dr. Boatwright is in physical medicine and he will not write narcotics.?1 486. This ROC was also forwarded to Purdue?s Risk Management department on July 2, 2008.582 487. On September 3, 2008, Sales Representative 5 called on an Ashland City pharmacy, where the pharmacist told him that ?most of the high dose oxycontin prescriptions are coming from rhode and [another 488. Despite documenting her concerns, Sales Representative 13 continued to regularly make sales calls to Dr. Rhodes.?4 Sales Representative 13?s October 30, 2008 call note for Dr. Rhodes stated: ?Went over the Drug monitoring program for Tn and Kentucky, said he has not 579 (emphasis added). 580 PTN000042217. 58? PTN000041565 (emphasis added). 5'82 PTN000041565. 583 PTN000119294. 584 142 beening [sic] doing those but will. Said he is changing the name of the clinic from pain clinic to medical clinic because he is having to submit some patients charts to the TN Boards.?585 489. Notably, on that same day, Sales Representative 13 also submitted three separate ROCs to Purdue?s Sales and Marketing Department concerning Dr. Rhodes.586 In the ?rst ROC, Dr. Rhodes was listed as the reporter and Sales Representative 13?s summary of the event stated: ?[He s]aid the Tn medical board is investigating him on some of his patient records and he is concerned. Said he feels he has been treating too many pain patients and he is going to have to change the name of his clinic from pain clinic to medical clinic.?587 490. Sales Representative 13?s second ROC on October 30, 2008 stated: Talked with [pharmacists], [pharmacist] said she is concerned Dr. Michael Rhodes may not be doing the right thin for his patients, she felt that he was just giving the patients whatever they want. [Pharmacist] said he tore up two scripts of Oxycontin yesterday from Dr. Micheal Rhodes clinic, one from the doctor and one from the NP within 10 days apart, called Dr. Rhodes and asked him to tear up the script.588 491. The third ROC submitted by Sales Representative 13 on October 30, 2008 stated: Doctor new to this practice and as we discussed the 10 point plan and Oxycontin, said asked if Dr.Rhodes was my highest prescriber for Oxycontin, I told her many physicians treat pain with Oxycontin. This made me quite uncomfortable.539 492. A little over a week later, on November 7, 2008, Sales Representative 5 called on Dr. Rhodes.590 585 PTN000042088 (emphasis added). 586 587 PTN000042204 (emphasis added). 538 PTN000042206 (emphasis added). 539 PTN000119294 (emphasis added). 590 PTN000042058. 143 493. on November 12,2008, an attorney emailed Sales Representative 13 with a request to call her at Sales Representative 13?s earliest convenience to discuss the second ROC.591 While the content of the call is not known to the State, Sales Representative 13 again called on Dr. Rhodes on December 11, 2008, and she and Sales Representative 5 continued regularly calling on Dr. Rhodes.592 494. On January 1, 2009, Purdue printed Sales Representative 13?s call notes for Dr. Rhodes from July 26, 2007 to December 11, same ones referenced above.593 495. Sales Representative 13 submitted another ROC to Purdue on February 6, 2009, which read: [Provider] asked if we recommend oxycontin to be taken more often than q12h, I stated no our product insert states clearly, we are only indicated q12h, he asked me to share that with Dr. Rhodes because he has seen him write it q8h and q6h. Told [Provider] I have shared that with Dr. Rhodes and will share that with him again.594 496. Sales Representative 13 entered a call note on March 4, 2009, which read, ?[Pharmacist] told me most of the high dose oxycontin prescriptions are coming from drs. rhodes [and other Multiple other pharmacies made similar statements to Purdue?s Sales Representatives 5 and 13.596 497. A call note entered by Sales Representative 13 on April 28, 2009 read as follows: Went over the conversion guide and reminded of the 15mg strength tablets. Said he would use the 15mg. Also went over the PI and the highest dose studied with oxycontin, said that information did help to see the average 591PTN000042205. 592 PTN000042058. 593 PTN000042086-88. 594 PTN000119294 (emphasis added). 595 PTN000119294. 596 19294. 144 dose of the study was 105mg strength. Reminded of the savings cards as well.597 498. On August 17, 2009, Purdue printed a report from NewsChannel 5 titled ?Mother accuses Spring?eld doctor of prescribing pain medication for no reason.?598 499. The report, which was dated four days earlier on August 13, 2009, stated: Tonight serious concerns about a pain clinic and whether prescriptions for powerful narcotics are written for no good medical reason. New at six, a young man is dead and a mother is grieving. But the doctor in question tells us he did nothing wrong. [Patient A?s Mother] says she lost her son to prescription narcotics. Patient A died in January. Each week his mother cleans his headstone and asked herself why. [Patient A ?s Mother] says her son did not suffer from chronic pain, yet he was able to obtain prescriptions for oxycodone from among other, Dr. Michael Rhodes Sr. at this Spring?eld pain clinic. Dr. Rhodes is still practicing medicine at the clinic in Spring?eld but the state board of medical examiners has taken notice, citing problems with nine di?erent patients. They issued a formal reprimand citing the doctor for unprofessional or unethical conduct, gross malpractice or negligence in the course of medical practice, and dispensing, prescribing any controlled substance not in good faith to relieve pain and suffering. [Clinic manager] says Dr. Rhodes sees many patients who have nowhere else to go, most of them on TennCare, and many seeking relief from pain. Dr. Rhodes says he does not prescribe narcotics for no medical reason. . .599 500. On August 24, 2009, Purdue documented that Patient A?s mother called the company and reported that: 597 PTN000042026 (emphasis added). 598 PTN000042043. 599 PTN0000-42043- (emphasis added). 145 0 her son?s autopsy revealed he had accidentally overdosed on OxyContin given by Dr. Rhodes; 0 Dr. Rhodes had given her son 90 80 mg OxyContin tablets and 60 Lyrica 75 mg tablets despite a history of addiction to OxyContin; 0 Dr. Rhodes started her son on 40 mg of OxyContin instead of 10 mg; a Dr. Rhodes still had his license but was reprimanded and charged with negligence and gross and repeated malpractice with 10 patients; and 0 ?Dr. Rhodes is feeding addicts.?600 501. Purdue submitted an FDA-required adverse event form on August 31, 2009 that stated that Patient A?s death was an accident and though he had previously taken Lyrica and Suboxone as concomitant medications, he died ?from the toxic effects of OxyContin.?601 ?m-v-i The patient died dun OBJAREOGQ from the toxic effects of OxyCon?n. The manner of death was. accidental. 502. Purdue also sent a letter to Dr. Rhodes concerning the adverse event report around the same time. 503. Before it submitted the adverse event form on August 31, 2009, Purdue received and reviewed a copy of the state medical examiner?s report, excerpted below, that stated, my opinion, the cause of death is toxic re?ects of oxycodone. The manner of death is accident.?602 miss smegma Malta man, was a history of drug abuse, was found unresponsive in has ras?aianm. Autopsy reveals pulmonary ads-ma, The mmo?ism blood non-tam an aiavatad taxes? of axycodona, in my opinion, the cause daath is toxic a?aota of Tina means: of death is seminar. 600 . 60} PTN000042103 . 602 PTN000042110 (emphasis added). 146 504. Sales Representative 5 next called on Dr. Rhodes on September 25, 2009 during which Dr. Rhodes ?told [the sales representative that] he received a letter from Purdue. must have been an adverse event. will be cautious in prescribing oxycontin.?603 The letter Purdue sent to Dr. Rhodes on September 1, 2009 informed him that Patient A had overdosed on OxyContin and that Patient A?s mother had given Purdue permission to contact Dr. Rhodes for more information.604 505. In addition to the NewsChannel 5 report that referenced the disciplinary action, Purdue?s internal records indicate that Purdue had knowledge no later than September 25, 2009 that the Tennessee Board of Medical Examiners formally disciplined Dr. Rhodes on July 21, 2009.605 506. The Tennessee Board of Medical Examiners found that Dr. Rhodes ?[pjrescribed controlled substances without documenting apprOpriate medical histories and/or performing adequate physical examinations to justify the medical necessity and/or duration of the medications.?606 As a result, the Board took action against Dr. Rhodes?s license and fined him.607 507. In spite of this disciplinary action by the Board and direct knowledge of his patient?s overdose death from OxyContin, Purdue continued to call on Dr. Rhodes. 603 PTN000042056. 60" PTN000042099. 605 PTN000042074. 606 PTN000042074 (emphasis added). 607 PTN000042074. 147 ??508; provided-by 'EPurdue-rsshow-that the?cornpany was aware of and classi?ed the events as red ?ags and suggested that sales representatives provide Dr. Rhodes with a documentation kit.608 Miler Eat/lain a: 4 My: 151,. yr. PM 1444,, can? W5 (W) 509. On December 2, 2009, Sales Representative 5 called on Dr. Rhodes and recorded that Dr. Rhodes ?told me some of the staff in the of?ce don?t trust me, but he has no problem because I gave him resources to help him in prescribing oxycontin.?609 510. Despite all of this information, Purdue closed its 17-month long investigation into Dr. Rhodes on April 1, 2010 and directed its sales representatives that they could continue calling on Dr. Rhodes.61? Sales representatives had not ceased calling on Dr. Rhodes during Purdue?s investigation, however, but instead called on him no fewer than 24 times during this period, once with a district manager present. Purdue never reprimanded or disciplined any of the sales representatives or district managers who called on Dr. Rhodes. 511. On July 26, 2010, Sales Representative 5 called on Dr. Rhodes and was accompanied by District Manager 1, who wrote the following: 608 609 PTN000119294. 610 PTN000031810. 148 Reviewed the updated OxyContin fpi, discussed patient selection and documentation, doctor agreed on to ?Ryzolt, doctor asked percentage of patients who receive ef?cacy with product. [Sales Representative good job with the Ryzolt fpi and discussing the clinical data within this document and the current indication. Doctor agreed and requested additional savings cards. Reminder on the Senokot for opioid induced constipation, dosing, and provided samples.611 512. On January 4, 2011, Purdue?s Law Department received an email from District Manager 1 that referenced another interaction with Patient A?s mother during which she said that her son died of an overdose from OxyContin originally prescribed by Dr. Rhodes. The body of the e?mail stated: Today, I was conducting a training meeting at the Hampton Inn and Suites in Mt. Juliet, TN. I was approached by the employee working the front desk and her name is [Patient A?s mother?s ?rst name]. She saw that Purdue Pharma was on the schedule for one of the meeting rooms and notified me that her son died of an overdose on OxyContin two years ago. She stated that he bought the drug of the street and that the drug was originally prescribed by Dr. Michael Rhodes of Springfield, TN. She said that she was on the television news two years ago on a segment regarding this physician. In addition, she has been working to change the Tennessee Intractable Pain Law that according to her does not allow prescribers to be criminally held responsible. She has also mentioned that she spoke to [Purdue] in the past regarding this situation.612 513. Purdue continued to pressure Dr. Rhodes to prescribe more and more Opioids, even when he expressed concerns regarding his own ability to competently do so. For example, on August 9, 2011, Sales Representative 5 called on Dr. Rhodes and recorded that found the Butrans dinner meeting as information overload. He felt Butrans is too complicated to prescribe. He wants to decrease patient?s use of short acting medication. I told him to prescribe Butrans. He is very reluctant.?613 611PTN000035268 ID1554 (emphasis added). 6?2 PTN000042037 (emphasis added). 613 PTN000119294 (emphasis added). 149 514. On March 30, 2012, Purdue veri?ed 'Dr. "Rho?des?s il?icensure status via the Tennessee Department of Health?s website which indicated that the Tennessee Board of Medical Examiners had reprimanded Dr. Rhodes for ?unprofessional conduct.?614 515. On April 23, 2012, District Manager 1 accompanied Sales Representative 5 on a sales call and wrote the following comment: Good job of ?nding Dr. Rhodes new practice. He had at least 20 patients waiting and he stated he did not have time today. Reminded him of OxyContin and Butrans, he stated he is seeing more Primary Care patients, asked you to come back in two weeks.615 516. Sales Representative 5 recorded the following for the same sales call: I reminded dr. rhodes that I continue to promote Butrans and oxycontin. He told me he is no longer in pain but primary practice. He refers his patients to a pain clinic. Doc told me to come back in two weeks and we will discuss his practice.?6 517. Sales Representative 5 called on Dr. Rhodes again on June 18, 2012, and Dr. Rhodes, again, told Sales Representative 5 that he was ?not a pain clinic and will not prescribe Butrans or oxycontin.? 518. On August 28, 2012, the next time Sales Representative 5 called on him, Dr. Rhodes once again ?said he is referring his pain patients to pain clinics. He said he is not prescribing Butrans or oxycontin. He is maintaining patients on what they are presently on, but no new prescriptions.?617 519. On August 27, 2012, District Manager 1 accompanied Sales Representative 5 on a sales call for Dr. Rhodes and wrote the following comment: 614 PTN000042040. 615 PTN000035268. 516 PTN000119294 (emphasis added). 617 PTN000119294. 150 520. problems. On October 9, 2012, Sales Representative 5 emailed Purdue?s Law Department and District Manager 1 to report that ?Dr. Rhodes told me he is meeting with his lawyer, on tomorrow, because Americhoice has accused him of ?aud. He mentioned that he wrote a wrong date on the chart, which led to the accusation. 521. [Sales Representative we need to wait a few months to see if this HCP is able to register as a Pain Clinic in Tennessee. He has been reported to the Law Department in the pastand we have been allowed to continue sales calls. Based on the information provided directly by the HOP this morning, he claims to not have any new pain patients in his practice and is getting away from treating pain. Please continue to provide any new information to the Law Department regarding changes to this practice as per the ADD policy.618 Purdue had knowledge of additional red ?ags about Dr. Rhodes?s prescribing ?619 On November 14, 2012, Purdue yet again determined that sales representatives may continue calling on Dr. Rhodes.620 522. On May 22, 2013, the Tennessee Board of Medical Examiners disciplined Dr. Rhodes for the second time and placed his license on restrictive probation for ?ve years. 523. Among other things, Dr. Rhodes admitted to: prescribing narcotics and other medications and controlled substances in amounts and/or for durations not medically necessary, advisable, or justi?ed for a diagnosed condition[;] prescrib[ing] controlled substances for pain for his patients without a clear objective finding of a chronic pain source to justify the ongoing and increasing prescribing[; prescrib[ing] controlled substances and other medication without documenting a written treatment plan with regard to the use of controlled substances and other medication; fail[ing] to prOperly or consistently monitor for or seek out and respond to signs of substance abuse on the part of his patients[;] [and] provid[ing] few modalities of treatment other than the prescription of controlled substances.621 613 (emphasis added). 619 (emphasis added). 620 621 (emphasis added). 151 (District ManagernL- emailed-Purdue?s LawDepartmentton-June .2013 .to.-report: was informed today that Michael Rhodes o?icially lost his medical license. He has [been] reported numerous times for various reasons.?622 525. In spite of this information, on August 26, 2013, Purdue?s Law Department sent an email stating that ?[sjales representatives may continue to call of Dr. Michael Rhodes. If however, any negative relevant information about Dr. Rhodes? prescribing or his practice comes to light, the sales force should contact the Law Department for review and recommendation.?623 526.. Sales Representatives continued to report red ?ags to Purdue, such as Dr. Rhodes?s of?ce being open on Christmas Eve in 2013, which Sales Representative 5 noted as ?[0]ne of the few offices open.? 527. As stated above, Purdue?s sales representatives called on Dr. Rhodes at least 31 times after his license was placed on restrictive probation.624 528. For example, Sales Representative 5 and District Manager 1 called on Dr. Rhodes on May 22, 2014 and continued to encourage him to write more prescriptions, despite his objection: Good delivery of Insight #16, developed constructive tension, doctor gave the getting out of Pain Management objection. Good job refocusing him to appropriate patients for OxyContin because he still sees Pain Patients.625 529. On September 18, 2015, the Tennessee Board of Medical Examiners revoked Dr. Rhodes?s license for repeatedly violating the Board?s orders. 622 PTN000042201 (emphasis added). 523 PTN000042089 (emphasis added). 624 PTN000031807. 625 PTN000035268 (emphasis added). 152 530. On October 22, 2015, Sales Representative 5 informed Purdue of the Board? action by submitting another ROC. It stated that ?Dr. Rhodes informed me that his medical license has been taken (revoked) by the Tennessee Medical board and his practice is currently closed.?626 This report was forwarded to Purdue?s ADD-Legal, Drug Safety, and Pharmacovigilance, and Risk Management departments the next day, and Purdue veri?ed his licensure that day as well.627 Purdue also printed Dr. Rhodes?s ?Current Prescriber on October 23, 2015, which showed him still prescribing hundreds and hundreds of narcotic painkillers per month.628 531. On November 3, 2015, six weeks after Dr. Rhodes lost his license to practice, Purdue ?nally placed him in cease calling status and instructed sales representatives that they 9 ?should not call on? him.62 Dr. James Pogue Cease Calling Status Date: July 30, 2012 532. Dr. James Pogue, a family doctor practicing in Brentwood, was the number one prescriber of OxyContin tablets in Tennessee from 2006 to 2016?despite not prescribing any tablets from 2013 to 2016.630 Dr. Pogue?s proli?c prescribing habits and use of OxyContin prescription savings cards for cash paying patients were indicative of red ?ags of which Purdue had knowledge. 533'. Between insurance, cash, Medicaid, and Medicare Part payors, Dr. Pogue prescribed a total of 562,703 tablets of 80 mg OxyContin631?mone of Purdue?s highest doses?and 626 PTN000042221 (emphasis added). 627 628 PTN000042038. 629 PTN000042091. 63? PTN000031809. 631 PTN000031809. 153 which translates into 240 MMEs per day when taken as directed.632 During a six month period in 2009, Dr. Pogue alone generated $655,106.19 in revenue for Purdue.633 534. From 2009 to 2012, Dr. Pogue?s patients redeemed approximately 2,733 OxyContin savings cards to pay in part for their prescriptions?? Approximately 1,808 of those savings cards handed out by Dr. Pogue were used for 80 mg OxyContin prescriptions.635 From January to October 2010, Dr. Pogue?s patients redeemed 1,808 OxyContin savings cards?? compared with a total redemption off-1,7 14for alt prescribers in his territory. 535. Data from savings card redemptions that Purdue collected and tracked also shows that Dr. Pogue wrote numerous, incredibly high dose prescriptions of OxyContin to younger patients. According to Purdue?s savings card data, the average age for Dr. Pogue?s patients who used savings cards was 39 and the average number of pills per prescription was 85.63? 536. Purdue?s savings card data for speci?c days tell a similar story. As a representative example, Purdue knew through its savings card data that Dr. Pogue prescribed 11,990 OxyContin 80 mg tablets and 130 OxvContin 60 mg tablets?5?33 to 20, mostly younger patients that redeemed savings cards at pharmacies on April 19, 2010 as indicated in the chart below: April 19, 2010 Savings Card Redemptions Patient Age and Dose Strength Number of Tablets Days? Supply Gender (?32 (?33 {?34 PTN000056673. 635 PTN000056673. ?3?5 PTN000108464. 63" ms PTN000056673. 154 537. High quantities of high dose OxyContin, such as those obtained on April 19, 2010 through OxyContin savings cards, are especially troubling because they pose a greater risk of abuse or diversion. While the street value of OxyContin can vary by geographic location, the US. Drug Enforcement Administration (DEA) has previously found that diverted OxyContin generally sells for $1 per milligram.639 At $1 per milligram, the prescription referenced above for a 30 day supply 639 1 0/1 0550/ 105 50p.pdf. 155 O?f 24080mg"oxyContint?tablets if diverted"Would"have?a?street value? 'of' $19,200 . ?As known to Purdue, Dr. Pogue also prescribed a 30-day supply of 240 tablets of 80 mg OxyContin that was purchased using a Purdue savings card with the same unique patient identi?er on February 18, 2010, March22, 2010, May 17, 2010, June 17, 2010, and July 13, 2010.640 At $1 per milligram, these prescriptions would have a street value of $1 15,200. 538. Purdue knew through the savings card data that it collected of other examples of many other high quantity/high dose prescriptions from Dr. Pogue that were extremely likely to have been diverted. Purdue compiled savings card data showing that Dr. Pogue wrote a 24 year? old male a 12?day prescription for 150 tablets of 80 mg OxyContin ?equivalent to 1,000 mg or 1,500 MMES a day. Dr. Pogue also wrote a 12-day prescription for 180 tablets of 80 mg OxyContin, which equals 16 tablets per day, or 1,920 MMES per day, over 2] times the CDC ?5 90 MME cautionary limit.641 539. Dr. Pogue or someone at his of?ce repeatedly asked for additional OxyContin or other prescription savings cards or coupons that his patients could use repeatedly to save up to $60 on co-pays at the time on January 2, 2008, September 30, 2008, February 12, 2009, July 20, 2009, July 30, 2009, November 6, 2009, March 2, 2010, April 16, 2010, and April 27, 2010.642 540. Purdue reviewed Dr. Pogue?s status on October 8, 2009, December 13, 2010, and April 29, 2011, and each time Purdue decided to keep him in continue calling status.643 541. Before moving Dr. Pogue to cease calling status on July 30, 2012, Purdue devoted substantial resources to Dr. Pogue. Purdue sales representatives called on Dr. Pogue at least 53 64? PTN000056673 ID636 (2/18/2010); PTN000056673 ID1547 (3/22/2010); PTN000056673 ID2868 (4/19/2010); PTN000056673 ID4702 (5/17/2010); PTN000056673 ID6922 (6/17/2010); and PTN000056673 ID8730 (7/13/2010). PTN000056673. 642 PTN000039189. 643 PTN000031810. 156 times from December 8, 2005 to May 1, 201,2?more than half of those occurring after his license was reprimanded in .2009.644 Sales Representative 11 also called on Dr. Pogue at least 5 times while Purdue was conducting an investigation, but Purdue never disciplined him for it. 542. In contrast, Purdue immediately took action after it was told that an insurance provider was not approving any long acting opioids for Dr. Pogue. On April 3, 2009, Sales Representative 11 checked internally with the Purdue Senior Account Manager of Managed Markets, after Dr. Pogue ?mentioned that americhoice is not approving any of [Dr. Pogue?s] long actings including morphine and opana in march. I did call [Purdue?s Senior Account Manager] and told him about this.?645 543. Aside from this, Purdue had knowledge of facts indicative of abuse or diversion of OxyContin at Dr. Pogue?s practice for years before placing him in cease calling status. In a sales call on October 22, 2007, Sales Representative 11 documented a discussion with Dr. Pogue in which he stated ?he did not know about the [state?s] prescription [drug] monitoring program.?646 544. Sales Representative 11?s call notes reference Dr. Pogue being rushed, too busy, or only being able to talk through the waiting room window on June 23, 2006, August 21, 2006, January 2, 2008, August 22, 2008, and September 30, 2008.647 545. According to an Internal Review Memo, during a three month period in 2009, Purdue documented that Dr. Pogue had 14% of patients receiving single entity opioids pay cash and 52% of patients receiving single entity opioid generics paid cash.648 Purdue had knowledge 644 PTN000031807. 645 PTN000039164. 646.PTN000039167. (?43 PTN000039171. 157 that 424 patients of Dr. Poguepaid in cash in 2010.649 Another Purdue report regarding Dr. Pogue?s prescribing data indicated that 23.49% of 479 transactions were in cash during a three month period in 2010.650 546. The Tennessee Board of Medical Examiners disciplined Dr. Pogue on September 15, 2009 for engaging in unprofessional conduct related to treatment of pain with human growth hormone and preprinted patient records. 547. Purdue had repeated notice of this disciplinary action as early as October 8, 2009 and again on December 13, 2010,651 April 29, 2011,652 May 25, 2011,653 and July 25, 2011,654 yet Purdue decided to allow sales representatives to continue calling on him. 548. On April 5, 2010, Sales Representative 16 submitted an ROC to Purdue which stated: ?[Pharmacist] then expressed concern about Dr. Pogue. He said the patients he gets coming into his pharmacy is paying cash for their Oxycontin.?655 549. Sales Representative 25 entered a call note on January 2, 2012, which read, ?[Pharmacist] said most of his scripts come from 'Dr. Pogue and Dr. Cochran downtown Nashville.?656 550. Less than two weeks later, on January 13, 2012, Sales Representative 13 submitted an ROC to Purdue which stated: ?[Pharmacist] said he has seen a few of his patients move from a 649 PTN000056674. 650 PW000039189. 652 PTN000039139 (print date April 29, 2011); see also PTN00039133 (Metadata lists last modi?ed date as of 4/29/2011). 653 PTN000039 90. 654 PTN000039194 (Metadata lists last modified date as 7/25/2011). 655 PTN000119294. 656 PTN000119294. 158 long acting opioids that was working to SA Oxycodone. The two doctors that stand out [Pharmacist] stated Dr. Cochren and Dr. Pogue.?657 551. On May 16, 2012, District Manager 1 forwarded a media report from Nashville?s CBS af?liate about Dr. Pogue titled ?Undercover Pain Clinic Video Shocks Lawmakers?658 that referenced ?people sitting in their cars and standing near the clinic instead of waiting inside an often fall waiting room,? people waiting at the clinic between 6 and 9 1/2 hours before seeing the doctor, patients sharing pills, a patient describing how she sells the drugs Dr. Pogue prescribed her, and patients snorting crushed pills in a car after ?lling a new prescription.659 552. Dr. Pogue was the only doctor at the clinic and pharmacy records for one patient showed the doctor had ?prescribed him 180 Oxycontin [sic] pills and 180 Oxycodone pills, month after month last year.? District Manager 1 stated in his May 16, 2012 email to Purdue?s Law Department, ?It appears this involves Dr. James Pogue who has been reported to your [Law] Department in the past.?660 553. On June 18, 2012, Sales Representative 5 submitted a ROC which was forwarded to Purdue?s ADD-Legal and Risk Management Departments that stated, ?Dr. Rhodes brought to our attention that a Dr. Pogue was videotaped, by channel 5 news, prescribing large quantities of Oxycontin and Roxicodone.?66.1 . 554. On June 22, 2012, Sales Representative 8 submitted another ROC to Purdue concerning Dr. Pogue: ?Pharmacy also reported Dr. James Pogue, located in Brentwood, TN. 557 PTN000119294. 558 PTN000039188. 659 (emphasis added). 660 PTN000039188 (emphasis added). 66? PTN000039181 (emphasis added). 159 ?Pharmacy stated-?that ?Pogueis?underinvesrigation for?misuse'iand "abuse-?for prescribing pain medications. Pharmacy will not?ll Dr. Pogues 555. On July 6, 2012, Sales Representative 13 called on a Nashville nurse practitioner who ?asked if 1 called on Dr. Pogue; told her no; [she] said that type of pain clinic makes it dif?cult for her to prescribe opioids.?663 556. On July 30, 2012, Purdue ?nally placed Dr. Pogue in cease calling status664m?75 days after Purdue?s Law Department was made aware of the NewsChannel 5 story. 557. Purdue?s placement of Dr. Pogue into cease calling status on July 30, 2012665 came almost three years after the Tennessee Board of Medical Examiners reprimanded Dr. Pogue on September 15, 2009 for ?unprofessional, unethical, or dishonorable conduct?666 for pain treatment involving human growth hormone. 558. The Tennessee Board of Medical Examiners later suspended Dr. Pogue?s license on November 28, 2012 for his prescription controlled substance practices including: prescribing . .. any controlled substance not in the course of professional practice, or not in good faith to relieve pain and suffering, or not to cure an ailment, physical in?rmity or disease or in amounts and/or for durations not medically necessary, advisable or justi?ed for a diagnosed condition? and ?prescribing a controlled substance if such person is addicted to the habit of using controlled substances without making a bona ?de effort to cure the habit of such patient.667 7. Between 2007 and 2010, Respondent failed to take an apprOpriate history or perform a medically appropriate physical examination and/or failed to document such, requisite to justify prescribing or dispensing of narcotics and other medications and controlled substances to [twenty?two patients] 662 PTN000037057 (emphasis added). 663 PTN000031807. 65? PTN000039214. 665 PTN000039214. ?6 PTN000039159. ?7 PTN000039159. 160 8. Between 2007 and 2010, Respondent failed to obtain medically appropriate diagnostic "teSts or ?obtain appropriate medical consultations and/or failed to document such, requisite for the appropriate initiation and/ or continuation of care for patients] 9. Between 2007 and 2010, Respondent prescribed or otherwise distributed controlled substances to [twenty?one patients] when the quantity, duration and method was such that the persons would likely become addicted to the habit of taking said controlled substances, failed to provide the patient with information about the bene?ts and risks of narcotics and/or other controlled substances or failed to document such and failed to make a bona ?de effort to cure the habit of such persons or failed to document any such effort[.] 10. Between 2007 and 2010, Respondent prescribed controlled substances to [twenty-one patients] when such prescriptions were not in the course of professional practice, not in good faith to relieve pain and suffering, or not medically necessary, advisable or justi?ed for a diagnosed 559. Purdue kept Dr. Pogue in continue calling status for three years after his license was reprimanded and despite knowledgeof red flags such as the high number of cash paying patients and the high volume of his practice. Even after the company had knowledge of a television report that stated Dr. Pogue was prescribing large quantities of OxyContin, had wait times up to nine and a half hours, and had patients waiting in the parking lot outside of his clinic, Purdue waited 75 days until placing him in cease calling status. Dr. Allen Foster Cease Calling Status Dates: January 9, 2007 to July 17, 2009; February 7, 2011 560. Dr. Allen Foster, an anesthesiologist who operated pain clinics in Morristown and Knoxville,669 was one of the top prescribers of OxyContin in Tennessee, especially in high ?53 036 l_1 12812. 669 PTN000041795. 161 doses.670 From 1998 to 2017, Dr. Foster prescribed 1,049,199 OxyContin tablets, of which 85% or 892,754 were 4-0 mg or higher.671 561. During a six month period from May 3, 2008 to November 3, 2008, Dr. Foster wrote 1,41 0 prescriptions for OxyContin, which generated $758, 580. 83 in revenue for Purdue.672 562. Purdue placed Dr. Foster in cease calling status on January 9, 2007.673 Purdue decided to move Dr. Foster back to continue calling status on July 17, 2009,674 presumably in response to a request from one of Purdue?s sales representatives. 563. Purdue placed Dr. Foster in continue calling status in 2009 in spite of a 2006 report that he was involved in a ?drug ring,? Purdue?s own referral of Dr. Foster to the DEA, and other red ?ags indicative of abuse or diversion. 564. Before and during the period from 2009 to 2011 that Purdue returned Dr. Foster to continue calling status, Purdue had knowledge of reliable evidence indicative of abuse or diversion. 565. On January 16, 2007, Purdue contacted the Nashville ?eld of?ce of the DEA to make a referral and submit a report regarding Dr. Foster?s prescribing habits of controlled substances.675 Despite this report, Purdue decided to place Dr. Foster in continue calling status in July 2009??over two years later. 566. On November 12, 2007, Sales Representative 2 and District Manager 2 called on Dr. Foster for a site inspection and the manager?s comments read: 67? PTN000031809. 671 PWG003984543. 672 PTN000041814. 673 PTN000041803. 674 PTN000041815. 675 PTN000045571. 162 . .. made:awzsite?inspection= call. per [PurdueLawDepartment] .on. .doctor. . Spoke with of?ce manager and she said they were using the for tn and were dismissing daily for misuse or failed uds. Spoke with both pa?s and doc. they are all doing uds and they are documenting and getting informed consent. doc was very knowledgeable about pain meds and his of?ce was fully staffed with lab on site and x-ray. the parking lot was full, but all tags were from the immediate area. they have a security guard on the premises. the waiting room was full and most looked legit. there were several young healthy males in the o?ice that did stand out. the rx pads were kept in a drawer in the o?ice managers o?ice. at one point a nurse came in and asked for a script pad and took one out of the drawer. i cannot say whether or not there are problems here for certain. [Sales Representative 2] and i will talk with legal about the status.676 567. Purdue continued to call on Dr. Foster?s clinic in spite of these red ?ags. 568. The Tennessee Board of Medical Examiners took disciplinary action against Dr. Foster?s medical license in December 2010 for violations concerning controlled substances and Dr. Foster agreed to temporarily restrict his prescribing privileges. 569. On February 2, 2011, Sales Representative 3 sent the following message to Purdue?s Law Department and his district manager: I got an odd call yesterday ?om [Pain Clinic and she told me in a very pleasant voice that if I didn?t come to their o?ice with some savings cards and senokot samples the Docs were going to quit prescribing my drugs. When I clari?ed who they were I determined that they are in your territory. Not sure how or why they had my . .. This o?ice, I think, was started by Dr. Allen Foster who I believe was established as a no?see. Not sure if the other Doc and the NP where ever made but you may want to double?check by calling [Purdue?s Law Department] at home of?ce to discern if they are appropriate to call on. I was told last week that Dr Allen Foster has recently been ?asked to retire his medical license. Call me if you have any 175.677 570. Only after the Tennessee Board of Medical Examiners suspended Dr. Foster?s prescribing privileges on February 7, 2011, did Purdue ?nally place him back in cease calling ?76 PTN000035268 (emphasis added). 677 PTN000036379 (emphasis added). 163 w- status.67?. On February 7,201 .Law..Department.informed thesalesforce.thatthey, should not call on Dr. Foster because his ?[p]rescribing privileges [were] suspended.?679 571. Ultimately, Dr. Foster pled guilty to criminal charges of health care fraud on February 23, 2011. On February 24, 2011, Sales Representative 16 forwarded the article referencing the guilty plea to fellow sales representatives and Purdue?s Law Department.680 572. Purdue again referred Dr. Foster and 81 other prescribers to the DEA during a meeting between Purdue and the DEA on April 12, 2011. 681 573. Dr. Foster?s license was revoked on January 27, 2012 as a result of his criminal conviction. 574. Purdue failed to place all of Dr. Foster?s pain clinic in cease calling status. Purdue ?3 sales representatives continued calling on providers associated with Dr. Foster ?3 clinic despite him being placed in cease calling status and even recruited one other prescriber to be a paid Speaker for Purdue.682 Dr. Robert Cochran Cease Calling Status Date: February 27, 2013 575. Dr. Robert Cochran, a Nashville internist, was another one of Purdue?s top OxyContin prescribers in Tennessee from 2006 to 2016, despite the fact that he retired in 2012. From 2006 to 2012, Dr. Cochran prescribed 1,171,588 tablets of OxyContin, 432,222 of which 673 PTN000031810. 679 PTN000041816. 63? PTN000041810. 63? PTN000045570. 582 See PTN000030245. 164 were 80 mg tabletsm?one of Purdue?s highest doses.683 From 1998 to 2017, Dr. Cochran prescribed 1,667,270 OxyContin tablets, of which 65.8% or 1,098,509 were 40 mg or higher.634 576. Between June 2009 and April 201 1, Dr. Cochran prescribed well over 1,000 opioids each month.685 In 2008, 151 of Dr. Cochran?s prescriptions for OxyContin were paid for with cash.686 Purdue classi?ed Dr. Cochran as a ?key thought leader.?687 577. Purdue reviewed Dr. Cochran?s ?le and kept him in continue calling status on September 16, 2011688 and March 30, 2012.689 Purdue ?nally placed Dr. Cochran in cease calling status on February 27, 2013.690 The Board of Medical Examiners issued an order for Dr. Cochran to cease and desist the practice of medicine in March 2013 stemming from his prescribing habits of controlled substances.691 578. According to Purdue?s records, Purdue sales representatives called on Dr. Cochran 110 times between February 5, 2006 and December 19, 2012.692 During this time, Purdue had knowledge of facts indicative of abuse or diversion. 579. On July 1, 2011, Sales Representative 5 submitted a ROC to Purdue that stated the following: Doc said he will be coming to butrans dinner meeting. He told me there is an investigation on him. No specifics. Dr Cochran was inquiring about di?erent pain clinics in the area. I told him of [other pain clinic providers]. He mentioned no medication. This is not an adverse event.693 633 PTN000031809. 634 PTN003984543. 635 PTN000037195. 686 PTN000056674. 687 PTN000035268 (6/20/11). 688 PTN000037183. 689 PTN000037203. 690 PTN000037199. 691 1913. 697? PTN000031807. 693 PTN000037161 (emphasis added). 165 580. Despite this information about a pending investigation, Purdue informed its sales representatives on September 16, 2011 that they could continue calling on Dr. Cochran. 694 581. The appearance of red ?ags regarding Dr. Cochran continued. On January 26, 2012, Sales Representative 13 submitted a ROC that a pharmacist ?was concerned when a patient that presents with an Oxycontin script written q6h. The prescriber was Dr.Robert Cochren.?695 582. One month later, on February 21, 2012, Sales Representative 21 sent a ROC to Purdue that led with a nurse practitioner?s concern about Dr. Cochran?s practice: [Nurse practitioner] stated she saw a patient of Dr. Cochran?s from Nashville taking six 15mg roxycodone a day. Patient was young with no updated imagining. Patient was on six 10mg hydrocodone a day with no long acting; MD switched to six 15mg roxycodone. [Nurse practitioner] stated she has concerns about Dr Cochran?s prescribing. It is her understanding he accepts cash only, has mostly out of state license plates, and sees about 50 patients a day. 696 583. Nevertheless, Purdue?s Law Department informed the Purdue sales force on March 30, 2012 that they may continue calling on Dr. Cochran with the caveat that ?if any negative relevant information comes to light, the sales force should contact the Of?ce of the General Counsel.?697 '584. Additional facts indicative of abuse or diversion continued to emerge. On July 23, 2012, Sales Representative 13 submitted a ROC that read: [Nurse Practitioner] said she had dinner with a representative and with Dr. Robert Cochran.(Dr. C) said he feels comfortable prescribing high doses of OxyContin; [Nurse Practitioner] said one of his patients was on a large dose of Oxycontin every 4 to 6 hours; [Nurse Practitioner] said if she has an apprOpriate patient who needs higher doses of Oxycontin she may refer to Dr. [Nurse Practitioner] said Dr. said he is running a pill mill; 694 PTN000037183. 695 (emphasis added). 69? PTN000037202 (emphasis added). 697 PTN000037203 (emphasis added). 166 [Nurse Practitioner] said he told her he was investigated once and it did not go anywhere; she sa?idDr.?C said he may retired or?hire amedi?cal director. [Nurse Practitioner] also asked if I knew she had been investigated when she ?rst started in pain management; told her no, I did not know that; [Nurse Practitioner] said the case had no merit; the patients complaint was because they did not receive the prescription they 585. On February 13, 2013, Sales Representative 13 ?led yet another ROC with Purdue that stated that another provider ?said he has seen several patients who were under Dr. Robert Cochran?s care and then Dr. {Cochran lost his prescribing licenses.?699 It took Purdue another two weeks before ?nally placing Dr. Cochran in cease calling status on February 27, 2013.700 586. Ultimately, Purdue knew that Dr. Cochran was being investigated by the Tennessee Board of Medical Examiners, of a report from another provider that Dr. Cochran admitted he was running a pill mill, and of concerns about Dr. Cochran?s practice from other providers and a pharmacist while Purdue kept Dr. Cochran in continue calling status. Drs. Mireille Lalanne and Visuvalingam Vilvarajah Dr. Lalanne Cease Calling Status Date: February 5, 2009 Dr. Vilvarajah Cease Calling Status Date: February 5, 2009 587. Dr. Mireille Lalanne and Dr. Visuvalingam Vilvarajah were previously married to one another and continued to practice together in Nashville after they divorced. Dr. Lalanne, an anesthesiologist, was one of the top prescribers of OxyContin in Tennessee from 2006 to 2016, despite the fact that she only wrote three prescriptions for OxyContin from 2010 to 2016.701 In the 702 span of three years from 2006 to 2009, Dr. Lalanne wrote 6,595 prescriptions for OxyContin totaling 305,894 tablets, 104,516 of which were 40 mg tablets paid for with cash.703 During a six? 698 (emphasis added). 699 (emphasis added). 700 PTN000037199. 701 PTN000031809. 702 PTN000052837. 703 PTN000031809. 167 month-period- from January June --1 2009, she for- -P'urdue from OxyContin prescriptions alone.704 588. Purdue had knowledge that 902 of Dr. Lalanne?s patients paid in cash for their OxyContin prescriptions in 2008.705 In 2007, 1,200 of her patients paid in cash for OxyContin.706 589. Purdue placed Dr. Lalanne in continue calling status from October 9, 2003 until February 5, 2009, when it ?nally told sales representatives to cease calling on her.707 590. Purdue also devoted substantial attention to Dr. Vilvarajah,708 Dr. Lalanne?s ex? husband, who likewise generated signi?cant revenue for Purdue. In the first six months of 2009, Dr. Vilvarajah generated $93, 63 4.3] for Purdue based on OxyContin tablets alone.709 591. Purdue reviewed Dr. Vilvarajah?s ?le and kept him in continue calling status after internal investigations on October 9, 2003 and December 27, 2004. Purdue failed to place him in cease calling status until February 5, 2009, following news of his and Dr. Lalanne?s arrests. 592. Purdue sales representatives called on Dr. Lalanne and Dr. Vilvarajah 82 times between January 20, 2006 and January 27, 2009.710 Twenty??ve of these visits were non-compliant calls made to Dr. Lalanne after an internal investigation had been opened but prior to Purdue making a decision on her call status. During this time, Purdue had knowledge of numerous facts indicative of abuse or diversion. 593. Purdue had knowledge of Dr. Vilvarajah?s disturbing history well before the implementation of its ADD program in 2007, including his criminal conviction of two counts of 704 PTN000039971. ??05 PTN000056674. ??05 PTN000056674. 707 PTN000031810. 708 PTN000035268. 709 PTN00003 8263. 71? PTN000031807. 168 second?degree murder in 1988.711 On August 19, 2003, Sales Representative 22 recorded that Dr. Vilvarajah told her that he had a male patient who overdosed and also wanted to know the highest dose of OxyContin that had been studied.712 Purdue?s internal notes from December 20, 2004 reveal concerns about Dr. Vilvarajah because he had ?a lot of cash paying pts? and he ?doesn?t take a lot of medicaid.?713 Despite this information, Purdue decided to keep him in continue calling status on December 27, 2004.714 594. On July 18, 2007, a Purdue ?eld researcher in the Risk Management and Health Policy Department reported to Purdue?s Legal Department that she had ?recently returned from a site visit to Harlan KY where the sheriff? department spoke of 3 physicians which in their opinion, had questionable prescribing practices involving OxyContin.?715 Two Of the three physicians referenced in this report of concern were Dr. Lalanne and Dr. Vilvarajah. 595. The report stated: According to the detective and sheriff, large numbers of OxyContin and methadone prescriptions are coming into Harlan from this practice. Dr. Lalanne is the ex-wife of Viso Vilvarajah, MD (License #9540). Dr. Vilvaraj ah has been subject to disciplinary actions in the past by the TN Department of Health. The sheri? and detective stated that when Dr. Vilvarajah experienced disciplinary actions he brought his ex-wife back into the practice so she could write for controlled substances. At present, their website lists Dr. Vilvarajah as a ?Medical Associate.?716 596. Purdue sales representatives called on Dr. Lalanne or Dr. Vilvarajah at least 48 times after this ?eld report was written. 711 PTN00003 8303. 712 PTN00003 8296 (created 2/12/2009); PTN000039979 (created 9/28/2009). 713 PTN000038299. 714 PTN000031810. 715 PTN000039938. 7?6 (emphasis added). 169 ?"597. On?S'eptember 12, '2007,? a Purdue employee - printed-a new-s article: from a -Memphis television station that referenced Dr. Vilvarajah?s previous conviction for second~degree murder of his ?rst wife.717 598. On February 4, 2008, a Nashville pharmacist told Sales Representative 5 that he ?see[s] scripts from lalanne, dr.v and dr. Cochran.? On February 6, 2008, a Nashville pharmacist told Sales Representative 5 that ?a lot of scripts [come] from drs. lalanne and That same day, Sales Representative 5 called on a different pharmacy in White House where the pharmacist told him that he ?sees a lot of scripts from dr. and lalanne.?719 Another Nashville pharmacy told Sales Representative 5 the next day that ?they get scripts from office of drs. and lalanne.?720 599. Sales Representative 5?s September 22, 2008 call note stated that Dr. Vilvarajah mentioned to him that another patient of his died from an overdose after taking 50 tablets and that the patient?s family blamed him.721 600. In February 2009, Dr. Lalanne and Dr. Vilvarajah were arrested and charged with three counts of engaging in organized crime, second-degree assault, and ?rst degree wanton endangerment.722 Dr. Lalanne pleaded guilty to facilitation of traf?cking in a controlled substance in the ?rst degree on January 11, 2010.723 Dr. Vilvaraj ah also pleaded guilty to a drug charge. 601. Dr. Vilvaraj ah?s license was summarily suspended and ultimately revoked by the Tennessee Board of Medical Examiners on January 29, 2010 and March 23, 2010 respectively.724 717 PTN000039966. 713 PTN000119294. 719 PTN000119294. 72? PTN000119294. 721 PTN000038287. 722 PTN00003 831 l. 723 PTN000039982 (Doc created/saved 10/2/2013); PTN000039959. 72? 170 602. Dr. Lalanne?s license was summarily suspended, placed on restrictive probation, and then revoked in orders by the Tennessee Board of Medical Examiners on January 29, 2010, March 23, 2010, and June 13, 2012.7325 603. Purdue ?nally placed both Dr. Lalanne and Dr. Vilvarajah in cease calling status on February 5, 2009, following news of their arrest. 604. In addition, an October 5, 2009 Field Research Signal Report for Harlan County, Kentucky, obtained by Purdue con?rmed that signi?cant amounts of diverted OxyContin were from Dr. Vilvarajah and Dr. Lalanne.726 605. Aside from other red ?ags, Purdue?s sales representatives submitted call notes from visits with Dr. Vilvarajah and Dr. Lalanne that repeatedly made reference to their of?ce being very busy, the high number of cash paying patients, and the high volume of prescription savings cards used by their patients.727 For example, call notes reported the ?of?ce packed? on May 3, 2007,728 ?packed with patients? on April 1, 2008,729 packed to the brim, as usual? on May 9, 2008,730 ?very busy, as usual? on May 16, 2008,731 and ?bustling with patients? on November 25, 2008.732 Call notes from February 6, 2008 stated that Dr. Vilvarajah ?sees a large number of cash paying patients.?733 Call notes from July 8, 2008 stated that ?doc mentioned that many of his cash paying patients are very appreciative of the oxycontin savings cards.?734 725 726 PTN000039991. 727 72" PTN000031807. 729 PTN000038288. 73? PTN000039942. 731 PTN000038288. 732 PTN000039941. 733 PTN000031807. 734 PTN000031807. 171 "6?06. "Sales'Representative"5 also recorded a call nO'teWith a representative of Pharmacy A, located in Nashville, who told Sales Representative 5 that long as possible, keep the of?ce of drs. Lalanne and vilavrajah stocked with savings cards. Where most of his oxycontin business comes from.?735 607. During the time that Purdue sales representatives called on Dr. Lalanne and Dr. Vilvaraj ah, Purdue had knowledge of numerous red ?ags that should have warranted cease calling status for both providers prior to their arrests in 2009, such as reports of questionable prescribing practices, at least two patients dying from overdoses, a high number of patients paying in cash, and, most notably, a direct report from law enforcement that speci?cally stated that OxyContin pills from these providers were being diverted. Dr. Frank McNiel and Dr. Dr. Frank McNiel Cease Calling Status Dates: April 1, 2003 to October 5, 2007; April 7, 2011 Dr. Cease Calling Date: April 7, 2011 608. Dr. Frank McNiel practiced family medicine at a large pain clinic in Knoxville, named Pain Clinic A, along with Dr. C736 From 2006 to 2016, Dr. Frank McNiel wrote 15,196 prescriptions for OxyContin and was one of the highest prescribers of OxyContin in Tennessee.737 During that time, he prescribed 1,655,940 tablets of OxyContin, 7584 78 of which were Purdue ?s 80 mg dose.738 From 1998 to 2017, Dr. Frank McNiel prescribed 3,350,167 tablets of OxyContin, of which 79.5% or 2,662,183 were 40 mg or higher.739 In 2008, 779 of his patients paid for their OxyContin prescriptions in cash and in 2009, 668 of his patients paid for their OxyContin 735 see also PTN000031807 (2120/2009) (Call note with Pharmacy A post-arrests of Drs. Lalanne and Vilvarajah stating the same pharmacy reported ?see[ing a] decrease in prescriptions since of?ce of lalanne and vilvarajah closed?). 736 See PTN000039869. 737 PTN000031809. 738 PTN000031809. 739 172 Dr.? Frank ?McNiel-salso prescribed as. 62 _=-year old .manvrla..-3.0 .day. supply consisting of 300 tablets of 80 mg OxyContin on 5 different occasions in 2010.741 609. Dr. was known as a co?owner of Pain Clinic A who most often worked at the same practice location as Dr. Frank McNiel.742 Dr. practices family medicine in Knoxville and was the eighth highest prescriber of OxyContin from 2006 to 2016. During that time, she wrote 88 72 prescriptions for OxyContin,743 which totaled 785,599 tablets, 344, 729 of which were 80 mgr/44 From 1998 to 2017, Dr. prescribed 1,155,706 tablets of OxyContin, of which 83.5% or 964, 586 were 40 mg or more.745 610. Purdue sales representatives called on Dr. Frank McNiel and Dr. at least 163 times in less than four years between May 13, 2007 and February 15, 2011746-~a number that does not include sales calls made to other Pain Clinic A providers or to a pharmacy closely linked to Pain Clinic A. 611. Purdue recommended that sales representatives cease calling on Dr. Frank McNiel on April 1, 2003, changed the recommendation to continue calling on October 5, 2007,747 and changed it back to cease calling on. April 7, 2011. Purdue reconsidered whether sales representatives could again call on Dr. Frank McNiel on April 27, 2012, but decided against it.748 74? PTN000056674. PWG003984543. 742 Cf. PTN000031807 ID20018 (11/21/2008); PTN0000031807 ID19464 (7/28/2008) (listing 429 Bearden Drive); PTN000031807 ID9555 (6/11/2007); PTN000031807 ID8101 (6/29/2007) (both listing 5612 Kingston Pike). 743 PTN000052837. 744 PTN000031809. 745 PWG003984543. 746 PTN000031807. 747 PTN000040534 (?Purdue has decided that the sales representative may call on Drs. Frank [McNiel] and Should the status of their medical or DEA licenses change, the sales representative should immediately notify the Law Department for further evaluation. **Sales operations: [Drs. Frank McNiel and have been region zero status since 748 see also PTN000039878 (Email dated 4/7/2011 containing message that sales representatives should not call on Drs. and Frank McNiel). 173 612. Purdue sales representatives in cease calling status. Sales Representative 2 called on him at least 14 times prior to October 5, 2007 while Dr. Frank McNiel was in cease call status and had been there for 4 years, yet Purdue never disciplined him. On April 18, 2012, when Dr. Frank McNiel was again in cease calling status, Sales Representative 16 recorded a call note with a pharmacist that stated ?[the pharmacist] asked if I still called on Dr [Frank] McNiel, I discussed that no, he was assigned to another rep.?749 613. Purdue had detailed knowledge about Dr. Frank McNiel?s controlled substance prescribing practices before 2007. Purdue placed Dr. Frank McNiel in cease calling status days after receiving a March 28, 2003 letter which contained a Tennessee Court of Appeals case, Frank McNiel, MD. and MD. v. Tennessee Board of Medical Examiners, No. 00383, 1997 WL 92071 (Tenn. Ct. App. March 5, 1997).7750 614. In that action, Dr. McNiel and Dr. had been disciplined by the Tennessee Board of Medical Examiners, which had concluded that ?Frank McNiel, MD. and MD. in prescribing controlled substances to 16 patients for chronic, nonmalignant pain, incompetence, unprofessional and unethical conduct, prescribing not in good faith to cure an ailment and prescribing to addicts without an attempt to cure their 615. Speci?cally, the Board found the following with respect to Dr. Frank McNiel: Respondent has administered controlled, mind-altering substances to these patients, and to many additional patients as is re?ected within several area pharmacy drug audits, in a rote fashion, rather than in a fashion tailored to the specific needs of the individual patient. Particularly with respect to his administration of benzodiazepines, [R]espondent has routinely administered the highest Valium dosage (10 mg) to most of his patients without ever attempting to titrate such dosages to individual patient needs. 749 PTN000031807 (emphasis added). 75? 751 PTN000040487. 174 Respondent has, in many instances, administered these controlled substances in excess of the recommended daily dosage limitations as indicated by the Physicians Desk Reference. His chronic, repeated administration of Schedule II-IV narcotic analgesics such as Lortab, Lorcet Plus, Vicodin, Percodan, Percocet, Tylenol Darvon and Darvocet for periods of time approximating 3 years in some patients is not recommended within this treatise, nor is such chronic administration of these substances recognized as appropriate care as a family practice physician, particularly when combined with administration of sedating benzoates-pines and sedative hypnotics (Phenobarbital and Halcyon) on such a long-term, chronic basis[.] Respondent?s administration of such combinations in such a chronic fashion fell below the standard of care expected of a reasonably competent primary case [sic] or family practice physician practicing in the State of Tennessee. Respondent constantly administered the combination of benzodiazepines and narcotic analgesics in a chronic fashion to most of the ten patients referred to herein (and to many others, too numerous to list), without attempting to justify or take precautions against the sedating, and potentially addictive consequences these combinations could have. In many instances, Respondent did not recognize, and in fact rewarded, drug seeking behavior manifested by his patients. This conduct on Respondent?s part fell below the standard of care of a reasonably competent primary care or family practice physician practicing in Tennessee. Respondent?s chronic use of narcotic analgesics for management of non[~ ]malignant pain in many patients fell below the standard of care expected of a reasonably competent primary care or family practice physician practicing in the State of Tennessee, which is that narcotics are to be avoided except in limited, acute pain cases, and, only after all other specific therapies have been exhausted and the patient has been evaluated according to a multi?disciplinary approach, including referrals to orthopedists, neurological surgeons, administration of steroidal anti?in?ammatory drugs, antidepressants, administration of a TENS unit, and hypnosis. None of the ten patients referred to herein suffered from malignant pain caused by organic disease, and the Respondent did not limit his administration of narcotics to short?term, intermittent, acute cases. Respondent did not, in any of the ten cases referred to herein, or in general with respect to most other patients, either refer patients to alternative therapies or to specialists in pain management, or refrain from continuing administration of strong narcotic analgesics and benzodiazepines while the patients were simultaneously undergoing treatment by such mental health and pain specialists. 175 =61 6. "The Tennessee! Gourtof Appeals ultimately?overturnedthe BoardZS decisiondue .to insuf?cient expert testimony, but speci?cally found that ?[t]he records of the respondents and their testimony adequately support the speci?c facts found by the Board.? Frank Mch'el, MD. and MD. 12. Tennessee Board ofMedical Examiners, No. 1997 WL 92071, *5 (Tenn. Ct. App. March 5, 1997).752 617. Purdue placed Dr. in continue calling status from June 27, 2003 to April 7, 2011, even though she worked at the same location as Dr. Frank McNiel who was placed in cease calling status for four years 753, and in spite of speci?c ?ndings by the Board that: The records of Dr. indicate that on March 7, 1988, Patient 6 was using ?too many Anexia?D? but the same entry shows the prescription for the same drug was renewed; that, on March 23, 1988, 6 ?wants pills early;? that, on March 28, 1988, the same medication was re?prescribed; that on April 6, 1988, the same prescription was renewed; that, on April 20, 1988, the chart for 6 indicates ?too many Anexia and Darvocet;? that, on April 21, 1988, Dr. told 6 she was addicted and recommended addiction treatment and wrote on the chart ?no more Anexia or Darvocet,? that on May 4, 1988, Halcyon, a controlled substance, was prescribed; that on May 5, 1988, Anexia was again prescribed; and that prescriptions for this drug continued from June, 1988 to October, 1988; that, in October 1988, Dr. began injections of Buprenex and prescribed 100 Percocets every two weeks; that, on January 6, 1992, the record states ?patient has been taking too many pain pills, naughty, naughty,? and that 100 more Percocet pills were prescribed on the dame [sic] date. Dr. testi?ed that, in June, 1992, she charted Patient 2 with a note ?caution with meds,? that a told Dr. in September, 10, 1992, that 2 ?doesn?t need meds? and 2 was ?milking Dr. for meds;? that 2 was charted for ?no more meds,? but from September 14, 1992 through January 1993, controlled substances were prescribed for 2 without an examination. Dr. June, 1992 chart for Patient 4 re?ects a plan for drug screens because of ?questions? about abuse, but prescriptions for controlled substances were continued to March 23, 1993, without a drug screen. 752 753 PTN000031810. 176 Dr. chart for Patient 5 on April 25, 1999, shows ?prob. multiple substance abuse? and ?no plan for substance abuse.? On January 1989, the record shows recommendation for drug rehabilitation and ?we will not treat her anymore.? The record re?ects that controlled substances were prescribed continuously throughout 1991 and 1992 without a charted physical examination. The record of Dr. for Patient 6 states ?using too many Anexia cautioned, wants pills early explained that she is addicted, thinks she can quit; recommended that she get help. Told her to call Jim Dunlap at New Day if she needs help; patient has been taking too many pain pills, naughty, naughty.? Dr. testi?ed that ?there were red ?ags? [sic] in respect to Patient 2, and her record on this patient stated ?caution with meds?? and ?no more controlled meds.? The record of Dr. on Patient contains: ?meds? recommended drug rehabilitation and ?we will not treat her anymore,? and that Dr. did not read this entry 2 years later before prescribing pain relievers, but she wishes she had ?because I feel it would have changed things.?754 618. In addition to the facts that led to Purdue?s 2003 cease calling recommendation, Purdue had knowledge of facts indicative of abuse or diversion before April 7, 2011 when Dr. Frank McNiel and Dr. were in continue calling status. 619. Before the reinstatement of Dr. Frank McNiel?s continue calling status in October 2007, Purdue had knowledge of suspicious OxyContin prescribing behavior by the two providers. For example, in a November 21, 2006 internal email titled ?Report of ?dirty doctors,m a ?eld researcher in Purdue?s Risk Management Health Policy Department submitted the following investigative report based on an interview with a Knox County Sheriff?s O?ice detective that: the most problematic physicians being investigated right now are: Frank McNeal, MD and MD both practicing in Knoxville. Apparently, Dr. McNeal works in a pain clinic with three other physicians has a separate o?ice), but all the prescriptions that come out of the o?ice for 754 177 .OxyContin .use. . his. .DEA number. .Most prescriptions arefor; .8 0 .80 mg OxyContin Tablets, 180 40 mg OxyContin Tablets, and an unspeci?ed amount ofXanax and Soma.755 620. The response from Purdue?s home of?ce stated, in relevant part, are familiar with the doctors you mentioned below. Our sales representatives have not been calling on these prescribers for some time, as in accordance with RSOP The ?eld researcher?s ?ndings about the couple were also contained in a December 5, 2006 ?eld report submitted to Purdue.756 621. Despite being in cease calling status until October 7, 2007, Sales Representative 2 called on Dr. Frank McNiel 13 times in 2007 before this date including May 7, May 14, May 15, June 6, June 18, June 25, June 29, July 9, July 16, July 30, August 23, September 12,757 and October 2, 2007.758 622. During the sales call on May 15, 2007, Sales Representative 2 and Dr. Frank McNiel discussed a lawsuit in which he was involved. Purdue?s representative reiterated the company?s commitment to its providers. Sales Representative 2?s call note stated: [Dr. Frank McNiel]. wanted to farther discuss the results of the lawsuite and how it would effect civil liabilities discussed in general the suit and that we ?wer committed to providers.759 623. On October 7, 2007, Purdue authorized its sales representatives to continue calling on Dr. Frank McNiel and Dr. C?even though these sales representatives had been calling on Dr. Frank McNiel anyway.760 755 PTN000041829 (emphasis added). 756 5997, ?6000. 757 PTN000031807. 758 PTN000031807. 759 PTN000031807 ID9567 15/2007) (emphasis added). 760 See, e. g. PTN000119294 ID15767 (8/23/2007). 178 624. Purdue continued to ignore red ?ags about the couple after October 7, 2007. On August 22, 2008, a Purdue sales representative reported an article that had appeared in Knoxville?s Metro Pulse titled ?Drug Zone.?761 625. The article stated: An astounding fact: According to experts within the Knoxville Police Department, [Pharmacy dispenses the highest volume of narcotic drugs oxycontin, hydrocodone, oxycodone) in the State of Tennessee. According to eyewitnesses and police reports, during the spring of 2008, some pharmacy customers were mugged as they left the store and their prescriptions stolen, some at gunpoint. Several shoppers had observed drug deals taking place in the parking lot. These crimes prompted [Pharmacy to hire armed Knoxville Police O?icers to guard the store during pharmacy hours. Just around the corner from [Pharmacy is [Pain Clinic a clinic operated by Drs. Frank [McNiel and According to one local Drug Enforcement Agency (DEA) official, this clinic, when it comes to overprescribing narcotics, is ?the biggest problem in the state. According to the Knoxville Police and the DEA, [Pharmacy is the only pharmacy in town still accepting prescriptions from the Drs. [Frank McNiel and A group of concerned neighbors has begun meeting to address this issue. Their goal is to persuade [Pharmacy to put neighbors ?rst and stop honoring the Drs. [FrankoNiel and ?s narcotic prescriptions at any of the Knoxville [Pharmacy pharmacies.762 626. Purdue was also aware that, on December 10, 2008, Dr. Frank McNiel paid what was classi?ed as an ?above average? settlement amount for a malpractice claim as reported to the Tennessee Department of Health.763 627. On February 15, 2011, Sales Representative 16 and District Manager 3 called on Dr. Frank McNiel and recorded the following call note: This was a challenging call and [Sales Representative 16] prepared for that. Dr McNeil was down on the reformulation. He brought up q8h dosing but [Sales Representative 16] pointed out the PI information. He acknowledged that he still prescribes the product. In terms of Butrans, he was also down 761 PTN000039866. 762 (emphasis added). 763 PTN000040501. 179 oriit and did not see'a place ?for?it in his practice WhiCh patients are onhigher doses of morphine equiv than suggested in P1. [Sales Representative 16 and District manager 3] asked him ?where do you see it ?tting in?? he responded with Family Practice. Submitted a MIRF for a speci?c question.764 628. Purdue sales representatives called on Dr. Frank McNiel and/or Dr. 102 times after Purdue received the August 22, 2008 ROC765 until the company ?nally placed them in cease calling status on April 7, 2011 because their DEA registrations to prescribe controlled substances had expired.766 629. On April 12, 2011, Purdue referred Dr. Frank McNiel to the DEA.767 Nevertheless, District Manager 3 still emailed Purdue?s Law Department on April 3, 2012 and requested that he be able to reevaluate Dr. Frank McNiel and Dr. in order-to resume calling on them,768 which Purdue did deny.769 630. Further, following the May 6, 2007 Judgment with the State of Tennessee, Purdue called on Dr. Frank McNiel repeatedly, even after Purdue was told that he and Dr. were the most problematic prescribers in the area by law enforcement and 13 times after Dr. Frank McNiel was in cease calling status. 631. On March 20, 2018, the Tennessee Board of Medical Examiners permanently revoked Dr. Frank McNiel?s medical license. The Stipulations of Fact in the Consent Order read, in part, as follows: i 2. The Department conducted an investigation of the Respondent?s prescribing practices, reviewing approximately 75 patient records. That investigation and review re?ected that, ?om 2002 to present and while practicing at [Pain Clinic in Knoxville, Respondent engaged in a pattern 764 PTN000035268 ID2078. 765 PTN000031807. 766 767 763 1. 759 PTN000036363. 180 of prescribing opio ids and other controlled substances in excessive amounts and inconsistent with and below the applicable standards of care. Speci?cally, he prescribed controlled substances in amounts and/or for durations not medically necessary, advisable, or justi?ed for a diagnosed condition and/or not for a legitimate medical purpose; without attempting alternative non?narcotic modalities; and without appropriately monitoring for abuse and diversion. Further, during this time period, Respondent served as supervising physician for multiple allied practitioners (advanced practice registered nurses and physician assistants) who continued such excessive prescribing of excessive amounts and inconsistent with and below the applicable standard of care in violation of the rules adopted by the Tennessee Board of Medical Examiners and the Tennessee Board of Nursing. Respondent failed to appropriate supervise such allied prescribers whose prescriptive services were within his control and responsibility under Tennessee law and failed to appropriately respond to conduct that was below the standard of care.770 Pain Clinic A Cease Calling Status Date: April 30, 2012 to date unknown Continue Calling Date: At least by August 2017771 632. Pain Clinic A was a pain clinic based in Knoxville, Tennessee that had many health care providers, but was most closely identi?ed with Dr. Frank McNiel and Dr. in internal Purdue documents.772 Besides Dr. Frank McNiel and Dr. C, Pain Clinic A?s other providers included Dr. D, Physician Assistant Lisa Adams, Nurse Practitioner E, Nurse Practitioner Brandy Burchell, Nurse Practitioner Christina Collins, Physician Assistant AA, Nurse Practitioner BB, Nurse Practitioner CC, Nurse Practitioner Teodora Neagu, Dr. DD, Nurse Practitioner F, Nurse Practitioner G, Physician Assistant EE, and Nurse Practitioner FF. 77? 1606m161 19_032018 (emphasis added). 771 See, PTN0001 19294 113301 165 (8/1/2017). 772 PTN000039658. 181 ?"633. these 15 with-PainClinic-VA, .13 were placed in cease calling status by Purdue at least once]73 and many were among the top OxyContin prescribers in Tennessee. 634. At various times, Purdue?s Phoenix database continued to include health care providers who had been placed in cease calling status, including those at Pain Clinic A774 635. As stated above, as a general rule, Purdue made recommendations about whether to cease calling on suspicious health care providers, not speci?c clinics or of?ces.775 Purdue did not list Pain Clinic A on its Suspicious Doctors List from 2002 to 2016, though it listed a few other clinics.776 At some point Purdue told sales representatives not to call on Pain Clinic A, but the earliest identi?ed directive is from April 30, 2012.777 636. However, this directive to cease calling on Pain Clinic A did not last. Purdue?s Phoenix database continued to list Pain Clinic A providers as potential sales targets as late as March 22, 2013.778 637. Further, Purdue sales representatives continued calling on providers known by Purdue to still be working at Pain Clinic A at least 13 times after April 30, 2012.779 773 PTN000031810. 774 PTN000036364. 775 PTN000038691. 776 PTN000031810. 777 PTN000036363. 778 779 PTN000119294 ID137939 (8/8/2013) (noti?cation that doctor was supervising physician at Pain Clinic PTN000119294 ID168024 (7/25/2014) (report that doctor was still the supervising physician at Pain Clinic PTN000119294 ID142209 (9/23/2013); PTN000119294 ID144696 (10/17/2013); PTN000119294 ID146491 (11/6/2013); PTN000119294 ID147280 (11/13/2013); PTN000119294 ID150180 (12/18/2013); PTN000119294 ID151387 (1/13/2014); PTN000119294 ID154177 (2/19/2014); PTN000119294 ID155218 (3/4/2014); PTN000119294 ID158660 (4/8/2014); PTN000119294 ID161081 (5/5/2014); PTN000119294 ID163625 (6/2/2014); PTN000119294 ID166526 (7/8/2014); and PTN000119294 ID169020 (8/6/2014). 182 "638. A?s 'Oth'er'prOVidersbesidesDr. Frank McNiel? and Dr. prescribed high amounts of OxyContin. For example, from 2006 to 2016, Nurse Practitioner Christina Collins wrote prescriptions for 292,960 tablets of OxyContin from all payors.780 She prescribed 1 42,395 OxyContin 80 mg tablets from 2006 to 2014.781 In 2011 alone, Ms. Collins wrote 935 prescriptions for OxyContin, 835 more than she had written in 2010.782 She wrote 1,444 prescriptions for OxyContin in 2012.783 Purdue placed Ms. Collins in cease calling status from April 30, 2012 until November 25, 2014, when Purdue moved her back to continue calling status784 following a request from Sales Representative 6.785 639. In addition to the facts about Dr. Frank McNiel and Dr. recited above, Purdue had knowledge of credible facts about Pain Clinic A that were indicative of abuse or diversion. 640. Purdue sales representatives made repeated sales calls to Pharmacy B, which was closely linked to Pain Clinic A, especially in 2007 and 2008.786 641. On May 21, 2007, Purdue?s Managed Care Sales Representative recorded the following from a sales call with a managed care group: Rumore of a pharmacy called [Pharmacy doing more scripts than any other pharmacy in Tennessee. A suggestion from the [Pharmacy Director of Managed Care Group] that it is a problem pharmacy. Representative said they do a lot of Oxycontin in this pharmacy as well. This is a ROC report. . . .737 78? PTN000031809. PTN000031809. 732 PTN000052837. 733 PTN000052837. 734 PTN000031810. 735 PTN000039267. 736 PTN000031807 ID9588 (5/17/2007); see also PTN000031807 ID104183 (7/16/2013) (referring to Pharmacy ??lling the majority of prescriptions for [Pain Clinic 737 (5/21/2007) (emphasis added). 183 642. On August 22, "2008, "Purdue?s sales representative repOrted an? article about concerns of high OxyContin prescribing from Pain Clinic A that had appeared in Knoxville, Tennessee?s Metro Pulse titled ?Drug Zone,?788 which is recited above in the section about Dr. Frank McNiel and Dr. C789 643. Pain Clinic A handed out a large number of OxyContin savings cards, which were used by a signi?cant number of cash-paying patients. In January and February 2008, Pain Clinic A accounted for 579 out of 665 $50 savings cards in the Purdue sales territory where Pain Clinic A is located.790 Pharmacy B, which was closely associated with Pain Clinic A, redeemed 1,327 out of 1,839 OxyContin savings cards paid?to?date and 213 out of 286 for the month of January 2008 alone in the same territory.791 By February 2008, Pharmacy accounted for 412 out of 565 savings cards for the year to date and 1,526 out of 2,1 18 total in the territory. 644. In addition to calling on Pain Clinic A itself, Purdue sales representatives also repeatedly called on Pharmacy a?er Purdue had knowledge that Pharmacy was a problem pharmacy that was dispensingmore prescriptions of OxyContin than any other pharmacy in the 733 789 79? PTN000070654. 79? PTN000083350. 184 State]?2 after Purdue had knowledge about the Metro Pulse article referenced above,793 after Purdue placed both Dr. Frank McNiel and Dr. in cease calling status on April 7, 2011,794 and even after Pain Clinic A was placed in cease calling status on April 30, 2012.795 645. After the Metro Pulse article was published in 2008, Sales Representative 2 recorded his interaction with Pharmacy on October 22, 2009, as follows: [Pharmacist] said they are ?lling and re?lling a prescription for [Pain Clinic dose 3 00 Discussed saving card program gave some value cards for pt also asked to hold any OxyContin 60$ cards that cant be used so I can take to [Pain Clinic A ].796 792 PTN000031807 ID13543 (7/2/2007); PTN000031807 ID13488 (7/9/2007); PTN000031807 ID13512 (7/11/2007); PTN000031807 ID10664 (7/16/2007); PTN000031807 ID10779 (8/1/2007); PTN000031807 ID10781 (8/3/2007); PTN000031807 ID14220 (8/8/2007); PTN000031807 ID10883 (8/13/2007); PTN000031807 ID10805 (8/22/2007); PTN000031807 ID10028 (9/4/2007); PTN000031807 ID10993 (9/12/2007); PTN000031807 ID10062 17/2007); PTN000031807 ID12484 (10/1/2007); PTN000031807 ID14123 (10/ 10/2007); PTN000031807 ID12400 (10/31/2007); PTN000031807 ID14303 (11/7/2007); PTN000031807 ID14335 (1 1/ 13/2007); PTN000031807 ID16462 (11/26/2007); PTN00031807 ID12940 (12/11/2007); PTN000031807 ID14833 (12/18/2007); PTN000031807 ID18582 (1/11/2008); PTN000031807 ID15772 (2/4/2008); PTN000031807 ID14080 (2/8/2008); PTN000031807 ID15993 (2/12/2008); PTN000031807 ID18157 (2/20/2008); PTN000031807 ID16203 (2/26/2008) (noting ?Product not moving?); PTN000031807 ID14941 (3/6/2008); PTN000031807 ID17440 (3/18/2008); PTN000031807 ID17415 (3/31/2008); PTN000031807 ID17151 15/2008); PTN000031807 ID20993 (5/8/2008); PTN000031807 ID20502 (6/5/2008); and PTN000031807 ID20007 16/2008). 793 See, e. g, PTN000039866 (listing article reported to Purdue on 8/22/2008); PTN000031807 ID23500 (9/10/2008); PTN000031807 ID21001 (10/22/2008); PTN000031807 ID22234 (12/11/2008); PTN000031807 ID22235 (12/19/2008) (stating ?Discussed RxPatrol and controls that protect pharmacy they said they use many including video security?); PTN000031807 ID22780 (1/7/2009); PTN000031807 ID25950 (2/9/2009); PTN000031807 ID23905 (2/24/2009); PTN000031807 ID28307 13/2009); PTN000031807 ID26428 (3/30/2009); PTN000031807 ID27460 (4/17/2009); PTN000031807 ID26887 (5/4/2009); PTN000031807 ID32079 (5/18/2009); PTN000031807 ID32539 (7/8/2009); PTN000031807 ID34271 (9/14/2009); PTN000031807 ID35121 (11/2/2009); PTN000031807 ID31778 (11/19/2009); PTN000031807 ID33450 (12/1/2009); PTN000031807 ID36592 (12/9/2009); PTN000031807 ID31997 (12/24/2009); PTN000031807 ID31667 15/2010); PTN00003 1807 ID31953 1/26/2010); PTN000031807 ID37353 (3/1/2010); PTN000031807 ID37476 (3/19/2010); PTN000031807 ID167855 (5/7/2010); PTN000031807 ID41256 (6/3/2010); PTN000031807 ID39244 (7/7/2010); PTN000031807 ID168145 (7/22/2010); PTN000031807 ID39049 (7/26/2010); PTN000031807 ID42380 (8/4/2010); PTN000031807 ID46255 13/2010); PTN000031807 ID46843 (10/19/2010); PTN000031807 ID45021 (11/3/2010); PTN000031807 ID46061 (12/9/2010); PTN000031807 ID49705 (1/4/2011); PTN000031807 ID49815 (1/5/2011); PTN000031807 ID45712 (1/25/2011); PTN000031807 ID52432 (2/11/2011). 794 PTN000031807 ID49992 (4/12/2011); PTN000031807 ID171739 (4/18/2011); PTN000031807 ID57311 (7/8/2011); PTN000031807 ID60826 (8/29/2011); PTN000031807 ID64704 (11/7/2011); PTN000031807 ID70179 (12/15/2011); PTN000031807 ID177858 (2/6/2012); PTN000031807 ID73219 (2/13/2012); PTN000031807 ID178515 (3/13/2012); PTN000031807 ID76199 (4/23/2012). 795 PTN000031807 ID180017 (6/1/2012). 796 PTN000031807 ID165638 (10/22/2009) (emphasis added). 185 646. Purdue continued to heavily promote 'OxyCoiitin to providers at 'P'ain'Clinic' A and focused on OxyContin savings cards. For example, on January 26, 2010, Sales Representative 2 recorded in a call note the following conversation with Pain Clinic A?s Nurse Practitioner Teodora Neagu: She said that her pt have been asking for OxyContin value cards and she was already out of the ten I gave her last week gave her 3 boxes and mentioned the 10,15,30 mg tablet for titration andd initiation of therapy. . .797 647. Purdue continued to receive red ?ags concerning Pain Clinic A. On October 15, 2010, Sales Representative 3 reported an adverse event that stated: This AE may have been previously reported by another rep [pharmacist girl?iend works at [Pain Clinic and they have apt close to death in a local hospital with G1 bleed that thinks is due to reformulation - he wants to know how/why reformulation could cause. adviSed he unsure I how but will report as an AB.798 648. On February 24, 2011, Sales Representative 16 submitted a ROC to Purdue, which stated: After Dr. left the lunch room. Dr asked me if [Pain Clinic had been closed yet. I said not to my knowledge, why? Dr said that he has heard from an employee who used to work at [Pain Clinic that they were going to be closed. Dr also said that according to the employee, [Pain Clinic has been raided by the FEDS twice previously. Dr said that he thinks [Pain Clinic should be closed. I asked why? Dr said that he think they just prescribe pills. Dr said that he has a patient who went to [Pain Clinic for neck pain. The patient told Dr that they did a neck xray and told him that he had arthritis and prescribed him a long acting Oxycodone and a short acting Oxycodone and Soma. When the patient came to Dr he ordered an MRI, saw the patient had a ruptured disc, the patient had surgery and is now fine.799 797 PTN000031807 113165734 (1/26/2010) (emphasis added). 798 PTN000031807 ID169415 (10/15/2010) (emphasis added). 799 (emphasis added). 186 649. On April 7, 2011, despite having knowledge about problematic prescribing practices implicating Pain Clinic A as a whole, Purdue only placed Dr. Frank McNiel and Dr. in cease calling status. Purdue allowed its sales representatives to continue calling on the actual clinic and the other providers at the clinic.800 650. Red ?ags continued to mount regarding Pain Clinic A and its providers. On June 21, 2011, Sales Representative 16 documented the following ROC: Lab tech was a former employee of [Pain Clinic (Frank McNiel). discussed several things. 1) She feels that Dr rank prescribes too much pain medication for his patients 2) She feels that Oxycontin should have an indication for certain types of pain only. feels that most patients should not be able to get Oxycontin. 3) While working at [Pain Clinic she and all employees would have to be escorted into work by police when Dr Frank had death threats. said that Dr Frank had several death threats while she worked there 4) also said that she did not feel that the parking lot was safe. said that thee were always people waiting in cars for patients to get their prescriptions, feet handing out of their cars and so on.801 651. On February 22, 2012, Sales Representative 16 again submitted a ROC to Purdue with the following information: Buffy discussed that at the pain clinic ([Pain Clinic she has been working at on Wednesday they do not take any patients from [Pain Clinic (Frank McNiel, and others). Bu??z said that patients from [Pain Clinic are prescribed unusually large quantities of both Long acting and short acting medications. said that at her new clinic that she and another NP are opening on March 1, they also will not accept patients from [Pain Clinic A .302 652. According to the records produced by Purdue to the State, the earliest identified date that Purdue placed Pain Clinic A in cease calling status is April 30, 2012.803 300 PTN000039878. (emphasis added); see also PTN000031807. 802 803 PTN000036363. 187 Phoenix database. continued .to ..list. known Pain .Clinic. A providers as potential targets for sales representatives as late as March 22, 2013.804 654. Purdue continued to call on providers known to be working at Pain Clinic A well after April 30, 2012. 655. For example, Sales Representative 16 was af?rmatively told on August 8, 2013805 and again on July 25, 2014806 that Dr. was the supervising physician at Pain Clinic A. Yet Sales Representative 8 called on Prescriber on September 23, 2013,807 October 17, 2013,808 November 6, 2013,809 November 13, 2013,810 December 18, 2013,811 January 13, 2014,812 February 19, 2014,813 March 4, 2014,814 April 8, 2014,815 May 5, 2014,816 June 2, 2014,817 July 8, 2014,818 and August 6, 2014.819 656. Purdue?s sales representatives continued to submit ROCS about Pain Clinic A even after Purdue placed Pain Clinic A in cease calling status. On June 4, 2012, Sales Representative 16 submitted the following ROC from Dr. J, which stated that Pain Clinic A was asking its patients to go to Pharmacy in Knoxvillelbecause they would never input prescriptions into the State?s prescription drug monitoring program (PDMP) website: 804 805 PTN000119294 1D137939 (8/8/2013). 806 PTN000119294 ID168024 (7/25/2014). 807 PTN000119294 1D142209 (9/23/2013). 808 PTN000119294 1D144696 (10/17/2013). 809 PTN000119294 1D146491 (11/6/2013). 81? PTN000119294 1D147280 (11/13/2013). 8?9111000119294 ID150180 (12/18/2013). 812 PTN000119294 ID151387 (1/13/2014). 813 PTN000119294 1D154177 (2/19/2014). 814 PTN000119294 1D155218 (3/4/2014). 315 PTN000119294 1D158660 (4/8/2014). 816 PTN000119294 1D161081 (5/5/2014). 817 PTN000119294 1D163625 (6/2/2014). 818 PTN000119294 1D166526 (7/8/2014). 819 PTN000119294 ID169020 (8/6/2014). 188 - ?Dr "asked what was happening" at? [Pharmacy I-isaid-r *I-edid not-know and asked Dr what he meant? Dr said that has noticed that several of his patients who get their pain medications ?lled at [Pharmacy never track on the PDMP website. Dr said that the patients bring their pill bottles in, so he knows they are ?lling the prescriptions, but they never track. Dr asked why all of the pain clinics around town are asking their patients to go to [Pharmacy I said that] was unaware that anyone but [Pain Clinic did this ?.820 657. On January 9, 2013, Sales Representative 16 recorded a ROC that stated that Pain Clinic A?s new medical director was responsible for another pharmacy?s closing. The ROC stated: [Pharmacist] discussed that Dr is now the medical director of [Pain Clinic A Chad said that Dr is credited with [Pharmacy closing. [Pharmacist] also discussed that he thinks he has ?lled prescriptions for 3 legitimate patients from [Pharmacy 658. On January 10, 2014, Physician Assistant Lisa Adams, who had been a provider at Pain Clinic A, signed a Consent Order with the Tennessee Board of Medical Examiners? Committee on Physician Assistants that contained the following factual allegations: 2. Pursuant to a complaint, the Department conducted an investigation that included the review of thirty-two (32) patient records prepared and kept by Respondent, re?ecting treatment from on or about April, 2010 to March, 2011 with controlled substances in higher amounts and/or for longer durations than the Board believes were necessary. 3. Respondent was employed as a physician assistant at [Pain Clinic a pain management clinic in Knoxville, Tennessee from April, 2010 through March 11, 2011, during which time Dr. Frank McNiel was her supervising physician. 4. Under Dr. McNiel?s training and direction, Respondent routinely prescribed controlled substances, primarily large quantities of opioids, for treatment of patients at [Pain Clinic Respondent did consistently check the Controlled Substance Monitoring Database for patients on each visit, and each patient chart included a criminal background check, numerous 82? PTN000031807 ID78628 (6/4/2012) (emphasis added). 821 PTN000031807 ID88954 (1/9/2013) (emphasis added). 189 ?u'r'ineidrug screens, and contracts With'ealCh patient 'allowi'ng?f'cir termination of treatment. 5. In September 2010, Respondent attended a chronic pain management seminar, at which point it became evident to her that the prescribing practices that she learned at the seminar were different from the practices under which Dr. McNiel trained her. 6. When respondent questioned Dr. McNiel about the quantities and combinations of controlled substances being prescribed at the practice after she attended the seminar, Dr. McNiel informed Respondent that higher doses generally led to a greater degree of functionality and quality of life. Thereafter, Respondent did not alter her prescribing practices through the remainder of her employment at [Pain Clinic 7. Respondent ceased her employment at [Pain Clinic citing her reason for leaving as not being comfortable with the prescribing policies at the clinic.822 659. Among other things, the Tennessee Board of Medical Examiners? Committee on Physician Assistants reprimanded Ms. Adams?s license and barred her from practicing in a pain management clinic. 660. Sales Representative 16 ?led an ROC with Purdue on April 14, 2014 stating that ?a Female PA, Lisa Adams who used to work at this clinic, lost her DEA license for overprescribing while she worked at [Pain Clinic Purdue downloaded the Consent Order on April 16, 2014.824 Purdue placed Ms. Adams in cease calling status on May 9, 2014.825 661. Despite knowledge of this history of problematic prescribers, beginning at least by August 1, 2017, Purdue began calling on Pain Clinic A again directly, including on August 1, 2017,826 August 9, 2017, August 30, 2017, September 5, 2017, September 12, 2017,827 September 822 (emphasis added). 323 PTN000038794. 82? PTN000038803 (metadata). 825 PTN000038800. 826 ID301165 (8/1/2017). 827 PTN000119294 ID307468 (9/12/2017). 190 .. 1.8, 2017,323 October 3, 2017,829 October 17, 2017,830 November 8, 2017,831 November 28, 2017,832 December 4, 2017,833 December 5, 2017}34 and December 15, 2017. 662. When Purdue ?nally placed both Dr. Frank McNiel and Dr. in cease calling status on April 7, 2011, despite being told in 2006 by law enforcement that both were the most problematic prescribers in the area, the company failed to place the other providers at Pain Clinic A in cease calling status until April 30, 2012, failed to ensure that providers at the clinic were removed from targeted lists after April 30, 2012, continued to call on the pharmacy closely linked to the clinic even after April 30, 2012, and started calling directly on the clinic again at least 13 times since August 1, 2017. Breakthrough Pain Therapy Center Cease Calling Status Date: 663. Breakthrough Pain Therapy Center (Breakthrough) was a pain clinic based in Maryville that was alleged to have been part of a wide-sweeping conspiracy to distribute oxycodone and other opioids. The Breakthrough clinic was owned by Sandy and Randy Kincaid, who were not licensed medical providers. The action by the US. Department of Justice led to guilty pleas in 2016 from Breakthrough providers or former providers including Drs. Deborah Thomas and James Joyner, former Nurse Practitioners Buffy Kirkland, Jamie Cordes, Sherry Fetzer, and Donna Smith, as well as former Physician Assistant David Blankenship.835 Another PTN000119294 ID308345 (9/13/2017). 329 PTN000119294 1133 10685 (10/3/2017). 830 19294 1133 12418 (10/17/2017). 831 PTN000119294 ID315690 (11/8/2017). 832 PTN000119294 113313317 (11/28/2017). 833 PTN000119294 113319077 (12/4/2017). 834 PTN000119294 113319441 (12/5/2017). 835 191 former Brickhouse, ?who was associated. with .the .clinic,..died .inan unrelated car crash before trial. 664. Purdue never placed the Breakthrough clinic in cease calling status despite knowing of the December 2010 indictments against Breakthrough?s owners, Sandy and Randy Kincaid, by January 18, 2011.836 665. Further, despite knowledge of numerous red ?ags indicative of abuse or diversion as early as 2010 concerning the clinic as a whole, Purdue only placed providers Dr. Deborah Thomas337 and Nurse Practitioner Donna Smith338 in cease calling status before news of the indictments against Breakthrough?s other providers became public in October 2014. 666. In 2010, Purdue had knowledge that the Breakthrough clinic was reported by at least two sources to have no examination tables, examination gloves, urine screens, or providers who performed independent pain diagnoses.839 667. Purdue had intimate knowledge about Breakthrough and the suspect practices of its providers. Sales Representative 16 even made a presentation to Breakthrough?s unlicensed owners, Sandy and Randy Kincaid, directly handed them OxyContin savings cards and other promotional materials, and continued to call on former Nurse Practitioners Buffy Kirkland and Jamie Cordes and Physician Assistant David Brickhouse years after Purdue knew of a federal raid on the clinic where they had worked. 336 (showing last modi?ed date as 1/18/2011). 337 PTN000031810 (cease calling status date: 12/10/2010). 333 PTN000031810 (cease calling status date: 6/23/201 1). 339 PTN000042515. 192 668. Well before it became public knowledge, Purdue knew that Breakthrough and another pain clinic were being investigated and was told that there was ?some illegal activity? at these two pain clinics in Maryville. 669. On May 14, 2010, Sales Representative 16 sent the following email with the subject line ?Maryville, TN Pain Clinic(s)? to Purdue?s Law Department:840 To Whom This May Concern: This is to reportthat there is some activity at one or more of?the new pain din-ta; in Maryville, TN. My son in: reporter?forthe Daily Times in Mamiite. TN. He overheard a?tonversation in the newsroom yesterday that one of the reporters wasgoing to do a story on the new pain ciinics that havetrocentlv opened in Manama. According to the reporter, the mount county She riff asked them not-to write a smarter a con we of months. According to the reporter, the sheriff'aISo. investigating these chains. The sheriff aisq reportediv said. that one on more of'them are writing pain medication?presc?p?ons for. peopiewho in Tennessee and than taking themto Florida tore-soil them. Nth; the shot-Eff supposediy mentioned that In two months, their investigation would'be tompfete and they woufo have indictments at that time. 670. On October 8, 2010, after receiving the above?referenced report from the Blouni County Sheri??aboui Breakthrough, Sales Representative 16 documented the following in a sales call with Sandy and Randy Kincaid, the unlicensed owners of Breakthrough: Met with Sandy and Randy today. Got list of all providers. Providers include: Deborah Thomas, Buffy Kirkland, Don Lewis, Walt Blankenship, Donna Smith, [Physician Assistant and Sherry Fetzer. Provided Sandy with a REMS packet for each provider. Also provided Oxycontin patient tear of sheets, TN managed care grids, conversion guides and savings cards. Sandy asked if the reformulated Oxycontin has effected company sales. I told Sandy that I truthfully did not know. Sandy asked what exactly changed with Oxycontin. Provided Sandy with a RFC sheet and read through ?rst two points. Discussed appropriate patient selection and provided Sandy with partnersagainstpain brochure and CD. Also provided Sandy "with Ryzolt slim Jim ?s and Senokot pamphlets for appropriate patients.842 34? PTN000041765 (emphasis added). [Physician Assistant now works at Pain Clinic A and is supervised by Dr. and other providers. 342 PTN000031807 ID47210 (10/8/2010) (emphasis added). 193 671. One week later, on October 15, 2010, Sales Representative 3 sent an email to Purdue?s Drug Safety and Pharmacovigilance and Purdue?s Risk Management Departments,843 copying Sales Representative 16, that stated: While in Knoxville TN I was told by the o?ice mgr, that she is hearing rumors that a pain mgmt. practice called Breakthru Pain in Maryville TN owned by an individual named Sanaj/ Kincaid is running an illegal physician practice. When I asked why she characterizes asillegal she reported to me that a PA she knows well told her of the following issues occurring at the clinic: N0 exam table in the office O?ice records scant or non existent a medical diagnosis and pt plan of care based from previous physician notes O?ice does not conduct UDT Prescriptions pre-written often dispensed without a physician present. Told me that Mrs. Kincaids daughter has opened another clinic South of Maryville towards Townsend TN and was duplication Breakthrus business model.844 672. Sales Representative 3?s October 15, 2010 ROC was later forwarded to Purdue?s Law Department on October 26, 2010.845 673. On October 20, 2010, Sales Representative 16 sent an email to Purdue?s Law Department that stated: As follow up to our conversation yesterday, I am removing these two clinics from my call list. Since the company looks at individual providers, here is what I know about these clinics: Breakthrough Pain Therapy Center Owned by Sandy and Randy Kincaid 843 PTN000042492. 844 PTN000042505 (emphasis added). 845 PTN000042492. 194 2211 East Broadway Maryville, TN 37804 Overseeing Physician: Deborah Thomas, MD Associated Providers: Buffy Kirkland, FNP Don Lewis FNP Walter Blankenship, PA Donna Smith, FNP [Physician Assistant Sherry Fetzer, FNP [Pain Clinic Owned by [Owner of Pain Clinic and his daughter [Male Owner of Pain Clinic is the ex?husband of Sandy Kincaid, and his daughter is also Sandy Kincaid?s daughter I will be adding call notes to each physician about our conversation yesterday and that you will let me know if these clinics should be called on at a future date.846 674. On November 11, 2010, Sales Representative 16 submitted a ROC to Purdue concerning Breakthrough that the pain clinic had no examination equipment, had no examining gloves, did not perform any urine drug screens, and that the physician would just ask a patient about their pain based on a previous doctor?s notes, stating in relevant part: Of?ce Manager told me today that she spoke with the owner of [a pharmacy in the area] this morning and that he told her that he is no longer taking any more patients from Breakthrough Pain Therapy Center. also told me that she knows the MD who works at Breakthrough Pain, because she had worked with them for a couple of months. said that the Dr has told her that they have no exam equipment at Breakthrough pain. said that the Dr said that patients sit across from a desk in an o?ce and the provider discussed their pain based on a previous physicians notes. said that the Dr also told her that they have no gloves and that they do not do any urine drug screens. 847 346 . 347 PTN000042515 (emphasis added). 195 675. on' November "11, ?2010," sales "Representative ?"16 submitted another concerning Breakthrough about information she received from a nearby pharmacy. She wrote: said that he is unsure about Breakthrough Pain down the street. said that the clinic has been there about two years. said that he has met with the owner Sandy a couple of times and talked with her about things. said that she answers all of the questions he has asked with the right answers. However, said that he still wonders about the practice. said that they are always busy. said that he ran some errands earlier today and drove by on his way back to the pharmacy and the parking lot at Breakthrough was full. said he wonders if there are really that many patients who have chronic pain issues.848 676. Despite the report that Sales Representative 16 would remove Breakthrough and its providers from her call list, she continued to call on the providers who she had identi?ed as being associated with Breakthrough well after her correspondence to her superiors at Purdue about the clinic and providers in October 2010.849 677. For example, on November 23, 2010, Sales Representative 16 recorded the following from a sales call with Nurse Practitioner Buffy Kirkland, a provider who was still working at Breakthrough: Buffy said that she got a call from someone asking her about a patient she has treated at the Breakthrough Pain Therapy Center. Buffy said that she was the last one to prescribe Oxycontin for this patient. Buf?z said that the patient ended up in the hospital with an abscess and track marks from where he had been shooting up Oxycontin. Bujfy said that whoever called asked if she knew that the patient was getting medications prescribed by other providers? Bujfy said that she asked who? Bu??z said that they are the other prescriber ?s at Breakthrough Pain. Bu??z said that the providers at Breakthrough do not have set appointments, that they see patients as they come in.850 84" (emphasis added). 849 PTN000031807 ID49661 (1/6/2011); PTN000031807 ID50441 (4/26/2011); PTN000031807 IDS 8212 PTN000031807 ID60967 (9/26/2011). 350 PTN000031807 ID48817 (11/23/2010) (emphasis added); see also PTN000039256 (11/23/2010 call note stating Ms. Kirkland was still working at Breakthrough on Wednesdays). 196 678. Purdue continued to receive reports concerning Breakthrough. On December 14, 2010, additional news broke that the US. Department of Justice raided Breakthrough and another clinic and arrested several people for conspiracy to distribute controlled substances, including oxycodone.851 679. On December 15, 2010, Sales RepreSentative 16 sent an email to Purdue?s Law Department that referenced ?Breakthrough Pain Therapy Center? and another clinic in the subject line and stated: FYI: My son spoke with the reporter who went with law enforcement to the Breakthrough Pain Therapy Center bust yesterday. He was told that indictments are coming for the [Drs. Deborah Thomas and James Joyner] involved. I asked if the reporter said anything about other prescribers. My son said-that he did not.852 680. On December 15, 2010, Purdue Sales Representative 16 also called on Jamie Cordes, a nurse practitioner who had previously worked at Breakthrough, and through her notes acknowledged that she had heard about the allegations against the clinic.853 The call note stated: jamie asked me #1 had heard about Breakthrough Pain. I told Jamie that I had heard. Jamie said that she had worked there and that she was shocked by all of the allegations she has heard about. Jamie said that she knew of some of the problems (see below), but was unaware of many of the problems there. Jamie said that Dr Thomas saw the new patients in the clinic and that the other providers would see patients for follow up visits. Jamie said that she refused to see some patients at Breakthrough Pain when she was there. Jamie said that she would refuse to see patients if she had asked for them to be fired from the practice, for any reason, or if the appropriate documentation was not in the chart.854 851 PTN000039573. 852 PTN000039570 (emphasis added). 853 PTN000031807 ID48324 (12/15/2010). ?54 PTN000031807 11348324 (12/15/2010) (emphasis added). 197 681.? Sales Representative 16 spoke with Pharmacist about Breakthrough the same day. In a call note dated December 15, 2010, Sales Representative 16 wrote: Met with pharmacist today. [Pharmacist] asked if] had heard about Breakthrough Pain and Maryville Pain. I told [pharmacist] that I had. [Pharmacist] said that he would have never guessed. [Pharniacist] said that they spoke with [Prescriber from Breakthrough every day on the phone. [Pharmacist] said that Maryville Pain had been closed by the DEA previously and that somehow they hired a new Dr and NP and were allowed to re-open. I told [Pharmacist] my that I did not know. [Pharmacist] asked if I knew anything about [Pain Clinic [Pharmacist] said that it just doesn?t make sense to him that a gynecologist would run a pain clinic. [Pharmacist] also suggested that I do not wear my name badge in public with the Purdue logo. [Pharmacist] said that many people are becoming- desperate. 855 682. On December 20, 2010, Purdue placed ?Drs. and Deborah Thomas of Breakthrough Pain Clinic? in cease calling status citing ?clinic reiided/owners/staff arrested? as the reason.856 Purdue did not place the other providers who it knew to be associated with this clinic in cease calling status at this time. Purdue?s sales representatives made repeated calls to Nurse Practitioners Buffy Kirkland and Jamie Cordes, who had both worked at Breakthrough, after December 2010.857 683. As known by Purdue, on October 9, 2014 and October 16, 2014, news broke of indictments against Dr. Thomas and Dr. oyner,8?58 Physician Assistants David Blankenship and David Brickhouse, and Nurse Practitioners Buffy Kirkland, Jamie Cordes, Sherry Fetzer, and Donna Smith.859 355 PTN000031807 1D5361 1 (12/15/2010) (emphasis added). 856 357 PTN000031807 IDS 8212 (6/14/2011); PTN000031807 ID60967 (9/16/2011); PTN00003 9229; 23 . 353 Voluntarily retired license on July 22, 2015. 359 PTN00003 6592. 198 684. Purdue Sales Representative 16 called on Nurse Practitioner Kirkland even after the October 9, 2014 story broke of her indictment and indictments against multiple other Breakthrough providers.860 Sales Representative 16 also called on providers who took over treating all of Ms. Kirkland?s opioid?prescribed patients, many of whom were on OxyContin, almost immediately after Breakthrough closedgm Buffy Kirkland, APRN Cease Calling Status Date: October 21, 2014 685. Buffy Kirkland was a nurse practitioner who worked in Maryville at several suspect pain clinics. As known to Purdue, Ms. Kirkland worked at Breakthrough and prescribed signi?cant amounts of OxyContin, especially between 2010 and 2014.862 From 1998 to 2017, Ms. Kirkland prescribed 68,438 tablets of OxyContin, of which 65.6% or 44,925 were 40 mg or higher.863 686. Ms. Kirkland began working for another physician after the raid by federal authorities at Breakthrough. But, as Purdue knew, Ms. Kirkland also kept working for Dr. Deborah Thomas, the supervising physician at Breakthrough. 687. Ms. Kirkland also worked for another clinic that was known to Purdue to be ?cash only.?864 Despite Purdue?s knowledge of her role with suspect clinics and other red ?ags, Ms. Kirkland was only placed in cease calling status on October 21, 2014.865 688. Purdue continued to make sales calls to Ms. Kirkland and extended repeated dinner program invitations366 to her in spite of facts indicative of abuse or diversion as detailed below. 36? PTN000039229. 36] See PTN000031807 ID138911 (11/13/2014). 362 PTN000030704 (242.3 ?2012), (284.3 ?2013), and 363 PWG003984543. 36? PTN000031807 ID176230 (11/17/2010). 365 PTN000031810. 366 PTN000039244. 199 689. Purdue sales representatives called on?Ms. Kirkland 'at'l?east "l 58~times between September 12, 2006 and October 13, 2014.867 690. Purdue had knowledge that Ms. Kirkland continued to work at Breakthrough even after receiving reports in October 2010 that the clinic was an illegal practice and had no examination equipment.868 691. On November 23, 2010, Sales Representative 16 recorded the following call note from a visit with Ms. Kirkland: Buffy told me about the patient below from Breakthrough Pain [shown below]. Bu?j/ said that this has made her feel bad and wonder if she should be working there on Wednesdays. Buffy said that the patient has passed all of the urine drug screens (even at the hospital). Buffy said that they do check the PMP website and that the patient was not Dr shopping.869 692. As stated above, Sales Representative 16 added: Buffy said that she got a call from someone asking her about a patient she has treated at the Breakthrough Pain Therapy Center. Buffy said that she was the last one to prescribe Oxycontin for this patient. Buf?/ said that the patient ended up in the hospital with an abscess and track marks from where he had been shooting up Oxycontin. Bu??z said that whoever called asked if she knew that the patient was getting medications prescribed by other providers? Bu?fy said that she asked who? Bu?fy said that they are the other prescriber?s at Breakthrough Pain. Bu?y said that the providers at Breakthrough do not have set appointments, that they see patients as they come in.870 693. At least by July 7, 201 1, Purdue had knowledge that Ms. Kirkland was still working with Dr. Thomas, the supervising physician at Breakthrough, yet allowed its sales representatives 867 PTN000031807. 868 PTN000042504. 359 PTN000039256 (emphasis added). 870 PTN000031807 ID48817 (11/23/2010) (emphasis added). 200 to keep making sales calls to Ms. Kirkland. On that day, July 7, 2011, Sales Representative 16 wrote following a sales call that: Bu?j} stated that she is working at a new pain clinic called [Pain Clinic on Gov. John Sevier Highway on Wednesdays (her day off from Dr of?ce). Bu?jx said that Dr Deborah Thomas is working there.871 694. Ms. Kirkland tried to work with other suspect providers and pain clinics besides Breakthrough. On June 14, 2011, Sales Representative 16 reported that Ms. Kirkland was interested in working for Pain Clinic A, a clinic whose providers, Dr. Frank McNiel and Dr. C, were also known by Purdue to have been problem prescribers and placed in cease calling status.872 On that day, Sales Representative 16 wrote: . Buffy discussed a few things: 1) She previously worked for Breakthrough Pain on her day off from Dr s?s o?zce and that she has heard that the court date for Breakthrough pain has been set for October. 2) She said that she did not believe that any of the charges in the indictment by the Feds were true, and that the owners of Breakthrough Pain have ?led a defamation of character lawsuit against the feds. 3) She asked several questions about [Pain Clinic and stated that she has been thinking about going to work there. 873 695. Ms. Kirkland did not end up working for Pain Clinic A. 696. On February 17, 2012, Purdue Sales Representative 16 stated in a call note following a discussion with Ms. Kirkland that ?Bu?fy discussed that she is opening her own pain clinic with another NP in Alcoa. Buffy discussed that she would like me to call on her there after March 1 . . . Bu?fj} said that our Oxycontin business would be better, since there is a shortage of Opana ?874 871 PTN000031807 ID173739 (7/7/2011) (emphasis added). 872 PTN000031810. 873 PTN000031807 ID58212 (6/14/2011) (emphasis added). 374 PTN000039251 (emphasis added). 201 697. Purdue had knowledge that when Ms. Kirkland was working'for anOther suspect clinic and in the process of opening her own practice, she described Pain Clinic A in more negative terms than just months before when she was considering working for that clinic. 698. On February 17, 2012, Sales Representative 16 wrote of the interaction with Ms. Kirkland: Buffy discussed that at the pain clinic ([Pain Clinic she has been working at on Wednesdays they do not take any patients from [Pain Clinic ([Drs. and others). Bu?fy said that the patients from [Pain Clinic are prescribed unusually large quantities of both Long acting and short acting medications. Bu?fy said that at her new clinic that she and another NP are opening on March 1, they also will not accept patients ?om [Pain Clinic A ].875 699. Purdue also had knowledge that Pain Clinic B, the clinic where Ms. Kirkland indicated she was working on Wednesdays, was suspect. In a November 17, 2011 call note describing a visit with an orthopedic surgeon, Sales Representative 16 wrote that Pain Clinic was ?a cash only o??ice.?876 700. Ms. Kirkland continued to associate with other providers from Pain Clinic B. Around March 1, 2012, Ms. Kirkland opened a new clinic with Nurse Practitioner who had worked at Pain Clinic 3373 701. On May 22, 2012, Sales Representative 16 stated in a call note from a visit with Nurse Practitioners Kirkland and LL that Nurse Practitioner LL was expanding and opening a clinic in another town.879 375 PTN000031807 ID69373 17/2012) (emphasis added); PTN000039864. 876 PTN000031807 ID176230 (11/17/2011) (emphasis added). 877 See PTN000039251 (3/14/2012). 373 PTN000047870. 379 PTN000039248. 202 ?702. of=OxyContinr ?On May 31, 2012, Sales Representative 16 noted the following in a call note from a sales visit with Ms. Kirkland: When I walked in Buj?/ said that she started another patient on Oxycontin this morning. said that she has started quite a few patients on Oxycontin recently. Buffy said that the patients seem to do better. Buffy also said that she is utilizing the cards and prescribing Oxycontin every 14 days for some patients who have dif?culty with the cost. 703. Elsewhere, Purdue had knowledge that Ms. Kirkland?s clinic had a suspect patient population. On July 19, 2012, Sales Representative 16 reported the following in a call note from a sales call with Ms. Kirkland: Bu?fy discussed that two area clinics closed recently: [Pain Clinic in Knoxville and a pain clinic in Vonore. Bu?fy discussed that many of those patients are calling and that they are seeing some of them. I asked what medications and doses these patients are currently taking when they come to her. Buffy said that vary are from taking anything from 2 hydrocodone/day to Oxycodone, possibly morphine and so on. With conversion guide I discussed appropriate conversion from other medications to Oxycontin.881 704. Sales Representative 16?s manager, District Manager 3, accompanied her on this sales call to Ms. Kirkland and he noted the following: PRESENTATIONS: You presented each product. During the call, the HCP had given you the info that there is a new in?ux of patients and several are on ?a couple of hydros a day that she-felt were perfect for Butrans. CLOSING: You asked for utilization in the new in?ux of patients.882 38? PTN000039248 (emphasis added). 33? (emphasis added). 832 PTN000035268 (emphasis added). 203 7 0 5. On '3 eptember "5 2012, ?Sales call with Ms. Kirkland as follows: Buffy discussed that she dismissed a patient for shooting up oxycodone when she saw the track marks on the patient ?s arms.883 706. On June 11, 2013, Purdue Sales Representative 16 made the following note about a sales call with Ms. Kirkland: [B]uffy discussed several issues she has had with patients recently. Buf?v discussed that she has had discharge several patients recently. Buf?z discussed that she dismissed three patients this week already.884 707. On September 22, 2014, Sales Representative 16 made the following note from a sales call with Ms. Kirkland: Brief call. . .. Buffy said that she has had a bad day. Bu?y discussed that she has had to dismiss two patients recently, one of whom she dismissed today. Buffy discussed that the patient she dismissed today was a patient she never would have suspected.885 708. In addition to other red ?ags, Purdue sales representatives reported during sales calls that Ms. Kirkland or her clinic was ?very busy?? or words to that effect on May 9, 2012, May 15, 2012, May 28, 2013, September 16, 2013, September 17, 2013, May 22, 2014, June 23, 2014, and August 11, 2014.886 709. Yet Purdue continued to call on Ms. Kirkland to promote OxyContin in 2014. On June 16, 2014, Sales Representative 16 made the following note from a sales call during which Ms. Kirkland proactively solicited Purdue to get more OxyContin savings cards: tr ?883 PTN000031807 ID80960 (emphasis added). 33? PTN000039239 (emphasis added). 835 PTN000039229 (emphasis added). 886 PTN000031807. 204 710. other providers at Breakthrough.888 Sales Representative 16 even called on Ms. Kirkland on October 13, 2014, after news of the indictments against the other Breakthrough providers were This call was in response to a message from Bu?j/ asking for additional OxyContin savings cards. Provided Buffy with two packs of OxyContin savings cards. I thanked Buffy for prescribing OxyContin.887 As stated above, on October 9, 2014 news broke of indictments against several reported.889 On October 16, 2014, news broke of the indictment against Ms. Kirkland.890 711. One month later, on November 13, 2014, Sales Representative 16 was already calling on the provider who took all of Ms. Kirkland?s patients. She reported: 712. discussed that they are now treating all of Kirkland ?s patients and that many of these patients were on oxycontin. said that most of these patients have BCBS for insurance. Discussed Butrans for appropriate patients with Helen patient pro?le. asked about adverse events. Discussed adverse events with vis aid. asked about the savings cards program. Discussed and provided cards.891 On November 18, 2015, Nurse Practitioner Kirkland was disciplined by the Tennessee Board of Nursing, which found the following: Respondent worked at [Breakthrough Pain Therapy Center] part time, (one day a week) from around August 2010 to December 2010. [Breakthrough] had no protocol for the treatment of its customers and the defendant was provided no medical supervision. While Respondent worked at [Breakthrough], [Breakthrough] did not have examination tables, medical equipment, hospital gowns, or gloves. Patients of [Breakthrough] were required to pay for their visits in cash and make a follow?up appointment before being seen by a provider. 387 PTN000039231 (emphasis added). 888 PTN000036592. 839 PTN000039229. 890 891 ID138911 (11/13/2014) (emphasis added). 205 ?Some patients were" treated at [Breakthroughl?by "Respondent ?and others based on old radiographic results or descriptions of the chronic pain they were feeling, with limited medical history regarding the pain and without being given a physical examination or without having been given a physical examination suf?cient to meet the standard of care. Some patients seen at [Breakthrough] by Respondent and other providers were written prescriptions for Schedule II controlled substances including morphine, oxycodone, and oxymorphone, and for Schedule IV controlled substances including alprazolam, without a legitimate medical purpose. The providers at [Breakthrough] including Respondent and others, did not always engage in screening patients foraberrant or drug seeking behavior. Some patients could have been observed dealing and using illicit drugs in the parking lot.892 713. On June 1, 2016, Ms. Kirkland and three others formerly employed at Breakthrough each pleaded guilty to a charge of conspiracy to distribute controlled substances. 714. Overall, Purdue ignored Ms. Kirkland?s connection to two suspect clinics, her continued connection to suspect providers including those that Purdue had already placed on cease calling status, and numerous other red ?ags indicative of abuse or diversion. Jamie Cordes, APRN Cease Calling Status Date: October 10, 2014 715. Jamie Cordes was a nurse practitioner who practiced at multiple clinics in the Knoxville area. As with Ms. Kirkland, Purdue knew that Ms. Cordes had been associated with the Breakthrough clinic and of other facts indicative of abuse or diversion, yet kept making sales calls to her of?ce. 392 0475,} 1 1815. 206 716. Ms. Cordes was once designated a ?core? prescriber for Purdue sales representatives893 due to her high volume prescribing amounts. Purdue sales representatives still called on her repeatedly after she was removed from the core list.894 717. According to the records Purdue produced to the State, Purdue?s sales representatives called on Ms. Cordes at least 60 times between August 17, 2009 and October 7, 2014. 895 718. Purdue ?nally placed Nurse Practitioner Cordes in cease calling status on October 10, 2014,896 after news broke of her indictment in a conspiracy involving the illegal distribution of prescriptions for controlled substances.897 Ms. Cordes later pleaded guilty to each criminal charge.898 719. From January to September 2010, Ms. Cordes?s patients redeemed 409 $70 OxyContin savings cards, almost 20% of the 2,223 total $70 OxyContin savings cards provided to patients by all of the prescribers in her Purdue sales territory.899 720. Purdue knew as early as December 15, 2010 that Nurse Practitioner Cordes had worked at Breakthrough. On that date, Ms. Cordes told Sales Representative 16 that she worked at one of the clinics that was accused of engaging in abuse and diversion. As recited above, the call note stated: Jamie asked me if I had heard about Breakthrough Pain. I told Jamie that I had heard. Jamie said that she had worked there and that she was shocked by all of the allegations she has heard about. Jamie said that she knew of 893 PTN000040739. 89? See PTN000040725. 395 PTN000031807. 896 PTN000040749. 897 393 899 PTN000071735. 207 some ?ofthe p'rdb'lems was unaware ?O?f m?any'of? the problems there.900 721. Purdue had knowledge of other red ?ags about Ms. Cordes. On May 25, 2011, Sales Representative 16 recorded the following interaction with Nurse Practitioner Cordes: Jamie said that she will start work for [a hospital] in the local Walmart clinic. Jamie said that she is over trying to treat chronic pain. Jamie discussed all of the pressure, concerns, etc she feels. Jamie said that there will be a new Dr coming to practice there.901 722. Despite this statement, Nurse Practitioner Cordes continued working with Breakthrough. On June 8, 2012, Sales Representative 16 entered a call note which stated ?Called on clinic and asked to see Jamie Cordes, FNP. The receptionist said that, ?They have 15 more patients to see this morning and 5 more to come in yet.?902 723. Additionally, on that same day, Sales Representative 16 reported the following in her ROC to Purdue concerning Ms. Cordes: This is approximately the fourth time I have called on this clinic. Today was the first time I observed the following: The parking lot was full of cars. Many of the cars had people sitting in them or smoking outside. The car parked directly behind mine had a person in the passenger seat who looked stoned. The license plates on the cars were primarily ?om Hamblen County (2 counties away), with two from Knox County (the county the office is in) and one from Washington County (with the person in the passenger seat). Washington County is approximately 4 counties away, about 2 or more hours of a drive away. 903 90? PTN000040736 (emphasis added). 90? (emphasis added). 902 19294 ID103746 (6/8/2012). 903 PTN000040722-23 (emphasis added). 208 724. - Despite -~witnessing this. concerning. Representative .16 ..asked .the receptionist to speak with Ms. Cordes, provided her business card, and left promotional materials for Purdue products including OxyContin and Butrans.904 725. Purdue kept Nurse Practitioner Cordes in continue calling status despite these continuing signs of abuse and diversion.905 On July 14, 2014, Sales Representative 3 recorded the following in his call notes about the clinic where Nurse Practitioner Cordes worked at the time: shared with me that they have lost credentials with BCBS, UHC, and Humana. They have laid off 17 people and others to follow. Not sure how providers will break up or where they will end up.?906 726. On July 25, 2014, Sales Representative 3 wrote the following about his interaction with Nurse Practitioner Cordes?s of?ce: . . sd of?ce hopefully returning to normal soon. . . Jamie cordes le? and unknown whereabouts.?9?7 On September 4, 2014, Sales Representative 6 noted in a call with Nurse Practitioner LL, Ms. Kirkland?s former partner who had also worked at Pain Clinic that Nurse Practitioner Cordes had opened up a clinic with Nurse Practitioner . 727. Additionally, the call notes from Purdue sales representatives show that Ms. Cordes had a high volume practice. On February 10, 2011, Sales Representative 16 recorded the following in her call notes: ?Also spoke with practice manager said that Jamie is currently seeing about 20 patients/day and that she rarely gets a break anymore.?910 904 PTN000040722. 905 PTN000040726. 906 PTN000040726 (emphasis added). 907 PTN000031807 ID196166 0/25/2014) (emphasis added). 908 PTN000047870. 909 PTN000031807 ID130884 (9/9/2014). 910 PTN000040735. 209 "728. As?n?o?ted? above, "on" June 8,1201 SalesRepresentative ?16 recorded-Gin {her-?cal-linotes: ?Called on clinic and asked to see Jamie Cordes, FNP. The receptionist said that, ?They have 15 more patients to see this morning and 5 more to come in yet. On July 30, 2013, Sales Representative 6 noted that providers including Ms. Cordes were ?[t]oo busy to talk.?912 On March 19, 2014, Sales Representative 3 noted: ?brief window call as again of?ce very bz. . . . ?913 729. Despite all of these reported signs of abuse and diversion associated with Ms. Cordes?s practice and associated clinics and providers, Purdue failed to place Ms. Cordes in cease calling status until October 10, 2014,914 after news broke of her indictment in a conspiracy involving the illegal distribution of prescriptions for controlled substances. Pain Clinic Cease Calling Status Date: 730. Pain Clinic was a pain clinic based in Knoxville that Purdue never placed in cease calling status. Purdue knew that Pain Clinic had a signi?cant number of cash paying customers and employed providers who were the subject of ROCs, who were placed in cease calling status themselves, or who had close ties with other suspicious providers or practices including Breakthrough. 731. Purdue had knowledge of facts indicative of abuse or diversion concerning Pain Clinic for many years. On November 17, 2011, Sales Representative 16 ?led a ROC in which two providers she called on two Pain clinics that are cash only? including Pain Clinic 915 9? PTN000040748. 9? PTN000040729. 9? PTN000040727. 9? PTN000040749. 915 PTN0000119294 ID89540 (emphasis added). 210 732. On January 29, 2013, Sales Representative 16 ?led a ROC after she called on a doctor who ?said that he has heard that [Pain Clinic was going to be shut down. Dr said he heard that they already had to close one of their of?ces.?916 733. At various times, Purdue also had knowledge of facts indicative of abuse or diversion at the clinic from the providers who worked there. Notably, Dr. Deborah Thomas, the supervising physician from Breakthrough that Purdue placed in continue calling status on December 10, 2010, worked at Pain Clinic as well as suSpect providers including Nurse Practitioners Buffy Kirkland (discussed above), Nurse Practitioner Brandy Burchell, Nurse Practitioner Christina Collins, and Nurse Practitioner II. 734. Despite Purdue?s knowledge of abuse and diversion associated with the clinic?s providers, Purdue failed to ever place the actual Pain Clinic on cease calling status. Brandy Burchell, APRN Cease Calling Status Period April 30, 2012 to November 25, 2014 735. Brandy Burchell was a nurse practitioner who worked at Pain Clinic but who also previously worked with Dr. Frank McNiel and Dr. at Pain Clinic A919 From 1998 to 2017, Ms. Burchell prescribed 285,652 tablets of OxyContin, of which 89.8% or 256,745 were 40 mg or hi gher.920 9?6 PTN0000119294 ID120529 (emphasis added). 9? PTN000119294 ID78705 (7/7/2011); PTN000031807 ID176230 (11/17/2011). See also PTN000047870 (identifying address as ?Deborah Thomas, MD 2805 West Govenor [sic] John Sevier Highway? as of 9/6/201 1) and PTN000031807 ID78675 (6/5/2012); PTN000031807 ID129722 (7/24/2014); PTN000031807 ID139688 (12/2/2014); PTN000031807 ID139782 (12/2/2014); PTN000031807 ID140651 (1/13/2015); PTN000031807 ID140980 (2/25/2015) (identifying same address as being associated with Pain Clinic B). 918 PTN000040261. 9?9 920 PWG003984543. 211 736. Purdue placeduMsi-sBurehellin -ce-ase..ca11i-ng.status onApril 3.0 ,g 20 1 2.9.21. . This. cease calling status lasted until November 25, 2014,922 when Purdue granted Sales Representative 6?s request that Ms. Burchell?s cease call status be changed. 737. During the time that Ms. Burchell was in cease calling status, Purdue sales representatives still called on her. For example, on July 24, 2014, Sales Representative 6 called on Nurse Practitioner Burchell at Pain Clinic and wrote: Met Brandy for the ?rst time. She had very little time to talk. Reminded her of the seven dosing and discussed their tapering efforts in patients getting them to the 200 mg morphine threshold. She said they?re trying hard to get most of their patients down to that level.923 738. Aside from the fact that a Purdue sales representative called on Ms. Burchell while she was in cease calling status and Purdue failed to discipline the sales representative, the sales call itself is problematic because of the high MME threshold reference. The CDC has stated the risk of overdose death increases twice at just 50 MMES and considers anything over 90 MMEs per day to be dangerous.924 739. Purdue Sales Representative 6 stated his ?Next Objective? from this call was to ??ollow up on OxyContin use in appropriate patients. Review the seven dosing and discuss how their titrating their Review the savings card program and discuss its application especially with cash pay pts.?925 740. On October 30, 2014, while Ms. Burchell was working at Pain Clinic 3,926 Sales Representative 6 wrote that he: 92} PTN000031810. 927' PTN000031810. 923 PTN000038107 ID129722 (emphasis added). 9?24 925 PTN000040264 (emphasis added). 926 See PTN000039266 (listing 2805 W. Governor John Sevier Highway as Ms. Burchell?s address). 212 after ?a?lea'd from'an? was ?entered into the system and popped up as a ?No call?. This HCP used to be in the [Pain Clinic and is not anymore. Could this HCP be re?evaluated to see if it would be ok to resume calling on?927 741. In response, on November 25, 2014, Purdue emailed its sales representatives notifying them that they may resume calling on Nurse Practitioner Burchell.928 742. Despite knowledge of Ms. Burchell?s connection to both Pain Clinic A and Pain Clinic and the high MME doses she had prescribed her patients, Purdue continued to call on her. Even when it placed her in cease calling status, Purdue sales representatives continued to call on Ms. Burchell. 743. On November 20, 2017, Ms. Burchell was disciplined by the Tennessee Board of Nursing and found to have acted below the standard of care with respect to prescribing controlled substances to 13 patients ?in amounts and/or for durations not medically necessary, advisable, or justi?ed for a diagnosed condition? from 2011 to 2013. The Board noted that Ms. Burchell ?often prescribed prescriptions to individual patients exceeding a daily dosage of one thousand (1000) morphine milligram equivalents,? in at least one case prescribed more than 3,000 MMES ?929 to at least one patient, and ?routinely ignored signs of abuse or diversion. Christina Collins, APRN Cease Calling Status Date: April 30, 2012 to November 25, 2014 744. Nurse Practitioner Christina Collins,930 who had previously worked for Pain Clinic A931 and Pain Clinic B932 was one of the top prescribers of OxyContin in Tennessee.933 Ms. Collins 927 PTN000039266. 928 PTN000040265. 929 12017. 930 PTN000039283. 93? PTN000039267. 932 PTN000039283. 933 PTN00003 I 809. 213 had a large portion of "her patients on ?i'highwlevels ?of opioids??4iricluding Oxy'ContinI'93'4 As mentioned above, from 2006 to 2016, Nurse Practitioner Collins wrote prescriptions for 292,960 tablets of OxyContin from all payors.935 She prescribed 142,395 OxyContin 80 mg tablets from 2006 to 2014.936 From 1998 to 2017, Ms. Collins prescribed 293,739 tablets of OxyContin, of which 90.9% or 267,062 were 40 mg or higher.937 In 2011 alone, Nurse Practitioner Collins wrote 935 prescriptions for OxyContin, 835 more than she had written in 2010.938 She wrote 1,444 prescriptions for OxyContin in 2012.939 745. Purdue placed Nurse Practitioner Collins and other prescribers at Pain Clinic A940 in cease calling status on April 30, 2012. Purdue moved Ms. Collins back to continue calling status on November 25, 2014.941 746. Before and during the time that Ms. Collins was placed in cease calling status, Purdue had knowledge of facts indicative of abuse or diversion. On July 24, 2014, Sales Representative 6, who had called on Nurse Practitioner Burchell when she was in cease calling status, also called on Nurse Practitioner Collins while she was in cease calling status. He reported: ?Met Christina for the ?rst time. Had good discussion around their efforts and tapering patients down due to the new dosing guidelines. Christina felt she has roughly 90% of her patients at or 934 PTN000038107 ID167818 (5/7/2010) (call note ?stated [she] has prescribed a couple of times but not as much as at old (emphasis added). 935 PTN000031809. 936 PTN000031809. 937 PWG003984543. 938 PTN000052837. 939 PTN000052837. 94? PTN000036363. PTN000031810. 214 below the ?200 mgr-morphine equi=-v alency.? .?As the sedoses are well ,abovethe 9O MME level that the CDC considers dangerousg?43 747. Despite the fact that Ms. Collins was prescribing opioids to some patients at dangerously high levels even while in cease calling status, Sales Representative 6 requested that Purdue move Ms. Collins back to continue calling status.944 Purdue granted this request on November 25, 2014 with emails from Purdue?s Law Department instructing the sales representatives that they may begin calling on Nurse Practitioner Burchell and Collins again without any justi?cation as to why it would be appropriate to resume calling on these previously identi?ed problem prescribers.945 748. Based on her documentation of pain treatment and ?her haphazard and unprofessional prescribing practices,? the Tennessee Board of Nursing disciplined Ms. Collins on March 6, 2018 by placing her license on probation for 2 years and prohibiting her from practicing in a licensed pain management clinic as a nurse practitioner.946 Nurse Practitioner II Cease Calling Status Date: 749. Nurse Practitioner II was another provider who worked at Pain Clinic in Knoxville at least by August 20, 2012.947 After reviewing Nurse Practitioner 11?s ?le, Purdue decided to keep her in continue calling status on June 24, 2014.948 942 PTN000038107 ID196137. 944 945 PTN000039280. 702?1282 8_0301 18. 947 PTN000049448. 943 PTN000036708. 215 .- 7 50.= . ?Beforeiandzafter Purduemade of. facts indicative of abuse or diversion, including that 50% of Nurse Practitioner 11? patients paid in cash from January 2014 to March 2014.949 751. On August 20, 2012, Nurse Practitioner II af?rmatively called Purdue to request that a ?sales rep bring OxyContin savings cards.?950 752. Nine days later, on August 29, 2012, Sales Representative 18 stated the following in his notes from a sales call with Nurse Practitioner II: We went over the different doses of oxycontin and she stated that her patients will tell her the 15mg doses does not exist. I explained that it does. She stated that it is an excuse the patients make up about the product. She stated that she is using the coupons. She stated that she is going to go to our speakers program.951 753. Elsewhere, Purdue received reports of Nurse Practitioner patients traveling from distant counties. On May 5, 2014, Purdue District Manager 3 accompanied Sales Representative 16 when she called on Nurse Practitioner II and he recorded: ?It was observed in the parking 10 that there were license plates ?om several counties, some as far as 3 hours away, patients waiting in cars outside of the clinic. In the clinic, we did not see any other causes for concern but this should be reported.?952 754. Four days later, on May 9, 2014, Sales Representative 16 submitted a ROC to Purdue concerning. Nurse Practitioner of?ce that said: ?Prior to making this call I noticed the following that car license plates ?om the following Tennessee counties were in the parking lot: 949 950 PTN000049448. 95? PTN000036709 (emphasis added). 952 PTN000035268 (emphasis added). 216 Gibson, Blount, Williamson, Sevier, Anderson, Knox and or these counties are located far from Nurse Practitioner H?s clinic, and the drivers of these cars would have access to many other health care providers in cities closer to home. For example, Gibson County is approximately 321 miles or over 5 hours driving by car to Knoxville. Williamson County is approximately 197 miles or 3 hours driving by car from Knoxville. 755. Purdue continued to have knowledge of red ?ags after it decided to keep Nurse Practitioner in continue calling status on June 24, 2014.954 On July 1, 2014, Sales Representative 3 made his initial call on Nurse Practitioner II and noted that: She came from [Pain Clinic and has no desire to become a huge prance. She her goal is to provide pain but giving attn to other medical needs as well and will not be writing huge doses and handing out Rx indiscriminately as she has seen other NP cl inics.955 756. In sales call notes, Sales Representative 3 documented multiple instances in which Nurse Practitioner II was too busy for a proper sales call. He attempted calls on August 5, 2014 (?Unable to see September 8, 2014 September 5, 2014 (?Unable to see September 24, 2014 (?unable to see December 9, 2014 (?Saw provi brie?y at February 24, 2015 (?attemptd April 29, 2015 May 1, 2015 (?Brief window call May 19, 2015,964 and June 1, 2015 (?Quick 953 PTN000036713 (emphasis added). 954 PTN000036708. 955 PTN000031807 ID126846 (7/24/2014) (emphasis added). 956 PTN000031807 113128837 (8/5/2014). 957 PTN000031807 ID130966 (9/8/2014). 958 PTN000031807 ID196614 (9/5/2014). 959 PTN000031807 ID197850 (9/24/2014). 960 PTN000031807 ID140438 (12/9/2014) 961 PTN000031807 lD144828 (2/24/2015). 962 PTN0000318071D150614 (4/29/2015). 963 PTN000031807 lD150216 (5/1/2015). 964 PTN000031807 1620 (5/19/2015). 965 PTN000031807 113204109 (6/1/2015). 217 757. On May 1, 2015, Sales?Representative 3 visited the 'Of?ce" in response to" Nurse Practitioner H?s call to Purdue requesting more OxyContin savings cards and reported it was once again a brief front desk window visit.966 758. Purdue failed to place Nurse Practitioner II in cease calling status despite her association with Pain Clinic B, her high number of cash-paying patients, her high volume practice, and other red ?ags, such as the presence of patients from distant counties at her clinic. Teodora Neagu, APRN Cease Calling Status Date: April 30, 2012 to May 1, 2014 759. Teodora Neagu is a nurse practitioner who works in the Knoxville area and whose license is currently on probation for over?prescribing or prescribing controlled substances in a manner inconsistent with the Tennessee Board of Medical Examiners? Rules?67 Nurse Practitioner Neagu worked for Pain Clinic A from 2008 to 2013968 and for Dr. MM in 2008?the same year he was placed in cease calling status.969 760. Despite not writing any prescriptions for OxyContin in 2006, 2007, or 2016, Nurse Practitioner Neagu was one of Purdue?s top 100 OxyContin prescribers in Tennessee between 2006-2016.970 Between 2008 and 2014, Ms. Neagu wrote 6,325 prescriptions for OxyContin, totaling 618,329 OxyContin tablets, 268, 716 of which were 80 mg tabletS??Purdue?s highest available dose at the time.971 In 2008, she wrote 924 prescriptions for OxyContin.972 Four years later in 2012, the number of OxyContin prescriptions written by Ms. Neagu increased to 1,745.973 966 PTN000031807 ID150216 (5/1/2015). 967 84ml 1 1717. 968 See PTN00003 63 63; 1 1717. 969 PTN00003 8024. 970 PTN000031407. 971 PTN000031407. 972 PTN000052837. 973 PTN000052837. 218 761. According to records produced by Purdue, from April 4, 2007 to December 8, 2014, Purdue sales representatives called on Nurse Practitioner Neagu at least 100 times,974 two of which were conducted while she was in cease call status from April 30, 2012 to May 1, 2014. While Ms. Neagu was in continue calling status, Purdue had knowledge of facts indicative of abuse or diversion. 762. On March 2, 2012, Purdue opened a ?le on Ms. Neagu, presumably because she let her DEA license lapse, but did not place her in cease calling status at that time.975 763. On April 30, 2012, Purdue determined that Ms. Neagu, along with Dr. Frank McNiel, Dr. C, and others associated with Pain Clinic A, should be placed in cease calling status.976 764. On October 1, 2013, Sales Representative 6 called on Nurse Practitioner Neagu while she was in cease calling status but Purdue did not discipline the sales representative.977 765. After a request from a sales representative, Purdue removed Ms. Neagu from Region 0 and allowed sales representatives to resume calling on her on May 1, 2014.978 A 766. Most recently, Ms. Neagu worked with Dr. another doctor Purdue reviewed to determine whether its representatives should continue calling on him.979 767. Despite her association with Pain Clinic A, her relationship with other suspect providers, and other red ?ags, Purdue decided to place Nurse Practitioner Neagu in continue 97? PTN000036345. 975 From Sales Representative 16?s April 18, 2012 call note: ?[Pharmacist] talked about how about a year ago, how both [Dr. Frank McNiel and Dr. and Teodora Neagu did not renew their DEA licenses. [Pharmacist] discussed that after they got them renewed (about two weeks later) he asked for c0pies before he ?lled their prescriptions.? 1. 975 977 PTN000031807 ID111986 (10/1/2013). 973 PTN000036362. 979 PTN000031810. 219 2014: ?Even-?when w-rst-atus,? ?Pvurduewsales representatives called on her. 768. In November 2017, the Tennessee Board of Medical Examiners brought a disciplinary action against Nurse Practitioner Neagu in which she admitted ?her prescribing of controlled substances was non-therapeutic in nature, neither justi?ed nor medically necessary for patients? diagnoses, and not for a legitimate purpose??0 In the Consent Order, which placed her license on restrictive probation, the Board found the following: 4. Respondent was employed as an APRN at [Pain Clinic a pain management clinic in Knoxville, Tennessee from 2008 to March 2013, during which time Dr. Frank McNiel was her supervising physician until he retired on December 25, 20-12. 5. While working at [Pain Clinic Dr. McNiel informed Respondent that higher doses of opioids generally led to a greater degree of functionality and quality of life. Thereafter, Respondent prescribed controlled substances in adherence to Dr. McNiel?s philosophy. 6. In each of the charts reviewed there was objective evidence, including for example X-Rays, MRIs, and small fiber conduction studies, to support that the patients at issue suffered from conditions that might cause pain. However, Respondent ?s prescribing was non?therapeutic in nature, neither justified nor medically necessary for patients? diagnoses, and not for a legitimate purpose. Respondent?s prescribing of controlled substances, while within adherence with Dr. McNiel ?s directive, fell below the minimum standard of care. 7. Respondent typically treated patients that had been receiving care from multiple providers at [Pain Clinic prior to her encounter with the patient. As opposed to treating patients based upon her own medical judgement, Respondent often mimicked the previous treatment provided. This regularly included prescribing large amounts of controlled substances for which patient charts did not provide sufficient justification.981 98? 1717. 93? (emphasis added). 220 Dr. Abdelrahman Mohamed Cease Calling Status Date: 769. Dr. Abdelrahman Mohamed, a neurologist based in Morristown, was one of Purdue?s top prescribers of OxyContin in Tennessee before he pleaded guilty to health care fraud in 2017.982 From 2006 to 2011, Dr. Mohamed prescribed 72,693 tablets of 80 mg of OxyContin.983 From 2006 to 2016, he prescribed 544,202 total tablets of OxyContin.984 Purdue regularly called on Dr. Mohamed, invited him to programs outside of the of?ce, and sent managed market specialists to answer his questions about third-party coverage of Purdue?s opioids.985 770. Purdue reviewed and determined that Dr. Mohamed should be in continue calling status on August 24, 2011.986 Purdue had not placed him in cease calling status as of 2016. During the time that Dr. Mohamed remained in continue calling status, Purdue knew of facts indicative of abuse or diversion. 771. 1 Purdue sales representatives called on Dr. Mohamed 350 times between February 15, 2006 and April 27, 2017.987 772. Purdue knew early on that Dr. Mohamed was prescribing high doses of opioids?-?? including OxyContin. On September 14, 2006, Sales Representative 3 reported that Dr. Mohamed said during a sales call that he has been getting a lot of patients from other providers ?on large doses ofopioids is drug screening trying to assess need hasn?t seen any problems with yet other than simply large doses.?988 conspiracy/article_t3 942944?3 fed?1 1e7?9234?ffdce9ace522.html. 983 see also PTN000031373 . 984 PTN000031809. 985 See, e.g. PTN000031807 ID141986 (1/14/2015). 986 PTN000031810. 987 PTN000031807. 938 PTN000031807 ID2605 (9/14/2006) (emphasis added). 221 "773. Dr. Mohamed ?asked what dosing limit on [oxycontin] advsed 160/day wwantd tamper resist rx pad.?989 774. Elsewhere, Purdue had knowledge about Dr. Mohamed?s suspect patient conversions to OxyContin. On March 22, 2010, Sales Representative 16 recorded the following from a sales call with Dr. Mohamed, in which he expressed a willingness to convert a patient from Suboxone, a drug used to treat opioid use disorder, to OxyContin. She stated: Walked in and Dr asked if we make a 60 mg Oxycontin. Reminded Dr. about the detail piece he hung up behind him on his bulletin board. Dr asked if had something bigger. Gave Dr. the Q12h detail piece. Dr said that he is trying to ?gure out how to convert patients from Symboxone to Oxycontin. Dr asked if I knew anything about how to convert patients. I said I'did not. . . Provided Dr. with Oxycontin conversion guide?90 775. Additionally, Purdue received reports of other signs indicative of abuse or diversion. On May 26, 201 1, Sales Representative 16 submitted a ROC that included the following: Dr. said that there have been reports of drug abuse and diversion in the parking lot of Bartlett Center in Morristown. Dr. said that some of the providers in the Center overprescribe medications. Dr said that Dr William Williams, Dr Abdelrahman Mohamed, FNP and PA all overprescribe pain medications. FYI: Dr also works weekends as an ER Dr at Lakeway Regional Hospital in Morristown.991 776. In spite of this reported concern, Purdue?s sales representatives continued to talk extensively with Dr. Mohamed about OxyContin and appear to have done nothing to act on the information concerning Dr. William Williams, who was also referenced in the ROC. 989 PTN000031807 11312529 (9/13/2007) (emphasis added). 990 PTN000031807 ID35062 (3/22/2010) (emphasis added). See also PTN00004651 l; PTN000046513. 99? PTN000038400 (emphasis added). 222 777. Dr. Williams was also a signi?cant preSCfiber of Oxycontin 'from'2'00'6 tow201?6. Purdue sales representatives called on Dr. Williams at least 448 times. Dr. Williams?s license was placed on probation following a Board of Osteopathic Examination consent order concerning the way in which he prescribed controlled substances and supervised others in the practice who prescribed controlled substances.992 I 778. In spite of the May 26, 2011 ROC, Purdue continued to call on Dr. Mohamed. On March 27, 2012, Sales Representative 18 recorded the following from a sales call with Dr. Mohamed: He and his staff stated that we should see a big increase in oxycontin. I asked why and he stated that he likes the product and there is no supply issue. He also stated that he has been using the savings coupon. 993 779. On August 2, 2012, Sales Representative 18 recorded the following from a sales call with Dr. Mohamed: . He stated that most of his patients are on oxycontin. He stated that the 20mg dose is what he uses the most with oxycontin. We discussed the different doses of oxycontin.994 780. On April 1, 2014, Sales Representative 9 recorded the following call note for her sales call with Dr. Mohamed: Dr.M0hamrned stated that he has many patients he has treated with OxyContin after taking SA opioids AT . He said he is treating a variety of conditions with OxyContin and his only concern is if the patients are able to get this medicine on their insurance formulary. 995 992 1907_962m050615. 993 PTN000031807 ID178190 (3/27/2012) (emphasis added). 994 ID180885 (8/2/2012) (emphasis added). 995 ID122458 (4/1/2014) (emphasis added). 223 781 . "'?Red ?flags continued-to be reported- to Purdue-in2011-4-1-and-12015 hOn April. .29, 2014, Sales Representative 9 recorded the following call note from her sales call with Dr. Mohamed: Dr. Mohamed ?s waiting room was standing room only and he was running behind. I acknowledged his time constraints and told him to make sure he had plenty of copay cards for his patients. He thanked me for recognizing his busy schedule today and stated that he has started several new patients on OxyContin since we last talked. 996 782. On May 14, 2015, Sales Representative 23 recorded her interaction with Dr. Mohamed during a sales call in which he referenced being warned by the State about his opioid prescribing habits. She reported: He said he likes that OxyContin has abuse deterrent labeling and he will convert a patient once they are taking 4 pills,per day. He said he doesn?t convert them sooner because of the TN restrictions. He said every now and then they send a nasty email and that they keep a close watch. He said when he converts them to and ER he has to give them an IR for breakthrough pain and then he has 2 scripts for schedule 11 drugs and they state watches how many scripts they write and that is why he keeps them on an IR longer. I asked him to simply do what is approp for patient.997 783. On August 13, 2015, Sales Representative 23 recorded her interaction with Dr. Mohamed during a sales call as follows: Quickly talked to Dr. Mohamed about oxycontin and Butrans. He said he . has been writing and went into his procedure. Talked to his nurse and she? said he is def writing a lot of oxycontin but not Butrans. Talked about approp patients for Butrans. She said most of their patients are on high morphine equivalents than what would be approp for convert to Butrans. .. 993 784. In addition to reporting these other concerning factors to Purdue, Purdue?s sales representatives regularly recorded that Dr. Mohamed was very busy, that his of?ce was 996 PTN000031807 113193933 (4/29/2014) (emphasis added). 997 PTN000031807 10203351 (5/14/2015) (emphasis added). 998 PTN000031807 ID155048 (8/13/2015) (emphasis added). 224 ?slammed,? or words to that effect on April 14, 2006,999 March 1, 2007,1000 August 9, 2007,1001 July 23, 2014,1002 December 23, 2014,1003 and January 21, 2015.1004 785. As of December 2016, Purdue had not placed Dr. Mohamed in cease calling status despite being told that abuse and diversion were taking place outside of his clinic, that he was overprescribing controlled substances, about his suspect conversions from-an opioid use disorder treatment to OxyContin, and that his of?ce was standing room only or very busy on multiple occasions. In 2017, Dir. Mohamed pleaded guilty to 11 federal felonies related to health care fraud.1005 In 2018, Dr. Mohammed permanently surrendered his license following a disciplinary action by. the Tennessee Board of Medical Examiners that also permanently barred him from practicing in a pain management clinic or prescribing controlled substances.1006 Dr. TT Cease Calling Status Dates: April 11, 2008 to March 14, 2012; April 25, 2012 786. Dr. TT was an internist based in Clarksville who also specialized in pediatrics. He was one of Purdue?s top prescribers of OxyContin in Tennessee. Between 2006 and 2016, Dr. TT prescribed 104,970 tablets of 80 mg OxyContin and 208,976 OxyContin tablets of all potencies.1007 999 PTN000031807 ID1295 (4/14/2006). 1000 PTN000031807 ID8594 (3/1/2007). 1001 PTN000031807 ID11630 (8/9/2007). 1902 PTN000031807 ID 126588 (7/23/2014). 1003 PTN000031807 ID199937 (12/23/2014). 1004 PTN000031807ID138751 (1/21/2015). ??05 terms/1045160185 1?06 3__012418. 1007 see also PTN000031435. 225 787 - A basic Googlersearch-for-Dr. thatuhe-was indictedtfor health .care fraud by a federal grand jury in 20051008 and later received pre?trial diversion.1009 Despite this publicly available information about Dr. criminal charges for health care fraud in 2005, Purdue took an additional three years until ?rst deciding to place him in cease calling status.1010 788. Purdue placed Dr. TT in cease calling status on January 25, 2008, approximately 7 months after a sales representative submitted the ?rst ROC about him.1011 On March 14, 2012, Purdue sales representatives were instructed that they may resume calling on Dr. TT and ?Sales [were] requested.?1012 This continue calling status lasted a little over a month, until April 25, 2012 when Purdue again placed Dr. TT in cease calling status.1013 789. Before and during the time that Dr. TT was placed in continue calling status, Purdue was aware of facts indicative of abuse or diversion. 790. On September 25, 2007, Sales Representative 17 ?led [a report concerning Dr. TT with Purdue?s Law Department1014 though the report itself does not appear to have been produced by Purdue to the State. 791. Purdue then instructed Sales Representative 17 that he could call on Dr. TT according to call notes entered on December 13, 2007.?015 1?03 1?09 Clarksville Doctor Cleared of Charges CLARKSVILLE LEAF CHRONICLE, Feb. 18, 2008, A1 (correction states that headline should have stated doctor received diversion of charges, which does not mean he was cleared of charges). 1010 PTN000031810. 10? PTN000042238. 1012 PTN000042243. 1013 PTN000042234. 10? PTN000031807 ID14472 (12/13/2007) (referencing 9/25/2007 HCP report). 1015 PTN000031807 ID14472 (12/13/2007). 226 .792. .On August 12, 2008, Sales Representative 5 was ?given atip byawpharmacist that Dr. TT was prescribing lots of OxyContin.10l6 793. On March 9, 2012, District Manager 1 accompanied Sales Representative 13 on a visit to Dr. TT and wrote: sent in by [Law Department] to assess of?ce under Purdue?s ADD Policy. No pain products were discussed, just reviewed the staff, patients, and notices on the wall. Review sent to [Law Department] via e?mail.?1017 Five days later, Purdue placed Dr. TT back in continue calling status. 794. On March 20, 2012, two weeks after Purdue decided to resume calling on Dr. TT, Sales Representative 13 submitted a ROC which said that a nurse told her that ?there are three candy men in town,? meaning ?a patient could approach the doctor and ask for any product they wanted and the doctor would prescribe it.?1018 She told Sales Representative 13 that Dr. TT was one of the ?three candy men.?1019 795. On April 19, 2012, Purdue created a Microsoft Word document which in part reads: The Tennessee Bureau of Investigation announced on February 13[, 2008] that [Dr. a licensed medical doctor in private practice, entered into a Pre-Trial Diversion Agreement in the United States District Court for the Middle District of Tennessee concerning seventeen charges, including healthcare fraud and money laundering.1020 796. On April 25, 2012, Purdue noti?ed sales representatives that Dr. TT had been placed in cease calling status and noted ?Sales reported.?1021 After Purdue had placed Dr. TT in cease calling status, Purdue?s sales representatives continued to make sales calls to the small, 1?16 PTN000031807. 1017 PTN000035268. (emphasis added). i019 PTN000040811. 1020 PTN000042228. 1021 PTN000042234. 227 - independentpharmacythat ?lled. prescriptions .for.alargepercentage of hispatientsas lateas May 29, 2014.1022 797. Despite his previous criminal indictment and diversion for health care fraud, ROCs from sales representatives, and his previous cease calling status, Purdue decided to keep Dr. TT in continue calling status. When Purdue found out from another provider that Dr. TT was ?one of three candy men? in town, it took almost a month to place him again in cease calling status and even then, Purdue continued to call on the small, independent pharmacy associated with Dr. practice. Physician Assistant Cease Calling Status Dates: September 16, 2010 to April 3, 2012; July 9, 2012 798. was a physician assistant based in onesborough who worked at Pain Clinic A1023 and wrote a signi?cant number of prescriptions of OxyContin in Tennessee. From 2006 to 2016, he wrote 10,143 prescriptions for OxyContin; 9,665 of which were Written between 2007 and 2010.1024 From 1998 to 2017, Mr. wrote prescriptions for 810,358 tablets of OxyContin, of which 84.7% or 687,117 were 40 mg or higher.1025 In 2008 alone, Mr. wrote 3,797 OxyContin prescriptions.1026 That same year, Mr. had 457 patients who paid in cash.1027 799. Purdue placed Physician Assistant in cease calling status on September 14, 2010 after Sales Representative 3 ?led a ROC stating that he had heard Physician Assistant lost his DEA license to prescribe controlled substances.1028 Purdue then returned Physician Assistant to ?022 PTN000031807 ID194943 (5/29/2014). 1023 PTN000031807 ID162814 (11/3/2008). ?324 PTN000052837. 1?25 PWGOO3984543. 1?26 PTN000052837. 1?27 PTN000056674. 1?28 228 continue calling status on April 3,2012'followmg a continue calling status lasted until July 9, 2012 when Purdue placed Mr. in cease calling status following news that he was blocked from Tennessee?s state Medicaid program.1030 800. Before and during the time that Purdue placed Physician Assistant in continue calling status, it had knowledge of facts indicative of abuse or diversion. As of May 29, 2008, Physician Assistant told Purdue?s sales representatives that he had patients who were trying to deceive him to obtain opioids. On that date, Sales Representative 2 recorded a discussion with Physician Assistant that stated, ?Said he uses Opana when he feels pt is on too much oxycontin or feels pt may be pulling his leg he feels opana does not have street value.?1031 801. Physician Assistant repeatedly told Purdue that he was continuing to work with . Dr. Frank McNiel and Dr. at Pain Clinic A. On September 9, 2008, Sales Representative 2 referenced in his call notes that ?[Physician Assistant was going to start working with [Dr. Frank McNiel and Dr. on Fridays.?1032 802. On November 3, 2008, Physician Assistant also referenced working with Dr. Frank McNiel and Dr. at Pain Clinic A. Sales Representative 2 wrote about a sales call with Physician Assistant T, stating: He said that he would go to 320mg He said that he had no objection to I prescribing Oxycontin. He said that had been out of town as 1d explain why prescriptions down. He is also working on Friday at [Pain Clinic He said he has been trying to limit those pt on dosing. Discussed that diversion could happen with all products he agreed that could happen with any scheduled drug.He did agree that oxycontin has always 1?29 PTN000040374 (subject line refers to a request to resume calling). 1030 PTN000040134. 10? PTN000040149 (emphasis added). ?032 PTN000040148 (emphasis added). 1033 PTN000031807 ID162814 (11/3/2008) (emphasis added). 229 .aP-hysiciani Assistant ., Trimalso .his concern about abuse and diversion at his clinic. On January 27, 2009, Sales Representative 2 recorded the following from a sales call with Physician Assistant T: He feels that Oxycodone is a effective pain reliever and that OxyContin is effective He is concerned about abuse and diversion and will write opana he feelss has less abuse discussed that all have abuse potential similar to morphine.1034 804. On April 12, 2011, more than six months after placing Physician Assistant in cease call status, Purdue referred Physician Assistant and 8] other prescribers to the DEA during a meeting between Purdue and the DEA.1035 805. On April 28, 201 1, Sales Representative 7 got a tip from a pharmacist that he should call on Physician Assistant T, who apparently had moved to the Johnson City area.1036 806. On March 7, 2012, Sales Representative 7 requested to resume calling on Physician Assistant T.1037 Despite the referral to the DEA less than a year before, Purdue granted the request and moved Mr. back to continue calling status on April 3, 2012.1038 807. On May 9, 2012, Purdue learned that Physician Assistant was blocked from billing TennCare after prescribing large amounts of addictive painkillers. 1039 Two months later, on July 9, 2012, Purdue?s Law Department instructed sales representatives to no longer call on Physician Assistant T1040 because of a report of licensing action against his supervisors for overprescribing.1041 Purdue appears to have considered changing his status again and checked his 1?34 PTN000031807 ID27295 (1/27/2009) (emphasis added). 3035 PTN000045569. 1?36 PTN000031807 ID56186 (4/28/2011). 1037 PTN000040133. 1?38 PTN000031810. 1039 1040 PTN000040137. 2041 PTN000041789. 230 DEA registration on August 29, 2013,1042 before ultimately moving him back to continue call status in April 2017.1043 808. In sum, Physician Assistant was in continue calling status after Purdue had knowledge of his connection to Pain Clinic A and suspect providers, after it knew that TennCare had blocked him for overprescribing, and after Purdue itself had even referred him to the DEA for suspicious prescribing habits, as well as other red ?ags. This status only changed because of reports of a licensing action against his supervisors for overprescribing. Despite all of this, Purdue sales representatives resumed calling on Physician Assistant in early 2017.1044 David Brickhouse, PA Cease Calling Status Date: October 13, 2014 809. David Brickhouse was a physician assistant in the Maryville area who was called on by at least two Purdue sales representatives:1045 Sales Representative 21046 and Sales Representative 31047 at the same time. As shown in sales call notes, Purdue knew that Mr. Brickhouse owned at least ?ve clinics called Pain Clinic D1048 and approved which opioids his providers, including physicians, would prescribe.1049 1?42 PTN000040154. ??43 PTN000119294 ID290037 (4/25/2017). ??44 PTN000119294 ID290037 (4/25/2017). 1045 PTN000031807. 10? PTN000031807 11334372 (9/1/2009). 10?? PTN000031807 ID31314 (9/21/2009); PTN000039607. ??43 PTN000031807 ID72422 (4/24/2012). 1049 (?Check with David on supporting his providers to the [sic] use of OxyContin where appropriate?); PTN000039607 said that David (Brickhouse, PA who own the clinic) has told her it would be okay for her to prescribe PTN000031807 ID80752 (9/7/2012) (10/1/2012) (11/8/2012) (7/9/2013) said he has no problem with his providers prescribing oxycontin in appropriate pts. . (emphasis added), 231 810. Purdue placed Mr. Brickhouse in cease calling status on October 13, Before being placed in this status, Purdue sales representatives called on him 40 times from September 1, 2009 to July 22, 2013, not including calls to other providers at his pain clinics.1051 811. Purdue had knowledge of facts indicative of abuse or diversion. Early on, Mr. Brickhouse expressed concern about the cost of OxyContin for his cash paying customers. On February 8, 2010, Sales Representative 3 recorded that Mr. Brickhouse ?[w]as concerened about cost of oxycontin for cash pay gave coupon.?1052 812. Elsewhere, Purdue was told by another provider that Mr. Brickhouse?s of?ce did not check the prescription drug monitoring program database before prescribing a controlled substance. Sales Representative 16 called on Dr. on April 29, 2011, and afterwards ?led the following ROC: Dr?s of?ce manager asked me if I knew of a Dr Brickhouse. I said that I have heard of a David Brickhouse who is a PA. said that they had a call from his of?ce this morning about a patient who has been seeing him since February. said that Dr has seen the patient for years and had been prescribing pain medications for the patient. said that the Brickhouse o?ice had a report that the patient was selling her medication. said that the Brickhouse office did not look up the patient ?s PMP information until after they had a report about the patient. said that they called Dr today after seeing that the patient had also been getting pain medications prescribed by Dr said that the Brickhouse o?ice had been prescribing the same pain medication for the patient as Dr since February. said that Dr had recently called the patient for a random pill count.1053 1050 PTN000037828. 105? PTN00031807. . 1?52 PTN000037821 (emphasis added). 1053 PTN000031807 (emphasis added). 232 1813. - As of that-:Mr: aphysicianassistant, owned ?ve clinics and employed Nurse Practitioner Cordes, who had also worked at Breakthrough and about whom Purdue had knowledge of suspicious prescribing.1054 814. On October 1, 2012, Sales Representative 16 recorded a call note about a visit with Dr. who worked in the same practice with Mr. 'Brickhouse.1055 Sales Representative 16 asked Dr. W, a medical doctor, to get Physician Assistant and clinic owner Brickhouse?s approval to write a controlled substance prescription.1056 815. Sales Representative 16 also reported that a similar situation occurred on November 2, 2012 whereby Dr. had sought approval from Mr. Brickhouse to prescribe certain opioids.1057 Sales Representative 16 also reported a similar situation occurred on November 2, 2012 whereby Dr. had sought approval from Mr. Brickhouse to prescribe certain opioids. Even after Purdue knew that Dr. worked for Mr. Brickhouse and took prescribing instructions from him, Purdue continued to call on Dr. as well.1058 816. The Purdue sales representatives who called on Mr. Brickhouse made repeated references to red ?ags including how busy the clinic and Mr. Brickhouse appeared to be when they visited. These notes included: ?of?ce packed,?1059 ?of?ce busy,?1060 ?visited 2163 today of?ce 1?54 PTN000031807 11372422 (4/24/2012). 1055 1?56 PTN000039607 1?57 PTN000039607. 1?58 PTN000039601 ID200691 (2/2/2015). 1059 PTN000037821 (1/5/2010); PTN000031807 ID36283 (1/5/2010); PTN000031807 ID36630 (4/7/2010). 1?60 PTN000037820 (4/23/2010). 233 ?"1061 c: 1921062: cc ?lled each time? unable to see prescribers, very busy as could se";e simply?toobusy-to stOp today,?1063 ?slammed,?1064 ?too bz to discuss,?1065 and ?of?ce BZ as always.?1066 817. On October 18, 2012, Sales Representative 3 attempted to call on Mr. Brickhouse, and noted the following: ?waited for approx. an hour to see mr Brickhouse eventually told me he would be unable to see me today was advised they adding 4 providers within a 818. Elsewhere, Purdue sales representative reported similar issues with being unable to call on Mr. Brickhouse. For example, on April 20, 2012, Sales Representative 3 reported that Mr. Brickhouse ?was hard to catch at farragut office.?1068 819. On May 1, 2013, Sales Representative 6 reported that the nurse would update Mr. Brickhouse ?when he had some free time.?1069 I 820. On October 16, 2014, news broke that nine health care providers, including Mr. 'Brickhouse, had been indicted in a conSpiracy involving illegal distribution of prescriptions for controlled substances. ?070 821. Mr. Brickhouse died in a car crash on April 5, 2016.10? 822. Purdue kept Mr. Brickhouse in continue calling status despite knowledge that his of?ce did not regularly check the prescription drug monitoring program database, that he made 10? PTN000031807 ID165257 (9/15/2009). 1062 PTN000037820 (4/7/2010). 1063 PTN000037819 (10/25/2010); PTN000031807 ID43122 (10/25/2010) 1064 PTN000037819 (11/22/2010); PTN000031807 ID44886 (11/22/2010). 1065 PTN000037819 (12/22/2010) 1066 PTN000037819 (2/4/2011); PTN000031807 1D53 504 (2/4/2011). 1067 PTN000037817. 1068 PTN000037818. 1?69 PTN000037816. 1070 PTN000036449. 10? wbir com/article/news/local/rnan accused?in pill mill scheme? dies? ?in? ?crash before?trial/ 122886912 234 prescribing decisions 'for doctors Who were supposed to superVise?him,? and of repeated're?ferences to his high volume practice, among other red ?ags. Dr. Cease Calling Status Date: April 16, 2015 823. Dr. was a family doctor based in the Knoxville area who was the Medical Director for Pain Clinic by 2013.1072 From 1998 to 2017, Dr. prescribed 32,245 OxyContin tablets, of which 70.3% or 22,699 were 40 mg or higher.1073 824. In 2012, Dr. worked at Pain Clinic 13.1074 Purdue?s sales representatives, including Sales Representative 6, called on Dr. to encourage him to prescribe OxyContin and noted ?he had a lot of in?uence.?10775 825. Purdue did not place Dr. in cease calling status until April 16, 2015,1076 following news reports that he was closely linked to a large pill mill?)77 826. Before this time, Purdue chose to defer to its sales representatives? discretion on whether to call on Dr. or not. In an email dated September 20, 2012, Purdue?s Law Department stated: ?Sales representatives may cease calling on [Pain Clinic and employees-[XV (emphasis in original).1078 827. Purdue sales representatives continued to call on Dr. and other providers from 2013 until 20151079 and had knowledge of facts indicative of abuse or diversion. 1072 PTN000031807 113103843 (7/19/2013). 1073 PWG003984543. 1?74 PTN000037480. 1075 PTN000031807 1D103843 (7/19/2013). 1076 PTN000040396. 1077 107* PTN00037480 (emphasis in original). 1079 See, PTN000031807 12139 (10/23/2013); PTN000031807 1D103843 (7/19/2013); PTN000031807 ID139935 (12/8/2014); PTN000031807 1Dl3954l (12/19/2014); PTN000031807 113138566 (1/5/2015); PTN000031807 1Dl43665 (2/2/2015). 235 828. On August 10,2012, 'Sales?Representative 3 submitted stated he was concerned about Pain Clinic where Dr. then worked. He wrote: The of?ce in Lenoir City has been present for approximately 2 years Uses a sign out front by the name of [Pain Clinic A seeming revolving door of providers. Indicators of I. present upon each visit (not many): crowded (and large) o?ice waiting room, few patients past 4 0yoa with no noticeable disabilities, armed security guard (none noted at last visit), evasive Office staff at window unwilling to provide schedule of what providers are present and what locations they typically work at, concerns voiced by local pharmacists regarding practice, large volume of short acting oxycodone only written by the prescribers I have seen data on.1080 829. After this report, Purdue continued to call on Dr. for the purpose of promoting OxyContin when he began working at Pain Clinic Pain Clinic had a policy of not prescribing OxyContin1081 that Purdue tried to change. 831. On July 19, 2013, Sales Representative 6 recorded a call note with Dr. in which he documented that Dr. was the Medical Director for Pain Clinic D. Sales Representative 6 also documented that Pain Clinic had a small number of patients who paid through commercial health insurance, which means the clinic likely had a large number of patients who paid for health expenditures in cash. The call note stated: [M]et with him for the first time. He?s the medical director for the [Pain Clinic He practices just a couple days a week but obviously has a lot of in?uence. I reinforced OxyContin and q12 dosing Leveraged the comments from David Brickhouse around patients on Q6 short acting opioids being transitioned to an extended release like OxyContin. He said that does make sense for some patients He did acknowledge they have a small percentage of commercial patients but though it might be an option to consider.1082 ?030 (emphasis added). 10? PTN000031807 ID112139 (10/23/2013) (?No interest in OxyContin because of prodigal policy?). 1082 PTN000031807 ID103843 (7/19/2013) (emphasis added). 236 832. On March 11, 2015, Sales Representative 16 forwarded an image of an article titled ?Dozens Arrested in Federal Pill?Mill Probe? to Purdue?s home of?ce with the subject line ?East Knoxville Healthcare Services, 509 Lovell Road, Knoxville, noting that the article contained a photograph of the practice group?s door that referenced Dr. among other providers.1083 833. On March 29, 2015, the Knoxville News Sentinel published an article, which was retained in Purdue?s internal records, referencing Dr. as being part of a $400 million pill mill conspiracy in East Tennessee in which he pretended to be an owner of the pill mill in exchange for $1 million.1084 834. On April 1, 2015, a Purdue employee accessed an article online titled agent testifies 2 people fatally overdosed from pills prescribed from alleged pill mill in Lenoir City? that referred to Dr. ?pro-signing prescriptions.?1085 835. Despite Purdue having knowledge for several years of suspicious conduct by Dr. X, including working at a clinic with an armed security guard and a crowded waiting room, Purdue waited until after Dr. was publicly known to be under criminal investigation to move him to cease calling status. 836. On April 16, 2015, Purdue instructed sales representatives not to call on Dr. X.1086 837. While Dr. was placed in cease calling status and was under criminal investigation, Purdue still failed to include him on the list Purdue kept of suspicious providers.1087 1?83 PTN000040393. 103? PTN000036220. 1?35 1?36 PTN000040396. i037 237 "Pain Clinic Cease Calling Status Date: 838. Purdue sales representatives regularly called on providers employed by Pain Clinic F, which was based in Maryville. Purdue had knowledge of facts indicative of abuse or diversion long before Purdue decided to place some of Pain Clinic F?s providers in cease calling status. 839. Dr. and Dr. were providers associated with Pain Clinic F.1088 Purdue placed Dr. B, a gynecologist, in cease calling status on December 20, 2010.1089 As of 2016, Purdue had not placed Dr. Y, also a gynecologist, in cease calling status.1090 Purdue moved Donna Smith, a nurse practitioner associated with Pain Clinic to cease calling status on June 23, 2011,1092 and noted that she was with [an] advertising pain clinic.?1093 As of 2016, Purdue had not placed Pain Clinic in cease calling status.1094 840. Purdue had general knowledge of red ?ags concerning Pain Clinic as a whole. For example, on October 20, 2010, Sales Representative 16 emailed Purdue?s Law Department to notify Purdue that she was removing two clinics from her call list.1095 One was Breakthrough, addressed above, and the other was the Pain Clinic F.1096 Notably, Breakthrough and Pain Clinic were both owned by the same family, Sandy and Randy Kincaid, as Sales Representative 16 pointed out in her email.1097 10? PTN000039890. i089 PTN000031810. 1?90 PTN000031810. 109? PTN000036251. 1?92 PTN000031810. 1?93 PTN000036283. 109" PTN000031810. ?095 PTN000042500. 1?96 1. 1?97 1. 238 841. On "Representative l"6' also note'd'th?at nurse practitioner associated with Pain Clinic F, had also worked at Breakthrough.1098 Purdue sales representatives continued to call on providers at Pain Clinic after October 20, 2010 for the purpose of promoting OxyContin.1099 For example, Sales Representative 6 called on Dr. on March 6, 2015 and left OxyContin promotional materials.1100 842. On December 15, 2010, Sales Representative 16 reported that during a pharmacy visit, a pharmacist ?asked if [she] knew anything about [Pain Clinic and ?said that it just doesn?t make sense to him that a gynecologist would run a pain clinic.?1101 843. This concern was reiterated by another pharmacist that Sales Representative 16 called on who said, ?he just doesn?t understand why some Dr?s are into pain. [He] gave two examples: [he] said like Dr who is a Gynecologist at [Pain Clinic In an email reporting this information to her manager at Purdue, District Manager 3, Sales Representative 16 also noted that ?Dr is already assigned to region zero. She is the Director for [Pain Clinic in Maryville.?1103 844. On April 8, 2011, Sales Representative 16 reported to Purdue that: I observed the waiting room was full of patients who appeared to be in their 20?s and 30 There was also an armed guard sitting at the of?ce entrance near the waiting room. I reported the above information to [Purdue?s Law Department], as well as, re~capping the history of the [Pain Clinic .1104 ?393 PTN000042500. 1099 PTN000031807 ID145201 (3/6/2015). ?00 PTN000031807 ID145201 (3/6/2015). 1101PTN000039571. ?02 PTN000031807. ?03 PTN000043039. ?04 PTN000036251 (emphasis added). 239 845. ?Her accompanying can note states: Donna [Smith, called me on the cell phone and asked if I was going to bring her savings cards or what? Donna has called me previously asking If I was her rep and if] could bring her some Oxycontin information ans savings cards. In the past I have'told her that call the company. I asked Donna if she called the company. Donna said that she did and they told her that I was her rep and gave her [District Manager 3] ?3 name and number too. I reiterated that I am not her rep, but that I was near her o?ice and would drop by some information and savings cards. 846. In addition to the above red ?ags, Purdue knew shortly after April 2011 that at least 25% of Nurse Practitioner Smith?s patients paid in cash,1105 yet Purdue still did not place her in cease calling status until two months later on June 23, 2011.1106 847. Purdue sales representatives continued to call on providers at Pain Clinic over the next few years. On December 9, 2015, District Manager 3 submitted the following ROC: I had just come ??om [Pain Clinic earlier in the day. I asked [the pharmacist] if he knows the clinic since it is so close to the pharmacy. He stated that he does not ?ll from that clinic. His managing pharmacist told him not bc it is ?sketchy prescriptions and the HCPS have odd specialties for a pain clinic Urology, He did not specify any particular product. The HCPs that are currently there are Dr. and Dr. 848. Nurse Practitioner Donna Smith was disciplined by the Tennessee Board of Nursing on August 14, 2015 and, among other things, the Board found the following: 3. Respondent was the second highest prescriber of opioids in Tennessee in 2013 and the highest prescriber of opioids in Tennessee in 2014. 5. Between January 2010 and October 2014, while employed as. a nurse practitioner at [Pain Clinic in Maryville, Tennessee, Respondent provided treatment for chronic pain to numerous patients which included ?05 ?06 PTN000031810. ?07 PTN000039890 (emphasis added). 240 prescribing large doses of narcotics and other controlled substances in amounts and/or for durations not medically necessary, and without documenting suf?cient justi?cation for such prescribing in the patients? charts. 6. Respondent prescribed controlled substances and other medication without documenting a written treatment plan with regard to the use of controlled substances and other medications. 7. Respondent failed to adequately counsel patients regarding anomalous urine drug screens, and failed to inform patients of the possible harmful effects of certain medication combinations, and/ or amounts. Respondent provided few modalities of treatment other than the prescription of controlled substances.1108 849. Despite reports that'the clinic had an armed security guard, had noticeably younger patients, was being run by a gynecologist, and had providers associated with the problematic Breakthrough clinic, Purdue never placed Pain Clinic in cease calling status. Purdue also never placed Dr. in ceasecalling status and failed to timely place Donna Smith in cease calling status despite the red ?ags identi?ed above. Alan Pecorella, PA Cease Calling Status Date: August 28, 2013 850. Alan Pecorella was a physician assistant based in Knoxville who prescribed signi?cant amounts of OxyContin, especially in 2011.1109 Purdue regularly called on Mr. Pecorella, invited him to speaker programs,1110 and knew that he worked at Pain Clinic All? 851. Purdue reviewed Mr. Pecorella?s ?le and deCided to keep him in continue calling status on July 18, 2013 in spite of a ROC submitted by Sales Representative 16 notifying the ?03 1729_081415. ?09 PTN000031465 (listing 287.85 prescriptions for 201 1). mo PTN000030156. ?11 PTN000031807 ID106923 (9/26/2013). 241 company that Physician Assistant Pecorella?s of?ce had young patients in the waiting room and the parking lot had several cars from distant counties.1112 852. Purdue later placed Mr. Pecorella in cease calling status on August 28, 2013 following a ROC that Sales Representative 16 submitted that described how a patient was being coached in the waiting room on how to ?ll out forms to obtain controlled substances.1113 853. The Tennessee Board of Medical Examiners later revoked Mr. Pecorella?s license in 2014 for two years for violations concerning controlled substances including a previous guilty plea for possession of a controlled substance.1114 854. During the time that Mr. Pecorella was in continue calling status, Purdue had knowledge of facts indicative of abuse or diversion. On May 14, 2013, Sales Representative 16 entered a call note from a sales call with Mr. Pecorella that stated, among other things: Al discussed that these patients try to tell Him what to prescribe. Al discussed that he tells the patients what he is willing to prescribe for them based on their MRI results, diagnosis and other factors.1115 855. On the same day, Sales Representative 116 submitted a ROC that stated: When I went into the of?ce today, I noticed that the waiting room was half full. I also noticed that with the exception of two elderly people most of the patients today appeared to be relatively young. I would guess that most of the patients were 3 040. When I left the o?ice, I looked at the license plates on the vehicles in the parking lot. Several were ?om other counties, including: Union, Roane, Morgan and Anderson. Also several cars had pe0ple waiting in them.1116 ?12 ?13 PTN00003333 8. ?14 1914. ?15 PTN00031807 ID100004 (5/14/2013) (emphasis added). ?16 PTN000038327 (emphasis added). 242 856. Purdue had knowledge of this suspiCious conduct, yet Still decided to?keep'Mr. Pecorella in continue calling status on June 7, 2013.1117 857. On July 9, 2013, Sales Representative 16 submitted a ROC to Purdue concerning Mr. Pecorella with the Drug Product Name listed as oxycodone that stated: While waiting in the waiting room today I observed the following: 1. A patient who was about 40 had a younger woman with her who appeared to be coaching the patient on how to ?ll out her forms. The patient appeared to be quite nervous. The woman she was with also appeared to be on edge, wanting the patient to do everything correctly. At one point the woman went out the car and brought back In a Manila envelope and told the patient she will need this. 2. There is a sign in the reception window advertising Imaging in Tucker, Georgia. The advertisement says that they do for $270 cash. They also accept MasterCard and Visa. When I got out the car, I googled Imaging and noted that they also have a facility in Pompano Beach Florida.1118 858. After receiving credible information that Mr. Pecorella?s patients were noticeably younger, were from distant counties, and other red ?ags, Purdue affirmatively decided to keep him in continue calling status. Even when Purdue received another report that patients were being coached in Mr. Pecorella?s waiting room about how to ?ll out forms to obtain controlled substances, it took 9 days for Purdue to open a ?le and 48 days for Purdue to decide to ?nally 1119 place Mr. Pecorella in cease calling status. Dr. Cease Calling Status Date: 859. Dr. was a family doctor in Lawrenceburg who prescribed OxyContin from 2007 to 2014. Purdue sales representatives continued to call on him after Purdue had facts indicative of abuse or diversion. ?17 PTN000031810. PTN000038338 (emphasis added). ?19 PTN000031810. 243 .1860. .to. Z?preseribed over twice as. many OxyContin doses over 40 mg than under 40 mg. In 2010, Dr. prescribed 7,033 OxyContin tablets that were 40 mg or higher compared to 1,790 OxyContin prescriptions that were less than 40 mg. ?20 861. Sales Representative 16 reported on October 28, 2009 that a nurse: shared with me that she was concerned there may be a drug ring in Lawrenceburg, TN Patsy found out at a healthy 28 year old female patient was seeing Dr. and receiving 80mg Oxycontin 20 pills a month Dr. and 10 days later Dr. re?lled another 1 20 pills for 80mg Oxycontin for this 28 year old patient and 6 days later received another 120 pills of 80 oxycontin for the same 28 year old patient, [Nurse] said the 28 year old female as taking some, selling some and giving some to Dr. [Nurse] stated that the 28 year old patient has been [arrested] but has not heard if anything has happened to Dr. yet.1121 862. On November 2, 2009, Purdue?s Law Department instructed sales representatives to continue calling on Dr. Z. 863. Despite the ROC notifying Purdue that Dr. may be involved in a drug ring and prescribed unusually high quantities of highdose OxyContin, Purdue never placed him in cease calling status.1122 Purdue sales representatives continued to Call on Dr. at least through 2017.1123 Dr. HH Cease Calling Status Date: 864. Dr. HH was an anesthesiologist in Antioch who prescribed large quantities of OxyContin and other opioids. Purdue sales representatives called on him after Purdue had facts indicative of abuse or diversion. ?20 PWGOO3984543. ?21 PTN000038963M65. ?22 PTN000031810. ?23 See, PTN000047136. 244 ?8?65. ""Call net'e's dating back to 2004?show "that Dr. HH previously? worked- at a pain clinic that had since closed.1124 Dr. HH worked at several high-volume pain clinics, including Pain Clinic in Camden and Pain Clinic in Antioch. 866. Additionally, on March 21, 2013, Sales Representative 13 entered a call note which included Dr. admission to recent recovery of a serious drug addiction: Inservice with Dr. we reviewed clinical data for Butrans, formulary grids and managed care;also spoke with [physician assistant] about the PA?s;said they do have a few pain patients who are doing well on Butrans. Dr. said he is a recovering drug addict of 20 months ?om Cocaine and Heroin. 1 125 867. Notably, Purdue sales representatives have called on Dr. HH for well over a decade??including during the period time Dr. HH asserted he was addicted to illegal opiates. 868. Purdue has never placed Dr. HH in cease calling status and continues to be called on by sales representatives. Furthermore, Purdue sales representatives consider him to be a ?Key with at least one district manager identifying Dr. HH as a KOL for Purdue.1127 869. Elsewhere, Purdue had knowledge of other red ?ags regarding Dr. HH. On December 12, 2016, Sales Representative 15 entered a call note which read, in part, discussed weaned off suboxone that meet indication, tolerated molecule; Reiterated Butrans not indicated for addiction, must meet indication.?1128 870. Despite knowing that Dr. HH had worked in several problematic pain clinics, being told by Dr. HH himself that he had been addicted to heroin within the last two years, and being ?24 PTN000041012. ?25 PTN000040966 (emphasis added). ?2?5 PTN000093607. ?27 PTN000097421. ?23 PTN000119294 (emphasis added). 245 told of suspect uses of opioids, Purduehas continued to make sales c?aIIS't'o at'least?through the end of 2017. G. PURDUE IS SUBSTANTIALLY RESPONSIBLE FOR THE OPIOID EPIDEMIC IN TENNESSEE 871. The United States has approximately 4.4% of the world?s population, but accounts for the vast majority of opioids consumed globally, including oxycodone, which is the concentrated active ingredient in OxyContin. In 2014, the United States accounted for 81% of the global total for oxycodone.1129 Within the United States, Tennessee accounts for disproportionately high rates of opioid consumption generally and oxycodone consumption speci?cally for its population. This is true as well in absolute numbers of oxycodone. As of 201 1, there were 21 pills of oxycodone for every Tennessean above the age of 12.1130 872. While some progress has been made, in 2015, Tennessee had the third highest prescription rate in the country1131 and one of the highest amounts of opioids prescribed per person in the country as measured in MMEs according to the CDC.1132 A substantial portion of Tennessee?s high MME level came from OxyContin. Between 2008 and 2017, 6,371,957,981 MMES of OxyContin were sold in Tennessee1133 with MME levels attributable to 40 mg or higher OxyContin tablets peaking at 797,153,640 MMEs in 2010. 873. A cause for this imbalance is not that Americans and Tennesseans experience pain at higher rates than their global or national peers or have greater access to healthcare. Rather, one ?29 Nora Volkow, M.D., America ?s Addiction to Opioids.? Heroin and Prescription Drug Abuse, NATIONAL INSTITUTE ON DRUG ABUSE (May 14, 2014) available at: (internal citations omitted). ?30 Prescription for Success, TENNESSEE DEPARTMENT OF MENTAL HEALTH AND SUBSTANCE ABUSE SERVICES, 11 (2014). ?31 ?32 opioids/ info ?33 246 of contributing factors to the severity of the current opioid crisis is ?aggressive marketing by pharmaceutical companies? as recognized by the Director to the National Institute on Drug Abuse within the National Institutes of Health in a 2014 report to the United States Senatem?4 874. Purdue?s aggressive marketing and other conduct has played a substantial role in creating and prolonging the opioid crisis in Tennessee. Purdue?s conduct led to addiction, abuse, diversion, and other negative outcomes that have caused the State and its political subdivisions to spend substantial resources to attempt to address. 875. Purdue?s OxyContin is the branded opioid that is most associated with the opioid crisis nationally and in Tennessee for good reason. Purdue created the market for a highly potent, extended release single entity opioid consisting of oxycodone that was easily manipulated by misrepresenting OxyContin?s potential for addiction. and abuse through an unprecedented marketing campaign for a Schedule II narcotic that targeted some of the highest prescribing providers and pharmacies of opioids and OxyContin in Tennessee. 876. In many cases, Purdue had knowledge of signs of abuse or diversion from the Tennessee providers and pharmacies that its sales representatives called upon and yet Purdue ignored these red ?ags. 877. Purdue?s marketing was effective. Purdue?s sales calls to providers generated more prescriptions for OxyContin and its other opioid products. Purdue found in internal marketing documents that Level is Highly Correlated to Call Activity.?1135 ?34 Nora Volkow, M.D., America ?s Addiction to Opioids: Heroin and Prescription DrugAbuse, NATIONAL INSTITUTE ON DRUG ABUSE (May 14, 2014) available at: ?35 PWG000324250. 247 e878. - ?Purdue knew-that more sales calls to -the-~topv prescribers of-i-ts- opioid product-s ?led to more prescriptions. A Purdue consultant found: ?For all deciles, increased calls are associated with higher OxyContin TRX growth?~?a sign of promotional sensitivity? in a marketing document from 2013 titled ?OxyContin Growth Opportunities.?1136 Similarly, Purdue had evidence that ?[r]eps who make more OxyContin on high?decile prescribers generate more OxyContin growth in their territory.?1137 denotes ?rst priority or presenting OxyContin ?rst in a sales call. 879. As part of these sales calls, Purdue emphasized ?new to brand? starts1138 and trained its Tennessee sales representatives to ?Ensure New [Patient] starts on Oxycontin.?1139 880. Purdue also fueled the opioid epidemic through its heavy promotion and use of OxyContin savings cards, which operated like a coupon to offset the cost of a prescription for a ?40 and were relied patient, could be used by cash-paying patients, could be used multiple times, on by highuvolume prescribers and pain clinics that exhibited strong signs of abuse or diversion of opioids. 881. Purdue used savings cards to generate new patient starts including to opioid?naive patients.1141 For example, Purdue found that a $0 co-pay for Butrans prescriptions ?[h]elps generate new trials, e?ectively acting like a ?36 PWG000447858 (referencing both a ?nal report and working draft). ?37 PWG000447879. ?38 PWG0004285342. ?39 PWG0004285342. ?40 PWG000004105. ?41 195230. 1 ?42 61 l. 248 -?--Purdue determined with OxyGontin- us es- arSavings' Card: with a new patient there is an 8.3% total prescription growth compared with HCPs that do not utilize a savings card. Also there is a higher persistency of new patients at 60 days when savings cards are used.?1143 883. Purdue found ?[d]ata proves that HCPs who use savings cards have a lift in ?1144 prescriptions and made increasing utilization of the OxyContin Patient Savings Program a strategic initiative.1145 884. Purdue trained its sales representatives to discuss savings cards on every call because the company had evidence that approximately 60% of patients stayed on the Purdue?s products more than 90 days if the savings card was redeemed.?46 In a 2012 sales training document, Purdue stated: [I]t is also important that the OxyContin Patient Savings Card is discussed on every sales call as market research has shown that ~60% more patients stay on therapy >90 days if a savings card is redeemed.1147 885. As Purdue knew through data the company collected and tracked, Purdue?s savings cards were frequently used to pay at least in part for high quantities of high dose OxyContin prescriptions.l 148 Purdue knew or should have known that these prescriptions were highly unlikely to be consumed by a single patient and were most likely diverted. ?43 PW6000028274. ?44 ?46 PWG000194960. ?47 PWG000194964. ?43 249 886. Purdue?s savings cards were used by patients to acquire high quantities of high dose OxyContin that had a signi?cant street value and could be easily diverted.1149 As one example, a Purdue savings card with a unique patient identi?er was used to purchase a 30 day supply of 240 80 mg OxyContin tablets on February 18, 2010, March 22, 2010, April 19, 2010, May 17, 2010, June 17, 2010, and July 13, 2010.1150 At $1 per milligram,1151 these prescriptions, which were purchased in part through a Purdue savings card with the same unique patient identi?er, would have a street value of $1 1 5,200. 887. In addition, Purdue worked with distributors to ensure that pharmacies had the maximum supply of OxyContin. Distributors set threshold limits for a pharmacy?s opioid supply that are supposed to serve as a protection against abuse or diversion. But as a self?described ?strategic imperative,? Purdue sought to have distributors create separate threshold limits for oxycodone and OxyContin, instead of one for oxycodone generally, and to create separate threshold limits for oxycodone immediate release 30 mg in order to ensure that pharmacies carried more OxyContin.1152 888. Purdue also had a replacement program for pharmacies whose inventories of Purdue opioid products were stolen or robbed that supplemented whatever the pharmacy?s insurance did not cover.1153 889. Purdue sales representatives made sales calls to and used pharmacies as a source of information regarding problematic prescribers. Purdue also used pharmacies as a source of ?49 PTN000056673. ?50 PTN000056673 ID636 (2/18/2010); PTN000056673 ID1547 (3/22/2010); PTN000056673 ID2868 (4/19/2010); PTN000056673 ID4702 (5/17/2010); PTN000056673 ID6922 (6/17/2010); and PTN000056673 ID8730 (7/13/2010). ?5 1 ?52 PWG000212739. ?53 ST000446. 250 information to track; down hi gh?prescribing ,doctors ,as .well. .to call on. For example, on February 16, 2012, Sales Representative 5 called on a Spring?eld pharmacy where the pharmacist told him the location where Dr. Rhodes had relocated. His district manager congratulated him on ?nding the new practice. 1 154 890. Purdue ignored red ?ags for abuse or diversion at Tennessee pharmacies and continued to push OxyContin. For example, Sales Representative 3 was told on July 11, 2013 that one of Pharmacy E?s distributors had stopped shipping it controlled substances1155 and yet continued to call on Pharmacy E.1156 891. Similarly, on August 16, 2013, Sales Representative 6 made a sales call to a pharmacist at Pha?acy D, who informed Sales Representative 6 that the pharmacy?s quantities of oxycodone were restricted. Sales Representative 6 documented his interaction as follows: Met with . .. the pharmacist. Reviewed the OxyContin pharmacy guide and discussed the promotional focus around conversions from oxycodone and Percocet. He did con?rm that that would help them out because their quantities of oxycodone are so restricted. I also mentioned the seven dosing and he said they are moving some 1157 892. Purdue also made sales calls to pharmacies that it knew from savings card data to dispense both significant quantities of and high percentages of high dose OxyContin. For example, between 2009 and 2016, the average number of OxyContin pills dispensed for each prescription that was paid for in part through a savings card in Tennessee was 62.1158 At Pharmacy B, that ?54 PTN000035268. ?55 PTN0001192941D135216 (7/11/2013). ?56 PTN000119294 1D135706 (7/17/2013); PTN000119294 113140094 (13/29/2013). ?57 PTN000119294 ID138805 (8/16/2013) (emphasis added). ?58 PTN000056673. 251 Purdue ?knew that-86% *of OxyContin- prescriptions -paid-- for-in part through a savings card and ?lled by Pharmacy were for high doses (greater than or equal to 40 mg).1160 Purdue also knew that 38% of all OxyContin purchased in part through a savings card at Pharmacy were for 80 mg tablets?: Purdue also knew that for all Tennessee pharmacies that ?lled an OxyContin prescription and accepted a savings card between December 31, 2009 and August 17, 2016, 50% were high dose (greater than or equal to 40 mg) and 16% were for 80 mg tablets.1162 893. Purdue?s marketing efforts worked in Tennessee. In Morristown, a city of 29,137 according to the 2010 census,1163 Purdue sold 100.6 OxyContin tablets per person from 2008 to 2017 compared with 9.1 OxyContin tablets per person in Memphis and 16.5 OxyContin tablets per person in Nashville over the same period.?64 In Knoxville, a city of 178,874 according to the 2010 census,??55 Purdue sold 96.3 OxyContin tablets per person from 2008 to 2017.?66 894. Purdue?s marketing worked particularly well for high dose OxyContin. As shown below, the majority of OxyContin tablets sold in Tennessee from 2008 to 2017 were high dose tablets of 40 mg and above. Out of the 104,340,372 total OxyContin tablets prescribed in ?59 PTN000056673. ?60 PTN000056673. ?61 PTN000056673. ?52 PTN000056673. ?64 PWG003984543. 1 . gov/ ee,maryvillecitytennes ?66 PWG003984543. 252 Tennessee from 2008 to 2017, 53. 7% of them were 40 mg or higher,,[ which if taken twice a day exceeds the daily amount of opioids the CDC warns against by over 33%. ?63 Tablet! of Prescribed in Tennessee 15.000.000 I greater than or equal to 40 mg ?moon I: less than 40 mg uncaring mountain 3. 7 3 3 2 smumn 5 ammo ammo Locum 2 200! zoos 201a 1011 2011 2013 1014 2015 2016 2017 895. From the approximately 1,471,006 prescriptions for in Tennessee from 2008 to 2017, 48.1% of these prescriptions were for doses of OxyContin 40 mg or highcr?m which if taken twice a day exceed the MME level the CDC warns against using by over 33 96.1?? ?57' PWG003 984543. ?53 PWGOO3984537. art.pdf; 253 896. Moreover, Purdue?sjoint marketing efforts to focus on high doses of OxyContin as well as nurse practitioners and physician assistants worked. As shown by the chart below, from January 2007 to August 2017, 69% of the OxyContin tablets prescribed by nurse practitioners or registered nurses in Tennessee were 40 mg or higher. Similarly, during the same period, 59% of the OxyContin tablets prescribed by physician assistants in Tennessee were 40 mg or higher. In comparison, 52% of the OxyContin tablets oncologists prescribed in Tennessee were 40 mg or higher and 33% of the OxyContin tablets orthopedic surgeons prescribed in Tennessee were 40 mg or higher during the same time period.' In Percentage of High Dose OxyContin Tablets (Within Specialty) Physician Oncologists Orthopedic Assistants Surgeons PWGOU3984543. 254 897. This large number of OxyContin prescriptions especially at high doses has equated to a substantial number of residents who have become addicted in Tennessee. A 2015 meta? analysis of 38 studies evaluating opioid misuse, abuse, and addiction in chronic pain patients found rates of addiction averaging between 8?12%1172 though the actual percentage is most likely higher because of those misclassi?ed as physically tolerant. 898. Most people with opioid addiction started with prescription painkillers. According to data from the Substance Abuse and Mental Health Services Administration, it is estimated that of the 4,850,000 adults in Tennessee, 221,000 (or 4.56%) have used prescription opioids for non- medical purposes. Of these, it is estimated that, as of 2014, at least 69,100 were addicted to opioids and required treatment for opioid abuse and 151,900 had risky prescription opioid use.1173 899. Within this subgroup, a substantial portion of Tennesseans were addicted to or because of OxyContin. OxyContin, which is highly concentrated oxycodone, has been consistently popular among those suffering from opioid use disorder or opioid abusers. 900. A study of 3,520 opioid?dependent individuals conducted by clinical investigators from Washington University in St. Louis and others found that oxycodone and hydrocodone are ?by far? the most popular drugs of choice among prescription opioid abusers.1174 Within that subset, oxycodone was the choice of signi?cantly more users than hydrocodone because the quality of the high was viewed to be much better by oxycodone users than ?72 Kevin E. Vowles, Rates of Opioid Misuse, Abuse, and Addiction in Chronic Pain: A Systematic Review and Data PAIN, 569, 156:4 (April 2015). ?73 Prescription for Success, TENNESSEE DEPARTMENT OF MENTAL HEALTH AND SUBSTANCE ABUSE SERVICES, 4 (2014). ?74 Theodore Cicero, Factors In?uencing the Selection of Hydrocodone and Oxycodone as Primary Opioids in Substance Abusers Seeking Treatment in the United States, PAIN, 154:12 (2013) available at: 255 hydrocodone users The that'hydrOCO'done waS"'less "attraCtive than oxycodone because of hydrocodone?s frequent combination with other products like acetaminophen. 1 176 901. Oxycodone?s popularity over other opioids is supported elsewhere in the literature. For example, another study found that oxycodone scored mo st favorably among patients dependent on heroin compared with fentanyl, buprenorphine, and morphine.1177 902. Given this preference for oxycodone, it is no surprise that OxyContin, which offered concentrated oxycodone that could be easily manipulated to access, was popular and a substantial contributOr to the opioid epidemic in Tennessee. 903. OxyContin?s addictive qualities and easy manipulation led a subset of addicts to turn to heroin, which was cheaper, when the Old formulation of OxyContin was removed from the market on August 5, 2010, and replaced with the reformulated version beginning August 9, 2010. 904. Highly credible statistical evidence shows that the abrupt growth in the heroin death rate, which the CDC found to have increased by more than ?ve times between 2010 and 2016,1178 was caused by the reformulated OxyContin. 905. A publication by the National Bureau of Economic Research reached this conclusion by analyzing time-series evidence that dated the changes in the heroin and opioid markets to the month in which reformulation occurred, by analyzing the availability of heroin in ?75 Theodore Cicero, Factors In?uencing the Selection of Hydrocodone and OxyCodone as Primary Opioids in Substance Abusers Seeking Treatment in the United States, PAIN, 154:12 (2013). ?76 Theodore Cicero, Factors In?uencing the Selection of Hydrocodone and OxyCodone as Primary Opioids in Substance Abusers Seeking Treatment in the United States, PAIN, 154: 12 (2013). ?77 Comer, SD. Relative Abuse Liability of Prescription Opioids Compared to Heroin in Morphine?maintained Heroin Abusers. 33(5): 1 1791 191 (2008)) (available at . ?73 Heroin Overdose Data, CENTERS FOR DISEASE CONTROL AND PREVENTION, available at 256 local markets, and by accounting for alternative theories. ?9 The study also found that outcomes such as deaths, poisonings, emergency room visits, and enrollments in treatment programs from heroin abuse have all increased since August 20] 0'13? 906. A similar working paper by the Rand Corporation in January 2017 stated ?[ojur results imply that a substantial share of the dramatic increase in heroin deaths since 2010 can be attributed to the reformulation of OxyContin.? 907. This conclusion is consistent with national data showing a spike in the number of overdose deaths involving heroin showing a Four-fold increase from 2010 as shown below.?Eu NIH . .. National Overdose Deaths in {a Number of Deaths Involving Heroin l? l-llIUU - 10ml lunmlu - H.000 II) M10 I Mm cm awoe?si?o seaside" 5 min-can?. grin-I.- William Evans, How the Reformniotion of OxyContin ignited the Heroin Epidemic, NATIONAL BUREAU OF ECONOMIC RESEARCH 6 (April 2018), available at: (hereinafter NBER) NBER (citing Paul Coplan, Changes in Gwendone and Heroin Exposures in the Notionoi Poison Data System n?er introduction of Extended i-etease Oxyeodone with Abuse-Deterrent Characteristics, P1 IARMACOEPIDEMJOLOGY AND DRUG SAFETY 23(12): 1 2T4-1282 (2013); Theodore Cicero, a?eet ofAbnse?Deterrent Fat-initiation ofOxyContin, NEW ENGLAND JOURNAL OF MEDICINE 361(2): 187-] 89 (20 Theodore Cicero, The Changing Face ofHeroin Use in the United States: a Retrospective Anniysis of the Past 50 Years," JAMA (2014); Theodore Cicero, Shifting Patterns of Prescription Opioid and Heroin Abuse in the United States, NEW ENGLAND JOURNAL OF MEDICINE, 328(18): 1789-1790 (2015); and Wilson Compton, between Nonmedieoi Prescriptionr?pioid Use and Heroin Use, NEW ENGLAND JOURNAL OF MEDICINE 374(2): 154-163 (2016)). Abby Alpert, Stippiy-Sitie Drag i?oiiqv in tire Presence of Substitutes: Evidenee?om the introduction ofAbttse? Deterrent Opioids, RAND (Jan. 20] 7). 25'? 908. Likewise, the ?nding is consistent with data from Tennessee where deaths from heroin overdoses have increased l5 times from 2010 to 2016?rising from 1? deaths in 2010 to at least 260 in 20145.I Number of Orr-and Related Overdose Duths in Tennis!" Ann I 11.50 *Ilnum 3 [[110 *hwmeln wands Kill 73*] a 1/ 5? am .pv?Hf' w" r? )full Source. CDC WONDER 909. This statistical evidence concerning heroin overdoses linked to the reformulation of OxyContin serves as a marker for those individuals addicted or otherwise impacted by the prior formulation of OxyContin. 910. The State and its political subdivisions have spent signi?cant public resources on treatment, toxicology reports and autopsies, law enforcement, corrections, intervention programs, drug courts, prosecution, probation, and child welfare related to opioids, OxyContin, and heroin and more funds are needed to address this public health crisis. 9] l. Opioid use, morbidity, and mortality have increased exponentially nationwide and across Tennessee in the years since Purdue first began aggressively marketing opioids for long- term use. ?33 Tennessee Opioid Summary, NATIONAL INSTITUTE on DRUG Aausn, available at 258 912. In 2015, Tennessee had 13,034 nonfatal overdose outpatient visits and 7,092 overdose inpatient stays.?4 In 2016, 7,636,112 opioids were prescribed in Tennessee. In 2016, there were 1,186 opioid-related overdose deaths in Tennessee-a rate of 18.1 deaths per 100,000 persons?higher than the national rate of 13.3 deaths per 913. SAMHSA has stated that the number of individuals enrolled in substance use treatment in Tennessee has varied between 16,590 in 2011, 19,115 in 2012, 14,149 in 2013, and 22,445 in 2015.1186 914. Similarly, SAMHSA has stated that 5,371 Tennesseans in 201 1, 6,079 Tennesseans in 2012, 2,422 Tennesseans in 2013, and 4,421 Tennesseans in 2015 were enrolled in an opioid treatment program and received medication-assisted therapy (MAT), excluding those receiving MAT through a private physician.1187 Similarly, the number of individuals receiving buprenorphine at substance use facilities in Tennessee has climbed from 299 in 2011, 475 in 2012, 488 in 2013, to 1,179 in 2015.1188 915. Still, a signi?cant number of Tennesseans remain to be treated. In Tennessee, only about 10.6% of individuals aged 12 or older with illicit drug dependence or abuse received treatment for their illicit drug use within the year prior to being surveyed.1189 ?34 ?35 Tennessee 'Opioid Summary, NATIONAL INSTITUTE ON DRUG ABUSE, available at ?35 Behavioral Health Barometer Tennessee, Vol. 4, SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION, 13 available at - 16-TN.pdf (hereinafter Behavioral Health Barometer Tennessee). ?37 Behavioral Health Barometer Tennessee, 13. ?33 Behavioral Health Barometer Tennessee, 14. ?39 K. Edwards, Opioid Abuse in Tennessee, TENNESSEE DEPARTMENT OF MENTAL HEALTH SUBSTANCE ABUSE SERVICES (citing SAMHSA Center for Behavioral Health Statistics and Quality, 2014), p. 1, available at 259 916. The opioid epidemic in Tennessee has also had a negative impact on infants, children, the elderly, and families generally. 917. Tennessee is ranked number 6 in the nation for rates of opioid?related hospital admissions among senior citizens. In 2005, 467 out of every 100,000 Tennesseans aged 65 and bolder spent time hOSpitalized from opioid related use. By 2015, that rate shot up to 1,055 out of every 100,000 Tennesseans aged 65 and older.1190 918. Opioid use and misuse have increased the numbers of infants suffering from neonatal abstinence (NAS), a withdrawal that occurs in infants exposed to opioids in utero. The number of NAS cases attributable to prescription opioids has been disproportionately high in Tennessee. A 2015 NAS update prepared by the Tennessee Department of Health shows that ?[w]hen categorized into mutually exclusive categories of exposure, 48.5% of cases were exposed to prescription drugs only, 26.8% were exposed only to illicit or diverted drugs, and 23.2% were exposed to a mix of prescription and illicit or diverted drugs.?1191 919. In Tennessee, the rate of NAS was three times above the national average between 2009 and 2012 and has been more than 10 times the national average in some areas of East Tennessee.1192 In 2013 and 2014, Tennessee had NAS rates of 25.5 and 28.5 per 1,000 live births respectively. 1 193 ?90 Anita Wadhwani, Opioid-related Hospitalizations More than Triple for Tennessee Seniors, THE TENNESSEAN, available at tennessee-seniors/545556001/ (citing the US. Agency for Healthcare Research and Quality). ?91 A.M. Miller, Neonatal Abstinence Surveillance Annual Report 2015, TENNESSEE DEPARTMENT OF HEALTH 5 (2015), available at 1 ?92 Paul Campbell, M.D., Neonatal Abstinence in East Tennessee: Characteristics and Risk Factors among Mothers and Infants in One Area of Appalachia, J. HEALTH CARE POOR UNDERSERVED 1293?1408, 28(4) 2017. ?93 Paul Campbell, M.D., Neonatal Abstinence in East Tennessee: Characteristics and Risk Factors among Mothers and Infants in One Area of Appalachia, J. HEALTH CARE POOR UNDERSERVED 12934408, 28(4) 2017 . 260 920. 'Urifair and deceptive marketing of opioids "by "Purdue "also?has a' signi?cant detrimental impact on children in Tennessee. Adolescent misuse of prescription opioids is particularly devastating because it is the peak period in life when people ?rst misuse opioids. Purdue pushing the overprescribing of opioids has given more young children access to them. 921. Parental substance abuse is a major risk factor for child fatalities, child maltreatment, and involvement with the child welfare system. Children removed from their home as a result of parental substance abuse are likely to remain in foster care longer and have signi?cantly higher rates of adoption than those in foster care for other reasons. A higher rate of adoption indicates that children removed from their homes remain in foster care longer and are less likely to exit from foster care to reunite with biological parents. 922. In February 2018, Purdue stated that it has ceased detailing its opioid products to health care providers. Even if true, this does not affect the State?s nuisance abatement action because the company could resume sales calls and other marketing, the effects of Purdue?s conduct are long?term, pervasive, and continuous, and substantial equitable costs of abating the nuisance remain. I VIOLATIONS OF THE LAW COUNT I: TENNESSEE CONSUMER PROTECTION ACT Tenn. Code Ann. and 923. The Plaintiff, the State of Tennessee, incorporates by reference and re?alleges each and every allegation contained in paragraphs 1w870 of this Complaint. 924. The Defendant?s advertising, promotion, and offering of its opioid products, as 7! CC alleged herein, constitutes ?trade, commerce? and/or a ?consumer transaction? as de?ned in Tenn. Code Ann. and as those terms have been interpreted by the Tennessee Supreme Court in ayne v. Vincent, 301 162, 175 (Tenn. 2009) and elsewhere. 261 925. As used in this Complaint, ?unsubstantiated? means not possessing competent and reliable scienti?c evidence, de?ned as tests, analyses, research, studies, or other evidence based upon the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons quali?ed to do so, using procedures generally accepted in the profession to yield accurate and reliable results, at the time a claim is made. In the alternative, the State submits that ?unsubstantiated? means not possessing substantial evidence, de?ned as adequate and well~controlled investigations, at the time a claim is made. The State submits that as applied there is no difference between the standards and that, regardless, Purdue?s unsubstantiated claims as referenced in this Complaint fail either standard. 926. By engaging in any act or practice that causes or tends to cause a consumer or any other person to believe what is false or that misleads or tends to mislead a consumer or any other person as to a matter of fact, the Defendant has violated Tenn. Code Ann. 927. By expressly claiming without quali?cation that OxyContin does not have a dose ceiling or through words or phrases of similar import when this is not the case or when this claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. and in each instance. 928. By expressly referencing pseudoaddiction in its marketing or through words or phrases of similar import when this claim was deceptive or unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. 47?18?104(a) and in each instance. 929. By expressly or implicitly claiming that an addiction mitigation tool including a patient contract, patient diary, patient self-report, urine drug screen, opioid risk tool, or other tool is more effective than it actually is or when this claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. and in each instance. 262 930. ?By expressly-or *implicitlyr-cla-iming that OxyContin- or ?Bu-trans? did not. produce peaks and valleys that led to feelings of euphoria or less effective pain relief or through words or phrases of similar import when this is not the case or when this claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. and in each instance. 931. By expressly or implicitly claiming that OxyContin?s pre?20 1 0 formulation could not be crushed, lique?ed, or abused when this was not the case or when this claim was unsubstantiated at the time made, the Defendant has violated ?fem. Code Ann. and in each instance. 932. By referring to the abuse?deterrent properties of OxyContin and Hysingla post?2010 formulations and failing to disclose that these properties do not deter or. otherwise impact oral ingestion, the most common form of abuse, the Defendant has violated Tenn. Code Ann. 47-18-104(a) and in each instance. 933. By expressly or implicitly understating the risk of addiction from its opioid products, the Defendant has violated Tenn. Code Ann. and in each instance. 934. By referring to ?seven dosing of OxyContin,? using a stair-step graphic for increased titration, or otherwise making claims about higher doses of its opioid products and failing to disclose the increased risk of addiction and other serious risks or side effects from higher doses of its opioid products, the Defendant has violated Tenn. Code Ann. and in each instance. 263 935. By promoting its opioids for long?term use and failing to' disdlose?th? lack 0f evidence for long?term use of its opioids, the Defendant has violated Tenn. Code Ann. 47?18? 104(a) and in each instance. 936. By expressly or implicitly claiming without qualification that its opioid products were safer than they actually were or when this claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. and in each instance. 937. By expressly or implicitly claiming that OxyContin was safer, more effective, as effective, or superior to Opana, Duragesic, methadone, or Avinza, or through words or phrases of similar import, when this is not the case or when the claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. and in each instance. 938. By expressly or impliCitly claiming that OxyContin was safer, more effective,i'as effective, or superior to immediate release opioids generally or Dilaudid, hydrocodone, immediate release opioids containing acetaminophen, hydrocodone combinations, Lortab, Vicodin, and Percocet speci?cally when this is not the case or when the claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. (except for Dilaudid), and. in each instance. 939. By expressly or implicitly claiming that OxyContin was safer, more effective, as effective, or superior to non?opioids when this is not the case or when the claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. and in each instance. I 940. By expressly or implicitly claiming that Butrans was safer, more effective, as effective, or superior to immediate release opioids such as hydrocodone, hydrocodone 264 combinations, Darvocet, tramadol, and Lortab when this is not the case or when the claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. and in each instance. 941. By expressly or implicitly claiming that Ryzolt was safer, more effective, as effective, or superior to immediate release opioids generally or Percocet speci?cally or through words or phrases of similar import when this is not the case or when the claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. and in each instance. 942. By expressly or implicitly claiming that Ryzolt was safer, more effective, as effective, or superior to opioids including immediate release tramadol generally or Ultram ER speci?cally or through words or phrases of similar import when this is not the case or when the claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. 47-18- 104(a), and in each instance. 943. By expressly or implicitly claiming that Hysingla ER was safer, more effective, as effective, or superior to immediate release opioids including hydrocodone combinations and those containing acetaminophen or through words or phrases of similar import when this is not the case or when the claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. and in each instance. 944. By expressly or implicitly representing that its opioid products improve a patient?s quality of life, or through words or phrases of similar import when this is not the case or when the claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. 47~18~ 104(a), and in each instance. 265 945. By expressly or implicitly representing that its opioid products improve a patient?s function or through words or phrases of similar import when this is not the case or when the claim was unsubstantiated at the time made, the Defendant has violated Tenn. Code Ann. and in each instance. 946. By expressly or implicitly representing that its opioid products act as a sleep aid, or through words or phrases of similar import when this is not the case or when the claim was unsubstantiated at the time made, the Defendant has violated Term. Code Ann. and in each instance. 947. By expressly or implicitly misrepresenting the safety of OxyContin 0r Butrans when taken by the elderly, the Defendant has violated Tenn. Code Ann. and in each instance. 948. By targeting health care providers who worked in nursing homes or who otherwise had large elderly patient populations for sales calls for OxyContin and Butrans, both of which have an increased risk of respiratory depression in the elderly, the Defendant has violated Tenn. Code Ann. 47~18~104(a) in each instance. 949. By referring to low?dose starts of OxyContin in elderly patients and failing to disclose that low dose starts most often lead to higher doses of OxyContin where safety risks in the elderly are increased, the Defendant has violated Term. Code Ann. 47?18?104(a) and in each instance. 950. By referring to recommendations or promotional, policy, educational, and other materials from the American Pain Society, the AmeriCan Pain Foundation, the American Academy of Pain Medicine, or other pain advocacy groups Purdue substantially funded in its marketing 266 without disclosing this connection, the Defendant has violated Tenn. Code Ann. 47-18-104(a) and in each instance. 951. By making sales calls to providers and pharmacies after knowing of likely indicators of abuse or diversion, the Defendant has violated Tenn. Code Ann. 47-18-104(a) and in each instance. COUNT II: VIOLATIONS OF 2007 AGREED FINAL JUDGMENT 952. The Plaintiff, the State of Tennessee, incorporates by reference and re?alleges each and every allegation contained in paragraphs 444?870 of this Complaint. 953. The Defendant had actual awareness of its violations of the 2007 Judgment as a reasonable person would have known or had reason to know that his or her conduct described above violated the 2007 Judgment. 954. By knowingly engaging in the conduct described above, the Defendant has violated the 2007 Judgment and Tenn. Code Ann. in each instance. COUNT COMMON LAW NUISANCE 955. The Plaintiff, the State of Tennessee, incorporates by references and re?alleges each and every allegation contained in paragraphs 1?922 of this Complaint. 956. Through the actions described above, Purdue has contributed to and/or assisted in creating and maintaining a condition that has interfered with the operation of the commercial market, interfered with public health, and endangered the lives and health of Tennessee residents. 957. The Defendant had a duty under the TCPA to disseminate non-misleading promotional material, had a duty under the TCPA to disclose material facts, had a duty under the 2007 Judgment to effectively establish, implement, and follow an abuse and diversion detection 267 program, ?a'n?d?had? a ?dUty' not" to 'in?di'r'eCtly offer ?or "sell ?an? unlawful product 'and?it violated these duties. 958. While the Defendant?s degree of care is not relevant in a common law nuisance suit brought by the sovereign State, the Defendant behaved negligently, recklessly, or intentionally as set forth above. - 959. Through the actions described above, Purdue has contributed to and/or assisted in creating and maintaining a condition that endangers the life or health of Tennessee residents and that unreasonably interferes with or obstructs rights common to the public. 960. Opioid use, abuse, addiction, and overdose deaths have increased throughout Tennessee. Locations such as the of?ces of high?prescribing health care providers and the pharmacies at which their patients ?ll opioid prescriptions have attracted drug dealers and those addicted to opioids. 961. The greater demand for emergency services, law enforcement, addiction treatment, and other social services places an unreasonable burden on governmental resources including the State and its political subdivisions. 962. Expanding the market for prescription opioids by making misrepresentations and omissions to health care providers, especially to general practitioners, nurse practitioners, and physician assistants, as well as targeting providers and pharmacies with practices that had actual abuse or diversion or signs indicative of abuse or diversion, has created an abundance of opioids available for criminal use andfueled a wave of addiction, abuse, injury, and death. 963. Purdue?s actions described above were a substantial factor in opioids becoming widely available, used, and all too often abused. 268 9'64." actions, "opioid so widespread, and the enormous public health hazard of opioid overuse, abuse, and addiction that now exists would have been averted. Purdue?s actions have and will continue to injure and harm many residents throughout Tennessee. 965. While tort based standards are not applicable to a public nuisance suit brought by the sovereign State, the public nuisance and associated ?nancial and economic losses were foreseeable to Purdue, who knew or should have known that its unfair and deceptive business practices regarding the safety, purported bene?ts, and comparative superiority or equivalency of its opioid products, its continued sales targeting of providers and pharmacies with practices that had actual abuse or diversion or signs indicative of abuse or diversion of opioids, and its other conduct described herein were creating a public nuisance. 966. Purdue intended health care providers to prescribe its extended release opioids for long?term use and for patients to ?ll those prescriptions and to keep ?lling those prescriptions at higher and higher doses. A reasonable person in Purdue?s position Would foresee not only an expanded market, but the other likely and foreseeable result of Purdue?s conduct?the widespread problems of opioid addiction and abuse, particularly given the easy manipulation of its prior formulation and its popularity among opioid abusers and those addicted. 967. Purdue was on notice and aware of signs both that health care providers were prescribing unreasonably high numbers of opioids and that the broader use of opioids were causing the kinds of harm described in this Complaint. 968. Purdue?s business practices generated a new and very pro?table circular market with the promotion of opioids?providing both the pro?table supply of narcotics to prescribe and sell, as well as causing addiction which fueled the demand to buy more. 269 ?"969. Purdue ?aCt?e?d Without ?e'xpre?SS' authority?iof'a statute? in?misrepresenting" the safety, comparative superiority or equivalence of its opioids to other products, and bene?ts of its opioid products, failing to disclose the increased risk of addiction at higher doses, and failing to disclose the lack of substantiation for long-term use of opioids among other conduct. 970. The health and safety of Tennessee residents, including those who use, have used, or will use opioids, as well as those affected by users of opioids, is a matter of great public interest and of legitimate concern to the State. Tennesseans have a right to be free from conduct that endangers their health and safety and that interferes with the commercial marketplace. Purdue?s conduct interfered in the enjoyment of these public rights. 971. As part of its nuisance action, the State does not seek any damages attributable to Tenncare, Medicaid, or Medicare. IV. PRAYER FOR RELIEF WHEREFORE, PREMISES CONSIDERED, Plaintiff, the State of Tennessee, ex rel. Herbert H. Slatery Attorney General and Reporter, pursuant to the TCPA, the Attorney General?s general statutory authority, the Attorney General?s authority at common law, and this Court?s equitable powers, prays: 1. That this Complaint be ?led without cost bond as provided by Tenn. Code Ann. 20?13?101 and 47?18?116; 2. That process issue and be served upon the Defendant requiring it to appear and answer; 3. That this Court adjudge and decree that the Defendant has engaged in the aforementioned acts or practices that violate the 270 4.. That pursuant to Tenn. Code Ann. and this Court permanently enjoin and restrain the Defendant from engaging in the aforementioned acts or practices which violate the 5. That the Court ?nd that the Defendant has made the material misrepresentations and omissions set forth above, that the misrepresentations and omissions were widely? disseminated, and that the Defendant?s opioid products were purchased; 6. That pursuant to Tenn. Code Ann. this Court make such orders or render such judgments as may be necessary to restore to any person, as de?ned in Tenn. Code Ann. who has suffered any ascertainable loss as de?ned in Tenn. Code Ann. including statutory interest and requiring that the Defendant pay all costs of distributing and administering the same, including through the use of third-party administrator; 7. That this Court make such orders or render such judgments as may be necessary to disgorge the pro?ts and ill?gotten gains the Defendant realized by reason of the alleged violations of the 8. That this Court adjudge and decree that the Defendant pays a civil penalty of $1,000.00 to the State for each violation of the TCPA as provided by Tenn. Code Ann. 47?18? 108(b)(3); 9. That apart from any civil penalties referenced above and pursuant to Tenn. Code Ann. 47?1 8?125, this Court adjudge and decree that the Defendant pays a civil penalty of $10,000 per violation for any method, act, or practice that violates the TCPA that the Court ?nds the Defendant knowingly, as de?ned in Tenn. Code Ann. 47*1 used which targeted elderly persons with each violation constituting each misrepresentation or deceptive statement that appeared on a solicitation or advertisement; 271 - for the reasonable costs and expenses of the investigation and prosecution of this action, including attorneys? fees and costs, expert and other witness fees, as provided by Tenn. Code Ann. 47-18? 108(a)(5) and and other state law; 11. That pursuant to Tenn. Code Ann. this Court adjudge and decree that the Defendant has knowingly violated paragraph 13 of the 2007 Judgment and that the Defendant shall pay the State $2,000 for each violation of the Judgment in addition to any other . appropriate relief; 12. That an order be entered that provides for abatement of the public nuisance the Defendant has created, the equitable costs of abating this nuisance, an award to the State for damages in an amount to be determined at trial, and any other relief or remedy allowable under state law; 13. That all costs, including discretionary costs, in this case be taxed against the Defendant; 14. That a jury be empaneled to hear and decide all appropriate matters; and 15. That this Court grant the State such other and further relief as this Court deems just and proper. Respectfully submitted, HERBERT H. SLATERY Attorney General and Reporter (34/ 27/ a? B.P.R. No. 009077 272 Senior Counsel MARGARET ROWLAND, B.P.R. No. 33513 Assistant Attorney General CAROLYN U. SMITH, B.P.R. No. 17166 Senior Counsel Of?ce of the Attorney General of Tennessee Consumer Protection and Advocate Division UBS Tower, 20th Floor 315 Deaderick Street Nashville, TN 37243 (615) 741-3549 (615) 532-2910 (fax) brant.ha1rell@ag.tn. gov margaret.rowland@ag.tn. gov carolyn.smith@ag.tn. gov 273 GLOSSARY OF TERMS AAPM American Academy of Pain Medicine ADD Abuse and Diversion Detection ADP abuse deterrent properties APAP acetaminophen or N?acetyl?para?aminophenol APF American Pain Foundation APS American Pain Society ASA aspirin or acetylsalicylic acid ATC around-the?clock CII or C2 controlled substance under Schedule II of the Controlled Substances Act HCPs health care providers KOLs - key opinion leaders LA long-acting NSAIDS non-steroidal anti?in?ammatory drugs Q12h once every 12 hours ROCS Reports of concern or records of contact SA short-acting SOP Standard Operating Procedure SOP 1.7.1 Section in Purdue?s Standard Operating Procedures concerning the ADD program 274