CONSUMERPROTECTIONDIVISION, IN THE CONSUMER OFFICE OF THE ATTORNEY GENERAL 200 St. Paul Place, 16th Floor Baltimore, Maryland 21202, PROTECTION DIVISION OF THE Proponent, OFFICE OF THE V. ATTORNEY GENERAL PURDUE PHARMA, L.P., THE PURDUE FREDERICK COMPANY, INC., PURDUEPHARMAINC., PURDUE PHARMACEUTICAL PRODUCTS L.P., AVRIOHEALTHLIMITEDPARTNERSHIP CPD Case No: 311366 OAH Case No.: (f/k/a PURDUE PRODUCTS L.P.), RHODES PHARMACEUTICALS L.P, RICHARD S. SACKLER, JONATHAND. SACKLER, MORTIMER D.A. SACKLER, KATHE A. SACKLER, ILENE SACKLER LEFCOURT, THERESA SACKLER, and DAVID A. SACKLER, Respondents. AMENDEDSTATEMENTOF CHARGES The Consumer Protection Division ofthe Office ofthe Attorney General of Maryland (the "Division") hereby institutes this proceeding on behalfofthe State ofMaryland to enjoin Purdue Pharma, L.P., The PurdueFrederickCompany, Inc., PurduePharmaInc., PurduePhannaceutical Products L.P., Avrio Health Limited Partnership (f/k/a Purdue Products L.P.), Rhodes Pharmaceuticals L.P., Richard S. Sackler, Jonathan D. Sackler, Mortimer D.A. Sackler, Kathe A. Sackler, Ilene Sackler Lefcourt, Theresa Sackler, and David A. Sackler (collectively, "Respondents") from engaging in unfair and deceptive trade practices and to obtain relief for consumersvictimizedby Respondents' unfairanddeceptivetradepractices. -1- For decades, Respondents have repeatedly engaged in unfair, abusive, and deceptive trade practices in violation ofthe Maryland Consumer Protection Act, Md. CodeAnn. §§ 13-101 etseq., bymarketing and selling opioids - which comprise a dangerous, highly addictive, and oflten lethal classofnatural, synthetic, andsemi-synthetic painkillers - forconditions forwhichthey areneither safe nor effective and which they, in fact, often exacerbate. Respondents disseminated to Maryland prescribers, consumers, and others, false and misleading information concerning the purported safety andefficacy ofopioid use for the treatment ofchronic pain. Respondents omitted material facts regarding the chemical properties ofopioids and minimized or failed to disclose the attendant risks of addiction, respiratory depression, and worsening pain (opioid-induced hyperalgesia). Respondents falsely marketed and sold opioids to at-risk Marylanders, who, because of their addiction, were unable to control or reduce their opioid use. Similarly, Respondents failed to report suspicious orders to regulators as required by law. Respondents' practices, as set forth in further detail herein, fueled the epidemic. They fed the addiction of a generation of Marylanders and, in so doing, have caused tremendous harm to the State and its citizens. I. INTRODUCTION 1. Maryland, like other states across the country, faces an unprecedented opioid epidemic caused byRespondents' unfair, abusive, anddeceptive misconduct. The opioid crisis has left a devastating wake of addiction and death in Maryland while Respondents have profited handsomely from their misconduct. 2. Opioids are powerful narcotic painkillers derived from opium poppy plants, although most prescription opioids today are actually synthetic or semi-synthetic derivatives of opium. When introduced into the central nervous system, opioids, like opium, bind to opioid receptors on neurons that control dopamine release. According to the Surgeon General, opioids, -2- like other addictive substances, have powerful effects on the brain. They "hijack" the brain's reward system by inducing feelings that motivate people to usethem repeatedly, despite associated risks. With continued exposure, progressive changes occur in the structure and function of the brain, compromisingbrainfunction and driving chronicmisuse. Addictionis now understoodto be a chronic disease that is subject to relapse and is characterized by clinically significant impairments in health, social function, andvoluntary control over substance use.' 3. Between doses ofopioids, patients can suffer body aches, nausea, sweats, racing heart, hypertension, insomnia, anxiety, agitation, opioid cravings, opioid-induced hyperalgesia (increased pain), and other symptoms of withdrawal. When the agony of withdrawal is relieved bythe nextdose, it creates a cycle ofeuphoriaanddysphoria thatfosters addiction anddependence. Even when prescribed for a legitimate pain condition, prescription opioids are as addictive as heroin because they have exactly the same addictive effects on the neurocircuitry of the brain. Additionally, the chronic use ofopioids has been shown to increase pain rather than reduce it, due to opioid-induced hyperalgesia. 4. Prior to 1980, out of appropriate concern that patients would become addicted, doctors prescribed opioid painrelievers sparingly, only for short-term use in cases ofsevere injury, surgery, or at the end of life, such as with cancer patients. Although there has never been any evidence to justify widespread opioid prescribing or to support a conclusion that long-term opioid use reduces pain or improves function. Respondents perpetuated misconceptions regarding the Facing Addiction in America, The Surgeon General's Spotlight on Opioids, U. S. Department of Health & Human Services Substance Abuse and Mental Health Services Administration at 12 (Sept. 2018), https://addiction. surgeongeneral. gov/sites/default/files/OC_SpotlightOnOpioids. pdf. -3- safetyandefficacyof opioids for chronicpain so as to effect a paradigm shift in the thinking on, and prescribing of, opioids - all to maximize sales. 5. According to the Maryland Department of Health ("MDH"), opioid-related fatalitiesincreasedin Marylandin 2017forthe seventhyearin a row, reachinganall-time highof 2, 009 deaths. This represents an increase of nearly 300% since 2010, when there were 504 reported opioid-related deaths. 3 Because not all opioid-related deaths are reported or detected, these figures may be understated. Figure 35. Number of Drug- and Alcohol-Related Intoxication Deaths Involving Opioids, 2007-2017. 2500 iTotal deaths 2000 2089 Not % 1500 125^ as .s tU4t 1000 694 73t 799 649 671 500 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 6. Whilethe finaltally of2018opioid-relateddeathsinMarylandis notyetavailable, preliminary data foun. , 114 opioid-related deaths in Maryland, a 5.2% increase over the prior 2 Unintentional Drug- and Alcohol-Related Intoxication Deaths in Maryland, Annual Report, 2077, Maryland Department of Health, at 15 (June 2018), https://bha. health. maryland. gov/ (hereinafter, OVERDOSE_PREVENTION/Documents/Dmg_Intox_Report_2017.pdf " UnintentionalDrug-andAlcohol-Related"). Id. -4- year. 4 For the first nine months of 2018, which is the most recent data for which the MDH has published statistics, the number ofopioid-related deaths in Maryland climbed by 10%, with 1,648 deaths reported from January through September 2018, compared to 1, 502 in 2017.5 7. Maryland ranks among the top five states for the highest rates of opioid-related overdose deaths. 6 The death rate in Maryland has consistently been above the national average since 1999, ranging from roughly 1. 5 to 3 times that average. Baltimore City, for example, hadan overdose death rate of 45 per 100,000 residents in 2016, compared with the national overdose deathrate of 13.3 per 100,000persons.7 4 Annual Report, Opioid Operational Command Center at 2 (May 9, 2019), https://beforeitstoolate. maryland. gov/wp-content/uploads/sites/34/2019/05/OOCC-Final-AnnualReport-2018.pdf 5 Dandan Zou, Opioid overdose deathrate stabilizes in region as statewide trend continues to surge. The Calvert Recorder (Jan. 17, 2019), https://www.somdnews.com/recorder/spotlight/ opioid-overdose-death-rate-stabilizes-in-region-as-statewide-trend/article_al66907d-8aad-5c87a666-lea0e6elde73. html. 6 Maryland Opioid Summary, Opioid-Related Overdose Deaths, National Institute on Drug Abuse, https://www.dmgabuse.gov/dmgs-abuse/opioids/opioid-summaries-by-state/marylandopioid-summary (last visited May 14, 2019) (hereinaflter, "Maryland Opioid Summary'"). 7 Unintentional Drug-and Alcohol-Related, supra n.2, at 44; Maryland OpioidSummary, supra n. 6. -5- Figure 2. Number of 0 ioid-Related Deaths Occurring in Ma land from Janua throu h Se tember of Each Year.* 1800 1648 1600 ISO! 1»M 1400 I ZOO 1000 777 sco 6S4 wo . tOO 4S» 192 390 Ml zoo 0 8. The trend in opioid-related overdose deaths is not limited to Maryland. In 2014, more than 47, 000 people died in the United States from lethal dmg overdoses, the majority of whichinvolved opioids. The total has risen eachyear since. The number of overdose deaths in 2017 is estimated to have been more than 72, 000. 9. More thanthree out offive ofthose deaths involve opioids, andnearlyhalfofthose involve legal opioids prescribed by doctors to treat pain. In all, more than 200, 000 people died in the United States between 1999 and 2017 from overdoses directly related to prescription opioids.8 10. Moreover, most illicit dmg users, including those who die from illicit opioid overdoses, suffer addictions that are directly linked to their use of legally manufactured prescription opioids. According to the National Institutes of Health, more than 80% of heroin users reported using prescription opioids before initiating heroin use.9 8 Prescription Opioid Data, Centers for Disease Control and Prevention: Opioid Overdose, https://www.cdc.gov/drugoverdose/data/overdose.html (lastvisitedMay 14, 2019). 9 Prescription Opioids and Heroin, National Institute on Drug Abuse (January 2018), https://www. drugabuse. gov/publications/research-reports/relationship-between-prescriptiondrug-heroin-abuse/prescription-opioid-use-risk-factor-heroin-use; see also Wilson M. Compton, -6- 11. Public health officials have called the current opioid epidemic the worst drug crisis in American history. 10 According to Robert Anderson, Chief ofthe Mortality Statistics Branch of the National Center for Health Statistics, "I don't think we've ever seen anything like this. Certainly not in modem times. "" 12. OnMarch 1, 2017, GovernorHogandeclareda state ofemergency"in responseto the heroin, opioid, and fentanyl crisis ravaging communities in Maryland and across the country. "12 On October 26, 2017, the federal government designated the opioid crisis a national public health emergency. According to recent estimates, as many as 145 people in the United States continue to die every dayfrom opioid overdoses. 13. Thecostofthe country's opioid crisis is estimated to have exceeded $1 trillionfrom 2001 to 2017 and is projected to cost anadditional $500 billion by 2020-14 et al.. RelationshipbetweenNonmedicalPrescription-OpioidUse andHeroinUse, 374N. Eng.J. Med 154-63 (2016), https://www. nejm. org/doi/full/10. 1056/NEJMral 508490. 10 Julie Bosman, Inside a Killer Drug Epidemic: A Lookat America 's Opioid Crisis, N.Y. Times (Jan. 6, 2017), https://www. nytimes. com/2017/01/06/us/opioid-crisis-epidemic. html. n Drug overdoses now kill more Americans than guns, CBS News (Dec. 9, 2016), https://www. cbsnews. com/news/drug-overdose-deaths-heroin-opioid-prescription-painkillersmore-than-guns/. 12 Press Release, Office of Governor Larry Hogan, Hogan-RutherfordAdministration Declares StateofEmergency,AnnouncesMajorFundingto CombatHeroinandOpioidCrisis in Maryland (Mar. 1, 2017), http://govemor. maryland. gov/2017/03/01/hogan-rutherford-administrationdeclares-state-of-emergency-announces-major-funding-to-combat-heroin-and-opioid-crisis-inmaryland/. 13 Patrick R. Keefe, The Family that Built an Empire of Pain, The New Yorker (Oct. 30, 2017), https://www. newyorker. com/magazine/2017/10/30/the-family-that-built-an-empire-of-pain (hereinafter, "Keefe, Empire of Pain"). 14 Economic Toll ofOpioid Crisis in U. S. Exceeded $1 Trillion Since 2001, Altarum (Feb. 13, 2018), https://altamm.org/abouVnews-and-events/economic-toll-of-opioid-crisis-in-u-sexceeded-l-trillion-since-2001. -7- Total and Projected Costs oftheOpioid EpidemFc S200 $199. 9 -^ / Clickfor detail / P'-ojected barden ai eurfent rates ^ $150 * $95.8 s S $100 $60.9 s .s S48.7 s ^ ?50 $29.1 $500 Billion $1 Trittion Total Projected $0 2001 2011 2006 2016 2020 . Dvfi<»lifl.iv&6rtttfhc\v, New Hope for Millions of Americans Suffering from Persistent Pain: Long-Acting OxyContin Tablets Now Available to Relieve Pain (May 31, 1996), https://www. freelibrary. com/NEW+HOPE+FOR+MILLIONS+OF+AMERICANS+ SUFFERING+FROM+PERSISTENT+PAIN%3A..-a018343260. . 50 Though the FDA's 1995 approval allowed Purdue to include a package insert for OxyContin declaring the drug to be saferthan its competitors due to its delayed release design, Purdue had m fact"conductedno clinical studiesonhowaddictiveorproneto abusethe dmgmightbe.... The F.D.A. examiner who oversaw the process. Dr. Curtis Wright, left the agency shortly afterward. Withintwo years, hehadtaken a job at Purdue." Keefe, EmpireofPain,supran.13. -36- 88. First, contrary to the claims of eliminating highs, Purdue designed OxyContin to \ continueto deliverthem by means of a bolus effect. In designinga long-actingproduct, through beading, coating, and other design featires, manufacturers can control the rate at which the opioid molecule is delivered over time, making it theoretically steady and smooth. But manufacturers can also choose to distort the delivery of the drug so that more is delivered early (to produce a high) and less is delivered late (to create withdrawal). While representingthat it was delivering smooth and steady pain relief, Purdue did exactly that. 89. Purdue designed OxyContin to have a "bolus effect. " What this means is that OxyContin was designed to deliver earlier a higher percentage ofthe oxycodone in the pill than it delivered later, to produce the high thatSatisfied patients. Purdue misled prescribers about OxyContin's "front-loaded" delivery, resulting in patients experiencing greater highs than their providers understood. Because ofthe bolus effect, Purdue'slong-acting'opioidsin factproduced the very highs that Purdue claimed they were designed to eliminate. At the same time, at least in part because of the bolus effect, Purdue's claims about its long-acting drugs' extended release propertieswere equally false. Purdue,for example,marketed OxyContinto Marylandprescribers asrequiringdosingevery 12hoursanddiscouragedphysiciansfromprescribingit morefrequently. 90. Thetruth, however,wasthatthe marketing claimsRespondentsmadein Maryland were false and highly deceptive. OxyContin was not superior to immediate-release opioids. It did not relieve pain for 12 hours. And it most certainly was addictive. 91. It is now recognized that OxyContin's stunning success masked a fundamental problem: as a LosAngelesTimes investigationuncovered,the dmgwearsoffhours early inmany -37- people. OxyContinis a chemicalcousinofheroin,andwhenit doesn'tlast,patientscanexperience excruciating symptoms ofwithdrawal, including an intense craving for the dmg. 51 92. Experts therefore have called 12-hour dosing of OxyContin "an addiction producing machine. "52 Respondents have known for decades that 12-hour relief was a false promise but nevertheless mobilized hundreds of sales representatives to "refocus" physicians on 12-hourdosing. 93. Even before OxyContin went on the market. Respondents knew that Purdue's claims about 12-hourdosingwere deceptive. The clinicaltrials for OxyContindemonstratedthat manypatients simplywerenotgettingthe 12hoursofreliefthatRespondentswouldsoonpromise. Since the dmg's debut in 1995, Respondents have been confronted with additional evidence, undermining repeated claims of 12-hour pain relief including complaints from doctors, reports from sales representatives, andPurdue's own independent research. 53 94. Nevertheless, Purduehas chosento hold fastto the claim of 12-hourrelief, in order to protect its revenue. Even as recently as 2015, for example, Purdue instructed its sales representatives to continue to reassure prescribers worried by the opioid crisis that OxyContin provided 12-hour relief. OxyContin's market dominance and its high price - up to hundreds of 51 The Los Angeles Times investigation, reported in three parts on May 5, July 10, and December 18, 2016, included the review of thousands of pages of confidential Purdue documents and court andotherrecords. They spanthree decades,from the conception ofOxyContinin the mid-1980s to 2011, and include emails, memoranda, meeting minutes, and sales reports, as well as sworn testimony by executives, sales representatives, andother employees. Ryan, Descriptionof Hell, supra n. 47. The Los Angeles Times reporters also examined PDA records, Patent Office files, and medical journal articles, and interviewed experts in pain treatment, addiction medicine, and phannacology. Id. 52 Kathleen Frydl, Purdue Pharma: Corporate Fraud With a Body Count, Altemet (May 18, 2016), http://www.altemet. org/drugs/purdue-pharrna-corporate-fraud-body-count. 53 Ryan, Description of Hell, supra n.47. -38- dollarsper bottle - hinge on its supposed 12-hourduration. Withoutthis claim, OxyContinloses its advantage over less expensive painkillers. 54 95. To make matters worse, when doctors began prescribing OxyContin at shorter intervals in the late 1990s, Purdue executives mobilized hundreds of sales representatives to "refocus" physicians on 12-hour dosing. Anything shorter "needs to be nipped in the bud. NOW!!" one manager wrote to her staff. 55 96. Purdue instructed doctors to remedy the problem by prescribing stronger doses, insteadof more frequent ones. That approachcreates other risks. Stronger doses create greater highs and lower lows. Research shows that the more potent the dose of an opioid such as OxyContin, the greater the possibility of overdose, respiratory depression, and death, and the greaterthe risk ofaddiction. 56 97. Purdue sales representatives regularly encouraged Maryland healthcare providers to increasethe doseofOxyContinwithoutdiscussingtherisksassociatedwithdoseincreases. For example, accordingto notes from salescalls madein Marylandbetween2006 and2016,a Purdue salesrepresentativenotedofhis call on a prescriberin 54 Id. 55 Id. 56 Id. -39- : 98. Additionally, one Purdue sales representative noted in her follow-up comments after a call with a 99. And a Purdue sales representative noted of her call on a 100. The company line, confirmed by one Maryland sales manager in testimony under oath to the Division, was that OxyContin lasted 12 hours if "dosed correctly. " Respondents directed their sales representatives to constantly encourage higher doses and incentivized their doingso. Duelargelyto the successoftheseefforts,morethanhalfoflong-term OxyContinusers are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for the Los Angeles Times, s^ 101. AsreportedbyTheNewYorkTimes,"internalPurduePharmadocumentsshowthat company officials recognized even before the dmg was marketed that they would face stiff resistance from doctors who were concerned about the potential of a high-powered narcotic like OxyContinto beabusedbypatients or causeaddiction. "58 To combatthisresistance. Respondents 57 Id. 58 Barry Meier, In Guilty Plea, OxyContin Maker to Pay $600 Million, N.Y. Times (May 10, 2007), http://www.nytimes.com/2007/05/10/business/lldmg-web.hftiil (hereinafter, "Meier, Guilty Plea"). -40- promised the long-acting, extended-release formulation as safer and "less prone to such problems. "59 102. Purdue's sales culture required aggressive sales of its opioids and embraced the sell-at-any-cost notion: sell or be gone. Aggressive quotas were put into place for opioids including OxyContin and Hysingla, at all dosage levels. The highest dosage for OxyContin was referred to by Purdue sales representatives as "hillbilly heroin. " When sales representatives failed to meettheir quotas, theywereplaced onperformance employment plans and/orterminated. When they were successful, they were richly rewarded with extravagant bonuses and prizes. There was somuch money to bemade, andsomuch pressure to meet quotas, that salesrepresentatives became desensitized to what they were selling. C. The Sackler Respondents Directed Purdue to Falsely Claim Low Addiction Risk, and Market Opioids to Patients for Whom Opioids Were Unnecessary, Inappropriate, Ineffective, and Dangerous 103. As noted above, prior to 1980, physicians correctly understood opioids as being appropriately reserved only for rare cases, such as in late-stage cancer patients. They were perceived as ineffective, inappropriate, andtoo dangerous for other types ofpatients, who should betreatedforpainwith othertherapies. 104. To overcome these limitations on the size of its market for opioids and to drive profits ever higher. Respondents increasingly marketed their opioids for use in non-cancer patients to whom opioids previously would not ordinarily havebeenprescribed. These patients todaymake up 86% ofthe total opioid market. 60 59 Id. 60 Charles Omstein & Tracy Weber, American Pain Foundation Shuts Downas Senators Launch Investigation of Prescription Narcotics, ProPublica (May 8, 2012, 8:57 PM), -41- 105. To reachthese patients, ratherthan targeting merely those physicians treating acute severe short-term pain, like post-operative painphysicians or oncologists treating end-stage cancer pain, reports indicate that Purdue heavily promoted OxyContin in Maryland and nationwide to doctors such as general practitioners, who often had little training in the treatment of serious pain or in recognizing signsofdrugabuseinpatients. 61 Accordingto a report inTheNew Yorker, "[a] major thmst of the sales campaign was that OxyContin should be prescribed not merely for the kind of severe short-term pain associated with surgery or cancer but also for less acute, longerlasting pain: arthritis, back pain, sports injuries, fibromyalgia, " such that "[t]he number of conditions thatOxyContin couldtreatseemedalmost unlimited. "62 106. Purdue also trained its Maryland sales representatives to call upon psychiatrists - physicians who treat patients with mental health disorders that place them at greater risk for opioid use disorders. 107. Sales representatives plied these and other physicians, and their patients, with coupons that patients could redeem for a 7- to 30-day supplies offree OxyContin, with the promise that OxyContin was generally safe and useful to ti-eat a variety of non-cancer pain conditions. Purdue "trained its sales representatives to carry the message that the risk of addiction was 'less than one percent, '" and "[a] consistent feature in the promotion and marketing ofOxyContin was a systematic efifort to minimize the risk of addiction in the use of opioids for the treatment of https://www. propublica. org/article/senate-panel-investigates-drug-company-ties-to-pain-groups/ (hereinafter, "Omstein, American Pain Foundation"). 61 Meier, Guilty Plea, supra n.58. 62 Keefe, Empire of Pain, supra n.13 -42- chronic non-cancer-related pain. "63 Thousands ofPurdue's free product coupons were distributed in Maryland through prescribers who treated common pain conditions for which Purdue's opioids were medically unnecessary. 108. At the SacklerRespondents' direction, Purdue managers hired andti-ained a sales force comprised of hundreds of sales reps. Purdue managers tested the sales reps on the most important false statements during training at headquarters - specifically that the risk of addiction was "less than one percent. " Purdue mailed promotional videos to thousands of doctors with the same false claim: "There's no question that our best, strongest pain medicines are the opioids. But these are the same dmgs that have a reputation for causing addiction and other terrible things. Now, in fact, the rate of addiction amongst pain patients who are treatedby doctors is much lessthan one percent. Theydon'twearout, they go on working, they do not have serious medical side effects." 109. Additionally, salesrepresentativesweredirectedto marketOxyContinasa product '"to start with and to stay with,"' and Respondents deliberately exploited a misconception they knew many doctors held that oxycodone was less potent than morphine. 64 Sales representatives also received training in overcoming doctors' concerns about addiction with talking points Respondents knew to be untme about the dmg's abuse potential. The New Yorker reported that "[i]n2002,a salesmanagerfromthecompany,WilliamGergely,tolda state investigatorinFlorida thatPurdue executives 'told usto saythings like it is "virtually" non-addicting. '"65 63 Art VanZee, The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, 99(2) Am. J. Pub. Health 221-27 (Feb. 2009) (hereinafter, "Van Zee, Promotion and Marketing). 64 Keefe, Empire of Pain, supra n.13. 65 Id. -43- 110. Further, to overcome objections about using dangerous opioids in an everbroadening class of patients, "[ajccording to training materials, Purdue instmcted sales representatives to assure doctors - repeatedly and without evidence - that 'fewer than one per cent' of patients who took OxyContin became addicted. " But "[i]n 1999, a Purdue-funded study of patients who used OxyContin forheadaches found thatthe addiction rate wasthirteen per cent. "66 Regardless, even as late as 2015, if not later, Purdue sales representatives were telling physicians OxyContin was addiction resistant andhadabuse-deterrent properties. Indeed, according to notes from sales calls made in Maryland, 111. Respondent David Sackler was deeply involved in the development ofPurdue's public messaging regarding the abuse-deterrent formulation ofOxyContin that it launched in 2010, messaging that was ultimately disseminated throughout Maryland. Respondents' claims that OxyContin was abuse-deterrent were deceptive. In reality, the claims were designed to falsely reassure public andprevent the erosion ofOxyContin's dominance in the market. 112. According to notes from Purdue sales representatives' calls onMaryland healthcare providers, Purdue salesrepresentatives 113. Providing Relief, Preventing Abuse: A Reference Guide to Control 66 Id. -44- Substance Prescribing Practices (2008), falsely informed Maryland prescribers that addiction "is notcausedbydrugs." Instead,PurdueassuredMarylandhealthcareprovidersthataddictionoccurs whenthe wrongpatients get dmgs and abusethem: "it is triggered in a susceptible individualby exposure to dmgs, most commonly through abuse. " This is incorrect. In fact, "many people with no addiction history can become addictedto opioid painkillers in the course of routine medical treatment. Furthermore, they can become addicted quickly, in a matter of days to weeks. "67 Moreover, Purdue's assurances encouraged these prescribers to believe that these physicians would be able to detect whichpatients were more susceptible to addiction, which in many cases wasbeyond the specialization andtraining thatmany ofthe recipients ofthese messages possessed. 114. Another Purdue publication the Resource Guide for People with Pain (2010), falsely assured patients that opioid medications are not addictive: "Many people living with pain and even some healthcare providers believe that opioid medications are addictive. The tmth is that when properly prescribed by a healthcare professional and taken as directed, these medications give relief- not a 'high. '" These statements are not tme. 115. Yet another Purdue publication , Clinical Issues in Opioid Prescribing, informed doctors that signsofaddiction may be indicative of"pseudoaddiction, " whichcanbetreated byprescribing more or more powerful opioids: 67 Lembke (2016), supra n.21, at 22 (citing Gillian A. Beauchamp, Erin L. Winstanley, Shawn A. Ryan & Michael S. Lyons, Moving beyond misuse and diversion: the urgent need to consider the role ofiatrogenic addiction in the current opioidepidemic, 104(11) Am. J.Public Health 2023 (2014), https://www. ncbi. nlm. nih. gov/pmc/articles/PMC4202970/. -45- "A term which has been used to describepatient behaviors that may occur when pain is undertreated. Patients with unrelieved pain may become focused on obtainingmedications,may 'clockwatch'andmayotherwiseseeminappropriately 'drug-seeking.' Even suchbehaviorsas illicit druguse anddeceptioncanoccur in the patient's efforts to obtain relief. Pseudoaddiction can be distinguished from tme addictionin thatthe behaviorsresolve whenthe pain is eflfectivelyti-eated." 116. Purdue's Maryland sales force told Maryland prescribers to ignore clear warning signs that their patients were addicted by deceptively dubbing the symptoms of real addiction to be pseudoaddiction. As one of Respondents' district managers in charge of sales in Maryland testified under oath to the Division, Maryland prescribers were informed that inappropriate drug- seeking behaviors, including even lying to-physicians about their pain itselfto obtain opioids, and the illegal use of heroin and cocaine - which are clear signs of addiction - were merely signs of pseudoaddiction and needed a higher dose. The solution to many of the problems Maryland prescribers identified with Respondents' opioids was often predictably that the patient simply needed a higher dose. 117. Respondents also promoted their opioids directly to Maryland patients with marketing that was designed to obscure the risk of addiction and even the fact that Purdue was behindthe campaign. Purduecreateda website,In the FaceofPain,thatpromotedpaintreatment by urging patients to "overcome" their "concerns about addiction. " Testimonials on the website that were presented as personal stories were in fact stories by Purdue consultants, whom Purdue hadpaid tens ofthousands to promote its drugs. Purdue sales representatives -46- 118. Through another unbranded consumer website Partners Against Painw Purdue stated the following: "Current Myth: Opioid addiction (psychological dependence) is an important clinical problem in patients with moderate to severe pain treated with opioids. Fact: Fears about psychological dependence are exaggerated when treating appropriate pain patients with opioids." It further reads: "Addiction risk also appears to be low when opioids are dosed properly for chronic, noncancer pain. " Purdue sales representatives 119. The marketing worked. Keith Humphreys, professor of psychiatry at Stanford University and drug-policy adviser to the Obama Administration, said, '"[t]hat's the real Greek tragedy of this - that so many well-meaning doctors got co-opted. The level of influence is just mind-boggling. Purdue gave money to continuing medical education, to state medical boards, to faux grassroots organizations. '"69 Purdue's payments were made at Respondents' direction. Maryland prescribers andpatients were deceived. 120. At the Sackler Respondents' direction, Purdue also tracked physicians' prescribing practices by reviewing pharmacy prescription data it obtained from IMS Health (now known as IQVIA),a companythatbuysbulkprescriptiondatafrompharmaciesandresells it to dmgmakers 68 Partners Against Painconsists ofboth a website, styled asan"advocacy community" forbetter pain care, and a set of medical education resources distributed to prescribers by sales representatives. It has existed since at least the early 2000s and has been a vehicle for Purdue to downplay the risks of addiction from long-term opioid use. One early pamphlet, for example, answered concerns about OxyContin's addictiveness by claiming: "Dmg addiction means using a drugto get 'high' rather than to relieve pain. You are taking opioid pain medication for medical purposes. The medical purposes are clear and the effects are beneficial, not harmful." 69 Keefe, Empire ofPain, supra n.13. -47- for marketing purposes. (Notably, Arthur Sackler co-founded IMSHealth. ) Rather than reporting the highly suspicious prescribing practices this information divulged, Purdue usedthe datato track physicians who prescribed some opioids and might be persuaded to prescribe more opioids. Purdue also could identify physicians writing large numbers ofprescriptions, and particularly for high-dose 80 mg pills - potential signs of diversion and drug dealing. 70 But instead ofreporting and ceasing sales to these high prescribers, Purdue targeted them for additional sales. Internally, it called these high-prescribing doctors "whales. "71 121. Respondents knew aboutmany suspicious doctors andpharmacies from prescribing records, pharmacy orders, field reports from sales representatives and. in some instances, its own surveillance operations. Since 2002, Purdue maintained a confidential roster of suspected reckless prescribers known as "Region Zero." By 2013, although there were more than 1,800 doctors inRegion Zero, Purdue hadreported only 8%ofthem to authorities. Maryland prescribers were among those listed in Region Zero. The Los Angeles Times reported that "[a] former Purdue 70 An 80 mg tablet is equivalent in strength to 16 Vicodin tablets, and was generally reserved by doctors for patients with severe, chronic pain who had built up a tolerance over months or years. In the illegal drugtrade, however, "80s"werethe most in demand. Forthose attemptingto detect how OxyContin was getting onto the black market, a physician writing a high volume of 80s was a red flag. Harriet Ryan, et al.. More than 1 million OxyContin pills ended up in the hands of criminals and addicts. What the drugmaker knew, L.A. Times (July 10, 2016), http://www. latimes. com/ projects/la-me-oxycontin-part2/ (hereinafter, "Ryan, M^ore than 1 million"). 7' Keefe, Empire ofPain, supra n.13. 72 Purdue's "Abuse andDiversion Detection" program requires its sales representatives to report to the company any facts that suggest a health care provider to whom it markets opioids may be involved in the abuse or illegal diversion of opioidproducts. Whena provider is reported under theprogram, Purdue [purportedly] conducts aninternal inquiry regardingtheprovider to determine whetherhe or she should beplacedon a "no-call" list. If a provider is placed on this list, Purdue sales representatives may no longer contact the provider to promote the company's opioid products. Bill Fallen, Purdue Pharma agrees to restrict marketing ofopioids, Stamford Advocate (Aug. 25, 2015, 3:32 PM), http://www. stamfordadvocate. com/ business/article/Purdue-Pharmaagrees-to-restrict-marketing-of-6464800.php. -48- executive, who monitored pharmacies for criminal activity, acknowledged that even when the company had evidence pharmacies were colluding with dmg dealers, it did not stop supplying distributors selling to those stores. "73 D. 122. At the Sackler Respondents' Direction, Purdue Falsely Marketed Progressively Higher Doses Forpatients, taking higher doses ofopioids increases the risk ofaddiction anddeath. But for Purdue, higher doses mean higher profits. Purdue aggressively marketed doctors to get patients on higherandhigherdoses. 123. Purdue earns more money every time a patient's dose is increased. In 2015, Purdue's prices increased dramatically athigher dosages. Purduemakes $38 for eachpatient taking the lowest dose pill twice a day for a week. Purdue's profits increase 450% to $210 if the patient is given the highest dose instead. OxyContin Prices bottle of 100tablets (10 mg) $269. 17 bottle of 100tablets (15 mg) $396.28 bottle of 100tablets (20 mg) $501.99 bottle of 100tablets (30 mg) $698. 15 bottle of 100 tablets (40 mg) $859. 72 bottle of 100 tablets (60 mg) $1,217. 22 bottle of 100tablets (80 mg) $1,500. 18 124. To increase profits, Purdue designed its sales tactics to increase doses. Purdue created a campaign for OxyContin with the slogan, "Individualize The Dose." Purdue's CEO gave a presentation to the Sackler Respondents explaining that Purdue would use Individualize the Dose to sell more ofits highest doses. WhenPurdue decided to refresh the campaign with a new slogan, it hiredconsultantsto studywhatwould increasedosesthe most. 125. Purdue trained its sales force on "titration" (escalating doses), a tactic it detennined waskeyto makingmore money. Purduepushed a one-waypath ofincreasing dosesand specifically cited "clinical need." 73 Ryan, More than 1 million, supra n. 70. -49- FLEXtBILinin t'rtration Titrate to the appropriate q12hdose - Increase 25%to 50%ofthetotal daily dose asclinical heeddictates ^^, ^'. ' s^fis:^: ^, -^ ^"";. _.,,, T'. "40. mg. 1- , ^w- , r.&^';j 'WFn6^:1",. ...-'...,'4 ^..^.. ^^-^^ ;^^l^,. di«.iJ . ^OxgCoittm*;II ayefe5 3l2h^QS6 ---?5f:ancl, 50<&;-" Purdue OpioidPromotionfrom 2008 Individually titrate Butrans to a dose that provides adequate analgesia and minimizes adverse reactions Minimumtitratfonintervalbttweendoseii$CTery72houn »mi»it iSmtj/hou tOmcg/hovt ^ SBMg/hOUI Appropriate patients maybetitrated diredty (rom 10mcg/hourto 20HKg/haar{afteratleast72houn) J at the pKStrilMBg bealthcare iwnfesttond's distn'tfon. frol>>min»i»(lui(w») Purdue OpioidPromotionfrom 2013 126. Purduetrackedwhethersalesreps were effectively gettingpatients on higherdoses andwarned staffwhenthey were not successful that "titration up to higher strengths, especially the 40mg and 80mg strengths, is declining. " Purdue required sales reps to "practice verbalizing the titration message"to getpatients on higherdoses. -50- 127. RespondentsknewthatPurdue'spromotiondrovepatientstohigherdoses. Purdue's internal analysis "found that there is greater loss in the 60mg and 80mg strengths (compared to other strengths) when we don't make primary sales calls. " Purdue's business plans emphasized that "OxyContin is promotionally sensitive, specifically with the higher doses, and recent research findings reinforce the value of sales calls. " In 2014, when public health experts tried to save patients' lives by warning against high doses ofopioids, Purdue pursued a "strategic initiative" to fightbackand"maintain2013 dosemix." 128. At the Sackler Respondents' direction, Purdue encouraged doctors to prescribe high dosesandfailedto warnthathigherdosescarry heightenedrisk ofaddiction, overdose, anddeath. Purdue further concealed risks from its own sales force. 129. The deceptionwas deliberate. Purdue claimed that "dosewas not a risk factor for opioid overdose, " even while it admitted in internal documents that it was"very likely" thatpatients face "dose-related overdose risk." 130. Respondents analyzed, down to the last dollar, how much of Purdue's profit depended on patients taking higher doses ofopioids. In the slide below, Purdue reminded staffthat a shiftto lowerdoses, whichreducesdangerto patients, wouldbebadforPurdue'sbottom line. -51- Impact of changes in dose mix (For illustration purposes) % shift from 20mg and 15mg down to 10mg Dose Forecast (Rx;( Forecast ($ 1% Shift 10 mg 15mg 40mg 60mg 80mg 3% Shift 1, 226, 840 $ 135, 005, 554 1, 242, 664 $ 136,746,931 $ 138,488,308 $ MO. 229, 686 180,831 $ 33, 261, 232 179, 023 $ 32,928,620 $ 32, 596.008 S 32. 263, 395 1,401, 616 $ 361,951,330 1,387,599 $ 358, 331, 817 S 354. 712, 303 ? 331,092,790 519,945 S 193,796,793 519,945 $ 193,796,793 $ 193, 796,793 $ 193, 796,793 1,085,624 S 577, 483, 835 1,085, 624 $ 577, 483, 835 $ 577,483,835 $ 577, 483, 835 436,272 $ 326,705, 155 436,272 $ 326, 705, 155 $ 326, 705, 155 $ 326, 705, 155 768,138 $ 931, 583, 802 768, 198 $ 931,583,802 $ 931.58a.802 $ 931, 583, 802 5,619,324 $ Z,SS9,7B7,70l 5,619,324 $ 2, SS7, 576, 952 $ 2, 555, 366, 204 $2.553, 155,456 20mg 30mg 2% Shift Total {.- $2, 210, 746 ! II A small shift of roughly 15K prescriptions from 20mg or 15mg down to 10mg has a $2MM impact PWtDUE Purdue Internal Strategy Presentation from 2012 131. When the CDC issued a national warning against the highest and most dangerous dosesof opioids, Purdue'sresponsewasto analyzeprescription datato calculate howmuchprofit it would lose if doctors followed the CDC's advice. E. The Sackler Respondents Directed Purdue to Fund Publications and Presentations That Inundated Prescribers and Patients with False and Misleading Messaging 132. Respondents' false marketing scheme was not limited to misrepresentations made byPurdue's own sales representatives andbranded marketing materials. In addition, in a carefully orchestratedscheme.Respondentsemployeda varietyofstrategiesto nonnalizetheuseofopioids for chroniclong-tennpainwithoutinformingthepublic andprescribersaboutthe very significant risk of addiction, overdose, and death. Essentially coopting science with money. Respondents sponsored purportedly neutral medical boards and foundations in order to promote the liberal -52- prescribing ofopioids for chronic pain. Furthering Respondents' unfair and deceptive scheme to market opioids, the following organizations, funded by Purdue, advised doctors that liberal prescribing ofopioids was both safe and effective. In tmth, it was neither. 133. Federation of State Medical Boards: The Federation of State Medical Boards ("FSMB")is a national organizationthat functions as a trade group representingthe 70 medical andosteopathicboardsin theUnited States. Amongthe FSMB'smembers istheMarylandBoard ofPhysicians. 134. The FSMB often develops guidelines that serve as the basis for model policies with the stated goal of improving medical practice. Since 1998, the FSMB has been developing treatment guides for the use of opioids for the treatment of pain. The 1998 version, Model Guidelines for the Use of Controlled Substances for the Treatment of Pain ("1998 Guidelines") wasproduced "in collaborationwith phannaceuticalcompanies," includingPurdue. These 1998 Guidelines that Respondents helped author taught not that opioids could be appropriate in only limited cases after other treatments had failed, but that opioids were "essential" for the treatment of chronic pain, including as a first prescription option. " Both a 2004 revision of the 1998 Guidelines and a 2007 guide by Dr. Scott Fishman ("Fishman") titled "Responsible Opioid Prescribing" (in the form ofa book, still availablefor sale on Amazon)madethe same claims as the 1998Guidelines. (Fishmanhashadrelationshipswithatleasteightpharmaceuticalcompanies, including Purdue, for which hewas a consultant, paid speaker, and recipient ofresearch support. 74) Purdue sales representatives 74 Tracy Weber & Charles Omstein, Two Leaders in Pain Treatment Have Long Ties to Drug Industry, ProPublica (Dec. 23, 2011, 9:14 AM), https://www. propublica. org/article/two-leadersin-pain-treatment-have-long-ties-to-drug-industry (hereinafter, "Weber, Two Leaders in Pain"). -53- Respondents thereby used FSMB as a frontto addlegitimacyto whatwere in factdeceptivemarketingclaims. 135. After adoptingFishman's"ResponsibleOpioidPrescribing:A Physician'sGuide," the FSMB reportedly asked Purdue for $100, 000 to help pay for printing and distribution. 75 Ultimately, with Respondents' sponsorship, the guide was disseminated by the FSMB to 700, 000 practicing physicians. 136. The guide's clear purpose is to focus prescribers on the purported undertreatment of pain and falsely assure them that opioid therapy is an appropriate treatment for chronic, noncancerpain. Among otherthings, it statesthe following: . Painmanagementis integralto goodmedicalpractice andfor all patients; . Opioidtherapyto relieve painandimprove function is a legitimatemedical practice for acute andchronicpain ofbothcancerandnon-cancerorigins; . Patients should not be denied opioid medications except in light of clear evidence that such medications are harmful to the patient. Four keyfactors contribute to the ongoingproblem ofunder-treatedpain: 1. Lack of knowledge of medical standards, current research, and clinical guidelines for appropriate pain treatment; 2. The perception that prescribingadequate amounts of opioids will result in unnecessary scmtiny by regulatory authorities; 3. Misunderstandingofaddictionanddependence;and 4. Lackofunderstanding ofregulatory policies andprocesses. 76 75 JohnFauber, Follow the Money: Pain, Policy, and Profit, MedPageToday (Feb. 19, 2012), https://www.medpagetoday.com/neurology/painmanagement/31256. 76 Scott M. Fishman, Responsible Opioid Prescribing: A Physician 's Guide 8-9 (Waterford Life Sciences 2007). -54- 137. While the guide acknowledges the risk of "abuse and diversion" (with little attention to addiction), it purports to offer "professional guidelines" that will "easily and efficiently" allow physicians to manage that risk and "minimize the potential for [such] abuse. "77 Indeed, it encourages the use of opioids even in patients who are at risk for substance abuse, suggesting that this risk "does not mean that opioid use will become problematic or that opipids are contraindicated, " but only requires that physicians use additional care in prescribing. These statements deceptivelyminimizethe risk ofaddiction. 138. The guide further warns physicians to "[b]e aware of the distinction between pseudoaddiction andaddiction" andteaches thatbehaviors suchas"[requesting [drugs] byname," "[djemandingormanipulativebehavior," "[ojbtainingopioiddmgsfrommorethanonephysician" and "[h]oarding opioids" - all red flag signs of genuine addiction - are merely signs of "pseudoaddiction. "78 The guide defines "Physical Dependence" as an acceptable result ofopioid therapy, notto be equated with addiction andstates thatwhile "[i]t may betempting to assume that patients with chronic pain anda history ofrecreational drugusewho arenot adherent to a treatment regimen are abusing medications, " there could be other acceptable reasons for non-adherence. 79 139. Purdue sales representatives For example, accordingto notes from a sales call to a doctor in , a Purdue sales representative noted the following communication: 77 /rf. at9. 78 Mat 62. 79 Id. -55- 140. Additionally, a sales representative's notes concerning a sales call to a doctor in provided: 141. Further, in follow-up comments regarding a sales call, the sales representative commented 142. With Respondents' sponsorship and active support, the FSMB guide became the seminal authority on opioid prescribing for the medical profession. It dramatically overstated the safety and efficacy of opioids and understated the risk of opioid addiction. According to notes of sales calls made to Maryland prescribers by Purdue sales representatives between 2006 and 2016, the 143. In 2012, Fishman updated the guide and continued emphasizing the "catastrophic" "under-treatment" ofpain and the "crisis" such under treatment created: Giventhemagnitudeoftheproblemsrelatedto opioidanalgesics,it canbetempting to resort to draconiansolutions: cliniciansmay simply stop prescribingopioids,or legislation intended to improve pharmacovigilance may inadvertently curtail patient access to care. As we work to reduce diversion and misuse ofprescription opioids, it's critical to remember that the problem of unrelieved pain remains as urgent as ever. 80 80 Scott M. Fishman, Responsible Opioid Prescribing: A Clinician's Guide 10-11 (Waterford Life Sciences 2012). -56- 144. The updated guide still assures that "fojpioid therapy to relieve pain and improve function is legitimate medicalpractice for acute andchronicpain of both cancer andnoncancer origins. 145. In yet another 2012 guide. Responsible Opioid Prescribing: A Physician's Guide, Fishman continues to downplay the risk of addiction: "7 believe clinicians must be very careful with the label 'addict. ' I draw a distinction between a 'chemical coper' and an addict. ^2 The guide also continues to present symptoms of addiction as symptoms of'pseudoaddiction." 146. The heightened focus on the undertreatment of pain was a concept designed by Respondents and other manufacturers to sell opioids. Indeed, Purdue sales representatives . With Respondents' support, the FSMB issued a report calling on medical boards topunish doctors for inadequately treating pain. s3 Among the drafters ofthis policy was Dr. J. David Haddox ("Haddox"), who coined the term "pseudoaddiction, " which wholly lacked scientific evidence but quickly became a common wayfor Respondents and their allies to promote the use of opioids even to patients displaying addiction symptoms. Respondent Richard Sackler later hired Haddox as a Purdue vice president. Haddox has likened OxyContin to a vegetable, statingata 2003 conference atColumbiaUniversity, 84"IfI gaveyoua stalkofcelery andyouate 81 Id. atU. 82 Scott M. Fishman, Listening to Pain: A Physician's Guide to Improving Pain Management Through Better Communication 45 (Oxford University Press 2012). 83 Thomas Catan & Evan Perez, A Pain-Drug Champion Has Second Thoughts atA 1, Wall St. J. (Dec. 17, 2012). 84 Gounder, Who Is Responsible, supra n.40. -57- that, it would be healthy. But if you put it in a blender and tried to shoot it into your veins, it would not be good. "85 147. Asnoted in section III.I. infra, in 2012 andagainin 2017,the guides andthe sources oftheir fundingbecamethe subjectofa Senateinvestigation. 148. On June 8, 2012, the FSMB submitted a letter to the Senate Finance Committee concerning the committee's investigation into the abuse andmisuse ofopioids. 86 While the letter acknowledged the escalation of drug abuse and related deaths resulting from prescription painkillers, the FSMB continued to focus on the "serious and related problem" that "[m]illions of Americans suffer from debilitating pain - a condition that. for some. can be relieved through the use of opioids. " Among other things, the letter stated that "[s]tudies have concluded that both acute pain and chronic pain are often under-treated in the United States, creating serious repercussions that include the loss ofproductivity and quality oflife. " But the letter cited no such studies. The letter also confirmed that the FSMB's "Responsible Opioid Prescribing: A Physician's Guide" hadbeendistributed in eachofthe 50 states andtheDistrict ofColumbia. 149. In addition, the FSMB letter disclosed payments the FSMB received from organizations that develop, manufacture, produce, market, or promote the use of opioid-based drugs from 1997through 2012. Included are the following payments from Purdue: 85 Keefe, Empire of Pain, supra n.13. 86 Letter from Federation of State Medical Boards to U. S. Senators Max Baucus and Charles Grassley (June 8, 2012). -58- Corn an Purdue FiscalYear Amount 2001 $38,324.56 2002 $10, 000. 00 $85, 180. 50 2003 2005 $87,895.00 $244,000.00 2006 $207, 000. 00 2007 $50,000.00 2004 $100,000.00 2008 Total Purdue Pa ments $822,400. 06 150. The letter also disclosed payments of $50,000 by Purdue to directly fund the production of "Responsible Opioid Prescribing" and disclosed that sales of "Responsible Opioid Prescribing" inMaryland generatedmorethan $51,000inrevenues. 87 151. The Joint Commission: The Joint Commission is an organization that establishes standardsfor treatment andaccreditshealthcareorganizationsin the United States. Respondents contributed misleading and groundless teaching materials and videos to the Joint Commission, which emphasized what Purdue and other opioid manufacturers coined the "under-treatment of pain, " referenced pain as the "fifth vital sign" (the first and only unmeasurable/subjective vital sign) thatmust bemonitored andtreated andencouraged the use ofprescription opioids for chronic pain while minimizing the danger of addiction. It also called doctors' concerns about addiction "inaccurateandexaggerated." Notably,RichardSacklermadesurethatPurdueboughttheinternet address 5thvitalsign. com so it could promote pain as the "fifth vital sign." 152. In 2000, the Joint Commission printed a book for purchase by doctors as part of required continuing education seminars that cited studies falsely claiming "there is no evidence that addictionis a significantissuewhenpersons aregiven opioidsfor paincontrol." Thebook wassponsoredby Purdue. 87 /rf. at 11-12, 15. -59- 153. In 2001,the JointCommissionandthe NationalPharmaceuticalCouncil (founded in 1953 and supported by the nation's major research-based biopharmaceutical companies)88 collaborated to issue a 101-page monograph titled, "Pain: Current understanding of assessment, management, and treatments. " The monograph states falsely that beliefs about opioids being addictive are "erroneous": Societal issues that contribute to the undertreatment of pain include drug abuse programs and erroneous beliefs about tolerance, physical dependence, and addiction (see I.E.5). For example, some clinicians incorrectly assume that exposure to an addictive drug usually results in addiction. * b. * * Etiology, issues, and concerns Many medications produce tolerance and physical dependence, and some (e. g., opioids, sedatives, stimulants, anxiolytics, some muscle relaxants) may cause addiction in vulnerable individuals. Most experts agreethatpatients whoundergo prolonged opioid therapy usually develop physical dependence but do not develop addictive disorders. In general, patients in pain do not become addicted to opioids. Although the actual risk of addiction is unknown, it is thought to be quite low. A recent study ofopioid analgesic use revealed "low and stable" abuse of opioids between 1990 and 1996 despite significant increases in opioids prescribed.... Fear ofcausing addiction (i. e., iatrogenic addiction), particularly with opioiduse, is a major barrier to appropriate pain management. This fear sometimes reflects a lack ofunderstanding ofthe risk ofaddiction withtherapeutic dmg use. Although studies suggest that the risk of iatrogenic addiction is quite low (e. g.. Perry and Heidrich, Zenz et al.), surveys indicate that clinicians often overestimate this risk. 89 88 Currently funded by Purdue, among others. 89 National Pharmaceutical Council, Inc., Pain: Current Understanding of Assessment, Management, and Treatments at 16-17 (Dec. 2001), http://www. npcnow. org/system/files/ research/download/Pain-Current-Understanding-of-Assessment-Management-and-Treatments. pdf. -60- 154. Additionally, the monograph recommends that "[p]ain ... is assessed in all patients" and suggests that long-acting(i. e., extendedrelease) pain medications are superior and should be used whenever possible: Long-acting and sustained-release opioids are useful for patients with continuous pain, as they lessen the severity of end-of-dosepain and ofiten allow thepatientto sleepthroughthe night. * . * * Administer opioids primarily via oral or transdennal routes, using long- actingmedications whenpossible. 90 155. Intruth, long-actingopioidsoften donotworkforthe full periodstatedandrequire additional doses for what is described as "breakthrough pain, " and "the higher the dose, the worse the side effects, including the risks ofaddiction anddeath dueto accidental overdose. "91 156. Purdue's infiltration of and influence over the Joint Commission's standards and literatureexertedoverwhelmingpressureondoctorsto treatandeliminatepain. Asmoreandmore doctors migrated from private practice to integrated healthcare systems in the 2000s, treatment options were dictated by, among other things, the Joint Commission's guidelines. 92 Consistent with the guidelines, doctors who left pain untreated were viewed as demonstratingpoor clinical skills and/orbeingmorally compromised. 93 157. The U. S. General Accounting Office's December 2003 Report to Congressional Requesters confirms that Purdue funded the "pain management educational courses" that taught the new standard ofcare for treating pain. It further revealed that Purdue disseminated educational 90 M at 67 (Table 38). 91 Lembke (2016), supra n. 21, at 60. 92 Id. at 119. 93 Mat 42. -61- materials on pain management, which '"facilitated [Purdue's] access to hospitals to promote OxyContin. '"94 158. The American Pain Foundation: The American Pain Foundation ("APF"), headquarteredin Baltimorethroughits dissolutionin 2012, describeditselfasthe nation's largest organization for pain patients. 95 While APF held itself out as an independent patient advocacy organization, in reality it received more than $10 million in funding from opioid manufacturers from 2007 to 2012, when it shut down only days after the U. S. Senate Committee on Finance ("SenateFinanceCommittee") launchedan investigationofthe APF'spromotion ofprescription opioids. 159. Payments to the APF were made with strings attached. Respondents, along with othermembers ofthe industry, were actively involved inthe planningofthe APF'scampaigns. 160. TheAPFpublishedguidesforpatients,journalists andpolicymakersthattrivialized the risk ofaddiction andgreatly exaggerated the benefits associated with opioidpainkillers. 96 161. For example, in 2001, the APF published "Treatment Options: A Guide for People Living with Pain, "97 which it disseminated throughout the United States, including in Maryland. The guide, which was produced with financial support from companies including Purdue, misrepresented the risks associated with opioid use. Among other things, the guide: 94 Gounder, Who Is Responsible, supra n. 40; U. S. General Accounting Office, GAO-04-110, Prescription Drugs, OxyContin Abuse and Diversion and Efforts to Address the Problem (Dec. 2003), http://www. gao. gov/new. items/d041 lO.pdf. 95 The APF was the focus of a December investigation by ProPublica in The Washington Post that detailed its close ties to drugmakers. 96 Omstein, American Pain Foundation, supra n. 60. 97 Treatment Options: A Guide for People Living with Pain, American Pain Foundation, https://assets. documentcloud. org/documents/277605/apf-treatmentoptions. pdf (last visited May 14, 2019). -62- . lamented that opioids were sometimes called narcotics because "[cjalling opioid analgesics 'narcotics' reinforces myths and misunderstandings as it places emphasis on their potential abuse rather than on the importance oftheir use as pain medicines";98 . stated that "[ojpioids are an essential option for treating moderate to severe pain associatedwith surgery ortrauma";99 and . opined that "[r]estricting access to the most effective medications for treating pain [opioids] is not the solution to drug abuse or addiction. "100 The guideincludedblurbs from Portenoy, who is quoted as saying"[t]his is a very goodresource for the pain patient," and Fishman, who is quoted as saying, "[w]hat a greatjob! Finally, a pill consumer resource created for patients with pain. A 'must have' for every physician's waiting room." 162. In 2003, the APF published a newsletter titled, "Best of... The Pain Community News" that purported to clarify any confusion over addiction and opioids and emphasized the "tragicconsequenceofleavingmanypeoplewith severepainunder-treatedbecausethey- ortheir doctors - fearthat opioids will cause addiction." The guidewas disseminatedin Maryland with fundingprovided by Purdue. 163. In2009,theAPFplayeda centralrole in a first-of-its-kind,web-basedseriescalled, "Let's Talk Pain, " hosted by veteran TV journalist Carol Martin. The series brought together healthcare providers and "people with pain to discuss a host of issues from managing health care for pain to exploring integrative treatment approaches to addressing the psychological aspects associatedwithpain." The "Let's Talk Pain"talk showis still availableonline. In the very first episodeofthistalk show,the followingexchangetookplace: 98 Mat 11. 99 Id. 100 Mat 15. -63- [Teresa Shaffer (APF Action Network Leader):] As a person who has been living withpainforover20years, opioidsarea bigpartofmypaintreatment. AndI have been hearing such negative things about opioids and the risk factors of opioids. Couldyoutalk withme a little bit aboutthat? [Dr. A] Anderson (AAPMBoard ofDirectors):] Thegeneralbeliefsystem in the public is thatthe opioids are a badthingto be givinga patient. Unfortunately, it's alsoprevalentinthemedicalprofession,sopatientshavedifficultyfindinga doctor when they are suffering from pain for a long period of time, especially moderate to severe pain. And that's the patients that we really need to use the opioids methods oftreatment, because they are the ones who need to have some help with the functionandthey'rethe onesthatneedto becontrolled enoughsothattheycan increase their quality of life. ° 164. Opioids,however,do not improvefunction, andthere is no evidencesubstantiating that the chronic use of opioids improves the quality ofpatients' lives. °2 To the contrary, there is ampleevidencethatopioidsimposesignificantrisksandadverseoutcomes on long-termusersand that they may actually reduce function. As a recent article in the New England Journal of Medicine concluded: "Although opioid analgesics rapidly relieve many types of acute pain and improve function, the benefits of opioids when prescribed for chronic pain are much more questionable." The article continues, "opioid analgesics are widely diverted and improperly used, and the widespread use of the drugs has resulted in a national epidemic of opioid overdose deaths and addictions. " More recent still, a study published in JAMA concluded that "[t]reatment with 101 Episode 1: Safe Use of Opioids (PainSAFE), Let's Talk Pain (Sept. 28, 2010), https://www. youtube. com/watch?v=zeAlVAMRgsk. 102 Lembke (2016), supra n. 21, at 59 (citing Richard Chou, et al.. Evidence Report/Technology Assessment: The Effectiveness and Risks ofLong-Term OpioidTreatment of Chronic Pain, 218 Agency for Healthcare Research and Quality (Sept. 2014), https://effectivehealthcare.ahrq.gov/ sites/default/files/related_files/chronic-pain-opioid-treatment_executive. pdf). 103 Nora D. Volkow & A. Thomas McLellan, Opioid Abuse in Chronic Pain - Misconceptions and Mitigation Strategies, 374 New Eng. J. Med. http://www. nejm. org/doi/full/10. 1056/NEJMral507771#t=article. -64- 1253-63 (Mar. 31, 2016), opioids was not superior to treatment with nonopioid medications for improving pain-related function over 12 months."104 165. The APF also developed the National Initiative on Pain Control ("NIPC"), which ran a facially unaffiliated website, www.painknowledge. org. NIPC promoted itself as an education initiative and promoted its expert leadership team, including purported experts in the pain management field. The website painknowledge. org provided that, on opioids, "your level of functionshouldimprove;youmayfindyou arenowableto participatein activities ofdailyliving, suchasworkandhobbies,thatyouwerenotableto enjoywhenyourpainwasworse." Elsewhere, the websitetouted improvedquality oflife and"improvedfunction"asbenefitsofopioidtherapy. InthebrochurePain: OpioidFacts,availableonpainknowledge.org,theNIPCmisleadinglystated that"peoplewhohavenohistoryofdrugabuse,includingtobacco,andusetheiropioidmedication as directed will probably not become addicted. "105 166. In or around 2011, the APF published "A Policymaker's Guideto Understanding Pain& Its Management," sponsoredbyRespondents,whichdispelledthe notionthat"strongpain medication leads to addiction" by characterizing it as a "common misconception\y: Many people living with pain, and even some health care practitioners, falsely believe that opioid pain medicines are universally addictive. As with any medication, there are risks, but these risks can be managed when these medicines are properly prescribed and taken as directed. For more information about safety issuesrelated to opioids andotherpaintherapies, visit http://www. painsafe. org. 106 104 Krebs, Effect ofOpioid vs. Nonopioid Medications, supra n.25. 105 Pain: Opioid Facts, Pain Knowledge (2007), https://web. archive. org/web/20101007102042/ http://painknowledge. org/patiented/pdf/Patient%20Education%20b380_b385%20%20pfB opiod. pdf (last visited May 14, 2019). /o20 106 A Policymaker's Guide to Understanding Pain & Its Management, American Pain Foundation at 5 (Oct. 2011),http://s3.documentcloud.org/documents/277603/apf-policymakers-guide.pdf. -65- 167. The guide describes "pain in America" - instead of addiction to Respondents' opioids - as "an evolving public health crisis" and characterizes concerns about, opioid addiction as misconceptions: "Unfortunately, too many Americans are not getting the pain care they need and deserve. Some common reasons for difficulty in obtaining adequate care include: ... Misconceptions about opioid addiction. "101 It even characterizes as a "myth" that "fcjhildren can easily become addicted to pain medications^ The guide further asserts that "multiple clinical studies" have shown that opioids are effective in improving daily function, psychological healthandhealth-related quality oflife forchronicpainpatients, claimsthataresimply false. 109 168. InDecember 2011, The Washington /)o^? reported on ProPublica's investigation of the APF, which detailed the APF's close ties to drugmakers: [T]he pills continue to have an influential champion in the American Pain Foundation,whichdescribes itselfas the nation's largest advocacygroup for pain patients. Its message: The risk of addiction is overblown, and the drugs are underused. What the nonprofit organization doesn't highlight is the money behind that message. 107 Id. at 6. 108 Id. at 40. 109 The "Policymaker's Guide" cites for support "Opioids for chronic noncancer pain: a meta- analysis of effectiveness and side effects, " a review published in 2006 in the Canadian Medical Association Journal. Id. at 34. However, the review concludes: "For functional outcomes, the other analgesics were significantly more effective than were opioids. " Andrea D. Furlan, et al., Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects, 174(11) Canadian Med. Assoc. J. 1589-94 (May 23, 2006), https://www. ncbi. nlm. nih.gov/pmc/articles/ PMC1459894/. The Purdue-sponsored guide failed to disclose both this conclusion and the fact that the review analyzed shidies that lasted, on average, five weeks and therefore could not support the long-term use ofopioids. -66- The foundation collected nearly 90percent of its $5 million in funding lastyear from the drug andmedical-device industry - and closely mirrors its positions, an examination byProPublica found. 110 169. In 2010alone, the APFreceived90%ofits fundingfrom drug andmedicaldevice companies. At the Sackler Respondents' direction, Purdue paid the APF unspecified amounts in 2008 and 2009 and between $100, 000 and $499, 999 in 2010. 'u 170. American Academ ofPain Medicine and American Pain Socie : Respondents contributedfundingto theAAPMandthe APSfor decades. 171. In 1997, the AAPM issued a "consensus" statement that endorsed opioids to treat chronic pain and claimed thatthe risk that patients would become addicted to opioids was low. At the time, the chairman of the committee that issued the statement, Haddox, was a paid speaker for Purdue. Haddox laterbecame a vice president for healthpolicy atPurdue, wherehewas employed between September 1999 and October 2018. The consensus statement, which also formed the foundation of the 1998 guidelines, was published on the AAPM's website. AAPM's corporate council includes Purdue, Depomed, Inc. ("Depomed"), Teva andotherpharmaceutical companies. AAPM's past presidents include Haddox (1998), Fishman (2005), Dr. Perry G. Fine ("Fine") (2011) and Lynn R. Webster (2013), all of whose connections to opioid manufacturers are well documented. 172. At or about the same time, the APS introduced the "Pain As the 5th Vital Sign" campaign, to require doctors to ask patients about their level ofpain at every visit, despite the fact 110 Charles Omstein & Tracy Weber, Patient advocacy group funded by success of painkiller drugs, probe finds. Wash. Post (Dec. 23, 2011), https://www. washingtonpost. com/nationaV health-science/patient-advocacy-group-funded-by-success-of-painkiller-drugs-probe-finds/2011 / 12/20/gIQAgvczDP_story.html?utm_term=. 22049984c606. 111 American Pain Foundation, 2010 Annual Report at 16-19, https://www.documentcloud.org/ documents/277604-apf-2010-annual-report#document/ (last visited May 14, 2019). -67- thatpain is a symptom that cannot bemeasured objectively, unlike the four objectively observable vital signs: body temperature, pulse rate, respiration rate, and blood pressure. The campaign successfully influenced prescribers and organizations throughout the United States to prescribe opioids in waysthat were not supported by science. The campaign influenced the addition ofpainrelatedquestionsto patientsatisfactionsurveysusedby CMSto determinehospitalreimbursement rates,therebylinkingreimbursementto patientsatisfactionwithpaintreatment. 173. The AAPM and APS issued Clinical Guidelinesfor the Use of Chronic Opioid Therapy in Chronic Noncancer Pain (the "Clinical Guidelines") in 2009 that continued to recommend the use of opioids to treat chronic pain. 112 Fourteen ofthe 21 panel members who drafted the 2009 Guidelines received funding from drug manufacftirers. Four of the 21, Fine, StevenD. Passik,Portenoy, andBenA. Rich, received direct fundingfrom Purdue. The Clinical Guidelines were published in The Journal of Pain, published by Elsevier on behalf of APS, distributednationwidein print and internationallyvia the Internet. The Clinical Guidelines, still availableonline, have been cited hundreds oftimes. 174. The Clinical Guidelineswerepublished, in theirownwords: to provide evidence-based recommendations for use of COT [chronic opioid therapy] for CNCP [chronic non cancer pain] in both primary care and specialty settings. The target audience is all clinicians who provide care for adults with CNCP, including cancer survivors with chronic pain due to their cancer or its treatment. Despite conceding that there is limited evidence - indeed, despite conceding that "the panel did not rate any of its 25 recommendations as supported by high quality evidence" - the Clinical Guidelines continuedto falsely state that chronic opioidtherapy is effective for the treatment of 112 Roger Chou, et al., Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain, 10(2) J. of Pain 113-30 (Feb. 2009), http://www.jpain.org/article/S15265900(08)00831-6/pdf (hereinafter, "Clinical Guidelines"). -68- chronic noncancer pain: "Although evidence is limited, an expert panel convened by [the American PainSociety] and [the American Association for PainManagement] concludes that COT canbeaneffectivetherapyfor carefullyselectedandmonitoredpatientswithCNCP." Amongthe unsupported claims nevertheless recounted, the Clinical Guidelines opined that the "[pjroposed benefits of transitioning to long-acting opioids with around-the-clock dosing include more consistentcontrol ofpain, improved adherence,andlowerrisk ofaddictionor abuse." 175. Reapingthe benefit from its contributions, Purduewidely cited andpromoted the Clinical Guidelinesin Marylandandnationallydespitetheirbeingmisleadingandunsubstantiated by scientificevidence. 176. The Alliance for PatientAccess:Foundedin 2006,the Alliance for PatientAccess ("APA") is a self-described patient advocacy andhealthprofessional organization that styles itself as "a national network of physicians dedicatedto ensuringpatient access to approved therapies and appropriate clinical care. "113 It is mn by Woodberry Associates LLC, a lobbying firm that was also established in 2006. 114 As of June 2017, the APA Usted 30 "Associate Members and FinancialSupporters," Purdueamongthem. 113 About AfPA, The Alliance for Patient Access, http://allianceforpatientaccess. org/about-afpa/ (last visited Jan. 30, 2019). References herein to APA include two affiliated groups: the Global Alliance for Patient Access and the Institute for Patient Access. 114 Mary Chris Jaklevic, Non-profit Alliance for Patient Access usesjournalists andpoliticians to push Big Pharma's agenda. Health News Review (Oct. 2, 2017), https://www. healthnewsreview. org/2017/10/non-profit-alliance-patient-access-uses-joumalistspoliticians-push-big-pharmas-agenda/ (heremafter, "Jaklevic, Non-profit Alliance for Patient Access"). -69- 177. APA's board members have also directly received substantial funding from pharmaceutical companies. 115 For instance, board vice president Dr. Srinivas Nalamachu ("Nalamachu"), who practices in Kansas, received more than $800, 000 from 2013 through 2015 from pharmaceutical companies - nearly all ofit from manufacturers ofopioids or dmgs that treat opioids' side-effects, including more than $150, 000 in consulting and speaking payments from Purdue. Nalamachu's clinic was raided by Federal Bureau of Investigation ("FBI") agents in connection with an investigation of Insys and its payment of kickbacks to physicians who prescribed Subsys. 116 Dr. HowardHoffbergfrom Maryland wasalso a boardmember oftheAPA, but his now-closed practice also was raided by the FBI in March 2018, Dr. Hoffberg received $153, 000 between 2013 and 2015 from pharmaceutical companies, including Purdue, which recruited Dr. Hoffberg as a paid speaker andpaid him more than $20, 000 in 2015 and 2016. 178. Among its activities, the APA issued a white paper titled, "Prescription Pain Medication:PreservingPatientAccessWhileCurbingAbuse." Thewhitepaperexpressesconcern about policies that have been enacted in response to the prevalence ofpill mills: Although well intentioned, many ofthe policies designed to address this problem have made it difficult for legitimate pain management centers to operate. For instance, in some states, [painmanagement] centers must be ownedby physicians or professional corporations, must have a Board certified medical director, may need to pay for annual inspections, and are subject to increased record keeping and reporting requirements.... [I\t is not even certain that the regulations are helping prevent abuses. 117 115 All information concerning pharmaceutical company payments to doctors in this paragraph is from ProPublica's Dollars for Docs database, available at https://projects. propublica. org/ docdollars/. 116 Andy Marso, FBI seizes records of Overland Parkpain doctor tiedto Insys, Kansas City Star (July 20, 2017), http://www. kansascity. com/news/business/health-care/articlel62569383. html. 117 /rf. at 5-6. -70- 179. In addition, in an echo of earlier industry efforts to push back against what they tenned "opiophobia," the whitepaper laments the stigma associatedwith prescribing and taking pain medication: Both pain patients and physicians can face negative perceptions and outright stigma. When patients with chronic pain can't get their prescriptions for pain medicationfilledata pharmacy,theymayfeel liketheyaredoingsomethingwrong - or even criminal.. .. Physicianscanface similarstigmafrompeers. Physicians in non-pain specialty areas often look down on those who specialize in pain management - a situation fueled by the numerous regulations and fines that surround prescription pain medications. 118 180. In conclusion, the white paper states that "[p]rescription pain medications, and specifically the opioids, canprovide substantial relieffor people who are recovering from surgery, afflicted by chronic painful diseases, or experiencingpain associated with other conditions that does not adequately respond to over-the-counter drugs. "l'9 Again, there exists no reliable evidence that opioids are safe and effective for the treatment of chronic pain. 181. The Financial Ties Between 0 ioid Manu acturers and Third-Par Grou s: A February 12, 2018 report titled, "Fuelingan EpidemicReport Two: Exposingthe FinancialTies Between Opioid Manufacturers and Third Party Advocacy Groups" issued by then-U. S. Senator Claire McCaskill sheds additional light on the financial connections between opioid manufacturers and purportedly neutral patient advocacy organizations and medical professional societies that, unsurprisingly, have "echoed and amplified messages favorable to increased opioid use - and ultimately the financial interests ofopioid manufacturers. "120 118 ^. at 6. 119 Mat 7. 120 February 2018 Report, supra n.18, at 1 -71- 182. The report details findings resulting from subpoenas issued by then-Senator McCaskill to 5 opioid manufacturers, including Purdue, and to 15 purportedly neutral patient advocacy organizations and medical professional societies. "The infonnation produced to the Committee demonstrates that many patient advocacy organizations and professional societies focusing on opioids policy have promoted messages and policies favorable to opioid use while receiving millions of dollars in payments from opioid manufacturers, " the report found. It continued: "Through criticism of government prescribing guidelines, minimization of opioid addiction risk, and other efforts, ostensibly neutral advocacy organizations have often supported industry interests atthe expense oftheir own constituencies. "121 183. According to the report, the five manufacturers whose information was subpoenaed by Senator McCaskill alone contributed almost $9 million combined to patient advocacy organizations and professional societies operating in the opioids policy area, including the APA, AAPM, the American Geriatrics Society, the APF, and the APS, among others. Payments from Purdue alone totaled over $4 million. 184. In addition to the nearly $9 million in payments to purportedly neutral patient advocacy organizations and medical professional societies, the five subpoenaed opioid manufacturers made an additional $1.6 million in payments to the organizations' and societies' group executives, staffmembers, board members, and advisory board members. When payments from all five opioidmanufacturers aretabulated, more than $10.6 million waspaidto individuals affiliatedwithsuchorganizationsand societiesfrom 2013throughthe date ofthe report. 185. Included in the above-referenced payments were payments of more than $140, 000 from opioid manufacturers, including Purdue, to ten members of the American Chronic Pain 121 /^. at 3. -72- Association Advisory Board, and more than $950,000 to members of The National Pain Foundation board of directors from various opioid manufacturers. 186. Most importantly, many ofthe groups investigated"amplified or issued messages that reinforce industry efforts to promote opioid prescription and use, including guidelines and policies minimizing the risk of addiction and promoting opioids for chronic pain. " Several ofthe groups "also lobbiedto change laws directed at curbing opioid use, strongly criticized landmark CDCguidelinesonopioidprescribing,andchallengedlegaleffortstoholdphysiciansandindustry executives responsible for overprescription andmisbranding." 187. The report foundthat, while health advocacyorganizationsare '"amongthe most influential and trusted stakeholders in U. S. health policy, '" the reality is that their '"positions closely correspondto the marketingaims ofpharmaceutical anddevicecompanies,'" includingin the areaofopioidspolicy. "Thefindingsin this report indicatethatthis tension exists in the area of opioids policy - that organizationsreceiving substantial fundingfrom manufacturers have, in fact, amplifiedandreinforcedmessagesfavoringincreasedopioiduse." This amplification"may have played a significant role in creating the necessary conditions for the U.S. opioids epidemic. ' 3 F. At the Sackler Respondents' Direction, Purdue Paid Key Opinion Leaders and Sponsored Speakers' Bureaus to Disseminate False and Misleading Messaging 188. Purduehasmadetens ofthousandsofpaymentsto physiciansnationwide,including in Maryland, to promote aggressive prescribing of opioids for chronic pain. Recently released federal data shows that Purdue increased such payments to physicians who treat chronic pain even 122 Id. at 12. 123 Id. at 17. -73- while the opioid crisis accelerated and overdose deaths from prescription opioids and related illicit drugs, such as heroin, soared to record rates. 124 According to data that began to be made publicly available in 2013 through the Center for Medicare and Medicaid Services, Purdue's payments to Maryland doctors increasedfromjust over $16,000 in 2013, to nearly $76,000 in 2014, to more than $189,000 in 2015. These payments come in the form of consulting and speakingfees, free food and beverages, discount coupons for dmgs, and other gifts. For example, Purduepaid Dr. William Tham approximately $19,600 in 2014 and 2015, and paid Dr. Howard Hoffberg more than $26,700 between 2013 and 2016, for "[p]romotional [s]peaking/[o]ther" related to Purdue opioids. This is tme even though Dr. Hoffberg's practice had been recognized as a problem practice and briefly removed from Purdue's call list in 2012 only to be later reinstated. Purdue removed problem prescribers from the call lists while they were under investigation; a Maryland sales managercould not recall a prescriber being removed due to Respondents' identificationof problems. The subsequent disciplinary or criminal action against prescribers upon whom Purdue called demonstrates that Respondents blithely ignored blazing red flags that placed Maryland patients in extreme danger. 189. Both Dr. Tham and Dr. Hoffberg have come under fire or investigation for inappropriateopioidprescribing. Dr. Thamwasnamedin a lawsuitfiledbyAnneArundelCounty. The lawsuitallegesthathereceivedmorethan $100,000frompharmaceuticalcompaniesbetween August2013 andDecember2015, andthat payments to Dr. Tham from Purdue and other opioid manufacturers (specifically, Teva, Janssen, Endo, and Insys) comprised more than 80% of 124 Joe Lawlor, Even ami'd crisis, opioid makers plied doctors withperks, Portland Press Herald (Dec. 25, 2016), http://www. pressherald. com/2016/12/25/even-amid-crisis-opioid-makers-plieddoctors-with-perks/. -74- payments to all doctors during that time frame. 125 According to another lawsuit. Dr. Tham also prescribed a single patient the equivalent of 5,000 Percocet pills per day. 126 Dr. Hoffberg's two clinics were raided in February 2018 by federal and state agents, including officialsassociated withtheAttorney General'sMedicaidFraudControl Unit. He andhispartner,Dr. NormanRosen, were named in a lawsuit by Baltimore County allegingthat their practice operated "as a pill mill thatsuppliedindividualswithmassivequantitiesofprescriptionopioidswithfewquestionsasked" for their role in "exacerbat[ing] the opioid crisis in Baltimore. " The Division has noted issues with both prescribers and their practices in an enforcement action against another opioid manufacturer widely accused ofpaying kickbacks to prescribers. 190. According to public records collected by ProPublica, in 2015 alone, Medicare Part D paid over $19million for claims arising from Maryland physicians' OxyContin prescriptions. 128 191. Thetotalpaymentsfrom opioidmanufacturers,includingPurdue,to doctorsrelated to opioidsdoubledfrom2014to 2015. Moreover, accordingto experts,researchshowsevensmall amounts ofmoney canhave large effects ondoctors' prescribing practices.129 Physicianswho are highprescribers are more likely to be invitedto participate in manufacturers' speakers' bureaus. 125 Phil Davis, Anne Arundel sues opioid manufacturers, distributors and local prescribers, Capital Gazette (Jan. 3, 2018), https://www.capitalgazette.com/news/for_the_record/ac-cnopioid-lawsuit-0104-story. html. 126 John Pacenti, Veteran, would-be lawyer, mom left dead or addicted after Subsys, The Palm Beach Post (Apr. 11, 2018), https://www. palmbeachpost. com/news/20180404/veteran-would-belawyer-mom-left-dead-or-addicted-after-subsys. 127 Alison Knezevich, Federal search-warrants executed atpain clinics in Baltimore County, The Baltimore Sun (Feb. 27, 2018), https://www. baltimoresun. com/news/maryland/baltimorecounty^s-md-co-clinics-searched-20180227-story. html. 128 Prescribers ofOXYCONTIN in Maryland, ProPublica, https://projects. propublica. org/ checkup/states/maryland(last visitedMay 14, 2019). 129 Id. -75- According to a study published by the National Institutes of Health, "[i]n the speakers' bureau system, physicians are recruited and trained bypharmaceutical, biotechnology, and medical device companies to deliver infonnation about products to other physicians, in exchange for a fee. "130 192. Accordingto a research letter published in JAMA Internal Medicine on May 14, 2018, doctors who had just one extra meal paid for by an opioid company were more likely to prescribe opioids than doctors who received fewer free meals. 193. The use of speakers' bureaus has led to substantial ethical concerns withm the medical field. As summarizedin a 2013publicationby the Institute on Medicineas'aProfession: The Problem: Pharmaceutical companies often recruit physicians to perform speeches or presentations for the purpose of marketing a specific drug. In 2010, 8.6% of physicians reported having received payments for participating in speakers' bureaus. These speakers' bureausleveragethe credibilityofphysiciansin orderto promote the use of pharmaceutical products. The physicians are generally trained to present a certain message, or are provided with pre-produced slides. The audiencemay assume that these presentations are objective, when in fact they are heavily biasedtowardsthe interests ofthe industry sponsor. Speakers' bureaus may leadto the dissemination offalse or biased information. Exposure to industry-sponsored speaking events is associated with decreased quality of prescribing. Additionally, the compensation provided for these engagements mayinfluencetheattitudes orjudgment ofthepresenter. 132 130 Lynette Reid & Matthew Herder, The speakers' bureau system: a form of peer selling, 7(2) Open Med. e31-e39 (Apr. 2, 2013), https://www. ncbi. nlm. nih. gov/pmc/articles/PMC3863750/. 13' ScottE.Hadland,et al., AssociationofPharmaceuticalIndustry MarketingofOpioidProducts to Physicians With Subsequent Opioid Prescribing, JAMA Intern. Med. (May 14, 2018), https://www. ncbi. nlm. nih.gov/pmc/articles/PMC6145750/. The study looked at the Open Payments database, whichwas usedto pull out non-research payments to doctors in 2014. It then compared that datato claims inthe Medicare PartD Opioid Prescriber Summary File from doctors who wrote opioid prescriptions in 2015, leaving in "all physicians with complete, nonduplicate information who had at least 10 opioid claims during 2015." 132 Speakers' Bureaus: Best Practices for Academic Medical Centers, D^IAP (Oct. 10, 2013), http://imapny. org/wp-content/themes/imapny/File%20Library/Best%20Practice%20toolkits/ -76- 194. For example, Fishman is a physician whose ties to the opioid drug industry, and Purdue in particular, are legion. He has served as an APF board member and as president of the AAPM, and has participated yearly in numerous CME activities for which he received "market rate honoraria. " As discussed above, he has authored publications, including the seminal guides on opioid prescribing, which were funded by the Purdue and other opioid manufacturers. He has also worked to oppose legislation requiring doctors and others to consult pain specialists before prescribinghighdosesofopioidsto non-cancerpatients. Hehashimselfacknowledgedhisfailure to disclose all potential conflicts of interest in a letter in JAMA titled, "Incomplete Financial Disclosures in a Letter on Reducing Opioid Abuse and Diversion. "133 195. Similarly, Fine's ties to opioid manufacturers, including Purdue, have been well documented. 134 He has authored articles and testified in court cases and before state and federal committees, and he, too, has served as president of the AAPM and argued against legislation restrictinghigh-doseopioidprescription fornon-cancerpatients. Multiple videosavailableonline featureFinedelivering educationaltalks aboutprescription opioids. He eventestifiedattrial that the 1,500pills a month prescribedto celebrity AnnaNicole Smith for pain did not make her an addict before her death. 135 He has also acknowledged having failedto disclose numerous conflicts of interest. Best-Practices_Speakers-bureaus. pdf (citing research in JAMA, The Journal of Law, Medicine & EthicsandAcademic Psychiatry). 133 Scott M. Fishman, Incomplete Financial Disclosures in a Letter on Reducing Opioid Abuse and Diversion, 306(13) JAMA 1445 (2011); Weber, Two Leaders in Pain, supra n. 74. 134 Weber, Two Leaders in Pain, supra n.74. 135 Linda Deutsch, Doctor: 1, 500 pills don't prove Smith was addicted, Seattle Times (Sept. 22, 2010, 5:16 PM), http://www. seattletimes. com/entertainment/doctor-1500-pills-dont-prove-smithwas-addicted/. -77- 196. Fishman and Fine are only two of the many physicians whom Purdue paid to present false or biased information on the use of opioids for chronic pain. G. Purdue's Guilty Pleas 197. In May 2007, Purdue and three of its executives pled guilty to federal charges of misbranding OxyContin for falsely marketing and promoting OxyContin as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal symptoms than other pain medications in what the company acknowledged was an attempt to mislead doctors. Purduewas ordered to pay $600 million in fines and fees. Purdue also entered into settlements with several states, includingMaryland,relatingto this misconduct. 198. In its federalpleaagreement,Purdueadmittedthatits promotionofOxyContinwas misleadingandinaccurate,misrepresentedthe risk ofaddiction, andwasunsupportedby science. Additionally, Michael Friedman, the company's president, pled guilty to a misbranding charge and agreed to pay $19 million in fines; Howard R. Udell ("Udell"), Purdue's top lawyer, pled guilty andagreedto pay$8million in fines;andPaulD. Goldenheim("Goldenheim"),itsformermedical director, pled guilty and agreed to pay $7. 5 million in fines. Specifically, Purdue pled guilty to illegally misbranding OxyContin in an effort to mislead and defraud physicians and consumers, while Michael Friedman, Udell, and Goldenheim pled guilty to the misdemeanor charge of misbranding OxyContin by introducing it into interstate commerce in violation of 21 U.S.C. §§331(a), 333(a)(l)-(2), and352(a). 199. In a statement announcing the guilty plea, John Brownlee, the U. S. Attorney for the Western District ofVirginia, stated: Purdue claimed it had created the miracle dmg - a low risk drug that could provide long acting pain relief but was less addictive and less subject to abuse. Purdue's marketing campaign worked, and sales for OxyContin skyrocketed - making billions for Purdue and millions for its top executives. -78- But OxyContin offered no miracles to those suffering in pain. Purdue's claims that OxyContin was less addictive and less subject to abuse and diversion were false - and Purdue knew its claims were false. The result of their misrepresentations andcrimes sparkedoneof our nation's greatestprescription drugfailures.... OxyContin wasthe child ofmarketeers andbottom line financial decisionmaking. 136 200. Even afiler this guilty plea, Purdue continued to pay doctors on speakers' bureaus to promote the liberal prescribing of OxyContin for chronic pain and fund seemingly neutral organizations to disseminate the message that opioids were effective and non-addictive, and continued to aggressively market the liberal prescribing of opioids for chronic pain while diminishingthe associateddangersofaddiction. 201. Since 1995, Purdue has earned more than $31 billion from OxyContin, the nation's best-selling painkiller, which constitutes approximately 30% of the United States market for painkillers. 137 Since2009, Purdue's national annual sales ofOxyContin have fluctuated between $2. 47 billion and $2. 99 billion, upthreefold from 2006 sales of$800 million. 13S According to data for the years 2006 through 2014 provided by the U. S. Dmg Enforcement Agency, Purdue sold dosage units ofopioids containing more than in Maryland. 136 PressRelease, U. S.Department ofJustice, Statement ofUnited States Attorney JohnBrownlee on the Guilty Plea ofthe Purdue Frederick Company and Its Executives for Illegally Misbranding OxyContin (May 10, 2007), http://www.ctnewsjunkie.com/upload/2016/02/usdoj-purdue-guiltyplea-5-10-2007. pdf. 137 MME stands for morphine milligram equivalent, the standard measure for opioid dosage potency. CDC guidelines state that dosages above 50 MME per day increase risks for overdose by at least two times more than 20 MME dosages. For example, each milligram of oxycodone, the opioid in OxyContin, is equivalent to 1.25 milligrams ofmorphine. 138 Katherm Eban, OxyContin: Purdue Pharma's painful medicine, FORTUNE (Nov. 9, 2011), http://fortune. com/2011/11/09/oxycontin-purdue-pharmas-painful-medicine/ (hereinafter, Eban, Purdue Pharma's painful medicine1 '1). -79- H. The Sackler Respondents Establish Rhodes as a "Landing Pad" from Purdue 202. In or around November 2007, in the immediate aftermath of the guilty plea by Purdueandits executivesregardingthe company'sfalseandmisleadingmarketingofOxyContin, the Sackler Respondents established Rhodes. Accordingto a former senior managerat Purdue, "Rhodeswas set up as a 'landing pad' for the SacklerRespondents in 2007, to prepare for the possibility thattheywould needto start afresh following the crisisthen engulfing OxyContin. "139 203. In other words, fearful that their ability to make money from Purdue would be negatively impacted or imperiled by Purdue's guilty plea, the Sackler Respondents quietly established a new company, seemingly unrelated to Purdue, through which they could continue to extract billions from the sale ofopioids. While the SacklerRespondents' concern over Purdue was ultimately unfounded - the company continued to profit handsomely through the sale of opioids- theywerecorrectthatRhodeswouldprovideanadditionalsourceofopioidrevenuesfor the family. In 2016, Rhodes' market share for opioids was three-and-one-halftimes larger than Purdue's. 140 204. The Sackler Respondents' involvement in Rhodes and its relationship to Purdue were not publicly known until the September 9, 2018 publication of an article in the Financial Times. According to the article, "Rhodes has not been publicly connected to the Sackler family before, andtheirownershipofthe companymayweakenone oftheir longstandingdefences: that 139 David Crow, How Purdue's 'one-two' punchfuelled the market for opioids. Financial Times (Sept. 9, 2018), https://www. ft.com/content/8e64ec9c-bl33-lle8-8dl4-6f049d06439c. 140 Id. -80- they cannot be heldresponsibleforthe opioidcrisis becausePurdueaccounts for a small fraction ofthe overall prescriptions. "141 205. Despitebeingregisteredasa separatecompanyfrom Purdue,employees at Rhodes and Purdue use the same employee handbook, and "little distinction is made internally between the two companies." 206. Rhodes manufactures, markets, sells, and distributes the following opioids in Maryland and nationwide: Dru Name/Chemical Name Descri tion H dromo hone h drochloride Generic o ioid a onist. CSA Gate o Schedule II Hydrocodone bitartrate and Generic opioid agonist. Schedule II acetaminoc'lien Oxycodone and acetammoohen Generic ooioid a onist. Buprenorphinehydrochloride Genericopioidagonistindicatedfor the treatment of opioid d Mo hine sulfate Ox codone hydrochloride Tapentadol hydrochloride 207. Schedule II ScheduleIII ndence. Generic o ioid agonist. Generic o ioid agonist. Generic opioid agonist. ScheduleII Schedule II Schedule II According to public records collected by ProPublica, in 2015 alone, Medicare Part D paid over $570,000 for claims arising from Maryland physicians' generic hydromorphone hydrochloride prescriptions, $3.6 million for claims arising from Maryland physicians' generic hydrocodone bitartrate/acetaminophen prescriptions, $8 million for claims arising jfrom Maryland physicians'genericoxycodone/acetaminophenprescriptions, $124, 1323forMarylandphysicians' generic buprenorphinehydrochloride, $5. 1 million for claims arisingfrom Marylandphysicians' genericextendedreleasemorphinesulfateprescriptions, and$7.35 million for claimsarisingfrom Maryland physicians' generic oxycodone hydrochloride prescriptions. 141 Id. 142 Id. -81- I. Senate Investigations of Purdue 208. In May 2012, the Chair and Ranking Member of the Senate Finance Committee launched an investigation into makers of narcotic painkillers and groups that champion them. The investigationwastriggeredby "anepidemic ofaccidentaldeathsandaddictionresulting from the increased sale and use of powerful narcotic painkillers," including popular brand names like OxyContin, Vicodin and Opana. 209. The committee sent letters to Purdue,Endo, andJohnson& Johnson,aswell asfive groups that support pain patients, physicians, or research, including the APF, AAPM, APS, University of Wisconsin Pain & Policy Studies Group, and the Center for Practical Bioethics. Letters also went to the FSMB and the Joint Commission. 210. As shown below in an excerpt from the Senators' letter to the APF, the Senators addressedthe magnitide of the epidemic and asserted that mounting evidence supports that the pharmaceuticalcompaniesmaybe responsible: It is clear that the United States is suffering from an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers [such as Oxycontin (oxycodone), Vicodin (hydrocodone), Opana (oxymorphone)]. According to CDC data, "more than 40% (14,800)" of the "36,500 drug poisoning deaths in 2008" were related to opioid-based prescription painkillers. Deaths from these dmgs rose more rapidly, "from about 4, 000 to 14, 800" between 1999 and 2008, than any other class of drugs, killing more peoplethanheroinandcocainecombined. Morepeoplein theUnitedStates now die from drugs than car accidents as a result of this new epidemic. Additionally, the CDCreports that improper "use ofprescription painkillers costs health insurers up to $72. 5 billion annually in direct health care costs." Concurrent with the growing epidemic, the New York Times reports that, based on federal data, "over the last decade, the number ofprescriptions for the strongest opioids has increasednearly fourfold, with only limited evidence of their longterm effectiveness or risks" while "[d]ata suggest that hundreds of thousands of patients nationwide may be on potentially dangerous doses." -82- There is growing evidence pharmaceutical companies that manufacture and marketopioidsmay beresponsible,atleastinpart,for thisepidemicbypromoting misleading information about the drugs' safety and effectiveness. Recent investigative reporting from the Afil-waukse Journal Sentinel/MedPage TodayandProPublicarevealedextensivetiesbetweencompaniesthatmanufacture and market opioids and non-profit organizations such as the American Pain Foundation,the AmericanPainSociety,the AmericanAcademyofPainMedicine, the Federation of State Medical Boards, and the University of Wisconsin Pain and Policy Study Group. According to the Milwaukee Journal Sentinel/MedPage Today, a "network of national organizations and researchers withfinancial connections to the makers ofnarcoticpainkillers... helpedcreatea body of dubiousinformation"favoring opioids "that can befound in prescribing guidelines, patient literature, position statements, books and doctor education courses. "143 In a ProPublica story published in the Washington Post, the watchdog organization examined the American Pain Foundation, a "health advocacy" organization that received "nearly 90 percent of its $5 million funding from the drug and medical device industry. " ProPublica wrote that its review of the American Pain Foundation's "guides for patients, journalists, and policymakers play down the risks associated with opioids and exaggerate their benefits. Some of the foundation'smaterialsonthe drugsincludestatementsthataremisleadingorbased on scant or disputed research." Although it is critical that patients continue to have access to opioids to treat serious pain, pharmaceutical companies and health care organizations must distribute accurate and unbiased information about these drugs in order to prevent improper use and diversion to drug abusers. 211. The Senators demanded substantial documents, such as payment information from the companies to various groups, including the front organizations identified above, and to physiciansincludingPortenoy,Fishman,andFine. Theyaskedaboutanyinfluencethe companies 143 For example, the Sentinel reported that the FSMB, with financial support from opioid manufacturers, distributed '"more than 160, 000 copies'" of a model policy book that drew criticism from doctors because '"it failed to point out the lack of science supporting the use of opioidsfor chronic,non cancerpain.'" JohnFauber, Follow the Money: Pain, Policy, andProfit, MedPage Today (Feb. 19, 2012), http://www.medpagetoday.com/Neurology/ PainManagement/31256. 144 Letter from U. S. Senators Charles E. Grassley and Max Baucus to Catherine Underwood, Executive Director, American Pain Society (May 8, 2012) (footnote added). . -83- hadona 2004painguideforphysiciansthatwasdistributedbytheFSMB,ontheAPS' guidelines, and on the APF's MilitaryA^eterans PainInitiative. Almost immediately upon the launch ofthe Senate investigation, the APF shut down '"due to irreparable economic circumstances.'" The opioid report resulting from this investigation hasnot been released. 145 212. OnMarch 29, 2017, it waswidelyreported146 that yet another Senate investigation had been launched: Missouri Senator Claire McCaskill has launched an investigation into some of the country's leading prescription drug manufacturers, demanding documents and recordsdatingbackthepastfiveyearswhichindicatejustwhatthecompaniesknew ofthe dmgs' risk for abuseaswell as documents detailingmarketingpracticesand sales presentations. Her office has sent letters to the heads of Purdue, Janssen/Johnson & Johnson, Insys, Mylan, and Depomed. The above-referenced companies were reportedly targeted based on their role in manufacturing someofthe opioidpainkillerswiththe highestsales in 2015. 213. On September 12, 2017, then-Senator McCaskill convened a Roundtable Discussionon OpioidMarketing. Duringthe hearing. SenatorMcCaskill stated: The opioid epidemic is the direct result ofa calculated marketing and sales strategy developedin the 90's, whichdeliveredthree simple messagesto physicians. First, that chronic pain was severely undertreated in the United States. Second, that opioids were the besttool to addressthat pain. And third, that opioids couldtreat pain without risk of serious addiction. As it turns out, these messages were exaggerationsat bestand outright lies at worst. Our national opioid epidemic is complex, but one explanation for this crisis is simple, pure greed. 145 Paul D. Thacker, Senators Hatch and Wyden: Do your jobs andrelease the sealedopioids report, StatNews (June 27, 2016), https://www. statnews. com/2016/06/27/opioid-addicti6n-orrinhatch-ron-wyden/; see also Omstein, American Pain Foundation, supra n.60. 146 NadiaKounang, Senator opens investigation into opioidmanufacturers, CNN (Mar. 29, 2017, 11:06 AM), http://www. cnn. com/2017/03/28/health/senate-opioid-rnanufacturer-investigation/ index.html. -84- 214. Professor Adriane Fugh-Berman ("Fugh-Berman"), Associate Professor at Georgetown University Medical Center and director of the Georgetown program Pharmed Out, whichconductsresearchon andeducatesthepublicaboutinappropriatepharmaceuticalcompany marketing, also testified during the hearing. She, too, blamed pharmaceutical companies for the opioid crisis: Since the 1990's, pharmaceutical companies have stealthily distorted the perceptions of consumers and healthcare providers about pain and opioids. Opioid manufacturers use drug reps, physicians, consumer groups, medical groups, accreditation and licensing bodies, legislators, medical boards and the federal government to advance marketing goals to sell more opioids. This aggressive marketing pushes resulted in hundreds of thousands of deaths from the overprescribingofopioids. TheU.S. is about- comprisesaboutfivepercentofthe world population, but we use about two-thirds ofthe world supply ofopioids. 215. Fugh-Bemian also provided insight regarding why doctors were able to be convinced by pharmaceutical companies' marketing efforts: Why do physicians fall for this? Well, physicians are overworked, overwhelmed, buried in paperwork and they feel unappreciated. Dmg reps are cheerful. They're charming. They provide both appreciation and information. Unfortunately, the information they provide is innately unreliable. Pharmaceutical companies influence healthcare providers' attitudes and their therapeutic choices through financial incentives that include research grants, educational grants, consulting fees, speaking fees, gifts and meals. 216. Fugh-Berman further described the false information provided by pharmaceutical companies and the industry creation of front organizations, includingthe APF, to pass industryinfluenced regulations and policies: Pharmaceutical companies convinced healthcare providers that they were opiophobic andthat they were causing suffering to their patients by denying opioids to patients with back pain or arthritis. They persuaded prescribers that patients with pain were somehow immune to addiction. Even when addiction was suspected, physicians were taught that it might not really be addiction, it might be pseudoaddiction, an invented condition that's treated by increasing opioid dosages. Industry created the American Pain Foundation co-opted other groups including medical organizations, and they change state laws to eliminate curbs on opioid -85- prescribing. Between 2006 and2015, pharmaceutical companies andthe advocacy groups they control employ 1,350 lobbyists a year in legislative hubs. Industryinfluenced regulations and policies ensure that hospitalized patients were and are berated constantly about their level ofpain andovermedicated with opioids for that pain. Evena weekofopioidscanleada patientinto addictionso manypatients are dischargedfrom hospitalsalreadydependenton opioids. 217. In addition, Fugh-Bermanpointed out that promotion of opioids remains ongoing despite increasingpublic concern abouttheiruse: Promotion of opioids is not in the past. Between 2013 and 2015, one in 12 physicians took out money from opioid manufacturers, a total of more than $46 million. Industry-friendly messages that pharmaceutical companies are currently perpetuating reassure physicians that prescribing opioids is safe as long aspatients do not havea history of substanceabuseor mental illness. 218. Fugh-Bermanconcludedby stating:"It is a misperceptionto thinkthatmost opioid deathsare causedbymisuse ofopioidsor overdoses. In fact, many deathsoccurwhenpeople are using opioids in exactly the way they were prescribed. Misuse isn't the problem; use is the problem." J. Respondents Failedto Report SuspiciousSalesas Required 219. The Controlled Substances Act ("CSA"), and the regulations promulgated thereunder, 21 C.F.R. §§1300 etseq; imposes on all "[r]egistrant[s]" the obligation to design and operate a system to disclose to the registrant suspicious orders of controlled substances and requires the registrant to notify the DEA field division office in its area of any suspicious orders. "Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency. " 21 C.F.R. §1301. 74(b). Maryland law also provides for the samereporting. Md. CodeAnn., Grim. Law. § 5-303(e); COMAR10. 19.03 et seq. 220. Purdue is a "[r]egistrant"underthe federal CSA. 21 C.F.R. §1300.02(b) defines a registrant as any person who is registered with the DBA under 21 U. S.C. §823. Section 823, in turn, requires manufacturers of Schedule II controlled substances to register with the DEA. -86- 221. Purdue,whichhas at all times representedto consumersthat it hasbeencompliant with regulatory requirements, was required by federal and state law to set up a system to prevent diversion, including excessive volume and other suspicious orders. This includes reviewing Purdue's own data, relying on their observations ofprescribers andpharmacies, and following up on reports or concerns ofpotential diversion. Despite having specialized and detailed knowledge of potential suspicious prescribing and dispensing of opioids through Maryland sales representatives' visits to healthcare providers, and Purdue's purchase of data from commercial sources, Respondents failed in Purdue's obligation to design and operate a system to disclose suspicious orders of controlled substances and/or failed ,to notify the appropriate DBA field divisionor state authorities of suspiciousorders, asrequiredby state andfederal law. K. The SacklerRespondents Oversawand DirectedPurdue'sUnlawful Conduct 222. The SacklerRespondents helped direct Purdue's unlawful marketing techniques, usingmanyofthe sameunethicaltechniquesdevelopedbyArthur Sackler,to maximizetheirsales of opioid products. The Sackler Respondents worked hard to ensure that Purdue succeeded financially. 223. OxyContin was launched with one of the largest pharmaceutical marketing campaigns in history. Purdue paid thousands ofphysicians to present to medical conferences on the benefits ofOxyContin. 224. Sales representatives touted the drug's benefits, recommending OxyContin as the solution not just for acute, short-term pain but also for less-acute, longer-lasting pain. Sales training included lessons in overcoming doctors' concerns about health and addiction by minimizingor downplayingOxyContin'saddictivequalities. -87- 225. The Sackler Respondents were deeply involved in OxyContin's marketing campaign. Family members were on site at Purdue's headquarters daily, controlling the managementofthe family business. Accordingto a former salesrepresentative whowastalking about OxyContin's sales success, Richard Sackler was '"the dude that made it happen.'" In responseto the concerns ofbenefitplans that OxyContinwasripe for addictiveuse, Richardsent an email to sales representatives, assertingthat "'addiction'may be a convenient wayto just say 'NO.'"147 226. The Sackler Respondents considered whether they could sell OxyContin as"non- narcotic," withoutthe safeguardsthatprotectpatientsfrom addictivedrugs, whichwouldresult in a "vast increase ofthe market potential." The inventor of OxyContin, Robert Kaiko ("Kaiko"), wrote to Richard Sackler in 1997 that he was "very concerned" about the danger of selling OxyContin without strict controls. Kaiko warned: "I don't believe we have a sufficiently strong case to argue that OxyContin has minimal or no abuse liability. " To the contrary, Kaiko wrote, "oxycodone containing products are still among the most abused opioids in the U.S." Kaiko predicted: "IfOxyContinis uncontrolled,.. . itis highlylikely that it will eventually be abused." Nevertheless, Richard Sackler responded: "How substantially would it improve your sales?" 227. In 1997, Richard and Kathe Sackler took part in a conspiracy to mislead doctors by claimingoxycodonewashalfas strongasmorphine. Thetruthwaspreciselytheopposite. Purdue engagedin this deception in the attempt to alleviate healthcareproviders fears in prescribingthe drug for non-acute pain. As recorded in internal correspondence, Richard Sackler directed Purdue staffnot to tell doctors the truth becausethe tmth could reduce OxyContin sales. 147 Keefe, Empire of Pain, supra n. l3. -88- 228. Around 1999 to 2003, Purdue had a system whereby company emails would self- eraseafterpre-detenninedtimes. Thispolicy createda system wherebypotentially incriminating documents would be automatically erased even if received by third parties. Richard, Jonathan, and Kathe Sackler were all aware and supportive of this system. L. The Sackler Respondents Were Aware of the Abuse Potential of OxyContin from at Least Summer 1999 229. The Sackler Respondents were aware that OxyContin and other prescription medication could lead to addiction. An internal memo prepared by Purdue employee Maureen Sarain 1999,forexample,describedthe abuseandrecreationaluseofOxyContin. Thememowas sent directlyto Purdue'sboardmembers, includingRichard,Jonathan,andKatheSackler. 230. The Sackler Respondents were thus aware of potential liability for Purdue since at least 1999 due to OxyContin's addictive nature. Around this time, the Sackler Respondents began to transfer profits from Purdue to their own private tmsts and accounts in order to shield their funds from creditors. In 2015, for example, the Sackler Respondents removed $700 million from their privately held companies, two-thirds of which came from Purdue. These transfers of ill-gotten gains were done for the purpose of protecting the money from any civil or criminal judgment against Purdue for its participation in the opioid crisis. These transfers also left Purdue undercapitalized andpotentially unable to compensate for the staggering injuries that its illegal conduct has created. 231. Rather than protect the public's health, at every turn, the Sackler Respondents protected- andsoughtto increase- theirownwealth. M. The Sackler Respondents Continued to Oversee Purdue's Wrongdoing Even After Repeated Warnings and Fines 232. The Sackler Respondents participated in the unfair and deceptive trade practices engagedin byPurdue. The SacklerRespondents eitherparticipateddirectly in or knewaboutthe -89- unfairanddeceptivetradepracticesandhadauthorityto stop them, but, insteadofstoppingthem, promoted their use. 233. The Sackler Respondents' liability extends beyond their leadership of Purdue. They were aware of, participated in, approved of, and were obligated to address, Purdue's conduct due to previous investigations into the company's deceptive practices. 234. Purdue was under investigation by 26 states and the U. S. Department of Justice from 2001 to 2017. In 2003, on the advice of legal counsel, each Sackler who held an executive role at Purdue resigned from his or her executive positions to avoid personal liability for the conduct in which they had engaged and continued to engage prior to and after their resignations. 235. In 2007, the directors of Purdue declared that it would pay roughly $700 million in connectionwiththe guiltypleafor misleadingpatients aboutOxyContin. (The entitythatpaidthe money, The Purdue Frederick Company, Inc., was a separate corporate entity that was controlled by the same people and shared the same headquarters as Purdue Pharma L.P.). Purdue acknowledged that its supervisors and employees had fraudulently promoted OxyContin as safer and less addictive than other pain medications. 236. Michael Friedman,the ChiefExecutiveOfficer("CEO")ofPurdue, pled guilty to criminal charges of fraudulent marketing. Udell, Purdue's chief lawyer, and Goldenheim, Purdue's chiefmedical officer, pled guilty to the same crime. The directors, including the Sackler Respondents, were forced to choose a new CEO; and the felony convictions resulted in mass-scale retraining of company employees. 237. The 2007 convictions warned Respondents against any further deception. 238. Respondents also agreed to a Consent Judgmentthat ordered Purdue not to make any false or misleading oral or written claims about OxyContin, including concerning the risk of -90- addiction. The Consent Judgment also required Purdue to establish a program that would identify high-prescribingdoctors, stoppromotingOxyContinto them, andreportthem. Thisprogramwas to last from 2007 to 2017. 239. The directors also entered a Corporate Integrity Agreement with the U. S. government, whereinPurduewouldappointa complianceofRcerto a seniormanagementposition atPurdue. Theofficerwouldmakeperiodicreports on compliancemattersto theBoardto ensure no deception took place again. Under the agreement, the directors and CEO were "Covered Persons"who hadto comply withrules prohibitingdeceptionregardingPurdue'sproducts. This status lastedfrom 2007to 2012 andrequiredthat leadershipreport all mle violations andundergo hours of compliancetraining. The directors and CEO were warnedof consequences in case of a violation and certified that they understood their new status. 240. Purdue's directors were clearly aware of their obligations under the above agreements. In 2009, Purdue had to report to the Inspector General of the U. S. Department of Health and Human Services ("HHS") that it had not immediately trained a new director on the terms ofthe Corporate Integrity Agreement. Purdue assured HHS that the director hadundergone the training the day after Corporate Compliance had learned ofthe issue. 241. The years afterthe 2007guiltyplea andCorporate IntegrityAgreementwerefilled with alarming reports and stories about the opioid crisis. However, in spite of these widespread warnings, Purdue's directors, including the Sackler Respondents, did nothing to stop Purdue's misconduct. Instead, they continued to concern themselves with howto protect and increase their wealth. 242. In April 2008, Richard Sackler sent Kathe, Ilene, David, Jonathan, and Mortimer Sackler a secret memo abouthowto keep money flowingto their family. Richardwrote that it -91- wascrucialto install a CEOwhowouldbeloyalto thefamily: "Peoplewhowill shifttheirloyalties rapidlyunderstress andtemptation canbecomea liabilityfrom the owners' viewpoint." Richard SacklerrecommendedJohnStewartforthepositionbecauseofhis loyalty. He alsoproposedthat the family shouldeithersell Purduein2008or, if they could not find a buyer, milk the profits out ofthe business, and "distribute more free cash flow" to themselves. 243. That month, the SacklerRespondentsvotedto havePurduepaythem $50,000,000. From the 2007 convictions until 2018, the Sackler Respondents voted dozens of times to pay out billions of dollars in Purdue's opioid profits to themselves. 244. In 2008, opioid overdoses killed more Americans than any previous year, a record that would continue to be broken each subsequent year through the present. 245. In 2009, the American Journal of Public Health published "The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy. "148 The article detailed the misleading and deceptive nature ofPurdue's opioid marketing, including the misuse of sales representatives, the targeting of high-prescribing practitioners, and deception about the potential rates of abuse. The CDC reported that deaths stemming from opioid use had tripled in the preceding year. 246. In 2010, TIME magazine published "The New Drug Crisis: Addiction by Prescription. "149 The article focused extensively on Purdue's line ofopioid products. Overdoses were the number one cause of accidental death in 15 states that year, and Purdue's directors were informed that Purdue would not be able to get product liability insurance to cover OxyContin. 148 Van Zee, Promotion andMarketing, supra n. 63. 149 Jeffrey Kluger, The New Drug Crisis: Addiction by Prescription, TES1E (Sept. 13, 2010), http://content. time. com/time/magazine/article/0, 9171, 2015763, 00.hfanl. -92- 247. In 2011,the WhiteHouseannouncedthatprescriptiondrugabusewasthe nation's fastest-growing dmg problem and called for educating healthcare providers about prescription dmg abuse to prevent overprescription. The CDC announced that prescription opioid overdoses hadreachednever-before-seenlevels andspecificallycalledoutPurdue'sline ofopioidproducts. Fortune magazinepublishedan article that sameyearwherePurdueexecutiveswere interviewed about the ongoing crisis and the involvement of the company and the Sackler Respondents. The interviewees included Purdue Vice President Alan Must, who admitted that Purdue was "well aware" of concerns about its conduct: "We are well aware of detractors. ... For those individuals who think we're evil ... I don't think there's anything we can do that is going to change their opinion. "150 248. In 2012, the U. S. Senate announced an investigation into Purdue's unlawful deceptionofdoctors andpatients aboutthenature ofits opioidproducts. The Senatorswarnedof "an epidemic of accidental deaths and addiction resulting from the increased sale and use of powerful narcotic painkillers" in a letter to the CEO ofPurdue Pharma, Inc. andPurduePharma L.P. 151 The Senate letter specifically warned of the danger of higher levels of opioid dosage: '"over the last decade, the number ofprescriptions for the strongest opioidshas increasednearly fourfold,withonly limitedevidenceoftheirlong-termeffectivenessorrisks' while '[d]atasuggest that hundreds of thousands of patients nationwide may be on potentially dangerous doses. " 5 The Senate letter also warned about Purdue's deceptive tactics with doctors and patients: "There is growing evidence pharmaceutical companies that manufacture and market opioids may be 150 Eban, Purdue Pharma's painful medicine, supra n. 138. 151 Letter from U. S. Senate Finance Committee to John H. Stewart, President and CEO ofPurdue PharmaL.P. (May 8, 2012), https://www.finance.senate.gov/imo/media/doc/Purdue_May_8.pdf. 152 Id. -93- responsible, at least in part, for this epidemic by promoting misleading information about the drugs' safety and effectiveness. "153 The Senate specifically warned the directors and CEO that they were under scrutiny, demanding that Purdue present a set of "presentations, reports, and communications to Purdue's management team or board of directors from 2007 to the present. "154 249. In 2013, the Los Angeles Times reported that Purdue had created a list of 1, 800 doctors suspected of recklessly prescribing its opioids over the past decade but had reported only 8% of them to authorities. Purdue attorney Robin Abrams ("Abrams") gave multiple interviews to the newspaper. Abrams was a Vice President of Purdue, and she signed Purdue's 2007 settlement agreement. In 2013, she admitted that Purdue had the list and said with regard to Purdue's unwillingness to disclose the list: '"I don't really want to open up an opportunity for folks [to] come in here andstart looking andsecond-guessing. '"155 250. Abrams and Purdue's directors had good reason to be concerned: the Commonwealth of Kentucky had brought a lawsuit against Purdue for deceiving doctors and patients about the nature of its opioid products. When Purdue's lawyers surveyed the local residents for potential jury service, one-third of respondents said they knew someone who had been hurt or had overdosed taking Purdue opioids, and 29% knew someone who had died. Purdue itself filed these findings in court. 251. In 2014, Edward Mahony, the Executive Vice President, Chief Financial Officer, and Treasurer of Purdue, announced that the Kentucky lawsuit was noteworthy enough to 153 Id. 154 Id. 155 Scott Glover & Lisa Girion, OxyContin maker closely guards its list of suspect doctors, Los Angeles Times (Aug. 11, 2013), https://www.latimes.com/local/la-me-rx-purdue-20130811story .html. -94- '"jeopardize Purdue's long-term viability. " 5 The Governor of Massachusetts declared the opioidcrisis a public healthemergencyin the sameyear. 252. In 2016, in an attempt to stop the threatening spread ofopioid overprescribing, the CDC published the CDC Guideline for Prescribing Opioids for Chronic Pain. The 2016 CDC Guideline provides recommendations for primary care clinicians who prescribe opioids for chronic pain outside of cancer treatment, palliative care, or end-of-life care. It was intended to "offer[] clarity on recommendations based on the most recent scientific evidence, informed by expert opinion and stakeholder and public input." In summary, the CDC concluded that "evidence on long-tenn opioid therapy for chronic pain outside of end-of-life care remains limited, with insufficient evidence to determine long-term benefits versus no opioid therapy, though evidence suggests risk for serious harms that appears to be dose-dependent." Among the CDC's recommendations are that "[n]onpharmacologic therapy and nonopoid pharmacologic therapy are preferred for chronic pain. "157 253. The Sackler Respondents, in their capacities as directors and executives, controlled theoperationofPurdue'ssalesrepresentatives. RichardSacklerhastestifiedthatPurdueprimarily promoted its opioidsthrough its sales representatives andthat regularvisits from representatives were the key to get doctorsto continue to prescribethe dmgs. The Board knewwhichdrugsthe sales representatives were to promote, the number ofvisits representatives madeto doctors, how much each visit cost the company and the quarterly plans for sales visits. The Board approved 156 Tracy Staton, Addiction-riddled Kentucky outfor blood in $1B suit against OxyContin-maker Purdue, FiercePharma (Oct. 20, 2014, 9:00 AM), https://www.fiercepharma.com/pharma/ addiction-riddled-kentucky-out-for-blood-lb-suit-against-oxycontin-maker-purdue. 157 Deborah Dowell, MD, et al., CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016, Centers for Disease Control and Prevention, https://www. cdc. gov/mmwr/ volumes/65/rr/rr6501el.htm (last visited May 14, 2019). -95- specific hiring plans for their sales representatives, hiring directors and regional managers and creating salesterritories for representativesto targetdoctors. 254. In April 2010, staff gave Ilene, Jonathan, Kathe, Mortimer, Richard, and Theresa Sacklerone ofmanydetailedreports on sales representatives' visits to prescribers. And in April 2015,David,Ilene, Jonathan,Kathe, Mortimer, Richard,andTheresaSacklervoted to expandthe salesforce by adding another 122 representatives. 255. Richard Sackler was intensely involved in Purdue's day-to-day operations. For example, in January 2010, he asked sales staff for new customized reports. Staff complained to each other until Sales Vice PresidentRussell Gasdia("Gasdia")asked Stewartto intervene: "Can you help with this? It seems like every week we get one off requests from Dr. Richard. " But neither Stewart nor anyone else could keep Richard out of sales. Days later, Richard was writing to a sales employee on a Saturday morning, orderingthat his need to review the sales plan was "urgent" and should be satisfied "this weekend." 256. The Sackler Respondents oversaw the specific tactics used by sales representatives to sell opioids. For example, a board report encouraged the use ofiPads during sales visits, which increased the average length of sales calls to 16. 7 minutes. 257. According to internal correspondence, at a 2011 Launch Meeting for Butrans, an opioid introduced by Purdue that releases opioids into the body via skin patch, Richard Sackler met with sales representatives for several days to discuss howthey would promote the newproduct. Richard Sackler followed up with sales management to demand a briefing on how the sales visits were going in the field: "I'd like a briefmg on the field experience and intelligence regarding Butrans. How are we doing, are we encountering the resistance that we expected and how well are we overcoming it, and are the responses similar to, better, or worse than when we marketed OxyContintablets?" -96- 258. The Sackler Respondents oversaw the promotional claims representatives used during sales visits. The directors and CEO, reviewed reports that Purdue sales representatives were deceptivelypromoting opioidsas an appropriatetreatment for minorpain, amonghundreds of other examples of unlawful marketing techniques in need of correction. 259. According to internal correspondence, Richard Sackler demanded that he be sent into the field with sales representatives. Richard wanted to shadow two Purdue sales representatives per day for a week. Gasdia reportedly appealed to Purdue's Chief Compliance OfiRcer in horror, warningthat Richard Sacklerpromoting opioids was "a potential compliance risk." The Compliance Officer replied: "LOL." To make sure the Sackler Respondents' involvement in marketing remained secret, staff instmcted: "Richard needs to be mum and be anonymous." 260. RichardSacklerindeedwent into the fieldto promote opioidsto doctors alongside a sales representative. When he returned, Richard reportedly argued to Gasdia that a legally requiredwarningaboutPurdue'sopioidswasnot needed. He assertedthatthe warning"implies a danger of untoward reactions and hazards that simply aren't there. " Richard insisted there should be "less threatening ways to describe Purdue opioids." 261. Additionally, the Sackler Respondents oversaw Purdue's research, which in some cases contradicted Purdue's marketing. The SacklerRespondents received detailed and specific reports concerning Purdue opioids being used for "opioid-nai've" patients and patients with osteoarthritis. Yet Purdue has continuedto promote the use of opioids in opioid-nai'vepatients, expanding its customer base to the detriment ofthese new opioid users. 262. According to internal correspondence, during a 2010 Purdue Board of Directors meeting, the Sackler Respondents inquired whether sales representatives could sell more Butrans -97- if they remained silent about failed clinical trials testing Butrans for patients with osteoarthritis: "Whatcanbe said in responseto a prescriberwho asks directly or indirectly, 'canthis productbe prescribed for my patient with [osteoarthritis]?' In responding are we required to specifically mention the failed trials in [osteoarthritis]?" 263. The Sackler Respondents supervised sales representatives' communications with healthcareproviders. Purduehada policyofprohibitingsalesrepresentativesfromcommunicating with doctors via email; when Purdue found that some representatives had in fact emailed doctors, Purdue"investigated"the matter andtold the Boardthat the representatives hadbeen disciplined and the matter would be discussed at the next Board meeting. 264. The Sackler Respondents oversaw Purdue's strategy to pay high-prescribing doctors to promote its opioids. The Board was aware of the amount paid to specific high prescribers andthe return on investment it received from thesepayments. The Board knew that Purdue allowed a gift spending limit of $750 per doctor per year and was told specifically that paying doctors was a high-risk activity that could result in improper ofF-label use or other promotional activity for opioids. Nevertheless, it continued to authorize these payments. 265. The SacklerRespondentsmanagedPurdue's focus on encouragingpatients to use higher and higher doses of opioids, leading to health issues, addiction, and greater profits for Purdue. Upon learning that sales of 40mg and 80mg strengths of OxyContin had fallen below sales targets, the Board received multiple reports that public health authority initiatives to have doctors consult with pain specialists before prescribing high opioid doses were a "threat. " The Board oversawmeasuresto opposethese initiatives andreceivedreports in 2013 that attempts to encourageincreasedtotal dailydoseshadhada positive impactonPurdue'sbottom line. -98- 266. In October 2017, Richard Sackler learned that insurance company Cigna had cut OxyContin from its list of covered drugs and replaced it with a drug from Purdue's competitor, Collegium. Collegium had agreedto encourage doctors to prescribe lower dosesof opioids, and Collegium's contract with Cigna was designed so Collegium would earn less money if doctors prescribed high doses. Cigna announced that opioid companies influence dosing: "While drug companies don't control prescriptions, they can help influence patient and doctor conversations by educating people about their medications. " According to internal correspondence, Richard Sackler's first thought was revenge: he immediately suggested that Purdue drop Cigna as the insurance provider for the company health plan. 267. The Sackler Respondents oversaw Purdue's plan to keep patients hooked on opioids for longer periods of time through higher doses. The Board received thorough reports of how many patients remained on Purdue opioids for extended lengths of time, as well as internal documents that indicated patients on higher doses used the product for longer amounts of time, creating greater chances of addiction and abuse. The Board was presented with a plan to create workshops and give specific direction to representatives about this link, and that increasing opioid use was a focus point of the company. The Board was told in writing that encouraging higher doses "is a focal point of our promotion" and that sales representatives should push doctors to increase patient doses as soon as three days after initial treatment. The Board knew or should have known that this sales tactic was both deceptive and placing patients at high risk of addiction and overdose. 268. In January 2018, Richard Sackler received a patent for a drug to treat opioid addictionfor whichhe had applied in 2007. He assignedit to a different companycontrolled by the Sackler Respondents instead ofPurdue. Notably, Richard Sackler's patent application says -99- opioids are addictive. The application calls the people who become addicted to opioids "junkies" and asks for a monopoly on a method oftreating addiction. 269. The Sackler Respondents oversaw Purdue's use of "savings cards" to get patients on Purdue opioids for longer periods of time. The Board knew exactly how many thousands of cards were used each quarter, the return on investment, and the goal of the program: for patients "to remain on therapy longer." 270. The Sackler Respondents oversaw Purdue's targeting ofprescribers without special knowledge ofopioids, as they were the most likely to respond to Purdue's sales techniques. Purdue proceededwith this strategy despite the DEA expressing concern that Purduewas marketing its opioids to doctors who were not appropriately trained in pain management. 271. The Sackler Respondents oversaw a strategy of targeting elderly patients, using images of older patients to target healthcare providers who practiced in long-term care. The Sackler Respondents knew or should have known both that this strategy was deceptive and that targeting doctors who lacked special training in pain management and elderly patients increased the risk of addiction and overdose. 272. The Sackler Respondents were aware of a plan to steer patients away from less dangerous pain-management medicines, which involved efforts to emphasize the danger of acetaminophen-based pain medication to the liver. These efforts included deceptive websites that the New York Attorney General specifically determined to be misleading in specific sections. 273. The Sackler Respondents oversaw the response to thousands of harm reports from patients, in one case receiving over 5,000 complaints in a single quarter. -100- 274. Proponent is informed and believes, and thereupon alleges, that Purdue possesses documents that show each ofthe reports mentioned above was sentto every individual respondent onthe Board, includingeach SacklerRespondentwith a boardposition. IV. IMPACT 275. The impact ofPurdue's false messaging has been profound. Respondents have profited handsomely as more and more people became addicted to opioids and died of overdoses. 158 Its opioid sales grew from $48 million per year in 1996, to over $1 billion per year in 2000,to $3. 1 billion per yearten years later. 276. By 2002, "[l]ifetime nonmedical use of OxyContin increased from 1. 9 million to 3. 1 million people between 2002 and 2004, and in 2004 there were 615, 000 new nonmedical users ofOxyContin;'159 277. By 2004, OxyContin had "become the most prevalent prescription opioid abused in the United States."160 278. As OxyContin sales grew between 1999 and 2002, so did sales of other opioids, including fentanyl (226%), morphine (73%), and oxycodone (402%). And, asprescriptions surged between1999and2010, so diddeathsfrom opioidoverdoses(from about4, 000to almost 17,000). Purdue's sales andmarketing in Marylandwas so successful that duringat least one year (20112012), Purdue's Maryland District SalesManager wasrewarded as a top performer nationally with a "President's Club" trip to South Beach, Florida. 158 German Lopez, How bigpharma got people hooked on dangerous opioids - and made tons of money off it. Vox (Sept. 22, 2016, 3:00 PM), http://www. vox. com/2016/2/5/10919360/opioidepidemic-chart. 159 Van Zee, Promotion and Marketing, supra n.63. 160 Id. -101- 279. Maryland, like the rest of the United States, is experiencing an unprecedented opioidaddictionandoverdoseepidemic, costingmillions in healthinsuranceandpublic safety, as well as lost productivity in the workforce. In 2012 alone, an estimated 259 million opioid prescriptions were filled, enough to medicate every adult in the United States for a month on a round-the-clock basis. 161 In 2014, there were more than 47, 000 drug overdose deaths nationwide, 61% involving a prescription or illicit opioid. The use ofprescription painkillers costs health insurers up to $72. 5 billion annually in direct healthcare costs. 163 According to a research paper published in 2018 by the American Enterprise Institute that set out to determine geographic variation in the costs of the ooioid crisis, estimated total per-capita costs of the opioid crisis in Maryland during 2015 were $3, 337. 164 Because Maryland's total population was approximately 5, 987, 000 in 2015, that figure indicates that the total costs of the opioid crisis in Maryland were in excess of $19. 97 billion in 2015 alone. 280. Respondents' duplicitous and unlawful acts have damaged, and continue to damage, Maryland andMaryland residents. Damages incurred by Maryland include: (a) the costs of treating opioid addiction, including addictiontreatment, emergency room visits and inpatient and outpatient,treatment; (b) the costs of maintaining harm reduction, overdose prevention and education onthe dangers ofopioid use; (c) special costs incurred by Maryland for the public safety, 161 Opioid Painkiller Prescribing, Centers for Disease Control and Prevention: Vital Signs (July 2014), https://www.cdc.gov/vitalsigns/opioid-prescribing/. 162 Rudd, Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015, Centers for Disease Control and Prevention (Dec. 30, 2016), https://www. cdc. gov/mmwr/ volumes/65/wr/mm655051e 1 .htm. 163 Eban, Pwdue Pharma's painful medicine, supra n. 138. 164 Alex Brill & Scott Ganz, The geographic variation in the cost of the opioid crisis, AEI Economics Working Paper 2018-03, at Table 1 (March 20, 2018), https://www.aei.org/wpcontent/uploads/2018/03/Geographic_Variation_in_Cost_of_Opioid_Crisis.pdf. -102- health and welfare of its citizens; and (d) the economic harm to Maryland resulting from the addiction epidemic. V. VIOLATIONSOF THE CONSUMERPROTECTIONACT 281. Proponent incorporates by reference and realleges each and every allegation contained in this Statement of Charges. 282. The Consumer Protection Act prohibits any unfair, abusive, or deceptive trade practices. Md. Code Ann., Corn. Law §§13-301 etseq. It expressly designates the following such practicesas unlawful: . Representations that have "the capacity, tendency, or effect of deceiving or misleading consumers" (Md. Code Ann., Corn. Law §13-301(1)); . Representations that consumer goods have a sponsorship, approval, characteristic, use or benefit that they do not have (Md. Code Ann., Corn. Law §13-301(2)(i)); . Representations that fail to "state a material fact if the failure deceives or tends to deceive" (Md. Code Ann., Corn. Law §13-301(3)); and . Any "[d]eception, fraud, false pretense, false premise, misrepresentation, or knowing concealment, suppression, or omission ofanymaterial factwiththe intent that the consumer rely on the same in connection with . .. [t]he promotion or sale ofany consumer goods" (Md. Code Ann., Corn. Law §13-301(9)). 283. During the relevant period and as detailed further herein, Respondents have each engaged repeatedly in such practices in violation of the Consumer Protection Act by actively promoting and marketing the use of opioids for indications not federally approved, circulating false andmisleading information concerning opioids' safety andefficacy, downplaying or omitting the risk of addiction arising from their use, and failing to comply with the Controlled Substances Act, aswell as failingto disclosethis noncomplianceto consumers. 284. Respondents' false and misleading statements and representations, including those regarding the appropriateness of opioids for particular conditions, in certain amounts and doses, and/or for specific patients, or as to opioids' benefits and risks, have had the capacity, tendency, -103- and/or effect of deceiving and misleading consumers and constitute unfair or deceptive trade practices as defined in §13-301(1) ofthe Consumer Protection Act. 285. Respondents' false and misleading representations, including those regarding the sponsorship, approval, characteristics, uses, orbenefits ofopioids, e. g., that they are safe, effective, and appropriate for particular conditions and/or specific patients induced prescribers to prescribe Respondents' opioids by deception and constitute unfair or deceptive trade practices as defined in §13-301(2)(i)ofthe ConsumerProtectionAct. 286. Respondents' failure to disclose material of facts, the omission of which deceived or tendedto deceive consumers, including their failure to disclose their marketing practices, the purpose of which was to induce prescribers to prescribe Respondents' opioids regardless of their safety, efficacy, and/or appropriateness, purpose, or associated risks, failure to disclose that Purdue opioids were not safe, effective, appropriate, and/ormedically necessary in the amounts or forthe conditions or patients for which they had been prescribed, and failure to disclose their lack of compliance with legal requirements designed to protect consumers from improper prescribing, constitute unfair, abusive, or deceptive trade practices as defined in §13-301(3) of the Consumer Protection Act. 287. Respondents' failure to design and operate a system to disclose suspicious orders of controlled substances, as well as the failure to actually disclose such suspicious orders, as required of "registrants" by the federal CSA, 21 C. F.R. §1301. 74(b), which is incorporated into Maryland law, see COMAR 10. 19. 03. 01 et seq., constitutes unfair, abusive, or deceptive trade practices, includingunder §13-301(9). 288. Inmarketingandsellingtheiropioids.Respondentsdevisedandknowinglycarried out a scheme and artifice to defraud by means of materially false or fraudulent pretenses, -104- representations, promises, or omissions of material facts regarding suspicious sales and the safe, non-addictive,andeffectiveuse ofopioidsfor long-term chronic,non-acute, andnon-cancerpain. Respondents intended that Proponent, Proponent's agents, prescribers, the public, and persons on whom Proponent and its agents relied would rely on deceptive conduct undertaken at the Sackler Respondents' direction. Such acts and omissions constitute an unfair, abusive, or deceptive trade practice as definedby §13-301(9)ofthe ConsumerProtectionAct. 289. Respondentsengagedin unfairpracticesinviolationof§13-303 by engaginginthe practices alleged above, whichcaused significant consumer harm; consumers could not reasonably avoid that harm; and the harm had no countervailing benefit to consumers or competition that outweighed it. 290. In selling and offering for sale opioids to at risk populations of medical patients, while in flagrant violation of federal and state law, under circumstances in which consumers became dependent and addicted. Respondents engaged in abusive trade practices prohibited by §13-303 of the Consumer Protection Act. 291. Respondents' unfair, abusive, or deceptive acts or practices in violation of the Consumer Protection Act offend Maryland public policy, are immoral, unethical, oppressive, or unscmpulous, aswell asmalicious, wanton, andmanifesting ill will, andcaused substantial injury to the State of Maryland. WHEREFORE, pursuant to the Consumer Protection Act §13-403(b)(l). Proponent respectfully requests that the Consumer Protection Division issue an Order: A. requiring Respondents to cease and desist from engaging in unfair or deceptive trade practices in violation ofthe Consumer Protection Act; -105- B. requiringRespondentsto take affirmativeactions,including,butnot limited to, the restitution and disgorgement of all moneys that it received in connection with their unfair or deceptive trade practices and the creation of an adequate addiction treatment program available to all individuals in Maryland who received Respondents' opioids; C. awarding economic damages; D. requiring Respondents to pay the costs of this proceeding, including all costs of investigation; E. requiringRespondentsto paycivil penaltiespursuantto §13-410for eachviolation of the Consumer Protection Act: and F. granting such other and further relief as is appropriate and necessary Respectfully submitted, Dated: May 29, 2019 BRIAN T. EDMUNDS SARA E. TONNESEN AssistantAttorneys General RYAN E. BOUNDS StaffAttorney Consumer Protection Division Office ofthe Attorney General ofMaryland 200 St. Paul Place, 16th Floor Baltimore, Maryland, 21202 (410) 576-6300 (main) bedmunds@oag.state.md.us stonnesen@oag. state. md. us Attorneys for Proponent -106- SPECIAL LITIGATION COUNSEL: ROBBINS GELLERRUDMAN & DOWD LLP PAUL J. GELLER MARK J. DEARMAN DOROTHY P. ANTULLIS 120 East Palmetto Park Road, Suite 500 BocaRaton, FL 33432 Telephone: 561/750-3000 561/750-3364 (fax) pgeller@rgrdlaw.com mdearman@rgrdlaw. com dantullis@rgrdlaw. com ROBBINS GELLERRUDMAN &DOWDLLP AELISH M. BAIG MATTHEW S. MELAMED Post Montgomery Center One Montgomery Street, Suite 1 800 SanFrancisco, CA 94104 Telephone: 415/288-4545 415/288-4534 (fax) aelishb@rgrdlaw.corn mmelamed@rgrdlaw.com ROBBINS GELLERRUDMAN & DOWD LLP THOMAS E. EGLER CARISSA J. DOLAN 655 WestBroadway,Suite 1900 San Diego, CA 92101 Telephone: 619/231-1058 619/231-7423(fax) tome@rgrdlaw. com cdolan@rgrdlaw. com -107- LIEFF,CABRASER,HEDMANN & BERNSTEIN, LLP ELIZABETH J. CABRASER 275 Battery Street, 29thFloor San Francisco, CA 94111-3339 Telephone: 415/956-1000 415/956-1008 (fax) ecabraser@lchb. com LIEFF,CABRASER,HEIMANN & BERNSTEIN,LLP PAULINA DO AMARAL 250 Hudson Street, 8th Floor New York, NY 10013 Telephone: 212/355-9500 212/355-9592(fax) pdoamaral@lchb. com LIEFF,CABRASER,HEMANN & BERNSTEIN, LLP MARK P. CHALOS 222 Second Avenue South, Suite 1640 Nashville, TN 37201 Telephone: 615/313-9000 615/313-9965 (fax) mchalos@lchb.com SILVERMAN, THOMPSON, SLUTKIN& WHITE,LLC STEVEN D. SILVERMAN ANDREW C. WHITE JOSEPHF. MURPHY,JR. WILLIAM SINCLAIR 201 N. Charles Street, 26th Floor Baltimore, MD 21201 Telephone: (410) 385-2225 (410)547-2432 (fax) ssilvenr»an@mdattomey. corn awhite@mdattomey. com josephmurphy@mdattomey.com bsinclair@mdattomey. com -108-