1 2 3 4 5 6 7 STATE OF WASHINGTON KING COUNTY SUPERIOR COURT 8 9 STATE OF WASHINGTON, Plaintiff, 10 11 12 13 14 v. NO. COMPLAINT FOR INJUNCTIVE AND OTHER RELIEF UNDER THE CONSUMER PROTECTION ACT, RCW 19.86, PUBLIC NUISANCE, AND NEGLIGENCE PURDUE PHARMA L.P.; PURDUE PHARMA INC.; THE PURDUE FREDERICK COMPANY; DOES 1 through 99; and DOE CORPORATIONS 1 through 99, 15 Defendants. 16 17 18 19 20 21 22 23 24 25 26 COMPLAINT ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 TABLE OF CONTENTS I. INTRODUCTION 1 II. PARTIES 3 III. JURISDICTION AND VENUE 6 IV. FACTS 7 4 5 6 7 A. 8 9 10 “The Science of Opioids Is Clear:” The Known, Serious, and Too-OftenFatal Risks Far Outweigh the Unproven and Transient Benefits of Opioids for Treating Chronic Non-Cancer Pain 9 1. Purdue designed and conducted an uncontrolled public health experiment on the American public about the risks of prescribing opioids for chronic non-cancer pain 10 2. Opioids are ineffective for pain relief and functional improvement for chronic non-cancer pain 11 12 13 3. 14 15 16 19 20 21 Evidence from the last two decades has confirmed that opioids are deadly drugs with dangerous side effects, particularly in vulnerable populations 16 4. Evidence from the last two decades has confirmed that opioids are highly addictive 18 5. Opioids are most dangerous when taken long-term and when taken in high doses 20 6. Opioids are only moderately effective at short-term relief 7. Despite the scientific evidence, Purdue continues to market opioids for chronic non-cancer pain 22 17 18 12 21 22 B. FDA Requirements for Promotion of Prescription Drugs 23 C. Washington State Has a Public Policy Interest in Reducing Opioid Addiction and Abuse 27 D. Purdue Used Sophisticated Branded and Unbranded Marketing Targeted at Washington Health Care Providers and Patients to Boost Opioid Prescribing and Its Own Profits 32 24 25 26 COMPLAINT - i 23 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 1. Purdue chased growth by promoting both opioids generally and its brand-name drugs in particular 34 2. Purdue continued to selectively support and disseminate misleading materials from third party groups 2 3 4 3. 5 6 E. 7 8 9 Purdue engaged in deceptive in-person marketing to Washington health care providers 42 Using These Marketing Channels, Purdue Disseminated Deceptive Statements and Assertions Designed to Increase Opioid Prescriptions 45 1. Purdue’s deceptive acts or practices relating to opioids’ ability to improve function 47 2. Purdue deceptively claimed OxyContin was effective for 12 hours 51 3. Purdue’s deceptive acts or practices relating to opioid addiction and opioid harms 56 4. Purdue’s deceptive acts or practices relating to managing addiction and abuse risks 10 11 37 12 13 14 58 5. Purdue petitioned the FDA to prohibit generic versions of Oxycontin’s original formulation, arguing that it presented a public health risk outweighing its benefits 60 6. Purdue deceptively claimed that abuse deterrent formulations could lower opioid risk 62 7. Purdue’s deceptive acts or practices relating to the significant additional risks posed by increased opioid doses 65 8. Purdue’s deceptive acts or practices relating to myths like “pseudoaddiction” 68 9. Purdue’s deceptive acts or practices relating to the management of withdrawal 73 10. Purdue’s deceptive acts or practices relating to the comparison between the risks and benefits of opioids and those of alternative forms of pain treatment 74 15 16 17 18 19 20 21 22 23 24 25 F. 26 COMPLAINT - ii Purdue’s Misconduct Stretches Back Two Decades and Continued Despite a Consent Judgment Regarding the Marketing of OxyContin 76 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 1. Purdue admitted its marketing conduct was unlawful in 2007 and promised to take corrective action 78 2. Despite its Promises of Reform, Purdue Continued its Unfair Practice of Marketing Opioids to, and Concealing from Oversight, its Highest Prescribers 80 5 3. Dr. Delbert Whetstone 81 6 4. Dr. Frank Li and Seattle Pain Center 85 7 5. Advanced Registered Nurse Practitioner Patricia Yetneberk 87 2 3 4 8 G. 9 Washington Prescribers and Their Patients Have Been Directly Affected by Purdue’s Marketing 89 10 1. Dr. Donald Dillinger 90 11 2. Dr. Frank Li and the Seattle Pain Center 97 12 3. Advanced Registered Nurse Practitioner Kelly Bell 101 13 4. Prescribers outstripping their peers 104 14 H. Opioids Have Severely Impacted Washington State 107 15 I. Purdue Is Responsible for Washington’s Opioid Crisis 115 16 V. 17 18 VI. FIRST CAUSE OF ACTION (Violations of the Consumer Protection Act, RCW 19.86) 115 SECOND CAUSE OF ACTION (Public Nuisance) 117 THIRD CAUSE OF ACTION (Common Law NEGLIGENCE) 121 PRAYER FOR RELIEF 123 19 20 21 VII. VIII. 22 23 24 25 26 COMPLAINT - iii ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 I. 1.1 INTRODUCTION On average, two Washingtonians die each day from opioid overdoses. In 2015, 3 opioid overdoses killed 718 Washingtonians, more than either car accidents or firearms. These 4 deaths are attributable to a flood of prescription opioids into the state over the last two decades. 5 Hundreds of millions of prescription opioid pills have been pumped into Washington, 6 including 112 million daily doses of prescription opioids in 2011 alone – enough for a 16-day 7 supply for every woman, man, and child in the state. Seven Washington counties currently 8 have more opioid prescriptions than people. 9 1.2 This enforcement action seeks to protect the public from deceptive and unfair 10 marketing practices in the sale of opioids – dangerous and deadly drugs that are ravaging 11 Washington’s communities and overwhelming public resources. 1 12 1.3 Defendants (collectively “Purdue”), who manufacture, sell, and market 13 extended release opioids, have made an estimated $35 billion selling opioids and should be 14 held responsible for the foreseeable, foreseen, and ongoing consequences of marketing opioids, 15 particularly after it became evident that opioids had caused and were continuing a national 16 epidemic. 17 1.4 This public lawsuit is unique because opioids are unique in the scope of deaths 18 and cost. The U.S. Department of Health and Human Services reported that 33,091 people died 19 of an opioid overdose in 2015. That year more than 12.5 million people misused prescription 20 opioids, and the crisis cost an estimated $78.5 billion to the economy. 2 21 22 1.5 This public lawsuit is unique because the origin of the opioid epidemic is unique. As Washington public health officials have noted, opioid use is the “worst manmade 23 24 25 26 1 Executive Order 16-09, Addressing the Opioid Use Public Health Crisis, available at: http://www.governor.wa.gov/sites/default/files/exe order/eo 16-09.pdf 2 The U.S. Opioid Epidemic, US. Department of Health & Human Services, available at: https://www hhs.gov/opioids/about-the-epidemic/index.html COMPLAINT - 1 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 epidemic in history.” 3 Twenty years ago, this problem did not exist; it was created. 1.6 This public lawsuit is unique because Purdue aggressively marketed what was 3 essentially an uncontrolled experiment on the American public. There was, and is, no reliable 4 evidence that opioids are effective at relieving chronic pain in the long term. As evidence has 5 mounted that, in fact, opioids are associated with poorer outcomes and unacceptably deadly 6 side effects, Purdue has offered half-solutions and half-truths as it continues to push its pills. 7 1.7 This public lawsuit is unique because Purdue cloaked the sale of its products in 8 the legitimacy of medicine. Unlike tobacco or alcohol about which no medical claims were 9 made, patients were told by health care providers that opioids are a powerful medicine, safe to 10 use as prescribed, and effective to relieve chronic pain. Against this message, the public had no 11 defense. 12 1.8 This public lawsuit is unique because of the addictiveness of opioids. Patients 13 quickly became dependent on opioids and, once hooked, susceptible to a host of foreseeable 14 adverse events including addiction and death. Purdue knew of, and profited from, the addictive 15 properties of its drugs. Purdue’s marketing campaign sold the idea that dependence on opioids 16 was an acceptable physiological reaction and that overdoses were the result of addicts misusing 17 the drugs. 18 1.9 This public lawsuit is unique because Purdue’s business practices were 19 specifically aimed at expanding the most dangerous and deadly kind of opioid use—the long- 20 term prescription of high dose opioids. 21 1.10 Purdue’s marketing campaign in support of its opioid drugs is, and has been, 22 deceptive. Purdue systematically overstated the effectiveness of its drugs for treating pain 23 long-term, understated the risk of addiction, and overstated the effectiveness of risk mitigation 24 strategies that Purdue claimed, without evidence, could render opioid use safe. 25 26 3 Gary Franklin et al., A Comprehensive Approach to Address the Prescription Opioid Epidemic in Washington State: Milestones and Lessons Learned, 105 Am. J. Pub. Health 463 (2015). COMPLAINT - 2 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 1.11 The Attorney General, on behalf of the State of Washington, asks this Court to 2 enjoin Purdue’s unfair and deceptive marketing practices related to opioids. The Attorney 3 General further asks this Court to order Purdue to abate the public nuisance created by its 4 marketing and business practices, to disgorge profits gained by its deceptive marketing and 5 business practices, to impose penalties for its illegal conduct, and to award damages. 6 1.12 Having played a significant part in creating this crisis and profiting to the tune 7 of $35 billion, Purdue is responsible for the costs of its conduct that are now being borne by 8 the public. 9 10 II. 2.1 PARTIES The Plaintiff is the State of Washington. The Attorney General is authorized to 11 commence this action pursuant to RCW 19.86.080 and RCW 19.86.140. The State, by and 12 through the Attorney General and the Consumer Protection Division, brings this action to 13 address practices that violate the Consumer Protection Act relating to the marketing and sale of 14 opioid medications. The Attorney General is also authorized to bring this action pursuant to its 15 common law and parens patriae authority to bring an action to abate a public nuisance and 16 vindicate the rights of the public. 17 2.2 Defendant Purdue Pharma L.P. is a limited partnership organized under the laws 18 of Delaware with its principal place of business in Connecticut. Purdue Pharma L.P. is 19 currently registered to do business under UBI 601711150. 4 20 2.3 Defendant Purdue Pharma Inc. is a New York corporation with its principal 21 place of business in Stamford, Connecticut. Purdue Pharma Inc. was previously registered with 22 the Washington Department of Revenue (WDOR) under UBI 602104563. 23 24 25 26 4 Affiliated company Purdue Pharmaceutical Products L.P. is also currently registered with the WDOR under UBI 602349549. COMPLAINT - 3 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2.4 Defendant The Purdue Frederick Company is a Delaware corporation with its 2 principal place of business in Stamford, Connecticut. The Frederick Purdue Company was 3 previously registered with the WDOR under UBI 602002636 and 600056165. 4 2.5 Collectively, the above-identified Defendants are referred to herein as “Purdue.” 5 2.6 Purdue is in the business of manufacturing, promoting, marketing, and 6 distributing opioids in the United States and in Washington. Purdue’s opioid brands include, 7 but are not necessarily limited to, the following: 8 a. OxyContin (oxycodone hydrochloride extended release), which is an 9 opioid agonist tablet indicated for the “management of pain severe enough to require daily, 10 around-the clock, long-term opioid treatment and for which alternative treatment options are 11 inadequate.” Prior to April 2014, OxyContin was indicated for the “management of moderate 12 to severe pain when a continuous, around the clock opioid analgesic is needed for an extended 13 period of time.” 5 14 b. MS Contin (morphine sulfate extended release), which is an opioid 15 agonist tablet indicated for the “management of pain severe enough to require daily, around- 16 the-clock, long-term opioid treatment and for which alternative treatment options are 17 inadequate.” Prior to April 2014, MS Contin was indicated for the “management of moderate 18 to severe pain when a continuous, around the clock opioid analgesic is needed for an extended 19 period of time.” 6 20 c. 21 Dilaudid (hydromorphone hydrochloride), which is an opioid agonist indicated for “the management of pain severe enough to require an opioid analgesic and for 22 23 24 25 26 5 Highlihgts of Prescribing Information: OXYCONTIN, https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s006lbl.pdf (last visited Sep 27, 2017) 6 MS Contin Label, https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019516s034lbl.pdf (last visited Sep 27, 2017) COMPLAINT - 4 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 which alternative treatments are inadequate.” Prior to 2016, Dilaudid injection was indicated 2 for the “management of pain where an opioid analgesic is appropriate.” 7 3 d. Dilaudid-HP (hydromorphone hydrochloride), which is an opioid 4 agonist indicated for the “use in opioid-tolerant patients who require higher doses of opioids 5 for the management of pain severe enough to require an opioid analgesic and for which 6 alternate treatments are inadequate.” 8 Prior to 2016, Dilaudid-HP injection was indicated for 7 “the management of moderate-to-severe pain in opioid-tolerant patients who require higher 8 doses of opioids.” Dilaudid-HP has also previously been indicated “for the relief of moderate- 9 to-severe pain in opioid-tolerant patients who require larger than usual doses of opioids to 10 provide adequate pain relief.” 9 11 e. Butrans (buprenorphine), which is an opioid partial agonist transdermal 12 patch and indicated for the “management of pain severe enough to require daily, around-the- 13 clock, long-term opioid treatment and for which alternative treatment options are inadequate.” 14 Prior to April 2014, Butrans was indicated for the “the management of moderate to severe 15 chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an 16 extended period of time.” 10 17 f. Hysingla ER (hydrocodone bitrate), which is an opioid agonist tablet 18 indicated “for the management of pain severe enough to require daily, around-the-clock, long- 19 term opioid treatment and for which alternative treatment options are inadequate.” g. 20 21 22 23 24 25 26 Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride), which is a combination product of oxycodone, an opioid agonist, and naloxone, an opioid 7 Highlihgts of Prescribing Information: DILAUDID, https://www.accessdata.fda.gov/drugsatfda docs/label/2011/019034s021lbl.pdf (last visited Sep 27, 2017) 8 Highlihgts of Prescribing Information: DILAUDID, https://www.accessdata.fda.gov/drugsatfda docs/label/2011/019034s021lbl.pdf (last visited Sep 27, 2017) 9 Dilaudid Label, https://www.accessdata fda.gov/drugsatfda docs/label/2009/019034s018lbl.pdf (last visited Sep 27, 2017) 10 Highlihgts of Prescribing Information: Butrans, https://www.accessdata.fda.gov/drugsatfda docs/label/2010/021306s000lbl.pdf (last visited Sep 27, 2017) COMPLAINT - 5 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 antagonist indicated for the “management of pain severe enough to require daily, around-the- 2 clock, long-term opioid treatment and for which alternative treatment options are inadequate.” 3 4 2.7 State arising from unlawful marketing of OxyContin, described in further detail below. 5 6 2.8 2.9 Upon information and belief, Defendants Doe Corporations 1 through 99 are corporations, the names and address of which are unknown. 9 10 Upon information and belief, Defendants Does 1 through 99 are individuals whose names and addresses of residence are unknown. 7 8 In May 2007, Purdue entered into a “Consent Judgment” in an action with the 2.10 At all relevant times, each Defendant acted individually or jointly with every other named Defendant in committing all acts alleged in this Complaint. 11 2.11 At all relevant times, each Defendant acted (a) as principal; (b) under express or 12 implied agency; and/or (c) with actual or ostensible authority to perform the acts alleged in this 13 Complaint on behalf of every other named Defendant. 14 2.12 At all relevant times, one or all of the Defendants acted as the agent of the 15 others, and all Defendants acted within the scope of their agency as if acting as the agent of the 16 others. 17 18 2.13 At all relevant times, each Defendant and its employees had awareness of the others’ conduct relating to the matters alleged within the Complaint. 19 20 III. 3.1 JURISDICTION AND VENUE The State files this complaint and institutes these proceedings under the 21 provisions of the Consumer Protection Act, RCW 19.86; the State also brings this action in its 22 parens patriae capacity for the benefit of the state’s residents, to protect their health and safety. 23 3.2 Purdue has engaged in the conduct set forth in this Complaint in King County 24 and elsewhere in the state of Washington. Personal jurisdiction is therefore appropriate under 25 RCW 19.86.160. 26 COMPLAINT - 6 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 3.3 Venue is proper in King County pursuant to RCW 4.12.020 and 4.12.025, and 2 Superior Court Civil Rule 82 because Defendants transact business in King County by 3 marketing and distributing the opioid products to health care providers and consumers in King 4 County, as described more fully below. 5 6 7 8 IV. 4.1 FACTS Purdue makes and markets extended release branded opioids for the treatment of chronic, 11 long-term pain. 4.2 As set forth below, the Attorney General alleges that opioids are not effective at 9 relieving long-term pain and that Purdue does not have sufficient evidence to make such 10 assertions. Moreover, the risks associated with such opioid use outweigh the transient and 11 unproven benefits of opioids. 12 4.3 Although the Food and Drug Administration has approved the sale of opioids, 13 Purdue’s marketing of these drugs has exceeded the labeled use and does not shield Purdue 14 from liability for its deceptive marketing or the public nuisance created by its business model. 15 4.4 Washington State has a strong public policy in favor of protecting its citizens, 16 which extends to preventing Purdue’s deceptive marketing campaign and abating the public 17 nuisance created by Purdue’s opioids. 18 4.5 In contravention of Washington’s public policy, Purdue used sophisticated and 19 highly targeted marketing to deceive and mislead Washington health care providers into 20 expanded and ongoing opioid prescribing in spite of massive and sustained public harms. 21 4.6 Using carefully selected third party materials as well as branded and unbranded 22 marketing, Purdue disseminated deceptive and misleading statements about the effectiveness 23 of opioids, minimized the risk of addiction, and made misleading statements about the ease 24 with which the risk of addiction could be managed. 25 11 26 Chronic pain means pain that lasts longer than three months. COMPLAINT - 7 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.7 Washington prescribers have been directly affected by Purdue’s marketing and 2 their prescribing behaviors have changed so as to increase the prescribing of opioid pain 3 medications. 4 4.8 Despite the associated risk, opioids are widely prescribed; in 2010, almost 20% 5 of visits to the doctor for pain relief resulted in an opioid prescription. 12 This represented a 6 73% increase in visits resulting in an opioid prescription from 2000. Over that same period, 7 non-opioid pain treatments remained relatively constant. 13 This means that the primary change 8 in treating pain in the United States over the last two decades has been the increased 9 prescription of opioids, without an impact on pain. In the last 20 years, opioid prescribing has 10 11 increased by 600%. 14 4.9 In 2012, U.S. health care providers wrote 259 million prescriptions for opioid 12 pain medication, enough for every adult in the United States to have a bottle of pills. 15 The 13 United States constitutes 4.6% of the world’s population, but consumed 80% of the world’s 14 opioid supply in 2011. 16 Washington has 0.09% of the world’s population, but in 2016 15 consumed 1.8% of the world’s opioids. 17 This means Washington consumes nearly 20 times 16 the opioids its population would suggest. 17 18 4.10 The result of Purdue’s deceptive and unfair and negligent conduct dramatically impacted Washington State and has caused extensive public harm. 19 20 21 22 23 24 25 26 12 Matthew Daubresse et al., Ambulatory Diagnosis and Treatment of Non-Malignant Pain in the United States, 2000-2010, 51 Med. Care 870 (2013). 13 Id. 14 Donald Teater, Nat'l Safety Council, The Psychological and Physical Side Effects of Pain Medications (2014), citing Leonard Paulozzi et al., CDC Grand Rounds Prescription Drug Overdoses – a U.S. Epidemic, 61 Morbidity and Mortality Weekly Report 10 (2012). 15 Deborah Dowell, Tamara M. Haegerich & Roger Chou, CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016, 65 Morbidity and Mortality Weekly Report 1 (2016) (2016 CDC Guideline). 16 Teater, supra, citing Daneshvari R. Solanki et al., Monitoring Opioid Adherence in Chronic Pain Patients: Assessment of Risk of Substance Abuse, 14 Pain Physician E119 (2011). 17 U.S. and World Population Clock, U.S. Census Bureau, https://www.census.gov/popclock/ (last visited Sep 27, 2017). COMPLAINT - 8 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 A. 2 “The Science of Opioids Is Clear:” The Known, Serious, and Too-Often-Fatal Risks Far Outweigh the Unproven and Transient Benefits of Opioids for Treating Chronic Non-Cancer Pain 3 4.11 Opioids are a class of central nervous system depressant drugs that attach to 4 receptors in the brain, spinal cord, and gastrointestinal tract and suppresses function. There are 5 several different opioid molecules—morphine, hydrocodone, oxycodone, oxymorphone, 6 hydromorphone, tapentadol, buprenorphine, and methadone being the most common. 7 4.12 Opioids come in two basic formulations: immediate release and extended 8 release. Immediate release opioids deliver the full dose quickly as the pill dissolves. Extended 9 release opioids are concentrated versions of the same active ingredients as immediate release 10 drugs, but contained in a time-release matrix that is supposed to release the drug over time. 11 OxyContin, for example, is oxycodone in a time-release matrix that claims to deliver the drug 12 over 12 hours. 13 4.13 The immediate release opioid market is heavily generic. The extended release 14 market has far more branded products, and Purdue’s drugs compose a majority of the extended 15 release market. 16 4.14 By design and marketing, Purdue’s drugs are intended for long-term use, and 17 Purdue has chosen to market them heavily for use with chronic non-cancer pain patients. As 18 described below, long-term use, particularly in higher doses, is the most deadly and least 19 effective opioid use. 20 4.15 Prescribed for pain relief, opioids also depress respiration, which is the primary 21 mechanism by which opioids have killed thousands of Washington citizens and hundreds of 22 thousands of Americans. It is undisputed that opioids are both addictive and deadly. 23 4.16 Prescription opioids constitute the largest component of the opioid epidemic, 24 25 26 COMPLAINT - 9 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 both in quantity and damage caused. 18 Overdose deaths parallel the prescribing of opioids. 19 In 2 fact, filling an opioid prescription is significant risk factor for overdose. 20 3 4 5 4.17 taken as prescribed; 21 the opioid epidemic is not a crisis of abuse – it is a crisis of use. 1. Purdue designed and conducted an uncontrolled public health experiment on the American public about the risks of prescribing opioids for chronic non-cancer pain 4.18 In the mid-1990s, at about the time Purdue launched OxyContin, the medical 6 7 Both opioid use disorder and overdose risk are present even when opioids are 8 community was aware of both the risks of opioids and the relative ineffectiveness of long-term 9 opioid use. Dr. Russell Portenoy, whose theories were later adopted by Purdue, acknowledged 10 11 12 13 14 15 the prevailing medical understanding regarding use of opioids long-term for non-cancer pain: The traditional approach to chronic non-malignant pain does not accept the long-term administration of opioid drugs. This perspective has been justified by the perceived likelihood of tolerance, which would attenuate any beneficial effect over time, and the potential for side effects, worsening disability, and addiction. According to conventional thinking, the initial response to an opioid drug may appear favorable, with partial analgesia and salutatory mood changes, but adverse effects will inevitably occur thereafter. 22 Thus, in 1994, conventional wisdom predicted that opioids would appear effective in the short 16 term, but prove ineffective over time with increasing negative effects. 17 4.19 The medical community knew from that published reports associated opioid use 18 “with heightened pain and functional impairment, neuropsychological toxicity, prevarication 19 20 21 22 23 24 25 26 18 In 2015, almost half of all opioid deaths involved prescription opioids, and from 1999 to 2015, 183,000 deaths involved prescription opioids. Rose A. Rudd et al., Increases in Drug and Opioid-Involved Overdose Deaths – United States, 2010-2015, 65 Morbidity and Mortality Weekly Report 1145 (2016). 19 CDC, January 1, 2016 Morbidity and Mortality Weekly Report; Rudd et al., Increases in Drug and Opioid Overdose Deaths – United States, 2000-2014, 16 American Journal of Transplantation 1323 (2016). 20 Dowell, supra note 15, at 22-24. 21 Letter from Janet Woodcock, MD., Dir., Center for Drug Eval. and Research, to Andrew Kolodny, M.D. (Sept 10, 2013). available at http://www.supportprop.org/wpcontent/uploads/2014/12/FDA CDER Response to Physicians for Responsible Opioid Prescribing Partial Pe tition Approval and Denial.pdf 22 Russell Portenoy, Opioid Therapy for Chronic Nonmalignant Pain: Current Status, 1 Progress in Pain Res. & Mgmt, 247 (1994). COMPLAINT - 10 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 about drug use, and poor treatment response.” 23 And Dr. Portenoy noted, “the problematic 2 nature of opioid therapy in some patients is unquestionable, and the potential adverse impact of 3 all possible outcomes related to treatment, including physical dependence, deserves to be 4 addressed.” 24 5 4.20 Standing against the conventional wisdom, Dr. Portenoy argued in favor of 6 expanding the use of opioids, pointing to evidence from opioid use among cancer patients. He 7 posited that there was a population of patients without cancer who could benefit from long- 8 term opioid use. Even then, he admitted, “controlled trials suggest favorable outcomes, but are 9 very limited. The generalizability of these data are questionable due to the brief periods of 10 11 12 treatment and follow-up.” 25 4.21 Dr. Portenoy claimed that the lack of evidence should not stop doctors from prescribing opioids, arguing there was a lack of data 15 that nonmalignant pain generally, or any patient subgroup with nonmalignant pain (such as those with neuropathic pain, low back pain, headache, or idiopathic pain), are inherently unresponsive to opioids drugs. Consequently, therapy cannot be withheld based on the a priori assumption that any particular pain or patient group will inevitably fail to benefit. 26 16 4.22 13 14 17 18 19 20 Dr. Portenoy then proposed what was, in effect, an uncontrolled experiment. Expand the use of opioids and then monitor to see what would happen: Controlled clinical trials of long-term opioid therapy are needed, but the lack of these trials should not exclude empirical treatment when medical judgment supports it and therapy is undertaken with appropriate monitoring. If treatment is offered, documentation in the medical record of pain, side effects, functional status, and drug-related behaviors must be ongoing and explicit. 27 21 22 23 24 25 26 23 Russell K. Portenoy, Opioid Therapy for Chronic Nonmalignant Pain: A Review of the Critical Issues, 11 J. Pain & Symptom Mgmt. 203, 206 (1996). 24 Id. 25 Id. at 204. 26 Id. at 206. 27 Id. at 212. COMPLAINT - 11 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.23 Purdue seized on the work of Dr. Portenoy. Where Portenoy proposed a clinical 2 experiment with “appropriate monitoring,” Purdue, through its marketing, expanded the 3 “empirical treatment” to thousands of busy primary care physicians, nurse practitioners, 4 physician assistants, and other prescribers, none of whom had Dr. Portenoy’s expertise. 5 4.24 Purdue’s business and marketing model nationalized an experiment in the 6 absence of good evidence. Purdue hired other health care professionals that Purdue identified 7 as “key opinion leaders” (or KOLs) and, through an extensive marketing scheme, set about 8 convincing the rest of the medical establishment, patients, and policy makers to participate 9 willingly in the experiment. As described below, Purdue did so by deceptively presenting the 10 experimental hypotheses – that (a) opioids would be more effective than alternatives at treating 11 chronic non-cancer pain long-term; and (b) the risks of addiction and associated problems were 12 both slight and manageable – as facts. Purdue’s factual claims were unsubstantiated and, 13 unfortunately for the many Washingtonians who have suffered as a result, untrue. 14 2. Opioids are ineffective for pain relief and functional improvement for chronic non-cancer pain 4.25 Central to this lawsuit is the scientific fact that there is reliable evidence that 15 16 17 opioids either relieve pain or improve function when taken long-term for chronic pain. The 18 Centers for Disease Control (CDC) published a Guideline for Prescribing Opioids for Chronic 19 Pain in 2016. This guideline, published after a “systematic review of the best available 20 evidence” by an expert panel free of conflicts of interest, 28 determined that no study exists to 21 show opioids are effective for outcomes related to pain, function, and quality of life. 29 22 23 4.26 Purdue’s decision to market opioids for long-term use despite the absence of clinical evidence and based on the hypothesis of a few cherry-picked doctors was a calculated 24 25 28 29 26 Dowell, supra note 15, at 2. Dowell, supra note 15. COMPLAINT - 12 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 gamble; Purdue bet that the conventional medical wisdom was wrong and that the detrimental 2 side effects of long-term opioid use could be acceptably managed. 3 4.27 The scientific reality is otherwise. As Dr. Thomas Frieden, the Director of the 4 CDC from 2011 to 2017, and Dr. Debra Houry, the Director of the National Center for Injury 5 Prevention and Control, explained in 2016: “the science of opioids for chronic pain is clear: for 6 the vast majority of patients, the known, serious, and too-often-fatal risks far outweigh 7 unproven and transient benefits.” 30 8 4.28 A University of Washington pain specialist, Dr. John Loesser, explained that 9 based on clinical experience, his clinic had developed a rule that it was not wise to use opioids 10 for chronic pain treatments. Of Dr. Portenoy’s theory that there was a population of non-cancer 11 patients who could safely and effectively use opioids, Dr. Loesser explained, 12 13 14 It did not enter our minds that there could be significant numbers of chronic pain patients who were successfully managed with opioids, because if there were any, we almost never saw them. 31 4.29 On a nationwide scale, opioids did not offer a solution for what Purdue claimed 15 was the widespread undertreatment of pain. Despite the fact that opioid prescriptions 16 quadrupled from 1999 to 2015, the overall prevalence of patient-reported pain has remained 17 consistent. 32 Thus, the massive expansion of prescribing opioids for pain has made little 18 progress in reducing chronic pain. 19 4.30 At first blush, it may seem counterintuitive that opioids, used to treat pain for 20 centuries, are ineffective at relieving pain. But 1994 conventional wisdom was prophetic. 21 Opioids, when used long-term, cause tolerance, meaning larger and larger doses are necessary 22 23 24 25 26 30 Thomas R. Frieden & Debra Houry, Reducing the Risks of Relief – The CDC Opioid-Prescribing Guideline, 374 New Eng. J. Med. 1501 (2016). 31 John D. Loeser, Five Crises in Pain Management, 20 Pain Clinical Updates 1 (2012). 32 Centers for Disease Control, Injury Prevention & Control: Opioid Overdoes, Understanding the Epidemic, https://www.cdc.gov/drugoverdose/epidemic/index html (last accessed 9/6/17) citing Daubresse et al., supra note 12. COMPLAINT - 13 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 to get the same effect. Long-term use also causes dependence, meaning that attempts to stop 2 using the drug cause withdrawal symptoms. 33 In addition, long-term opioid use is associated 3 with hyperalegisa, or heightened sensitivity to pain. 34 4 4.31 While opioids may provide relief in the short term, they fail for their stated 5 purpose of relieving pain in chronic pain conditions. In 2009, Dr. Andrea Rubenstein described 6 a common experience for patients on long-term opioid treatment: 7 8 9 10 Opioids may work acceptably well for a while, but over the long term, function generally declines, as does general health, mental health, and social functioning. Over time, even high doses of potent opioids often fail to control pain, and these patients are unable to function normally. 35 4.32 The 2016 CDC guideline notes that “patients who do not experience clinically 11 meaningful pain relief early in treatment (i.e. within 1 month) are unlikely to experience pain 12 relief with longer-term use.” 36 13 4.33 A 2006 Danish study found that “it is remarkable that opioid treatment of 14 chronic non-cancer pain does not seem to fulfill any of the key outcome goals; pain relief, 15 improved quality of life and improved functional capacity” and noted that in one study, opioid 16 users were more likely to report pain, having more pain locations, being more depressed and 17 physically disabled than non-opioid users.” 37 18 19 4.34 A 2006 Canadian meta-study, which noted that a majority of studies were funded by the pharmaceutical industry, still found no evidence that opioids improved function 20 21 22 23 24 25 26 33 Mitchell H. Katz, Long-term Opioid Treatment of Nonmalignant Pain, 170 Archives of Internal Med. 1422 (2010). 34 Marion S. Greene & R. Andrew Chambers, Pseudoaddiction: Fact or Fiction? An Investigation of the Medical Literature, 2 Current Addiction Reports 310 (2015). 35 A. Rubenstein, Are We Making Pain Patients Worse?, Sonoma Medicine, http://www.nbcms.org/aboutus/sonoma-county-medical-association/magazine/sonoma-medicine-acute-and-chronic-pain-inorthopedics.aspx?pageid=145&tabid=747 (last visited Sep 27, 2017). 36 Dowell, supra note 15, at 2. 37 Jørgen Eriksen et al., Critical Issues on Opioids in Chronic Non-Cancer Pain: An Epidemiological Study, 125 Pain 172, 176-77 (2006). COMPLAINT - 14 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 more than other non-opioid analgesics, finding instead that, “for functional outcomes the other 2 analgesics were significantly more effective than were opioids. 38 3 4.35 The deleterious effects of long-term opioid use are supported by a 2008 study 4 which found daily opioid use at modest doses over six months is linked with self-reported 5 poorer physical function and poorer general health. 39 Similarly, a 2008 study in the journal 6 Spine found that long-term opioid users are more likely to be disabled and unable to work, as 7 well as more likely to be addicted. 40 8 9 10 11 4.36 A 2012 study in the Journal of Pain, which followed 69,000 women over three years, found that patients who received opioid treatment were less likely to have improvement in pain, and had worsened function. 41 4.37 In 2012, a group of medical providers petitioned the FDA to impose limits on 12 opioid use. The FDA considered the state of evidence and concluded that it was “not aware of 13 adequate and well-controlled studies of opioid use longer than 12-weeks.” 42 The FDA went on 14 to note that more data was needed “on the point at which the risk of opioid use at escalating 15 doses and longer durations of treatment may outweigh the benefits of opioid analgesic 16 therapy.” 43 17 4.38 The evidence from real world opioid use similarly reflects a lack of efficacy. 18 Analyses of workers’ compensation claims have found that workers who take opioids are 19 almost four times more likely to reach costs over $100,000, owing to greater side effects and 20 21 22 23 24 25 26 38 Andrea D. Furlan et al., Opioids for Chronic Noncancer Pain: A Meta-analysis of Effectiveness and Side Effects, 174 Canadian Med. Ass’n J. 1589 (2006). 39 Rubenstein, supra note 35, citing citing Kathryn Sullivan Dillie et al., Quality of Life Associated with Daily Opioid Therapy in a Primary Care Chronic Pain Sample, 21 Journal of the American Board of Family Medicine 108 (2008). 40 Jeffrey Dersh et al., Prescription Opioid Dependence Is Associated With Poorer Outcomes in Disabling Spinal Disorders, 33 Spine 2219 (2008). 41 Frieden, supra note 30, citing Jennifer Brennan Braden et al., Predictors of Change in Pain and Physical Functioning Among Post-Menopausal Women with Recurrent Pain Conditions in the Women’s Health Initiative Observational Cohort, 13 J. Pain 64 (2012). 42 Woodcock Letter (Sept 10, 2013). 43 Woodcock Letter (Sept 10, 2013). COMPLAINT - 15 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 slower returns to work. 44 In addition, receiving an opioid for more than seven days increased 2 patients’ risk of being on work disability one year later; and that an opioid prescription as the 3 first treatment for a workplace injury doubled the average length of the claim. 4 4.39 Thus, just as was the case with Dr. Portenoy’s work in 1990s, the pattern of the 5 opioid experiment remained the same: In the face of mounting evidence of a developing opioid 6 epidemic, Purdue was marketing drugs for which there was no evidence of effectiveness. 7 3. Evidence from the last two decades has confirmed that opioids are deadly drugs with dangerous side effects, particularly in vulnerable populations 4.40 The last 20 years have proven that the conventional understanding of the danger 8 9 10 and relative ineffectiveness of opioids was more accurate than Dr. Portenoy’s hypothesis and 11 Purdue’s marketing in support of their widespread use. Opioids are massively dangerous. 12 4.41 Between 1999 and 2014, more than 165,000 Americans died of opioid 13 overdose. 45 Deaths related to opioids are accelerating. In 2015, opioids killed 33,091 people 14 and the opioid death rate increased by 15.6%. 46 15 16 17 18 19 20 21 4.42 Dr. Freidan from the CDC explained, “We know of no other medication routinely used for a nonfatal condition that kills patients so frequently.” 47 4.43 Aside from overdose, long-term opioid use is associated with a significant increase in mortality from other causes. 48 4.44 Opioids are also associated with numerous other side effects including gastrointestinal impacts, delayed recovery from injury, cognitive impacts, endrocrine impacts, hyperalgesia (increased sensitivity to pain), increased risks of fractures, gastrointestinal 22 44 23 24 25 26 Gary M. Franklin et al., Early Opioid Prescription and Subsequent Disability Among Workers With Back Injuries, 33 Spine 199 (2008). 45 Dowell, supra note 15. 46 Washington experienced a 12.5% increase in opioid death rates in 2015. Rudd et al., supra note 18. 47 Frieden, supra note 30 48 Wayne A. Ray et al., Prescription of Long-Acting Opioids and Mortality in Patients With Chronic Noncancer Pain, 315 J. Am. Med. Ass'n 2415 (2016). COMPLAINT - 16 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 bleeding, hospitalization among the elderly, tolerance (need for increasing dose to maintain 2 effect), dependence (causing withdrawal if stopped), and addiction. 49 3 4.45 Opioids carry special risks for certain vulnerable populations. For example, 4 opioid use during pregnancy has seen a three to- to four-fold increase between 2000 and 2009, 5 with increased fetal, obstetrical, and neonatal abstinence syndrome risk. Neonatal abstinence 6 syndrome may occur in up to 60-80% of infants exposed to opioids and has increased every 7 year through 2013. 50 Of pregnant women enrolled in Medicaid from 2000 to 2007, 21.6% 8 filled an opioid prescription during pregnancy. 51 9 4.46 Opioids also pose risks for children and adolescents. Most of the use in this 10 population is off-label as opioids are not approved for children. Use of prescription opioid pain 11 medication before high school graduation is associated with a 33% increase in the risk of later 12 opioid misuse. The misuse of opioids in adolescents strongly predicts the later onset of heroin 13 use. 52 Nonetheless, the 2016 CDC guidelines found that there have been significant increases 14 in opioid prescribing for children and adolescents, for conditions such as headaches and sports 15 injuries. 16 4.47 Opioids also pose special risks for older patients as well, in part due to the 17 decline in the ability to metabolize and excrete opioids. Older patients on opioids are 18 particularly prone to constipation, have increased risk for falls and fractures, and have a higher 19 risk of opioid-related adverse drug events. 53 20 21 22 23 49 Teater, supra note 14. Washington State Agency Medical Director’s Group (WSAMDG), Interagency Guideline on Prescribing Opioids for Pain, 49, 3rd ed. (2015). 51 WSAMDG, supra, at 42. 52 Dowell, supra note 15. 53 WSAMDG, supra, at 47-48. 50 24 25 26 COMPLAINT - 17 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4. Evidence from the last two decades has confirmed that opioids are highly addictive 4.48 Opioids are also extremely addictive. Studies have found diagnosed addiction 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 rates in primary care settings as high as 26%. 54 Among opioid users who received four prescriptions in a year, 41.3% meet diagnostic criteria for a lifetime opioid-use disorder. 55 4.49 Once a patient starts opioid treatment, it is extraordinarily difficult to stop. A 2017 CDC study determined that the probability of long-term use escalates most sharply after five days, and surges again when one month of opioids are prescribed. 56 A patient initially prescribed one month of opioids has a 29.9% chance of still using at one year. 57 In one study, almost 60% of patients who used opioids for 90 days were still using opioids five years later. 58 4.50 The difficulty in stopping use is particularly true for patients first prescribed an extended release opioid. Patients who initiated treatment on an extended release opioid – such as OxyContin – have a 27.3% likelihood to be using opioids one year later, and a 20.5% likelihood of using opioids three years later. 59 4.51 In 2013, the FDA observed that extended release opioids, like those Purdue markets, present “disproportionate safety concerns” and that the data show that the risk of misuse and abuse is greater for extended release opioids. 60 In requiring a new black-box warning on the labels of all immediate release opioids in March 2013, the FDA noted the 54 Dowell, supra note 15, at 22-24. Joseph A. Boscarino, Stuart N. Hoffman & John J. Han, Opioid-Use Disorder Among Patients on Long-Term Opioid Therapy: Impact of Final DSM-5 Diagnostic Criteria on Prevalence and Correlates, 6 Substance Abuse and Rehabilitation 83 (2015); see also Joseph A. Boscarino et al., Prevalence of Prescription Opioid-Use Disorder Among Chronic Pain Patients: Comparison of the DSM-5 vs. DSM-4 Diagnostic Criteria, 30 Journal of Addictive Diseases 185 (2011) (showing a 34.9% lifetime opioid use disorder). 56 Anuj Shah, Corey J. Hayes & Bradley C. Martin, Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use – United States, 2006-2015, 66 Morbidity and Mortality Weekly Report 265–269 (2017). 57 Id. 58 Bradley C. Martin et al., Long-Term Chronic Opioid Therapy Discontinuation Rates from the TROUP Study, 26 J. Gen. Internal. Med. 1450 (2011). 59 Shah, supra. 60 Woodcock Letter (Sept 10, 2013). 55 COMPLAINT - 18 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 “known serious risk[] of ... addiction” which was present “even at recommended doses of all 2 opioids.” 61 3 4.52 The CDC found that “[o]pioid pain medication use presents serious risks, 4 including overdose and opioid use disorder” – a technical term for addiction. 62 The CDC 5 emphasized that “continuing opioid therapy for 3 months substantially increases risk for opioid 6 use disorder.” 63 7 4.53 Whether in the end a patient meets the clinical definition of addiction or is 8 simply dependent and unable to stop using opioids, once opioids are prescribed for even a short 9 period of time, patients are hooked. 10 11 4.54 Purdue’s marketing strategy, and business model, relies on this fact. According to internal documents, 12 . Similarly, 13 . Purdue’s profits depend on keeping continuing patients. 14 4.55 Marketing a substance as dangerous and addictive as opioids quickly crosses the 15 line into an unfair trade practice. Indeed, after one Longview health care provider told a Purdue 16 sales representative that 17 18 , the sales representative was nevertheless instructed to follow up and convince the provider to 19 20 Because opioids cause tolerance and dependence, patients who take the 21 drugs for even a short time become a physiologically captured market. If Purdue convinces a 22 doctor and patient to start opioid treatment, Purdue knew that the patient would keep taking 23 them. 24 61 25 26 Woodcock Letter (Sept 10, 2013). Dowell, supra note 15, at 2. 63 Dowell, supra note 15, at 21. 62 COMPLAINT - 19 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 5. Opioids are most dangerous when taken long-term and when taken in high doses 4.56 The risk of addiction and negative consequences increases when opioids are 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 administered long-term. 64 In 2013, the FDA noted that the data show that risk of misuse and abuse is greatest for extended release opioids and observed that these drugs are often used chronically. 65 4.57 One study has shown that the duration of opioid therapy is a strong risk factor for opioid use disorder, even more important than daily dose (which is itself a strong predictor of continued opioid use). 66 In fact, a study published in 2015 found that 1 in 5 patients on longterm opioid treatment will develop opioid use disorder. 67 4.58 Higher doses of opioids are dangerous in a number of ways. A CDC clinical evidence review found that higher opioid dosages were associated with increased risks of motor vehicle injury, opioid use disorder, and overdose, and that the increased risk rises in a dose-dependent manner. 68 Another study found that higher daily doses and possible opioid misuse were also (a) strong predictors of continued use, and (b) associated with increased risk of overdoses, fractures, dependence, and death. 69 4.59 Accordingly, the CDC recommended that physicians carefully reassess increasing opioid doses beyond 50 morphine milligram equivalents (MMEs), and avoid exceeding 90 MMEs/day. 70 Roughly translated, a single 60 mg pill of oxycodone, the active 64 See e.g. Wilson M. Compton & Nora D. Volkow, Major Increases in Opioid Analgesic Abuse in the United States: Concerns and Strategies, 81 Drug and Alcohol Dependence 103, 104 (2006) ( noting increased risk of addiction for long-term administration of opioids). 65 Woodcock Letter (Sept 10, 2013). 66 Mark J. Edlund et al., The Role of Opioid Prescription in Incident Opioid Abuse and Dependence Among Individuals with Chronic Non-cancer Pain, 30 Clin. J. Pain 557–564 (2014). 67 WSAMDG, supra note 42, citing Louisa Degenhardt et al., Agreement between definitions of pharmaceutical opioid use disorders and dependence in people taking opioids for chronic non-cancer pain (POINT): a cohort study, 2 The Lancet Psychiatry 314–322 (2015). 68 Dowell, supra note 15, at 22-24. 69 Edlund, supra. 70 Dowell, supra note 15, at 22-24. COMPLAINT - 20 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 ingredient in OxyContin, is 90 MME; a 40 mg pill is 60 MME; and a single 30 mg pill is 45 2 MME. Since patients take 12-hour OxyContin twice a day, a prescription for 30 mg pills of 3 OxyContin is already at the CDC’s upper threshold. 4 4.60 Measured against the general risk, the likelihood of developing an opioid use 5 disorder increases threefold for acute patients prescribed even low dose opioids. For patients 6 taking a daily dose of more than 120 MMEs over the long term, the chance of developing an 7 opioid use disorder increases 122-fold. 71 8 9 10 4.61 At high doses, patients are also at higher risk of poor functional status, increased pain sensitivity, and continuation of opioid treatment for a prolonged period. 72 4.62 Overdose risk from opioids begins at very low doses, doubling when the daily 11 dose is between 20 MMEs and 49 MMEs; by 100 MMEs, the risk of death increases 9-fold.73 12 Recent studies of Washington workers’ compensation and Medicaid populations found that 13 nearly half of all overdose hospitalizations occur in patients who are on intermittent or lower 14 dose opioids. 74 15 4.63 Overall, 1 in every 550 patients on opioid treatment dies of opioid-related 16 causes a median of 2.6 years after their first opioid prescription. That number increases to 1 in 17 32 for patients receiving 200 MMEs/day. 75 18 19 4.64 In short, there are no safe opioid doses, but the higher the dose and the longer the treatment, the more likely serious adverse events are to occur. 20 6. Opioids are only moderately effective at short-term relief 21 4.65 Although there is evidence that opioids are effective in treating acute and short- 22 term painful conditions, the perception of their effectiveness exceeds their actual utility. 23 71 24 25 26 WSAMDG, supra note 42, at 7-8. WSAMDG, supra note 42, at 13. 73 WSAMDG, supra note 42, at 12. 74 WSAMDG, supra note 42, at 13. 75 Frieden, supra note 30. 72 COMPLAINT - 21 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.66 Even for short-term use, opioids are only modestly effective. In a 2004 meta- 2 analysis, opioids reduced pain by only 30%, or 2 points on a scale of 1-10 over placebo for 3 neuropathic pain conditions. For osteoarthritis, musculoskeletal pain, and mixed pain 4 conditions, opioids provided either insignificant relief or less than the 30% reduction. 76 Even 5 then, several studies suggest that ibuprofen and acetaminophen are better than opioids at 6 relieving pain such as dental pain, low back pain, and moderate acute traumatic pain. 77 7 7. Despite the scientific evidence, Purdue continues to market opioids for chronic non-cancer pain 4.67 Purdue’s decision to promote expansive opioid use without good evidence of 8 9 10 efficacy and in spite of the recognized risks created what Washington state public health 11 officials have described as, “one of the worst manmade epidemics in history.” 78 12 4.68 Remarkably, more than 20 years after Dr. Portenoy pointed out that there were 13 no reliable clinical trials about long-term opioid use, there are still no reliable clinical studies 14 supporting the use of opioids over the long term. On the contrary, there exists a wealth of 15 evidence establishing that opioids are both addictive and deadly. 16 4.69 Indeed, the original proponents of expanded opioid prescribing now admit error. 17 Purdue key opinion leader Dr. Portenoy has admitted that he overstated opioids’ benefits and 18 downplayed their risks: “Did I teach about pain management, specifically about opioid therapy, 19 in a way that reflects misinformation? Well, against the standards of 2012, I guess I did . . . We 20 didn’t know then what we know now.” 79 21 22 23 4.70 Purdue, nevertheless, continues to market opioids as necessary to address chronic pain and that its drugs can used long-term with the appropriate patient. 76 Rubenstein, supra note 35. Teater, supra note 14. 78 Franklin et al., supra note 3. 79 Thomas Catan & Evan Perez, A Pain-Drug Champion Has Second Thoughts, The Wall Street Journal, Dec. 17, 2012, https://www.wsj.com/articles/SB10001424127887324478304578173342657044604 (last visited September 27, 2017). 77 24 25 26 COMPLAINT - 22 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.71 Purdue’s stated motive for promoting opioids was providing pain relief, but its 2 underlying motive was profit. Purdue’s aggressive marketing of opioids for the most dangerous 3 kind of opioid use has been exceedingly financially lucrative. 4 4.72 Purdue, which is a privately-owned family company, has generated an estimated 5 $35 billion in sales since 1995, with annual revenues around $3 billion. 80 In 2012, the extended 6 release opioid market recorded $5.2 billion in sales. OxyContin alone generated $2.8 billion, or 7 more than half of that amount. In 2014, the total opioid market reached $11 billion and is 8 projected to continue generating these levels of revenues. 81 9 B. 10 FDA Requirements for Promotion of Prescription Drugs 4.73 The Food and Drug Administration (FDA) regulates drugs manufactured for 11 sale in the United States. But the FDA’s regulatory scheme is limited in important ways and 12 Purdue took advantage of those limitations. While the FDA approves drug and drug labels, the 13 drug companies remain liable for misleading marketing under both federal and state law. 14 15 16 17 18 19 20 21 22 23 24 25 26 4.74 As a pharmaceutical manufacturer that markets opioids, Purdue is subject to federal rules requiring truthful marketing of prescription drugs. The Food, Drug & Cosmetic Act (FDCA) regulates the promotion of prescription drugs. 21 U.S.C. §§ 301, et seq. The FDA must approve a drug’s label and promotional activity at the time of application. 82 4.75 Drug companies’ promotional activity can be branded or unbranded. Unbranded marketing does not refer to a specific drug, but promotes a type of treatment generally, and 80 Alex Morrell, The OxyContin Clan: The $14 Billion Newcomer to Forbes 2015 List of Richest U.S. Families, Forbes, July 1, 2015, https://www.forbes.com/sites/alexmorrell/2015/07/01/the-oxycontin-clan-the-14billion-newcomer-to-forbes-2015-list-of-richest-u-s-families/#4348400475e0 (last visited Sept. 20, 2017). 81 GBI Research, Despite Substance Abuse Concerns, the US Opioid Market Will Hit $17.7 Billion by 2021, March 31, 2016 , http://gbiresearch.com/media-center/press-releases/despite-substance-abuse-concerns-theus-opioid-market-will-hit-177-billion-by-2021 (last visited Sept. 27, 2017). 82 The FDCA, 21 U.S.C. § 32l(m), defined labeling to include "all labels and other written, printed, or graphic matter ... accompanying [a drug]." Title 21, Code of Federal Regulations, Section 202. l (1)(2) provided that labeling included brochures, booklets, mailing pieces, detailing pieces, bulletins, letters, motion picture films, sound recordings, exhibits, literature, and reprints and similar pieces of printed, audio, or visual matter descriptive of a drug which were disseminated by or on behalf of a drug's manufacturer, packer, or distributor. Such items "accompanied" a drug if they were designed for use and used in the distribution and sale of the drug. COMPLAINT - 23 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 unbranded materials are not typically reviewed by the FDA. Moreover, by using unbranded 2 communications, drug companies can evade the regulatory framework governing branded 3 communications. 4 4.76 Conversely, branded marketing, which identifies and promotes a specific drug, 5 such as OxyContin or Butrans, is subject to FDA review and must: (a) be consistent with its 6 label and supported by substantial scientific evidence; (b) not include false or misleading 7 statements or material omissions; and (c) fairly balance the drug’s benefits and risks. 83 8 4.77 The FDCA expressly prohibits the sale of drugs that are “misbranded.” A drug 9 is “misbranded” if it lacks “adequate directions for use” or if the label is false or misleading “in 10 any particular.” 84 “Labeling” includes more than the drug’s physical label; it also includes “all 11 . . . other written, printed, or graphic matter . . . accompanying” the drug, including 12 promotional material. 85 Thus, Purdue’s promotional materials are part of its drugs’ labels and 13 required to be accurate, balanced, and not misleading. 86 14 4.78 Labeling is misleading if it is not based on substantial evidence, if it materially 15 misrepresents the benefits of the drug, or if it omits material information about or minimizes 16 the frequency or severity of a product’s risks. “The most serious risks set forth in a product’s 17 labeling are generally material to any presentation of efficacy.” The FDA notes that “[b]ecause 18 people expect to see risk information, there is no reason for them to imagine that the product 19 20 21 22 23 24 25 26 83 21 U.S.C. § 352(a); 21 C.F.R. §§ 1.21(a), 202.1(e)(3), 202.1(e)(6). 21 U.S.C. §§ 352(a) 85 21 U.S.C. § 321(m) “The term “accompanying” is interpreted broadly to include promotional materials—posters, websites, brochures, books, and the like—disseminated by or on behalf of the manufacturer of the drug. 86 The FDCA, 21 U.S.C. § 32l(n), states that “[i]n determining whether the labeling ... [was] misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representation or material with respect to the consequences which may result from the use ... to which the labeling ... relates under the conditions of use prescribed in the labeling or under such conditions of use as are customary or usual.” 84 COMPLAINT - 24 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 has important risks that have been omitted . . . especially if some risks are included.” 87 2 Promotional materials or marketing that fail to present the drug’s most significant risks as 3 prominently as its benefits lack fair balance and are therefore deceptive. 88 4 4.79 Purdue is also prohibited from distributing materials that exclude contrary 5 evidence or information about the drug’s safety or efficacy or that present conclusions that 6 “clearly cannot be supported by the results of the study.” 89 Pharmaceutical companies must not 7 make comparisons between their drugs and other drugs in which they represent or suggest that 8 “a drug is safer or more effective than another drug in some particular when it has not been 9 demonstrated to be safer or more effective in such particular by substantial evidence or 10 11 substantial clinical experience.” 90 4.80 The public policy underpinning this regulatory framework is designed to ensure 12 that drug companies, which are in the best position to understand the effects and risks of their 13 drugs, are responsible for providing prescribers with the information the prescribers need to 14 accurately assess the risks and benefits of drugs for their patients. Purdue’s misbranded 15 marketing and deceptive unbranded marketing of opioids are contrary to that purpose. 16 4.81 While the FDA must approve a drug’s label, it is Purdue’s responsibility to 17 ensure that the material in its label is accurate and complete and to update the label 91 to reflect 18 any new information. Promotional materials also must be submitted to the FDA when they are 19 20 21 22 23 24 25 26 87 FDA, Draft Guidance for Industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion, at 14 (2009). 88 The State is not alleging a cause of action against Purdue for mislabeling under the Food, Drug & Cosmetic Act. The State’s deception claims are alleged herein pursuant to Washington’s Consumer Protection Act, RCW 19.86. 89 21 C.F.R. § 99.101(a)(4). 90 21 C.F.R. § 202.1(e)(6)(ii) 91 See 21 C.F.R. § 201.56 (providing general requirements for prescription drug labeling); see also Wyeth v. Levine, 555 U.S. 555 (2009) (holding that a drug company bears responsibility for the content of its drug labels at all times); 21 C.F.R. § 314.70(c)(6) (iii)(A-C) (allowing manufacturers to make changes that “strengthen . . . a warning, precaution, or adverse reaction” or “strengthen a statement about drug abuse, dependence, psychological effect, or overdosage”). COMPLAINT - 25 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 first used or disseminated, however the FDA does not have to approve these materials in 2 advance. 3 4.82 The FDA does not monitor the in-person sales representatives detailing visits to 4 prescribers. The FDA does not ask companies to submit preplanned messages or training 5 materials such as sales scripts, talking points, sales bulletins, or sales training videos that are 6 provided to sales representatives for their study and use making a sales pitch to prescribers. 7 The FDA does not require submission of any prepared text in response to unsolicited drug 8 queries made to pharmaceutical companies by prescribers; and the FDA does not directly 9 regulate funding for or content of continuing medical education. 92 10 4.83 Critically, as Purdue’s internal documents explain, in 11 12 13 14 f 15 16 4.84 Thus, to avoid stifling drug development, the FDA-approved labeling does not 17 address the most crucial component of this lawsuit—the long-term (beyond 12 weeks) use of 18 opioid medications. Through this gap in FDA regulation, Purdue drove a multibillion dollar 19 experiment with disastrous results. 20 21 4.85 In addition, Purdue’s marketing, described below, operated outside the FDA labeling system. For example, as the FDA explained, the label is designed to encourage 22 92 23 24 25 26 Jesse R. Catlin & Cornelia (Connie) Pechmann, An Investigation of Consumer and Doctor Regulatory Beliefs and Regulatory Knowledge About Pharmaceutical Drug Promotions, 1 J. Ass’n of Consumer Research 392 (2016); About the Center for Drug Evaluation and Research: The Office of Prescription Drug Promotion (OPDP), U.S. Food & Drug Administration, https://www fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090142 htm (last visited Sep 27, 2017); U.S. Dep’t of Health and Human Servs. et al., Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices (2011). COMPLAINT - 26 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 prescribers to exercise “thoughtful determination” that pain is “severe enough to require daily, 2 around-the-clock, long-term opioid treatment.” 93 Purdue’s marketing through unbranded, and 3 therefore unregulated, materials manipulated prescribers’ and patients’ perception of when 4 pain was severe enough and when opioids were required. 5 4.86 Similarly, the labels do not address the use of opioids in treating specific 6 conditions such as lower back pain, headaches, or fibromyalgia, three conditions for which 7 opioids are ineffective, but for which Purdue marketed its drugs. 8 4.87 Additionally, although the labels contain warnings about addiction, the severity 9 of that risk is not quantified. Purdue’s marketing, both branded and unbranded, asserted that 10 screening, abuse deterrent formulations, or urinalysis can adequately manage the risk of 11 developing an addiction without evidence to support those claims. 12 4.88 Nor do the labels address the critical issue of opioid dosage. The CDC 13 recommends that caution be used with doses over 50 MME and recommends against 90 MME 14 doses. As described below, Purdue’s sales staff regularly visited prescribers that were writing 15 doses far in excess of these thresholds. 16 C. 17 18 Washington State Has a Public Policy Interest in Reducing Opioid Addiction and Abuse 4.89 In contrast to the federal labeling regulatory scheme, Washington State’s 19 consumer protection statute and common law protect consumers from the kind of marketing 20 conduct that Purdue employed to encourage the most dangerous kind of opioid use in spite of 21 growing and irrefutable evidence of widespread negative impacts. 22 4.90 Washington State has a strong public policy to preserve and protect the health 23 and welfare of its citizens by ensuring high-quality health care and preventing abuse of 24 prescription and non-prescription drugs. 25 93 26 Woodcock Letter (Sept 10, 2013). COMPLAINT - 27 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4.91 Washington regulates the practice of medicine because “the health and well- being of the people of this state are of paramount importance.” RCW 18.71.003. 4.92 Washington has a strong public policy to prevent opioid addiction and abuse. 4 Washington has categorized opioids as Schedule II drugs, RCW 69.50.206(b)(1), meaning that 5 they have “a high potential for abuse,” which “may lead to severe psychological or physical 6 dependence.” 94 7 4.93 To further its public policy, Washington has taken steps to regulate opioid use. 8 This was prompted initially by the Washington workers’ compensation system, which saw a 9 dramatic increase in Schedule II opioid prescribing from 1996 to 2002, and a 50% increase in 10 the average daily MME among injured workers taking these potent medications. 95 By 2000, 11 the Department of Labor & Industries noted an alarming rise in overdose deaths. 96 A manual 12 review of all opioid overdose death certificates by the Department of Health showed an 13 increase in the number of overdose deaths involving prescription opioids from 24 in 1995 to 14 351 in 2004. By 2006, the CDC had identified Washington to be in the highest tertile of 15 mortality (10.8 deaths/100,000) 97 from unintentional drug overdoses in the United States. At 16 that same time, approximately 10,000 Washington patients in public insurance programs were 17 taking at least 120 milligrams per day MED. 98 Accordingly, Washington acted. 18 4.94 In March 2007, the Washington State Agency Medical Directors’ Group 19 (AMDG), consisting of the medical directors for the Washington State Departments of 20 Corrections, Social and Health Services (Medicaid), Labor and Industries, and the Health Care 21 Authority, published its “Interagency Guideline on Opioid Dosing for Non-cancer Pain: An 22 educational guide to improve care and safety with opioid therapy.” Washington was the first 23 94 RCW 69.50.205(a)(1) & (3). Franklin et al., supra note 3, at 464, citing to n16 96 Id. 97 Franklin et al., supra note 3, at 464, citing to n14. 98 Franklin et al., supra note 3, at 464; Strong epidemiological studies now support a dosing threshold or range around 80 to 100 milligrams per day. Franklin et al., supra note 3, at 465, citing to n27-29. 95 24 25 26 COMPLAINT - 28 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 jurisdiction in the country to issue guidelines recommending caution in using high dose 2 opioids. 99 3 4.95 The 2007 AMDG guidelines were relatively simple, with modest 4 recommendations. Noting that increasing opioid doses may not improve pain control and 5 function, the guideline recommended the lowest possible effective dose, and monitoring of 6 function rather than pain scores. If function did not improve, if adverse effects occurred, or if 7 there were drug-seeking behaviors, the guidelines recommended discontinuing opioids. The 8 guidelines proposed a 120 MME dose as threshold for seeking specialized care. 9 4.96 Purdue’s response to these modest 2007 guidelines was to participate in a “Pain 10 Care Forum” subcommittee on Washington State with representatives from other 11 pharmaceutical manufacturers, key opinion leaders like Dr. Scott Fishman, professional 12 associations like the American Academy of Pain Medicine, and members of pain advocacy 13 groups to revise and oppose the AMDG guidelines. The American Academy of Pain Medicine 14 issued a position statement opposing the guideline because recommending a consultation could 15 impair “legitimate patients…appropriate dosing with opioids.” 100 16 4.97 In a letter to the AMDG, Purdue explained its position regarding opioids, 17 offering its “extensive experience with clinical issues regarding pain management due to our 18 portfolio of pain medications.” Purdue explained that OxyContin’s “safety and efficacy” was 19 established, and defended the use of more than 120 MME per day. Purdue also advised that 20 drug-seeking behaviors could be misinterpreted and constituted “pseudoaddiction” rather than 21 addiction. Finally, Purdue wrote that even when an opioid “causes significant adverse effects 22 that are not otherwise manageable, this does not preclude a trial of another opioid.” 101 23 24 25 26 99 Franklin et al., supra note 3, at 464, citing to n18. In 2006 a consortium of all WA agencies that purchase or regulate health care (the Agency Medical Directors’ Group (AMDG) collaborated with 15 WA pain management experts (the Clinical Advisory Group) to develop an opioid prescribing guideline. 100 “A Position Statement from the American Academy of Pain Medicine” available at: http://www.painmed.org/files/washington-state-amdg-opioid-guidelines-statement.pdf. 101 Letter from Lally Samuel, RPh, MS, Purdue, to Gary Franklin, MD, MPH (May 9, 2007). COMPLAINT - 29 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.98 In 2009, the Washington Attorney General’s office funded a study on how the 2 AMDG guideline was functioning. Among the findings from the study was that Schedule II 3 opioids represented the largest increase in opioid prescriptions from 1996 to 2008, and the 4 average daily dose of long-acting opioids, like those sold by Purdue, had steadily increased 5 from the late 1990s. 6 4.99 In 2010, the AMDG issued updated guidelines that provided tools for 7 calculating dosages, screening for substance abuse, mental health, and addiction, clinical tools, 8 and patient education materials and resources. 9 4.100 Also in 2010, the Washington Legislature began enacting legislation to address 10 the threat opioids posed to public health. Public testimony, as summarized by non-partisan 11 legislative staff, revealed the concerns motivating lawmakers: 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Over the last decade we’ve seen a huge increase in the dosing levels of narcotics and that has driven a dramatic increase in dependency, addiction, overdoses, deaths, and bad interaction with other drugs. This is a public health emergency. More people die from prescription drug overdoses in this state than in car accidents. We have to change prescribing practices, through education and setting guidelines, to help practitioners who are under pressure to increase doses well beyond what is safe and useful. The rampant use of opiods [sic], sold as prescriptions, means that kids think these are safe and are using them straight out of their parents' medicine cabinets. . . . We have to stop drug surfing and find ways to assist practitioners and pharmacists who feel at risk because the demand for these drugs is so high. 4.101 This public testimony about the burgeoning opioid epidemic resulted in a strong bi-partisan consensus to confront the public health problems caused by opioid use. The Senate voted 36-12 and the House of Representatives voted 96-1 to require Washington medical boards to adopt new regulations. 4.102 In accordance with the Legislature’s directive, those agencies promulgated new standards for opioid prescriptions for the treatment of chronic non-cancer pain. The Department of Health explains that: The boards and commissions are committed to protecting and improving the health of people in Washington State. The pain management rules' goals are to COMPLAINT - 30 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 keep patients safe, and to give practitioners who prescribe opioids the best practices in pain management. A key component of the rules is to encourage practitioners to become better educated in the safe and effective uses of these powerful drugs. 4.103 As it had with the first set of guidelines, Purdue opposed Washington’s efforts to urge caution. As discussed below, Purdue partnered with the American Pain Foundation and provided significant material support to the Washington Pain Alliance to oppose the new regulations in Washington State. 4.104 The new guidelines had a significant effect. Prescription opioid overdose death rates in Washington declined by 27% from 2008 to 2012, and overdose hospitalization rates declined for the first time in 2012. The percentage of Washington residents who have used prescription pain medication nonmedically in the past year declined from 6.2% in 2009-2010 to 5.1% in 2011-2012. 4.105 Unfortunately, although Washington has seen a decline in prescription overdose deaths, it has been more than offset by a corresponding rise in heroin overdose deaths. The rise in illicit opioid deaths is a foreseeable consequence of Purdue’s manipulation of the opioid market. Nearly 80% of heroin users report using prescription opioids before beginning heroin use. 102 Having created physically dependent patients through widespread opioid prescribing, efforts to restrict prescribing inevitably pushed those patients into finding alternate sources of opioids. 4.106 In June 2015, the AMDG released another update to the Interagency Guidelines. Washington Secretary of Health John Wiseman noted that “Washington and many other states are in the midst of an epidemic of opioid misuse, abuse, and overdose,” and warned that “[a]lthough opioids can be a useful option for pain management, their inappropriate use can result in significant harms, including addiction and death.” He therefore urged prescribers to 102 Prescription Opioids and Heroin, National Institute on Drug Abuse, https://www.drugabuse.gov/publications/research-reports/prescription-opioids-heroin (last visited Sept 20, 2017). COMPLAINT - 31 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 “help us improve the health of Washington residents by following this updated AMDG 2 evidence-based practice guideline.” 103 3 4.107 The 2015 AMDG guidelines recommend reserving opioids for acute pain 4 resulting from severe injuries or medical conditions when alternatives are ineffective or 5 contraindicated. Even then, opioids should be prescribed at the lowest necessary dose and for 6 the shortest duration and should not be prescribed at all for low back pain, headaches, or 7 fibromyalgia. Long-term opioid use is not recommended unless there is sustained clinically 8 meaningful improvement in function, and, even then, it is to be carefully monitored. 9 4.108 In 2016, Governor Jay Inslee issued an executive order recognizing that 10 medically prescribed opioids have contributed to an opioid epidemic that is devastating 11 Washington communities and families, and overwhelming law enforcement, health care, and 12 social service providers. Governor Inslee directed state agencies to prevent inappropriate 13 opioid prescribing, reduce opioid misuse and abuse, expand treatment resources, and use data 14 to detect and intervene to prevent mortality. At the same time, Washington created an 15 interagency opioid working plan to implement the Governor’s order. 16 4.109 In addition to medical guideline and legislative action, Washington’s consumer 17 protection laws also prohibit Purdue from engaging in unfair or deceptive acts or practices in 18 the conduct of any trade. As is detailed below, Purdue’s marketing was both deceptive and 19 misleading and, in the context of the addictive and deadly properties of opioids, unfair to the 20 citizens of Washington. 21 D. 22 Purdue Used Sophisticated Branded and Unbranded Marketing Targeted at Washington Health Care Providers and Patients to Boost Opioid Prescribing and Its Own Profits 23 4.110 Purdue engaged in a marketing campaign to deceive health care providers and 24 patients into believing that opioids in general and Purdue drugs in particular were effective and 25 103 26 WSAMDG, supra note 42. COMPLAINT - 32 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 safe, and should therefore be widely prescribed. Upon information and belief, Purdue centrally 2 developed its marketing strategies and materials, which were deployed at the local level in 3 Washington and nationwide. 4 4.111 Russell Gasda, a current Purdue executive and former Vice President for Sales 5 and Marketing, testified regarding Purdue’s message when marketing any drug. He explained 6 that “ 7 ” The marketing “ 8 9 10 11 ” 4.112 He also testified that “ 12 13 14 ” Thus, “ 15 16 ” 4.113 Finally, he explained that “ 17 18 ” 19 4.114 Purdue knew that its in-person marketing worked. The effects of sales calls on 20 prescribing behavior are well-documented in the literature, including a 2009 study correlating 21 the nearly ten-fold increase in OxyContin prescriptions between 1997 and 2002 to Purdue’s 22 doubling of its sales force and trebling of sales calls. 104 A 2017 study found that physicians 23 ordered fewer promoted brand-name medications and prescribed more cost-effective generic 24 versions if they worked in hospitals that instituted rules about when and how pharmaceutical 25 26 104 Art Van Zee, The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, 99 Am. J. Pub. Health 221–227 (2009). COMPLAINT - 33 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 sales representatives were allowed to detail prescribers. 105 The changes in prescribing behavior 2 appeared strongest at hospitals that implemented the strictest detailing policies and included 3 enforcement measures. 106 4 4.115 Purdue’s deceptive opioid marketing focused on convincing doctors that (a) 5 opioids were effective at relieving pain and improving function; (b) the adverse effects of 6 opioids (including addiction) were overstated and could be managed; and (c) in light of (a) and 7 (b), opioids were a superior option to other pain treatments. 8 4.116 Purdue pushed this central, deceptive message in ways strategically designed to 9 deceive health care providers and patients. As discussed below, Purdue authored and 10 disseminated both its own branded materials, as well as unbranded materials from third-party 11 groups that Purdue funded but which were designed to look independent. Purdue followed 12 these materials with one-on-one visits to health care providers to persuade them to prescribe 13 more Purdue opioids. 14 1. 15 Purdue chased growth by promoting both opioids generally and its brandname drugs in particular 16 4.117 Purdue’s marketing strategy encompassed promotion of both (a) opioid therapy 17 in general, and (b) its own opioids – MSContin, OxyContin, Butrans, and Hysingla – in 18 particular. Promotion of opioids in general was important to Purdue’s business plan and 19 marketing strategy for several reasons. 20 4.118 First, by deceptively changing the medical community’s and public’s perception 21 of opioids as a class of drugs, Purdue also sought to change the perception of its own opioid 22 products, which were part of that larger class. Although Purdue would not capture all the 23 24 105 25 26 Ian Larkin et al., Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing, 317 J. Am. Med. Ass'n 1785 (2017). 106 Id. COMPLAINT - 34 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 benefits of its investment in general opioid re-education, it would profit handsomely by 2 increased prescriptions of its own brand-name drugs. 3 4 4.119 Second, once health care providers initially prescribed immediate-release opioids – often generics – to treat a patient’s pain, Purdue sought to 5 6 7 8 . Indeed, Purdue’s 2015 marketing plan noted that, and that “ ” 9 4.120 Purdue carefully coordinated its sponsored Continuing Medical Education 10 courses (CME) marketing with its one-on-one sales representative visits to maximize 11 conversions to OxyContin and its other extended release opioids. For example, following a 12 campaign on the 13 14 15 16 Purdue made sure to have its sales representatives re-enforce the message. As Purdue explained to its sales force in an 17 18 19 20 21 4.121 Purdue trained its sales representatives to 22 23 24 25 26 COMPLAINT - 35 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 4.122 Accordingly, Purdue sales representatives’ call notes for Washington health care providers 3 . For example: 4 a. 5 This question was repeated times in the call notes during a period 6 from detailing one pain specialist who prescribed significant 7 numbers of opioids. Starting with the next sales visit, Purdue’s sales representative began 8 focusing on 9 10 . b. This sentence was repeated in call notes with the same pain specialist times in less than 11 from 12 4.123 Purdue sales representatives are specifically trained to ask these questions in 13 14 . trainings like 4.124 Purdue also trained its sales representatives to handle the 15 16 17 . 4.125 Purdue sales representatives were then trained that 18 19 20 Purdue therefore inserted its sales representatives directly into prescribers’ decision- 21 making process concerning the type and dose of opioid to prescribe – upon information and 22 belief, these conversations that took place without the patient present. 23 4.126 In addition to persuading health care providers 24 25 , Purdue also undertook efforts to persuade health care providers to 26 COMPLAINT - 36 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 4.127 As part of this effort, and to gain market share, Purdue commissioned a 2016 marketing study to 5 6 7 As discussed below, 8 Purdue targeted Washington prescribers with the strategies for spreading its deceptive message 9 that were recommended in the marketing study. 10 11 12 13 2. Purdue continued to selectively support and disseminate misleading materials from third party groups 4.128 Purdue has an active grant program supporting third party organizations. From 2006 to the end of 2016, Purdue provided more than $ in direct grants including: 14 a. $ to the ; 15 b. $ to the ; 16 c. $ to the 17 d. $ to the 18 e. $ 19 f. $ 20 g. $ 21 h. $ to the 22 i. $ to the 23 j. $ to the 24 k. $ to the 25 l. $ to the ; ; to the ; to the ; to the ; ; ; ; ; and . 26 COMPLAINT - 37 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.129 On information and belief, many of these grants were targeted for specific 2 purposes to assist Purdue’s marketing efforts. For example, pharmaceutical companies, 3 including Purdue, provided almost all of the funding for the American Pain Foundation (APF), 4 which offered publications for health care providers, patients, policymakers and journalists.107 5 APF’s materials, discussed below, contain misrepresentations about opioids’ efficacy and 6 safety. 7 8 4.130 Purdue Executive Pamela Bennett explained the company’s support for APF as follows: 9 10 11 4.131 12 13 14 15 16 17 108 18 19 4.132 , the 20 President of American Academy of Pain Management, Dr. Perry Fine, the President of APF, 21 Dr. Scott Fishman, and the President of the American Pain Society, Dr. Seddon Savage, wrote 22 23 24 25 26 107 Charles Ornstein & Tracy Weber, The Champion of Painkillers, Propublica, Dec. 23, 2011, https://www.propublica.org/article/the-champion-of-painkillers (last visited Sept. 27, 2017). 108 The Attorney General does not assert a claim based on Purdue’s representations to government officials or regulators. COMPLAINT - 38 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 an editorial in the Seattle Times asserting it was unreasonable to recommend that primary care 2 physician consult with a specialist before prescribing high dose opioids. 109 3 4 5 4.133 This article failed to disclose that Dr. Fishman was a consultant for Purdue Pharma and that Dr. Fine was on the advisory board for Purdue. 110 4.134 As part of the same effort to maintain robust opioid sales in Washington, 6 7 8 9 10 11 12 4.135 In addition to selecting and funding third parties to conduct such campaigns, 13 Purdue also incorporated apparently neutral entities in its direct marketing to Washington 14 prescribers. 15 4.136 In 2009, the American Academy of Pain Medicine and American Pain Society 16 issued Clinical Guidelines (2009 APS Guidelines). These guidelines claimed that opioid 17 treatment for chronic pain “can be an effective therapy for carefully selected and monitored 18 patients with chronic non-cancer pain.” The guidelines cautioned, however, that to be safe and 19 effective, such treatment required “clinical skills and knowledge in both the principles of 20 opioid prescribing and on the assessment and management of risks associated with opioid 21 abuse, addiction, and diversion.” 111 22 109 23 24 25 26 Perry G. Fine, Scott M. Fishman, & Seddon R. Savage, Bill to Combat Prescription Abuse Really Will Harm Patients in Pain, Seattle Times, Mar. 16, 2010. 110 Scott M. Fishman, Incomplete Financial Disclosures in a Letter on Reducing Opioid Abuse and Diversion, 306 J. Am. Med. Ass’n 1445 (2011). 111 Roger Chou et al., Clinical Guidelines for Use of Chronic Opioid Therapy in Chronic Noncancer Pain, 10 J. Pain 113 (2009). Of the 21 members of the APS panel, 6 disclosed payments from Purdue, and only 6 claimed no conflicts of interest. Dr. Russell Portenoy and Dr. Perry Fine were both on the panel. COMPLAINT - 39 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.137 Purdue incorporated and disseminated these guidelines without disclosing its 2 contributions to both the American Academy of Pain Medicine and the American Pain Society. 3 For example, Purdue’s Partners Against Pain website incorporated sections of a 2001 APS 4 consensus statement about addiction to bolster Purdue’s position that drug-seeking behavior in 5 chronic pain patients should be interpreted as “pseudoaddiction” rather than addiction. As 6 discussed below, “pseudoaddiction” is an unvalidated theory Purdue used to mislead 7 prescribers about the risks of opioid use. 8 9 4.138 When Washington prescribers contacted Purdue for information about its opioids, Purdue 10 11 12 13 4.139 14 15 . 16 4.140 Although Washington’s AMDG guidelines were available, Purdue did not 17 recommend Washington prescribers consult them. Nor did Purdue notify the prescribers that 18 only skilled clinicians should be prescribing extended release opioids like OxyContin, Butrans, 19 or Hysingla. 20 4.141 Purdue’s promotion of these guidelines is particularly troubling in light of 21 22 23 24 25 26 COMPLAINT - 40 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 4.142 Purdue funded and acted through these third-party groups because doctors were 3 conditioned to trust them – more so than branded marketing material – when making 4 prescribing decisions. 5 4.143 Indeed, a 2016 Purdue-commissioned marketing study of doctors recommended 6 that 7 f 8 9 10 11 12 4.144 By using third party materials and detailing visits to disseminate its messaging, Purdue was able to exert significant and unidentified influence over prescribers. For example: a. 13 14 15 16 17 18 19 20 compared the messages retained by medical students who reviewed an industry-funded CME article on opioids versus another group who reviewed a non-industry-funded CME article. Students who read the industry-funded article more frequently noted the impression that opioids were underused in treating chronic pain, while those reading the non-industry-funded CME mentioned the risks of death and addiction much more frequently. Critically, neither group could accurately identify whether the article they read was industry-funded, illustrating health care providers’ trouble screening and accounting for source bias. 112 b. 21 22 One study by a Georgetown University Medical Center professor A recent study of the effect of regulatory beliefs on the persuasive value of pharmaceutical marketing found that doctors inaccurately believed that the FDA regulates 23 24 112 25 26 Adriane Fugh-Berman, Marketing Messages in Industry-Funded CME, PharmedOut, June 25, 2010, http://pharmedout.galacticrealms.com/Fugh-BermanPrescriptionforConflict6-25-10.pdf (last visited September 27, 2017). COMPLAINT - 41 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 continuing education programs, which could lead to doctors scrutinizing the information 2 presented at industry-funded CMEs less carefully than they otherwise might. 113 3 c. Indeed, following one CME presentation f 4 5 6 3. 7 Purdue engaged in deceptive in-person marketing to Washington health care providers 8 4.145 Purdue marketed its brand-name opioids, such as OxyContin, MS Contin, 9 Butrans, and Hysingla, directly to health care providers in Washington through in-person visits 10 from sales representatives, also known as “detailers.” These sales representatives misleadingly 11 portrayed the risks and benefits of opioids – particularly Purdue-branded drugs – for the 12 treatment of chronic non-cancer pain, and worked systematically to increase prescriptions of 13 Purdue opioids. 14 4.146 Purdue’s former Vice President for Marketing explained f , 15 16 17 18 19 20 21 22 23 24 (Emphasis added.) 4.147 Upon information and belief, Purdue carefully trained its sales representatives to deliver company-approved messages designed to generate prescriptions of Purdue’s drugs in 25 113 26 Catlin, supra note 92. COMPLAINT - 42 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 particular and opioids in general. To ensure that sales representatives delivered the desired 2 messages to prescribers, Purdue directed and monitored its sales representatives through detailed 3 action plans, trainings, tests, scripts, role-plays, supervisor tag-alongs, and review of 4 representatives’ call notes from each visit. Purdue likewise required its sales representatives to use 5 sales aids reviewed, approved, and supplied by the company and forbade them from using 6 promotional materials not approved by the company's marketing and compliance departments. 7 Purdue further ensured marketing consistency nationwide through national and regional sales 8 representative training. 9 4.148 Purdue’s sales representative or detailer call notes were intended to 10 11 12 13 4.149 Upon information and belief, Purdue sought to establish, and did establish, the 14 same prominence in the market and medical community with respect to opioids in general as 15 with its brand-name opioids. 16 4.150 It did so for a reason: studies indicate that marketing can and does impact 17 doctors’ prescribing habits, 114 and also indicate that face-to-face “detailing” – which Purdue 18 engaged in heavily, as described below – has the greatest influence. 19 4.151 In addition to “handling” the “objections” of health care providers who were not 20 inclined to prescribe opioids, Purdue sought to become a “resource” and a source of 21 information to which health care providers looked in making prescribing decisions. They did 22 114 23 24 25 26 See, e.g., Puneet Manchanda & Pradkeep K. Chintagunta, Responsiveness of Physician Prescription Behavior to Salesforce Effort: An Individual Level Analysis, 15 Mktg. Letters 129 (2004) (detailing impacts prescriptions written); Ian Larkin et al. Restrictions on Pharmaceutical Detailing Reduced Off-Label Prescribing of Antidepressants and Antipsychotics in Children, 33 Health Aff. 1014 (2014) (academic medical centers that restricted direct promotion by sales representatives resulted in 34% decline in on-label use of promoted drugs); see also Van Zee, supra note 104 (increase of OxyContin prescriptions 1997 to 2002 correlated with doubling of Purdue’s sales force and trebling of sales calls). COMPLAINT - 43 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 so by delivering and discussing the sort of deceptive unbranded materials described below 2 directly to Washington prescribers to help “educate” them one-on-one. Purdue’s call notes for 3 Washington prescribers include the following examples: 4 a. One sales representative made a note to 5 6 7 8 b. 9 10 11 12 c. 13 14 4.152 Purdue distributed other purportedly third-party materials, 15 16 17 4.153 Purdue pursued a two-pronged strategy for targeting health care providers. 18 Purdue targeted primary care physicians, physician assistants, and nurse practitioners, who 19 were least likely to have the training and experience to evaluate Purdue’s marketing claims. 20 Purdue also promoted marketed OxyContin, Butrans, and Hysingla for chronic non-cancer pain 21 to the highest opioid prescribers, who often worked at “pain clinics” and who accounted for an 22 outsized portion of opioid prescriptions. 23 4.154 As the practice of medicine has changed, so too has Purdue’s marketing strategy 24 and efforts. As nurse practitioners and physicians assistants became more active in prescribing 25 opioids, Purdue shifted resources to follow them. 26 COMPLAINT - 44 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 5 6 7 8 9 4.155 Finally, both third-party materials and Purdue-branded educational resources 10 were targeted at patients, and designed to persuade patients through misleading statements, that 11 opioids were both effective and safe. Purdue created and disseminated marketing materials 12 directly to patients, such as patient brochures and branded public-facing websites like 13 HysinglaER.com, encouraging consumers to seek out Purdue opioids from their health care 14 providers. Upon information and belief, Purdue also disseminated nonbranded marketing 15 materials directed toward patient consumers, such as the website In The Face of Pain, Partners 16 Against Pain “Pain Management Kits,” patient comfort assessment guides, and other resources 17 guiding patients to use opioids. 18 19 Similarly, as discussed below, 20 various third party groups produced patient guides and pamphlets that Purdue either distributed 21 or sponsored. 22 E. 23 Using These Marketing Channels, Purdue Disseminated Deceptive Statements and Assertions Designed to Increase Opioid Prescriptions 24 4.156 As described in more detail below, Purdue engaged in numerous deceptive or 25 unfair acts and practices designed to convince health care providers to continue prescribing 26 COMPLAINT - 45 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 opioids despite the lack of evidence of effectiveness and despite the risks of opioid use, 2 including without limitation: 3 a. Marketing Purdue’s opioid drugs, both directly and indirectly through 4 third party groups, as a solution to the undertreatment of pain and either stating directly, or 5 implying, that opioids are effective to treat or relieve long-term chronic pain; 6 b. Marketing Purdue’s opioid drugs, both directly and indirectly through 7 third party groups, for the treatment of specific pain conditions including neurological pain, 8 headaches, low back pain, and fibromyalgia, despite evidence that opioids were not effective at 9 treating these conditions; 10 c. Selectively supporting third party groups and employing unbranded 11 marketing to promote and defend the long-term use of opioids and at higher doses as an 12 effective pain relief tool for the treatment of chronic pain; 13 14 15 d. Misrepresenting and making unsubstantiated claims that, and the extent to which, opioids improve function; e. Misrepresenting the truth and making unsubstantiated claims about how 16 (and how frequently) opioids lead to addiction and the extent to which addiction risk can be 17 managed and addiction prevented; 18 f. Misleadingly using terms like addiction, dependence, tolerance, physical 19 dependence, and “pseudoaddiction” to persuade health care providers and patients that the 20 addiction risk of opioids could be successfully managed; 21 22 23 24 25 26 g. Misrepresenting and making unsubstantiated claims that increased doses of opioids do not pose significant additional risks; h. Misrepresenting and making unsubstantiated claims about the challenges entailed in managing withdrawal; i. Misrepresenting and making unsubstantiated claims regarding the factors for comparing the risks and benefits of opioids with those of alternative forms of pain COMPLAINT - 46 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 treatment; and 2 j. Marketing Purdue’s abuse deterrent formulations of opioid medications 3 as a means of reducing abuse and addressing the opioid epidemic without any evidence to 4 support such a claim. Purdue intended prescribers and policy makers to believe these abuse 5 deterrent formulations were safer than opioids without these formulations. 6 7 4.157 Purdue’s impact on the marketing of opioids has been significant. As Purdue’s internal documents observed 8 9 10 11 12 13 Purdue has dominated the market for opioid marketing since the 1990s. 1. 14 Purdue’s deceptive acts or practices relating to opioids’ ability to improve function 15 4.158 Consistent with Purdue’s marketing strategy described above, Purdue made 16 deceptive and unsubstantiated claims regarding the efficacy of opioids in general and its own 17 drugs in particular. 18 4.159 Opioids may initially improve function by providing pain relief in the short 19 term, but as explained above there is no evidence that opioids improve patients’ function in the 20 long-term. 21 4.160 Despite the lack of evidence of improved function long-term, Purdue 22 deceptively promoted opioids as improving function and quality of life without disclosing the 23 lack of evidence for this claim. For example: 24 a. Purdue sponsored The Federation of State Medical Boards’ Responsible 25 Opioid Prescribing (2007), which taught that relief of pain itself improved patients’ function: 26 “While significant pain worsens function, relieving pain should reverse that effect and improve COMPLAINT - 47 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 function.” In fact, on the first page, Responsible Opioid Prescribing represents that patients 2 “rely on opioids for . . . improved function.” 115 Purdue provided $800,000 dollars in various 3 grants in support of various Federation initiatives related to opioids, including $100,000 to 4 disseminate Responsible Opioid Prescribing and $50,000 to fund Dr. Scott Fishman’s 5 production of the book. Also according to the Federation, more than 15,000 copies of the book 6 were distributed to Washington prescribers by 2012. 116 7 b. Purdue sponsored the APF’s Treatment Options: A Guide for People 8 Living with Pain (2007), which taught patients that opioids, when used properly “give [pain 9 patients] a quality of life we deserve.” The Treatment Options guide notes that non-steroidal 10 anti-inflammatory drugs (e.g., aspirin or ibuprofen) have greater risks with prolonged duration 11 of use, but there was no similar warning for opioids. 12 c. Purdue sponsored APF’s A Policymaker' s Guide to Understanding Pain 13 & Its Management (2011), which inaccurately claimed that “multiple clinical studies have 14 shown that long-acting opioids in particular are effective in improving” “[d]aily function, 15 “[p]sychological health,” and “health-related quality of life for people with chronic pain,” with 16 the implication that these studies presented claims of long-term improvement. But in fact, the 17 sole reference for these claims (i) noted the absence of long-term studies and (ii) actually stated 18 that “[f]or functional outcomes, the other analgesics were significantly more effective than 19 were opioids.” 117 20 d. 21 Purdue sponsored Exit Wounds, which taught veterans, another vulnerable population, that opioid medications “increase your level of functioning.” 22 23 115 24 25 26 Scott M. Fishman, Responsible Opioid Prescribing, Federation of State Medical Boards, Waterford Life Sciences (2007). 116 Letter from Humayun J. Chaudhry, DO, FACP, Federation of State Medical Boards, to Sen. Max Baucus and Charles Grassley, (June 8, 2012). 117 Furlan et al., supra note 38. COMPLAINT - 48 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 e. Purdue sponsored a CME entitled Managing Patient’s Opioid Use: 2 Balancing the Need and the Risk, which made unsubstantiated and false claims about improved 3 functionality. One copy provided to Purdue as part of a funding request stated, in the context of 4 promoting opioids for chronic non-cancer pain relief, that effective pain control 5 6 7 The presentation explained that prescribers should conduct 8 9 10 Upon information and belief, these deceptive statements about opioids’ ability to improve function were included in the final presentation. 11 4.161 Purdue also published misleading studies to enhance the perception that opioids 12 are effective long-term for chronic pain conditions. One study asserts that OxyContin is safe 13 and effective for the chronic pain condition osteoarthritis. The study, sponsored by Purdue, 14 involved (1) providing oxycodone for 30 days, and then (2) randomizing participants and 15 providing a placebo, IR oxycodone with acetaminophen (like Percocet), or OxyContin. Only 16 107 of the 167 patients advanced to the second phase of the study, and most participants who 17 withdrew left because of adverse events (nausea, vomiting, drowsiness, dizziness, or headache) 18 caused by the opioid or because the opioid provided ineffective treatment. Despite relating to a 19 chronic condition, opioids were provided only short-term. The authors even acknowledge that 20 the “results ... should be confirmed in trials of longer duration to confirm the role of opioids in 21 a chronic condition such as OA [osteoarthritis].” 118 Yet the authors concluded that "[t]his 22 clinical experience shows that opioids were well tolerated with only rare incidence of addiction 23 and that tolerance to the analgesic effects was not a clinically significant problem when 24 118 25 26 Jacques R. Caldwell et al., Treatment of Osteoarthritis Pain with Controlled Release Oxycodone or Fixed Combination Oxycodone Plus Acetaminophen Added to Nonsteroidal Antiinflammatory Drugs: A Double Blind, Randomized, Multicenter, Placebo Controlled Trial, 26 J. Rheumatology 862 (1999). COMPLAINT - 49 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 managing patients with opioids longterm.” 119 This statement is not supported by the data, 2 because (a) a substantial number of patients dropped out because of adverse effects, (b) there 3 was no reported data regarding addiction, and (c) the study was not long-term. 4 4.162 As noted above, the available evidence indicates opioids are not effective to 5 treat chronic non-cancer pain – indeed, they may harm patients’ health. 120 Thus, “for the vast 6 majority of patients, the known, serious, and too-often-fatal risks far outweigh the unproven 7 and transient benefits [of opioids for chronic pain].” 121 Similarly, a 2014 internal Purdue study 8 of 9 f 10 11 12 Purdue’s efficacy claims to the contrary were misleading. 13 4.163 Indeed, there is evidence that these unsubstantiated and false efficacy claims 14 influenced health care providers. For example, a 2016 marketing study commissioned by 15 Purdue found that 16 17 18 f (Emphasis added.) The same study noted that health care 19 providers 20 21 22 23 119 24 25 26 Id. See, e.g. Furlan et al., supra note 38. Furlan noted that even those studies that did show efficacy did not typically show data on opioid addiction, and also pre-screened the study pool to remove patients who might have been more prone to addiction; see also Dersh et al., supra note 40. 121 See Friedan, supra note 30, at 1503. 120 COMPLAINT - 50 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 2. 4 4.164 In addition to claiming efficacy for long-term pain relief, Purdue also 5 deceptively promoted OxyContin as delivering a full 12 hours of “steady state” pain relief. 6 This meant that OxyContin was purportedly both (a) more effective than immediate-release 7 opioids, and (b) less likely to result in crashes and cravings that lead to addiction and abuse. In 8 reality, OxyContin does not last for 12 hours in many patients, a fact Purdue has known since 9 the product's launch. Purdue deceptively claimed OxyContin was effective for 12 hours 10 4.165 OxyContin has been FDA-approved for twice-daily “Ql2”-dosing frequency 11 since its debut in 1996. Purdue chose to submit OxyContin for approval with 12-hour rather 12 than 8-hour dosing, and then made the 12-hour claim central to its marketing campaign. 122 13 14 15 16 17 18 19 20 21 22 23 24 25 26 122 Under FDA guidelines for establishing dosing, Purdue merely had to show that OxyContin lasted for 12 hours for at least half of patients, and Purdue submitted a single study that cleared that bar. While the OxyContin label indicates that "[t]here are no well-controlled clinical studies evaluating the safety and efficacy with dosing more frequently than every 12 hours," Purdue has conducted no such studies. COMPLAINT - 51 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.166 Purdue promoted OxyContin as providing continuous, round-the-clock pain 2 relief with the convenience of not having to wake up to take a third or fourth pill. The 3 advertising claimed that OxyContin provides “Consistent Plasma Levels Over 12 Hours” and 4 included a chart depicting plasma levels on a logarithmic scale. The chart deceptively 5 concealed the steep decline in OxyContin's effectiveness over 12 hours by manipulating the 6 scale of the chart’s Y-axis to make 10 mg appear to be half of 100 mg. This sleight of hand 7 manipulated the curve and made the absorption rate appear more steady or consistent than it 8 really was. 9 10 11 12 13 14 15 16 17 18 19 20 21 22 4.167 Purdue senior medical director, Dr. J. David Haddox, told a reporter in 2001 that “[a] lot of these people say, ‘Well, I was taking the medicine like my doctor told me to,’ and then they start taking them more and more and more….I don’t see where that’s my problem.” 123 23 24 25 26 123 Quoted in Harriet Ryan et al., “You Want A Description of Hell?” OxyContin’s 12-Hour Problem, Los Angeles Times, May 5, 2016. COMPLAINT - 52 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.168 In fact, upon information and belief, Purdue knew, according to its own 2 research during the development of OxyContin and after, that the drug wears off in under 6 3 hours in one quarter of patients and in under 10 hours in more than half. The FDA found in 4 2008 that a “substantial number” of chronic pain patients taking OxyContin experience “end of 5 dose failure” with little or no pain relief at the end of the dosing period. 124 In a 2013 public 6 hearing, Dr. David Egliman testified: 12 Now, why did we get to a Q12 dose? It wasn’t because of the data on efficacy of the drug. It was because Purdue Pharma needed something to distinguish is drug from other short-acting narcotics, and this became the main marketing device to increase profits. On the other hand, the data showed something else. As you can see, at 10 milligrams, the OxyContin product release was effective for less than six hours in at least 25 percent of patients. And the 20 and 30 milligram dose were effective for less than 10 hours in at least 50 percent of patients. Other Purdue studies, all of them in fact, allowed rescue or short-acting oxy to cover patients who had pain breakthrough before 12 hours. However, this does not—and this information is omitted from the label. 125 13 4.169 Nevertheless, Purdue still emphasized 12-hour dosing in detailing visits to 14 Washington prescribers, though that often did not match the physicians’ anecdotal experience. 15 Purdue was also aware of the common practice of prescribing OxyContin more frequently than 16 12 hours to address end-dose failure experienced by the patients, up to three or four doses per 17 day: 7 8 9 10 11 18 a. One Washington prescriber reported to a Purdue sales representative that 19 20 21 22 23 124 24 25 26 2008 FDA response to Citizen Petition by Connecticut Attorney General. Testimony of David Egilman, Impact of Approved Drug labeling on Chronic Opioid Therapy at 91:6-11, FDA Center for Drug Evaluation and Research Public Hearing (Feb. 8, 2013), https://wayback.archiveit.org/7993/20170113151848/http:/www fda.gov/downloads/Drugs/NewsEvents/UCM342713.pdf (last visited Sept. 27, 2017). 125 COMPLAINT - 53 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 b. Four years later, a sales representative asked a Washington prescriber 2 3 The prescriber responded that he 4 5 4.170 Purdue did promote a “solution”: increase the dosage of the opioid, rather than 6 the frequency, even though higher dosing carries higher risks of addiction and overdose. 7 Purdue’s solution exposed patients to higher highs and lower lows, increasing their craving for 8 their next pill. But sales representatives were trained to reassure prescribers that there is no 9 ceiling on the amount of OxyContin a patient could be prescribe. And many prescribers 10 followed the recommendation of the sales representatives to increase the dose rather than the 11 frequency: 12 a. When a prescriber reported to the sales representative b. A sales representative asked one Washington high prescriber 13 14 15 16 17 f 18 19 20 21 22 23 24 25 26 COMPLAINT - 54 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.171 These 12-hour pain relief misrepresentations are particularly dangerous because 2 when a patient is inadequately dosed, they begin to experience distressing psychological and 3 physical withdrawal symptoms, followed by a euphoric rush with their next dose -- a cycle that 4 fuels addiction. Many patients will exacerbate this cycle by taking their next dose ahead of 5 schedule or resorting to a rescue dose of another opioid, increasing the overall amount of 6 opioids they are taking. 7 4.172 Nationwide, based on an analysis by the Los Angeles Times, more than 52% of 8 patients taking OxyContin longer than three months are on doses greater than 60 milligrams 9 per day-which converts to the 90 milligrams of morphine equivalent that the CDC Guideline 10 urges prescribers to “avoid” or “carefully justify.” 126 11 4.173 According to a Los Angeles Times article, a West Virginia circuit court judge in 12 a November 2004 order denying summary judgment found that “[m]ost of the patients in the 13 clinical trials required additional medication, so called ‘rescue medications,’ that accompanied 14 their 12-hour OxyContin dose…Purdue could have tested the safety and efficacy of OxyContin 15 at eight hours, and could have amended their label, but did not.” 127 16 4.174 Instead, Purdue has remained committed to 12-hour dosing because it is key to 17 OxyContin's market dominance and comparatively high price. 12-hour dosing set OxyContin 18 apart from its competitors, and from less expensive, short-acting opioids. In a 2004 letter to the 19 FDA, Purdue acknowledged that it had not pursued approval to allow more frequent dosing in 20 the label (e.g., every 8 hours), and explained that “Purdue has always trained its sales force to 21 promote q12h dosing only” because “[t]he 12 hour dosing schedule represents a significant 22 competitive advantage of OxyContin over other products.” 128 23 24 126 Ryan et al., supra not 123. Id. citing to West Virginia v. Purdue Pharma L.P., Order Deying Purdue Pharma’s Motion for Summary Judgment on Preemption (Circuit Court of McDowell County, WV Nov. 5, 2004). 128 April 14, 2014 Comments on Citizen Petition Docket #2004P-0043, at 12-13. 127 25 26 COMPLAINT - 55 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.175 Purdue’s 12-hour dosing efficacy claims misrepresent the duration of pain relief 2 from OxyContin and fuel the cycle of addiction with crashes and cravings. To fix a misleading 3 marketing campaign, Purdue’s solution was to make the drug more deadly by encouraging 4 physicians to titrate doses up. Purdue had every opportunity to correct its labeling to reflect 5 appropriate dosing for OxyContin and chose not to do so, all to support its misleading claim 6 that OxyContin was unique amongst opioids and therefore worth the price. 7 4.176 Purdue’s claims that opioids improve function are unsubstantiated and 8 misleading because they have not been demonstrated by substantial evidence or substantial 9 clinical experience. But more than being unsubstantiated, those claims were and are untrue. 10 3. 11 Purdue’s deceptive acts or practices relating to opioid addiction and opioid harms 12 4.177 Consistent with the marketing strategy described above, Purdue also sought to 13 mislead health care providers and patients about the adverse effects of opioids, particularly the 14 risk of addiction. For example, as the United States Department of Justice found in resolving 15 criminal charges against Purdue in 2007, sales representatives had “falsely told some health 16 care providers that OxyContin had less euphoric effect and less abuse potential than short- 17 acting opioids.” 129 18 4.178 Purdue funded, influenced and distributed third party publications of doctor and 19 patient “educational” materials that misled their target audiences about the additional danger of 20 21 22 23 prescription opioids. Indeed, many of these publications sought to turn the tables and asserted that doctors who did not treat patients’ pain complaints with opioids were failing their patients, while those who prescribed long-term opioid treatment were following the compassionate (and professionally less risky) approach. For example: 24 25 26 129 United States v. The Purdue Frederick Company, Inc., et al., 1:07-cr-00029 (W.D. Va.), Criminal Information, ¶ 24. COMPLAINT - 56 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 a. Upon information and belief, Purdue maintained a website, In the Face 2 of Pain, from 2008 through 2015, which asserted that policies limiting access to opioids are “at 3 odds with best medical practices” and encouraged patients to be “persistent” in finding doctors 4 who will treat their pain. The website contained testimonials from several dozen physician 5 “advocates” speaking positively about opioids. Eleven of these advocates received a total of 6 $231,000 in payments from Purdue from 2008 to 2013. 130 Purdue omitted this material fact 7 from the site. 131 Purdue deactivated In the Face of Pain in the face of an investigation, and 8 later settlement, by the New York Attorney General. 132 9 b. Purdue sponsored APF’s Treatment Options: A Guide for People Living 10 with Pain (2007), which taught that addiction is rare and limited to extreme cases of 11 unauthorized dose escalations, obtaining opioids from multiple sources, or theft. The 12 Treatment Options guide also states “[d]espite the great benefits of opioids, they are often 13 underused,” and emphasized that “[r]estricting access to the most effective medications for 14 treating pain is not the solution to drug abuse or addiction.” The brochure also explained that 15 opioids’ “under-use has been responsible for much unnecessary suffering.” 16 c. Purdue sponsored APF’s Exit Wounds (2009), which taught veterans that 17 “[l]ong experience with opioids shows that people who are not predisposed to addiction are 18 very unlikely to become addicted to opioid pain medications.” Although the term “very 19 unlikely” is not defined, the overall presentation suggests that the rate is so low as to be 20 immaterial. 21 d. Purdue sponsored APF’s A Policymaker's Guide to Understanding Pain 22 & Its Management, which inaccurately claimed that less than 1% of children prescribed 23 opioids would become addicted. It also misleadingly concluded that “[u]nfortunately, too many 24 25 26 130 Attorney General of the State of New York, In the Matter of Purdue Pharma L.P., Assurance No.: 15151 (August19, 2015). 131 Id. 132 Id. COMPLAINT - 57 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 Americans are not getting the pain care they need and deserve. Some common reasons for 2 difficulty in obtaining adequate care include ... misconceptions about opioid addiction.” 133 3 e. Providing Relief, Preventing Abuse, a pamphlet published by Purdue in 4 2011 for prescribers and law enforcement, includes pictures of the signs of injecting or 5 snorting opioids—skin popping, track marks, and perforated nasal septa—under the heading 6 “Indications of Possible Drug Abuse.” But it is uncommon for opioid addicts to resort to these 7 extremes – they more typically become dependent and addicted to swallowing pills as Purdue 8 designed and intended the drug to be ingested. Purdue sales representatives gave the pamphlet 9 Providing Relief, Preventing Abuse to prescribers in Washington, including, by way of 10 example, . 11 4.179 In fact, as discussed above, up to 26% of opioid users and as many as 30% or 12 even 40% of long-term opioid users experience problems with addiction. Purdue’s 13 representations that the risk of addiction was either low or acceptable were misleading. 14 4. 15 Purdue’s deceptive acts or practices relating to managing addiction and abuse risks 16 4.180 Purdue knew it probably could not persuade doctors to disregard the risk of 17 opioid addiction entirely, and therefore sought to reassure them that doctors could effectively 18 manage risks and prevent addiction in their patients by using tools that Purdue and its third- 19 party groups provided. 20 21 4.181 Purdue deceptively claimed that screening patients could effectively manage addiction risk. For example: a. 22 Purdue sponsored APF’s Treatment Options: A Guide for People Living 23 with Pain (2007), which falsely reassured patients that “opioid agreements” between doctors 24 and patients can “ensure that you take the opioid as prescribed.” 25 133 26 This claim also appeared in a 2009 publication by APF, A Reporter's Guide. COMPLAINT - 58 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 b. Purdue sponsored a 2011 webinar taught by Dr. Webster entitled 2 Managing Patient’s Opioid Use: Balancing the Need and Risk. This publication misleadingly 3 taught prescribers that screening tools, urine tests, and patient agreements have the effect of 4 preventing “overuse of prescriptions” and “overdose deaths.” 5 c. On information and belief, Purdue sales representatives gave the 6 Partners Against Pain “Pain Management Kit,” which contained several “drug abuse screening 7 tools,” to Washington prescribers. These screening tools included the “Opioid Risk Tool” – a 8 five question, one-minute screening tool that relies on patient self-reporting to identify whether 9 there is a personal history of substance abuse, sexual abuse, or “psychological disease.” 10 d. Purdue also promoted the Opioid Risk Tool in CME material, including 11 a 2013 CME entitled Is It Pain? And upon information and belief, a Purdue sales 12 representative 13 14 4.182 Purdue’s deceptive statements about prescribers’ ability to manage the risk of 15 addiction and prevent abuse by their patients influenced Washington prescribers. Indeed, 16 Purdue sales call notes for Dr. Dillinger – whose prescribing habits were profitable to Purdue 17 but problematic for the public health, as discussed below – report his statement that he 18 19 4.183 Convincing prescribers that they could effectively manage risk and prevent 20 addiction was essential to Purdue’s marketing strategy of increasing the number of 21 prescriptions of opioids and its own branded drugs. It was also unsubstantiated. 22 4.184 A 2014 Evidence Report by the Agency for Healthcare Research and Quality 23 (AHRQ) “systematically review[ed] the current evidence on long-term opioid therapy for 24 chronic pain” and identified “[n]o study” that had “evaluated the effectiveness of risk 25 mitigation strategies, such as use of risk assessment instruments, opioid management plans, 26 patient education, urine drug screening, prescription drug monitoring program data, monitoring COMPLAINT - 59 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 instruments, more frequent monitoring intervals, pill counts, or abuse-deterrent formulations 2 on outcomes related to overdose, addiction, abuse or misuse.” 134 3 4.185 Similarly, the evidence shows that methods for preventing abuse and addiction 4 when prescribing opioids to high-risk patients – like those with a documented predisposition to 5 substance abuse – such as patient contracts, more frequent refills, and urine drug screening 6 often do not work in the real world. 135 7 4.186 Even if these risk mitigation strategies did work, prescribers to which Purdue 8 marketed often did not use them. In practice, opioids are all too often prescribed to patients at 9 serious risk for addiction or who are already addicted to opioids – often at high doses. 136 In the 10 call notes and medical board actions described in this complaint, pain sufferers frequently have 11 a history of substance abuse or current substance abuse issues and were still prescribed opioids. 12 Purdue knew that this was a common practice, and continued marketed to prescribers who 13 were doing so. 14 5. 15 16 17 18 19 Purdue petitioned the FDA to prohibit generic versions of Oxycontin’s original formulation, arguing that it presented a public health risk outweighing its benefits 4.187 In 2010, Purdue introduced a reformulation of OxyContin and discontinued marketing its original formulation. This meant that other manufacturers could petition the FDA for permission to make generic OxyContin. The FDA’s regulations required it to determine whether original OxyContin was voluntarily withdrawn from sale for “safety or effectiveness 20 21 22 23 24 25 26 134 The Effectiveness and Risks of Long-term Opioid Treatment of Chronic Pain, Agency for Healthcare Res. & Quality, Sept.19, 2014. 135 Michael Von Korff et al., Long-Term Opioid Therapy Reconsidered, 155 Annals of Internal Med. 325 (2011); Laxmaiah Manchikanti et al., American Society of Interventional Pain Physicians (ASIPP) Guidelines for Responsible Opioid Prescribing in Chronic Non-Cancer Pain: Part I – Evidence Assessment, 15 Pain Physician S1 (2012). 136 Karen H. Seal, Association of Mental Health Disorders With Prescription Opioids and High-Risk Opioids in US Veterans of Iraq and Afghanistan, 307 J. Am. Med. Ass'n 940 (2012). In addition to studies, a review of Purdue call notes and MQAC disciplinary actions reveal that health care providers regularly prescribe opioids to patients with a history of substance abuse and/or current substance abuse issues. COMPLAINT - 60 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 reasons” before approving an Abbreviated New Drug Application (“ANDA”) – basically, a 2 generic version. 137 3 4.188 Generic OxyContin was a threat to Purdue’s bottom line, and the company 4 therefore implemented a cynical strategy: it submitted a citizen petition to the FDA on July 13, 5 2012, arguing that original OxyContin was actually unsafe. Purdue argued that if generic 6 original OxyContin were allowed, “abuse of extended release oxycodone could return to the 7 levels experienced prior to the introduction of reformulated OxyContin.” In short, Purdue 8 argued that the very same high OxyContin abuse rates that it caused and enabled through the 9 deceptive marketing described above were an unacceptable public health crisis, and the drug 10 that caused it should be banned – but only after Purdue had profited handsomely from creating 11 the crisis. 138 12 4.189 Purdue’s petition to the FDA confirms that the company’s epiphany was 13 prompted not by a newfound concern for the public health, but by a desire to continue reaping 14 blockbuster profits. By blocking generic versions of original OxyContin, Purdue maintained 15 the dominant market position for extended release oxycodone under its well-established 16 OxyContin brand name. And Purdue’s hired consultant explained to the FDA that allowing 17 original OxyContin generics would “substantially reduce[]” the “incentives to invest in the 18 significant research and development necessary to bring tamper-resistant products to market.” 19 Making its own deadly-but-profitable product safer apparently ranked lower on the list of 20 motivations. 21 4.190 On April 18, 2013, the FDA found that Purdue had voluntarily withdrawn 22 original OxyContin from sale for safety reasons, closing the door on generic manufacturers. 23 The agency explained that considering OxyContin: 24 137 25 26 21 C.F.R. § 314.161. Indeed, Purdue unfairly ramped up its deceptive promotion of original OxyContin from 2007-2009, a time when it knew original OxyContin was unsafe and being abused at unconscionable rates. 138 COMPLAINT - 61 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 has long considered the abuse potential of a drug in numerous regulatory contexts. Where appropriate, FDA may take into account abuse potential as part of the safety profile of a drug when weighing its benefits and risks. In this case, FDA has considered the abuse potential as part of the Agency’s determination of whether the original formulation of OxyContin was withdrawn from sale for reasons of safety or effectiveness. This approach is particularly appropriate here in light of the extensive and well-documented history of OxyContin abuse. 5 6 7 8 9 10 11 12 13 Original OxyContin has the same therapeutic benefits as reformulated OxyContin. Original OxyContin, however, poses an increased potential for abuse by certain routes of administration, when compared to reformulated OxyContin. Based on the totality of the data and information available to the Agency at this time, FDA concludes that the benefits of original OxyContin no longer outweigh its risks. 139 4.191 The FDA’s proper refusal to allow easily-abused generic OxyContin onto the market has had the unintended consequence – by the FDA – of further lining Purdue’s pockets. First, Purdue enjoyed protection from generic competition for years while deceptively promoting and profiting from an admitted easily-abused drug and fueling an abuse and addiction crisis. Second, that very Purdue-fueled abuse crisis served as the justification for 14 further competitive protection for – and associated profits from – reformulated OxyContin. 15 16 6. Purdue deceptively claimed that abuse deterrent formulations could lower opioid risk 17 4.192 The 2010 reformulation instituted what Purdue calls “abuse deterrent” 18 formulations of its extended release opioids. Because Purdue’s extended release opioids are 19 essentially very large doses of opioids placed in a timed-release matrix designed to release the 20 drug over time, if the time release formulation can be defeated, then the user can get the 21 concentrated dose all at once. In addition, by dissolving the drug, the user can inject it directly 22 into the bloodstream to receive a high. The abuse deterrent formulations were designed to 23 make opioid pills harder to crush, dissolve, or otherwise manipulate so as to defeat this 24 problem. 25 139 26 Federal Register, Vol. 78, No. 75, Thursday, April 18, 2013, Notices, at 23273. COMPLAINT - 62 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.193 As Purdue’s website explains, abuse deterrent formulations “are designed to 2 provide pain relief when taken as directed while also deterring abuse by snorting and injection” 3 and are “intended to help deter the abuse, misuse, and diversion of these prescription pain 4 medications, while ensuring that patients in pain continue to have appropriate access to these 5 important therapies.” 140 6 4.194 As Purdue was the first opioid manufacturer to create an FDA-approved abuse 7 deterrence formula, it has featured prominently in Purdue’s marketing of its drugs. A 2014 8 marketing plan defined 9 A 2015 marketing plan, for example, emphasized 10 11 12 Purdue’s strategic plan for 2015 13 14 A 2016 marketing analysis 15 . 16 4.195 A 2014 Marketing document displays how Purdue used abuse deterrence to 17 distinguish its drugs. 18 19 20 21 ” 22 4.196 Most opioids that are abused, however, are swallowed whole, and oral ingestion 23 is equally risky. In fact, studies suggest that only about 10% to 20% of all opioid users snort or 24 25 26 140 Opioids with Abuse Deterrent Properties, Purdue Pharma, http://www.purduepharma.com/healthcareprofessionals/responsible-use-of-opioids/opioids-with-abuse-deterrent-properties (last visited 9/17/17). COMPLAINT - 63 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 inject pills, and there is no evidence that orally administered opioids are less addictive. 141 In its 2 2012 medical office review of Purdue’s application to include abuse deterrence in its FDA 3 label for OxyContin, the FDA noted that the vast majority of deaths were associated with oral 4 consumption and that only 2% of deaths linked to OxyContin were associated with recent 5 injection and 0.2% with snorting the drug. 142 The CDC also observed that abuse deterrent 6 technologies do not prevent overdose through oral intake. 143 7 4.197 Purdue’s efforts to associate abuse deterrent formulas with safety have borne 8 fruit. In a 2016 survey, 46% of physicians surveyed erroneously stated that abuse deterrent 9 formulations were less addictive than non-abuse deterrent formulations. 144 10 4.198 The 2016 CDC guideline found no evidence or studies to support the notion that 11 abuse deterrent formulations have any effectiveness as a risk mitigation strategy for deterring 12 or preventing abuse. The CDC noted the exception was a study that suggested that the abuse 13 deterrent formulation was associated with increased uses of other opioids, including heroin. 145 14 15 4.199 After being informed of a newspaper story critical of Purdue’s marketing of abuse deterrent formulation in late 2016, Purdue 16 17 18 19 4.200 In 2016, The Pharmaceutical Manufacturing Research Services, Inc. filed a 20 citizen’s petition with the FDA, asking the FDA to withdraw its approval of abuse deterrent 21 labeling on OxyContin. The petition asserted that, in fact, it was “exceedingly easy” to extract 22 the active ingredient from OxyContin via small volume extraction. In fact, it is easier to extract 23 24 25 26 141 Catherine S. Hwang et al., Primary Care Physicians’ Knowledge and Attitudes Regarding Prescription Opioid Abuse and Diversion, 32 Clinical J. Pain 279 (2016). 142 FDA_2013summary review, Reference ID 325870, 4-5. 143 Dowell, supra note 15, at 2. 144 Hwang et al., supra note 143. 145 Dowell, supra note 15, at 2. COMPLAINT - 64 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 the active ingredient from OxyContin than it is to extract from Opana, Endo Pharmaceutical’s 2 extended release drug, 146 which was so unsafe that the FDA requested it be removed from the 3 market. 147 4 4.201 Since the introduction of the reformulated OxyContin, there is little to no data to 5 suggest that it has had meaningful reduction in abuse. 148 And, in fact, as noted above, despite 6 the introduction of abuse deterrent formulas in 2010, opioid deaths have continued to 7 accelerate. 8 7. 9 Purdue’s deceptive acts or practices relating to the significant additional risks posed by increased opioid doses 10 4.202 Because Purdue urged doctors to respond to evidence of addiction by increasing 11 opioid dosage, it had to convince those doctors that the escalated doses were safe. It did so 12 through deceptive marketing materials. For example: a. 13 Purdue sponsored APF’s Treatment Options: A Guide for People Living 14 with Pain (2007), which claims that some patients “need” a larger dose, regardless of the dose 15 currently prescribed, and that opioids have “no ceiling dose.” b. 16 Purdue sponsored APF’s A Policymaker's Guide to Understanding Pain 17 & Its Management, which taught that dose escalations are “sometimes necessary,” even 18 indefinite ones, but did not disclose the risks from high-dose opioids. This publication is still 19 available online. 20 c. 21 Purdue sponsored Overview of Management Options, a CME issued by the AMA in 2003, 2007, 2010, and 2013. 149 The 2013 version remains available for CME 22 23 146 February 19, 2016 Citizen Petition, Pharmaceutical Manufacturing Research Services, Inc. FDA Requests Removal of Opana ER for Risks Related to Abuse, FDA, June 8, 2017, https://www fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm (last visited Sept. 27, 2017). 148 Id. 149 AMA Education Center, Module 02 – Pain Management – Overview of Management Options, https://cme.ama-assn.org/activity/1296783/detail.aspx (last visited Sept. 27, 2017). 147 24 25 26 COMPLAINT - 65 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 credit. The CME was edited by Dr. Portenoy, among others, and upon information and belief 2 taught that NSAIDs and other drugs, but not opioids, are unsafe at high doses. 3 4.203 Furthermore, Purdue knew or should have known that the prescribers targeted 4 by sales representatives – high volume pain clinics, primary care physicians, nurse 5 practitioners, and physician assistants – frequently had limited resources or time to scrutinize 6 Purdue’s claims or conduct the necessary research about the efficacy and risks of high doses of 7 extended release opioids themselves. In fact, Purdue was aware that prescribers often relied 8 upon Purdue sales representatives and the materials that they provided as “someone they can 9 look to for the information they need to make prescribing decisions.” 10 4.204 Purdue sales representatives took the opportunity, when visiting with at least 11 one Washington prescriber, to “discuss proper titration to get adequate analgesic effect” – that 12 13 14 Purdue’s visual aids prompt health care providers to titrate, or adjust doses up, not down: 15 16 17 18 19 20 21 22 23 24 25 26 COMPLAINT - 66 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 4.205 Purdue sales representatives 23 24 By beginning sales pitches with the appropriate 25 dose of branded opioids, Purdue sales representatives shifted the discussion from “should this 26 COMPLAINT - 67 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 patient be taking opioids chronically?” to “which Purdue opioid is easier for your patient to use 2 long-term?” 3 8. 4 Purdue’s deceptive “pseudoaddiction” acts or practices relating to myths like 5 4.206 Purdue downplayed the problem of addiction by simply re-labeling it. 6 According to Purdue, the signs of addiction are actually the product of untreated pain, which 7 should be treated by prescribing even more opioids. 8 4.207 The term “pseudoaddiction” was coined by Dr. J. David Haddox, and 9 popularized for opioid treatment for chronic pain by Purdue. “Pseudoaddiction” was meant to 10 differentiate between “undertreated pain” and “true addiction” – as if the two were mutually 11 exclusive. 12 13 14 4.208 Purdue promoted the concept of “pseudoaddiction” while failing to disclose that it was not substantiated by competent scientific evidence. For example: a. Purdue sponsored the Federation of State Medical Boards’ Responsible 15 Opioid Prescribing (2007), which claimed that behaviors such as “requesting drugs by name,” 16 “demanding or manipulative behavior,” seeing more than one doctor to obtain opioids, and 17 hoarding, are not signs of genuine addiction, but only signs of “pseudoaddiction.” 18 b. Purdue also posted an unbranded pamphlet entitled Clinical Issues in 19 Opioid Prescribing on the Partners Against Pain website in 2005, and upon information and 20 belief circulated this pamphlet after 2007. The pamphlet represented that conduct like “illicit 21 drug use and deception” was not evidence of “true” addiction, but instead an indication of 22 “pseudoaddiction” caused by untreated pain. It explained: “Pseudoaddiction is a term which 23 has been used to describe patient behaviors that may occur when pain is untreated .... Even 24 such behaviors as illicit drug use and deception can occur in the patient’s efforts to obtain 25 relief. Pseudoaddiction can be distinguished from true addiction in that the behaviors resolve 26 when the pain is effectively treated.” COMPLAINT - 68 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 c. Purdue sponsored A Policymaker’s Guide to Understanding Pain & Its 2 Management, which deceptively promoted the concept of “pseudoaddiction,” by explaining 3 that “[p]atients with unrelieved pain may become focused on obtaining medications and may 4 otherwise seem inappropriately ‘drug seeking,’ which may be misidentified as addiction by the 5 patient’s physician.” 6 d. A 2010 Purdue “Training Guide for Healthcare Providers” on 7 OxyContin taught that “[b]ehaviors that suggest drug abuse exist on a continuum, and pain- 8 relief seeking behavior can be mistaken for drug-seeking behavior.” 9 e. Purdue disseminated the Definitions Related to the Use of Opioids for 10 the Treatment of Pain section of an APS consensus statement though the Partners Against Pain 11 website. APS defined pseudoaddiction in the same terms endorsed by Purdue: 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Physical dependence, tolerance, and addiction are discrete and different phenomena that are often confused…. Pseudoaddiction is a term which has been used to describe patient behaviors that may occur when pain is undertreated. Patients with unrelieved pain may become focused on obtaining medications, may "clock watch," and may otherwise seem inappropriately "drug seeking." Even such behaviors as illicit drug use and deception can occur in the patient's efforts to obtain relief. Pseudoaddiction can be distinguished from true addiction in that the behaviors resolve when pain is effectively treated. Physical dependence on and tolerance to prescribed drugs do not constitute sufficient evidence of psychoactive substance use disorder or addiction. They are normal responses that often occur with the persistent use of certain medications.…A patient who is physically dependent on opioids may sometimes continue to use these despite resolution of pain only to avoid withdrawal. Such use does not necessarily reflect addiction. f. Purdue sponsored Exit Wounds, which sought to reassure veterans about addiction concerns by explaining that although they may become physically dependent on opioids, they will not become addicted: Physical dependence means that a person will develop symptoms and signs of withdrawal (e.g., swearing, rapid heart rate, nausea, diarrhea, goose bumps, or anxiety) if a drug medication is suddenly stopped or the dose is lowered too quickly. . . . Physical dependence is normal. This does not mean you are addicted. 26 COMPLAINT - 69 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 5 6 7 Opioid medications can, however, be abused or used as recreational drugs, and some people who use drugs in this way will become addicted. Addiction is a disease state in which people can no longer control their use of a drug that is causing them harm. (Emphasis in original.) g. Purdue directly disseminated materials about “pseudoaddiction” to all Washington prescribers. Following the entry of a 2007 Consent Judgment discussed further below, Purdue was obligated to provide information about abuse and diversion to prescribers. 8 Under the guise of education, Purdue sent annual “Dear Healthcare 9 10 11 12 13 14 15 16 17 18 19 20 21 Provider” letters to all Washington health care providers who prescribed opioids, and enclosed two copies of Providing Relief, Preventing Abuse. Purdue represented that “[t]he brochure contains important information” about topics like “definitions related to the use of opioids for the treatment of pain,” as well as [i]ndicators of possible abuse” and “[s]trategies for identifying opioid abusers.” Various editions of Providing Relief, Preventing Abuse contained deceptive statements about “pseudoaddiction.” h. The 2008 edition of Providing Relief, Preventing Abuse explained that the term “pseudoaddicton” describes the misinterpretation by members of the health care team of reliefseeking behaviors in a person whose pain is inadequately treated as though they were drug-seeking behaviors as would be common in the setting of abuse. The lack of appropriate response to the behaviors can result in an escalation of them by the patient, in an attempt to get adequate analgesia. i. The 2008 edition of Providing Relief, Preventing Abuse further 22 explained that “[p]seudoaddiction can be distinguished from addiction in that the behaviors 23 resolve when pain is effectively treated.” 24 25 j. By 2011, Purdue had revised the brochure, and the second edition of Providing Relief, Preventing Abuse explained that 26 COMPLAINT - 70 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 5 [s]ome patients may exhibit behaviors aimed at obtaining pain medication because their pain treatment is inadequate. The term pseudoaddiction has emerged in the literature to describe the inaccurate interpretation of these behaviors in patients who have pain that has not been effectively treated. Pseudoaddiction behaviors can be distinguished from addiction by the fact that, when adequate analgesia is achieved, the patient who is seeking pain relief demonstrates improved function, uses the medications as prescribed, and does not use drugs in a manner that persistently causes sedation or euphoria. k. 6 By 2014, the term “pseudoaddiction” no longer appeared in Providing 7 Relief, Preventing Abuse, but the brochure included an “Other Considerations” section that 8 taught “[s]ome patients may exhibit behaviors aimed at obtaining pain medication because 9 their pain treatment is inadequate. Such behaviors may occur occasionally even with successful 10 opioid therapy for pain; a pattern of persistent occurrences should prompt concern and further 11 assessment.” l. 12 The 2007 Purdue-sponsored book Responsible Opioid Prescribing 13 warns doctors to “[b]e aware of the distinction between pseudoaddiction and addiction.”150 14 (Emphasis in original.) It explains that “[p]atients who are receiving an inadequate dose of 15 opioid medication often “seek” more pain medications to obtain pain relief,” and “[t]his is 16 called pseudoaddiction because healthcare practitioners can mistake it for the drug-seeking 17 behavior of addiction.” 151 This confusion arises because the “same behavioral signs [of 18 pseudoaddiction] can also indicate addiction.” 152 19 i. Prescribers were instructed to tell pseudo- from “true” addiction 20 by “observing as closely as possible the functional consequences of opioid use. Whereas 21 pseudoaddiction resolves when the patient receives adequate analgesia, addictive behavior 22 does not.” 153 23 24 150 Responsible Opioid Prescribing (2007), at 62 (emphasis in original). Id. 152 Id. 153 Id. 151 25 26 COMPLAINT - 71 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 ii. In short, to tell whether a patient is addicted to opioids, doctors 2 are to give the patient more opioids and then see if he keeps engaging in “demanding or 3 manipulative behavior” after his demands are met or the manipulation has achieved its desired 4 result. 154 5 iii. Other examples of addiction-indicating behavior listed in the 6 book – such as “[b]ought pain medications from a street dealer” and “[t]ried to get opioids 7 from more than one source” 155 – are likely to cease if a single doctor is willing to provide all 8 the opioids the patient needs to satisfy his needs. 9 iv. Conversely, the more extreme examples of addiction-indicating 10 behavior listed in the book – such as “[s]tole money to obtain drugs,” “[p]erformed sex for 11 drugs,” and “[p]rostituted others for money to obtain drugs” – are more indicative of the 12 patient’s financial ability to buy prescription opioids than his underlying need for, and 13 dependence on, opioids. 14 m. Thus, the difference between “pseudoaddiction” and “true” addiction is really 15 whether the patient has (a) a doctor willing to prescribe more opioids until “need” is met, and 16 (b) the insurance and money to pay for those opioids without resorting to theft or prostitution. 17 As long as doctors follow Purdue’s instructions and increase opioid doses, they will see very 18 few patients who are “addicted” to opioids as Purdue trained them to understand the condition. 19 4.209 Purdue’s efforts to promote “pseudoaddiction” successfully convinced 20 Washington opioid prescribers to ignore the fact that their patients were addicted. For example, 21 sales call notes reflect that 22 23 24 25 154 155 26 Id. Responsible Opioid Prescribing (2007), at 63. COMPLAINT - 72 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 . 5 4.210 In fact, Purdue KOL Dr. Lynn Webster acknowledged: “[Pseudoaddiction] 6 obviously became too much of an excuse to give patients more medication. It led us down a 7 path that caused harm. It is already something we are debunking as a concept.” 156 8 9. 9 Purdue’s deceptive acts or practices relating to the management of withdrawal 10 4.211 Purdue also downplayed the impact of addiction by representing that physical 11 dependence on opioids is not the same as addiction and could be addressed by gradually 12 tapering patients’ dosage to avoid withdrawal. Purdue downplayed the difficult and painful 13 effects that many patients experience when dosages are lowered or opioids are discontinued, 14 which decrease the likelihood those patients will be able to stop using opioids. For example: a. 15 Purdue sponsored APF's A Policymaker's Guide to Understanding Pain 16 & Its Management, which taught that “[s]ymptoms of physical dependence can often be 17 ameliorated by gradually decreasing the dose of medication during discontinuation,” but did 18 not disclose the significant hardships that often accompany cessation of use, even gradual 19 tapering off. b. 20 A 2010 Purdue “Training Guide for Healthcare Providers” on 21 OxyContin claimed that patients who were physically dependent on opioids, but who had not 22 developed an “addiction disorder” “[c]an generally discontinue their medicine with mild to no 23 withdrawal syndrome once their symptoms are gone by gradually tapering the dosage 24 according to their doctor’s orders.” 25 26 156 John Fauber & Ellen Gabler, Networking Fuels Painkiller Boom, Milwaukee Wisc. J. Sentinel, Feb. 19, 2012. COMPLAINT - 73 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.212 In fact, as discussed above, it is very difficult to stop using opioids once they 2 have been prescribed. It is not, as Purdue implied, a simple matter to taper the drug and stop 3 using opioids. 4 10. 5 Purdue’s deceptive acts or practices relating to the comparison between the risks and benefits of opioids and those of alternative forms of pain treatment 6 4.213 As the final element of its marketing plan – after misrepresenting opioids’ 7 efficacy and adverse effects – Purdue presented a misleading comparison between the risks and 8 benefits of opioids and other pain treatment methods by influencing and controlling marketing 9 materials that (a) omitted known risks of chronic opioid treatment; and (b) emphasized or 10 exaggerated risks of competing products. These practices had the capacity to deceive 11 prescribers and patients, who would then be more likely to choose opioids and would favor 12 opioids over other therapies such as over-the-counter acetaminophen or over-the-counter or 13 prescription NSAIDs. For example: 14 15 16 17 a. Purdue sponsored APF’s Treatment Options: A Guide for People Living with Pain (2007), which claims that some opioids differ from NSAIDs in that they have “no ceiling dose as there is with the NSAIDs” and are therefore the most appropriate treatment for severe pain. Treatment Options attributed 10,000 to 20,000 deaths annually to NSAID 18 overdose, when the true figure was closer to 3,200 at the time. 157 Treatment Options also 19 warned that risks of NSAIDs increase if “taken for more than a period of months,” but omitted 20 any corresponding warning about the long-term risks of opioids. 21 22 b. Purdue sponsored APF’s Exit Wounds (2009), which omits warnings about potentially fatal interactions between opioids and anti-anxiety medicines called 23 24 157 25 26 Robert E. Tarone et al., Nonselective Nonaspirin Nonsteroidal Anti-Inflammatory Drugs and Gastrointestinal Bleeding: Relative and Absolute Risk Estimates from Recent Epidemiologic Studies, 11 Am. J. of Therapeutics 17 (2004). COMPLAINT - 74 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 benzodiazepines, commonly prescribed to veterans with post-traumatic stress disorder – the 2 target audience for Exit Wounds. 3 c. The Purdue-Sponsored CME Managing Patient’s Opioid Use: 4 Balancing the Need and the Risk contains a deceptive assertion in its very title. Rather than 5 framing the question whether to prescribe opioids properly – as a weighing of the potential 6 benefits and risks, as well as an analysis of other pain treatment options – the presentation 7 implicitly tilts the scales by presenting a “need” for opioids that may or may not exist. 8 9 10 11 d. The 2007 Purdue-sponsored book Responsible Opioid Prescribing represents on Page 1 that “[p]atients in pain who rely on opioids for analgesia” should not be deprived of “optimal pain-relief.” e. 12 13 14 15 4.214 These claims were not supported by competent scientific evidence. As 16 explained above, comparisons between Purdue’s drugs and other drugs cannot represent or 17 suggest that Purdue’s drug is safer or more effective than its competitor unless it has been 18 demonstrated by substantial evidence or clinical trials. Purdue’s 19 20 21 . 4.215 In that same presentation, 22 23 24 Yet in a detailing visit to a Washington prescriber, one sales representative told the prescriber 25 26 COMPLAINT - 75 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.216 Similarly, Purdue paid lip service to the rule that for 2 3 Yet a Purdue sales representative 4 5 6 7 8 9 4.217 Purdue’s campaign worked, and opioids replaced other, safer options in health 10 care providers’ pain treatment repertoires. For example, a study of 7.8 million doctor visits 11 between 2000 and 2010 found that while prescriptions for NSAIDs and acetaminophen fell 12 from 38% to 29%. Opioid prescriptions increased from 11.3% to 19.6% of visits, driven 13 primarily by the decline in NSAID prescribing. 158 14 F. 15 Purdue’s Misconduct Stretches Back Two Decades and Continued Despite a Consent Judgment Regarding the Marketing of OxyContin 16 4.218 Purdue’s marketing campaign to convince prescribers and patients that long- 17 term opioid use was effective for long-term treatment of pain and that its risks could be safely 18 managed is not new. Purdue’s aggressive marketing extends back more than two decades. 19 From the beginning, Purdue employed a wide variety of marketing strategies to accomplish its 20 goal of recklessly increasing opioid sales. 21 4.219 In 1995, as Purdue prepared to launch OxyContin, it conducted market research 22 and determined that the “biggest negative of [OxyContin]” was the abuse potential.” Beginning 23 158 24 25 26 Daubresse et al., supra note 12. For back pain alone, the percentage of patients prescribed opioids increased from 19% to 29% between 1999 and 2010, even as the use of NSAIDs or acetaminophen declined from 39.9% to 24.5% of these visits; and referrals to physical therapy remained steady; see also John N. Mafi et al., Worsening Trends in the Management and Treatment of Back Pain, 173 J. Am. Med. Ass'n Internal Med. 1573, 1573 (2013). COMPLAINT - 76 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 in 1995, Purdue employees set about marketing OxyContin as less addictive, less subject to 2 abuse and diversion, and less likely to cause tolerance. 159 For example, Purdue created and 3 maintained public facing websites, such as “Partners Against Pain,” as well as brochures and 4 videotapes for patients in which Purdue asserted that the risk of addiction from OxyContin was 5 small. 160 6 4.220 From the beginning, much of Purdue’s marketing was directed at prescribers. 7 By 2000, Purdue had approximately 94,000 doctors on its physician call list. 161 Purdue also 8 recruited and paid respected health care professionals as “speakers” who presented Purdue- 9 approved programs to other prescribers at lunch and dinner events. From 1996 to 2001, Purdue 10 held more than 40 national conferences and more than 5,000 physicians, pharmacist, and 11 nurses attended these speaker conferences. 162 In addition to speaker programs, Purdue targeted 12 doctors with “educational” programing and funded more than 20,000 pain-related educational 13 programs through direct sponsorship or financial grants by July 2002. 163 14 4.221 Purdue also paid for direct advertising to physicians in medical journals and 15 distributed thousands of videos, many of which made the claim that addiction occurred in less 16 than 1% of patients. 164 This claim came from a 1980 one-paragraph letter to the editor of the 17 New England Journal of Medicine. It was not a study and did not support the assertion that 18 addiction occurred in less 1% of patients. Despite that, after Purdue began aggressively 19 utilizing the letter as “evidence” that opioids were not addictive, citations to this article in 20 21 22 23 24 25 26 159 United States v. Purdue Frederick Co., Inc., 495 F.Supp.2d 569, 571 (W.D. VA 2007); United States v. Purdue Frederick Co., Inc. et. al. Case 1:07-cr-00029-JPL, Dkt. 5-2, at 5-6. 160 Van Zee, supra note 104. 161 Id. 162 Id. 163 Van Zee, supra note 104. 164 Purdue admitted it distribute 14,000 copies of From on Paint Patient to Another: Advice from Patients Who Have Found Relieffor doctors to make available to patients, and 15,000 copies of I Got My Life Back: Patients in Pain Tell Their Story. Prescription Drugs: OxyContin Abuse and Diversion and Efforts to Address the Problem. Washington DC; General Accounting Office: December 2003 Publication GAO-04-110, 24-27. COMPLAINT - 77 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 medical literature exploded: the article has been cited 608 times. More than 70% of these 2 citations claimed that it was evidence that addiction was rare, and 80% failed to accurately 3 describe the one paragraph letter. 165 4 4.222 The impact of Purdue’s efforts to disseminate this letter can be measured. The 5 other 11 letters published in the same issue of the journal were only cited a median number of 6 11 times. 166 7 4.223 The marketing materials from the early 2000s had a long tail. As illustrated by 8 the longevity of the 1980 one-paragraph letter, misrepresentations that make it into the 9 scientific literature continued to be cited long after publication. Similarly, prescribers trained at 10 Purdue CMEs continue practicing. These early manipulations of prescribers provided fertile 11 ground for Purdue’s later, more nuanced misrepresentations like “pseudoaddiction.” 12 1. 13 Purdue admitted its marketing conduct was unlawful in 2007 and promised to take corrective action 14 4.224 In 2007, Purdue Pharma and several Purdue executives entered in a guilty plea 15 to a criminal charge of Misbranding and paid $634 million dollars in fines related to the 16 marketing campaign for OxyContin. 167 17 4.225 At the same time, Washington brought an action against Purdue related to the 18 marketing campaign for OxyContin. The State alleged that Purdue aggressively promoted 19 OxyContin as a first line response to pain and a powerful and effective pain reliever, 168 While 20 minimizing the risks of abuse, dependence, addiction, and diversion. In videos and pamphlets 21 22 165 23 24 25 26 Pamela T.M. Leung et al., Correspondence, A 1980 Letter on the Risk of Opioid Addiction, 376 New Eng. J. Med. 2194 (2017). 166 Id. 167 United States v. Purdue Frederick Co., Inc., 495 F.Supp.2d 569, 571 (W.D. VA 2007); United States v. Purdue Frederick Co., Inc. et. al. Case 1:07-cr-00029-JPL, Dkt. 5-2. 168 State v. Purdue, Cause No. 07-2-00917-2, Complaint for Injunctive and Other Relief Under the Consumer Protection Act, ¶¶ 26-27, filed May 9, 2007. COMPLAINT - 78 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 for doctors, Purdue directly and falsely asserted that fewer than 1% of opioid using patients 2 become addicted. 169 Washington further alleged that 5 Purdue could have used the prescribing data to readily identify potential sources of abuse and diversion…For years Purdue did not take those steps…Purdue sales representatives instead targeted the highest prescribers and encouraged them to prescribe more OxyContin, in larger doses, to more patients. Purdue’s marketing practices thus exacerbate the abuse and diversion risks. 170 6 4.226 Purdue entered into a Consent Judgment with Washington in 2007 to resolve 3 4 7 these allegations. In that Consent Judgment Purdue agreed, inter alia, 8 9 a. Not to market OxyContin with any claim that is false, misleading or b. Not to misrepresent the existence, non-existence, or findings of any deceptive; 10 11 medical or scientific evidence, including anecdotal evidence, relating to the Off-Label uses of 12 OxyContin; c. 13 To establish, implement, and follow an OxyContin abuse and diversion 14 detection program to internally report apparent pattern of excessive numbers of patients, 15 atypical patterns of prescribing techniques or locations, information that a Health Care 16 Professional or their patients are abusing or diverting medications, sudden unexplained 17 changes in prescribing, disproportionate number of patients paying in cash, multiple 18 allegations of overdose and “take such further steps as may be appropriate based on the facts 19 and circumstances d. 20 21 To provide written, non-branded education information to all health care professionals related to detecting and preventing abuse and diversion of opioid analgesics. 171 22 23 169 24 25 26 State v. Purdue, Cause No. 07-2-00917-2, Complaint for Injunctive and Other Relief Under the Consumer Protection Act,, ¶ 40-41, filed May 9, 2007. 170 State v. Purdue, Cause No. 07-2-00917-2, Complaint for Injunctive and Other Relief Under the Consumer Protection Act, ¶ 48, filed May 9, 2007. 171 State v. Purdue, Cause No. 07-2-00917-2, Consent Judgment, at 2-14, filed May 9, 2007. COMPLAINT - 79 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 2. Despite its Promises of Reform, Purdue Continued its Unfair Practice of Marketing Opioids to, and Concealing from Oversight, its Highest Prescribers 3 4.227 The 2007 Consent Judgment required Purdue, among other things, to: 4 establish, implement and follow an OxyContin abuse and diversion program consisting of internal procedures designed to identify potential abuse or diversion of OxyContin in certain settings (the “OxyContin Abuse and Diversion Detection Program”). The OxyContin Abuse and Diversion Detection Program will apply to Purdue employees and contract or third-party sales representatives, including Medical Liaisons, who contact practicing Health Care Professions in person or by telephone for the purpose of promoting OxyContin. That Program directs those persons to report to the Office of the General Counsel situations [suggestive of OxyContin abuse or diversion]. 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 4.228 The Consent Judgment set out a non-exhaustive list of examples of situations that raise an inference of abuse or diversion, and which needed to be reported by sales representatives and subsequently investigated. These situations include (a) excessive numbers of patients for the practice type, which could be indicated by long lines, “standing-room-only” capacity, and brief interactions between prescriber and patient; (b) “an atypical pattern of prescribing techniques or locations”; (c) credible information “that a Health Care Professional or their patients are abusing or diverting medications”; (d) unexplained and unjustified changes in prescribing or dispensing patterns; (e) a disproportionate number of patients paying for office visits or medications with cash; (f) “multiple allegations that individuals from a particular practice have overdosed”; or (g) “unauthorized individuals signing prescriptions or dispensing controlled substances.” 4.229 When the OxyContin Abuse and Diversion Detection Program turned up information suggesting abuse or diversion, Purdue promised to: conduct an internal inquiry which will include but not be limited to a review of the Health Care Professional’s prescribing history . . . and shall take such further steps as may be appropriate based on the facts and circumstances, which may include ceasing to promote Purdue products to the particular Health Care Professional, providing further education to the Health Care Professional about appropriate use of opioids, or providing notice of such potential abuse or diversion to appropriate medical, regulatory or law enforcement authorities. COMPLAINT - 80 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.230 Even apart from the Consent Judgment, Purdue had an obligation to monitor 2 and report suspicious conduct to the federal Drug Enforcement Administration (“DEA”). See 3 21 U.S.C. § 823(e); 21 C.F.R. 1301.74(b). 172 4 4.231 Upon information and belief, Purdue’s implementation of the OxyContin Abuse 5 and Diversion Detection Program failed to meet minimal standards of diligence and 6 effectiveness, and Purdue routinely failed to (a) detect or investigate potential abuse or 7 diversion, and (b) take appropriate action to stop it. 8 4.232 For example, in the 10 years following entry of the Consent Judgment, the 9 Consumer Protection Division of the Attorney General’s Office has been unable to find 10 evidence of a single instance in which Purdue provided notice of potential diversion or abuse 11 to Washington State authorities such as the Washington Attorney General’s Office or the 12 Medical Quality Assurance Commission. 13 4.233 Purdue failed to investigate and take action in instances that reasonably would 14 raise an inference of abuse or diversion – in other words, where it had information that its 15 product was likely harming the public health. The following are offered by way of example 16 only – upon information and belief, Purdue unfairly continued to market to these opioid 17 prescribers and concealed them from the scrutiny of regulators while collecting the profits 18 from their excessive and dangerous prescription volumes. 19 3. 20 4.234 Dr. Delbert Whetstone was an osteopathic physician who practiced owned and 21 operated Doctors Osteopathic Care, located at 9629 Evergreen Way, Suite 102 in Everett, 22 Washington. Dr. Delbert Whetstone 23 24 25 26 172 For the avoidance of confusion, the State does not allege a cause of action under these or other federal laws. COMPLAINT - 81 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.235 On , a Purdue sales representative 2 3 4 The also described: 5 6 7 8 9 4.236 An internal Purdue report rephrases the foregoing as 10 11 The same report notes that 12 13 . 14 4.237 The report was 15 16 4.238 Purdue was again alerted to diversion and abuse of OxyContin by Dr. 17 Whetstone and 18 19 20 21 22 23 24 25 26 COMPLAINT - 82 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.239 All of this is particularly astonishing 2 3 4.240 Despite these clear indications of diversion, Purdue did not alert Washington 4 authorities. Instead, it chose to remain silent and reap the profits from what turned out to be 5 exactly what it looked like – an organized criminal enterprise to procure OxyContin and 6 distribute it on the black market, thereby poisoning an entire community. Its economic 7 incentive to do so was clear: an internal Purdue document shows 8 9 . 10 4.241 On October 8, 2010, the U.S. Department of Justice filed a complaint against 11 Dr. Whetstone for structuring financial transactions to avoid reporting requirements. The 12 complaint was supported by an investigation by the U.S. Drug Enforcement Administration 13 (DEA), and alleged that the DEA executed a search warrant on October 5, 2010 for Dr. 14 Whetstone’s offices, where it found an account statement reflecting a balance of $447,697.89, 15 as well as a history of daily (and twice-daily) deposits just below $10,000. The DEA also 16 found $46,784.00 in cash in a locked filing cabinet. 17 4.242 This cash was generated by illegal and voluminous prescriptions of OxyContin. 18 An undercover DEA agent obtained three OxyContin prescriptions from Dr. Whetstone in 19 December 2009 and January 2010. Dr. Whetstone never physically examined the undercover 20 officer, though he falsely entered such an examination in his chart. The undercover officer’s 21 second and third encounters with Dr. Whetstone, during which he obtained additional 22 OxyContin prescriptions, lasted 49 seconds and 72 seconds, respectively. 23 4.243 The DEA’s review of prescription data revealed that Dr. Whetstone wrote 24 prescriptions for 87,977 80 mg tablets of OxyCotnin (a dose popular for illicit street sales) 25 26 COMPLAINT - 83 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 during a 10-month period in 2009.173 By way of comparison, the Providence Regional Medical 2 Center, Everett’s largest hospital, ordered only 13,400 of those tablets during the same period. 3 4 4.244 On December 22, 2010, a federal grand jury returned an indictment against Dr. Whetstone for structuring transactions to avoid reporting requirements. 5 4.245 On February 27, 2012, the government filed an Information charging Dr. 6 Whetstone with distribution of a controlled substance. The next day, Dr. Whetstone pleaded 7 guilty to (a) Structuring Transactions to Avoid Reporting Requirements, and (b) Distribution of 8 a Controlled Substance – the latter of which means that he knowingly and intentionally 9 prescribed a controlled substance (OxyContin), and that the prescription was outside the scope 10 of professional practice and not for a legitimate medical purpose. 11 4.246 In sentencing Dr. Whetstone, U.S. District Court Judge Robert Lasnik “Judge 12 Lasnik noted that “[n]ever once did I hear you address what happened to these individuals who 13 are addicted to the drugs you were putting them on,” or “What happened to the people who 14 went out in the community and sold those drugs to people who were pathologically addicted to 15 those drugs, who then broke into pharmacies, who then broke into houses, who then stole cars, 16 who then robbed people to keep this habit going?” 17 18 19 4.247 Judge Lasnik concluded by telling Dr. Whetstone that “the community was harmed by your practice of medicine.” 4.248 Documents produced by Purdue 20 . But by then Purdue had reaped its profits from the illicit sale and 21 distribution of OxyContin, the damage to the community had been done, the DEA had 22 conducted its undercover investigation, and Dr. Whetstone was under federal indictment. 23 24 25 26 173 Looking at Dr. Whetstone’s opioid prescriptions more broadly, he issued 5,189 prescriptions for oxycodone products (308,466 tablets) during the same 10-month time period. COMPLAINT - 84 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4. Dr. Frank Li and Seattle Pain Center 2 4.249 During Purdue’s sales representatives’ frequent visits to the Seattle Pain Center, 3 they often noted circumstances that should have led Purdue to discontinue sales calls and 4 report Dr. Li and his staff to the appropriate authorities. Instead, it unfairly continued to target 5 him for detailing visits that incited him to prescribe even more opioids, with disastrous 6 consequences for the public health. 174 7 4.250 Purdue’s sales call notes repeatedly reference how busy Dr. Li and his staff 8 were – which, combined with the exceptionally high opioid prescription numbers discussed 9 below, should have been another red flag that OxyContin and other opioids were likely being 10 abused. On 11 12 13 14 sales call notes reflect that the This was a trigger specifically identified in the Consent Judgment as requiring investigation and potential action. There is no indication that such action was taken. 4.251 That Seattle Pain Center’s lobby and schedule were so congested is particularly troubling given its practice – again, noted by Purdue – of writing prescriptions for 15 16 17 This revelation should also have 18 raised red flags about whether Seattle Pain Center had implemented adequate practices and 19 procedures to detect diversion and abuse. 20 4.252 Full lobbies and a packed opioid-prescribing schedule were fully consistent with 21 Pain Relief Center’s business model as Dr. Li explained it to Purdue. Purdue’s sales call notes 22 reflect that Dr. Li was 23 from Purdue about and he sought information 24 174 25 26 Purdue’s extensive and successful marketing efforts aimed at Dr. Frank Li and the Seattle Pain Center are set forth in more detail below to illustrate how Purdue’s deceptive marketing practices affected Washington health care providers. COMPLAINT - 85 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 . Conversely, Dr. Li did 2 3 4 4.253 The alarm should also have been sounded as the result of three interactions between Purdue and Dr. Li in 5 6 a. On : , following Purdue’s reformulation of OxyContin, Dr. Li 7 By itself, 8 this would not necessarily be cause for concern. But the following calls should have cast this 9 inquiry in a very different light and revealed a serious abuse and diversion problem. 10 b. 11 On , Dr. Li and the sales representative had to remind him 12 13 14 15 . 16 17 c. Potentially even more troubling, on the same call Dr. Li noted that OxyContin 18 19 20 21 22 . d. Even worse yet, on the same call Dr. Li 23 24 25 26 f COMPLAINT - 86 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 . 4 5 e. On , the Purdue sales representative learned from a physician assistant 6 7 8 9 10 11 4.254 If that were not enough, as discussed below, Seattle Pain Center’s patients died 12 at an alarming rate -- 60 between 2010 and 2015 – all too often of overdose. Some of these 13 deceased patients were treated with OxyContin, MS Contin, and Dilaudid. Purdue either (a) 14 designed and implemented a monitoring system that failed to detect these tragedies, or (b) 15 ignored them and continued to promote OxyContin and its other products to the Seattle Pain 16 Center without reporting the issue to authorities even as the clinic’s body count continued to 17 rise. 18 19 20 4.255 Despite all this, Purdue It did not report him to Washington authorities, but instead unfairly encouraged more prescribing and remained silent in order to reap profits that cost Washingtonians their lives. 21 5. 22 4.256 Patricia Yetneberk was an advanced registered nurse practitioner who practiced 23 24 Advanced Registered Nurse Practitioner Patricia Yetneberk in Snoqualmie, Washington. 4.257 A red flag should have been raised with respect to Ms. Yetneberk, who 25 26 COMPLAINT - 87 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 . This was at least the second time Ms. Yetneberk had described this practice – earlier sales notes state that: 5 6 f 7 8 4.258 The sales representative nevertheless continued to 9 10 . Rather than ceasing 11 promotion and alerting authorities to this troubling misuse of OxyContin, after Ms. 12 Yetneberk’s second statement, the sales representative 13 14 15 16 representative 17 18 19 20 4.259 After Purdue introduced reformulated OxyContin – which was designed to be resistant to being ground up and smoked – Ms. Yetneberk 21 . Ms. Yetneberk 22 23 it 24 25 26 that COMPLAINT - 88 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 f 3 4 . But rather than discontinue its marketing efforts or reporti 5 this disturbing information, Purdue unfairly continued to market OxyContin and other 6 prescription opioids to Ms. Yetneberk. 7 4.260 Purdue’s sales notes also repeatedly reference 8 9 10 None of these reports were flagged by the sales representative as problematic. 11 12 4.261 Purdue’s incentive to ignore these red flags and continue to target Ms. Yetneberk with sales pitches was clear. Upon information and belief, at her peak in 13 14 15 16 17 when Ms. Yetneberk agreed to disciplinary action through the Washington Nursing Care 18 Quality Assurance Commission (NCQAC). These detailing visits worked: Upon information 19 and belief, from 2007 to 2016, Ms. Yetneberk wrote more than 20 prescriptions of the next highest prescriber, despite the 2014 MQAC discipline that prevented 21 her opioid prescribing during the final two years of the period. 22 G. 23 times the OxyContin Washington Prescribers and Their Patients Have Been Directly Affected by Purdue’s Marketing 24 4.262 Purdue’s marketing has been effective in changing the prescribing patterns of 25 health care providers both nationally and in Washington. These methods were specifically 26 COMPLAINT - 89 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 tailored to deceive health care providers and increase opioid prescriptions, including 2 prescriptions of Purdue products. 175 3 4.263 Purdue's misrepresentations about the safety and efficacy of extended release 4 opioids encouraged health care providers to prescribe and patients to take increasing 5 numbers of opioids for the treatment of chronic pain. 6 4.264 Between January 2007 and November 2016, Purdue sales representatives 7 documented 8 2009 and 2010, Purdue 9 alone, 10 11 12 13 to Washington individual prescribers and clinics. Between its sales force in Washington from Purdue sales representatives made than to . In 2011 detailing visits or the equivalent of more every business day that year. 4.265 The significant time and resources devoted to detailing prescribers in Washington indicates that Purdue recognized the effectiveness of in-person marketing. 4.266 The following examples illustrate the interaction between Purdue’s 14 misrepresentations, delivered through “educational” materials and personal sales calls, and 15 opioid prescribing practices. 16 17 18 1. Dr. Donald Dillinger 4.267 Purdue targeted Dr. Donald Dillinger, an Everett physician who ran a pain management clinic in Everett, with marketing including the following: 19 a. 20 b. 21 c. 22 ; ; ; 23 24 25 26 175 Purdue also gave out “swag.” According to the DEA, Purdue's use of branded promotional items was unprecedented among Schedule II opioids, and was an indicator of Purdue's aggressive and inappropriate marketing of OxyContin. GAO, OxyContin Abuse and Diversion and Efforts to Address the Problem, at 25 (2003). COMPLAINT - 90 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 d. 2 e. 3 4 f. 5 6 g. 7 8 h. 9 i. 10 11 . 12 4.268 Purdue’s use of key opinion leaders and presentations at conferences and CMEs 13 was successful at influencing Washington prescribers. For example, Purdue sales call notes 14 reveal that Dr. Dillinger 15 And following a 16 reported to Purdue that 17 18 Dr. Dillinger 4.269 Purdue sales representatives conducted numerous sales calls and check-ins with Dr. Dillinger. 19 20 21 22 : a. then 23 24 25 26 COMPLAINT - 91 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 b. 4 . 5 c. 6 d. . 7 8 e. 9 f. 10 11 12 13 14 (Emphasis added.) 4.270 Purdue’s efforts to change Dr. Dillinger’s prescribing practices were successful. For example, Purdue sales call notes reflect: a. 15 16 b. 17 c. 18 19 20 21 d. 22 23 24 e. 25 26 COMPLAINT - 92 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 f. 2 3 4 g. 5 6 4.271 From 2007 through 2016, Dr. Dillinger wrote times more than the average Everett prescriber, and nearly prescriptions of OxyContin 7 – times as many as the next 8 highest in his community. But rather than viewing this pattern as a cause for concern, Purdue 9 saw an opportunity for profit. 10 4.272 Indeed, Purdue’s efforts to influence Dr. Dillinger intensified as his 11 prescriptions of OxyContin began increasing in 2008 when it likely identified him as a high 12 prescriber, and continued after his peak OxyContin prescription year of 2010. As set forth in 13 the chart below, Purdue contacted Dr. Dillinger just 14 to times per month by times per month in , but increased , the year after his OxyContin prescribing peak: 15 16 17 18 19 20 21 22 23 4.273 Indeed, Purdue’s efforts were so successful that its sales call notes 24 25 26 COMPLAINT - 93 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.274 As a result of this relentless marketing, Dr. Dillinger prescribed OxyContin at 2 extremely high rates. According to data produced by Purdue, Dr. Dillinger issued between 3 approximately and 4 opioid prescriptions – including generic drugs – each month from through . As described above, Dr. Dillinger’s OxyContin 5 prescriptions increased regularly from 6 sales visits from Purdue representatives 7 market and 8 Dillinger’s 9 prescriptions of generics, 10 through – a period when he received regular . As Purdue brought new opioids to , Dr. declined, but his overall opioid prescriptions, including 4.275 Once Dr. Dillinger became a reliable Purdue opioid subscriber, Purdue 11 12 13 . Dr. Dillinger consulted with primary care physicians (PCPs) who referred patients to him. Purdue’s sales call notes reflect the following: 14 a. 15 16 17 b. Asking (i) 18 ; (ii) 19 20 ; (iii) (iv) ; ; (v) 21 ; (vi) 22 ; (vii) 23 24 25 4.276 This strategy of obtaining of opioid prescribing practices is consistent with Purdue’s research, which found that 26 COMPLAINT - 94 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 The report noted that 5 6 7 4.277 Purdue’s marketing report recommended that Purdue 8 9 because 10 11 Indeed, call notes with Dr. Dillinger reflect that he 12 13 ; Purdue then attempted to use Dr. Dillinger to 14 15 . 4.278 Purdue’s efforts to recruit Dr. Dillinger 16 17 : a. 18 19 b. 20 c. 21 d. 22 23 24 4.279 Dr. Dillinger’s opioid prescription practices, encouraged by Purdue, did not end 25 well. On August 23, 2017, Washington Department of Health, Medical Quality Assurance 26 Commission (“MQAC”) issued its Findings of Fact, Conclusions of Law, and Final Order (the COMPLAINT - 95 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 “Final Order”) In the matter of Donald Stephen Dillinger, License No. MD.MD.00017867, 2 Master Case No. M2015-280. The Final Order found that the Department of Health proved by 3 “clear and convincing evidence” that Dr. Dillinger engaged in improper treatment of patients 4 with opioids, including by: 5 a. Failing to document required information in the patient treatment plans. 6 b. Failing to “obtain informed consent and to discuss the risks and 7 treatment regarding his opioid treatment.” 8 9 c. outlined the [patients’] responsibilities.” 10 11 Failing “to update and enforce written agreements for treatment that 4.280 The Final Order details Dr. Dillinger’s treatment of several patients, who are designated by letter to protect their identities. For example: 12 a. Dr. Dillinger failed to address indications that Patient B was misusing or 13 diverting prescription opioids, and notes that when Patient B complained that Fentanyl patches 14 were falling off, Dr. Dillinger switched her to OxyContin. Dr, Dillinger then prescribed her a 15 three-month supply of opioids while she would be out of town without putting any procedures 16 in place to ensure they were not abused or diverted. 17 b. Patient C had a history of obtaining “street drugs,” and at several points 18 sought additional opioids from Dr. Dillinger by explaining that her prescriptions were either 19 lost or stolen. Dr. Dillinger did not recognize these incidents as red flags for diversion and 20 abuse. 21 c. Similarly, Patient E reported five (5) incidents of drug theft from 2006 22 to 2011, but Dr. Dillinger took no precautions to prevent diversion or abuse. Nor did Dr. 23 Dillinger take action when Patient E tested positive for cocaine, when she was incarcerated, or 24 when she experienced deep vein thrombosis caused by injecting drugs into the femoral artery. 25 26 d. Dr. Dillinger began treating Patient F after she failed a urinalysis and her previous health care provider refused to continue treating her with opioids. Dr Dillinger’s COMPLAINT - 96 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 charts reveal that he did not contact Patient F’s previous provider, and did not institute 2 additional controls when she reported her opioid medications stolen. 3 4.281 Among other conditions, the Final Order imposed three years of oversight, 4 permanently restricted Dr. Dillinger “from the practice of treating chronic pain patients,” 5 prohibits him from prescribing “more than three-days of opioid medication in the treatment of 6 non-chronic pain patient[s],” and requires him to register with the Washington Prescription 7 Monitoring Program, or “PMP.” 8 2. 9 4.282 A Statement of Charges was filed against Dr. Frank Li, owner and operator of 10 the Seattle Pain Center, providing further, tragic examples of the damage wrought upon 11 Washington citizens by Purdue’s misinformation campaign about the benefits and risks of 12 opioids, and the resulting prescription patterns. 176 His license was summarily suspended. 13 14 15 4.283 Despite its name, the now-shuttered Seattle Pain Center operated clinic locations throughout Western Washington – in Seattle, Renton, Everett, Tacoma, Olympia, Poulsbo, and Vancouver – in addition to a location in Spokane. 16 17 18 19 20 Dr. Frank Li and the Seattle Pain Center 4.284 Upon information and belief, Seattle Pain Center represented itself as a pain treatment center focused on “finding treatment alternatives to narcotic pain medications” by incorporating “emerging best practices.” It employed five physicians and numerous mid-level practitioners, such as Advanced Registered Nurse Practitioners (ARNPs) and Physician Assistants (PAs), often newly licensed and with little experience. 177 In reality, Seattle Pain 21 22 23 24 25 26 176 On July 13, 2016, MQAC lodged a Statement of Charges against Dr. Li under Master Case No. M2016-705. 177 Purdue sales representatives targeted . For example, sales call notes reflect plans to r and as well as the p COMPLAINT - 97 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 Center’s prescribers often used opioids as the exclusive method to treat chronic non-cancer 2 pain without even exploring other treatment options. 3 4.285 Seattle Pain Center’s opioid prescriptions were extraordinarily high. For 4 example, from to , Dr. Li alone wrote OxyContin prescriptions. Most Seattle 5 Pain Center locations closed in July 2016, after the Washington State Medical Commission 6 suspended Dr. Li’s license. 7 4.286 Seattle Pain Center was also the target of a concerted marketing effort by 8 Purdue to promote its brand-name drugs and opioids in general. Dr. Li and Seattle Pain Center 9 staff received numerous sales calls and visits, including lunches. Purdue also invited Dr. Li, at 10 his request, to dinner programs. Finally, Purdue supplied Dr. Li and the mid-level practitioners 11 he employed with its “educational” materials promoting opioids, including 12 . Sales call notes reflect Seattle Pain Center’s reliance on Purdue’s materials: 13 a. 14 15 16 17 18 19 ” c. 20 21 22 23 d. 24 25 26 COMPLAINT - 98 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 e. 2 3 4 f. 5 6 g. 7 8 h. 9 4.287 As a result, Seattle Pain Center’s practices were consistent with the false, and 10 dangerous, misrepresentations about opioid treatment pushed by Purdue directly and through 11 its KOLs and Front Groups. 12 4.288 Purdue promoted opioids as effective at treating chronic non-cancer pain, and 13 superior to other options. Upon information and belief, Seattle Pain Clinic routinely prescribed 14 opioids without exploring other treatment options. For example, MQAC alleged: 15 a. “[Dr. Li] treated Patient A with an aggressive regimen of oxycodone 16 without conducting an objective physical examination” and “without crucial consideration of 17 physical co-morbidities . . . .” 178 18 b. “Patient P was maintained on an oxycodone regimen on his request, and 19 there was no documented objective diagnosis, review of prior medical records, or risk 20 assessments.” 21 4.289 Purdue downplayed the risks of long-term opioid use. Upon information and 22 belief, Seattle Pain Center routinely provided its patients with opioids for years, often without 23 creating any plan to wean or discontinue the use of opioids. For example, MQAC alleged: 24 25 178 26 MQAC noted that “Patient A died 12 days after filling her prescription for oxycodone.” COMPLAINT - 99 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 a. “SPC treated Patient P’s chronic pain by prescribing oxycodone at 180 2 [morphine equivalent dose] for greater than two years without evidence of improvement” and 3 without “implement[ing] an opioid exit strategy.” 4 5 b. For two years, “[Dr. Li] and SPC providers prescribed [Patient Q] escalating monthly doses of oxycodone HCL and OxyContin.” 6 4.290 Purdue promoted the myth of “pseudoaddiction” that should be treated with 7 additional opioids, as well as the notion that there was no “ceiling” for opioid doses, such that 8 patients could simply be prescribed additional opioids when they developed tolerance. Upon 9 information and belief, Seattle Pain Center routinely increased opioid doses of its patients, 10 even with signs of addiction or abuse. For example, MQAC alleged: 11 a. “[Dr. Li] and SPC providers continued to escalate Patient A’s opioid 12 dose despite Patient A’s known overuse of Percocet, doctor-shopping for medications, requests 13 for early refills, and repeated presence of alcohol in her UDS.” 14 b. “SPC providers prescribed increasing methadone doses of 30 mg to 40 15 mg daily even after Patient C admitted to taking more pills than prescribed, and had a history 16 of overdose, and continued to smoke marijuana.” 17 c. “Patient H had four SPC office visits where [Dr. Li] and a PA he 18 supervised prescribed increasing doses of [Purdue drug] MS Contin and oxycodone at each 19 visit despite awareness of Patient H’s high risk factors for opioid misuse.” 20 21 “SPC providers . . . continued prescribing hydromorphone at escalating e. “[I]n less than six months Patient M was switched from morphine to an doses.” 22 23 d. escalated dose of prescribed methadone.” 24 f. “SPC providers documented multiple aberrant behaviors of drug- 25 seeking, but deemed the conduct not egregious and maintained Patient N on escalating opioid 26 doses.” COMPLAINT - 100 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.291 Purdue downplayed the danger of opioid abuse and promoted the notion that it 2 could be curtailed using tools presented by its KOLs and Front Groups. Upon information and 3 belief, Seattle Pain Clinics routinely prescribed opioids despite evidence of its patients’ actual 4 or potential abuse. For example, MQAC alleged that “SPC providers initiated an opiate 5 regimen of morphine, [Purdue drug] Dilaudid, and Flexeril despite Patient D’s history of 6 critical opioid risk factors . . . .” 179 7 4.292 Seattle Pain Clinic’s profligate prescribing practices had deadly consequences. 8 Upon information and belief, Sixty (60) of its patients died between 2010 and 2015. MQAC 9 investigated eighteen (18) of these deaths, and found that sixteen (16) of them “listed acute 10 drug intoxication as a cause or likely contributing cause of death.” In short, these Seattle Pain 11 Clinic patients died of overdose – often shortly after filling their final prescriptions for opioids. 12 For example, MQAC alleged that: 13 14 a. “Patient G died 15 days after filling her last prescriptions of morphine and [Purdue drug] Dilaudid prescribed by SPC.” 15 b. “Patient O filled her final methodone prescription from SPC just five 16 days prior to her death” from “acute combined hydrocodone, hydromorphone, and methadone 17 intoxication.” 18 19 3. Advanced Registered Nurse Practitioner Kelly Bell 4.293 Kelly Bell was an advanced registered nurse practitioner in Vancouver, 20 Washington who regularly treated patients complaining of pain with opioids, including 21 OxyContin. 22 4.294 Purdue aggressively targeted Ms. Bell with medical “education” materials 23 designed to persuade her to prescribe opioids for pain, as discussed above. For example, 24 Purdue Sales representative call notes reflect discussions and that included 25 179 26 MQAC noted that “Patient D died nine days after filling his last prescription from SPC.” COMPLAINT - 101 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 and as well as 2 3 4 4.295 Purdue’s efforts to “educate” Ms. Bell were successful. As noted above, sales call notes reflect that 5 . On 6 7 8 9 10 11 12 13 14 – i.e., that she would prescribe them opioids in the amounts they desired. 4.296 Purdue’s “education” efforts also touched on applicable regulations, with call notes indicating plans to 15 16 17 18 19 20 21 22 23 4.297 Purdue’s education efforts successfully primed Ms. Bell to reject the opioid 24 prescribing recommendations in Washington’s Agency Medical Director’s Group Interagency 25 Guideline on Opioid Dosing for Chronic Non-cancer Pain. Sales call notes reveal that the sales 26 COMPLAINT - 102 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 representative and Ms. Bell had a 2 3 4.298 The results of Purdue’s re-education efforts were huge amounts of opioids 4 pumped into Ms. Bell’s patients and the Vancouver community, and significant profits for 5 Purdue. For example, an internal Purdue study of Ms. Bell’s prescriptions 6 f 7 8 4.299 Indeed, Ms. Bell wrote so many prescriptions for so many opioids that she met 9 resistance from insurance companies who balked at paying for the flood of drugs. Purdue’s 10 sales call notes reflect that: 11 a. 12 b. 13 14 c. 15 16 17 4.300 Ms. Bell’s high opioid prescription rate also put a strain on her patients’ digestive tracts from opioid-induced constipation. This resulted in 18 19 20 . Senokot is a laxative produced and sold by Purdue. Purdue’s sales call notes reflect during a -month stretch. For example, 21 22 23 24 25 26 COMPLAINT - 103 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.301 Despite Ms. Bell’s alarmingly high opioid and OxyContin prescription rates, 2 Purdue unfairly continued to call her and promote its products – and reap the profits from her 3 prescriptions – until 4 Commission (NCQAC) filed a statement of charges against her. The Statement of Charges 5 alleged that Ms. Bell “prescribed extremely high doses of opioids” to patients to treat 6 “complaints of chronic, non-cancer pain” without engaging in “appropriate assessment or 7 appropriate ongoing monitoring.” This put patients “at risk of serious physical harm or death.” before Washington’s Nursing Care Quality Assurance 8 4.302 Ms. Bell entered into an Agreed Order with NCQAC in which she admitted 9 putting patients at risk of “moderate to severe harm” and that her treatment of chronic non- 10 cancer pain fell below the standard of care for a “reasonably competent advanced registered 11 nurse practitioner and a reasonably competent registered nurse in the state of Washington.” 12 The Agreed Order also suspended Ms. Bell’s privilege to prescribe all Schedule II drugs 13 indefinitely. 14 4. 15 4.303 Purdue methodically tracks prescriptions and sales of its branded opioids in 16 Washington by prescriber, drug strength, pill quantity, days supplied, pharmacy, personal 17 identifying information of the patient, and many other factors. For example, Purdue has precise 18 data itemizing the number of OxyContin, Butrans, and Hysingla prescriptions written in 19 Prescribers outstripping their peers Washington . 20 4.304 Using these granular sales data, Purdue undertook a business practice of 21 marketing aggressively to the highest decile prescribers of Purdue branded opioids in 22 Washington. In a 2014 internal marketing document, 23 24 In 2016, Purdue’s data showed 25 . In a 2011 document, 26 COMPLAINT - 104 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 Purdue found 2 3 . 4.305 4 5 6 . 7 4.306 This carefully considered marketing strategy established an insidious group of 8 local Purdue-targeted prescribers and pharmacists who wrote and dispensed prescriptions for 9 Purdue opioids at a rate vastly exceeding peers in their locality or their specialty. For example, 10 between 2008 and 2016: 11 a. 12 13 This physician’s rate f 14 15 16 i. 17 18 ii. 19 20 b. 21 22 23 24 180 25 26 The number of prescriptions of OxyContin, Butrans, and Hysingla attributed to prescribers in this section were calculated from commercial prescriber data produced by Purdue to the Consumer Protection Division in response to a civil investigative demand. COMPLAINT - 105 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 i. 2 3 4 ii. 5 6 7 iii. 8 9 10 11 4.307 Purdue’s two-pronged strategy of marketing to primary care physicians, 12 physician assistants, and nurse practitioners, and to pain clinics resulted in a noticeable and 13 alarming trend of outlier prescribers in geographically disparate Washington cities and towns 14 who flooded the state with opioid prescriptions. For example: 15 16 a. Arlington, WA has a population of approximately 19,000 people. Two providers in 17 18 19 . The next two highest prescribers of those same Purdue opioids in Arlington 20 21 b. In Olympia and Yelm, 22 23 24 Olympia has a population of approximately 51,000 and Yelm has a population of fewer than 9,000. 25 26 COMPLAINT - 106 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 c. Similar patterns of local clinics prescribing vastly more Purdue opioids than their next highest-prescribing competitors in that locality are repeated in 5 , in in , in , and all over the state. 6 4.308 The prescribers and clinics listed above demonstrate how effectively Purdue 7 targeted its deceptive practices at Washington health care providers, and Purdue’s significant 8 influence on their opioid prescribing habits. 9 H. Opioids Have Severely Impacted Washington State 10 4.309 Opioid use, morbidity, and mortality have increased exponentially nationwide 11 and across Washington State in the years since Purdue first began aggressively marketing 12 opioids for long-term use. Prescriptions and sales of opioids in Washington skyrocketed more 13 than 500% between 1997 and 2011. 181 14 4.310 In 2011, at the peak of overall sales in Washington, more than 112 million 15 daily doses of all prescription opioids were dispensed in the state – enough for a 16-day supply 16 for every woman, man, and child in the state. Since 2011, sales of extended release opioids have 17 plateaued somewhat, although there were still more than 18.2 million daily doses of oxycodone 18 distributed in 2015. 19 4.311 Nearly one-fourth of all Washington residents received at least one opioid 20 prescription in 2014. 182 Even as prescription rates decline, in 2016 there were still seven 21 22 23 24 181 Franklin et al., supra note 3. PDMP County Profiles 2014: Executive Summary, Washington State Department of Health, http://www.doh.wa.gov/Portals/1/Documents/2600/PMPcountyProfiles/630-126CountyProfilesExecutiveSummary2014.pdf (last visited Sept. 27, 2017). 182 25 26 COMPLAINT - 107 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 counties in which enough opioid prescriptions were dispensed for every person in that county 2 to have one. 183 3 4.312 According to the CDC, between 1999 and 2015 more than 194,000 people 4 died in the United States from prescription-related overdoses. There have been more than 5 10,000 deaths attributable to any opiate in Washington alone since turn of the 21st century. 184 6 a. Overall, the majority of drug overdose deaths in Washington (more than 7 6 out of 10) involve an opioid. 185 8 b. Overdose deaths – specifically opioid overdose – have overtaken those 9 causes that have traditionally had the highest rates of accidental death. In 2015, the number of 10 overdose deaths in Washington (718) surpassed both the number of deaths in car accidents 11 (592) and from firearms – suicide, homicide, and accidental (714). 12 c. Drug-caused deaths involving opioids increased 31% statewide, with 13 increases in most counties. The total number of drug-caused deaths involving opioids in 2013 14 was 718, with 7595 deaths total from 2006–2016. 186 The annual rate of opioid deaths has not 15 changed from 2008 to 2013. A similar pattern emerges with prescription-type opioids peaking 16 between 2008–2010, while heroin continued increasing through 2013. 17 18 d. In King County, prescription-type opioid trends are down somewhat from peaks around 2010, however prescription-type opioid-involved deaths are persisting at 19 20 21 183 22 23 24 25 26 The CDC data show the estimated rate of opioid prescriptions per 100 U.S. residents in 2016, including rates of 150.9 in Asotin County; 119.9 in Columbia County; 119.7 in Clallam County; 119 in Garfield County; 118 in Pend Oreille County; 113 in Grays Harbor County; and 102.4 in Benton County. CDC U.S. Prescribing Rate Maps. https://www.cdc.gov/drugoverdose/maps/rxrate-maps.html (last visited Sept. 27, 2017). 184 Center for Health Statistics, Washington State Department of Health. 185 Rudd et al., supra note 18. 186 DOH Opioid-Related Deaths in Washington State, 2006-2016, Washington State Department of Health, https://www.doh.wa.gov/Portals/1/Documents/Pubs/346-083-SummaryOpioidOverdoseData.pdf (last visited Sept. 27, 2017). COMPLAINT - 108 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 elevated rates and are second only to heroin in terms of most common drugs identi?ed in fatal overdoses. 187 4.313 Geographic areas with higher per-capita rates of opioid prescribing show a strong correlation with higher overdose rates. 4.314 The death rates in Washington are geographically disparate and are concentrated in the counties with the highest rates of opioid prescriptions. For instance: a. In 2014, Pend Oreille County in the northeastern comer of the state had a rate of opioid substance use of 282.3 patients prescribed opioids per 1,000 residents and a corresponding 10.10 deaths attributable to any opioid per 100,000 residents between 2013- 2015. That overdose death rate was a more than 200% increase from 2002-2004. Similarly, Cowlitz County in the southwestern corner of the state had a rate of opioid substance use of 273 patients prescribed opioids per 1,000 residents and a corresponding 13.49 deaths attributable to any opioid per 100,000 residents between 2013-2015. This pattern can be seen repeated in many Washington counties. 4.315 Clallam, Cowlitz, and Snohomish counties have opioid overdose rates higher than the state average. While not located in the one of the four corners, Snohomish County has experienced a 23.7% increase in deaths involving any opiate between 2002-2004 and 2013- 2015 beams Involving any opiate. per 100,000 residents. 201.; 2015 .x All OPIOIDS by County. 2014: Recipients per 1,000 Residents A State 9.52 187 ADAI 2016 Drug Use Trends in King County. Washington (July 2017) Contributors: Caleb Banta- Green. Jason Williams. Robyn Smith. Brad Finegood. Laurie Sylla. Richard Hamiff. Joe Tinsley. Meaghan Murm, Julia Hood. Susan Buskin, Sara Glick. Steve Freng. Fiona Couper. Ed Suzuki. Johrmy Ohta. Jim Pugel. Mary Taylor ONIPLAHQT - 109 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fi?h Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 4.316 The scope of human suffering and economic cost of opioids on Washington 2 reverberates far beyond overdose mortality rate. The State spends significant public resources 3 on medical services, law enforcement, corrections, workers’ compensation, diversion 4 programs, prosecution, probation, treatment, and child welfare. 5 a. The cumulative rate of opioid-related inpatient hospital and clinic stays 6 increased by 60.1 percent in Washington between 2009 and 2014, the fourth greatest increase 7 in the nation. 188 That rate of 313.2 opioid-related inpatient stays per 100,000 in population 8 placed Washington eighth in the nation. 189 9 b. The Washington State Toxicology Laboratory, housed within 10 Washington State Patrol, has received a significant increase in the number of cases submitted 11 for testing in recent years by approximately 1,000 cases per year since 2013. The increased 12 caseload results in a backlog of samples waiting to be tested. 13 c. Crime lab data for police evidence testing for opioids indicate an 85% 14 increase statewide between 2002-2004 and 2011-2013, with increases in most counties. Police 15 evidence testing results show that oxycodone has consistently been the most common 16 prescription-type-opioid detected in all years. 190 17 18 d. Publicly funded drug treatment admissions for opioids as the primary drug increased 197% statewide, with increases in 38 of 39 counties. 191 19 4.317 Deceptive and unfair marketing of opioids by Purdue also has a significant 20 detrimental impact on children in Washington. Adolescent misuse of prescription-type-opioids 21 is very important because it is the peak period in life when people first misuse opioids. 192 The 22 188 23 24 25 26 HCUP Opioid-Related Inpatient Stays and Emergency Department Visits by State, 2009-2014 (Dec 2106, revised Jan 2017), at *7-8. 189 HCUP Opioid-Related Inpatient Stays and Emergency Department Visits by State, 2009-2014 (Dec 2106, revised Jan 2017), at *5. 190 ADAI Opioid Trends Across Washington State (April 2015) ADAI-IB 2015-01. 191 ADAI Opioid Trends Across Washington State (April 2015) ADAI-IB 2015-01. 192 Opioid Trends in Pierce County (February 2017), citing to Meier et al., 2012. COMPLAINT - 110 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 overprescribing of opioids for chronic pain has given young children access to opioids, nearly 2 all of which were prescribed for adults in their household or to the children by dentists. 3 a. The 2016 Healthy Youth Survey revealed that a significant portion of 4 Washington students misuse prescription drugs – about 4,500 twelfth graders use prescription 5 opioids to get high in any given month, and about 3,600 have tried heroin at least once. 193 6 b. Washington dentists are the biggest prescribers of opioids to youth, 7 prescribing more than 13,000 pills to youth age 14-19 in one six-month period in 2015. For 8 comparison, emergency medicine providers, the second highest prescribers, issued 9 prescriptions for approximately 2,500 pills in the same period. 10 c. While Healthy Youth Survey data for King County tenth graders indicate 11 a significant decline in the proportion reporting past month use of prescription-type-opioids to 12 get high, that decline is being offset somewhat by increased rates of heroin use. In 2006, 10% 13 of King County tenth graders reported past month use of prescription-type-opioids to get high; 14 that number has steadily declined in bi-annual surveys to 4% in 2014 and the same proportion 15 in 2016.194 However, in 2016 there was a strong association between reporting use of 16 prescription-type-opioids to get high and having ever used heroin (26%), compared to only 2% 17 reporting ever having used heroin if they had not used prescription-type- opioids to get high. 18 4.318 Even infants have not been immune to the impact of opioid abuse and 19 overprescription. There has been a dramatic increase in the number of infants who are born 20 addicted to opioids due to prenatal exposure and suffer from neonatal abstinence syndrome 21 (NAS), which can occur in an infant exposed in utero to addictive, illegal or prescription drugs. a. 22 23 Neonatal abstinence syndrome (NAS) can occur in an infant exposed in utero to addictive, illegal or prescription drugs. Babies born with NAS may experience a 24 193 25 26 2016 Washington State Healthy Youth Survey. Data Brief: Prescription Drugs and Opiates. http://www.doh.wa.gov/Portals/1/Documents/8350/160-NonDOH-DB-Opiates.pdf. 194 2016 Washington State Healthy Youth Survey www.askhys net COMPLAINT - 111 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 variety of withdrawal symptoms, medical complications and have prolonged hospital stays. 2 According to the Centers for Disease Control and Prevention, the incidence rate of NAS in 3 Washington State increased from a rate of 1.5 for every 1,000 hospital births in 1999 to a rate 4 of 7.9 for every 1,000 hospital births in 2013. In Washington, prenatal exposure to opioids 5 increased from 11.5 percent of all drug-exposed neonates in 2000 to 24.4 percent in 2008, and 6 41.7 percent of infants diagnosed with NAS were exclusively exposed to opioids. 195 7 4.319 Opioid use has had a significant impact on Washington’s child welfare system. 8 Parental substance abuse is a major risk factor for child fatalities, child maltreatment, and 9 involvement with the child welfare system. 10 a. From calendar year 2013 to 2016, the Office of the Family & Children’s 11 Ombuds identified 33 maltreatment related fatalities of children ages 0 to 3 years where a 12 caregiver’s opiate use was a known risk factor. 196 13 b. Upon information and belief, a review of a representative sample of 14 dependency petitions filed 2014-2016 in Snohomish County found that in more than 95% of 15 cases where children were removed from the home due to parental drug use, the drug involved 16 was an opioid. 17 c. Children removed from their home as a result of parental substance 18 abuse are likely to remain in foster care longer and have significantly higher rates of adoption 19 than those in foster care for other reasons. 197 A higher rate of adoption indicates that children 20 21 195 22 23 24 25 26 August 2017 WA Office of the Family and Childrens’ Ombuds report “Child Fatalities and Near Fatalities in Washington State” p.21-22, citing to Neonatal Abstinence Syndrome: How States Can Help Advance the Knowledge Base for Primary Prevention and Best Practices of Care, (2014) http://www.astho.org/prevention/nas-neonatal-abstinence-report (last visited Sept. 27, 2017). 196 Office of the Family and Childrens’ Ombuds “Child Fatalities and Near Fatalities in Washington State” (August 2017), p.21 197 2017 WA Child and Family Ombuds report p.21, citing to Family-Based Recovery: An Innovative InHome Substance Abuse Treatment Model for Families with Young Children, By Hanson, Karen E.; Saul, Dale H.; Vanderploeg, Jeffrey J.; Painter, Mary; Adnopoz, Jean COMPLAINT - 112 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 removed from their homes remain in foster care longer and are less likely to exit from foster 2 care to reunification with biological parents. 3 4.320 The initial rise in prescription-type opioids came while heroin deaths, crime lab 4 cases, and treatment rates were on the decline, and the recent decline for prescription-type 5 opioids comes as heroin returns to prominence. Since the statewide peak in 2011, the number 6 of prescriptions of extended release opioids has declined and correspondingly so has the rate of 7 overdose deaths attributed to prescription opiates. The overall rate of overdose in Washington 8 State, however, has stayed relatively flat through 2015 because of an increase in heroin use and 9 overdose deaths attributed to heroin. 10 11 4.321 Many individuals who use heroin, and the majority of young adults who use heroin, report using prescription-type opioids prior to switching to heroin. 198 12 4.322 The Evergreen Treatment clinic in Seattle currently treats 1400 people with 13 opioid use disorder, 95% of whom are active heroin users. According to anonymous incoming 14 patient surveys, 90% of patients started using with prescription opioids. 15 4.323 Five percent of Pierce County 10th graders reported lifetime heroin use and 16 current painkiller use “to get high” in 2014. While most students report using neither, 3% had 17 tried heroin, 4.4% reported current painkiller use only, and 1% reported both. To illustrate the 18 association between heroin and other opioids, among those who have tried heroin, the current 19 painkiller use rate is 34.7% versus 4.5% among those who report no lifetime heroin use. Nearly 20 one in five students who report painkiller use in the past month report ever using heroin. 199 21 4.324 Heroin indicators remain at high levels in 2016 across all measures: 22 23 198 24 25 26 K. Michelle Peavy et al., “Hooked on” Prescription-Type Opiates Prior to Using Heroin: Results from a Survey of Syringe Exchange Clients, 44 JOURNAL OF PSYCHOACTIVE DRUGS 259–265 (2012); Emily R. Cedarbaum & Caleb J. Banta-Green, Health behaviors of young adult heroin injectors in the Seattle area, 158 DRUG AND ALCOHOL DEPENDENCE 102–109 (2016). 199 Opioid Trends in Pierce County (February 2017), p. 5 COMPLAINT - 113 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 a. Heroin deaths more than doubled between 2010 and 2015. 200 2 b. Heroin was the most common drug reported as primary in 2016, 3 accounting for 31% of all treatment admissions, a numerical and proportional increase 4 compared to 2012. 201 5 c. There were more than four calls per day to King County’s Recovery 6 Helpline seeking assistance regarding heroin. 202 Heroin-related calls to the Recovery Helpline 7 have consistently been the most common drug for calls regarding young adults. There were 476 8 calls in 2016, similar to prior years. For adults 26 and older, heroin was consistently the second 9 most common substance reported in calls to Recovery Helpline, and there were a total of 1,179 10 calls in 2016 similar to the prior year. 11 d. For adults ages 18-25 admitted to treatment, heroin was numerically and 12 proportionally much more common than other drugs, with a relatively large proportion, 19%, of 13 admissions for heroin ages 18-25. 203 14 e. In Pierce County, a recent rise in police evidence testing cases and drug 15 overdose deaths is being driven by increases in heroin use over the past few years. 204 16 Correspondingly, treatment admissions in Pierce County for heroin and first admissions for 17 heroin have risen precipitously since 2013. 18 19 20 21 22 23 24 25 26 200 Washington State Department of Health. (2017). Opioid-related Deaths in Washington State, 20062016. Retrieved from http://www.doh.wa.gov/Portals/1/Documents/Pubs/346-083SummaryOpioidOverdoseData.pdf 201 ADAI 2016 Drug Use Trends in King County, Washington (July 2017) Contributors: Caleb BantaGreen, Jason Williams, Robyn Smith, Brad Finegood, Laurie Sylla, Richard Harruff, Joe Tinsley, Meaghan Munn, Julia Hood, Susan Buskin, Sara Glick, Steve Freng, Fiona Couper, Ed Suzuki, Johnny Ohta, Jim Pugel, Mary Taylor 202 ADAI 2016 Drug Use Trends in King County, Washington (July 2017) Contributors: Caleb BantaGreen, Jason Williams, Robyn Smith, Brad Finegood, Laurie Sylla, Richard Harruff, Joe Tinsley, Meaghan Munn, Julia Hood, Susan Buskin, Sara Glick, Steve Freng, Fiona Couper, Ed Suzuki, Johnny Ohta, Jim Pugel, Mary Taylor 203 ADAI 2016 Drug Use Trends in King County, Washington (July 2017) 204 Opioid Trends in Pierce County (February 2017) COMPLAINT - 114 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 4.325 The staggering rise in use of heroin and heroin-related overdose deaths is a predictable result from the declining opioid prescriptions rates across the state. 205 3 4 4.326 Purdue’s business model depends on creating addicts to fuel its sales of branded extended release opioids, because according to internal documents, 5 When dependent users are unable to obtain 6 prescription opioids they turn to illicit sources of opiates such as heroin. 7 I. Purdue Is Responsible for Washington’s Opioid Crisis 8 4.327 As detailed in this complaint, the impacts of opioids on Washington are 9 inextricably linked with Purdue’s marketing campaign designed to convince prescribers, 10 patients, and the public that opioids were an effective medical solution for chronic pain. 11 4.328 When evidence of the widespread impacts opioids were having on Washington 12 and across the nation, Purdue carefully packaged and targeted its messages to convince 13 prescribers that the risks of addiction were overstated and could be managed. 14 15 16 17 18 19 4.329 As a result of Purdue’s efforts, opioid use has grown to epidemic proportions and the death rates continue to rise while Purdue continue to market and sell drugs that it knows are deadly. 4.330 The Attorney General asks the court to stop Purdue’s deceptive marketing and order legal and equitable remedies to begin addressing the opioid epidemic. 20 V. FIRST CAUSE OF ACTION (VIOLATIONS OF THE CONSUMER PROTECTION ACT, RCW 19.86) 21 5.1 22 The State incorporates Paragraphs 1.1 through 4.330 herein as if set forth in their entirety. 23 5.2 24 commerce. RCW 19.86.020 prohibits “unfair” or “deceptive” acts or practices in trade or 25 205 26 Franklin et al., supra note 3, citing to n45-47 COMPLAINT - 115 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 5.3 The marketing, distribution, and sale of opioids to health care providers and consumers in Washington constitutes “trade” or “commerce” defined by RCW 19.86.010(2). 5.4 4 Purdue engaged in numerous deceptive acts or practices, including the following: a. Marketing opioids, including its own drugs, both directly and indirectly 5 through third party groups, as a solution to the undertreatment of pain and either stating 6 directly or implying that opioids are effective to treat or relieve long-term chronic pain and 7 improve function and quality-of-life. 8 9 b. Misrepresenting and making unsubstantiated claims that, and the extent to which, opioids improve function over the long term. 10 c. Misrepresenting the truth and making unsubstantiated claims about how 11 (and how frequently) opioids lead to addiction and the extent to which addiction risk can be 12 managed and addiction prevented. 13 d. Misleadingly using terms like addiction, dependence, tolerance, physical 14 dependence, and “pseudoaddiction” to persuade health care providers and patients that the 15 addiction risk of opioids could be successfully managed. 16 17 e. Misrepresenting and making unsubstantiated claims that increased doses of opioids do not pose significant additional risks. 18 f. Misrepresenting and making unsubstantiated claims regarding the 19 factors for comparing the risks and benefits of opioids with those of alternative forms of pain 20 treatment. 21 g. Marketing Purdue’s abuse deterrent formulations of opioid medications 22 as a means of reducing abuse and addressing the opioid epidemic without any evidence to 23 support such a claim. 24 25 26 5.5 Purdue engaged in numerous unfair acts or practices, including the following: a. Marketing and selling opioids for long-term use in treating chronic pain without sufficient evidence of efficacy, while also understating the risk of addiction and the COMPLAINT - 116 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 ease with which addiction could be treated. 2 3 b. Influencing health care providers’ prescription decisions for particular patients in sales calls for which the patient was not present. 4 c. Encouraging health care providers to ignore or reject regulatory 5 guidance from the Washington’s Agency Medical Director’s Group, thereby undermining 6 Washington’s public policy to diminish the amount of addictive and dangerous opioids 7 prescribed to its residents. 8 d. Targeting and encouraging health care providers with high rates of 9 opioid prescription through in-person detailing, dissemination of educational materials and 10 programs, and third party materials containing misleading statements about the efficacy and 11 risks of opioids. This targeted marketing sought to cause high volume prescribers to continue 12 prescribing at those rates and encouraging additional prescriptions despite observing 13 indications that the health care provider was not meeting the standard of care, and/or that 14 opioids were being diverted or abused, thereby harming the public health. 15 e. Failing to report and/or concealing from relevant law enforcement and 16 medical regulators suspicious, excessive, and illegal opioid prescribing practices, while 17 profiting from inflated prescriptions of OxyContin and other Purdue-branded opioids. 18 5.6 Purdue’s unfair and deceptive conduct in the marketing, distribution, and sale of 19 opioids to health care providers and consumers in Washington affects the public interest because 20 the opioids were marketed and issued to numerous consumers in Washington, injured numerous 21 Washington consumers, created a public health crisis and a public nuisance, were part of Purdue’s 22 very business model and regular course of business operations, and were repeated. 23 VI. 24 25 26 6.1 SECOND CAUSE OF ACTION (PUBLIC NUISANCE) The State incorporates Paragraphs 1.1 through 5.6 herein as if set forth in their entirety. COMPLAINT - 117 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 6.2 2 [n]uisance consists in unlawfully doing an act, or omitting to perform a duty, which act or omission either annoys, injures or endangers the comfort, repose, health or safety of others, offends decency, or unlawfully interferes with, obstructs or tends to obstruct, or render dangerous for passage, any lake or navigable river, bay, stream, canal or basin, or any public park, square, street or highway; or in any way renders other persons insecure in life, or in the use of property. 3 4 5 6 7 8 6.3 unequal.” 6.4 13 14 6.5 Washingtonians and/or interferes with the comfortable enjoyment of life in violation of Washington law. For example: 19 20 21 22 23 24 25 a. Opioid use, abuse, and overdose deaths have increased throughout the b. Locations such as the offices of high-prescribing health care practitioners state. 17 18 Through the actions described above, Purdue has contributed to and/or assisted in creating and maintaining a condition that is unreasonable and harmful to the health of 15 16 Finally, RCW 7.48.010 defines an “actionable nuisance” to include “whatever is injurious to health or indecent or offensive to the senses.” 11 12 Pursuant to RCW 7.48.130, a “public nuisance” is a nuisance that “affects equally the rights of the entire community or neighborhood, although the extent of the damage may be 9 10 RCW 7.48.120 provides that: and the pharmacies at which their patients fill opioid prescriptions have attracted drug dealers and addicts. c. Locations such as abandoned homes and some public spaces have attracted drug dealers and addicts, rendering them and the surrounding private property less safe or unsafe. In addition, family medicine cabinets became outlets for diversion and abuse due to overprescribing, and the foreseeable failure to safely dispose of opioids. d. The greater demand for emergency services, law enforcement, addiction treatment, and social services places an unreasonable burden on State and local resources. 26 COMPLAINT - 118 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 e. Expanding the market for prescription opioids to primary care patients and 2 chronic conditions has also created an abundance of drugs available for criminal use and fueled a 3 wave of addiction, abuse, and injury. 4 f. The creation of additional illicit markets in other opiates, particularly 5 heroin. Many users who were initially dependent on prescription opioids and then were unable to 6 obtain or afford prescription opioids turned to heroin as an alternative, fueling a new heroin 7 epidemic in the process. 8 g. Increased health care costs for individuals, families, and the State. 9 h. Purdue also interfered with enjoyment of the public right by failing to 10 report suspicions of illicit prescribing to the State, law enforcement, or the Board of Medicine, 11 allowing health care providers who were profitable to Purdue but problematic for the public health 12 to continue prescribing increasing numbers of opioids throughout the state. 13 6.6 The public nuisance created by Purdue’s actions is substantial and unreasonable – 14 it has caused significant harm to communities across Washington, outweighing any offsetting 15 benefit. Purdue knew or should have known that its sales and promotion of long-term opioid use 16 for chronic pain would create a public nuisance. 17 6.7 Purdue’s actions described above were a substantial factor in opioids becoming 18 widely available, used, and all too often abused. These actions were a substantial factor in doctors 19 and patients not accurately assessing and weighing the risks and benefits of opioids for chronic 20 non-cancer pain, and in distorting the medical standard of care for treatment of chronic pain that 21 resulted in pervasive overprescribing of opioids and the failure to provide more appropriate pain 22 treatment. 23 6.8 But for Purdue’s actions, opioid use would not have become so widespread, and 24 the enormous public health hazard of opioid overuse, abuse, and addiction that now exists would 25 have been averted. Purdue’s actions have and will continue to injure and harm many residents 26 COMPLAINT - 119 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 throughout the state, including patients with chronic non-cancer pain who take opioids, their 2 families, and their communities at large. 3 6.9 The public nuisance and associated financial and economic losses were 4 foreseeable to Purdue, who knew or should have known that its unfair business practices and 5 deceptive statements regarding the risks and benefits of opioids were creating a public nuisance. 6 As alleged herein, Purdue engaged in and disseminated widespread deceptive promotion of 7 opioids despite knowing that opioids carried serious risks of addiction, injury, overdose, and 8 death. 9 6.10 The intent of Purdue’s sale of extended release opioids and the promotion of 10 opioids was for health care providers to prescribe opioids for treatment of long-term chronic pain, 11 for patients to fill those prescriptions, and then to keep filling those prescriptions at higher and 12 higher doses. A reasonable person in Purdue's position would foresee not only a vastly expanded 13 market for chronic opioid therapy, but also the other likely and forseeable result of Purdue’s 14 conduct – the widespread problems of opioid addiction and abuse. In fact, Purdue was on notice 15 and aware of signs that health care providers were prescribing unreasonably higher numbers of 16 opioids and that the broader use of opioids was causing just the kinds of injuries described in this 17 Complaint. 18 6.11 Purdue’s business practices generated a new and very profitable circular market 19 with the promotion of opioids – providing both the profitable supply of narcotics to prescribe and 20 sell, as well as causing addiction which fueled the demand of users to buy more. 21 6.12 Purdue is liable for a public nuisance because they acted without express authority 22 of a statute in knowingly promoting off label opioid prescribing; in engaging in a pattern of 23 conduct that overstated the benefits of long-term opioid use, misrepresented the duration of 24 efficacy of extended release opioids, failed to disclose the lack of evidence supporting long-term 25 use of opioids, and misrepresented the serious risk of addiction from legitimate and prescribed use 26 COMPLAINT - 120 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 of opioids; and in creating and maintaining the prescription and sale of opioids for long-term 2 treatment of chronic pain at such volumes and degree as to create an epidemic. 3 6.13 The health and safety of Washington residents, including those who use, have used 4 or will use opioids, as well as those affected by users of opioids, is a matter of great public interest 5 and of legitimate concern to the State, whose duty to protect the health, safety, and well-being of 6 its residents is paramount. Washington and its residents have a right to be free from conduct that 7 endangers their health and safety. Purdue’s deceptive marketing and unfair business practices 8 interfered in the enjoyment of this public right by the State and its citizens. 9 6.14 Pursuant to RCW 7.48.020 and 7.48.180, the State seeks an order that provides for 10 abatement of the public nuisance Purdue has created, enjoining Purdue from future violations of 11 RCW chapter 7.48, and awards the State damages in an amount to be determined at trial. 12 VII. THIRD CAUSE OF ACTION (COMMON LAW NEGLIGENCE) 13 7.1 14 15 entirety. 7.2 16 17 20 21 7.3 24 25 26 Purdue owed a duty of care to the citizens of Washington, including but not limited to exercise reasonable care in the marketing and sale of a highly addictive drug like opioids. Purdue knew or should have known that its affirmative conduct in aggressive and misleading marketing and sale of opioids created an unreasonable risk of harm. 7.4 22 23 Under Washington law, a cause of action arises for negligence when defendant owes a duty to a plaintiff and breaches that duty, and proximately causes the resulting injury. 18 19 The State incorporates Paragraphs 1.1 through 6.14 herein as if set forth in their A reasonably prudent manufacturer would be aware that aggressively marketing opioids for chronic pain would result in the severe harm of addiction for large numbers of Washingtonians and that increasing the numbers of prescription opioids available in the market would lead to massive harm to the public including increased hospitalizations, overdoses, and deaths. COMPLAINT - 121 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 7.5 In fact, Purdue was aware from internal sales data, adverse event reports, publicly 2 available studies and reports, and other sources that the rapid expansion of prescription products, 3 including its specific opioid products, was causing the massive public harm that was reasonably 4 foreseeable. Purdue failed to take reasonable steps in response to that information, choosing 5 instead to offer inadequate measures to mitigate risk while continuing to aggressively market 6 drugs in such a way as to ensure high prescribing of opioids continued 7 7.6 A reasonably prudent manufacturer of opioids could reasonably foresee that long- 8 term use of opioids at increasing dosages was a particularly addictive and dangerous use of 9 opioids and that aggressively marketing opioids for long-term treatment of chronic pain would 10 make opioids more dangerous and deadly. 11 7.7 In fact, Purdue was aware from internal sales data, adverse event reports, publicly 12 available studies and reports, and other sources that its aggressive marketing was expanding the 13 use of opioids for long-term treatment of chronic pain conditions and was causing massive public 14 harm. 15 7.8 A reasonably prudent manufacturer of opioids could reasonably foresee that 16 aggressive, targeted marketing of opioids would lead to increased opioid prescriptions. A 17 foreseeable consequence of expanded opioid prescriptions is the expansion of use of illicit and 18 diverted opioids. 19 7.9 In fact, Purdue was aware from internal sales data, adverse event reports, publicly 20 available studies and reports, and other sources that its aggressive, targeting marketing of opioids 21 was causing increased opioids prescriptions in Washington state and was fueling a massive 22 increase in heroin use and the diversion of opioid pain medications. Even knowing that, Purdue 23 continue its marketing of these drugs. 24 7.10 By misrepresenting the addictive nature of opioids, aggressively promoting its 25 opioids, and opioids generally, for long-term treatment of chronic pain, Purdue breached its duty 26 of reasonable care as a manufacturer of dangerous opioids and increased the risk for public harm , COMPLAINT - 122 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 1 2 3 4 5 7.11 As set forth above, and incorporated by reference, Purdue’s misrepresentations include the deceptive conduct described above. 7.12 Purdue’s conduct was a proximate cause of increased opioid prescribing along with the inevitable and foreseeable consequences and public harms. 7.13 As a direct and proximate cause of Purdue’s unreasonable and negligent conduct, 6 Washington has suffered and will continue to suffer harm, and is entitled to damages in an amount 7 determined at trial. 8 9 10 VIII. PRAYER FOR RELIEF Wherefore, the State prays for the following relief: 8.1 A declaration that Defendants’ acts described above are unfair or deceptive acts or 11 practices in trade or commerce, affecting the public interest, and in violation of the Consumer 12 Protection Act, RCW 19.86; 13 8.2 An injunction pursuant to RCW 19.86.080(1) enjoining Defendants and from 14 engaging in any acts that violate the Washington Consumer Protection Act, including, but not 15 limited to, the unfair and deceptive acts and practices alleged herein; 16 8.3 An order necessary to restore to any person an interest in any moneys or property, 17 real or personal, which may have been acquired by means of an act prohibited by the Consumer 18 Protection Act, pursuant to RCW 19.86.080(2); 19 20 21 22 8.4 An award of a civil penalty in the amount of $2,000.00 for each and every violation of Washington’s Consumer Protection Act, pursuant to RCW 19.86.140; 8.5 An award of the State’s reasonable costs and attorney’s fees incurred in this action, pursuant to RCW 19.86.080(1); 23 8.6 An order requiring Defendants to abate the public nuisance that they created; 24 8.7 An award of damages in an amount determined at trial for injury sustained by the 25 State as a result of Defendants’ unreasonable and negligent conduct; 26 COMPLAINT - 123 ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745 8.8 Equitable relief requiring restitution and disgorgement of the revenues wrongfully obtained from sale of extended release opioids as a result of Defendants? wrongful conduct; 8.9 An award ofpre?judgment and post?judgment interest, as provided by law; and 8.10 Any other and further relief the Court deems just and equitable. JURY DEMAND ENDORSEMENT Plaintiff, State of Washington, demands a trial by jury on public nuisance and negligence claims to the maximum number of jurors permitted by law. DATED this 28th day of September, 2017. COMPLAINT 124 ROBERT W. FERGUSON Attorney General TAD ROBINSON #37153 KATHARINE F. BARACH, WSBA #51766 Assistant Attorneys General Attorneys for Plaintiff State of Washington ATTORNEY GENERAL OF WASHINGTON Consumer Protection Division 800 Fifth Avenue, Suite 2000 Seattle, WA 98104-3188 (206) 464-7745