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  • Summons and Complaint: The County of Schuyler V Purdue Pharma L.P.

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    Supreme Court, State of New York, County of Schuyler. Index No. 18-91 THE COUNTY OF SCHUYLER, Plaintiff, - against - PURDUE PHARMA L.P.; PURDUE PHARMA INC.; THE PURDUE FREDERICK COMPANY, INC.; TEVA PHARMACEUTICALS USA, INC.; CEPHALON, INC.; JOHNSON & JOHNSON; JANSSEN PHARMACEUTICALS, INC.; ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC. N/K/A JANSSEN PHARMACEUTICALS, INC.; JANSSEN PHARMACEUTICA, INC. N/K/A JANSSEN PHARMACEUTICALS, INC.; ENDO PHARMACEUTICALS, INC.; ALLERGAN PLC F/K/A ACTAVIS PLC; ACTAVIS, INC. F/K/A WATSON PHARMACEUTICALS, INC.; WATSON LABORATORIES, INC.; ACTAVIS LLC; ACTAVIS PHARMA, INC. F/K/A WATSON PHARMA, INC., ENDO HEALTH SOLUTIONS INC.; INSYS THERAPEUTICS, INC.; MCKESSON CORPORATION; CARDINAL HEALTH, INC.; AMERISOURCEBERGEN CORPORATION; AMERICAN MEDICAL DISTRIBUTORS, INC.; BELLCO DRUG CORP.; BLENHEIM PHARMACAL, INC.; DARBY GROUP COMPANIES, INC.; EVEREADY WHOLESALE DRUGS LTD.; KINRAY, LLC; PSS WORLD MEDICAL, INC.; ROCHESTER DRUG COOPERATIVE, INC.; PERRY FINE; SCOTT FISHMAN; and LYNN WEBSTER, Defendants.

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    Supreme Court, State of New York, County of Schuyler. Index No. 18-91 THE COUNTY OF SCHUYLER, Plaintiff, - against - PURDUE PHARMA L.P.; PURDUE PHARMA INC.; THE PURDUE FREDERICK COMPANY, INC.; TEVA PHARMACEUTICALS USA, INC.; CEPHALON, INC.; JOHNSON & JOHNSON; JANSSEN PHARMACEUTICALS, INC.; ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC. N/K/A JANSSEN PHARMACEUTICALS, INC.; JANSSEN PHARMACEUTICA, INC. N/K/A JANSSEN PHARMACEUTICALS, INC.; ENDO PHARMACEUTICALS, INC.; ALLERGAN PLC F/K/A ACTAVIS PLC; ACTAVIS, INC. F/K/A WATSON PHARMACEUTICALS, INC.; WATSON LABORATORIES, INC.; ACTAVIS LLC; ACTAVIS PHARMA, INC. F/K/A WATSON PHARMA, INC., ENDO HEALTH SOLUTIONS INC.; INSYS THERAPEUTICS, INC.; MCKESSON CORPORATION; CARDINAL HEALTH, INC.; AMERISOURCEBERGEN CORPORATION; AMERICAN MEDICAL DISTRIBUTORS, INC.; BELLCO DRUG CORP.; BLENHEIM PHARMACAL, INC.; DARBY GROUP COMPANIES, INC.; EVEREADY WHOLESALE DRUGS LTD.; KINRAY, LLC; PSS WORLD MEDICAL, INC.; ROCHESTER DRUG COOPERATIVE, INC.; PERRY FINE; SCOTT FISHMAN; and LYNN WEBSTER, Defendants.

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    Summons and Complaint: The County of Schuyler V Purdue Pharma L.P.

    Uploaded by

    Steven Getman
    Supreme Court, State of New York, County of Schuyler. Index No. 18-91 THE COUNTY OF SCHUYLER, Plaintiff, - against - PURDUE PHARMA L.P.; PURDUE PHARMA INC.; THE PURDUE FREDERICK COMPANY, INC.; TEVA PHARMACEUTICALS USA, INC.; CEPHALON, INC.; JOHNSON & JOHNSON; JANSSEN PHARMACEUTICALS, INC.; ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC. N/K/A JANSSEN PHARMACEUTICALS, INC.; JANSSEN PHARMACEUTICA, INC. N/K/A JANSSEN PHARMACEUTICALS, INC.; ENDO PHARMACEUTICALS, INC.; ALLERGAN PLC F/K/A ACTAVIS PLC; ACTAVIS, INC. F/K/A WATSON PHARMACEUTICALS, INC.; WATSON LABORATORIES, INC.; ACTAVIS LLC; ACTAVIS PHARMA, INC. F/K/A WATSON PHARMA, INC., ENDO HEALTH SOLUTIONS INC.; INSYS THERAPEUTICS, INC.; MCKESSON CORPORATION; CARDINAL HEALTH, INC.; AMERISOURCEBERGEN CORPORATION; AMERICAN MEDICAL DISTRIBUTORS, INC.; BELLCO DRUG CORP.; BLENHEIM PHARMACAL, INC.; DARBY GROUP COMPANIES, INC.; EVEREADY WHOLESALE DRUGS LTD.; KINRAY, LLC; PSS WORLD MEDICAL, INC.; ROCHESTER DRUG COOPERATIVE, INC.; PERRY FINE; SCOTT FISHMAN; and LYNN WEBSTER, Defendants.

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    SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF SCHUYLER x THE COUNTY OF SCHUYLER, Plaintifé, ae Index No: 18-O1 PURDUE PHARMA L.P.; PURDUE PHARMA SUMMONS INC. THE PURDUE FREDERICK COMPANY, INC, TEVA PHARMACEUTICALS USA, INC; CEPHALON, INC.; JOHNSON & JOHNSOt JANSSEN PHARMACEUTICALS, INC, ORTHO- MCNEIL-JANSSEN PHARMACEUTICALS, INC. N/K/A JANSSEN PHARMACEUTICALS, INC; | JANSSEN PHARMACEUTICA, INC. N/K/A | JANSSEN PHARMACEUTICALS, INC. ENDO PHARMACEUTICALS, INC; ALLERGAN PLC F/K/A ACTAVIS PLC; ACTAVIS, ING. F/K/A WATSON PHARMACEUTICALS, INC; WATSON LABORATORIES, INC. ACTAVIS LLC; ACTAVIS PHARMA, INC. F/K/A WATSON PHARMA, INC, ENDO HEALTH SOLUTIONS INC; INSYS THERAPEUTICS, INC; MCKESSON CORPORATION; CARDINAL HEALTH, INC, AMERISOURCEBERGEN CORPORATION: AMERICAN MEDICAL DISTRIBUTORS, INC; BELLCO DRUG CORP, BLENHEIM L PHARMACAL, INC; DARBY GROUP COMPANIES, INC, EVEREADY WHOLESALE { DRUGS LTD.; KINRAY, LLC; PSS WORLD : I MEDICAL, INC, ROCHESTER DRUG COOPERATIVE, INC; PERRY FINE; SCOTT. FISHMAN; and LYNN WEBSTER, Date Index No, Purchased: 5|1*[18 | | | | Defendants. 8 = 2 2 GQ3AIZ02u TO: The above named Defendant(s): a 8 z z = SB 3 2 = 2 2 in zg O oO YOU ARE HEREBY SUMMONED to answer the Verified Complaint in this action and to serve a copy of your Answer, or, if the Verified Complaint is not served with this Summons, to serve a notice of appearance, on the plaintiff's attorney within 20 days after service of this ‘Summons, exclusive of the day of service, whete service is made by delivery upon you personally within the state, or within 30 days after completion of service where service is made in any other manner. In case of your failure to appeat ot answer, judgment will be taken against you by default for the relief demanded in the Verified Complaint. The basis of the venue is the Plaintiff's location, Dated: Watkins Glen, New York TO: May 1, 2018 Actavis, Ine. F/I, c/o Teva Pharmaceuticals 425 Privet Road Horsham, PA 19454 Actavis LLC c/o Teva Pharmacenticals 425 Privet Road Horsham, PA 19454 County, pursuant to CPLR § 503(a) and the location in which this cause of action arose ven J. Getman SCHUYLER COUNTY ATTORNEY 4105 Ninth Se, Unit 5 ‘Watkins Glea, New York 14891 607.535.8121 attorney @co.schuyleeny.as NAPOLI SHKOLNIK PLLC By Paul Nia Salvatore C. Badsla Joseph L. Ciaecio 400 Broad Hollow Road ~ Suite 305 Melville, NY 11747 (212) 397-1000 son Pharmaceuticals, Inc, © Actavis Pharma, Inc. E/IK/A Watson Pharma, Inc, c/o Teva Pharmaceuticals 425 Privet Road Horsham, PA 19454 Alleegan PLC _E/K/A Actavis Ple c/o Teva Pharmaceuticals 425 Privet Road Horsham, PA 19454 Ametisourcebery 1300 Morris Dr. Chesterbrook, PA 19087 ardinal Health, In 7000 Cacdinal Place Dublin, OH 43017 Cephalon, Inc. 1090 Horsham Road North Wales, PA 19454 Endo Health Solutions Ine 1400 Atwater Dr, Malvern, PA 19355 Endo Pharmaccuticals, Inc, 1400 Atwater Dr. Malvern, PA 19355, Ing a 1333 S. Spectrum Blvd. #100 Chandler, AZ 85286 116 Pine Street Suite 320 Harrisburg, PA 17101 sen Phas Inc. N/K/A Ini 116 Pine Street Suite 320 Harrisburg, PA 17101 Johnson & Johnson ‘One Johnson & Johnson Plaza New Brunswick, NY 08933, eo oO Lynn Webster PRA Health Sciences 3838 $ 700 B #202 Salt Lake City, UT 84106 One Post Street San Francisco, CA 94901 th Inc. tical, In Bob Sersch (Mgt @ Ct Corp) C/O Ortho-Meneil-Janssen Phatmaceuticals Inc. Pine Steet Suite 320 Hairisburg, PA £7101 Perry Fine 615 Arapeen Way, Suite 100 Salt Lake City, UT 84132 Purdue Pharma Inc. 201 Tresser Blvd, Stamford, CT 06901 Purdue Pharma LP. 201 Tresser Blvd Stamford, CT 06901 Scott Fishman 2221 Stockton Blvd Sacramento, CA 95817 7 Inc. 1090 Horshan Road | North Wales, PA 19454 Th z Inc. 201 Tresser Blvd. Stamford, CT 06901 ‘Wasson Laboratories Inc, 311 Bonnie Circle Corona, CA 92880 LLC 152-35 10" Avenue Whitestone, NY 11357 e a) BSS World Medical, Inc. C/O McKesson Medical-Surgical 4345 Southpoint Boulevard, #10 Jacksonville, FL. 32216 ‘and C/O Corporation Service Co, 1201 Hays Street Tallahassee, FL 32301 ter Dr erativ 50 Jetview Drive Rochester, NY 14626 ‘Dathy Group Companies, Inc. 300 Jeticho Quadrangle Jesicho, NY 11753 . Amesican Medical Distributors. Inc, 100 New Highway N. Amityville, NY 11701 And C/O CT Corporation System 111 Bighth Avenue New York, NY 10011 Belleo Dr 2 1300 Morris Drive Chesterbrook, PA 19087 Blenheim Pharmacal, Inc. 119 Creamery Road North Blemheim, NY 12131 Eveteady Wholesale Drugs, Ltd, 23 Hilltop Drop MeWville, NY 11747 ce SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF SCHUYLER ‘THE COUNTY OF SCHUYLER, Plaintiff, Index No (8-4 ~ against - VERIFIED COMPLAINT PURDUE PHARMA LP; PURDUE PHARMA PLAINTIFF DEMANDS A TRIAL INC; THE PURDUE FREDERICK COMPANY, BY JURY INC; TEVA PHARMACEUTICALS USA, INC. Filed oslulis, or pm CEPHALON, INC; JOHNSON & JOHNSON; Senuyler Iyer JANSSEN PHARMACEUTICALS, INC; ORTHO- MCNEIL-JANSSEN PHARMACEUTICALS, INC. N/K/A JANSSEN PHARMACEUTICALS, INC; JANSSEN PHARMACEUTICA, INC. N/K/A. JANSSEN PHARMACEUTICALS, INC. ENDO. PHARMACEUTICALS, INC; ALLERGAN PLC F/K/A ACTAVIS PLC; ACTAVIS, INC, F/K/A WATSON PHARMACEUTICALS, INC. WATSON LABORATORIES, INC; ACTAVIS LLC; ACTAVIS PHARMA, INC. F/K/A WATSON PHARMA, INC., ENDO HEALTH SOLUTIONS INC, INSYS THERAPEUTICS, INC; MCKESSON CORPORATION; CARDINAL HEALTH, INC; AMERISOURCEBERGEN CORPORATION; AMERICAN MEDICAL DISTRIBUTORS, INC.; BELLCO DRUG CORP; BLENHEIM PHARMACAL, INC; DARBY GROUP COMPANIES, INC; EVEREADY WHOLESALE DRUGS LTD,; KINRAY, LLC; PSS WORLD MEDICAL, INC.; ROCHESTER DRUG. COOPERATIVE, INC; PERRY FINE; SCOTT. FISHMAN; and LYNN WEBSTER, Defendants. © & INTRODUCTION... a JURISDICTION AND VENUE. wld PARTIES sesesien 12 a 12 B. Defendants... ais 12 FACTS RELEVANT TO ALI. CAUSES OF ACTION. 39 A. Backgtound on Pain Medicine. ati 39 1. Safe and Effective Treatment of Chronic Pain Centers on Informed Risk Management. 39 Opioid Use Is Associated with Known and Substantial Risks. 40. 3. Long-Term Opioid Use Benefits Are Unproven and Contradicted., AS. 4. Defendants’ Impact on the Perception and Presctibing of Opioids 48 B. _ Defendants Promoted Their Branded Products Through Ditect Marketing to Presceibers and Consumer: - vs a en 50 1. Defendants Relied Upon Branded Advertisements... 2, Defendants Relied Upon Theit Sales Forces and Recruited Physician Speakers. 1.51 3. Defendants Directed These Promotional Efforts Through Detailed Marketing Plans... 54 a. Targeting categories of prescribers oe b. Increasing “direct to consumes” marketing... 56 c. Differentiating each brand... ete encase eee eee 56 d. Moving beyond office visits i 37 4. Deferidants Marketed Opioids in Schuyler County Using the Same Strategies and ‘Messages They Employed Nationwide. See a cea, C. Defendants Used “Unbranded” Marketing to Evade Regulations and Consumer Protection Laws. 38 1. Regulations Governing Branded Promotion Reguite that it Be Truthful, Balanced, and Supported by Substantial Evidence... : pee eee eee 60) 2. Defendants Deployed Front Groups and Doctors to Disserninate Unbranded Information on Theit Behalf... sae a, Defendants’ Use of KOLs... i, Russell Portentoy. i, Defendant Lynn Webster... b, “Research” That Lacked Supporting Evidence....su.nn cc. Treatment Guidelines. i PSMB.... ii, AAPM/APS Guidelines. ii, American Geriatrics Society... iv. Guidelines That Did Not Receive Defendants’ Suppott.. Continuing Medicat Education Unbranded Patient Education ose £ Defendants’ Use of Front Groups... 3. Defendants Acted in Concert with KOLs and Front ‘Groups in the Creation, Promotion, and Control of Unbranded Marketing. ae : 4, Defendants Tatgeted Vulnerable and Lucrative Populations. a. The Elderly D. Why Defendants’ Marketing Messages Are Misleading and Unfait...u.u 1. Defendants and Their Third-Party Allies Macepresented that Opioids Improve Function. 90 2. Defendants and Their Third-Party Allies Concealed the Truth About the Risk of i Addiction ftom Long-Term Opioid Use av.rsanninnnnnnnenitnnninneinnnne 98 3. Defendants and Their Third-Party Allies Miseprerenied that Addiction Risk Can Be i ‘Avoided or Managed nee Sse 0s 4, Defendants and Theit Thitd-Party Allies Created Confusion By Promodog te | Misleading Term “Pseudoaddiction,” vnnnnnannae nine 107 i 5. Defendants and Their Thitd-Party Allies Claimed Withdrawal is Simply Managed... 110 © © 6. Defendants and Their Third-Party Allies Misrepresented that Increased Doses Pose No Significant Additional Risks.... aaa AM 7. Defendants and Theit Third-Party Allies Deceptively Omitted or Minimized Adverse Effects of Opioids and Overstated the Risks of Alternative Forms of Pain Treatment 4 7 E. Each Defendant Engaged in Deceptive Marketing, Both Branded and Unbranded, that ‘Targeted and Reached County Prescribers soe 120 1. Actavis... 121 & Actavis’ Deceptive Direct Marketing. somone 121 i. Actavis’ Deceptive Sates Training... seosoe ii Actavis' Deceptive Speaking Tiaining sen 127 b. Actavis’s Deceptive Statements to Schuyler County area prescribers and Parients.....129 2. Cephalonia ee 130 a. Cephalon’s Deceptive Direct Marketing... non 130 i Cephalon’s Fraudulent Off-Label Matketing of Actiq and Pentort......sssmn 31 @) Cephalon launched its fraudulent marketing scheme for Actiq ... 131 b) October 1, 2006 ~ Cephalon fraudulently marked Actiq’s successor drug, Fentora... : ae “ 133, ©) September 2007 - Reports of death and serious side effects led the FDA to issue a ete 135 public health warning for Fentora 4) May 6, 2008 - ‘The FDA rejected Cephalon’s request for expanded approval of Fentora... ' rnnernsanan oat seventeen vs ¢) March 26, 2009 ~ the FDA’s Division of Drag Marketing, Advertising and ‘Communications (“DDMAC”) warned Cephalon about its misleading advertising of Fentora ennsnn : rises eer s 8) Cephalon continues to knowingly, deceptively, and illegally promote Fenotra for offlabel wse5..c0nn . ceeeareeentte 1138 ii, Cephalon’s Misrepresentation of the Risks Associated with the Use of Opioids for the Long-Term Treatment of Chronic Pain... eee : 139 b. Cephalon’s Deceptive Third-Party Statements ... aa 141 3. 4, « a b, « c oO i, FSMB — Responsible Opioid Prescribing. 141 i, APF — Treatment Options: A Guide for People Living with Pains. .nuueenunu 142 ii, Key Opinion Leaders and Misleading Science cea 45 fv. Misleading Continuing Medical Education. 146 Cephalon’s Deceptive Third-Party Statements to County Prescribers and Patients... 149 Endo. 149 Endo’s Deceptive Direct Matketing.. 150 150 i, Endo’s Sales Force and Deceptive Sales Training a) __ Endo’s Sales Force Deceptively Minimized the Risks of Addiction Associated with Chronic Opioid Therapy. pene 153 b)__Eindo’s Sales Force Deceptively Implied that Chronic Opioid Therapy Would Improve Patients’ Ability to Function. ...um : 155 ©) Endo’s Sales Force Deceptively presented the Risks and Benefits of Opioids to Make Them Appear Safet Than Other Analgesics. 157 ii, Endo’s Speakers Bureau Programs Deceptively Minimized the Risks of Addiction Associated with Chronic Opioid Therapy... 157 ili, Endo’s Misleading Journal Supplement... 159 iv, Bndo’s Deceptive Unbranded Advertising . 1159 Endo's Deceptive Thitd-Pasty Statements. 160 i APF a oe GL 4) Misleading Medical Education... ses A b) Painknowledge.com 166 ©) Exit Wounds .. 168 ii, Other Front Groups: FSMB, AAPM, and AGS iii. Key Opinion Leaders and Misleading Science. 7 170 Endo’s Deceptive Statements to County Preseribers and Patients 174 Janssen. is ee iv b, “4 b. © eo Janssen’s Deceptive Direct Marketing. 576 i. Janssen’s Deceptive Sales Training... 176 ji, Janssen’s Deceptive Speakers Burcau Programs.. 178 ii, Janssen’s Deceptive Unbranded Advertising... 179 Janssen’s Deceptive Third-Party Statements... 180 1 AAPM and AGS — Finding Relief: Pain Management for Older Adult8....0.00u.180 li, AGS - Misleading Medical Education.. 183 is AP Eerie See eae etatoreseeeipateeees eleecee eee 184 3) Let’s Talk Pain... 184 b) Exit Wounds 187 Janssen’s Deceptive Statements to Schuyler County area prescribers and Patients... 188 i. Janssen’s Deceptive Medical Education Programs in Schuyler County... 1188 ji, Janssen’s Deceptive Detailing Practices in Schuyler County. 1188 Purdue. 188 Purdue's Deceptive Direct Marketing .. 189 Purdue’s Deceptive Third-Pacty Statements. 194 APF sou 194 a) Purdue's Contzal of APF vases 1194 b) A Policymaker’s Guide . i 199 ©) Treatment Options: A Guide for People Living with Pain. 1-201 i Purdue's Work with Other Thied Party Front Groups and KOLs 202 9) FSMB —Responsible Opioid Prescribing eee eee eeeeeer 03 b) AGS — Pharmacological Management of Persistent Pain in Older Persons .xouu.202 ©) Chronic Pain Management and Opioid Use: Easing Fea, Managing Risks, and Improving Outcomes. . Beene ape ) Managing Patient’s Opioid Use: Balancing the Noed and Risk ssn 204 o O Abuse.... ©) Path of the Patient, Managing Chronic Pain in Younger Adults at Risk for 1 204 ) Overview of Management Options... 205 di, Purdue's Misleading Science... 205 a) _ Purdue's Deceptive Statements to Schuyler County atea prescribers and Patients... : ‘ 206 6. Insys 208 F. The Result of Defendants’ Fraudulent Scheme 215 1. Defendants’ Fraudulent and Decepive Marketing oF Opioids Dicey Caused Harm to Schuyler Countyievinsnuinne sone BAS 4 Increase in Opioid Prescribing Nationally 216 b. The County's Increased Spending 0 OD iOS... suannon seateeeeaaeeteeaaD, | i. Defendants’ Mistepresentations Were Material il, The County's Increased Costs Correlate with Defendants’ Promotion. | 1223 | 2. Defendants’ Ftaudulent and Deceptive Marketing of Opioids Ditectly Caused Harm to | Schuyler County Consumers eee eae 223 & Increased Opioia Use Has Led to an Increase in picid Abuse, Addiction, and i Death vena : s : 223 b. Increased Opioid Use Has Incteased Costs Related to Addiction Treatment osssno.225 Increased Opioid Use Has Fueled An eg Secondary Market for Narcotics and the ! Criminals Who Support It. 225 3. Defendants’ Fraudulent Marketing Has Led to Record Profits. 227 4. Defendants Fraudulently Concealed Their Misrepresentations.. e227 G. Defendants Entered into and Engaged in a Civil Conspiacy... 228 Hi Defendants Flooded Plintitt Schuyles County with Suspiciously Large Amounts of Opioids, 229 e° oO Plainif, the County of Schuyler, New York ("Plaintiff “County,” ot “Schuyler County”), by and through their attorneys, against Defendants Purdue Phatma LP. Purdue Pharma Inc. the Purdue Frederick Company, Ine; Teva Pharmaceuticals USA, Incj Cephalon, Ine; Johnson & Johnson; Janssen Pharmaceuticals, Inc; Janssen Pharmaceutics, lac. n/k/2 Janssen Phatmnaccuticals, Ines Ortho-McNeil-Janssen Pharmaceuticals, Inc. n/k/a Janssen Pharmaceuticals, Inc; Endo Health Solutions Ine.; Eado Pharmaceuticals, Inc Allergan ple £/k/a Actavis ple; Actavis, Ine. f/k/a Watson Pharinaceuticals, Ines Watson Laboratories, Inc; Actavis LLC; and Actavis Pharma, Inc. (/k/a Watson Pharma, Ines Insys Therapeutics, Inc. (collectively, “Manufacturers,” “Manufacouet Defendants,” or “Defendants’); MeKesson Corporation, Cardinal Health Inc, Amesisource Drag Corporation, American Medical Distributors, Inc; Bellco Drag Corp Blenheim Pharmzcal, Ine. Duby Group Companies, Inc; Eveready Wholesale Drugs Led; Kinray, LLC; PSS World Medical, Incs Rochester Drug Cooperative, Ines (Collectively, “Distributots,” “Distributor Defendants,” or “Defendants") Russell Portenoy; Perry Fine; Scott Fishman; end Lynn Webster, (collectively, “Physicians,” “Physician Defendants,” or “Defendants”) (collectively, “Defendants”) alleges as follows: INTRODUCTION 1 Tis case is about one thing: comporate greed, Defendants put their desire for profits above the health and well-being of Schuyler County consumers at the cost of Plaintiff 2 Schuyler County expends substantial resources each year to provide and pay for health care, setvices, pharmaceutical care and other necessary services and programs on behalf of residents of its County whom are indigent or otherwise eligible for services, including payments theaugh sexvices such as Medicaid for prescription opium painkillers (Yopiaids”) which are manufactured, matketed, promoted, sold, and/or distributed by the Defendants & oO 3. Schuyler County also provides 4 wide range of other services to its residents, including lw enforcement, services for families and children, and public assistance. 4 In recent years, the County of Schuyler has been forced to expend exorbitant amounts of money, described further below, due to what is commonly refected to asthe “opioid epidemic” and asa direct result of the actions of Defendants, 5: Plaintiff is also responsible for either partially or fally funding a medical insurance pln for their employees, including the costs of prescription drugs, including opioids. 6 Addiction is a spectrum of substance use disorders that range from misuse and abuse of drugs to addiction. Throughout this Complaint, “addiction” refers to the entire sange of substance abuse disorders. Individuals suffer negative consequences wherever they fall on the substance use disorder spectrum, 7 Defendants knew that opioids were effective teatments for short-teim post-surgical and trauma-selated pain, and for palliative (end-of-life) care. Yet they also knew-and had known for years-that opioids were addictive and subject to abuse, pasticularly when used long-term for chronic nom-cancer pain (pain lasting thtee months or longer, hereinafter referred t0 as “chronic pain”), and should not be used except as a last-resort. 8. Defendants knew that, basting exceptional ciscumstances, opioids were too addictive ‘nd too debilitating for long-terin use for chronic non-cancer pain lasting three months or longer: 9. Defendants further knew-and had known for years-that with prolonged use, the effectiveness of opioids wanes, requiring increases in doses and markedly increasing the risk of significant side effects and addiction.* * | Dingnostic and Statistical Manual of Mental Disordess (54 ed. 2013) (‘DSMLV"), 2a fy Rossel Powtenoy, Opiaid Thay for Chri Newmans Paine Cart State Progcss in Pain Res, gant 247 (1984) 2 The authoritative Diggnast and Statistical Manual of Menial Dizerdey, (Sth ed, 2013) (“DSMLV") cassifes addition as a ‘Pectrum of “substance use disorders” chat ranges from miuse and abuse of dings to addiction, Patients suffer negative 2 a oO 10. Defendants also knew that controlled studies of the safety and efficacy of opioids were {mited to short-tesm use (aot longer than 90 days), and in managed settings 4g, hospitals), where the Xk of addiction and other adverse outcomes was much less significant. HN. Tndeed, the U'S. Food and Drug Administration (“FDA") las expressly recognized that there have been no long-term studies demonstrating the safety and efficacy of opioids for long-term 12, Prescription opioids, which include well-known brand-name drugs like OxyContin and Percocet, and generics like Oxycodone and hydrocodone, are narcoties. They ate detived from or Possess Properties similar to opium and heroin, which is why they are regulated as controlled substances.’ Like heroin, presctiption opioids work by binding to ceceptors on the spinal cord and in the brain, dampening the perception of pain. Opioids also can cteate a euphoric high, which can make them addictive, At ceztain doses, opioids can slow the users brenthing, causing respiratory depression and desth, 15. In order to expand the market for opioids and realize blockbuster profits, Defendants needed to create 2 sea of change in the medical and public perception that would permit the use of Goufebences wherever they fll on the ubstance use disorder continuum. Throughout this Complaint, “addiction” sefete to this range of substance use disorders. paste: fiom Janet Woodcock, MD, Dis, Cx for Drug Eval &e Ree, to Andcew Kolodny, MD. Pres. Physicians foe Responsible Opioid Presccibing, Re Docket No. FDA-2012-P-0818 Sept. 10, 2013), Since passage of the Controlled Substances Act ("CSA") in 1970, opioids have been culated ae controlled substances, Controlled substances ar categorized in five schedules, caked inorder of their potential for sbae, with Sehedas t being the highest. The CSA imposes a hierarchy of estcictions on prescribing and dispensing drags bared on ther evict ‘ils likelihood of addiction oc abuse, and safety. Opioids generally had been categonzed a Schedule Ul or Sched [IL (empboss in original) ® July 25, 2012 lewer feo PROP to FDA, accessed at htep//wwrwcitizen ozg/documents/2048,pdf on May 30, 2017 44 ae the high sisk of addiction, the exaggesated and false benefits, and further medically backed reasons to ‘change the labelling of opicid medications to reduce prescribing 216, In 2013, in response to a petition to require manufacturers to strengthen warnings on the labels of long-acting opioid products, the FDA wamed of the “grave tisks” of opioids, including “addiction, overdose, and even death.” The FDA further warned, “[elven proper use of opioids uncer medical supervision can result in life- thteatening respizatory depression, coma, and death.” Because of those grave risks, the FDA said that long-acting or extended release opioids “should be used only when alternative treatments are inadequate’ The FDA required that — going forward opioid makers of long-acting formulations clearly communicate these tisks on theit labels. 217. In 2016, the FDA expanded its warnings for immediate-release opioid pain medications, requiring similar changes to the labeling of immedizte-release for opioid pain medications as it had for extended release opioids in 2013. The FDA also required several additional safety-labeling changes across all prescription opioid products to include additional information on the risk of these medications." 218. The facts on which the FDA telied in 2013 and 2016 were well known to Defendants for many years since they began marketing these drugs. 3. Long-Term Opioid Use Benefits Are Unproven and Contradicted, 219. Despite the fact ‘that opioids ate now routinely prescribed, there has never been evidence of theit safety and efficacy for long-term use. 220. Defendants have always been aware of these gaps in knowledge. While promoting opioids to weat chronic pain, Defendants have failed to disclose the lack of evidence to support their @ Letter fom Janet Woodcock, M.D, Dit, Ctr. For Dag Eval & Res, to And:ew Koloday, MD., Pres, Plyshian for Responsible Opiaid Prusnbing, Re Docket No. FDA-2012-P-0818 (Sept. 10, 2013) (emphasis in orginal) © EDA announces enhanced warnings for immediate-release opioid pain medications related to visks of misuse, abuse, addiction, overdose and death. Available at tp wwew Fan gov /newsevents/newsroom/pressannouncements/‘uem¢91739.htm (accessed May 30, 2047) 45 e o long-term use and have failed to disclose the contradictory evidence that chronic opioid thermpy actually makes patients sicker, 221, There are no conwrolled studies of the use of opioids beyond 16 weeks, and no evidence that opioids improve patients’ pain and function long-term. The fitst ratidom, placebo- controlled studies appeared in the 1990s, and revealed evidence only for short-term efficacy and only in a minority of patients,” 222, A 2004 report reviewed 213 randomized, controlled trials of treatments for cancer pain and showed that, while opioids had short-term efficacy, the data was insufficient to establish long-term ffectiveness. Subsequent reviews of the use of opioids for cancer and non-cancet pain consistently note the lack of data to assess long-term outcomes. For example, a 2007 systematic review of opioids for back pain concluded that opioids have limited, if any, efficacy for back pain and that evidence did ‘not allow judgments regarding long-term use. Similarly, a 2011 systematic review of studies for non- ‘ances pain found that evidence of long-term efficacy is poor. One year later, a similar review reported poor evidence of long-term efficacy for morphine, tramadol, and oxycodone, and fair evidence for ‘tansdermal fentanyl (approved only for use for cancer pain). 223. On the contrary, evidence exists to show that opioid drugs are not effective to teat chzonie paia, and may worsen patients’ health. A 2006 stady-of-studies found that opioids as a class did not demonstrate improvement in functional outcomes over other non-addicting treatments. Most sotably, it stated: “For functional outcomes, the other analgesics were significantly more effective than were opioids.“ Another review of evidence relating to the use of opioids for chronic pain found that {8 Nathaniel Katz, Opis: Afar Thnsond of Years Still Gating to Knew Yow, 23(4) Clin]. Pan 303 (2007); Roget Chow et al, Reseavh Gaps on Us of Opi fr Chronic Noman Ptr, 102)}, Pain 147 (2009). ‘

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