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NYC Opioids Complaint.Pdf CAUTION: THIS DOCUMENT HAS NOT YET BEEN REVIEWED BY THE COUNTY CLERK. (See below.) INDEX NO. UNASSIGNED NYSCEF DOC. NO. 2 RECEIVED NYSCEF: 01/23/2018 SUPREME COURT OF THE STATE OF NEW YORK COUNTY OF NEW YORK ------------------------------------------------------------------------ THE CITY OF NEW YORK, Index No.: Plaintiff, VERIFIED COMPLAINT -against- PLAINTIFF DEMANDS A PURDUE PHARMA L.P.; PURDUE PHARMA INC.; THE TRIAL BY JURY PURDUE FREDERICK COMPANY, INC.; TEVA PHARMACEUTICALS USA, INC.; CEPHALON, INC.; JOHNSON & JOHNSON; JANSSEN PHARMACEUTICALS, INC.; ORTHOMCNEIL- 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., MCKESSON CORPORATION; CARDINAL HEALTH, INC.; AMERISOURCEBERGEN DRUG CORPORATION, Defendants. ------------------------------------------------------------------------ This is a copy of a pleading filed electronically pursuant to New York State court rules (22 NYCRR §202.5-b(d)(3)(i)) which, at the time of its printout from the court system's electronic website, had not yet been reviewed and approved by the County Clerk. Because court rules (22 NYCRR §202.5[d]) authorize the County Clerk to reject filings for various reasons, readers should be aware that documents bearing this legend may not have been accepted for filing by the County Clerk. 1 of 256 CAUTION: THIS DOCUMENT HAS NOT YET BEEN REVIEWED BY THE COUNTY CLERK. (See below.) INDEX NO. UNASSIGNED NYSCEF DOC. NO. 2 RECEIVED NYSCEF: 01/23/2018 TABLE OF CONTENTS Page INTRODUCTION .......................................................................................................................... 1 THE MANUFACTURERS’ ROLE .................................................................................... 7 THE DISTRIBUTORS’ ROLE ........................................................................................ 21 JURISDICTION AND VENUE ................................................................................................... 27 PARTIES ...................................................................................................................................... 27 FACTS RELEVANT TO ALL CAUSES OF ACTION .............................................................. 36 A. BACKGROUND ON PAIN MEDICINE. ............................................................ 36 1. Safe and Effective Treatment of Chronic Pain Centers on Informed Risk Management. .................................................................................... 36 2. Opioid Use Is Associated with Known and Substantial Risks. ................ 37 3. Long-Term Opioid Use Benefits Are Unproven and Contradicted. ......... 43 4. The Defendants’ Impact on the Perception and Prescribing of Opioids. ..................................................................................................... 46 B. THE MANUFACTURERS PROMOTED THEIR BRANDED PRODUCTS THROUGH DIRECT MARKETING TO PRESCRIBERS AND CONSUMERS. ..................................................................................................... 48 1. The Manufacturers Relied Upon Branded Advertisements. ..................... 49 2. The Manufacturers Relied Upon Their Sales Forces and Recruited Physician Speakers.................................................................................... 49 3. The Manufacturers Directed These Promotional Efforts Through Detailed Marketing Plans. ......................................................................... 53 a. Targeting categories of prescribers .................................................... 54 b. Increasing “direct to consumer” marketing ....................................... 54 c. Differentiating each brand ................................................................. 55 d. Moving beyond office visits .............................................................. 56 i This is a copy of a pleading filed electronically pursuant to New York State court rules (22 NYCRR §202.5-b(d)(3)(i)) which, at the time of its printout from the court system's electronic website, had not yet been reviewed and approved by the County Clerk. Because court rules (22 NYCRR §202.5[d]) authorize the County Clerk to reject filings for various reasons, readers should be aware that documents bearing this legend may not have been accepted for filing by the County Clerk. 2 of 256 CAUTION: THIS DOCUMENT HAS NOT YET BEEN REVIEWED BY THE COUNTY CLERK. (See below.) INDEX NO. UNASSIGNED NYSCEF DOC. NO. 2 RECEIVED NYSCEF: 01/23/2018 4. The Manufacturers Marketed Opioids within New York City Using the Same Strategies and Messages They Employed Nationwide. ............ 56 C. THE MANUFACTURERS USED “UNBRANDED” MARKETING TO EVADE REGULATIONS AND CONSUMER PROTECTION LAWS. ............ 57 1. Regulations Governing Branded Promotion Require that It Be Truthful, Balanced, and Supported by Substantial Evidence. .................. 58 2. The Manufacturers Deployed Front Groups and Doctors to Disseminate Unbranded Information on Their Behalf. ............................. 60 a. Defendants’ Use of KOLs ................................................................. 64 b. “Research” That Lacked Supporting Evidence ................................. 69 c. Treatment Guidelines ......................................................................... 72 d. Continuing Medical Education .......................................................... 78 e. Unbranded Patient Education ............................................................ 81 f. Defendants’ Use of Front Groups ...................................................... 81 3. The Manufacturers Acted in Concert with KOLs and Front Groups in the Creation, Promotion, and Control of Unbranded Marketing. ............. 85 4. The Manufacturers Targeted Vulnerable and Lucrative Populations. ...... 87 a. The Elderly ........................................................................................ 87 b. Veterans ............................................................................................. 88 D. WHY DEFENDANTS’ MARKETING MESSAGES ARE MISLEADING ....... 90 1. The Manufacturers and Their Third-Party Allies Misrepresented that Opioids Improve Function ........................................................................ 91 2. The Manufacturers and Their Third-Party Allies Concealed the Truth About the Risk of Addiction from Long-Term Opioid Use ..................... 96 3. The Manufacturers and Their Third-Party Allies Misrepresented that Addiction Risk Can Be Avoided or Managed ........................................ 106 4. The Manufacturers and Their Third-Party Allies Created Confusion By Promoting the Misleading Term “Pseudoaddiction.” ....................... 109 5. The Manufacturers and Their Third-Party Allies Claimed Withdrawal is Simply Managed ................................................................................. 111 This is a copy of a pleading filed electronically pursuant toii New York State court rules (22 NYCRR §202.5-b(d)(3)(i)) which, at the time of its printout from the court system's electronic website, had not yet been reviewed and approved by the County Clerk. Because court rules (22 NYCRR §202.5[d]) authorize the County Clerk to reject filings for various reasons, readers should be aware that documents bearing this legend may not have been accepted for filing by the County Clerk. 3 of 256 CAUTION: THIS DOCUMENT HAS NOT YET BEEN REVIEWED BY THE COUNTY CLERK. (See below.) INDEX NO. UNASSIGNED NYSCEF DOC. NO. 2 RECEIVED NYSCEF: 01/23/2018 6. The Manufacturers and Their Third-Party Allies Misrepresented that Increased Doses Pose No Significant Additional Risks ......................... 113 7. The Manufacturers and Their Third-Party Allies Deceptively Omitted or Minimized Adverse Effects of Opioids and Overstated the Risks of Alternative Forms of Pain Treatment. .................................................... 116 8. Purdue Misleadingly Promoted OxyContin as Providing 12 Hours of Relief ....................................................................................................... 120 E. EACH MANUFACTURER DEFENDANT ENGAGED IN DECEPTIVE MARKETING, BOTH BRANDED AND UNBRANDED, THAT TARGETED AND REACHED PRESCRIBERS WITHIN THE CITY. ........... 124 1. Actavis .................................................................................................... 125 a. Actavis’ Deceptive Direct Marketing .............................................. 125 b. Actavis’s Deceptive Statements to Prescribers and Patients Within the City ............................................................ 134 2. Cephalon ................................................................................................. 134 a. Cephalon’s Deceptive Direct Marketing ......................................... 135 b. Cephalon’s Deceptive Third-Party Statements ................................ 146 c. Cephalon’s Deceptive Third-Party Statements to Prescribers and Patients Within the City ..................................... 155 3. Endo ........................................................................................................ 156 a. Endo’s Deceptive Direct Marketing ................................................ 157 b. Endo’s Deceptive Third-Party Statements ....................................... 167
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