Case: 1:19-op-46042-DAP Doc #: 1 Filed: 11/20/19 1 of 214. PageID #: 1 IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF OHIO EASTERN DIVISION IN RE: NATIONAL PRESCRIPTION ) MDL 2804 OPIATE LITIGATION ) ) Case No. THIS DOCUMENT RELATES TO: ) ) Judge Dan Aaron Polster THE BOARD OF EDUCATION OF THE ) CITY OF CHICAGO, SCHOOL DISTRICT ) NO. 299 (“CHICAGO PUBLIC SCHOOLS”), ) on behalf of itself and others similarly situated, ) ) v. ) ) CLASS ACTION COMPLAINT CEPHALON, INC., TEVA ) PHARMACEUTICAL INDUSTRIES LTD., ) TEVA PHARMACEUTICALS USA, INC., ) ENDO INTERNATIONAL PLC, ENDO ) HEALTH SOLUTIONS INC., ENDO ) PHARMACEUTICALS INC., JANSSEN ) PHARMACEUTICALS, INC., ORTH- ) MCNEIL-JANSSEN PHARMACEUTICALS, ) INC., n/k/a/ JANSSEN PHARMACEUTICA, ) INC., n/k/a JANSSEN PHARMACEUTICALS, ) INC., JOHNSON & JOHNSON, INC., INSYS ) THERAPEUTICS, INC., MALLINCKRODT, ) PLC, MALLINCKRODT LLC, ALLERGAN ) PLC f/k/a ACTAVIS PLC, WATSON ) PHARMACEUTICALS, INC. n/k/a ACTAVIS, ) ) INC., WATSON LABORATORIES, INC., ) ACTAVIS LLC, ACTAVIS PHARMA, INC. ) f/k/a/ WATSON PHARMA, INC., ) AMERISOURCEBERGEN CORPORATION, ) CARDINAL HEALTH, INC., McKESSON ) CORPORATION, CVS HEALTH ) CORPORATION, WALGREENS BOOTS ) ALLIANCE, INC., A/K/A WALGREEN CO., ) and WALMART INC., F/K/A WAL-MART ) STORES, INC., ) Defendants. ) Case: 1:19-op-46042-DAP Doc #: 1 Filed: 11/20/19 2 of 214. PageID #: 2 TABLE OF CONTENTS I. INTRODUCTION. ............................................................................................................. 1 II. PARTIES. ......................................................................................................................... 15 A. Plaintiff. ................................................................................................................ 15 B. “Manufacturing Defendants.” ............................................................................... 17 C. “Distributor Defendants.” ..................................................................................... 19 1. “National Retail Pharmacies” ................................................................... 19 D. Unnamed Co-Conspirators.................................................................................... 20 III. JURISDICTION AND VENUE. ...................................................................................... 22 IV. FACTUAL ALLEGATIONS. .......................................................................................... 23 A. Prescription Opioids.............................................................................................. 23 B. Over the Course of More Than Two Decades, the Manufacturing Defendants Misled the Public Regarding the Dangers of Opioid Addiction and the Efficacy of Opioids for Long-Term Use, Causing Sales and Overdose Rates to Soar............ 26 1. Background on Opioid Overprescribing. .................................................. 26 2. The Fraudulent Sales Practices. ................................................................ 31 3. The Manufacturing Defendants Funded Front Organizations that Published and Disseminated False and Misleading Marketing Materials. 31 4. The Manufacturing Defendants Paid Key Opinion Leaders and Sponsored Speakers’ Bureaus to Disseminate False and Misleading Messaging. ..... 50 5. Senate Investigations of the Manufacturing Defendants. ......................... 53 6. The Devastating Impact of the Manufacturing Defendants’ Propaganda Campaign. ................................................................................................. 56 C. The Manufacturing Defendants’ and Co-Conspirators’ Specific Unlawful Practices that Targeted Illinois and Chicago-area Prescribers. ............................. 57 1. The Purdue Co-Conspirators..................................................................... 57 a) Purdue Falsely Marketed Extended-Release Drugs as Safer and More Effective than Regular-Release Drugs. ............................... 58 Case: 1:19-op-46042-DAP Doc #: 1 Filed: 11/20/19 3 of 214. PageID #: 3 b) Purdue Falsely Marketed Low Addiction Risk to Wide Swaths of Physicians. .................................................................................... 62 c) Purdue Funded Publications and Presentations with False and Misleading Messaging. ................................................................. 65 d) The Guilty Pleas. ........................................................................... 66 e) The Sacklers Establish Rhodes as a “Landing Pad” from Purdue. 69 f) Purdue Failed to Monitor and Report Suspicious Sales as Required. ....................................................................................................... 71 2. The Sackler Family Co-Conspirators........................................................ 71 a) The Individual Sacklers Direct and Control Purdue. .................... 71 b) The Sacklers Oversee and Direct Purdue’s Unlawful Conduct. ... 74 c) Sacklers Were Aware of the Abuse Potential of OxyContin Since at Least 1996. ................................................................................ 75 d) The Sacklers’ Full Understanding Of Opioid Abuse And Addiction Risk is Underscored By Their Pursuit of Business Opportunities In Medications That Treat Addiction Their Own Opioids Caused. .. 78 e) The Sacklers Continued to Oversee Purdue’s Wrongdoing Even After Repeated Warnings and Fines. ............................................ 80 3. The Johnson & Johnson Defendants. ........................................................ 89 a) Janssen .......................................................................................... 90 b) The FDA Warned Janssen Regarding Its False Messaging. ......... 91 c) The Johnson & Johnson Defendants Funded False Publications and Presentations. ................................................................................ 94 d) The Johnson & Johnson Defendants Failed to Monitor and Report Suspicious Sales as Required by Federal Law. ............................. 98 e) In addition to marketing its own opioids, Johnson & Johnson owned two companies that grew, imported, and processed the raw materials to make opioids and sold them to many of the other Manufacturing Defendants, including Purdue. ............................. 99 4. Endo. ....................................................................................................... 101 a) Endo Falsely Marketed Opana ER as Crush Resistant. .............. 102 ii Case: 1:19-op-46042-DAP Doc #: 1 Filed: 11/20/19 4 of 214. PageID #: 4 b) New York’s Investigation Found Endo Falsely Marketed Opana ER. .............................................................................................. 104 c) Endo Funded False Publications and Presentations. ................... 107 d) FDA Requested Endo Withdraw Opana ER Due to the Public Health Consequences of Abuse. ................................................. 109 e) Endo Failed to Monitor and Report Suspicious Sales as Required. ..................................................................................................... 110 5. Cephalon. ................................................................................................ 111 a) Cephalon Falsely and Aggressively Marketed Cancer Drug Actiq to Non-Cancer Treating Physicians. ........................................... 113 b) Government Investigations Found Cephalon Falsely Marketed Actiq for Off-Label Uses. ........................................................... 115 c) Cephalon Falsely and Aggressively Marketed Cancer Drug Fentora to Non-Cancer Treating Physicians. ........................................... 116 d) The FDA Warned Cephalon Regarding its False and Off-Label Marketing of Fentora. ................................................................. 117 e) Cephalon Funded False Publications and Presentations. ............ 119 f) Cephalon Failed to Monitor and Report Suspicious Sales as Required. ..................................................................................... 128 6. Insys ........................................................................................................ 128 a) Federal Investigation of Insys. .................................................... 131 b) The Indictment of Insys Executives and the Arrest of Its Founder. ..................................................................................................... 131 c) Insys Targeted Non-Cancer Treating Physicians and Funded False Publications and Presentations. ................................................... 133 d) Insys Failed to Monitor and Report Suspicious Sales as Required. ..................................................................................................... 138 7. Mallinckrodt ............................................................................................ 138 a) Mallinckrodt Funded False Publications and Presentations. ...... 140 b) The DEA Investigates Suspicious Orders. .................................. 142 iii Case: 1:19-op-46042-DAP Doc #: 1 Filed: 11/20/19 5 of 214. PageID #: 5 c) Mallinckrodt Failed to Monitor and Report Suspicious Sales as Required. ..................................................................................... 144 8. Actavis. ................................................................................................... 144 a) The FDA Issued a Warning Letter to Actavis Concerning Extensive False and Misleading Claims in Kadian Marketing Materials. ...................................................................................