Case: 1:17-md-02804-DAP Doc #: 525 Filed: 05/30/18 1 of 315. PageID #: 13544 UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF OHIO EASTERN DIVISION IN RE NATIONAL PRESCRIPTION MDL No. 2804 OPIATE LITIGATION Case No. 17-md-2804 This document relates to: Judge Dan Aaron Polster Case No. 18-OP-45332 (N.D. Ohio) BROWARD COUNTY, FLORIDA, SECOND AMENDED COMPLAINT (REDACTED) Plaintiff, DEMAND FOR JURY TRIAL vs. PURDUE PHARMA L.P., PURDUE PHARMA INC., THE PURDUE FREDERICK COMPANY, INC., ENDO HEALTH SOLUTIONS INC., ENDO PHARMACEUTICALS, INC., PAR PHARMACEUTICAL, INC., PAR PHARMACEUTICAL COMPANIES, INC., JANSSEN PHARMACEUTICALS, INC., JANSSEN PHARMACEUTICA, INC. n/k/a JANSSEN PHARMACEUTICALS, INC., NORAMCO, INC., ORTHO-MCNEIL- JANSSEN PHARMACEUTICALS, INC. n/k/a JANSSEN PHARMACEUTICALS, INC., JOHNSON & JOHNSON, TEVA PHARMACEUTICAL INDUSTRIES LTD., TEVA PHARMACEUTICALS USA, INC., CEPHALON, INC., ALLERGAN PLC f/k/a ACTAVIS PLC, ALLERGAN FINANCE LLC, f/k/a ACTAVIS, INC., f/k/a WATSON PHARMACEUTICALS, INC., WATSON LABORATORIES, INC., ACTAVIS LLC, ACTAVIS PHARMA, INC. f/k/a WATSON PHARMA, INC., INSYS THERAPEUTICS, INC., MALLINCKRODT PLC, 1545690.37 Case: 1:17-md-02804-DAP Doc #: 525 Filed: 05/30/18 2 of 315. PageID #: 13545 MALLINCKRODT LLC, SPECGX LLC, CARDINAL HEALTH, INC., McKESSON CORPORATION, AMERISOURCEBERGEN CORPORATION, HEALTH MART SYSTEMS, INC., H. D. SMITH, LLC d/b/a HD SMITH, f/k/a H.D. SMITH WHOLESALE DRUG CO., H. D. SMITH HOLDINGS, LLC, H. D. SMITH HOLDING COMPANY, CVS HEALTH CORPORATION, WALGREENS BOOTS ALLIANCE, INC. a/k/a WALGREEN CO., and WAL-MART INC. f/k/a WAL-MART STORES, INC., Defendants. 1545690.37 Case: 1:17-md-02804-DAP Doc #: 525 Filed: 05/30/18 3 of 315. PageID #: 13546 TABLE OF CONTENTS Page INTRODUCTION ......................................................................................................................... 3 JURISDICTION AND VENUE .................................................................................................... 8 PARTIES ....................................................................................................................................... 9 I. Plaintiff .............................................................................................................................. 9 II. Defendants ....................................................................................................................... 10 A. Marketing Defendants. ......................................................................................... 10 1. Purdue Entities ......................................................................................... 10 2. Actavis Entities ........................................................................................ 12 3. Cephalon Entities ..................................................................................... 13 4. Janssen Entities ........................................................................................ 14 5. Endo Entities ............................................................................................ 16 6. Insys Therapeutics, Inc. ........................................................................... 18 7. Mallinckrodt Entities ............................................................................... 18 B. Distributor Defendants ......................................................................................... 21 1. Cardinal Health, Inc. ................................................................................ 21 2. McKesson Corporation ............................................................................ 22 3. AmerisourceBergen Drug Corporation .................................................... 22 4. CVS Health Corporation .......................................................................... 23 5. Health Mart Systems, Inc. ........................................................................ 23 6. H. D. Smith, LLC ..................................................................................... 23 7. Walgreens Boots Alliance, Inc. ............................................................... 24 8. Wal-Mart Inc. ........................................................................................... 24 C. Agency and Authority .......................................................................................... 25 FACTUAL ALLEGATIONS ...................................................................................................... 25 III. Facts Common to All Claims ........................................................................................... 25 A. Opioids and Their Effects .................................................................................... 25 B. The Resurgence of Opioid Use in the United States ............................................ 29 1. The Sackler Family Integrated Advertising and Medicine ...................... 29 2. Purdue and the Development of OxyContin ............................................ 31 3. Other Marketing Defendants Leapt at the Opioid Opportunity ............... 36 -i- 1545690.37 Case: 1:17-md-02804-DAP Doc #: 525 Filed: 05/30/18 4 of 315. PageID #: 13547 TABLE OF CONTENTS (continued) Page C. Defendants’ Conduct Created an Abatable Public Nuisance ............................... 38 D. The Marketing Defendants’ Multi-Pronged Scheme to Change Prescriber Habits and Public Perception and Increase Demand for Opioids ........................ 39 1. The Marketing Defendants Promoted Multiple Falsehoods About Opioids ..................................................................................................... 40 a. Falsehood #1: The risk of addiction from chronic opioid therapy is low ............................................................................... 41 i. Purdue’s misrepresentations regarding addiction risk.................................................................................... 42 ii. Endo’s misrepresentations regarding addiction risk ........ 49 iii. Janssen’s misrepresentations regarding addiction risk.................................................................................... 51 iv. Cephalon’s misrepresentations regarding addiction risk.................................................................................... 53 v. Actavis’s misrepresentations regarding addiction risk.................................................................................... 54 vi. Mallinckrodt’s misrepresentations regarding addiction risk .................................................................... 56 b. Falsehood #2: To the extent there is a risk of addiction, it can be easily identified and managed .......................................... 58 c. Falsehood #3: Signs of addictive behavior are “pseudoaddiction,” requiring more opioids ................................. 60 d. Falsehood #4: Opioid withdrawal can be avoided by tapering ........................................................................................ 63 e. Falsehood #5: Opioid doses can be increased without limit or greater risks.............................................................................. 64 f. Falsehood #6: Long-term opioid use improves functioning ........ 68 g. Falsehood #7: Alternative forms of pain relief pose greater risks than opioids ......................................................................... 73 h. Falsehood #8: OxyContin provides twelve hours of pain relief ............................................................................................. 77 i. Falsehood #9: New formulations of certain opioids successfully deter abuse ............................................................... 82 -ii- 1545690.37 Case: 1:17-md-02804-DAP Doc #: 525 Filed: 05/30/18 5 of 315. PageID #: 13548 TABLE OF CONTENTS (continued) Page i. Purdue’s deceptive marketing of reformulated OxyContin and Hysingla ER ........................................... 83 ii. Endo’s deceptive marketing of reformulated Opana ER .................................................................................... 86 iii. Other Marketing Defendants’ misrepresentations regarding abuse deterrence .............................................. 92 2. The Marketing Defendants Disseminated Their Misleading Messages About Opioids Through Multiple Channels ............................ 94 a. The Marketing Defendants Directed Front Groups to Deceptively Promote Opioid Use ................................................ 95 i. American Pain Foundation .............................................. 97 ii. American Academy of Pain Medicine and the American Pain Society ..................................................... 99 iii. FSMB ............................................................................. 102 iv. The Alliance for Patient Access ..................................... 104 v. The U.S. Pain Foundation (“USPF”) ............................. 108 vi. American Geriatrics Society (“AGS”) ........................... 108 b. The Marketing Defendants Paid Key Opinion Leaders to Deceptively Promote Opioid Use .............................................. 110 i. Dr. Russell Portenoy ...................................................... 112 ii. Dr. Lynn Webster........................................................... 115 iii. Dr. Perry Fine................................................................. 116 iv. Dr. Scott Fishman .......................................................... 119 c. The Marketing Defendants Disseminated Their Misrepresentations