UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA THE CITY OF ORLANDO, FLORIDA Case No.: Plaintiff, vs. PURDUE PHARMA L.P., PURDUE PHARMA INC., THE PURDUE FREDERICK COMPANY, INC., ENDO HEALTH SOLUTIONS INC., ENDO COMPLAINT PHARMACEUTICALS, INC., PAR PHARMACEUTICAL, INC., PAR DEMAND FOR JURY TRIAL 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, 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., CVS ORLANDO, FLORIDA DISTRIBUTION, L.L.C., CVS VERO, FLORIDA DISTRIBUTION, L.L.C., WALGREEN CO., and WAL-MART INC. f/k/a WAL-MART STORES, INC., Defendants. TABLE OF CONTENTS Page INTRODUCTION ......................................................................................................................... 2 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 ............................................................................... 19 B. Distributor Defendants ......................................................................................... 21 1. Cardinal Health, Inc. ................................................................................ 22 2. McKesson Corporation ............................................................................ 22 3. AmerisourceBergen Drug Corporation .................................................... 23 4. CVS Entities............................................................................................. 23 5. Health Mart Systems, Inc. ........................................................................ 24 6. H. D. Smith, LLC ..................................................................................... 24 7. Walgreen Co. ........................................................................................... 25 8. Wal-Mart Inc. ........................................................................................... 25 C. Agency and Authority .......................................................................................... 26 FACTUAL ALLEGATIONS ...................................................................................................... 26 III. Facts Common to All Claims ........................................................................................... 26 A. Opioids and Their Effects .................................................................................... 26 B. The Resurgence of Opioid Use in the United States............................................ 30 1. The Sackler Family Integrated Advertising and Medicine ...................... 30 2. Purdue and the Development of OxyContin ............................................ 32 3. Other Marketing Defendants Leapt at the Opioid Opportunity ............... 37 -i- TABLE OF CONTENTS (continued) Page C. Defendants’ Conduct Created an Abatable Public Nuisance ............................... 39 D. The Marketing Defendants’ Multi-Pronged Scheme to Change Prescriber Habits and Public Perception and Increase Demand for Opioids ........................ 40 1. The Marketing Defendants Promoted Multiple Falsehoods About Opioids ..................................................................................................... 41 a. Falsehood #1: The risk of addiction from chronic opioid therapy is low ............................................................................... 43 i. Purdue’s misrepresentations regarding addiction risk.................................................................................... 44 ii. Endo’s misrepresentations regarding addiction risk ........ 50 iii. Janssen’s misrepresentations regarding addiction risk.................................................................................... 52 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 ........ 67 g. Falsehood #7: Alternative forms of pain relief pose greater risks than opioids ......................................................................... 73 h. Falsehood #8: OxyContin provides 12 hours of pain relief ......... 76 i. Falsehood #9: New formulations of certain opioids successfully deter abuse ............................................................... 81 i. Purdue’s deceptive marketing of reformulated OxyContin and Hysingla ER ........................................... 82 -ii- TABLE OF CONTENTS (continued) Page ii. Endo’s deceptive marketing of reformulated Opana ER .................................................................................... 85 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 ................................................ 94 i. American Pain Foundation .............................................. 96 ii. American Academy of Pain Medicine and the American Pain Society ..................................................... 99 iii. Federation of State Medical Boards ............................... 102 iv. The Alliance for Patient Access ..................................... 104 v. The U.S. Pain Foundation .............................................. 108 vi. American Geriatrics Society .......................................... 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................................................................. 117 iv. Dr. Scott Fishman .......................................................... 120 c. The Marketing Defendants Disseminated Their Misrepresentations Through Continuing Medical Education Programs .................................................................................... 121 d. The Marketing Defendants Used “Branded” Advertising to Promote Their Products to Doctors and Consumers .................. 124 e. The Marketing Defendants Used “Unbranded” Advertising to Promote Opioid Use for Chronic Pain Without FDA Review ....................................................................................... 125 f. The Marketing Defendants Funded, Edited. and Distributed Publications that Supported Their Misrepresentations ..................................................................... 126 -iii- TABLE OF CONTENTS (continued) Page g. The Marketing Defendants Used Detailing