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CITY of DELRAY BEACH, Plaintiff Case 9:17-cv-81384-XXXX Document 1 Entered on FLSD Docket 12/21/2017 Page 1 of 148 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA Case No. _____-Civ-_________________ CITY OF DELRAY BEACH, ) ) Plaintiff, ) ) vs. ) ) PURDUE PHARMA L.P., CEPHALON, INC., ) DEMAND FOR JURY TRIAL TEVA PHARMACEUTICAL INDUSTRIES ) LTD., TEVA PHARMACEUTICALS USA, INC., ) ENDO INTERNATIONAL PLC, ENDO ) PHARMACEUTICALS, INC., JANSSEN ) PHARMACEUTICALS, INC., INSYS ) THERAPEUTICS, INC., MALLINCKRODT ) PLC, MALLINCKRODT PHARMACEUTICALS, ) AMERISOURCEBERGEN CORPORATION, ) CARDINAL HEALTH, INC. and McKESSON ) CORPORATION, ) ) Defendants. ) ) COMPLAINT FOR (1) VIOLATION OF THE FLORIDA DECEPTIVE AND UNFAIR TRADE PRACTICES ACT; (2) PUBLIC NUISANCE; (3) NEGLIGENCE; (4) UNJUST ENRICHMENT; AND (5) VIOLATION OF THE RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS ACT Case 9:17-cv-81384-XXXX Document 1 Entered on FLSD Docket 12/21/2017 Page 2 of 148 TABLE OF CONTENTS Page I. INTRODUCTION ...............................................................................................................1 II. PARTIES ...........................................................................................................................11 III. JURISDICTION AND VENUE ........................................................................................12 IV. FACTUAL ALLEGATIONS ............................................................................................13 A. 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 ..........................................................................................13 1. Background on Opioid Overprescribing ....................................................13 2. The Fraudulent Sales Practices ..................................................................18 a. The Manufacturing Defendants Funded Front Organizations that Published and Disseminated False and Misleading Marketing Materials ....................................................18 b. The Manufacturing Defendants Paid Key Opinion Leaders and Sponsored Speakers’ Bureaus to Disseminate False and Misleading Messaging ...................................................................37 c. Senate Investigations of the Manufacturing Defendants ...............39 3. The Devastating Impact .............................................................................44 B. The Manufacturing Defendants’ Specific Unlawful Practices that Targeted Delray Beach Prescribers .......................................................................................48 1. Purdue ........................................................................................................48 a. Purdue Falsely Marketed Extended-Release Drugs as Safer and More Effective than Regular-Release Drugs ..........................49 b. Purdue Falsely Marketed Low Addiction Risk to Wide Swaths of Physicians......................................................................51 c. Purdue Funded Publications and Presentations with False and Misleading Messaging ............................................................54 d. The Guilty Pleas .............................................................................56 e. Purdue Failed to Report Suspicious Sales as Required .................59 - i - Case 9:17-cv-81384-XXXX Document 1 Entered on FLSD Docket 12/21/2017 Page 3 of 148 Page 2. Janssen .......................................................................................................60 a. The FDA Warned Janssen Regarding Its False Messaging ...........61 b. Janssen Funded False Publications and Presentations ...................65 c. Janssen Failed to Report Suspicious Sales as Required.................68 3. Endo ...........................................................................................................69 a. Endo Falsely Marketed Opana ER as Crush Resistant ..................71 b. New York’s Investigation Found Endo Falsely Marketed Opana ER .......................................................................................73 c. Endo Funded False Publications and Presentations .......................76 d. The FDA Requested Endo Withdraw Opana ER Due to the Public Health Consequences of Abuse ..........................................79 e. Endo Failed to Report Suspicious Sales as Required ....................80 4. Cephalon ....................................................................................................81 a. Cephalon Falsely and Aggressively Marketed Cancer Drug Actiq to Non-Cancer Treating Physicians .....................................83 b. Government Investigations Found Cephalon Falsely Marketed Actiq for Off-Label Uses ...............................................85 c. Cephalon Falsely and Aggressively Marketed Cancer Drug Fentora to Non-Cancer Treating Physicians ..................................87 d. The FDA Warned Cephalon Regarding its False and Off- Label Marketing of Fentora ...........................................................88 e. Cephalon Funded False Publications and Presentations ................89 f. Cephalon Failed to Report Suspicious Sales as Required .............98 5. Insys ...........................................................................................................99 a. The Indictment of Insys Executives and Arrest of Its Founder ........................................................................................101 - ii - Case 9:17-cv-81384-XXXX Document 1 Entered on FLSD Docket 12/21/2017 Page 4 of 148 Page b. Insys Targeted Non-Cancer Treating Physicians and Funded False Publications and Presentations ..............................103 c. Insys Failed to Report Suspicious Sales as Required ..................106 6. Mallinckrodt .............................................................................................107 a. Mallinckrodt Funded False Publications and Presentations ........109 b. The DEA Investigates Suspicious Orders ....................................111 c. Mallinckrodt Failed to Report Suspicious Sales as Required ......114 C. The Wholesaler Defendants Failed to Track and Report Suspicious Sales as Required by Florida and Federal Law .............................................................115 1. McKesson ................................................................................................117 2. Cardinal Health ........................................................................................120 3. AmerisourceBergen .................................................................................122 FIRST CAUSE OF ACTION ......................................................................................................124 SECOND CAUSE OF ACTION .................................................................................................125 THIRD CAUSE OF ACTION .....................................................................................................127 FOURTH CAUSE OF ACTION .................................................................................................129 FIFTH CAUSE OF ACTION ......................................................................................................130 PRAYER FOR RELIEF ..............................................................................................................142 JURY DEMAND .........................................................................................................................142 - iii - Case 9:17-cv-81384-XXXX Document 1 Entered on FLSD Docket 12/21/2017 Page 5 of 148 I. INTRODUCTION 1. Florida, like many states across the country, is facing an unprecedented opioid addiction epidemic. Florida healthcare providers wrote 67.1 prescriptions for opioid medications per 100 people in 2015 and 66.6 per 100 people in 2016. Of the 33,000 people who died nationwide of opioid overdoses in 2015, approximately 12% were Floridians. On May 4, 2017, Governor Rick Scott officially declared the opioid epidemic a public health emergency in Florida, stating, “The individuals struggling with drug use are sons, daughters, mothers, fathers, sisters, brothers and friends and each tragic case leaves loved ones searching for answers and praying for help. Families across our nation are fighting the opioid epidemic, and Florida is going to do everything possible to help our communities.”1 2. In 2014, more than 47,000 people died in the United States from lethal drug overdoses. In 2015, that number exceeded 52,000,2 more deaths than caused by car crashes and gun homicides combined. In 2016, the number had grown to more than 64,000 – more than the number of U.S. soldiers who died during the entirety of the Vietnam War.3 Sadly, this trend shows no sign of slowing. More than three out of five of these deaths involve opioids – a dangerous, highly addictive and often lethal class of natural, synthetic and semi-synthetic painkillers. Nearly half of 1 Michael Auslen, Gov. Scott declares public health emergency over opioid crisis, Miami Herald (May 3, 2017), http://www.miamiherald.com/news/health-care/article148355444.html. 2 Rose A. Rudd, et al., Increases in Drug and Opioid-Involved Overdose Deaths – United States, 2010-2015, 65 Morbidity & Mortality Weekly Report 1445-52 (2016), https://www.cdc.gov/mmwr/volumes/65/ wr/mm655051e1.htm (hereinafter “Rudd, Increases in Drug and Opioid-Involved Overdose”).
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