2:17-cv-13334-JCO-EAS Doc # 1 Filed 10/12/17 Pg 1 of 193 Pg ID 1 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN COUNTY OF WAYNE and COUNTY ) Civ. No. OF OAKLAND, ) ) COMPLAINT FOR (1) VIOLATION Plaintiffs, ) OF MICHIGAN CONSUMER ) PROTECTION ACT; (2) PUBLIC vs. ) NUISANCE; (3) NEGLIGENCE; (4) UNJUST ENRICHMENT; AND (5) PURDUE PHARMA L.P., ) VIOLATION OF THE RACKETEER CEPHALON, INC., TEVA ) INFLUENCED AND CORRUPT PHARMACEUTICAL INDUSTRIES ) ORGANIZATION ACT LTD., TEVA PHARMACEUTICALS ) USA, INC., ENDO INTERNATIONAL ) PLC, JANSSEN ) PHARMACEUTICALS, INC., INSYS ) THERAPEUTICS, INC., ) DEMAND FOR JURY TRIAL MALLINCKRODT PLC, ) MALLINCKRODT ) PHARMACEUTICALS, ) AMERISOURCEBERGEN ) CORPORATION, CARDINAL ) HEALTH, INC. and McKESSON ) CORPORATION, ) ) Defendants. ) 2:17-cv-13334-JCO-EAS Doc # 1 Filed 10/12/17 Pg 2 of 193 Pg ID 2 TABLE OF CONTENTS Page I. INTRODUCTION ........................................................................................... 1 II. PARTIES ....................................................................................................... 14 III. JURISDICTION AND VENUE .................................................................... 17 IV. FACTUAL ALLEGATIONS ........................................................................ 17 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 ......................................... 17 1. Background on Opioid Overprescribing ................................... 18 2. The Fraudulent Sales Practices ................................................. 24 a. The Manufacturing Defendants Funded Front Organizations that Published and Disseminated False and Misleading Marketing Materials .................... 24 b. The Manufacturing Defendants Paid Key Opinion Leaders and Sponsored Speakers’ Bureaus to Disseminate False and Misleading Messaging ............... 44 c. Senate Investigations of the Manufacturing Defendants ...................................................................... 48 3. The Devastating Impact ............................................................ 55 B. The Manufacturing Defendants’ Specific Unlawful Practices that Targeted Wayne County and Oakland County Prescribers ......... 58 1. Purdue ....................................................................................... 58 a. Purdue Falsely Marketed Extended-Release Drugs as Safer and More Effective than Regular-Release Drugs ............................................................................... 60 - i - 2:17-cv-13334-JCO-EAS Doc # 1 Filed 10/12/17 Pg 3 of 193 Pg ID 3 Page b. Purdue Falsely Marketed Low Addiction Risk to Wide Swaths of Physicians ............................................. 63 c. Purdue Funded Publications and Presentations with False and Misleading Messaging ........................... 66 d. The Guilty Pleas ............................................................. 68 e. Purdue Failed to Report Suspicious Sales as Required .......................................................................... 72 2. Janssen....................................................................................... 73 a. The FDA Warned Janssen Regarding Its False Messaging ....................................................................... 75 b. Janssen Funded False Publications and Presentations ................................................................... 81 c. Janssen Failed to Report Suspicious Sales as Required .......................................................................... 86 3. Endo .......................................................................................... 88 a. Endo Falsely Marketed Opana ER as Crush Resistant .......................................................................... 90 b. New York’s Investigation Found Endo Falsely Marketed Opana ER ....................................................... 93 c. Endo Funded False Publications and Presentations ....... 97 d. FDA Requests Endo Withdraw Opana ER Due to the Public Health Consequences of Abuse ................... 103 e. Endo Failed to Report Suspicious Sales as Required ........................................................................ 104 4. Cephalon ................................................................................. 105 - ii - 2:17-cv-13334-JCO-EAS Doc # 1 Filed 10/12/17 Pg 4 of 193 Pg ID 4 Page a. Cephalon Aggressively Marketed Cancer Drug to Non-Cancer Treating Physicians .................................. 108 b. Government Investigations Found Cephalon Falsely Marketed Actiq for Off-Label Uses ................. 110 c. Cephalon Focused on Non-Cancer Treating Physicians in Falsely Marketing Fentora ..................... 112 d. The FDA Warned Cephalon Regarding its False and Off-Label Marketing of Fentora ............................ 114 e. Cephalon Funded False Publications and Presentations ................................................................. 116 f. Cephalon Failed to Report Suspicious Sales as Required ........................................................................ 128 5. Insys ........................................................................................ 129 a. The Indictment of Insys Executives ............................. 132 b. Insys Targeted Non-Cancer Treating Physicians and Funded False Publications and Presentations ........ 134 c. Insys Failed to Report Suspicious Sales as Required ........................................................................ 139 6. Mallinckrodt ............................................................................ 140 a. Mallinckrodt Funded False Publications and Presentations ................................................................. 142 b. The DEA Investigates Suspicious Orders .................... 146 c. Mallinckrodt Failed to Report Suspicious Sales as Required ........................................................................ 150 - iii - 2:17-cv-13334-JCO-EAS Doc # 1 Filed 10/12/17 Pg 5 of 193 Pg ID 5 Page C. The Wholesaler Defendants Failed to Track and Report Suspicious Sales as Required by Michigan and Federal Law ........... 151 1. McKesson ................................................................................ 152 2. Cardinal Health ....................................................................... 155 3. AmerisourceBergen ................................................................ 158 FIRST CAUSE OF ACTION ................................................................................ 161 SECOND CAUSE OF ACTION ........................................................................... 163 THIRD CAUSE OF ACTION ............................................................................... 165 FOURTH CAUSE OF ACTION ........................................................................... 167 FIFTH CAUSE OF ACTION ................................................................................ 169 PRAYER FOR RELIEF ........................................................................................ 185 JURY DEMAND ................................................................................................... 186 - iv - 2:17-cv-13334-JCO-EAS Doc # 1 Filed 10/12/17 Pg 6 of 193 Pg ID 6 I. INTRODUCTION 1. Michigan, like many states across the country, is facing an unprecedented opioid addiction epidemic. Michigan healthcare providers wrote 11 million prescriptions for opioid drugs in 2015 and another 11 million in 2016 – more annual opioid prescriptions than Michigan has people. On June 18, 2015, Governor Rick Snyder appointed a task force to address the prescription opioid, heroin and fentanyl crisis and appointed Lieutenant Governor Brian Calley to lead the effort. On October 26, 2015, the task force issued a comprehensive report of their findings and issued more than two dozen recommendations to address the growing problem. On receiving the report, Governor Snyder stated: “‘The impact of prescription drug and opioid abuse is being felt in every community across Michigan. It crosses all demographic, geographic and political lines . .”1 On June 23, 2016, Governor Snyder issued an executive order creating an advisory commission to review the Report of Findings and 1 Ex. 1 (Press Release, Office of Governor Rick Snyder, Prescription Drug and Opioid Abuse Task Force releases findings and recommendations (Oct. 26, 2015), http://www.michigan.gov/snyder/0,4668,7-277--367961--,00.html). All exhibits referenced herein are attached hereto unless otherwise stated. - 1 - 2:17-cv-13334-JCO-EAS Doc # 1 Filed 10/12/17 Pg 7 of 193 Pg ID 7 Recommendations for Action from the Michigan Prescription Drug and Abuse Task Force and develop policies to implement the report’s recommendations.2 2. In 2014, more than 47,000 people died in the United States from lethal drug overdoses. In 2015, that number exceeded 52,000,3 more deaths than caused by car crashes and gun homicides combined. Sadly, this trend shows no sign of slowing.4 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 those involve legal opioids prescribed by doctors to treat pain. These prescription opioids have included brand-name medications like OxyContin, Opana, Subsys, Fentora and Duragesic, as well as generics like oxycodone, methadone and fentanyl.