Case: 1:14-cv-04361 Document #: 76 Filed: 07/17/14 Page 1 of 126 PageID #:1233 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS COUNTY DEPARTMENT, LAW DIVISION CITY OF CHICAGO, a municipal corporation, Plaintiff, v. PURDUE PHARMA L.P.; PURDUE INC.; THE Case No.: PURDUE FREDERICK COMPANY, INC.; JURY TRIAL DEMANDED TEVA PHARMACEUTICAL INDUSTRIES, LTD.; CEPHALON, INC.; JOHNSON & JOHNSON; JANSSEN PHARMACEUTICALS, INC.; ENDO HEALTH SOLUTIONS INC.; and ACTAVIS PLC, Defendants. COMPLAINT Plaintiff City of Chicago, by its attorney, Stephen R. Patton, Corporation Counsel of the City of Chicago, for its Complaint against Defendants Purdue Pharma L.P., Purdue Inc., the Purdue Frederick Company, Inc., Teva Pharmaceutical Industries, Ltd., Cephalon, Inc., Johnson & Johnson, Janssen Pharmaceuticals, Inc., Endo Health Solutions Inc., and Actavis plc (collectively, “Defendants”), alleges as follows: TABLE OF CONTENTS Page I. INTRODUCTION ...............................................................................................................1 II. PARTIES .............................................................................................................................9 A. Plaintiff ....................................................................................................................9 B. Defendants ...............................................................................................................9 III. JURISDICTION AND VENUE ........................................................................................11 - i - Case: 1:14-cv-04361 Document #: 76 Filed: 07/17/14 Page 2 of 126 PageID #:1234 IV. JURY DEMAND ...............................................................................................................11 V. FACTUAL ALLEGATIONS ............................................................................................12 A. Before Defendants’ Deceptive Marketing Campaign, Opioids Were Rarely Prescribed by Physicians Because of Their Known Serious Side Effects and Substantial Risk of Addiction .........................................................................12 B. Defendants Are Obligated to Ensure that their Marketing is Truthful, Complete, and Balanced ........................................................................................13 C. Defendants’ Marketing of Opioids for Long-Term Use to Treat Chronic Non-Cancer Pain was False, Misleading, Imbalanced, and Unsupported by Science ...................................................................................................................15 1. Defendants’ misrepresentations regarding the benefits of opioids for chronic non-cancer pain. ......................................................................16 2. Defendants’ misrepresentations regarding the adverse outcomes and risks of opioids. ...................................................................................22 a. Risk of addiction and abuse. ..........................................................22 (1) Minimizing the risk of addiction. .......................................23 (2) Claiming the risk of addiction can be identified and managed. ............................................................................27 (3) Deflecting attention to “undertreated” pain. ......................29 (4) Physical dependence vs. addiction. ....................................31 (5) Pseudoaddiction. ................................................................33 (1) Other adverse effects. .........................................................37 3. Misrepresentations regarding superiority. .................................................42 D. Defendants, Directly and Through Their Agents and Front Organizations, Made and Caused Their Misrepresentations to Be Made and Broadly Disseminated ..........................................................................................................44 1. Method 1: Key opinion leaders (“KOLs”) .................................................44 2. Method 2: Co-opting of chronic pain advocacy and research groups to promote opioid use. ....................................................................48 a. American Pain Foundation. ...........................................................49 b. American Academy of Pain Medicine. ..........................................51 3. Method 3: Treatment guidelines. ...............................................................53 4. Method 4: Continuing medical education. ................................................56 5. Method 5: Scientific articles. ....................................................................59 6. Method 6: Patient education. ....................................................................61 - ii - Case: 1:14-cv-04361 Document #: 76 Filed: 07/17/14 Page 3 of 126 PageID #:1235 a. Elderly patients ..............................................................................62 b. Veterans .........................................................................................63 E. Defendants Often Acted Together in Promoting Opioids, Opposing Regulation and Facilitating Supportive Standards to Approve Opioids ................66 F. Defendants Also Acted Individually to Deceptively Promote Their Opioids for Chronic Non-Cancer Pain. ..................................................................68 1. Cephalon fraudulently marketed Actiq and Fentora. .................................69 a. Cephalon launches its fraudulent marketing scheme of Actiq. ..............................................................................................69 b. Cephalon fraudulently marketed Actiq’s successor drug, Fentora. ..........................................................................................70 c. October 1, 2006 – Cephalon launches Fentora and immediately begins deceptive marketing campaign. .....................72 d. September 2007 – Reports of death and serious side effects lead the FDA to issue a public health warning for Fentora. ..........73 e. Cephalon sponsored CMEs used to promote the off-label use of Actiq and Fentora – 2007-2008, in spite of the FDA warnings. ........................................................................................74 f. May 6, 2008 – The FDA rejects Cephalon’s request for expanded approval of Fentora. .......................................................75 g. March 26, 2009 – the FDA’s Division of Drug Marketing, Advertising and Communications (“DDMAC”) warned Cephalon about its misleading advertising of Fentora. ..................76 h. Cephalon continues to knowingly, deceptively, and illegally promote Fentora for off-label uses. ..................................77 2. Purdue’s role in deceptively promoting opioids for treatment of chronic non-cancer pain. ............................................................................78 a. Purdue’s marketing of OxyContin was deceptive from the start. ................................................................................................78 b. Purdue continued to engage in false marketing, misrepresenting OxyContin’s benefits and the risk of addiction when taken long-term for chronic non-cancer pain. ................................................................................................81 c. Purdue was aware of, and has profited from, misuse and diversion of its opioids. ..................................................................82 G. Defendants Knew That Their Marketing of Chronic Opioid Therapy Was False, Unfounded and Dangerous, and Would Harm Chicago Residents. ............84 H. Defendants Fraudulently Concealed their Misrepresentations ..............................85 - iii - Case: 1:14-cv-04361 Document #: 76 Filed: 07/17/14 Page 4 of 126 PageID #:1236 I. Defendants’ Fraudulent and Deceptive Marketing of Opioids Directly Caused Harm to the City of Chicago and Chicago Consumers. ............................86 J. Defendants’ Fraudulent and Deceptive Marketing of Opioids Caused False Claims for Payment to Be Submitted to the City ...................................................92 K. Defendants’ Fraudulent and Deceptive Marketing of Opioids Has Caused the City to Incur Related Costs ..............................................................................95 VI. COUNT ONE: CONSUMER FRAUD VIOLATIONS OF CHICAGO MUNICIPAL CODE § 2-25-090 .......................................................................................96 VII. COUNT TWO: MISREPRESENTATIONS IN CONNECTION WITH SALE OR ADVERTISEMENT OF MERCHANDISE VIOLATIONS OF CHICAGO MUNICIPAL CODE § 4-276-470 ...................................................................................103 VIII. COUNT THREE: FALSE STATEMENTS TO THE CITY VIOLATIONS OF CHICAGO MUNICIPAL CODE § 1-21-010, ET SEQ. ...............................................105 IX. COUNT FOUR: FALSE CLAIMS VIOLATIONS OF CHICAGO MUNICIPAL CODE § 1-22-020 ............................................................................................................108 X. COUNT FIVE: CONSPIRACY TO DEFRAUD BY GETTING FALSE OR FRAUDULENT CLAIMS PAID OR APPROVED BY THE CITY VIOLATIONS OF CHICAGO MUNICIPAL CODE § 1-22-020 ..................................111 XI. COUNT SIX: RECOVERY OF CITY COSTS OF PROVIDING SERVICES VIOLATIONS OF THE CHICAGO MUNICIPAL CODE § 1-20-020 .........................114 XII. COUNT SEVEN: INSURANCE FRAUD VIOLATIONS OF 720 ILCS 5/17- 10.5...................................................................................................................................115