Margaret H. Olson (Bar No. 6296) SUMMIT COUNTY ATTORNEY [email protected] 60 North Main Street Coalville, Utah 84017 (435)336-3206 Colin P. King (Bar No. 1815) Michael A. Worel (Bar No. 12741) [email protected] [email protected] DEWSNUP KING OLSEN WOREL HAVAS MORTENSEN 36 South State Street, Suite 2400 Salt Lake City, Utah 84111-0024 Telephone: (801) 533-0400 Donald J. Winder (Bar No. 3519) Edgar R. Cataxinos (Bar No. 7162) James E. Magleby (Bar No. 7247) Matthew B. McCune (Bar No. 15895) [email protected] [email protected] MAGLEBY CATAXINOS & GREENWOOD 170 South Main Street, Ste 1100 Salt Lake City, Utah 84101 Telephone: (801)359-9000 Attorneys for Plaintiff Summit County IN THE THIRD DISTRICT COURT OF THE DISTRICT OF THE STATE OF UTAH, IN AND FOR THE COUNTY OF SUMMIT, SILVER SUMMIT DIVISION SUMMIT COUNTY UTAH ) Coalville, UT ) Plaintiff, ) v. ) ) CASE NO.: 180500119 PURDUE PHARMA L.P. ) c/o The Prentice Hall Corporation ) 2711 Centerville Road ) Wilmington, DE 19808 ) ) and ) COMPLAINT FOR DAMAGES ) PURDUE PHARMA INC. ) (JURY DEMAND) c/o The Prentice Hall Corporation ) 2711 Centerville Road ) TIER 3 Wilmington, DE 19808 ) ) Judge: Kent Holmberg and ) ) THE PURDUE FREDERICK COMPANY, INC. ) c/o The Prentice Hall Corporation ) 2711 Centerville Road ) Wilmington, DE 19808 ) ) and ) ) TEVA PHARMACEUTICALS USA, INC. ) c/o Corporate Creations Network Inc. ) 3411 Silverside Road ) Wilmington, DE 19180 ) ) and ) ) CEPHALON, INC. ) c/o Corporate Creations Network Inc. ) 3411 Silverside Road ) Wilmington, DE 19180 ) ) and ) ) JOHNSON & JOHNSON ) One Johnson & Johnson Plaza ) New Brunswick, NJ 08933 ) ) and ) ) JANSSEN PHARMACEUTICALS, INC. ) 116 Pine Street, Suite 320 ) Harrisburg, PA 17101 ) ) and ) ) ORTHO-MCNEIL-JANSSEN ) PHARMACEUTICALS, INC. N/K/A JANSSEN ) PHARMACEUTICALS, INC. ) 116 Pine Street, Suite 320 ) Harrisburg, PA 17101 ) ) and ) ) JANSSEN PHARMACEUTICA, INC. N/K/A ) JANSSEN PHARMACEUTICALS, INC. ) 116 Pine Street, Suite 320 ) Harrisburg, PA 17101 ) ) and ) ) ENDO PHARMACEUTICALS, INC. ) c/o The Corporation Trust Co. ) 1209 Orange Street ) Wilmington, DE 19801 ) ) and ) ) ALLERGAN PLC F/K/A ACTAVIS PLC ) CT Corporation System ) 4400 Easton Commons Way, Suite 125 ) Columbus, OH 43215 ) ) and ) ) ACTAVIS, INC. F/K/A WATSON ) PHARMACEUTICALS, INC. ) Corporate Creations Network, Inc. ) 119 E. Court Street ) Cincinnati, OH 45202 ) ) and ) ) ) WATSON LABORATORIES, INC. ) Corporate Creations Network Inc. ) 119 E. Court Street ) Cincinnati, OH 45202 ) ) and ) ) ACTAVIS LLC ) Corporate Creations Network Inc. ) 119 E. Court Street ) Cincinnati, OH 45202 ) ) and ) ) ACTAVIS PHARMA, INC. F/K/A WATSON ) PHARMA, INC. ) Corporate Creations Network Inc. ) 119 E. Court Street ) Cincinnati, OH 45202 ) ) and ) ) ENDO HEALTH SOLUTIONS INC. ) c/o The Corporation Trust Co. ) 1209 Orange Street ) Wilmington, DE 19801 ) ) and ) ) INSYS THERAPEUTICS, INC. ) 1333 S. Spectrum Blvd. #100 ) Chandler, AZ 85286 ) ) and ) ) MALLINCKRODT LLC ) c/o The Corporation trust Company ) Corporation Trust Center ) 1209 Orange Street ) Wilmington, DE 19801 ) ) and ) ) ) ) MCKESSON CORPORATION ) Mckesson Corporation ) One Post Street ) San Francisco, CA 94901 ) and ) ) CARDINAL HEALTH, INC. ) 7000 Cardinal Place ) Dublin, Ohio 43017 ) and ) ) AMERISOURCEBERGEN CORPORATION ) AmerisourceBergen Corporation ) 1300 Morris Dr. ) Chesterbrook, PA 19087 ) ) and ) ) RUSSELL PORTENOY ) 39 Broadway, 1st Floor ) New York, NY 10006 ) ) and ) ) PERRY FINE ) 615 Arapeen Way, Suite 155 ) Salt Lake County, UT 84132 ) ) and ) ) SCOTT FISHMAN ) 2221 Stockton Blvd. ) Sacramento, CA 95817 ) ) and ) ) LYNN WEBSTER ) PRA Health Sciences 3838 S 700 E #202 Salt Lake County, UT 84106 Defendants. INTRODUCTION ................................................................................................................... 1 PARTIES ................................................................................................................................. 13 A. Plaintiff. .................................................................................................................................. 13 B. Defendants. ............................................................................................................................ 14 FACTS RELEVANT TO ALL CAUSES OF ACTION ......................................................... 24 A. Background on Pain Medicine. ............................................................................................ 24 1. Safe & Effective Treatment of Chronic Pain Centers on Informed Risk Management. 25 2. Opioid Use Is Associated with Known and Substantial Risks. .............................................. 25 3. Long-Term Opioid Use Benefits Are Unproven and Contradicted. ..................................... 31 4. Defendants’ Impact on the Perception and Prescribing of Opioids. ................................... 34 B. Defendants Promoted Their Branded Products Through Direct Marketing to Prescribers and Consumers. ................................................................................................. 36 1. Defendants Relied Upon Branded Advertisements. .................................................................. 36 2. Defendants Relied Upon Their Sales Forces and Recruited Physician Speakers. ........... 37 3. Defendants Directed These Promotional Efforts Through Detailed Marketing Plans. 41 a. Targeting categories of prescribers ........................................................................................................ 41 b. Increasing “direct to consumer” marketing ........................................................................................... 42 c. Differentiating each brand..................................................................................................................... 42 d. Moving beyond office visits .................................................................................................................. 43 4. Defendants Marketed Opioids in Summit County Using the Same Strategies and Messages They Employed Nationwide. ....................................................................................... 43 C. Defendants Used “Unbranded” Marketing to Evade Regulations and Consumer Protection Laws. .................................................................................................................... 44 1. Regulations Governing Branded Promotion Require that it Be Truthful, Balanced, and Supported by Substantial Evidence. ...................................................................................... 46 2. Defendants Deployed Front Groups and Doctors to Disseminate Unbranded Information on Their Behalf. ........................................................................................................... 48 a. Defendants’ Use of KOLs .................................................................................................................... 51 i. Defendant Russell Portenoy .................................................................................................................... 53 ii. Defendant Lynn Webster ....................................................................................................................... 54 b. “Research” That Lacked Supporting Evidence ...................................................................................... 55 c. Treatment Guidelines ............................................................................................................................ 58 i. FSMB ............................................................................................................................................... 58 ii. AAPM/APS Guidelines ..................................................................................................................... 60 iii. American Geriatrics Society ................................................................................................................... 61 iv. Guidelines That Did Not Receive Defendants’ Support ............................................................................... 63 d. Continuing Medical Education .............................................................................................................. 64 e. Unbranded Patient Education ............................................................................................................... 66 f. Defendants’ Use of Front Groups ......................................................................................................... 67 i. American Pain Foundation ......................................................................................................................... 67 ii. The American Academy of Pain Medicine ................................................................................................... 70 i 3. Defendants Acted in Concert with KOLs and Front Groups in the Creation, Promotion, and Control of Unbranded Marketing. ................................................................... 71 4. Defendants Targeted Vulnerable and Lucrative Populations. ............................................... 73 a. The Elderly ........................................................................................................................................... 73 b. Veterans ................................................................................................................................................ 73 D. Why Defendants’ Marketing Messages Are Misleading and Unfair ................................