`
`UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF IOWA
`CENTRAL DIVISION
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`Case No.: _______________
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`COMPLAINT
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`DEMAND FOR JURY TRIAL
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`
`
`This Complaint Relates to In Re National
`Prescription Opiate Litigation, MDL No. 2804
`
`Case No. 17-md-2804
`
`Judge Dan Aaron Polster
`N.D. Ohio (Eastern Division)
`
`
`
`APPANOOSE COUNTY, CERRO GORDO
`COUNTY, CHEROKEE COUNTY,
`CHICKASAW COUNTY, EMMET COUNTY,
`FREMONT COUNTY, HANCOCK COUNTY,
`HENRY COUNTY, IDA COUNTY, JONES
`COUNTY, KEOKUK COUNTY, MADISON
`COUNTY, MUSCATINE COUNTY, OSCEOLA
`COUNTY, POCAHONTAS COUNTY,
`POWESHIEK COUNTY, WEBSTER COUNTY,
`WINNEBAGO COUNTY, and WRIGHT
`COUNTY,
`
`
`Plaintiffs,
`
`vs.
`
`ALLERGAN PLC f/k/a ACTAVIS PLC,
`ALLERGAN FINANCE LLC f/k/a ACTAVIS,
`INC. f/k/a WATSON PHARMACEUTICALS,
`INC., ALLERGAN SALES, LLC, ALLERGAN
`USA, INC., WATSON LABORATORIES, INC.,
`WARNER CHILCOTT COMPANY, LLC,
`ACTAVIS PHARMA, INC. f/k/a WATSON
`PHARMA, INC., ACTAVIS SOUTH
`ATHLANTIC LLC, ACTAVIS ELIZABETH
`LLC, ACTAVIS MID ATLANTIC LLC,
`ACTAVIS TOTOWA LLC, ACTAVIS LLC,
`ACTAVIS KADIAN LLC, ACTAVIS
`LABORATORIES UT, INC. f/k/a WATSON
`LABORATORIES, INC.-SALT LAKE CITY,
`ACTAVIS LABORATORIES FL, INC. f/k/a
`WATSON LABORATORIES, INC.-FLORIDA,
`TEVA PHARMACEUTICALS USA, INC.,
`TEVA PHARMACEUTICAL INDUSTRIES
`LTD., CEPHALON, INC., JOHNSON &
`JOHNSON, JANSSEN PHARMACEUTICALS,
`INC., NORAMCO, INC., ORTHO-MCNEIL-
`JANSSEN PHARMACEUTICALS, INC.,
`JANSSEN PHARMACEUTICA, INC., ENDO
`HEALTH SOLUTIONS INC., ENDO
`
`
`
`
`
`Case 4:21-cv-00095-JAJ-CFB Document 1 Filed 03/24/21 Page 2 of 411
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`PHARMACEUTICALS, INC., PAR
`PHARMACEUTICAL, INC., PAR
`PHARMACEUTICAL COMPANIES, INC. f/k/a
`PAR PHARMACEUTICAL HOLDINGS, INC.,
`ENDO INTERNATIONAL PLC, CARDINAL
`HEALTH, INC., McKESSON CORPORATION,
`AMERISOURCEBERGEN CORPORATION,
`ANDA, INC., CVS HEALTH CORPORATION;
`CVS INDIANA L.L.C.; CVS RX SERVICES,
`INC.; CVS TN DISTRIBUTION, LLC; CVS
`PHARMACY, INC.; OMNICARE
`DISTRIBUTION CENTER LLC; OHIO CVS
`STORES, LLC; WALGREEN CO.;
`WALGREENS BOOTS ALLIANCE, INC.;
`WALGREEN EASTERN CO., INC.; THE
`KROGER CO.; RITE AID CORP.; RITE AID
`HDQTRS. CORP.; ECKERD CORPORATION
`D/B/A RITE AID LIVERPOOL DISTRIBUTION
`CENTER; RITE AID OF OHIO, INC.; RITE AID
`OF MARYLAND, INC.; WALMART INC.
`F/K/A WAL-MART STORES, INC.; WAL-
`MART STORES EAST, LP; WSE
`MANAGEMENT, LLC; WSE INVESTMENT
`LLC; WAL- MART STORES EAST, INC.; KVK
`TECH, INC.; MYLAN PHARMACEUTICALS,
`INC.; SANDOZ, INC.; WEST-WARD
`PHARMACEUTICALS CORP.; SUPERVALU,
`INC. D/B/A ADVANTAGE LOGISTICS;
`DAKOTA DRUG, INC.; HY-VEE, INC.;
`PHARMACY BUYING ASSOCIATION, INC.;
`and SAJ DISTRIBUTORS,
`
`Defendants.
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`
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`
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`Case 4:21-cv-00095-JAJ-CFB Document 1 Filed 03/24/21 Page 3 of 411
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`TABLE OF CONTENTS
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`Page
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`B.
`
`
`INTRODUCTION ......................................................................................................................... 3
`JURISDICTION AND VENUE .................................................................................................... 9
`PARTIES ....................................................................................................................................... 9
`I.
`PLAINTIFFS ..................................................................................................................... 9
`II.
`DEFENDANTS ............................................................................................................... 11
`A.
`Marketing Defendants. ......................................................................................... 11
`1.
`Actavis Entities ........................................................................................ 11
`2.
`Cephalon Entities ..................................................................................... 17
`3.
`Janssen Entities ........................................................................................ 18
`4.
`Endo Entities ............................................................................................ 20
`5.
`Allegations Against Additional Manufacturing Defendants .................... 22
`Distributor & Dispenser Defendants .................................................................... 25
`1.
`Cardinal Health, Inc. ................................................................................ 26
`2.
`McKesson Corporation ............................................................................ 26
`3.
`AmerisourceBergen Drug Corporation .................................................... 27
`4.
`Anda, Inc. ................................................................................................. 27
`5.
`CVS .......................................................................................................... 27
`6.
`Walgreens ................................................................................................ 28
`7.
`Rite-Aid.................................................................................................... 30
`8.
`Walmart.................................................................................................... 32
`9.
`The Kroger Co. ........................................................................................ 32
`10.
`H.D. Smith ............................................................................................... 33
`11.
`Allegations Against Additional Distributor Defendants .......................... 33
`Agency and Authority .......................................................................................... 36
`C.
`FACTUAL ALLEGATIONS ...................................................................................................... 37
`I.
`Facts Common to All Claims ........................................................................................... 37
`A.
`Opioids and Their Effects .................................................................................... 37
`B.
`The Resurgence of Opioid Use in the United States ............................................ 41
`1.
`The Sackler Family Integrated Advertising and Medicine ...................... 41
`2.
`Purdue and the Development of OxyContin ............................................ 43
`
`
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`-i-
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`Case 4:21-cv-00095-JAJ-CFB Document 1 Filed 03/24/21 Page 4 of 411
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`TABLE OF CONTENTS
`(continued)
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`Page
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`C.
`D.
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`
`
`ii.
`iii.
`
`iv.
`
`v.
`
`3.
`Other Marketing Defendants Leapt at the Opioid Opportunity ............... 47
`Defendants’ Conduct Created an Abatable Public Nuisance ............................... 50
`The Marketing Defendants’ Multi-Pronged Scheme to Change Prescriber
`Habits and Public Perception and Increase Demand for Opioids ........................ 51
`The Marketing Defendants Promoted Multiple Falsehoods About
`1.
`Opioids ..................................................................................................... 52
`Falsehood #1: The risk of addiction from chronic opioid
`a.
`therapy is low ............................................................................... 53
`Purdue’s misrepresentations regarding addiction
`i.
`risk.................................................................................... 54
`Endo’s misrepresentations regarding addiction risk ........ 59
`Janssen’s misrepresentations regarding addiction
`risk.................................................................................... 61
`Cephalon’s misrepresentations regarding addiction
`risk.................................................................................... 62
`Actavis’s misrepresentations regarding addiction
`risk.................................................................................... 63
`vi. Mallinckrodt’s misrepresentations regarding
`addiction risk .................................................................... 63
`Falsehood #2: To the extent there is a risk of addiction, it
`can be easily identified and managed .......................................... 65
`Falsehood #3: Signs of addictive behavior are
`“pseudoaddiction,” requiring more opioids ................................. 67
`Falsehood #4: Opioid withdrawal can be avoided by
`tapering ........................................................................................ 70
`Falsehood #5: Opioid doses can be increased without limit
`or greater risks.............................................................................. 71
`Falsehood #6: Long-term opioid use improves functioning ........ 73
`Falsehood #7: Alternative forms of pain relief pose greater
`risks than opioids ......................................................................... 78
`Falsehood #8: OxyContin provides twelve hours of pain
`relief ............................................................................................. 82
`Falsehood #9: New formulations of certain opioids
`successfully deter abuse ............................................................... 87
`
`b.
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`c.
`
`d.
`
`e.
`
`f.
`g.
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`h.
`
`i.
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`-ii-
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`TABLE OF CONTENTS
`(continued)
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`Page
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`2.
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`
`
`i.
`
`ii.
`
`iii.
`
`b.
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`Purdue’s deceptive marketing of reformulated
`OxyContin and Hysingla ER ........................................... 88
`Endo’s deceptive marketing of reformulated Opana
`ER .................................................................................... 91
`Other Marketing Defendants’ misrepresentations
`regarding abuse deterrence .............................................. 96
`The Marketing Defendants Disseminated Their Misleading
`Messages About Opioids Through Multiple Channels ............................ 97
`The Marketing Defendants Directed Front Groups to
`a.
`Deceptively Promote Opioid Use ................................................ 98
`i.
`American Pain Foundation ............................................ 100
`ii.
`American Academy of Pain Medicine and the
`American Pain Society ................................................... 103
`FSMB ............................................................................. 106
`iii.
`The Alliance for Patient Access ..................................... 107
`iv.
`The U.S. Pain Foundation (“USPF”) ............................. 111
`v.
`American Geriatrics Society (“AGS”) ........................... 112
`vi.
`The Marketing Defendants Paid Key Opinion Leaders to
`Deceptively Promote Opioid Use .............................................. 113
`i.
`Dr. Russell Portenoy ...................................................... 115
`ii.
`Dr. Lynn Webster........................................................... 118
`iii.
`Dr. Perry Fine................................................................. 120
`iv.
`Dr. Scott Fishman .......................................................... 123
`The Marketing Defendants Disseminated Their
`Misrepresentations Through Continuing Medical Education
`Programs .................................................................................... 124
`The Marketing Defendants Used “Branded” Advertising to
`Promote their Products to Doctors and Consumers ................... 127
`The Marketing Defendants Used “Unbranded” Advertising
`To Promote Opioid Use For Chronic Pain Without FDA
`Review ....................................................................................... 128
`The Marketing Defendants Funded, Edited And
`Distributed Publications That Supported Their
`Misrepresentations ..................................................................... 129
`
`c.
`
`d.
`
`e.
`
`f.
`
`-iii-
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`Case 4:21-cv-00095-JAJ-CFB Document 1 Filed 03/24/21 Page 6 of 411
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`TABLE OF CONTENTS
`(continued)
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`Page
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`E.
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`
`
`3.
`4.
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`5.
`
`g.
`
`h.
`
`b.
`
`The Marketing Defendants Used Detailing To Directly
`Disseminate Their Misrepresentations To Prescribers .............. 131
`Marketing Defendants Used Speakers’ Bureaus and
`Programs to Spread Their Deceptive Messages ......................... 135
`The Marketing Defendants Targeted Vulnerable Populations ............... 136
`Insys Employed Fraudulent, Illegal, and Misleading Marketing
`Schemes to Promote Subsys .................................................................. 138
`The Marketing Defendants’ Scheme Succeeded, Creating a Public
`Health Epidemic..................................................................................... 142
`The Marketing Defendants dramatically expanded opioid
`a.
`prescribing and use .................................................................... 142
`Marketing Defendants’ deception in expanding their market
`created and fueled the opioid epidemic ..................................... 145
`Defendants Throughout the Supply Chain Deliberately Disregarded Their
`Duties to Maintain Effective Controls and to Identify, Report, and Take
`Steps to Halt Suspicious Orders ......................................................................... 146
`All Defendants Have a Duty to Report Suspicious Orders and Not
`1.
`to Ship Those Orders Unless Due Diligence Disproves Their
`Suspicions .............................................................................................. 148
`Defendants Were Aware of and Have Acknowledged Their
`Obligations to Prevent Diversion and to Report and Take Steps to
`Halt Suspicious Orders .......................................................................... 153
`Defendants Worked Together to Inflate the Quotas of Opioids
`They Could Distribute............................................................................ 156
`Defendants Kept Careful Track of Prescribing Data and Knew
`About Suspicious Orders and Prescribers .............................................. 165
`Defendants Failed to Report Suspicious Orders or Otherwise Act
`to Prevent Diversion .............................................................................. 172
`Defendants Delayed a Response to the Opioid Crisis by Pretending
`to Cooperate with Law Enforcement ..................................................... 175
`The Chain Pharmacies Were on Notice of and Contributed to
`Illegal Diversion of Prescription Opioids .............................................. 180
`a.
`The Chain Pharmacies Have a Duty to Prevent Diversion ........ 183
`b.
`Retail Pharmacies Were Aware of and Have
`Acknowledged Their Obligations to Prevent Diversion and
`to Report and Take Steps to Halt Suspicious Orders. ................ 190
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`-iv-
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`TABLE OF CONTENTS
`(continued)
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`Page
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`
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`F.
`G.
`
`H.
`
`c.
`
`d.
`
`e.
`
`Defendants Were Uniquely Positioned to Guard Against
`Diversion. ................................................................................... 201
`Defendants were Uniquely Positioned to Guard Against
`Diversion. ................................................................................... 203
`i.
`CVS ................................................................................ 204
`ii.
`Walgreens ...................................................................... 218
`iii.
`Rite Aid .......................................................................... 244
`iv. Walmart.......................................................................... 253
`Multiple Enforcement Actions against the Chain
`Pharmacies Confirms their Compliance Failures. ..................... 267
`i.
`CVS ................................................................................ 267
`ii.
`Walgreens ...................................................................... 272
`iii.
`Rite Aid .......................................................................... 275
`iv. Walmart.......................................................................... 278
`Defendants Performance Metrics Put Profits Before Safety. ..... 280
`Defendants Worked Together to Increase Their Profits and
`Lobbied Against Restrictions on Opioid Use and DEA
`Enforcement. .............................................................................. 288
`Defendants Also Entered Into Joint Ventures that Further
`Undermined their Outside Vendors Incentive to Conduct
`Due Diligence, While Increasing their Own Access to
`Information. ............................................................................... 292
`Defendants Worked With Opioid Manufacturers to
`Promote Opioids and Bolster Their Profits at the Expense
`of Communities Like these Counties. ........................................ 293
`Defendants Delayed a Response to the Opioid Crisis by
`Pretending to Cooperate with Law Enforcement. ...................... 300
`The Opioids the Defendants Sold Migrated into Other Jurisdictions ................ 305
`Iowa-Specific Facts ............................................................................................ 310
`1.
`Defendants Breached Their Duties in Iowa ........................................... 310
`2.
`The Devastating Effects of the Opioid Crisis in Iowa ........................... 311
`Facts Specific to Plaintiffs ................................................................................. 316
`1.
`The Opioid Epidemic Has Impacted Plaintiffs’ Communities .............. 317
`
`f.
`g.
`
`h.
`
`i.
`
`j.
`
`-v-
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`TABLE OF CONTENTS
`(continued)
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`Page
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`2.
`
`3.
`
`2.
`
`b.
`
`c.
`
`d.
`
`Defendants Actively Promoted Opioids in Plaintiffs Communities
`and Were Aware of the Excessive Prescribing Practices That
`Followed ................................................................................................ 318
`Plaintiffs’ Communities Have Borne and Will Continue to Bear
`Substantial Costs as a Direct Result of Defendants’ Misconduct .......... 319
`No Federal Agency Action, Including The FDA, Can Provide the Relief
`Sought Here ....................................................................................................... 320
`The Defendants Conspired To Engage In The Wrongful Conduct
`Complained Of Herein and Intended To Benefit Both Independently and
`Jointly From Their Conspiracy .......................................................................... 321
`1.
`Conspiracy Among Marketing Defendants ........................................... 321
`2.
`Conspiracy Among All Defendants ....................................................... 324
`Statutes Of Limitations Are Tolled and Defendants Are Estopped From
`Asserting Statutes Of Limitations As Defenses ................................................. 325
`1.
`Continuing Conduct. .............................................................................. 325
`2.
`Equitable Estoppel and Fraudulent Concealment .................................. 326
`Facts Pertaining to Punitive Damages ............................................................... 329
`The Marketing Defendants Persisted in Their Fraudulent Scheme
`1.
`Despite Repeated Admonitions, Warnings, and Even Prosecutions ...... 330
`FDA Warnings to Janssen Failed to Deter Janssen’s
`a.
`Misleading Promotion of Duragesic .......................................... 330
`Governmental Action, Including Large Monetary Fines,
`Failed to Stop Cephalon from Falsely Marketing Actiq for
`Off-Label Uses ........................................................................... 331
`FDA Warnings Did Not Prevent Cephalon from Continuing
`False and Off-Label Marketing of Fentora ................................ 332
`A Guilty Plea and a Large Fine Did Not Deter Purdue from
`Continuing Its Fraudulent Marketing of OxyContin ................. 333
`Repeated Admonishments and Fines Did Not Stop Defendants
`from Ignoring Their Obligations to Control the Supply Chain and
`Prevent Diversion................................................................................... 334
`Facts Pertaining To Claims Under Racketeer-Influenced and Corrupt
`Organizations (“RICO”) Act .......................................................................................... 340
`A.
`The Opioid Marketing Enterprise ...................................................................... 340
`
`I.
`
`J.
`
`K.
`
`L.
`
`
`
`II.
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`
`
`
`-vi-
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`TABLE OF CONTENTS
`(continued)
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`Page
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`
`
`1.
`
`The Common Purpose and Scheme of the Opioid Marketing
`Enterprise ............................................................................................... 340
`The Conduct of the Opioid Marketing Enterprise violated Civil
`RICO ...................................................................................................... 345
`The RICO Marketing Defendants Controlled and Paid Front
`Groups and KOLs to Promote and Maximize Opioid Use .................... 349
`Pattern of Racketeering Activity ............................................................ 350
`4.
`The Opioid Supply Chain Enterprise ................................................................. 353
`B.
`CLAIMS FOR RELIEF ............................................................................................................. 364
`FIRST CLAIM FOR RELIEF Violation of RICO, 18 U.S.C. § 1961 et seq. – Opioid
`Marketing Enterprise (Against All Marketing Defendants) .......................................... 364
`SECOND CLAIM FOR RELIEF Violation of RICO, 18 U.S.C. § 1961 et seq. – Opioid
`Supply Chain Enterprise (Against All Supply Chain Defendants– “RICO Supply
`Chain Defendants”) ........................................................................................................ 375
`THIRD CLAIM FOR RELIEF Violations of Iowa’s Private Right of Action for
`Consumer Frauds Act (Against All Defendants) ........................................................... 383
`FOURTH CLAIM FOR RELIEF Common Law Absolute Public Nuisance (Against All
`Defendants) .................................................................................................................... 385
`FIFTH CLAIM FOR RELIEF Public Nuisance (Against All Defendants) ............................... 392
`SIXTH CLAIM FOR RELIEF Negligence (Against All Defendants) ...................................... 393
`SEVENTH CLAIM FOR RELIEF Unjust Enrichment (Against All Defendants) ................... 394
`EIGHTH CLAIM FOR RELIEF Fraud (Against All Defendants) ............................................ 396
`NINTH CLAIM FOR RELIEF Civil Conspiracy (Against All Defendants) ............................ 398
`PRAYER FOR RELIEF ............................................................................................................ 400
`
`2.
`
`3.
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`
`
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`-vii-
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`
`
`1.
`
`Appanoose County, Cerro Gordo County, Cherokee County, Chickasaw County,
`
`Emmet County, Fremont County, Hancock County, Henry County, Ida County, Jones County,
`
`Keokuk County, Madison County, Muscatine County, Osceola County, Pocahontas County,
`
`Poweshiek County, Webster County, Winnebago County, and Wright County (“Plaintiffs”) bring
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`this action to prevent future harm and to redress past wrongs against Defendants:
`
` Cephalon, Inc.; Teva Pharmaceuticals Industries, Ltd.; and Teva Pharmaceuticals USA,
`
`Inc.;
`
` Janssen Pharmaceuticals, Inc.; (formerly known as Ortho-McNeil-Janssen
`
`Pharmaceuticals, Inc. and Janssen Pharmaceutica, Inc.); Johnson & Johnson; and
`
`Noramco, Inc.;
`
` Endo International plc; Endo Health Solutions Inc.; Endo Pharmaceuticals, Inc.; Par
`
`Pharmaceutical, Inc.; and Par Pharmaceutical Companies, Inc. (formerly known as Par
`
`Pharmaceutical Holdings, Inc.);
`
` Allergan PLC (formerly known as Actavis PLC); Allergan Finance LLC (formerly
`
`known as Actavis, Inc., formerly known as Watson Pharmaceuticals, Inc.); Watson
`
`Laboratories, Inc.; Actavis Pharma, Inc. (formerly known as Watson Pharma, Inc.);
`
`Actavis LLC; Allergan Sales, LLC; Allergan USA, Inc.; Warner Chilcott Company,
`
`LLC; Actavis Elizabeth LLC; Actavis Mid Atlantic LLC; Actavis Kadian LLC; Actavis
`
`Totowa LLC; Actavis South Atlantic LLC; Actavis Laboratories UT, Inc. (formerly
`
`known as Watson Laboratories, Inc. – Salt Lake City); and Actavis Laboratories FL, Inc.
`
`(formerly known as Wat Laboratories, Inc. – Florida);
`
` AmerisourceBergen Drug Corporation;
`
` Cardinal Health, Inc.;
`
`
`
`1
`
`
`
`Case 4:21-cv-00095-JAJ-CFB Document 1 Filed 03/24/21 Page 11 of 411
`
`
`
` McKesson Corporation;
`
` Anda, Inc.;
`
` CVS Health Corporation; CVS Indiana L.L.C.; CVS Rx Services, Inc.; CVS TN
`
`Distribution, LLC; CVS Pharmacy, Inc.; Omnicare Distribution Center LLC; Ohio CVS
`
`Stores, LLC;
`
` Walgreen Co.; Walgreens Boots Alliance, Inc.; Walgreen Eastern Co., Inc.;
`
` Rite Aid Corp.; Rite Aid Hdqtrs. Corp.; Eckerd Corporation d/b/a Rite Aid Liverpool
`
`Distribution Center; Rite Aid of Ohio, Inc.; Rite Aid of Maryland, Inc.;
`
` Walmart Inc. (formerly known as Wal-Mart Stores, Inc.), Wal-Mart Stores East, LP;
`
`WSE Management, LLC; WSE Investment LLC; and Wal-Mart Stores East, Inc.
`
` The Kroger Co.;
`
` H. D. Smith, LLC d/b/a HD Smith, f/k/a H. D. Smith Wholesale Drug Co., H.D. Smith
`
`Holdings, LLC, H.D. Smith, LLC d/b/a HD Smith, f/k/a H.D. Smith Wholesale Drug Co.,
`
`H.D. Smith Holdings, LLC, and H.D. Smith Holding Company; and
`
` KVK Tech, Inc.; Mylan Pharmaceuticals, Inc.; Sandoz, Inc.; West-Ward Pharmaceuticals
`
`Corp.; Supervalu, Inc. D/B/A Advantage Logistics; Dakota Drug, Inc.; Hy-Vee, Inc.;
`
`Pharmacy Buying Association, Inc.; and SAJ Distributors.
`
`2.
`
`Plaintiffs assert claims against the pharmaceutical manufacturers of prescription
`
`opioid drugs that engaged in a massive false marketing campaign to drastically expand the
`
`market for such drugs and their own market share; claims against entities in the supply chain that
`
`reaped enormous financial rewards by refusing to monitor and restrict the improper distribution
`
`of those drugs; and claims to hold accountable the Chain Pharmacies that reaped enormous
`
`
`
`2
`
`
`
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`
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`financial rewards by refusing to monitor and restrict the improper sale and distribution of opioids
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`and abate the opioid epidemic in the Counties.
`
`INTRODUCTION
`
`3.
`
`This case arises from the worst man-made epidemic in modern medical history—
`
`the misuse, abuse, and over-prescription of opioids.1
`
`4.
`
`By now, most Americans have been affected, either directly or indirectly, by the
`
`opioid disaster. But few realize that this crisis arose from the opioid manufacturers’ deliberately
`
`deceptive marketing strategy to expand opioid use, together with the distributors’ equally
`
`deliberate efforts to evade or curtail restrictions on opioid distribution. Manufacturers and
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`distributors alike acted without regard for the lives that would be trammeled in pursuit of profit.
`
`5.
`
`Since the push to expand prescription opioid use began in the late 1990s, the
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`death toll has steadily climbed, with no sign of slowing. The number of opioid overdoses in the
`
`United States rose from 8,000 in 1999 to over 20,000 in 2009, and over 33,000 in 2015.2 In the
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`twelve months that ended in September 2017, opioid overdoses claimed 45,000 lives.
`
`6.
`
`From 1999 through 2016, overdoses killed more than 350,000 Americans.3 Over
`
`200,000 of them, more than were killed in the Vietnam War, died from opioids prescribed by
`
`doctors to treat pain.4 These opioids include brand-name prescription medications such as
`
`
`1 Unless otherwise indicated, as used herein, the term “opioid” refers to the entire family of
`opiate drugs including natural, synthetic and semi-synthetic opiates.
`2 Overdose Death Rates, NIH Nat’l Inst. on Drug Abuse, https://www.drugabuse.gov/related-
`topics/trends-statistics/overdose-death-rates (revised Sept. 2017).
`3 Understanding the Epidemic, Ctrs. for Disease Control and Prevention,
`https://www.cdc.gov/drugoverdose/epidemic/index.html (last updated Aug. 30, 2017).
`4 Prescription Opioid Overdose Data, Ctrs. for Disease Control and Prevention,
`https://www.cdc.gov/drugoverdose/data/overdose.html (last updated Aug. 1, 2017).
`
`
`
`3
`
`
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`
`
`OxyContin, Opana ER, Vicodin, Subsys, and Duragesic, as well as generics like oxycodone,
`
`hydrocodone, and fentanyl.
`
`7.
`
`Most of the overdoses from non-prescription opioids are also directly related to
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`prescription opioids. Many opioid users, having become addicted to but no longer able to obtain
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`prescription opioids, have turned to heroin. According to the American Society of Addiction
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`Medicine, 80% of people who initiated heroin use in the past decade started with prescription
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`opioids—which, at the molecular level and in their effect, closely resemble heroin. In fact,
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`people who are addicted to prescription opioids are 40 times more likely to become addicted to
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`heroin, and the Centers for Disease Control and Prevention (“CDC”) identified addiction to
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`prescription opioids as the strongest risk factor for heroin addiction.
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`8.
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`As a result, in part, of the proliferation of opioid pharmaceuticals between the late
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`1990s and 2015, the life expectancy for Americans decreased for the first time in recorded
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`history. Drug overdoses are now the leading cause of death for Americans under 50.
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`9.
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`In the words of Robert Anderson, who oversees death statistics at the Centers for
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`Disease Control and Prevention, “I don’t think we’ve ever seen anything like this. Certainly not
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`in modern times.” On October 27, 2017, the President declared the opioid epidemic a public
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`health emergency.
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`10.
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`This suit takes aim at primary causes of the opioid crisis: (a) a marketing scheme
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`involving the false and deceptive marketing of prescription opioids, which was designed to
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`dramatically increase the demand for and sale of opioids and opioid prescriptions; and (b) a
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`supply chain scheme, pursuant to which the various entities in the supply chain, including
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`distributors and pharmacies, failed to design and operate systems to identify suspicious orders of
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`prescription opioids, maintain effective controls against diversion, and halt suspicious orders
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`4
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`Case 4:21-cv-00095-JAJ-CFB Document 1 Filed 03/24/21 Page 14 of 411
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`when they were identified, thereby contributing to the oversupply of such drugs and fueling an
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`illegal secondary market.
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`11.
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`On the demand side, the crisis was precipitated by the defendants who
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`manufacture, sell, and market prescription opioid painkillers. Through a massive marketing
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`campaign premised on false and incomplete information, the Marketing Defendants engineered a
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`dramatic shift in how and when opioids are prescribed by the medical community and used by
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`patients. The Marketing Defendants relentlessly and methodically, but untruthfully, asserted that
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`the risk of addiction was low when opioids were used to treat chronic pain, and overstated the
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`benefits and trivialized the risk of the long-term use of opioids.
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`12.
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`The Marketing Defendants’ goal was simple: to dramatically increase sales by
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`convincing doctors to prescribe opioids not only for the kind of severe pain associated with
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`cancer or short-term post-operative pain, but also for common chronic pains, such as back pain
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`and arthritis. They did this even though they knew that opioids were addictive and subject to
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`abuse, and that their other claims regarding the risks, benefits, and superiority of opioids for
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`long-term use were untrue and unfounded.
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`13.
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`The Marketing Defendants’ push to increase opioid sales worked. Through their
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`publications and websites, endless stream of sales representatives, “education” programs, and
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`other means, Marketing Defendants dramatically increased their sales of prescription opioids and
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`reaped billions of dollars of profit as a result. Since 1999, the amount of prescription opioids sold
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`in the U.S. nearly quadrupled. In 2016, 289 million prescriptions for opioids were filled in the
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`U.S.—enough to medicate every adult in America around the clock for a month.
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`5
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`Case 4:21-cv-00095-JAJ-CFB Document 1 Filed 03/24/21 Page 15 of 411
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`14. Meanwhile, the Defendants made blockbuster profits. In 2012 alone, opioids
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`generated $8 billion in revenue for drug companies. By 2015, sales of opioids grew to
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`approximately $9.6 billion.
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`15.
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`On the supply side, the crisis was fueled and sustained by those involved in the
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`supply chain of opioids, including manufacturers, distributors, and