Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 1 of 232 PageID 14847
`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 1 of 232 PagelD 14847
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`EXHIBIT 104
`EXHIBIT 104
`
`
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 2 of 232 PageID 14848
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 1 of 231
`
`THE UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF FLORIDA
`PENSACOLA DIVISION
`
`
`CITY OF PENSACOLA, FLORIDA,
`
`
`
`)
`)
`)
`)
`)
`)
`Plaintiff, )
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`))
`
`)
`
`
`v.
`
`AMERISOURCEBERGEN DRUG
`CORPORATION; CARDINAL
`HEALTH, INC.; McKESSON
`CORPORATION;
`PURDUE PHARMA L.P.; PURDUE
`PHARMA, INC.; THE PURDUE
`FREDERICK COMPANY, INC.; TEVA
`PHARMACEUTICAL INDUSTRIES,
`LTD.; TEVA PHARMACEUTICALS
`USA, INC.; CEPHALON, INC.;
`JOHNSON & JOHNSON; JANSSEN
`PHARMACEUTICALS, INC.; ORTHO-
`MCNEIL-JANSSEN
`PHARMACEUTICALS, INC. n/k/a
`JANSSEN PHARMACEUTICALS,
`INC.; JANSSEN PHARMACEUTICA
`INC. n/k/a JANSSEN
`PHARMACEUTICALS, INC.;
`NORAMCO, INC.; ENDO HEALTH
`SOLUTIONS INC.; ENDO
`PHARMACEUTICALS, INC.;
`ALLERGAN PLC f/k/a ACTAVIS PLS;
`WATSON PHARMACEUTICALS,
`INC. n/k/a ACTAVIS, INC.; WATSON
`LABORATORIES, INC.; ACTAVIS
`LLC; ACTAVIS PHARMA, INC. f/k/a
`
`
`
`
`
`
`
`
`
`
`
`
`
`CASE NO.:
`
`
`
`
`
`
`
`
`
`COMPLAINT
`
`Complaint for Public Nuisance,
`Violations of Racketeer Influenced
`and Corrupt Organizations Act
`(RICO) 18 U.S.C. § 1961 et seq.,
`Violations of 18 U.S.C. § 1962 et
`seq., Negligence and Negligent
`Misrepresentation, Negligence Per
`Se, Civil Conspiracy, Fraud and
`Fraudulent Misrepresentation
`(F.S.A. § 817.41 and common law),
`and Unjust Enrichment.
`
`
`JURY TRIAL DEMANDED AND
`ENDORSED HEREON
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 3 of 232 PageID 14849
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 2 of 231
`
`
`
`
`)))
`
`
`)
`)
`)
`)
`
`WATSON PHARMA, INC.;
`MALLINCKRODT PLC and
`MALLINCKRODT LLC.
`
`
`Defendants.
`
`_________________________________
`
`
`
`
`
`
`ii
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 4 of 232 PageID 14850
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 3 of 231
`
`TABLE OF CONTENTS
`I. INTRODUCTION ................................................................................................ 1
`II. PARTIES ............................................................................................................. 2
`A. Plaintiff. ........................................................................................................... 2
`B. Defendants....................................................................................................... 4
`1. Manufacturer Defendants. ........................................................................ 4
`2. Distributor Defendants. ........................................................................... 12
`III. JURISDICTION & VENUE .......................................................................... 14
`IV. FACTUAL BACKGROUND ......................................................................... 16
`A. THE OPIOID EPIDEMIC. .........................................................................16
`1. The National Opioid Epidemic. .............................................................. 16
`2. Florida’s Opioid Epidemic. ..................................................................... 21
`3. The Opioid Epidemic in Plaintiff’s Community. .................................. 25
`B. THE MANUFACTURER DEFENDANTS’ FALSE, DECEPTIVE AND
`UNFAIR MARKETING OF OPIOIDS. .........................................................28
`1. Each Manufacturer Defendant Used Multiple Avenues to
`Disseminate Their False and Deceptive Statements About Opioids. ...... 31
`i. Direct Marketing. ...........................................................................32
`
`ii.
`
`Indirect Marketing. .......................................................................34
`
`2. The Manufacturer Defendants’ Marketing Scheme
`Misrepresented the Risks and Benefits of Opioids. .................................. 49
`i.
`The Manufacturer Defendants embarked upon a campaign of
`false, deceptive and unfair assurances grossly understating and
`misstating the dangerous addiction risks of the opioid drugs. ...........49
`
`
`
`iii
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 5 of 232 PageID 14851
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 4 of 231
`
`ii. The Manufacturer Defendants embarked upon a campaign of
`false, deceptive and unfair assurances grossly overstating the benefits
`of the opioid drugs. .................................................................................68
`
`3. The Manufacturer Defendants Targeted Susceptible
`Prescribers and Vulnerable Patient Populations. .................................... 79
`4. The Manufacturer Defendants Made Materially Deceptive
`Statements and Concealed Material Facts. ............................................... 80
`5. The Manufacturer Defendants Fraudulently Concealed Their
`Misconduct. .................................................................................................. 93
`C. THE DISTRIBUTOR DEFENDANTS’ UNLAWFUL DISTRIBUTION
`OF OPIOIDS. ....................................................................................................96
`1. Wholesale Drug Distributors Have a Duty Under State and
`Federal Law to Guard Against and Report Unlawful Diversion
`and to Report and Prevent Suspicious Orders. ........................................ 98
`2. The Distributor Defendants Breached Their Duties. ......................... 107
`3. The Distributor Defendants Have Sought to Avoid and Have
`Misrepresented Their Compliance with Their Legal Duties. ................ 110
`D. THE MANUFACTURER DEFENDANTS’ UNLAWFUL FAILURE TO
`PREVENT DIVERSION AND MONITOR, REPORT AND PREVENT
`SUSPICIOUS ORDERS. ................................................................................122
`E. DEFENDANTS’ UNLAWFUL CONDUCT AND BREACHES OF
`LEGAL DUTIES CAUSED THE HARM ALLEGED HEREIN AND
`SUBSTANTIAL DAMAGES. ........................................................................130
`F. STATUTES OF LIMITATIONS ARE TOLLED AND DEFENDANTS
`ARE ESTOPPED FROM ASSERTING STATUTES OF LIMITATIONS
`AS DEFENSES. ...............................................................................................133
`1. Continuing Conduct. ............................................................................. 134
`2. Equitable Estoppel. ................................................................................ 134
`3. Fraudulent Concealment. ..................................................................... 138
`
`
`
`iv
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 6 of 232 PageID 14852
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 5 of 231
`
`VI. LEGAL CAUSES OF ACTION ................................................................... 139
`COUNT I - PUBLIC NUISANCE ...................................................................... 139
`COUNT II - RACKETEER-INFLUENCED AND CORRUPT
`ORGANIZATIONS ACT 18 U.S.C. 1961, et seq. ............................................. 152
`A. THE OPIOID DIVERSION ENTERPRISE ...........................................158
`B. CONDUCT OF THE OPIOID DIVERSION ENTERPRISE ...............176
`C. PATTERN OF RACKETEERING ACTIVITY. ....................................183
`1. The RICO Defendants Engaged in Mail and Wire Fraud. ............... 183
`2. The RICO Defendants Manufactured, Sold and/or Dealt in
`Controlled Substances, and Their Crimes Are Punishable as
`Felonies. ..................................................................................................... 195
`D. DAMAGES .................................................................................................203
`COUNT III - RACKETEER-INFLUENCED AND CORRUPT
`ORGANIZATIONS ACT 18 U.S.C. 1962(d), et seq. ........................................ 204
`A.
`THE OPIOID DIVERSION ENTERPRISE. .....................................205
`B. CONDUCT OF THE OPIOID DIVERSION ENTERPRISE. .........205
`C.
`PATTERN OF RACKETEERING ACTIVITY. ..............................205
`D. DAMAGES. ...........................................................................................205
`COUNT IV – NEGLIGENCE AND NEGLIGENT
`MISREPRESENTATION ................................................................................... 207
`COUNT V - NEGLIGENCE PER SE ................................................................ 213
`COUNT VI - CIVIL CONSPIRACY ................................................................. 214
`COUNT VII - FRAUD AND FRAUDULENT MISREPRESENTATION
`Florida Statutes § 817.41 and Common Law .................................................... 217
`COUNT VIII - UNJUST ENRICHMENT......................................................... 219
`PUNITIVE DAMAGES ....................................................................................... 222
`v
`
`
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 7 of 232 PageID 14853
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 6 of 231
`
`
`
`Plaintiff, CITY OF PENSACOLA, FLORIDA, brings this Complaint
`
`against Defendants Purdue Pharma L.P.; Purdue Pharma, Inc.; The Purdue
`
`Frederick Company,
`
`Inc.; Teva Pharmaceutical
`
`Industries, LTD.; Teva
`
`Pharmaceuticals USA, Inc.; Cephalon, Inc.; Johnson & Johnson; Janssen
`
`Pharmaceuticals, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc. n/k/a Janssen
`
`Pharmaceuticals, Inc.; Janssen Pharmaceutica Inc. n/k/a Janssen Pharmaceuticals,
`
`Inc.; Noramco, Inc.; Endo Health Solutions, Inc.; Endo Pharmaceuticals, Inc.;
`
`Allergan PLC f/k/a Actavis PLS; Watson Pharmaceuticals, Inc. n/k/a Actavis, Inc.;
`
`Watson Laboratories, Inc.; Actavis, LLC; Actavis Pharma, Inc. f/k/a Watson
`
`Pharma, Inc.; Mallinckrodt plc; Mallinckrodt LLC; McKesson Corporation;
`
`Cardinal Health, Inc.; and AmerisourceBergen Drug Corporation (collectively
`
`“Defendants”) and alleges as follows:
`
`I. INTRODUCTION
`
`1. Plaintiff brings this civil action to eliminate the hazard to public health
`
`and safety caused by the opioid epidemic, to abate the nuisance caused thereby and
`
`to recoup monies spent because of Defendants’ false, deceptive and unfair
`
`marketing and/or unlawful diversion of prescription opioids.1 Such economic
`
`damages were foreseeable to Defendants and were sustained because of
`
`Defendants’ intentional and/or unlawful actions and omissions.
`
`1 As used herein, the term “opioid” refers to the entire family of opiate drugs including natural, synthetic and semi-
`synthetic opiates.
`
`
`
`
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 8 of 232 PageID 14854
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 7 of 231
`
`
`
`2. Opioid analgesics are widely diverted and improperly used, and the
`
`widespread abuse of opioids has resulted in a national epidemic of opioid overdose
`
`deaths and addictions.2
`
`3. The opioid epidemic is “directly related to the increasingly widespread
`
`misuse of powerful opioid pain medications.”3
`
`4. Plaintiff brings this suit against the manufacturers of prescription
`
`opioids. The manufacturers aggressively pushed highly addictive, dangerous
`
`opioids, falsely representing to doctors that patients would only rarely succumb to
`
`drug addiction. These pharmaceutical companies aggressively advertised to and
`
`persuaded doctors to prescribe highly addictive, dangerous opioids, which turned
`
`patients into drug addicts for their own corporate profit. Such actions were
`
`intentional and/or unlawful.
`
`5. Plaintiff also brings this suit against the wholesale distributors of these
`
`highly addictive drugs. The distributors and manufacturers intentionally and/or
`
`unlawfully breached their legal duties under federal and state law to monitor,
`
`detect, investigate, refuse and report suspicious orders of prescription opiates.
`
`II. PARTIES
`
`A. PLAINTIFF.
`
`
`2 See Nora D. Volkow & A. Thomas McLellan, Opioid Abuse in Chronic Pain—Misconceptions and Mitigation
`Strategies, 374 N. Eng. J. Med. 1253 (2016).
`3 See Robert M. Califf et al., A Proactive Response to Prescription Opioid Abuse, 374 N. Eng. J. Med. 1480 (2016).
`
`
`
`2
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 9 of 232 PageID 14855
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 8 of 231
`
`
`
`6.
`
`Plaintiff CITY OF PENSACOLA, FLORIDA (“Pensacola” or
`
`“Plaintiff”) has the power to bring the claims asserted herein. See generally FLA.
`
`STAT. §166.021; Art. VIII, § 2(b), Fla. Const. (1968).
`
`7.
`
`Plaintiff has standing to take action to protect the public health, safety
`
`and welfare of its citizens.
`
`8. Plaintiff has declared, inter alia, that opioid abuse, addiction, morbidity
`
`and mortality have created a serious public health and safety crisis and are a public
`
`nuisance and that the diversion of legally produced controlled substances into the
`
`illicit market causes or contributes to this public nuisance.
`
`9. The distribution and diversion of opioids into Florida (the “State”), and
`
`into the CITY OF PENSACOLA and its surrounding areas (collectively,
`
`“Plaintiff’s Community”), created the foreseeable opioid crisis and opioid public
`
`nuisance for which Plaintiff here seeks relief.
`
`10. Plaintiff directly and foreseeably sustained all economic damages
`
`alleged herein. Defendants’ conduct has exacted a financial burden for which the
`
`Plaintiff seeks relief. Categories of past and continuing sustained damages include,
`
`inter alia: (1) costs for providing medical care, additional therapeutic and
`
`prescription drug purchases, and other treatments for patients suffering from
`
`opioid-related addiction or disease, including overdoses and deaths; (2) costs for
`
`providing treatment, counseling and rehabilitation services; (3) costs for providing
`
`
`
`3
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 10 of 232 PageID 14856
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 9 of 231
`
`
`
`treatment of infants born with opioid-related medical conditions; (4) costs
`
`associated with law enforcement and public safety relating to the opioid epidemic;
`
`and (5) costs associated with providing care for children whose parents suffer from
`
`opioid-related disability or incapacitation. The Plaintiff has suffered and continues
`
`to suffer these damages directly.
`
`11. Plaintiff also seeks the means to abate the epidemic Defendants’
`
`wrongful and/or unlawful conduct has created.
`
`12. Plaintiff has standing to bring an action for the opioid epidemic
`
`nuisance created by Defendants.
`
`13. Plaintiff has standing to recover damages incurred as a result of
`
`Defendants’ actions and omissions. Plaintiff has standing to bring all claims pled
`
`herein, including, inter alia, to bring claims under the federal RICO statute,
`
`pursuant to 18 U.S.C. § 1961(3) (“persons” include entities which can hold legal
`
`title to property) and 18 U.S.C. § 1964 (“persons” have standing).
`
`14. Plaintiff does not bring, or seek to bring, a product liability action.
`
`B. DEFENDANTS.
`1. Manufacturer Defendants.
`15. The Manufacturer Defendants are defined below. At all relevant times,
`
`the Manufacturer Defendants have packaged, distributed, supplied, sold, placed
`
`into the stream of commerce, labeled, described, marketed, advertised, promoted
`
`
`
`4
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 11 of 232 PageID 14857
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 10 of 231
`
`
`
`and purported to warn or purported to inform prescribers and users regarding the
`
`benefits and risks associated with the use of the prescription opioid drugs. The
`
`Manufacturer Defendants, at all times, have manufactured and sold prescription
`
`opioids without fulfilling their legal duty to prevent diversion and report suspicious
`
`orders.
`
`16. PURDUE PHARMA L.P. is a limited partnership organized under the
`
`laws of Delaware. PURDUE PHARMA, INC. is a New York corporation with its
`
`principal place of business in Stamford, Connecticut and THE PURDUE
`
`FREDERICK COMPANY is a Delaware corporation with its principal place of
`
`business in Stamford, Connecticut (collectively, “Purdue”).
`
`17. Purdue manufactures, promotes, sells and distributes opioids such as
`
`OxyContin, MS Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla ER and Targiniq
`
`ER in the United States. OxyContin is Purdue’s best-selling opioid. Since 2009,
`
`Purdue’s annual nationwide sales of OxyContin have fluctuated between $2.47
`
`billion and $2.99 billion, up four-fold from its 2006 sales of $800 million.
`
`OxyContin constitutes roughly 30% of the entire market for analgesic drugs
`
`(painkillers).
`
`18. CEPHALON, INC. is a Delaware corporation with its principal place
`
`of business in Frazer, Pennsylvania. TEVA PHARMACEUTICAL INDUSTRIES,
`
`LTD. (“Teva Ltd.”) is an Israeli corporation with its principal place of business in
`
`
`
`5
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 12 of 232 PageID 14858
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 11 of 231
`
`
`
`Petah Tikva, Israel. In October 2011, Teva Ltd. acquired Cephalon, Inc. TEVA
`
`PHARMACEUTICALS USA, INC. (“Teva USA”) is a Delaware corporation and
`
`is a wholly owned subsidiary of Teva Ltd. in Pennsylvania.
`
`19. Cephalon, Inc. manufactures, promotes, sells and distributes opioids,
`
`such as Actiq and Fentora, in the United States. The FDA has approved Actiq only
`
`for the “management of breakthrough cancer pain in patients 16 years and older
`
`with malignancies who are already receiving and who are tolerant to around-the-
`
`clock opioid therapy for the underlying persistent cancer pain.”4 The FDA has
`
`approved Fentora only for the “management of breakthrough pain in cancer
`
`patients 18 years of age and older who are already receiving and who are tolerant
`
`to around-the-clock opioid therapy for their underlying persistent cancer pain.”5 In
`
`2008, Cephalon pled guilty to a criminal violation of the Federal Food, Drug and
`
`Cosmetic Act for its misleading promotion of Actiq and two other drugs and
`
`agreed to pay $425 million.6
`
`20. Teva Ltd., Teva USA and Cephalon, Inc. work together closely to
`
`market and sell Cephalon products in the United States. Teva Ltd. conducts all
`
`sales and marketing activities for Cephalon in the United States through Teva USA
`
`4 Highlights of Prescribing Information, ACTIQ® (fentanyl citrate) oral transmucosal lozenge, CII (2009),
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020747s030lbl.pdf.
`5
` Highlights of Prescribing Information, FENTORA® (fentanyl citrate) buccal
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021947s015lbl.pdf.
`6 Press Release, U.S. Dep’t of Justice, Biopharmaceutical Company, Cephalon, to Pay $425 Million & Enter Plea
`to Resolve Allegations of Off-Label Marketing (Sept. 29, 2008),
`https://www.justice.gov/archive/opa/pr/2008/September/08-civ-860.html.
`
`tablet, CII (2011),
`
`
`
`6
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 13 of 232 PageID 14859
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 12 of 231
`
`
`
`and has done so since its October 2011 acquisition of Cephalon. Teva Ltd. and
`
`Teva USA hold out Actiq and Fentora as Teva products to the public. Teva USA
`
`sells all former Cephalon-branded products through its “specialty medicines”
`
`division. The FDA-approved prescribing information and medication guide, which
`
`is distributed with Cephalon opioids, discloses that Teva USA submitted the guide
`
`and directs physicians to contact Teva USA to report adverse events.
`
`21. All of Cephalon’s promotional websites, including those for Actiq and
`
`Fentora, display Teva Ltd.’s logo.7 Teva Ltd.’s financial reports list Cephalon’s
`
`and Teva USA’s sales as its own, and its year-end report for 2012 – the year
`
`immediately following the Cephalon acquisition – attributed a 22% increase in its
`
`specialty medicine sales to “the inclusion of a full year of Cephalon’s specialty
`
`sales,” including, inter alia, sales of Fentora®.8 Through interrelated operations
`
`like these, Teva Ltd. operates in the United States through its subsidiaries,
`
`Cephalon and Teva USA. The United States is the largest of Teva Ltd.’s global
`
`markets, representing 53% of its global revenue in 2015, and, were it not for the
`
`existence of Teva USA and Cephalon, Inc., Teva Ltd. would conduct those
`
`companies’ business in the United States itself. Upon information and belief, Teva
`
`Ltd. directs the business practices of Cephalon and Teva USA, and their profits
`
`
`7 E.g., ACTIQ, http://www.actiq.com/ (displaying logo at bottom-left) (last visited Aug. 21, 2017).
`8 Teva Ltd., Annual Report (Form 20-F) 62 (Feb. 12, 2013),
`http://annualreports.com/HostedData/AnnualReportArchive/t/NASDAQ_TEVA_2012.pdf.
`
`
`
`7
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 14 of 232 PageID 14860
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 13 of 231
`
`
`
`inure to the benefit of Teva Ltd. as controlling shareholder. Teva Pharmaceutical
`
`Industries, Ltd.; Teva Pharmaceuticals USA, Inc.; and Cephalon, Inc. are referred
`
`to as “Cephalon.”
`
`22. JANSSEN PHARMACEUTICALS,
`
`INC.
`
`is
`
`a Pennsylvania
`
`corporation with its principal place of business in Titusville, New Jersey and is a
`
`wholly owned subsidiary of JOHNSON & JOHNSON (J&J), a New Jersey
`
`corporation with its principal place of business in New Brunswick, New Jersey.
`
`NORAMCO, INC. (“Noramco”) is a Delaware company headquartered in
`
`Wilmington, Delaware and was a wholly owned subsidiary of J&J until July 2016.
`
`ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC., now known as
`
`Janssen Pharmaceuticals, Inc., is a Pennsylvania corporation with its principal
`
`place of business in Titusville, New Jersey. JANSSEN PHARMACEUTICA,
`
`INC., now known as Janssen Pharmaceuticals, Inc., is a Pennsylvania corporation
`
`with its principal place of business in Titusville, New Jersey. J&J is the only
`
`company that owns more than 10% of Janssen Pharmaceuticals’ stock and
`
`corresponds with the FDA regarding Janssen’s products. Upon information and
`
`belief, J&J controls the sale and development of Janssen Pharmaceuticals’ drugs
`
`and Janssen’s profits inure to J&J’s benefit. Janssen Pharmaceuticals, Inc., Ortho-
`
`McNeil-Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica, Inc., Noramco and
`
`J&J are referred to as “Janssen.”
`
`
`
`8
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 15 of 232 PageID 14861
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 14 of 231
`
`
`
`23. Janssen manufactures, promotes, sells and distributes drugs in the
`
`United States, including the opioid Duragesic (fentanyl). Before 2009, Duragesic
`
`accounted for at least $1 billion in annual sales. Until January 2015, Janssen
`
`developed, marketed and sold the opioids Nucynta (tapentadol) and Nucynta ER.
`
`Together, Nucynta and Nucynta ER accounted for $172 million in sales in 2014.
`
`24. ENDO HEALTH SOLUTIONS, INC. is a Delaware corporation with
`
`its principal place of business
`
`in Malvern, Pennsylvania. ENDO
`
`PHARMACEUTICALS, INC. is a wholly owned subsidiary of Endo Health
`
`Solutions, Inc. and is a Delaware corporation with its principal place of business in
`
`Malvern, Pennsylvania. Endo Health Solutions, Inc. and Endo Pharmaceuticals,
`
`Inc. are referred to as “Endo.”
`
`25. Endo develops, markets and sells prescription drugs, including the
`
`opioids Opana/Opana ER, Percodan, Percocet and Zydone, in the United States.
`
`Opioids made up roughly $403 million of Endo’s overall revenues of $3 billion in
`
`2012. Opana ER yielded $1.15 billion in revenue from 2010 and 2013 and
`
`accounted for 10% of Endo’s total revenue in 2012. Endo also manufactures and
`
`sells generic opioids, such as oxycodone, oxymorphone, hydromorphone and
`
`hydrocodone products, in the United States, by itself and through its subsidiary,
`
`QUALITEST PHARMACEUTICALS, INC.
`
`
`
`9
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 16 of 232 PageID 14862
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 15 of 231
`
`
`
`26. ALLERGAN PLC is a public limited company incorporated in Ireland
`
`with its principal place of business in Dublin, Ireland. ACTAVIS PLC acquired
`
`Allergan PLC in March 2015, and the combined company changed its name to
`
`Allergan PLC in January 2013. Before that, WATSON PHARMACEUTICALS,
`
`INC. acquired ACTAVIS, INC. in October 2012, and the combined company
`
`changed its name to Actavis, Inc. as of January 2013 and then Actavis PLC in
`
`October 2013. WATSON LABORATORIES, INC. is a Nevada corporation with
`
`its principal place of business in Corona, California and is a wholly-owned
`
`subsidiary of Allergan PLC (f/k/a Actavis, Inc., f/k/a Watson Pharmaceuticals,
`
`Inc.). ACTAVIS PHARMA, INC. (f/k/a Actavis, Inc.) is a Delaware corporation
`
`with its principal place of business in New Jersey and was formerly known as
`
`WATSON PHARMA, INC. ACTAVIS LLC is a Delaware limited liability
`
`company with its principal place of business in Parsippany, New Jersey. Allergan
`
`PLC owns each of these defendants and uses them to market and sell its drugs in
`
`the United States. Upon information and belief, Allergan PLC exercises control
`
`over these marketing and sales efforts and profits from the sale of Allergan/Actavis
`
`products ultimately inure to its benefit. Allergan PLC; Actavis PLC; Actavis, Inc.;
`
`Actavis LLC; Actavis Pharma, Inc.; Watson Pharmaceuticals, Inc.; Watson
`
`Pharma, Inc. and Watson Laboratories, Inc. are referred to as “Actavis.”
`
`
`
`10
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 17 of 232 PageID 14863
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 16 of 231
`
`
`
`27. Actavis manufactures, promotes, sells and distributes opioids, including
`
`the branded drugs Kadian and Norco, a generic version of Kadian and generic
`
`versions of Duragesic and Opana, in the United States. Actavis acquired the rights
`
`to Kadian from King Pharmaceuticals, Inc. on December 30, 2008 and began
`
`marketing Kadian in 2009.
`
`28. MALLINCKRODT, PLC
`
`is an Irish public
`
`limited company
`
`headquartered in Staines-upon-Thames, United Kingdom, with its United States
`
`headquarters in St. Louis, Missouri. MALLINCKRODT, LLC is a limited liability
`
`company organized and existing under the laws of the State of Delaware.
`
`Mallinckrodt, LLC
`
`is a wholly owned subsidiary of Mallinckrodt, plc.
`
`Mallinckrodt, plc and Mallinckrodt, LLC are referred to as “Mallinckrodt.”
`
`29. Mallinckrodt manufactures, markets and sells drugs in the United
`
`States including generic oxycodone, of which it is one of the largest manufacturers.
`
`In July 2017, Mallinckrodt agreed to pay $35 million to settle allegations brought
`
`by the Department of Justice that it failed to detect and notify the DEA of
`
`suspicious orders of controlled substances.9
`
`
`9 Press Release, U.S. Dep’t of Justice, Mallinckrodt Agrees to Pay Record $35 Million Settlement for Failure to
`Report Suspicious Orders of Pharmaceutical Drugs and for Recordkeeping Violations, July 11, 2017,
`https://www.justice.gov/opa/pr/mallinckrodt-agrees-pay-record-35-million-settlement-failure-report-suspicious-
`orders, last visited October 26, 2017.
`
`
`
`11
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 18 of 232 PageID 14864
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 17 of 231
`
`
`
`2. Distributor Defendants.
`30. The Distributor Defendants are defined below. At all relevant times, the
`
`Distributor Defendants have distributed, supplied, sold and placed into the stream
`
`of commerce the prescription opioids, without fulfilling the fundamental duty of
`
`wholesale drug distributors to detect and warn of diversion of dangerous drugs for
`
`non-medical purposes. The Distributor Defendants universally failed to comply
`
`with federal and/or state law. The Distributor Defendants are engaged in
`
`“wholesale distribution,” as defined under state and federal law. Plaintiff alleges
`
`the unlawful conduct by the Distributor Defendants is responsible for the volume
`
`of prescription opioids plaguing Plaintiff’s Community.
`
`31. McKESSON CORPORATION (“McKesson”) at all relevant times
`
`operated as a licensed pharmacy wholesaler in Florida. McKesson is a Delaware
`
`corporation. McKesson has its principal place of business located in San Francisco,
`
`California.
`
`32. CARDINAL HEALTH, INC. (“Cardinal”) at all relevant times
`
`operated as a licensed pharmacy wholesaler in Florida. Cardinal’s principal office
`
`located in Dublin, Ohio.
`
`33. AMERISOURCEBERGEN
`
`DRUG
`
`CORPORATION
`
`(“AmerisourceBergen”) at all relevant times operated as a licensed pharmacy
`
`
`
`12
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 19 of 232 PageID 14865
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 18 of 231
`
`
`
`wholesaler in Florida. AmerisourceBergen’s principal place of business is located
`
`in Chesterbrook, Pennsylvania.
`
`34. The data that reveals and/or confirms the identity of each wrongful
`
`opioid distributor is hidden from public view in the DEA’s confidential ARCOS
`
`database. See Madel v. USDOJ, 784 F.3d 448 (8th Cir. 2015). Neither the DEA10
`
`nor the wholesale distributors11 will voluntarily disclose the data necessary to
`
`identify with specificity the transactions that will form the evidentiary basis for the
`
`claims asserted herein.
`
`35. Consequently, Plaintiff has named the three (3) wholesale distributors
`
`(i.e., AmerisourceBergen Drug Corporation, Cardinal Health, Inc. and McKesson
`
`Corporation) that dominate 85% of the market share for the distribution of
`
`prescription opioids. These “Big 3” are Fortune 500 corporations listed on the New
`
`York Stock Exchange whose principal business is the nationwide wholesale
`
`distribution of prescription drugs. See Fed. Trade Comm’n v. Cardinal Health,
`
`Inc., 12 F. Supp. 2d 34, 37 (D.D.C. 1998) (describing Cardinal Health, Inc.,
`
`McKesson Corporation and AmerisourceBergen Drug Corporation predecessors).
`
`
`10 See Declaration of Katherine L. Myrick, Chief, Freedom of Information (FOI)/Privacy Act Unit (“SARF”), FOI,
`Records Management Section (“SAR”), Drug Enforcement Administration (DEA), United States Department of
`Justice (DOJ), Madel v. USDOJ, Case 0:13-cv-02832-PAM-FLN, (Document 23) (filed 02/06/14) (noting that
`ARCOS data is “kept confidential by the DEA”).
`11 See Declaration of Tina Lantz, Cardinal Health VP of Sales Operation, Madel v. USDOJ, Case 0:13-cv-02832-
`PAM-FLN, (Document 93) (filed 11/02/16) (“Cardinal Health does not customarily release any of the information
`identified by the DEA notice letter to the public, nor is the information publicly available. Cardinal Health relies on
`DEA to protect its confidential business information reported to the Agency.”).
`
`
`
`13
`
`

`

`Case 8:22-cv-02569-CEH-AEP Document 181-4 Filed 04/03/23 Page 20 of 232 PageID 14866
`Case 3:18-cv-00417-MCR-GRJ Document 1 Filed 03/13/18 Page 19 of 231
`
`
`
`The DEA has investigated and/or fined each for the failure to report suspicious
`
`orders. Plaintiff has reason to believe each has engaged in unlawful conduct that
`
`resulted in the diversion of prescription opioids into Plaintiff’s Community, and
`
`that discovery will likely reveal others who likewise engaged in unlawful conduct.
`
`Plaintiff names each of the “Big 3” herein as defendants and places the industry on
`
`notice that the Plaintiff is acting to abate the public nuisance plaguing the
`
`community. Plaintiff will request expedited discovery pursuant to Rule 26(d) of the
`
`Federal Rules of Civil Procedure to secure the data necessary to reveal and/or
`
`confirm the identities of the wholesale distributors, including data from the
`
`ARCOS database.
`
`III. JURISDICTION & VENUE
`
`36. This Court has subject matter ju