THE UNITED STATES DISTRICT COURT 

SOUTHERN DISTRICT OF OHIO 

EASTERN DIVISION AT COLUMBUS 

 ) 

CRAWFORD COUNTY BOARD 

OF COUNTY COMMISSIONERS, 

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) 

 ) 

Plaintiff, ) 

 ) 

v. ) CIVIL ACTION NO. 2:17-cv-00975 

 ) 

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 WATSON 

PHARMA, INC.; 

MALLINCKRODT PLC and 

MALLINCKRODT LLC. 

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COMPLAINT 

Complaint for Public Nuisance; 

Violations of Racketeer Influenced and 

Corrupt Organizations Act (RICO) 18 

U.S.C. § 1961 et seq.; Violations of Ohio 

Corrupt Practices Act; Ohio Revised Code 

§ 2307.60; Negligence and Negligent 

Misrepresentation; Negligence Per Se; 

Violation of Ohio Deceptive Trade 

Practices Act, Ohio Revised Code Ch. 

4165; Civil Conspiracy; and Fraud and 

Fraudulent Misrepresentation 

Defendants.

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 ) JURY TRIAL DEMANDED AND 

 ) ENDORSED HEREON 

) 

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TABLE OF CONTENTS 

I. INTRODUCTION ......................................................................................................................1

II. PARTIES ...................................................................................................................................2

A. Plaintiff ................................................................................................................................ 2

B. Defendants........................................................................................................................... 4

1. Manufacturer Defendants. ............................................................................................4

2. Distributor Defendants. .................................................................................................9

III. JURISDICTION & VENUE ................................................................................................11

IV. FACTUAL BACKGROUND ...............................................................................................13

A. THE OPIOID EPIDEMIC. ............................................................................................. 13

1. The National Opioid Epidemic. ..................................................................................13

2. Ohio’s Opioid Epidemic. .............................................................................................17

3. The Opioid Epidemic in Plaintiff’s Community. ......................................................21

B. THE MANUFACTURER DEFENDANTS’ FALSE, DECEPTIVE, AND UNFAIR 

MARKETING OF OPIOIDS............................................................................................... 22

1. Each Manufacturer Defendant Used Multiple Avenues to Disseminate 

Their False and Deceptive Statements about Opioids. .................................................24

i. Direct Marketing. ............................................................................................ 25

ii. Indirect Marketing.......................................................................................... 26

2. The Manufacturer Defendants’ Marketing Scheme Misrepresented the 

Risks and Benefits of Opioids. ........................................................................................38

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. ...................................................... 38

ii. The Manufacturer Defendants embarked upon a campaign of false, 

deceptive, and unfair assurances grossly overstating the benefits of the opioid 

drugs. .......................................................................................................................... 49

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3. The Manufacturer Defendants Targeted Susceptible Prescribers and 

Vulnerable Patient Populations. .....................................................................................57

4. The Manufacturer Defendants made Materially Deceptive Statements and 

Concealed Materials Facts. .............................................................................................58

5. The Manufacturer Defendants Fraudulently Concealed Their Misconduct. .........64

C. THE DISTRIBUTOR DEFENDANTS’ UNLAWFUL DISTRIBUTION OF 

OPIOIDS. ............................................................................................................................... 66

1. The Distributor Defendants Have a Duty under Federal and State Law to 

Guard Against, and Report, Unlawful Diversion and to Report and Prevent 

Suspicious Orders. ...........................................................................................................67

2. The Distributor Defendants Breached their Duties. .................................................74

3. The Distributor Defendants Have Sought to Avoid and Have 

Misrepresented their Compliance with their Legal Duties. .........................................77

D. THE MANUFACTURER DEFENDANTS’ UNLAWFUL FAILURE TO PREVENT 

DIVERSION AND MONITOR, REPORT, AND PREVENT SUSPICIOUS ORDERS.

................................................................................................................................................. 85

E. DEFENDANTS’ UNLAWFUL CONDUCT AND BREACHES OF LEGAL DUTIES 

CAUSED THE HARM ALLEGED HEREIN AND SUBSTANTIAL DAMAGES. ...... 90

F. STATUTES OF LIMITATIONS ARE TOLLED AND DEFENDANTS ARE 

ESTOPPED FROM ASSERTED STATUTES OF LIMITATIONS AS DEFENSES. .. 93

1. Continuing Conduct. ...................................................................................................93

2. Equitable Estoppel. ......................................................................................................94

3. Fraudulent Concealment. ............................................................................................96

V. LEGAL CAUSES OF ACTION ............................................................................................97

COUNT I.......................................................................................................................................97

COUNT II ...................................................................................................................................105

A. THE OPIOID DIVERSION ENTERPRISE ........................................................ 110

B. CONDUCT OF THE OPIOID DIVERSION ENTERPRISE ............................ 124

C. PATTERN OF RACKETEERING ACTIVITY. ................................................. 129

1. The RICO Defendants Engaged in Mail and Wire Fraud. ....................................129

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2. The RICO Defendants Manufactured, Sold and/or Dealt in Controlled 

Substances and Their Crimes Are Punishable as Felonies. .......................................138

D. DAMAGES .............................................................................................................. 144

COUNT III .................................................................................................................................145

A. THE OPIOID DIVERSION ENTERPRISE. ....................................................... 145

B. CONDUCT OF THE OPIOID DIVERSION ENTERPRISE. ........................... 145

C. PATTERN OF RACKETEERING ACTIVITY. ................................................. 145

D. DAMAGES. ............................................................................................................. 146

COUNT IV ..................................................................................................................................146

A. The Opioid Diversion Enterprise. ......................................................................... 147

B. Conduct of the Opioid Diversion Enterprise. ....................................................... 148

C. CORRUPT ACTIVITY -- I.E., PATTERN OF RACKETEERING ACTIVITY.

 148

D. DAMAGES .............................................................................................................. 149

COUNT V ...................................................................................................................................150

COUNT VI ..................................................................................................................................151

COUNT VII ................................................................................................................................155

COUNT VIII...............................................................................................................................156

COUNT IX ..................................................................................................................................160

COUNT X ...................................................................................................................................162

PUNITIVE DAMAGES.............................................................................................................164

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Plaintiff, the CRAWFORD COUNTY BOARD OF COUNTY COMMISSIONERS 

(“Plaintiff”), 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 that 

have been 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. 

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

 

1

 As used herein, the term “opioid” refers to the entire family of opiate drugs including natural, synthetic and semisynthetic opiates. 

2 See Nora D. Volkow & A. Thomas McLellan, Opioid Abuse in Chronic Pain—Misconceptions and Mitigation 

Strategies, 374 N. Eng. J. Med. 1253 (2016). 

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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 and 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 

6. Plaintiff, Crawford County Board of County Commissioners (“Plaintiff”), is the 

policy-determining body of Crawford County, Ohio (“the County”), and has all the powers and 

duties vested by law. The Crawford County Board has standing to bring this suit. OHIO REV.

CODE ANN. § 305.12 (“The board of county commissioners may sue and be sued, and plead and 

be impleaded, in any court . . . [and] shall demand and receive, by suit or otherwise, any . . . 

money or other property due the county.”). Plaintiff has declared, inter alia, that opioid4 abuse, 

addiction, morbidity and mortality has created a serious public health and safety crisis, and is a 

public nuisance, and that the diversion of legally produced controlled substances into the illicit 

market causes or contributes to this public nuisance. 

 3 See Robert M. Califf et al., A Proactive Response to Prescription Opioid Abuse, 374 N. Eng. J. Med. 1480 (2016). 

4

 As used herein, the term “opioid” refers to the entire family of opiate drugs including natural, synthetic and semisynthetic opiates. 

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7. The distribution and diversion of opioids into Ohio (“the State”), and into the 

County and surrounding areas (collectively, “Plaintiff’s Community”), created the foreseeable 

opioid crisis and opioid public nuisance for which Plaintiff here seeks relief. 

8. 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 

treatment of infants born with opioid-related medical conditions; (4) costs associated with law 

enforcement and public safety relating to the opioid epidemic; (5) and costs associated with 

providing care for children whose parents suffer from opioid-related disability or incapacitation. 

These damages have been suffered, and continue to be suffered directly, by the Plaintiff. 

9. Plaintiff also seeks the means to abate the epidemic created by Defendants’ 

wrongful and/or unlawful conduct. 

10. 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,

standing to recover damages caused by a criminal act, pursuant to Ohio Revised Code §§ 

2307.60, 2307.011(F) (“person” includes “political subdivisions”); standing to recover damages 

under the Deceptive Trade Practices Act pursuant to Ohio Revised Code § 4165.01(D) (“person” 

includes corporations, governments, and government subdivisions) and §4165.03(A)(2) (injured 

“persons” have standing); standing to bring claims under the Ohio racketeering statute, the Ohio 

Corrupt Practices Act, pursuant to Ohio Revised Code § 2923.31(G) (“persons” include 

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governmental entities); § 2923.34(A) (“persons” have standing); and standing 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). 

B. DEFENDANTS. 

1. Manufacturer Defendants. 

11. 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 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 prevent diversion and report 

suspicious orders. 

12. 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”). 

13. 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). 

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14. 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 Petah Tikva, Israel. In 2011, Teva Ltd. 

acquired Cephalon, Inc. TEVA PHARMACEUTICALS USA, INC. (“Teva USA”) is a Delaware 

corporation which is registered to do business in Ohio and is a wholly owned subsidiary of Teva 

Ltd. in Pennsylvania. Teva USA acquired Cephalon in October 2011. 

15. Cephalon, Inc. manufactures, promotes, sells, and distributes opioids such as 

Actiq and Fentora in the United States. Actiq has been approved by the FDA 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.”5

 Fentora has been approved by the FDA 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.”6

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.7

16. 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 and has done so since its October 2011 

acquisition of Cephalon. Teva Ltd. and Teva USA hold out Actiq and Fentora as Teva products 

 

5

 Highlights of Prescribing Information, ACTIQ® (fentanyl citrate) oral transmucosal lozenge, CII (2009), 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020747s030lbl.pdf. 

6

 Highlights of Prescribing Information, FENTORA® (fentanyl citrate) buccal tablet, CII (2011), 

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021947s015lbl.pdf. 

7

 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. 

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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 the guide was submitted by Teva USA, and 

directs physicians to contact Teva USA to report adverse events. 

17. All of Cephalon’s promotional websites, including those for Actiq and Fentora, 

display Teva Ltd.’s logo.8

 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®.9

 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 

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.” 

18. 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 

 

8

 E.g., ACTIQ, http://www.actiq.com/ (displaying logo at bottom-left) (last visited Aug. 21, 2017). 

9

 Teva Ltd., Annual Report (Form 20-F) 62 (Feb. 12, 2013), 

http://annualreports.com/HostedData/AnnualReportArchive/t/NASDAQ_TEVA_2012.pdf. 

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2016. ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC., now known as JANSSEN 

PHARMACEUTICALS, INC., is a Pennsylvania corporation registered to do business in Ohio 

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.” 

19. 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. 

20. 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 registered to do 

business in Ohio with its principal place of business in Malvern, Pennsylvania. Endo Health 

Solutions Inc. and Endo Pharmaceuticals Inc. are referred to as “Endo.” 

21. 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 

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billion in revenue from 2010 and 2013, and it 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. 

22. 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 registered to do business with the Ohio 

Secretary of State as 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. Each of these 

defendants is owned by ALLERGAN PLC, which 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.” 

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23. 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. 

24. MALLINCKRODT, PLC is an Irish public limited company headquartered in 

Staines-upon-Thames, United Kingdom, with its U.S. headquarters in St. Louis, Missouri. 

MALLINCKRODT, LLC is a limited liability company organized and existing under the laws of 

the State of Delaware and licensed to do business in Ohio. Mallinckrodt, LLC is a wholly owned 

subsidiary of Mallinckrodt, plc. Mallinckrodt, plc and Mallinckrodt, LLC are referred to as 

“Mallinckrodt.” 

25. 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. 

2. Distributor Defendants. 

26. The Distributor Defendants also 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 

Distributors universally failed to comply with federal and/or state law. Plaintiff alleges the 

unlawful conduct by the Distributor Distributors is responsible for the volume of prescription 

opioids plaguing Plaintiff’s Community. 

27. McKESSON CORPORATION (“McKesson”) at all relevant times, operated as a 

licensed pharmacy wholesaler in Ohio. McKesson is registered with the Ohio Secretary of State 

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as a Delaware corporation. McKesson has its principal place of business located in San 

Francisco, California. McKesson operates distribution centers in Ohio, including in Washington 

Court House, Ohio. 

28. CARDINAL HEALTH, INC. (“Cardinal”) at all relevant times, operated as a 

licensed pharmacy wholesaler in Ohio. Cardinal is registered with the Ohio Secretary of State as 

an Ohio corporation, with its principal office located in Dublin, Ohio. Cardinal operates 

distribution centers in Ohio, including in Groveport, Ohio and Zanesville, Ohio. Cardinal Health, 

Inc. is an Ohio corporation with its principal place of business in Dublin, Ohio. 

29. AMERISOURCEBERGEN DRUG CORPORATION (“AmerisourceBergen”) at 

all relevant times, operated as a licensed pharmacy wholesaler in Ohio. AmerisourceBergen is 

registered with the Ohio Secretary of State as a Delaware corporation which may be served 

through its registered agent for service of process. AmerisourceBergen’s principal place of 

business is located in Chesterbrook, Pennsylvania. AmerisourceBergen operates distribution 

centers in Ohio, including in Lockbourne, Ohio. 

30. The data which 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 which will 

form the evidentiary basis for the claims asserted herein. 

 

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.”). 

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31. Consequently, Plaintiff has named the three (3) wholesale distributors (i.e., 

AmerisourceBergen Drug Corporation, Cardinal Health, Inc., and McKesson Corporation) which 

dominate 85% of the market share for the distribution of prescription opioids. The “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). Each has been 

investigated and/or fined by the DEA for the failure to report suspicious orders. Plaintiff has 

reason to believe each has engaged in unlawful conduct which resulted in the diversion of 

prescription opioids into our 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 

32. This Complaint was filed as an original action in this District. 

33. This Court has subject matter jurisdiction under 28 U.S.C. § 1331 based upon the 

federal claims asserted under the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. 

§ 1961, et seq. (“RICO”). This Court has supplemental jurisdiction over Plaintiff’s state law 

claims pursuant to 28 U.S.C. § 1367 because those claims are so related to Plaintiff’s federal 

claims that they form part of the same case or controversy. 

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34. This Court has personal jurisdiction over Defendants because they conduct 

business in Ohio, purposefully direct or directed their actions toward Ohio, consented to be sued 

in Ohio by registering an agent for service of process, consensually submitted to the jurisdiction 

of Ohio when obtaining a manufacturer or distributor license, and have the requisite minimum 

contacts with Ohio necessary to constitutionally permit the Court to exercise jurisdiction. 

35. This Court also has personal jurisdiction over all of the defendants under 18 

U.S.C. 1965(b). This Court may exercise nation-wide jurisdiction over the named Defendants 

where the “ends of justice” require national service and Plaintiff demonstrates national contacts. 

Here, the interests of justice require that Plaintiff be allowed to bring all members of the 

nationwide RICO enterprise before the court in a single trial. See, e.g., Iron Workers Local 

Union No. 17 Insurance Fund v. Philip Morris Inc., 23 F. Supp. 2d 796 (1998) (citing LaSalle 

National Bank v. Arroyo Office Plaza, Ltd., 1988 WL 23824, *3 (N.D. Ill. Mar 10, 1988); 

Butcher’s Union Local No. 498 v. SDC Invest., Inc., 788 F.2d 535, 539 (9th Cir. 1986). 

36. Venue is proper in this District under Southern District of Ohio Local Rule 

82.1(c), which provides “[a]n action against a defendant or defendants resident in this District 

shall be filed at the location of Court that serves a county in which at least one defendant 

resides.” See also, 28 U.S.C. § 1391(c). Defendant, CARDINAL HEALTH, INC., is an Ohio 

corporation with its principal office located in Dublin, Franklin County, Ohio, which is located 

in the Eastern Division of the Southern District of Ohio and served by the Columbus location of 

Court. Venue is further proper in this District pursuant to 28 U.S.C. § 1391 and 18 U.S.C. § 

1965 because a substantial part of the events or omissions giving rise to the claim occurred in 

this District and each Defendant transacted affairs and conducted activity that gave rise to the 

claim of relief in this District. 28 U.S.C. §§ 1391(b); § 1965(a). 

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37. Plaintiff does not bring any product liability claims or causes of action and does 

not seek compensatory damages for death, physical injury to person, or emotional distress. 

Claimant does not bring common law claims for property damage. 

IV. FACTUAL BACKGROUND 

A. THE OPIOID EPIDEMIC. 

1. The National Opioid Epidemic. 

38. The past two decades have been characterized by increasing abuse and diversion 

of prescription drugs, including opioid medications, in the United States.12 

39. Prescription opioids have become widely prescribed. By 2010, enough 

prescription opioids were sold to medicate every adult in the United States with a dose of 5 

milligrams of hydrocodone every 4 hours for 1 month.13 

40. By 2011, the U.S. Department of Health and Human Resources, Centers for 

Disease Control and Prevention, declared prescription painkiller overdoses at epidemic levels. 

The News Release noted: 

a. The death toll from overdoses of prescription painkillers 

has more than tripled in the past decade. 

b. More than 40 people die every day from overdoses 

involving narcotic pain relievers like hydrocodone 

(Vicodin), methadone, oxycodone (OxyContin), and 

oxymorphone (Opana). 

c. Overdoses involving prescription painkillers are at 

epidemic levels and now kill more Americans than heroin 

and cocaine combined. 

 

12 See Richard C. Dart et al, Trends in Opioid Analgesic Abuse and Mortality in the United States, 372 N. Eng. J. 

Med. 241 (2015). 

13 Katherine M. Keyes at al., Understanding the Rural-Urban Differences in Nonmedical Prescription Opioid Use 

and Abuse in the United States, 104 Am. J. Pub. Health e52 (2014). 

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d. The increased use of prescription painkillers for 

nonmedical reasons, along with growing sales, has 

contributed to a large number of overdoses and deaths. In 

2010, 1 in every 20 people in the United States age 12 and 

older—a total of 12 million people—reported using 

prescription painkillers non-medically according to the 

National Survey on Drug Use and Health. Based on the 

data from the Drug Enforcement Administration, sales of 

these drugs to pharmacies and health care providers have 

increased by more than 300 percent since 1999. 

e. Prescription drug abuse is a silent epidemic that is stealing 

thousands of lives and tearing apart communities and 

families across America. 

f. Almost 5,500 people start to misuse prescription painkillers 

every day.14

41. The number of annual opioid prescriptions written in the United States is now 

roughly equal to the number of adults in the population.15 

42. Many Americans are now addicted to prescription opioids, and the number of 

deaths due to prescription opioid overdose is unacceptable. In 2016, drug overdoses killed 

roughly 64,000 people in the United States, an increase of more than 22 percent over the 52,404 

drug deaths recorded the previous year.16 

43. Moreover, the CDC has identified addiction to prescription pain medication as the 

strongest risk factor for heroin addiction. People who are addicted to prescription opioid 

painkillers are forty times more likely to be addicted to heroin.17 

 

14 See Press Release, Ctrs. for Disease Control and Prevention, U.S. Dep’t of Health and Human Servs., Prescription 

Painkiller Overdoses at Epidemic Levels (Nov. 1, 2011), 

https://www.cdc.gov/media/releases/2011/p1101_flu_pain_killer_overdose.html. 

15 See Califf et al., supra note 3. 

16 See Ctrs. for Disease Control and Prevention, U.S. Dep’t of Health and Human Servs., Provisional Counts of Drug 

Overdose Deaths, (August 8, 2016), https://www.cdc.gov/nchs/data/health_policy/monthly-drug-overdose-deathestimates.pdf. 

17 See Ctrs. for Disease Control and Prevention, U.S. Dep’t of Health and Human Servs., Today’s Heroin Epidemic, 

https://www.cdc.gov/vitalsigns/heroin/index.html (last updated July 7, 2015). 

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44. Heroin is pharmacologically similar to prescription opioids. The majority of 

current heroin users report having used prescription opioids non-medically before they initiated 

heroin use. Available data indicates that the nonmedical use of prescription opioids is a strong 

risk factor for heroin use.18 

45. The CDC reports that drug overdose deaths involving heroin continued to climb 

sharply, with heroin overdoses more than tripling in 4 years. This increase mirrors large 

increases in heroin use across the country and has been shown to be closely tied to opioid pain 

reliever misuse and dependence. Past misuse of prescription opioids is the strongest risk factor 

for heroin initiation and use, specifically among persons who report past-year dependence or 

abuse. The increased availability of heroin, combined with its relatively low price (compared 

with diverted prescription opioids) and high purity appear to be major drivers of the upward 

trend in heroin use and overdose.19

46. The societal costs of prescription drug abuse are “huge.”20

47. Across the nation, local governments are struggling with a pernicious, everexpanding epidemic of opioid addiction and abuse. Every day, more than 90 Americans lose 

their lives after overdosing on opioids.21 

 

18 See Wilson M. Compton, Relationship Between Nonmedical Prescription-Opioid Use and Heroin, 374 N. Eng. J. 

Med. 154 (2016). 

19 See Rose A. Rudd et al., Increases in Drug and Opioid Overdose Deaths—United States, 2000–2014, 64 

Morbidity & Mortality Wkly. Rep. 1378 (2016). 

20 See Amicus Curiae Brief of Healthcare Distribution Management Association in Support of Appellant Cardinal 

Health, Inc., Cardinal Health, Inc. v. United States Dept. Justice, No. 12-5061 (D.C. Cir. May 9, 2012), 2012 WL 

1637016, at *10 [hereinafter Brief of HDMA]. 

21 Opioid Crisis, NIH, National Institute on Drug Abuse (available at https://www.drugabuse.gov/drugsabuse/opioids/opioid-crisis, last visited Sept. 19, 2017) (“Opioid Crisis, NIH”) (citing at note 1 Rudd RA, Seth P, 

David F, Scholl L, Increases in Drug and Opioid-Involved Overdose Deaths — United States, 2010–2015, MMWR

MORB MORTAL WKLY REP. 2016;65, doi:10.15585/mmwr.mm655051e1). 

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48. The National Institute on Drug Abuse identifies misuse and addiction to opioids 

as “a serious national crisis that affects public health as well as social and economic welfare.”22

The economic burden of prescription opioid misuse alone is $78.5 billion a year, including the 

costs of healthcare, lost productivity, addiction treatment, and criminal justice expenditures.23 

49. The U.S. opioid epidemic is continuing, and drug overdose deaths nearly tripled 

during 1999–2014. Among 47,055 drug overdose deaths that occurred in 2014 in the United 

States, 28,647 (60.9%) involved an opioid.24 

50. The rate of death from opioid overdose has quadrupled during the past 15 years in 

the United States. Nonfatal opioid overdoses that require medical care in a hospital or emergency 

department have increased by a factor of six in the past 15 years.25 

51. Every day brings a new revelation regarding the depth of the opioid plague: just to 

name one example, the New York Times reported in September 2017 that the epidemic, which 

now claims 60,000 lives a year, is now killing babies and toddlers because ubiquitous, deadly 

opioids are “everywhere” and mistaken as candy.26

52. In 2016, the President of the United States declared an opioid and heroin 

epidemic.27 

 

22 Opioid Crisis, NIH. 

23 Id. (citing at note 2 Florence CS, Zhou C, Luo F, Xu L, The Economic Burden of Prescription Opioid Overdose, 

Abuse, and Dependence in the United States, 2013, MED CARE 2016;54(10):901-906, 

doi:10.1097/MLR.0000000000000625). 

24 See Rose A. Rudd et al., Increases in Drug and Opioid-Involved Overdose Deaths—United States, 2010–2015, 65 

Morbidity & Mortality Wkly. Rep. 1445 (2016). 

25 See Volkow & McLellan, supra note 1.

26 Julie Turkewitz, ‘The Pills are Everywhere’: How the Opioid Crisis Claims Its Youngest Victims, N.Y. Times, 

Sept. 20, 2017 (“‘It’s a cancer,’ said [grandmother of dead one-year old], of the nation’s opioid problem, ‘with 

tendrils that are going everywhere.’”). 

27 See Proclamation No. 9499, 81 Fed. Reg. 65,173 (Sept. 16, 2016) (proclaiming “Prescription Opioid and Heroin 

Epidemic Awareness Week”). 

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53. The epidemic of prescription pain medication and heroin deaths is devastating 

families and communities across the country.28 Meanwhile, the manufacturers and distributors 

of prescription opioids extract billions of dollars of revenue from the addicted American public 

while public entities experience tens of millions of dollars of injury caused by the reasonably 

foreseeable consequences of the prescription opioid addiction epidemic. 

54. The prescription opioid manufacturers and distributors, including the Defendants, 

have continued their wrongful, intentional, and unlawful conduct, despite their knowledge that 

such conduct is causing and/or continuing to the national, state, and local opioid epidemic. 

2. Ohio’s Opioid Epidemic. 

55. Ohio has been especially ravaged by the national opioid crisis. 

56. Ohio has an opioid prescription rate of 100.1 per 100 persons, which ranks twelfth 

in the country (U.S. median rate: 82.5) and a benzodiazepine prescription rate of 41.3 per 100 

persons which ranks twentieth nationally (U.S. median rate: 37.6).29 

57. As reported by the Ohio Department of Health, Ohio has been among the states 

hardest hit by the opioid epidemic for years. From 2000 to 2015, Ohio’s death rate due to 

unintentional drug poisonings increased 642 percent, driven largely by opioid-related 

overdoses.30 In 2015, there were 3050 Ohio overdose deaths, up 20.5 percent from 2531 Ohio 

 

28 See Presidential Memorandum – Addressing Prescription Drug Abuse and Heroin Use, 2015 Daily Comp. Pres. 

Doc. 743 (Oct. 21, 2015), https://www.gpo.gov/fdsys/pkg/DCPD-201500743/pdf/DCPD-201500743.pdf. 

29 See Leonard J. Paulozzi, M.D., et al., Vital Signs: Variation Among States in Prescribing of Opioid Pain Relievers 

and Benzodiazepines – United States, 2012, Morbidity and Mortality Weekly Report, Centers for Disease Control 

and Prevention, U.S. Department of Health and Human Services (July 4, 2014). The combination of hydrocodone, 

oxycodone, and benzodiazepines is referred to as the “holy trinity” and significantly increases the risk of harm to 

those that abuse prescription pills. 

30 Ohio Department of Health, Prevalence and Trends in Unintentional Drug Overdose, 

https://www.odh.ohio.gov/health/vipp/drug/dpoison.aspx (last visited Sept. 15, 2017). 

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overdose deaths in 2014.31 85% of these overdoses involved opioids.32 The problem is only 

getting worse: between 2015 and 2016, overdose deaths in Ohio rose by nearly 33 percent.33 

58. The number of Ohio adults who had friends or family experiencing problems with 

opioid abuse also rose sharply from 2014 to 2015.34 

 

31 See Governor’s Cabinet Opiate Action Team at http://fightingopiateabuse.ohio.gov/, (last visited September 17, 

2017). 

32 Id. 

33 Ohio Department of Health, 2016 Ohio Drug Overdose Data: General Findings, https://www.odh.ohio.gov/-

/media/ODH/ASSETS/Files/health/injury-prevention/2016-Ohio-Drug-Overdose-Report-FINAL.pdf?la=en (last 

visited Sept. 15, 2017). 

34 OHIP 2015 Ohio Health Issues Poll, available at 

https://www.interactforhealth.org/upl/Heroin_use_prescription_drug_misuse_still_climbing_in_Ohio.pdf, last 

visited July 12, 2017. 

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59. Unintentional fatal drug overdoses cost Ohioans $2.0 billion in 2012 in medical 

and work loss costs; while non-fatal, hospital-admitted drug poisonings cost an additional $39.1 

million. The total cost equaled an average of $5.4 million each day in medical and work loss 

costs in Ohio.35

60. The Opioid epidemic is largely responsible for an 11 percent increase in children 

in state custody in Ohio in the past six years.36 Seventy percent of infants placed in Ohio’s foster 

care system are children of parents with opioid addictions.37 Children with parents addicted to 

drugs tend to stay in foster care longer, and they often enter the system having experienced 

significant trauma, which makes their care more expensive.38

61. Data maintained by the Agency for Healthcare Research and Quality for 2007 

through 2016 document a sharp increase in opioid-related inpatient hospital stays in Ohio. The 

annual rate of such stays per 100,000 population has continued to increase: 

 

35 Ohio Department of Health, Cost to Ohio, https://www.odh.ohio.gov/health/vipp/drug/dpoison.aspx (last visited 

Sept. 15, 2017). 

36 Public Children Services Association of Ohio, Ohio’s Opiate Epidemic and Child Protection (2016), available at 

http://www.pcsao.org/programs/opiate-epidemic, last visited July 12, 2017. 

37 Ohio Child Welfare Opiate Engagement Project (Sept. 2014), page 1, available at 

http://www.pcsao.org/perch/resources/downloads/cw-opiate-white-paper-final-9-18-14.pdf, last visited July 12, 

2017. 

38 Trista Thurston, Drug addiction drives spike in Ohio foster care, Newark Advocate (Mar. 23, 2017), available at 

http://www.newarkadvocate.com/story/news/crime/high-in-ohio/2017/03/23/drug-addiction-drives-spike-ohiofoster-care/99545804/, last visited July 12, 2017. 

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62. The rate of opioid related Emergency Department visits increased 106% in 

Ohio between 2009 and 2014.39

 

39 Agency for Healthcare Research and Quality, Healthcare Cost and Utilization Project, Statistical Brief #219, 

Opioid-Related Inpatient Stays and Emergency Department Visits by State, 2009-2014, https://www.hcupus.ahrq.gov/reports/statbriefs/sb219-Opioid-Hospital-Stays-ED-Visits-by-State.pdf. 

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3. The Opioid Epidemic in Plaintiff’s Community. 

63. The opioid epidemic is particularly devastating in Plaintiff’s Community. 

64. Plaintiff’s Community is experiencing an excessive drug overdose rate40 related to 

an excessive volume of prescription opiates41 proximately caused by the wrongful conduct by the 

Defendants described and named herein. 

 

40 2015 Ohio Drug Overdose Data: General Findings, Ohio Department of Health, pages 10-11, available at 

https://www.odh.ohio.gov/-/media/ODH/ASSETS/Files/health/injury-prevention/2015-Overdose-Data/2015-OhioDrug-Overdose-Data-Report-FINAL.pdf, last visited July 12, 2017. 41 Id. 

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B. THE MANUFACTURER DEFENDANTS’ FALSE, DECEPTIVE, 

AND UNFAIR MARKETING OF OPIOIDS. 

65. The opioid epidemic did not happen by accident. 

66. Before the 1990s, generally accepted standards of medical practice dictated that 

opioids should only be used short-term for acute pain, pain relating to recovery from surgery, or 

for cancer or palliative (end-of-life) care. Due to the lack of evidence that opioids improved 

patients’ ability to overcome pain and function, coupled with evidence of greater pain complaints 

as patients developed tolerance to opioids over time and the serious risk of addiction and other 

side effects, the use of opioids for chronic pain was discouraged or prohibited. As a result, 

doctors generally did not prescribe opioids for chronic pain. 

67. Each Manufacturer Defendant has conducted, and has continued to conduct, a 

marketing scheme designed to persuade doctors and patients that opioids can and should be used 

for chronic pain, resulting in opioid treatment for a far broader group of patients who are much 

more likely to become addicted and suffer other adverse effects from the long-term use of 

opioids. In connection with this scheme, each Manufacturer Defendant spent, and continues to 

spend, millions of dollars on promotional activities and materials that falsely deny or trivialize 

the risks of opioids while overstating the benefits of using them for chronic pain. 

68. The Manufacturer Defendants have made false and misleading claims, contrary to 

the language on their drugs’ labels, regarding the risks of using their drugs that: (1) downplayed 

the serious risk of addiction; (2) created and promoted the concept of “pseudoaddiction” when 

signs of actual addiction began appearing and advocated that the signs of addiction should be 

treated with more opioids; (3) exaggerated the effectiveness of screening tools to prevent 

addiction; (4) claimed that opioid dependence and withdrawal are easily managed; (5) denied the 

risks of higher opioid dosages; and (6) exaggerated the effectiveness of “abuse-deterrent” opioid 

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formulations to prevent abuse and addiction. The Manufacturer Defendants have also falsely 

touted the benefits of long-term opioid use, including the supposed ability of opioids to improve 

function and quality of life, even though there was no scientifically reliable evidence to support 

the Manufacturer Defendants’ claims. 

69. The Manufacturer Defendants have disseminated these common messages to 

reverse the popular and medical understanding of opioids and risks of opioid use. They 

disseminated these messages directly, through their sales representatives, in speaker groups led 

by physicians the Manufacturer Defendants recruited for their support of their marketing 

messages, and through unbranded marketing and industry-funded front groups. 

70. Defendants’ efforts have been wildly successful. Opioids are now the most 

prescribed class of drugs. Globally, opioid sales generated $11 billion in revenue for drug 

companies in 2010 alone; sales in the United States have exceeded $8 billion in revenue annually 

since 2009.42 In an open letter to the nation’s physicians in August 2016, the then-U.S. Surgeon 

General expressly connected this “urgent health crisis” to “heavy marketing of opioids to doctors 

. . . [m]any of [whom] were even taught – incorrectly – that opioids are not addictive when 

prescribed for legitimate pain.”43 This epidemic has resulted in a flood of prescription opioids 

available for illicit use or sale (the supply), and a population of patients physically and 

psychologically dependent on them (the demand). And when those patients can no longer afford 

or obtain opioids from licensed dispensaries, they often turn to the street to buy prescription 

opioids or even non-prescription opioids, like heroin. 

 

42 See Katherine Eban, Oxycontin: Purdue Pharma’s Painful Medicine, Fortune, Nov. 9, 2011, 

http://fortune.com/2011/11/09/oxycontin-purdue-pharmas-painful-medicine/; David Crow, Drugmakers Hooked on 

$10bn Opioid Habit, Fin. Times, Aug. 10, 2016, https://www. ft.com/content/f6e989a8-5dac-11e6-bb77-

a121aa8abd95. 

43 Letter from Vivek H. Murthy, U.S. Surgeon General (Aug. 2016), http://turnthetiderx.org/. 

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71. The Manufacturer Defendants intentionally continued their conduct, as alleged 

herein, with knowledge that such conduct was creating the opioid nuisance and causing the 

harms and damages alleged herein. 

1. Each Manufacturer Defendant Used Multiple Avenues to 

Disseminate Their False and Deceptive Statements about Opioids. 

72. The Manufacturer Defendants spread their false and deceptive statements by 

marketing their branded opioids directly to doctors and patients in and around the State, 

including in Plaintiff’s Community. Defendants also deployed seemingly unbiased and 

independent third parties that they controlled to spread their false and deceptive statements about 

the risks and benefits of opioids for the treatment of chronic pain throughout the State and 

Plaintiff’s Community. 

73. The Manufacturer Defendants employed the same marketing plans and strategies 

and deployed the same messages in and around the State, including in Plaintiff’s Community, as 

they did nationwide. Across the pharmaceutical industry, “core message” development is funded 

and overseen on a national basis by corporate headquarters. This comprehensive approach 

ensures that the Manufacturer Defendants’ messages are accurately and consistently delivered 

across marketing channels – including detailing visits, speaker events, and advertising – and in 

each sales territory. The Manufacturer Defendants consider this high level of coordination and 

uniformity crucial to successfully marketing their drugs. 

74. The Manufacturer Defendants ensure marketing consistency nationwide through 

national and regional sales representative training; national training of local medical liaisons, the 

company employees who respond to physician inquiries; centralized speaker training; single sets 

of visual aids, speaker slide decks, and sales training materials; and nationally coordinated 

advertising. The Manufacturer Defendants’ sales representatives and physician speakers were 

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required to stick to prescribed talking points, sales messages, and slide decks, and supervisors 

rode along with them periodically to both check on their performance and compliance. 

i. Direct Marketing. 

75. The Manufacturer Defendants’ direct marketing of opioids generally proceeded 

on two tracks. First, each Manufacturer Defendant conducted and continues to conduct 

advertising campaigns touting the purported benefits of their branded drugs. For example, upon 

information and belief, the Manufacturer Defendants spent more than $14 million on medical 

journal advertising of opioids in 2011, nearly triple what they spent in 2001. 

76. Many of the Manufacturer Defendants’ branded ads deceptively portrayed the 

benefits of opioids for chronic pain. For example, Endo distributed and made available on its 

website opana.com a pamphlet promoting Opana ER with photographs depicting patients with 

physically demanding jobs like construction worker, chef, and teacher, misleadingly implying 

that the drug would provide long-term pain-relief and functional improvement. Upon information 

and belief, Purdue also ran a series of ads, called “Pain vignettes,” for OxyContin in 2012 in 

medical journals. These ads featured chronic pain patients and recommended OxyContin for 

each. One ad described a “54-year-old writer with osteoarthritis of the hands” and implied that 

OxyContin would help the writer work more effectively. 

77. Second, each Manufacturer Defendant promoted the use of opioids for chronic 

pain through “detailers” – sales representatives who visited individual doctors and medical staff 

in their offices – and small-group speaker programs. The Manufacturer Defendants have not 

corrected this misinformation. Instead, each Defendant devoted massive resources to direct sales 

contacts with doctors. Upon information and belief, in 2014 alone, the Manufacturer Defendants 

spent in excess of $168 million on detailing branded opioids to doctors, more than twice what 

they spent on detailing in 2000. 

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78. The Manufacturer Defendants’ detailing to doctors is effective. Numerous studies 

indicate that marketing impacts prescribing habits, with face-to-face detailing having the greatest 

influence. Even without such studies, the Manufacturer Defendants purchase, manipulate and 

analyze some of the most sophisticated data available in any industry, data available from IMS 

Health Holdings, Inc., to track, precisely, the rates of initial prescribing and renewal by 

individual doctor, which in turn allows them to target, tailor, and monitor the impact of their core 

messages. Thus, the Manufacturer Defendants know their detailing to doctors is effective. 

79. The Manufacturer Defendants’ detailers have been reprimanded for their 

deceptive promotions. In March 2010, for example, the FDA found that Actavis had been 

distributing promotional materials that “minimize[] the risks associated with Kadian and 

misleadingly suggest[] that Kadian is safer than has been demonstrated.” Those materials in 

particular “fail to reveal warnings regarding potentially fatal abuse of opioids, use by individuals 

other than the patient for whom the drug was prescribed.”44

ii. Indirect Marketing. 

80. The Manufacturer Defendants’ indirectly marketed their opioids using unbranded 

advertising, paid speakers and “key opinion leaders” (“KOLs”), and industry-funded 

organizations posing as neutral and credible professional societies and patient advocacy groups 

(referred to hereinafter as “Front Groups”). 

81. The Manufacturer Defendants deceptively marketed opioids in the State and 

Plaintiff’s Community through unbranded advertising – e.g., advertising that promotes opioid 

use generally but does not name a specific opioid. This advertising was ostensibly created and 

disseminated by independent third parties. But by funding, directing, reviewing, editing, and 

 

44 Letter from Thomas Abrams, Dir., Div. of Drug Mktg., Advert., & Commc’ns, U.S. Food & Drug Admin., to 

Doug Boothe, CEO, Actavis Elizabeth LLC (Feb. 18, 2010), 

http://www.fdanews.com/ext/resources/files/archives/a/ActavisElizabethLLC.pdf.

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distributing this unbranded advertising, the Manufacturer Defendants controlled the deceptive 

messages disseminated by these third parties and acted in concert with them to falsely and 

misleadingly promote opioids for the treatment of chronic pain. Much as Defendants controlled 

the distribution of their “core messages” via their own detailers and speaker programs, the 

Manufacturer Defendants similarly controlled the distribution of these messages in scientific 

publications, treatment guidelines, Continuing Medical Education (“CME”) programs, and 

medical conferences and seminars. To this end, the Manufacturer Defendants used third-party 

public relations firms to help control those messages when they originated from third-parties. 

82. The Manufacturer Defendants marketed through third-party, unbranded 

advertising to avoid regulatory scrutiny because that advertising is not submitted to and typically 

is not reviewed by the FDA. The Manufacturer Defendants also used third-party, unbranded 

advertising to give the false appearance that the deceptive messages came from an independent 

and objective source. Like the tobacco companies, the Manufacturer Defendants used third 

parties that they funded, directed, and controlled to carry out and conceal their scheme to deceive 

doctors and patients about the risks and benefits of long term opioid use for chronic pain. 

83. Defendants also identified doctors to serve, for payment, on their speakers’ 

bureaus and to attend programs with speakers and meals paid for by Defendants. These speaker 

programs provided: (1) an incentive for doctors to prescribe a particular opioid (so they might be 

selected to promote the drug); (2) recognition and compensation for the doctors selected as 

speakers; and (3) an opportunity to promote the drug through the speaker to his or her peers. 

These speakers give the false impression that they are providing unbiased and medically accurate 

presentations when they are, in fact, presenting a script prepared by Defendants. On information 

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and belief, these presentations conveyed misleading information, omitted material information, 

and failed to correct Defendants’ prior misrepresentations about the risks and benefits of opioids. 

84. Borrowing a page from Big Tobacco’s playbook, the Manufacturer Defendants 

worked through third parties they controlled by: (a) funding, assisting, encouraging, and 

directing doctors who served as KOLS, and (b) funding, assisting, directing, and encouraging 

seemingly neutral and credible Front Groups. The Manufacturer Defendants then worked 

together with those KOLs and Front Groups to taint the sources that doctors and patients relied 

on for ostensibly “neutral” guidance, such as treatment guidelines, CME programs, medical 

conferences and seminars, and scientific articles. Thus, working individually and collectively, 

and through these Front Groups and KOLs, the Manufacturer Defendants persuaded doctors and 

patients that what they have long known – that opioids are addictive drugs, unsafe in most 

circumstances for long-term use – was untrue, and that the compassionate treatment of pain 

required opioids. 

85. In 2007, multiple States sued Purdue for engaging in unfair and deceptive 

practices in its marketing, promotion, and sale of OxyContin. Certain states settled their claims 

in a series Consent Judgments that prohibited Purdue from making misrepresentations in the 

promotion and marketing of OxyContin in the future. By using indirect marketing strategies, 

however, Purdue intentionally circumvented these restrictions. Such actions include contributing 

the creation of misleading publications and prescribing guidelines which lack reliable scientific 

basis and promote prescribing practices which have worsened the opioid crisis. 

86. Pro-opioid doctors are one of the most important avenues that the Manufacturer 

Defendants use to spread their false and deceptive statements about the risks and benefits of 

long-term opioid use. The Manufacturer Defendants know that doctors rely heavily and less 

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critically on their peers for guidance, and KOLs provide the false appearance of unbiased and 

reliable support for chronic opioid therapy. For example, the State of New York found in its 

settlement with Purdue that the Purdue website “In the Face of Pain” failed to disclose that 

doctors who provided testimonials on the site were paid by Purdue and concluded that Purdue’s 

failure to disclose these financial connections potentially misled consumers regarding the 

objectivity of the testimonials. 

87. Defendants utilized many KOLs, including many of the same ones.

88. Dr. Russell Portenoy, former Chairman of the Department of Pain Medicine and 

Palliative Care at Beth Israel Medical Center in New York, is one example of a KOL whom the 

Manufacturer Defendants identified and promoted to further their marketing campaign. Dr. 

Portenoy received research support, consulting fees, and honoraria from Cephalon, Endo, 

Janssen, and Purdue (among others), and was a paid consultant to Cephalon and Purdue. Dr. 

Portenoy was instrumental in opening the door for the regular use of opioids to treat chronic 

pain. He served on the American Pain Society (“APS”) / American Academy of Pain Medicine 

(“AAPM”) Guidelines Committees, which endorsed the use of opioids to treat chronic pain, first 

in 1996 and again in 2009. He was also a member of the board of the American Pain Foundation 

(“APF”), an advocacy organization almost entirely funded by the Manufacturer Defendants.

89. Dr. Portenoy also made frequent media appearances promoting opioids and 

spreading misrepresentations, such as his claim that “the likelihood that the treatment of pain 

using an opioid drug which is prescribed by a doctor will lead to addiction is extremely low.” He 

appeared on Good Morning America in 2010 to discuss the use of opioids long-term to treat 

chronic pain. On this widely-watched program, broadcast across the country, Dr. Portenoy 

claimed: “Addiction, when treating pain, is distinctly uncommon. If a person does not have a 

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history, a personal history, of substance abuse, and does not have a history in the family of 

substance abuse, and does not have a very major psychiatric disorder, most doctors can feel very 

assured that that person is not going to become addicted.”45

90. Dr. Portenoy later admitted that he “gave innumerable lectures in the late 1980s 

and ‘90s about addiction that weren’t true.” These lectures falsely claimed that fewer than 1% of 

patients would become addicted to opioids. According to Dr. Portenoy, because the primary goal 

was to “destigmatize” opioids, he and other doctors promoting them overstated their benefits and 

glossed over their risks. Dr. Portenoy also conceded that “[d]ata about the effectiveness of 

opioids does not exist.”46 Portenoy candidly stated: “Did I teach about pain management, 

specifically about opioid therapy, in a way that reflects misinformation? Well, . . . I guess I 

did.”47 

91. Another KOL, Dr. Lynn Webster, was the co-founder and Chief Medical Director 

of Lifetree Clinical Research, an otherwise unknown pain clinic in Salt Lake City, Utah. Dr. 

Webster was President of American Academy of Pain Medicine (“AAPM”) in 2013. He is a 

Senior Editor of Pain Medicine, the same journal that published Endo special advertising 

supplements touting Opana ER. Dr. Webster was the author of numerous CMEs sponsored by 

Cephalon, Endo, and Purdue. At the same time, Dr. Webster was receiving significant funding 

from the Manufacturer Defendants (including nearly $2 million from Cephalon).

92. During a portion of his time as a KOL, Dr. Webster was under investigation for 

overprescribing by the U.S. Department of Justice’s Drug Enforcement Agency, which raided his 

 

45 Good Morning America (ABC television broadcast Aug. 30, 2010). 

46 Thomas Catan & Evan Perez, A Pain-Drug Champion Has Second Thoughts, Wall St. J., Dec. 17, 2012, 

https://www.wsj.com/articles/SB10001424127887324478304578173342657044604. 

47 Id.

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clinic in 2010. Although the investigation was closed without charges in 2014, more than 20 of 

Dr. Webster’s former patients at the Lifetree Clinic have died of opioid overdoses.

93. Ironically, Dr. Webster created and promoted the Opioid Risk Tool, a five 

question, one-minute screening tool relying on patient self-reports that purportedly allows 

doctors to manage the risk that their patients will become addicted to or abuse opioids. The 

claimed ability to pre-sort patients likely to become addicted is an important tool in giving 

doctors confidence to prescribe opioids long-term, and for this reason, references to screening 

appear in various industry-supported guidelines. Versions of Dr. Webster’s Opioid Risk Tool 

appear on, or are linked to, websites run by Endo, Janssen, and Purdue. Unaware of the flawed 

science and industry bias underlying this tool, certain states and public entities have incorporated 

the Opioid Risk Tool into their own guidelines, indicating, also, their reliance on the 

Manufacturer Defendants and those under their influence and control.

94. In 2011, Dr. Webster presented, via webinar, a program sponsored by Purdue 

entitled “Managing Patient’s Opioid Use: Balancing the Need and the Risk.” Dr. Webster 

recommended use of risk screening tools, urine testing, and patient agreements as a way to 

prevent “overuse of prescriptions” and “overdose deaths.” This webinar was available to and was 

intended to reach doctors in the State and doctors treating members of Plaintiff’s Community.48

95. Dr. Webster also was a leading proponent of the concept of “pseudoaddiction,” 

the notion that addictive behaviors should be seen not as warnings, but as indications of 

undertreated pain. In Dr. Webster’s description, the only way to differentiate the two was to 

increase a patient’s dose of opioids. As he and co-author Beth Dove wrote in their 2007 book 

 

48 See Emerging Solutions in Pain, Managing Patient’s Opioid Use: Balancing the Need and the Risk, 

http://www.emergingsolutionsinpain.com/ce-education/opioidmanagement?option=com_continued&view=frontmatter&Itemid=303&course=209 (last visited Aug. 22, 2017). 

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Avoiding Opioid Abuse While Managing Pain—a book that is still available online—when faced 

with signs of aberrant behavior, increasing the dose “in most cases . . . should be the clinician’s 

first response.”49 Upon information and belief, Endo distributed this book to doctors. Years later, 

Dr. Webster reversed himself, acknowledging that “[pseudoaddiction] obviously became too 

much of an excuse to give patients more medication.”50

96. The Manufacturer Defendants also entered into arrangements with seemingly 

unbiased and independent patient and professional organizations to promote opioids for the 

treatment of chronic pain. Under the direction and control of the Manufacturer Defendants, these 

“Front Groups” generated treatment guidelines, unbranded materials, and programs that favored 

chronic opioid therapy. They also assisted the Manufacturer Defendants by responding to 

negative articles, by advocating against regulatory changes that would limit opioid prescribing in 

accordance with the scientific evidence, and by conducting outreach to vulnerable patient 

populations targeted by the Manufacturer Defendants. 

97. These Front Groups depended on the Manufacturer Defendants for funding and, 

in some cases, for survival. The Manufacturer Defendants also exercised control over programs 

and materials created by these groups by collaborating on, editing, and approving their content, 

and by funding their dissemination. In doing so, the Manufacturer Defendants made sure that the 

Front Groups would generate only the messages that the Manufacturer Defendants wanted to 

distribute. Despite this, the Front Groups held themselves out as independent and serving the 

needs of their members – whether patients suffering from pain or doctors treating those patients. 

 

49 Lynn Webster & Beth Dove, Avoiding Opioid Abuse While Managing Pain (2007). 

50 John Fauber, Painkiller Boom Fueled by Networking, Milwaukee Wisc. J. Sentinel, Feb. 18, 2012, 

http://archive.jsonline.com/watchdog/watchdogreports/painkiller-boom-fueled-by-networking-dp3p2rn139609053.html. 

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98. Defendants Cephalon, Endo, Janssen, and Purdue, in particular, utilized many 

Front Groups, including many of the same ones. Several of the most prominent are described 

below, but there are many others, including the American Pain Society (“APS”), American 

Geriatrics Society (“AGS”), the Federation of State Medical Boards (“FSMB”), American 

Chronic Pain Association (“ACPA”), the Center for Practical Bioethics (“CPB”), the U.S. Pain 

Foundation (“USPF”) and Pain & Policy Studies Group (“PPSG”).51

99. The most prominent of the Manufacturer Defendants’ Front Groups was the 

American Pain Foundation (“APF”), which, upon information and belief, received more than $10 

million in funding from opioid manufacturers from 2007 until it closed its doors in May 2012, 

primarily from Endo and Purdue. APF issued education guides for patients, reporters, and 

policymakers that touted the benefits of opioids for chronic pain and trivialized their risks, 

particularly the risk of addiction. APF also launched a campaign to promote opioids for returning 

veterans, which has contributed to high rates of addiction and other adverse outcomes – 

including death – among returning soldiers. APF also engaged in a significant multimedia 

campaign – through radio, television and the internet – to educate patients about their “right” to 

pain treatment, namely opioids. All of the programs and materials were available nationally and 

were intended to reach citizens of the State and Plaintiff’s Community. 

100. In 2009 and 2010, more than 80% of APF’s operating budget came from 

pharmaceutical industry sources. Including industry grants for specific projects, APF received 

about $2.3 million from industry sources out of total income of about $2.85 million in 2009; its 

budget for 2010 projected receipts of roughly $2.9 million from drug companies, out of total 

 

51 See generally, e.g., Letter from Sen. Ron Wyden, U.S. Senate Comm. on Fin., to Sec. Thomas E. Price, U.S. 

Dep’t of Health and Human Servs., (May 5, 2015), 

https://www.finance.senate.gov/imo/media/doc/050517%20Senator%20Wyden%20to%20Secretary%20Price%20re

%20FDA%20Opioid%20Prescriber%20Working%20Group.pdf.

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income of about $3.5 million. By 2011, upon information and belief, APF was entirely 

dependent on incoming grants from defendants Purdue, Cephalon, Endo, and others to avoid 

using its line of credit. 

101. APF held itself out as an independent patient advocacy organization. It often 

engaged in grassroots lobbying against various legislative initiatives that might limit opioid 

prescribing, and thus the profitability of its sponsors. Upon information and belief, it was often 

called upon to provide “patient representatives” for the Manufacturer Defendants’ promotional 

activities, including for Purdue’s Partners Against Pain and Janssen’s Let’s Talk Pain. APF 

functioned largely as an advocate for the interests of the Manufacturer Defendants, not patients. 

Indeed, upon information and belief, as early as 2001, Purdue told APF that the basis of a grant 

was Purdue’s desire to “strategically align its investments in nonprofit organizations that share 

[its] business interests.” 

102. Plaintiff is informed, and believes, that on several occasions, representatives of 

the Manufacturer Defendants, often at informal meetings at conferences, suggested activities and 

publications for APF to pursue. APF then submitted grant proposals seeking to fund these 

activities and publications, knowing that drug companies would support projects conceived as a 

result of these communications. 

103. The U.S. Senate Finance Committee began looking into APF in May 2012 to 

determine the links, financial and otherwise, between the organization and the manufacturers of 

opioid painkillers. The investigation caused considerable damage to APF’s credibility as an 

objective and neutral third party, and the Manufacturer Defendants stopped funding it. Within 

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days of being targeted by Senate investigation, APF’s board voted to dissolve the organization 

“due to irreparable economic circumstances.” APF “cease[d] to exist, effective immediately.”52

104. Another front group for the Manufacturer Defendants was the American Academy 

of Pain Medicine (“AAPM”). With the assistance, prompting, involvement, and funding of the 

Manufacturer Defendants, the AAPM issued purported treatment guidelines and sponsored and 

hosted medical education programs essential to the Manufacturer Defendants’ deceptive 

marketing of chronic opioid therapy. 

105. AAPM received substantial funding from opioid manufacturers. For example, 

AAPM maintained a corporate relations council, whose members paid $25,000 per year (on top 

of other funding) to participate. The benefits included allowing members to present educational 

programs at off-site dinner symposia in connection with AAPM’s marquee event – its annual 

meeting held in Palm Springs, California, or other resort locations. AAPM describes the annual 

event as an “exclusive venue” for offering education programs to doctors. Membership in the 

corporate relations council also allows drug company executives and marketing staff to meet 

with AAPM executive committee members in small settings. Defendants Endo, Purdue, and 

Cephalon were members of the council and presented deceptive programs to doctors who 

attended this annual event. 

106. Upon information and belief, AAPM is viewed internally by Endo as “industry 

friendly,” with Endo advisors and speakers among its active members. Endo attended AAPM 

conferences, funded its CMEs, and distributed its publications. The conferences sponsored by 

AAPM heavily emphasized sessions on opioids – 37 out of roughly 40 at one conference alone. 

 

52 Charles Ornstein & Tracy Weber, Senate Panel Investigates Drug Companies’ Ties to Pain Groups, Wash. Post, 

May 8, 2012, https://www.washingtonpost.com/national/health-science/senate-panel-investigates-drug-companiesties-to-pain-groups/2012/05/08/gIQA2X4qBU_story.html. 

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AAPM’s presidents have included top industry-supported KOLs Perry Fine and Lynn Webster. 

Dr. Webster was even elected president of AAPM while under a DEA investigation. 

107. The Manufacturer Defendants were able to influence AAPM through both their 

significant and regular funding and the leadership of pro-opioid KOLs within the organization. 

108. In 1996, AAPM and APS jointly issued a consensus statement, “The Use of 

Opioids for the Treatment of Chronic Pain,” which endorsed opioids to treat chronic pain and 

claimed that the risk of a patients’ addiction to opioids was low. Dr. Haddox, who co-authored 

the AAPM/APS statement, was a paid speaker for Purdue at the time. Dr. Portenoy was the sole 

consultant. The consensus statement remained on AAPM’s website until 2011, and, upon 

information and belief, was taken down from AAPM’s website only after a doctor complained.53

109. AAPM and APS issued their own guidelines in 2009 (“AAPM/APS Guidelines”) 

and continued to recommend the use of opioids to treat chronic pain.54 Treatment guidelines 

have been relied upon by doctors, especially the general practitioners and family doctors targeted 

by the Manufacturer Defendants. Treatment guidelines not only directly inform doctors’ 

prescribing practices, but are cited throughout the scientific literature and referenced by thirdparty payors in determining whether they should cover treatments for specific indications. 

Pharmaceutical sales representatives employed by Endo, Actavis, and Purdue discussed 

treatment guidelines with doctors during individual sales visits. 

110. At least fourteen of the 21 panel members who drafted the AAPM/APS 

Guidelines, including KOLs Dr. Portenoy and Dr. Perry Fine of the University of Utah, received 

support from Janssen, Cephalon, Endo, and Purdue. The 2009 Guidelines promote opioids as 

 

53 The Use of Opioids for the Treatment of Chronic Pain: A Consensus Statement From the American Academy of 

Pain Medicine and the American Pain Society, 13 Clinical J. Pain 6 (1997). 

54 Roger Chou et al., Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Non-Cancer Pain, 10 J. 

Pain 113 (2009). 

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“safe and effective” for treating chronic pain, despite acknowledging limited evidence, and 

conclude that the risk of addiction is manageable for patients regardless of past abuse histories.55

One panel member, Dr. Joel Saper, Clinical Professor of Neurology at Michigan State University 

and founder of the Michigan Headache & Neurological Institute, resigned from the panel 

because of his concerns that the 2009 Guidelines were influenced by contributions that drug 

companies, including Manufacturer Defendants, made to the sponsoring organizations and 

committee members. These AAPM/APS Guidelines have been a particularly effective channel of 

deception and have influenced not only treating physicians, but also the body of scientific 

evidence on opioids; the Guidelines have been cited hundreds of times in academic literature, 

were disseminated in the State and/or Plaintiff’s Community during the relevant time period, are 

still available online, and were reprinted in the Journal of Pain. The Manufacturer Defendants 

widely referenced and promoted the 2009 Guidelines without disclosing the lack of evidence to 

support them or the Manufacturer Defendants financial support to members of the panel. 

111. The Manufacturer Defendants worked together, through Front Groups, to spread 

their deceptive messages about the risks and benefits of long-term opioid therapy. For example, 

Defendants combined their efforts through the Pain Care Forum (“PCF”), which began in 2004 

as an APF project. PCF is comprised of representatives from opioid manufacturers (including 

Cephalon, Endo, Janssen, and Purdue) and various Front Groups, almost all of which received 

substantial funding from the Manufacturer Defendants. Among other projects, PCF worked to 

ensure that an FDA-mandated education project on opioids was not unacceptably negative and 

did not require mandatory participation by prescribers, which the Manufacturer Defendants 

determined would reduce prescribing. 

 

55 Id.

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2. The Manufacturer Defendants’ Marketing Scheme Misrepresented 

the Risks and Benefits of Opioids. 

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. 

112. To falsely assure physicians and patients that opioids are safe, the Manufacturer 

Defendants deceptively trivialized and failed to disclose the risks of long-term opioid use, 

particularly the risk of addiction, through a series of misrepresentations that have been 

conclusively debunked by the FDA and CDC. These misrepresentations – which are described 

below – reinforced each other and created the dangerously misleading impression that: (1) 

starting patients on opioids was low risk because most patients would not become addicted, and 

because those at greatest risk for addiction could be identified and managed; (2) patients who 

displayed signs of addiction probably were not addicted and, in any event, could easily be 

weaned from the drugs; (3) the use of higher opioid doses, which many patients need to sustain 

pain relief as they develop tolerance to the drugs, do not pose special risks; and (4) abusedeterrent opioids both prevent abuse and overdose and are inherently less addictive. The 

Manufacturer Defendants have not only failed to correct these misrepresentations, they continue 

to make them today. 

113. Opioid manufacturers, including Defendants Endo Pharmaceuticals, Inc. and 

Purdue Pharma L.P., have entered into settlement agreements with public entities that prohibit 

them from making many of the misrepresentations identified in this Complaint. Yet even 

afterward, each Manufacturer Defendant continued to misrepresent the risks and benefits of 

long-term opioid use in the State and Plaintiff’s Community and each continues to fail to correct 

its past misrepresentations. 

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114. Some illustrative examples of the Manufacturer Defendants’ false, deceptive, and 

unfair claims about the purportedly low risk of addiction include: 

a. Actavis’s predecessor caused a patient education brochure, Managing Chronic 

Back Pain, to be distributed beginning in 2003 that admitted that opioid addiction 

is possible, but falsely claimed that it is “less likely if you have never had an 

addiction problem.” Based on Actavis’s acquisition of its predecessor’s marketing 

materials along with the rights to Kadian, it appears that Actavis continued to use 

this brochure in 2009 and beyond. 

b. Cephalon and Purdue sponsored APF’s Treatment Options: A Guide for People 

Living with Pain (2007), which suggested that addiction is rare and limited to 

extreme cases of unauthorized dose escalations, obtaining duplicative opioid 

prescriptions from multiple sources, or theft. This publication is still available 

online.56

c. Endo sponsored a website, “PainKnowledge,” which, upon information and 

belief, claimed in 2009 that “[p]eople who take opioids as prescribed usually do 

not become addicted.” Upon information and belief, another Endo website, 

PainAction.com, stated “Did you know? Most chronic pain patients do not 

become addicted to the opioid medications that are prescribed for them.” Endo 

also distributed an “Informed Consent” document on PainAction.com that 

misleadingly suggested that only people who “have problems with substance 

abuse and addiction” are likely to become addicted to opioid medications. 

 

56 Am. Pain Found., Treatment Options: A Guide for People Living in Pain (2007) [hereinafter APF, Treatment 

Options], https://assets.documentcloud.org/documents/277605/apf-treatmentoptions.pdf. 

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d. Upon information and belief, Endo distributed a pamphlet with the Endo logo 

entitled Living with Someone with Chronic Pain, which stated that: “Most health 

care providers who treat people with pain agree that most people do not develop 

an addiction problem.” 

e. Janssen reviewed, edited, approved, and distributed a patient education guide 

entitled Finding Relief: Pain Management for Older Adults (2009), which 

described as “myth” the claim that opioids are addictive, and asserted as fact that 

“[m]any studies show that opioids are rarely addictive when used properly for the 

management of chronic pain.” 

f. Janssen currently runs a website, Prescriberesponsibly.com (last updated July 2, 

2015), which claims that concerns about opioid addiction are “overestimated.” 

g. Purdue sponsored APF’s A Policymaker’s Guide to Understanding Pain & Its 

Management, which claims that less than 1% of children prescribed opioids will 

become addicted and that pain is undertreated due to “[m]isconceptions about 

opioid addiction.”57

h. Consistent with the Manufacturer Defendants’ published marketing materials, 

upon information and belief, detailers for Purdue, Endo, Janssen, and Cephalon in 

the State and Plaintiff’s Community minimized or omitted any discussion with 

doctors of the risk of addiction; misrepresented the potential for abuse of opioids 

with purportedly abuse-deterrent formulations; and routinely did not correct the 

misrepresentations noted above. 

 

57 Am. Pain Found., A Policymaker’s Guide to Understanding Pain and Its Management 6 (2011) [hereinafter APF, 

Policymaker’s Guide], http://s3.documentcloud.org/documents/277603/apf-policymakers-guide.pdf. 

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i. Seeking to overturn the criminal conviction of a doctor for illegally prescribing 

opioids, the Manufacturer Defendants’ Front Groups APF and NFP argued in an 

amicus brief to the United States Fourth Circuit Court of Appeals that “patients 

rarely become addicted to prescribed opioids,” citing research by their KOL, Dr. 

Portenoy.58

115. These claims are contrary to longstanding scientific evidence. A 2016 opioidprescription guideline issued by the CDC (the “2016 CDC Guideline”) explains that there is 

“[e]xtensive evidence” of the “possible harms of opioids (including opioid use disorder [an 

alternative term for opioid addiction], [and] overdose . . .).”59 The 2016 CDC Guideline further 

explains that “[o]pioid pain medication use presents serious risks, including overdose and opioid 

use disorder” and that “continuing opioid therapy for 3 months substantially increases risk for 

opioid use disorder.”60

116. The FDA further exposed the falsity of Defendants’ claims about the low risk of 

addiction when it announced changes to the labels for extended-release and long-acting 

(“ER/LA”) opioids in 2013 and for immediate release (“IR”) opioids in 2016. In its 

announcements, the FDA found that “most opioid drugs have ‘high potential for abuse’” and that 

opioids “are associated with a substantial risk of misuse, abuse, NOWS [neonatal opioid 

withdrawal syndrome], addiction, overdose, and death.” According to the FDA, because of the 

“known serious risks” associated with long-term opioid use, including “risks of addiction, abuse, 

 

58 Brief of the American Pain Foundation, the National Pain Foundation, and the National Foundation for the 

Treatment of Pain in Support of Appellant and Reversal of the Conviction, United States v. Hurowitz, No. 05-4474 

(4th Cir. Sept. 8, 2005) [hereinafter Brief of APF] at 9. 

59 Deborah Dowell et al., CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016, Morbidity 

& Mortality Wkly. Rep., Mar. 18, 2016, at 15 [hereinafter 2016 CDC Guideline], 

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm. 

60 Id. at 2, 25. 

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and misuse, even at recommended doses, and because of the greater risks of overdose and 

death,” opioids should be used only “in patients for whom alternative treatment options” like 

non-opioid drugs have failed.61

117. The State of New York, in a 2016 settlement agreement with Endo, found that 

opioid “use disorders appear to be highly prevalent in chronic pain patients treated with opioids, 

with up to 40% of chronic pain patients treated in specialty and primary care outpatient centers 

meeting the clinical criteria for an opioid use disorder.”62 Endo had claimed on its 

www.opana.com website that “[m]ost healthcare providers who treat patients with pain agree 

that patients treated with prolonged opioid medicines usually do not become addicted,” but the 

State of New York found that Endo had no evidence for that statement. Consistent with this, 

Endo agreed not to “make statements that . . . opioids generally are non-addictive” or “that most 

patients who take opioids do not become addicted” in New York. Endo remains free, however, to 

make those statements in this State. 

118. In addition to mischaracterizing the highly addictive nature of the drugs they were 

pushing, the Manufacturer Defendants also fostered a fundamental misunderstanding of the signs 

of addiction. Specifically, the Manufacturer Defendants misrepresented, to doctors and patients, 

that warning signs and/or symptoms of addiction were, instead, signs of undertreated pain (i.e. 

 

61 Letter from Janet Woodcock, M.D., Dir., Ctr. For Drug Evaluation and Research, U.S. Food and Drug Admin., 

U.S. Dep’t of Health and Human Servs., to Andrew Koldny, M.D., President, Physicians for Responsible Opioid 

Prescribing (Sept. 10, 2013), https://www.regulations.gov/contentStreamer?documentId=FDA-2012-P-0818-

0793&attachmentNumber=1&contentType=pdf.; Letter from Janet Woodcock, M.D., Dir., Ctr. For Drug Evaluation 

and Research, U.S. Food and Drug Admin., U.S. Dep’t of Health and Human Servs., to Peter R. Mathers & Jennifer 

A. Davidson, Kleinfeld, Kaplan and Becker, LLP (Mar. 22, 2016), 

https://www.regulations.gov/contentStreamer?documentId=FDA-2014-P-0205-

0006&attachmentNumber=1&contentType=pdf. 

62 Assurance of Discontinuance, In re Endo Health Solutions Inc. and Endo Pharm. Inc. (Assurance No. 15-228), at 

16, https://ag.ny.gov/pdfs/Endo_AOD_030116-Fully_Executed.pdf. 

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pseudoaddiction) – and instructed doctors to increase the opioid prescription dose for patients 

who were already in danger. 

119. To this end, one of Purdue’s employees, Dr. David Haddox, invented a 

phenomenon called “pseudoaddiction.” KOL Dr. Portenoy popularized the term. Examples of the 

false, misleading, deceptive, and unfair statements regarding pseudoaddiction include: 

a. Cephalon and Purdue sponsored Responsible Opioid Prescribing (2007), which 

taught that behaviors such as “requesting drugs by name,” “demanding or 

manipulative behavior,” seeing more than one doctor to obtain opioids, and 

hoarding, are all signs of pseudoaddiction, rather than true addiction.63 The 2012 

edition, which remains available for sale online, continues to teach that 

pseudoaddiction is real.64

b. Janssen sponsored, funded, and edited the Let’s Talk Pain website, which in 2009 

stated: “pseudoaddiction . . . refers to patient behaviors that may occur when pain 

is under-treated . . . . Pseudoaddiction is different from true addiction because 

such behaviors can be resolved with effective pain management.” 

c. Endo sponsored a National Initiative on Pain Control (“NIPC”) CME program in 

2009 entitled “Chronic Opioid Therapy: Understanding Risk While Maximizing 

Analgesia,” which, upon information and belief, promoted pseudoaddiction by 

teaching that a patient’s aberrant behavior was the result of untreated pain. Endo 

appears to have substantially controlled NIPC by funding NIPC projects; 

developing, specifying, and reviewing content; and distributing NIPC materials. 

 

63 Scott M. Fishman, M.D., Responsible Opioid Prescribing: A Physician’s Guide (2007) at 62. 

64 See Scott M. Fishman, M.D., Responsible Opioid Prescribing: A Physician’s Guide (2d ed. 2012). 

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d. Purdue published a pamphlet in 2011 entitled Providing Relief, Preventing Abuse, 

which, upon information and belief, described pseudoaddiction as a concept that 

“emerged in the literature” to describe the inaccurate interpretation of [drugseeking behaviors] in patients who have pain that has not been effectively 

treated.” 

e. Upon information and belief, Purdue sponsored a CME program titled “Path of 

the Patient, Managing Chronic Pain in Younger Adults at Risk for Abuse”. In a 

role play, a chronic pain patient with a history of drug abuse tells his doctor that 

he is taking twice as many hydrocodone pills as directed. The narrator notes that 

because of pseudoaddiction, the doctor should not assume the patient is addicted 

even if he persistently asks for a specific drug, seems desperate, hoards medicine, 

or “overindulges in unapproved escalating doses.” The doctor treats this patient 

by prescribing a high-dose, long-acting opioid. 

120. In the 2016 CDC Guideline, the CDC rejects the validity of the pseudoaddiction 

fallacy invented by a Purdue employee as a reason to push more opioid drugs onto already 

addicted patients. 

121. In addition to misstating the addiction risk and inventing the pseudoaddiction 

falsehood, a third category of false, deceptive, and unfair practice is the Manufacturer 

Defendants’ false instructions that addiction risk screening tools, patient contracts, urine drug 

screens, and similar strategies allow them to reliably identify and safely prescribe opioids to 

patients predisposed to addiction. These misrepresentations were especially insidious because the 

Manufacturer Defendants aimed them at general practitioners and family doctors who lack the 

time and expertise to closely manage higher-risk patients on opioids. The Manufacturer 

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Defendants’ misrepresentations made these doctors feel more comfortable prescribing opioids to 

their patients, and patients more comfortable starting on opioid therapy for chronic pain. 

Illustrative examples include: 

a. Endo paid for a 2007 supplement in the Journal of Family Practice written by a 

doctor who became a member of Endo’s speakers bureau in 2010. The 

supplement, entitled Pain Management Dilemmas in Primary Care: Use of 

Opioids, emphasized the effectiveness of screening tools, claiming that patients at 

high risk of addiction could safely receive chronic opioid therapy using a 

“maximally structured approach” involving toxicology screens and pill counts. 

b. Purdue, upon information and belief, sponsored a 2011 webinar, Managing 

Patient’s Opioid Use: Balancing the Need and Risk, which claimed that screening 

tools, urine tests, and patient agreements prevent “overuse of prescriptions” and 

“overdose deaths.” 

c. As recently as 2015, upon information and belief, Purdue has represented in 

scientific conferences that “bad apple” patients – and not opioids – are the source 

of the addiction crisis and that once those “bad apples” are identified, doctors can 

safely prescribe opioids without causing addiction. 

122. The 2016 CDC Guideline confirms the falsity of these claims. The Guideline 

explains that there are no studies assessing the effectiveness of risk mitigation strategies “for 

improving outcomes related to overdose, addiction, abuse or misuse.”65

123. A fourth category of deceptive messaging regarding dangerous opioids is the 

Manufacturer Defendants’ false assurances regarding the alleged ease of eliminating opioid 

 

65 Id. at 11. 

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dependence. The Manufacturer Defendants falsely claimed that opioid dependence can easily be 

addressed by tapering and that opioid withdrawal is not a problem, but they failed to disclose the 

increased difficulty of stopping opioids after long-term use. In truth, the 2016 CDC Guideline 

explains that the symptoms of opioid withdrawal include abdominal pain, vomiting, diarrhea, 

sweating, tremor, tachycardia, drug cravings, anxiety, insomnia, spontaneous abortion and 

premature labor in pregnant women.66

124. The Manufacturer Defendants nonetheless downplayed the severity of opioid 

detoxification. For example, upon information and belief, a CME sponsored by Endo, entitled 

Persistent Pain in the Older Adult, claimed that withdrawal symptoms can be avoided by 

tapering a patient’s opioid dose by 10%-20% for 10 days. And Purdue sponsored APF’s A 

Policymaker’s Guide to Understanding Pain & Its Management, which claimed that 

“[s]ymptoms of physical dependence can often be ameliorated by gradually decreasing the dose 

of medication during discontinuation” without mentioning any hardships that might occur.67 

125. A fifth category of false, deceptive, and unfair statements the Manufacturer 

Defendants made to sell more drugs is that opioid dosages could be increased indefinitely 

without added risk. The ability to escalate dosages was critical to Defendants’ efforts to market 

opioids for long-term use to treat chronic pain because, absent this misrepresentation, doctors 

would have abandoned treatment when patients built up tolerance and lower dosages did not 

provide pain relief. The Manufacturer Defendants’ deceptive claims include: 

a. Upon information and belief, Actavis’s predecessor created a patient brochure for 

Kadian in 2007 that stated, “Over time, your body may become tolerant of your 

current dose. You may require a dose adjustment to get the right amount of pain 

relief. This is not addiction.” Based on Actavis’s acquisition of its predecessor’s 

 

66 Id. at 26. 

67 APF, Policymaker’s Guide, supra note 48, at 32. 

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marketing materials along with the rights to Kadian, Actavis appears to have 

continued to use these materials in 2009 and beyond. 

b. Cephalon and Purdue sponsored APF’s Treatment Options: A Guide for People 

Living with Pain (2007), which claims that some patients “need” a larger dose of 

an opioid, regardless of the dose currently prescribed. The guide stated that 

opioids have “no ceiling dose” and insinuated that they are therefore the most 

appropriate treatment for severe pain.68 This publication is still available online. 

c. Endo sponsored a website, “PainKnowledge,” which, upon information and 

belief, claimed in 2009 that opioid dosages may be increased until “you are on the 

right dose of medication for your pain.” 

d. Endo distributed a pamphlet edited by a KOL entitled Understanding Your Pain: 

Taking Oral Opioid Analgesics (2004 Endo Pharmaceuticals PM-0120). In Q&A 

format, it asked “If I take the opioid now, will it work later when I really need it?” 

The response is, “The dose can be increased. . . . You won’t ‘run out’ of pain 

relief.”69

e. Janssen sponsored a patient education guide entitled Finding Relief: Pain 

Management for Older Adults (2009), which was distributed by its sales force. 

This guide listed dosage limitations as “disadvantages” of other pain medicines 

but omitted any discussion of risks of increased opioid dosages. 

f. Upon information and belief, Purdue’s In the Face of Pain website promoted the 

notion that if a patient’s doctor does not prescribe what, in the patient’s view, is a 

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dosage of opioids, he or she should find another doctor who will. 

g. Purdue sponsored APF’s A Policymaker’s Guide to Understanding Pain & Its 

Management, which taught that dosage escalations are “sometimes necessary,” 

and that “the need for higher doses of medication is not necessarily indicative of 

addiction,” but inaccurately downplayed the risks from high opioid dosages.70

h. In 2007, Purdue sponsored a CME entitled “Overview of Management Options” 

that was available for CME credit and available until at least 2012. The CME was 

edited by a KOL and taught that NSAIDs and other drugs, but not opioids, are 

unsafe at high dosages. 

 

68 APF, Treatment Options, supra note 47, at 12. 

69 Margo McCaffery & Chris Pasero, Endo Pharm., Understanding Your Pain: Taking Oral Opioid Analgesics

(Russell K Portenoy, M.D., ed., 2004). 

70 APF, Policymaker’s Guide, supra note 48, at 32. 

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i. Purdue presented a 2015 paper at the College on the Problems of Drug 

Dependence, “the oldest and largest organization in the US dedicated to 

advancing a scientific approach to substance use and addictive disorders,” 

challenging the correlation between opioid dosage and overdose.71

j. Seeking to overturn the criminal conviction of a doctor for illegally prescribing 

opioids, the Manufacturer Defendants’ Front Groups APF and NFP argued in an 

amicus brief to the United States Fourth Circuit Court of Appeals that “there is no 

‘ceiling dose’” for opioids.72

126. Once again, the 2016 CDC Guideline reveals that the Manufacturer Defendants’ 

representations regarding opioids were lacking in scientific evidence. The 2016 CDC Guideline 

clarifies that the “[b]enefits of high-dose opioids for chronic pain are not established” while the 

“risks for serious harms related to opioid therapy increase at higher opioid dosage.”73 More 

specifically, the CDC explains that “there is now an established body of scientific evidence 

showing that overdose risk is increased at higher opioid dosages.”74 The CDC also states that 

there is an increased risk “for opioid use disorder, respiratory depression, and death at higher 

dosages.”75 That is why the CDC advises doctors to “avoid increasing dosage” to above 90 

morphine milligram equivalents per day.76 

127. Defendants’ deceptive marketing of the so-called abuse-deterrent properties of 

some of their opioids has created false impressions that these opioids can cure addiction and 

abuse. 

128. The Manufacturer Defendants made misleading claims about the ability of their 

so-called abuse-deterrent opioid formulations to deter abuse. For example, Endo’s 

 

71 The College on Problems of Drug Dependence, About the College, http://cpdd.org (last visited Aug. 21, 2017). 

72 Brief of APF, supra note 49, at 9. 

73 2016 CDC Guideline, supra note 50, at 22–23. 

74 Id. at 23–24. 

75 Id. at 21. 

76 Id. at 16. 

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advertisements for the 2012 reformulation of Opana ER claimed that it was designed to be crush 

resistant, in a way that suggested it was more difficult to abuse. This claim was false. The FDA 

warned in a 2013 letter that Opana ER Extended-Release Tablets’ “extended-release features can 

be compromised, causing the medication to ‘dose dump,’ when subject to . . . forms of 

manipulation such as cutting, grinding, or chewing, followed by swallowing.”77 Also troubling, 

Opana ER can be prepared for snorting using commonly available methods and “readily 

prepared for injection.”78 The letter discussed “the troubling possibility that a higher (and rising) 

percentage of [Opana ER Extended-Release Tablet] abuse is occurring via injection.”79 Endo’s 

own studies, which it failed to disclose, showed that Opana ER could still be ground and chewed. 

In June 2017, the FDA requested that Opana ER be removed from the market. 

ii. The Manufacturer Defendants embarked upon a campaign of 

false, deceptive, and unfair assurances grossly overstating the 

benefits of the opioid drugs. 

129. To convince doctors and patients that opioids should be used to treat chronic pain, 

the Manufacturer Defendants also had to persuade them that there was a significant upside to 

long-term opioid use. But as the CDC Guideline makes clear, “[n]o evidence shows a long-term 

benefit of opioids in pain and function versus no opioids for chronic pain with outcomes 

examined at least 1 year later (with most placebo-controlled randomized trials ≤ 6 weeks in 

duration)” and that other treatments were more or equally beneficial and less harmful than longterm opioid use.80 The FDA, too, has recognized the lack of evidence to support long-term opioid 

 

77 Letter from Janet Woodcock, M.D., Dir., Ctr. For Drug Evaluation and Research, U.S. Food and Drug Admin., 

U.S. Dep’t of Health and Human Servs., to Robert Barto, Vice President, Reg. Affairs, Endo Pharm. Inc. (May 10, 

2013), at 5. 

78 Id. at 6. 

79 Id. at 6 n.21. 

80 Id. at 15. 

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use. Despite this, Defendants falsely and misleadingly touted the benefits of long-term opioid use 

and falsely and misleadingly suggested that these benefits were supported by scientific evidence. 

130. Some illustrative examples of the Manufacturer Defendants’ false claims are: 

a. Upon information and belief, Actavis distributed an advertisement claiming that 

the use of Kadian to treat chronic pain would allow patients to return to work, 

relieve “stress on your body and your mental health,” and help patients enjoy their 

lives. 

b. Endo distributed advertisements that claimed that the use of Opana ER for chronic 

pain would allow patients to perform demanding tasks like construction work or 

work as a chef and portrayed seemingly healthy, unimpaired subjects. 

c. Janssen sponsored and edited a patient education guide entitled Finding Relief: 

Pain Management for Older Adults (2009) – which states as “a fact” that “opioids 

may make it easier for people to live normally.” The guide lists expected 

functional improvements from opioid use, including sleeping through the night, 

returning to work, recreation, sex, walking, and climbing stairs. 

d. Janssen promoted Ultracet for everyday chronic pain and distributed posters, for 

display in doctors’ offices, of presumed patients in active professions; the caption 

read, “Pain doesn’t fit into their schedules.” 

e. Upon information and belief, Purdue ran a series of advertisements for OxyContin 

in 2012 in medical journals entitled “Pain vignettes,” which were case studies 

featuring patients with pain conditions persisting over several months and 

recommending OxyContin for them. The ads implied that OxyContin improves 

patients’ function. 

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f. Responsible Opioid Prescribing (2007), sponsored and distributed by Cephalon, 

Endo and Purdue, taught that relief of pain by opioids, by itself, improved 

patients’ function. 

g. Cephalon and Purdue sponsored APF’s Treatment Options: A Guide for People 

Living with Pain (2007), which counseled patients that opioids “give [pain 

patients] a quality of life we deserve.”81 This publication is still available online. 

h. Endo’s NIPC website “PainKnowledge” claimed in 2009, upon information and 

belief, that with opioids, “your level of function should improve; you may find 

you are now able to participate in activities of daily living, such as work and 

hobbies, that you were not able to enjoy when your pain was worse.” Elsewhere, 

the website touted improved quality of life (as well as “improved function”) as 

benefits of opioid therapy. The grant request that Endo approved for this project 

specifically indicated NIPC’s intent to make misleading claims about function, 

and Endo closely tracked visits to the site. 

i. Endo was the sole sponsor, through NIPC, of a series of CMEs entitled 

“Persistent Pain in the Older Patient.”82 Upon information and belief, a CME 

disseminated via webcast claimed that chronic opioid therapy has been “shown to 

reduce pain and improve depressive symptoms and cognitive functioning.” 

j. Janssen sponsored and funded a multimedia patient education campaign called 

“Let’s Talk Pain.” One feature of the campaign was to complain that patients 

were under-treated. In 2009, upon information and belief, a Janssen-sponsored 

 

81 APF, Treatment Options, supra note 47. 

82 E.g., NIPC, Persistent Pain and the Older Patient (2007),

https://www.painedu.org/Downloads/NIPC/Activities/B173_Providence_RI_%20Invite.pdf. 

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website, part of the “Let’s Talk Pain” campaign, featured an interview edited by 

Janssen claiming that opioids allowed a patient to “continue to function.” 

k. Purdue sponsored the development and distribution of APF’s A Policymaker’s 

Guide to Understanding Pain & Its Management, which claimed that “[m]ultiple 

clinical studies” have shown that opioids are effective in improving “[d]aily 

function,” “[p]sychological health,” and “[o]verall health-related quality of life 

for chronic pain.”83 The Policymaker’s Guide was originally published in 2011. 

l. Purdue’s, Cephalon’s, Endo’s, and Janssen’s sales representatives have conveyed 

and continue to convey the message that opioids will improve patient function. 

131. As the FDA and other agencies have made clear for years, these claims have no 

support in the scientific literature. 

132. In 2010, the FDA warned Actavis, in response to its advertising of Kadian 

described above, that “we are not aware of substantial evidence or substantial clinical experience 

demonstrating that the magnitude of the effect of the drug [Kadian] has in alleviating pain, taken 

together with any drug-related side effects patients may experience . . . results in any overall 

positive impact on a patient’s work, physical and mental functioning, daily activities, or 

enjoyment of life.”84 And in 2008, upon information and belief, the FDA sent a warning letter to 

an opioid manufacturer, making it clear “that [the claim that] patients who are treated with the 

drug experience an improvement in their overall function, social function, and ability to perform 

daily activities . . . has not been demonstrated by substantial evidence or substantial clinical 

experience.” 

 

83 APF, Policymaker’s Guide, supra note 48, at 29. 

84 Letter from Thomas Abrams to Doug Boothe, supra note 32. 

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133. The Manufacturer Defendants also falsely and misleadingly emphasized or 

exaggerated the risks of competing medications like NSAIDs, so that doctors and patients would 

look to opioids first for the treatment of chronic pain. Once again, these misrepresentations by 

the Manufacturer Defendants contravene pronouncements by and guidance from the FDA and 

CDC based on the scientific evidence. Indeed, the FDA changed the labels for ER/LA opioids in 

2013 and IR opioids in 2016 to state that opioids should only be used as a last resort “in patients 

for which alternative treatment options” like non-opioid drugs “are inadequate.” And the 2016 

CDC Guideline states that NSAIDs, not opioids, should be the first-line treatment for chronic 

pain, particularly arthritis and lower back pain.85 Purdue misleadingly promoted OxyContin as 

being unique among opioids in providing 12 continuous hours of pain relief with one dose. In 

fact, OxyContin does not last for 12 hours – a fact that Purdue has known at all times relevant to 

this action. Upon information and belief, Purdue’s own research shows that OxyContin wears off 

in under six hours in one quarter of patients and in under 10 hours in more than half. This is 

because OxyContin tablets release approximately 40% of their active medicine immediately, 

after which release tapers. This triggers a powerful initial response, but provides little or no pain 

relief at the end of the dosing period, when less medicine is released. This phenomenon is known 

as “end of dose” failure, and the FDA found in 2008 that a “substantial proportion” of chronic 

pain patients taking OxyContin experience it. This not only renders Purdue’s promise of 12 

hours of relief false and deceptive, it also makes OxyContin more dangerous because the 

declining pain relief patients experience toward the end of each dosing period drives them to take 

more OxyContin before the next dosing period begins, quickly increasing the amount of drug 

they are taking and spurring growing dependence. 

 

85 2016 CDC Guideline, supra note 50, at 12. 

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134. Purdue’s competitors were aware of this problem. For example, upon information 

and belief, Endo ran advertisements for Opana ER referring to “real” 12-hour dosing. 

Nevertheless, Purdue falsely promoted OxyContin as if it were effective for a full 12 hours. 

Upon information and belief, Purdue’s sales representatives continue to tell doctors that 

OxyContin lasts a full 12 hours. 

135. Front Groups supported by Purdue likewise echoed these representations. For 

example, in an amicus brief submitted to the Supreme Court of Ohio by the American Pain 

Foundation, the National Foundation for the Treatment of Pain and the Ohio Pain Initiative in 

support of Purdue, those amici represented: 

OxyContin is particularly useful for sustained long-term pain because it comes in 

higher, compact pills with a slow release coating. OxyContin pills can work for 

12 hours. This makes it easier for patients to comply with dosing requirements 

without experiencing a roller-coaster of pain relief followed quickly by pain 

renewal that can occur with shorter acting medications. It also helps the patient 

sleep through the night, which is often impossible with short-acting medications. 

For many of those serviced by Pain Care Amici, OxyContin has been a miracle 

medication.86

136. Cephalon deceptively marketed its opioids Actiq and Fentora for chronic pain 

even though the FDA has expressly limited their use to the treatment of cancer pain in opioid 

tolerant individuals. Both Actiq and Fentora are extremely powerful fentanyl-based IR opioids. 

Neither is approved for or has been shown to be safe or effective for chronic pain. Indeed, the 

FDA expressly prohibited Cephalon from marketing Actiq for anything but cancer pain, and 

refused to approve Fentora for the treatment of chronic pain because of the potential harm, 

including the high risk of “serious and life-threatening adverse events” and abuse – which are 

greatest in non-cancer patients. The FDA also issued a Public Health Advisory in 2007 

 

86 Reply Brief of Amicus Curiae of the American Pain Foundation, The National Foundation for the Treatment of 

Pain and the Ohio Pain Initiative Supporting Appellants, Howland v. Purdue Pharma L.P., No. 2003-1538 (Ohio 

Apr. 13, 2004), 2004 WL 1637768, at *4 (footnote omitted). 

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emphasizing that Fentora should only be used for cancer patients who are opioid-tolerant and 

should not be used for any other conditions, such as migraines, post-operative pain, or pain due 

to injury.87 Specifically, the FDA advised that Fentora “is only approved for breakthrough cancer 

pain in patients who are opioid-tolerant, meaning those patients who take a regular, daily, 

around-the-clock narcotic pain medication.”88

137. Despite this, Cephalon conducted and continues to conduct a well-funded 

campaign to promote Actiq and Fentora for chronic pain and other non-cancer conditions for 

which it was not approved, appropriate, and for which it is not safe. As part of this campaign, 

Cephalon used CMEs, speaker programs, KOLs, journal supplements, and detailing by its sales 

representatives to give doctors the false impression that Actiq and Fentora are safe and effective 

for treating non-cancer pain. For example: 

a. Cephalon paid to have a CME it sponsored, Opioid-Based Management of Persistent 

and Breakthrough Pain, published in a supplement of Pain Medicine News in 2009. 

The CME instructed doctors that “[c]linically, broad classification of pain syndromes 

as either cancer- or non-cancer-related has limited utility” and recommended Actiq 

and Fentora for patients with chronic pain. 

b. Upon information and belief, Cephalon’s sales representatives set up hundreds of 

speaker programs for doctors, including many non-oncologists, which promoted 

Actiq and Fentora for the treatment of non-cancer pain. 

c. In December 2011, Cephalon widely disseminated a journal supplement entitled 

“Special Report: An Integrated Risk Evaluation and Mitigation Strategy for Fentanyl 

Buccal Tablet (FENTORA) and Oral Transmucosal Fentanyl Citrate (ACTIQ)” to 

Anesthesiology News, Clinical Oncology News, and Pain Medicine News – three 

publications that are sent to thousands of anesthesiologists and other medical 

professionals. The Special Report openly promotes Fentora for “multiple causes of 

pain” – and not just cancer pain. 

 

87 See U.S. Food & Drug Admin., Public Health Advisory: Important Information for the Safe Use of Fentora 

(fentanyl buccal tablets) (Sept. 26, 2007), 

https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm051273.htm. 

88 Id. 

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138. Cephalon’s deceptive marketing gave doctors and patients the false impression 

that Actiq and Fentora were not only safe and effective for treating chronic pain, but were also 

approved by the FDA for such uses. 

139. Purdue also unlawfully and unfairly failed to report or address illicit and unlawful 

prescribing of its drugs, despite knowing about it for years. Purdue’s sales representatives have 

maintained a database since 2002 of doctors suspected of inappropriately prescribing its drugs. 

Rather than report these doctors to state medical boards or law enforcement authorities (as 

Purdue is legally obligated to do) or cease marketing to them, Purdue used the list to demonstrate 

the high rate of diversion of OxyContin – the same OxyContin that Purdue had promoted as less 

addictive – in order to persuade the FDA to bar the manufacture and sale of generic copies of the 

drug because the drug was too likely to be abused. In an interview with the Los Angeles Times, 

Purdue’s senior compliance officer acknowledged that in five years of investigating suspicious 

pharmacies, Purdue failed to take action – even where Purdue employees personally witnessed 

the diversion of its drugs. The same was true of prescribers; despite its knowledge of illegal 

prescribing, Purdue did not report that a Los Angeles clinic prescribed more than 1.1 million 

OxyContin tablets and that Purdue’s district manager described it internally as “an organized 

drug ring” until years after law enforcement shut it down. In doing so, Purdue protected its own 

profits at the expense of public health and safety.89

140. Like Purdue, Endo has been cited for its failure to set up an effective system for 

identifying and reporting suspicious prescribing. In its settlement agreement with Endo, the State 

of New York found that Endo failed to require sales representatives to report signs of abuse, 

diversion, and inappropriate prescribing; paid bonuses to sales representatives for detailing 

 

89 Harriet Ryan et al., More Than 1 Million Oxycontin Pills Ended Up in the Hands of Criminals and Addicts. What 

the Drugmaker Knew, L.A. Times, July 10, 2016, http://www.latimes.com/projects/la-me-oxycontin-part2/. 

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prescribers who were subsequently arrested or convicted for illegal prescribing; and failed to 

prevent sales representatives from visiting prescribers whose suspicious conduct had caused 

them to be placed on a no-call list. 

3. The Manufacturer Defendants Targeted Susceptible Prescribers 

and Vulnerable Patient Populations. 

141. As a part of their deceptive marketing scheme, the Manufacturer Defendants 

identified and targeted susceptible prescribers and vulnerable patient populations in the U.S., 

including this State and Plaintiff’s Community. For example, the Manufacturer Defendants 

focused their deceptive marketing on primary care doctors, who were more likely to treat chronic 

pain patients and prescribe them drugs, but were less likely to be educated about treating pain 

and the risks and benefits of opioids and therefore more likely to accept the Manufacturer 

Defendants’ misrepresentations. 

142. The Manufacturer Defendants also targeted vulnerable patient populations like the 

elderly and veterans, who tend to suffer from chronic pain. The Manufacturer Defendants 

targeted these vulnerable patients even though the risks of long-term opioid use were 

significantly greater for them. For example, the 2016 CDC Guideline observes that existing 

evidence confirms that elderly patients taking opioids suffer from elevated fall and fracture risks, 

reduced renal function and medication clearance, and a smaller window between safe and unsafe 

dosages.90 The 2016 CDC Guideline concludes that there must be “additional caution and 

increased monitoring” to minimize the risks of opioid use in elderly patients. Id. at 27. The same 

is true for veterans, who are more likely to use anti-anxiety drugs (benzodiazepines) for posttraumatic stress disorder, which interact dangerously with opioids. 

 

90 2016 CDC Guideline, supra note 50, at 13. 

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4. The Manufacturer Defendants made Materially Deceptive 

Statements and Concealed Materials Facts. 

143. As alleged herein, the Manufacturer Defendants made and/or disseminated 

deceptive statements regarding material facts and further concealed material facts, in the course 

of manufacturing, marketing, and selling prescription opioids. The Manufacturer Defendants’ 

actions were intentional and/or unlawful. Such statements include, but are not limited to, those 

set out below and alleged throughout this Complaint. 

144. Defendant Purdue made and/or disseminated deceptive statements, and concealed 

material facts in such a way to make their statements deceptive, including, but not limited to, the 

following: 

a. Creating, sponsoring, and assisting in the distribution of patient education 

materials distributed to consumers that contained deceptive statements; 

b. Creating and disseminating advertisements that contained deceptive statements 

concerning the ability of opioids to improve function long-term and concerning 

the evidence supporting the efficacy of opioids long-term for the treatment of 

chronic non-cancer pain; 

c. Disseminating misleading statements concealing the true risk of addiction and 

promoting the deceptive concept of pseudoaddiction through Purdue’s own 

unbranded publications and on internet sites Purdue operated that were marketed 

to and accessible by consumers; 

d. Distributing brochures to doctors, patients, and law enforcement officials that 

included deceptive statements concerning the indicators of possible opioid abuse; 

e. Sponsoring, directly distributing, and assisting in the distribution of publications 

that promoted the deceptive concept of pseudoaddiction, even for high-risk 

patients; 

f. Endorsing, directly distributing, and assisting in the distribution of publications 

that presented an unbalanced treatment of the long-term and dose-dependent risks 

of opioids versus NSAIDs; 

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g. Providing significant financial support to pro-opioid KOL doctors who made 

deceptive statements concerning the use of opioids to treat chronic non-cancer 

pain; 

h. Providing needed financial support to pro-opioid pain organizations that made 

deceptive statements, including in patient education materials, concerning the use 

of opioids to treat chronic non-cancer pain; 

i. Assisting in the distribution of guidelines that contained deceptive statements 

concerning the use of opioids to treat chronic non-cancer pain and misrepresented 

the risks of opioid addiction; 

j. Endorsing and assisting in the distribution of CMEs containing deceptive 

statements concerning the use of opioids to treat chronic non-cancer pain; 

k. Developing and disseminating scientific studies that misleadingly concluded 

opioids are safe and effective for the long-term treatment of chronic non-cancer 

pain and that opioids improve quality of life, while concealing contrary data; 

l. Assisting in the dissemination of literature written by pro-opioid KOLs that 

contained deceptive statements concerning the use of opioids to treat chronic 

noncancer pain; 

m. Creating, endorsing, and supporting the distribution of patient and prescriber 

education materials that misrepresented the data regarding the safety and efficacy 

of opioids for the long-term treatment of chronic non-cancer pain, including 

known rates of abuse and addiction and the lack of validation for long-term 

efficacy; 

n. Targeting veterans by sponsoring and disseminating patient education marketing 

materials that contained deceptive statements concerning the use of opioids to 

treat chronic non-cancer pain; 

o. Targeting the elderly by assisting in the distribution of guidelines that contained 

deceptive statements concerning the use of opioids to treat chronic non-cancer pain 

and misrepresented the risks of opioid addiction in this population; 

p. Exclusively disseminating misleading statements in education materials to hospital 

doctors and staff while purportedly educating them on new pain standards; 

q. Making deceptive statements concerning the use of opioids to treat chronic 

noncancer pain to prescribers through in-person detailing; and 

r. Withholding from law enforcement the names of prescribers Purdue believed to be 

facilitating the diversion of its opioid, while simultaneously marketing opioids to 

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these doctors by disseminating patient and prescriber education materials and 

advertisements and CMEs they knew would reach these same prescribers. 

145. Defendant Endo made and/or disseminated deceptive statements, and concealed 

material facts in such a way to make their statements deceptive, including, but not limited to, the 

following: 

a. Creating, sponsoring, and assisting in the distribution of patient education materials 

that contained deceptive statements; 

b. Creating and disseminating advertisements that contained deceptive statements 

concerning the ability of opioids to improve function long-term and concerning the 

evidence supporting the efficacy of opioids long-term for the treatment of chronic 

non-cancer pain; 

c. Creating and disseminating paid advertisement supplements in academic journals 

promoting chronic opioid therapy as safe and effective for long term use for high risk 

patients; 

d. Creating and disseminating advertisements that falsely and inaccurately conveyed the 

impression that Endo’s opioids would provide a reduction in oral, intranasal, or 

intravenous abuse; 

e. Disseminating misleading statements concealing the true risk of addiction and 

promoting the misleading concept of pseudoaddiction through Endo’s own unbranded 

publications and on internet sites Endo sponsored or operated; 

f. Endorsing, directly distributing, and assisting in the distribution of publications that 

presented an unbalanced treatment of the long-term and dose-dependent risks of 

opioids versus NSAIDs; 

g. Providing significant financial support to pro-opioid KOLs, who made deceptive 

statements concerning the use of opioids to treat chronic non-cancer pain; 

h. Providing needed financial support to pro-opioid pain organizations – including over 

$5 million to the organization responsible for many of the most egregious 

misrepresentations – that made deceptive statements, including in patient education 

materials, concerning the use of opioids to treat chronic non-cancer pain; 

i. Targeting the elderly by assisting in the distribution of guidelines that contained 

deceptive statements concerning the use of opioids to treat chronic non-cancer pain 

and misrepresented the risks of opioid addiction in this population; 

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j. Endorsing and assisting in the distribution of CMEs containing deceptive statements 

concerning the use of opioids to treat chronic non-cancer pain; 

k. Developing and disseminating scientific studies that deceptively concluded opioids 

are safe and effective for the long-term treatment of chronic non-cancer pain and that 

opioids improve quality of life, while concealing contrary data; 

l. Directly distributing and assisting in the dissemination of literature written by proopioid KOLs that contained deceptive statements concerning the use of opioids to 

treat chronic non-cancer pain, including the concept of pseudoaddiction; 

m. Creating, endorsing, and supporting the distribution of patient and prescriber 

education materials that misrepresented the data regarding the safety and efficacy of 

opioids for the long-term treatment of chronic non-cancer pain, including known rates 

of abuse and addiction and the lack of validation for long-term efficacy; and 

n. Making deceptive statements concerning the use of opioids to treat chronic noncancer pain to prescribers through in-person detailing. 

146. Defendant Janssen made and/or disseminated deceptive statements, and concealed 

material facts in such a way to make their statements deceptive, including, but not limited to, the 

following: 

a. Creating, sponsoring, and assisting in the distribution of patient education 

materials that contained deceptive statements; 

b. Directly disseminating deceptive statements through internet sites over which 

Janssen exercised final editorial control and approval stating that opioids are safe 

and effective for the long-term treatment of chronic non-cancer pain and that 

opioids improve quality of life, while concealing contrary data; 

c. Disseminating deceptive statements concealing the true risk of addiction and 

promoting the deceptive concept of pseudoaddiction through internet sites over 

which Janssen exercised final editorial control and approval; 

d. Promoting opioids for the treatment of conditions for which Janssen knew, due to 

the scientific studies it conducted, that opioids were not efficacious and 

concealing this information; 

e. Sponsoring, directly distributing, and assisting in the dissemination of patient 

education publications over which Janssen exercised final editorial control and 

approval, which presented an unbalanced treatment of the long-term and dose 

dependent risks of opioids versus NSAIDs; 

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f. Providing significant financial support to pro-opioid KOLs, who made deceptive 

statements concerning the use of opioids to treat chronic non-cancer pain; 

g. Providing necessary financial support to pro-opioid pain organizations that made 

deceptive statements, including in patient education materials, concerning the use 

of opioids to treat chronic non-cancer pain; 

h. Targeting the elderly by assisting in the distribution of guidelines that contained 

deceptive statements concerning the use of opioids to treat chronic non-cancer 

pain and misrepresented the risks of opioid addiction in this population; 

i. Targeting the elderly by sponsoring, directly distributing, and assisting in the 

dissemination of patient education publications targeting this population that 

contained deceptive statements about the risks of addiction and the adverse effects 

of opioids, and made false statements that opioids are safe and effective for the 

long-term treatment of chronic non-cancer pain and improve quality of life, while 

concealing contrary data; 

j. Endorsing and assisting in the distribution of CMEs containing deceptive 

statements concerning the use of opioids to treat chronic non-cancer pain; 

k. Directly distributing and assisting in the dissemination of literature written by 

pro-opioid KOLs that contained deceptive statements concerning the use of 

opioids to treat chronic non-cancer pain, including the concept of 

pseudoaddiction; 

l. Creating, endorsing, and supporting the distribution of patient and prescriber 

education materials that misrepresented the data regarding the safety and efficacy 

of opioids for the long-term treatment of chronic non-cancer pain, including 

known rates of abuse and addiction and the lack of validation for long-term 

efficacy; 

m. Targeting veterans by sponsoring and disseminating patient education marketing 

materials that contained deceptive statements concerning the use of opioids to 

treat chronic non-cancer pain; and 

n. Making deceptive statements concerning the use of opioids to treat chronic noncancer pain to prescribers through in-person detailing. 

147. Defendant Cephalon made and/or disseminated untrue, false and deceptive 

statements, and concealed material facts in such a way to make their statements deceptive, 

including, but not limited to, the following: 

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a. Creating, sponsoring, and assisting in the distribution of patient education materials 

that contained deceptive statements; 

b. Sponsoring and assisting in the distribution of publications that promoted the 

deceptive concept of pseudoaddiction, even for high-risk patients; 

c. Providing significant financial support to pro-opioid KOL doctors who made 

deceptive statements concerning the use of opioids to treat chronic non-cancer pain 

and breakthrough chronic non-cancer pain; 

d. Developing and disseminating scientific studies that deceptively concluded opioids 

are safe and effective for the long-term treatment of chronic non-cancer pain in 

conjunction with Cephalon’s potent rapid-onset opioids; 

e. Providing needed financial support to pro-opioid pain organizations that made 

deceptive statements, including in patient education materials, concerning the use of 

opioids to treat chronic non-cancer pain; 

f. Endorsing and assisting in the distribution of CMEs containing deceptive statements 

concerning the use of opioids to treat chronic non-cancer pain; 

g. Endorsing and assisting in the distribution of CMEs containing deceptive statements 

concerning the use of Cephalon’s rapid-onset opioids; 

h. Directing its marketing of Cephalon’s rapid-onset opioids to a wide range of doctors, 

including general practitioners, neurologists, sports medicine specialists, and 

workers’ compensation programs, serving chronic pain patients; 

i. Making deceptive statements concerning the use of Cephalon’s opioids to treat 

chronic non-cancer pain to prescribers through in-person detailing and speakers’ 

bureau events, when such uses are unapproved and unsafe; and 

j. Making deceptive statements concerning the use of opioids to treat chronic noncancer pain to prescribers through in-person detailing and speakers’ bureau events. 

148. Defendant Actavis made and/or disseminated deceptive statements, and concealed 

material facts in such a way to make their statements deceptive, including, but not limited to, the 

following: 

a. Making deceptive statements concerning the use of opioids to treat chronic noncancer pain to prescribers through in-person detailing; 

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b. Creating and disseminating advertisements that contained deceptive statements that 

opioids are safe and effective for the long-term treatment of chronic non-cancer pain 

and that opioids improve quality of life; 

c. Creating and disseminating advertisements that concealed the risk of addiction in the 

long-term treatment of chronic, non-cancer pain; and 

d. Developing and disseminating scientific studies that deceptively concluded opioids 

are safe and effective for the long-term treatment of chronic non-cancer pain and that 

opioids improve quality of life while concealing contrary data. 

5. The Manufacturer Defendants Fraudulently Concealed Their 

Misconduct. 

149. The Manufacturer Defendants, both individually and collectively, made, 

promoted, and profited from their misrepresentations about the risks and benefits of opioids for 

chronic pain even though they knew that their misrepresentations were false and deceptive. The 

history of opioids, as well as research and clinical experience establish that opioids are highly 

addictive and are responsible for a long list of very serious adverse outcomes. The FDA warned 

Defendants of this, and Defendants had access to scientific studies, detailed prescription data, 

and reports of adverse events, including reports of addiction, hospitalization, and death – all of 

which clearly described the harm from long-term opioid use and that patients were suffering 

from addiction, overdose, and death in alarming numbers. More recently, the FDA and CDC 

have issued pronouncements, based on medical evidence, that conclusively expose the falsity of 

Defendants’ misrepresentations, and Endo and Purdue have recently entered agreements in New 

York prohibiting them from making some of the same misrepresentations described in this 

Complaint. 

150. At all times relevant to this Complaint, the Manufacturer Defendants took steps to 

avoid detection of and to fraudulently conceal their deceptive marketing and unlawful, unfair, 

and fraudulent conduct. For example, the Manufacturer Defendants disguised their role in the 

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deceptive marketing of chronic opioid therapy by funding and working through third parties like 

Front Groups and KOLs. The Manufacturer Defendants purposefully hid behind the assumed 

credibility of these individuals and organizations and relied on them to vouch for the accuracy 

and integrity of the Manufacturer Defendants’ false and deceptive statements about the risks and 

benefits of long-term opioid use for chronic pain. Defendants also never disclosed their role in 

shaping, editing, and approving the content of information and materials disseminated by these 

third parties. The Manufacturer Defendants exerted considerable influence on these promotional 

and “educational” materials in emails, correspondence, and meetings with KOLs, Front Groups, 

and public relations companies that were not, and have not yet become, public. For example, 

PainKnowledge.org, which is run by the NIPC, did not disclose Endo’s involvement. Other 

Manufacturer Defendants, such as Purdue and Janssen, ran similar websites that masked their 

own role. 

151. Finally, the Manufacturer Defendants manipulated their promotional materials 

and the scientific literature to make it appear that these documents were accurate, truthful, and 

supported by objective evidence when they were not. The Manufacturer Defendants distorted the 

meaning or import of studies they cited and offered them as evidence for propositions the studies 

did not support. The Manufacturer Defendants invented “pseudoaddiction” and promoted it to an 

unsuspecting medical community. The Manufacturer Defendants provided the medical 

community with false and misleading information about ineffectual strategies to avoid or control 

opioid addiction. The Manufacturer Defendants recommended to the medical community that 

dosages be increased, without disclosing the risks. The Manufacturer Defendants spent millions 

of dollars over a period of years on a misinformation campaign aimed at highlighting opioids’ 

alleged benefits, disguising the risks, and promoting sales. The lack of support for the 

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Manufacturer Defendants’ deceptive messages was not apparent to medical professionals who 

relied upon them in making treatment decisions, nor could it have been detected by the Plaintiff 

or Plaintiff’s Community. Thus, the Manufacturer Defendants successfully concealed from the 

medical community, patients, and health care payors facts sufficient to arouse suspicion of the 

claims that the Plaintiff now asserts. Plaintiff did not know of the existence or scope of the 

Manufacturer Defendants’ industry-wide fraud and could not have acquired such knowledge 

earlier through the exercise of reasonable diligence. 

C. THE DISTRIBUTOR DEFENDANTS’ UNLAWFUL 

DISTRIBUTION OF OPIOIDS. 

152. The Distributor Defendants owe a duty under both federal law (21 U.S.C. § 823, 

21 CFR 1301.74) and Ohio law (e.g., OHIO REV. CODE ANN. § 4729.01(F), OHIO ADMIN. CODE

§§ 4729-9-12, 4729-9-16, 4729-9-28), to monitor, detect, investigate, refuse to fill, and report 

suspicious orders of prescription opioids originating from Plaintiff’s Community as well as those 

orders which the Distributor Defendants knew or should have known were likely to be diverted 

into Plaintiff’s Community. 

153. The foreseeable harm from a breach of these duties is the diversion of prescription 

opioids for nonmedical purposes. 

154. Each Distributor Defendant repeatedly and purposefully breached its duties under 

state and federal law. Such breaches are a direct and proximate causes of the widespread 

diversion of prescription opioids for nonmedical purposes into Plaintiff’s Community. 

155. The unlawful diversion of prescription opioids is a direct and proximate cause of 

the opioid epidemic, prescription opioid abuse, addiction, morbidity and mortality in the State 

and in Plaintiff’s Community. This diversion and the epidemic are direct causes of harms for 

which Plaintiff seeks to recover here. 

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156. The opioid epidemic in Ohio, including inter alia in Plaintiff’s Community, 

remains an immediate hazard to public health and safety. 

157. The opioid epidemic in Plaintiff’s Community is a temporary and continuous 

public nuisance and remains unabated. 

158. The Distributor Defendants’ intentionally continued their conduct, as alleged 

herein, with knowledge that such conduct was creating the opioid nuisance and causing the 

harms and damages alleged herein. 

1. The Distributor Defendants Have a Duty under Federal and State 

Law to Guard Against, and Report, Unlawful Diversion and to Report 

and Prevent Suspicious Orders. 

159. Opioids are a controlled substance and are categorized as “dangerous drugs” 

under Ohio law. See OHIO REV. CODE ANN. § 4729.01(F). These “Schedule II” drugs are 

controlled substances with a “high potential for abuse.” 21 U.S.C. §§ 812(b), 812(2)(A)-(C). 

160. As wholesale drug distributors, each Distributor Defendant was required under 

Ohio law to obtain a license as a wholesaler of controlled substances from the state board of 

pharmacy. OHIO REV. CODE ANN. § 4729.52.91 Each Distributor Defendant is licensed by the 

Ohio Board of Pharmacy and is a “registrant” or “licensee” as a wholesale distributor in the 

chain of distribution of Schedule II controlled substances and assumed a duty to comply with all 

security requirements imposed under the regulations adopted by the Ohio Board of Pharmacy. 

161. Each Distributor Defendant was further required to register with the DEA, 

pursuant to the federal Controlled Substance Act. See 21 U.S.C. § 823(b), (e); 28 C.F.R. § 

0.100. Each Distributor Defendant is a “registrant” as a wholesale distributor in the chain of 

distribution of Schedule II controlled substances with a duty to comply with all security 

 

91 See also former requirement under OHIO REV. CODE ANN. § 3719.021, repealed 2017. 

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requirements imposed under that statutory scheme. Those requirements are adopted and 

incorporated into Ohio law. OHIO ADMIN. CODE § 4729-9-16(L); see also § 4729-9-28(I). 

162. Each Distributor Defendant has an affirmative duty under federal and Ohio law to 

act as a gatekeeper guarding against the diversion of the highly addictive, dangerous opioid 

drugs. Federal law requires that Distributors of Schedule II drugs, including opioids, must 

maintain “effective control against diversion of particular controlled substances into other than 

legitimate medical, scientific, and industrial channels.” 21 U.S.C. §§ 823(b)(1). Ohio 

incorporates these requirements through Ohio’s Pharmacy Board Regulations, which mandate 

that “[w]holesale drug distributors shall operate in compliance with applicable federal, state, and 

local laws and regulations.” OHIO ADMIN. CODE § 4729-9-16(L); see also § 4729-9-28(I). 

163. The Ohio Pharmacy Board requires that drug wholesalers “shall establish and 

maintain inventories and records of all transactions regarding the receipt and distribution or other 

disposition of dangerous drugs,” and that, as a minimum requirement of wholesale distribution in 

this State, “[a] system shall be designed and operated to disclose orders for controlled 

substances and other dangerous drugs subject to abuse.” OHIO ADMIN. CODE § 4729-9-16(H) 

(emph. added). 

164. Ohio regulations further mandate that suspicious orders, defined as unusual in size 

or frequency or deviation from buying patterns, be reported to the Ohio Board of Pharmacy: 

 The wholesaler shall inform the state board of pharmacy of suspicious 

orders for drugs when discovered. Suspicious orders are those which, in 

relation to the wholesaler's records as a whole, are of unusual size, unusual 

frequency, or deviate substantially from established buying patterns. 

 Reports generated by the system shall be furnished to the state board of 

pharmacy within three working days of receipt of a request from the 

board. The reports shall include the name and address of the purchaser, 

date of purchases, product trade name, national drug code (NDC) number, 

size of package, and quantity purchased. 

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OHIO ADMIN. CODE § 4729-9-16(H)(1)(e) (emph. added); see also 4729-9-12(G); 4729-9-28(E). 

165. Federal regulations, incorporated by Ohio law (OHIO ADMIN. CODE § 4729-9-

16(L); see also § 4729-9-28(I)), similarly impose a non-delegable duty upon wholesale drug 

distributors to “design and operate a system to disclose to the registrant suspicious orders of 

controlled substances. The registrant [distributor] shall inform the Field Division Office of the 

Administration in his area of suspicious orders when discovered by the registrant. Suspicious 

orders include orders of unusual size, orders deviating substantially from a normal pattern, and 

orders of unusual frequency.” 21 C.F.R. § 1301.74(b). 

166. “Suspicious orders” include orders of an unusual size, orders of unusual 

frequency or orders deviating substantially from a normal pattern. See 21 CFR 1301.74(b); OHIO 

ADMIN. CODE § 4729-9-16(H)(1)(e)(i). These criteria are disjunctive and are not all inclusive. 

For example, if an order deviates substantially from a normal pattern, the size of the order does 

not matter and the order should be reported as suspicious. Likewise, a wholesale distributor need 

not wait for a normal pattern to develop over time before determining whether a particular order 

is suspicious. The size of an order alone, regardless of whether it deviates from a normal pattern, 

is enough to trigger the wholesale distributor’s responsibility to report the order as suspicious. 

The determination of whether an order is suspicious depends not only on the ordering patterns of 

the particular customer but also on the patterns of the entirety of the wholesale distributor’s 

customer base and the patterns throughout the relevant segment of the wholesale distributor 

industry. 

167. In addition to reporting all suspicious orders, distributors must also stop shipment 

on any order which is flagged as suspicious and only ship orders which were flagged as 

potentially suspicious if, after conducting due diligence, the distributor can determine that the 

order is not likely to be diverted into illegal channels. See Southwood Pharm., Inc., 72 Fed. Reg. 

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36,487, 36,501 (Drug Enf’t Admin. July 3, 2007); Masters Pharmaceutical, Inc. v. Drug 

Enforcement Administration, No. 15-11355 (D.C. Cir. June 30, 2017). Regardless, all flagged 

orders must be reported. Id.

168. These prescription drugs are regulated for the purpose of providing a “closed” 

system intended to reduce the widespread diversion of these drugs out of legitimate 

channels into the illicit market, while at the same time providing the legitimate drug industry 

with a unified approach to narcotic and dangerous drug control.92

169. Different entities supervise the discrete links in the chain that separate a consumer 

from a controlled substance. Statutes and regulations define each participant’s role and 

responsibilities.93 

170. As the DEA advised the Distributor Defendants in a letter to them dated 

September 27, 2006, wholesale distributors are “one of the key components of the distribution 

chain. If the closed system is to function properly ... distributors must be vigilant in deciding 

whether a prospective customer can be trusted to deliver controlled substances only for lawful 

purposes. This responsibility is critical, as ... the illegal distribution of controlled substances has 

a substantial and detrimental effect on the health and general welfare of the American people.”94 

 

92 See 1970 U.S.C.C.A.N. 4566, 4571-72. 

93 Brief for Healthcare Distribution Management Association and National Association of Chain Drug Stores as 

Amici Curiae in Support of Neither Party, Masters Pharm., Inc. v. U.S. Drug Enf’t Admin. (No. 15-1335) (D.C. Cir. 

Apr. 4, 2016), 2016 WL 1321983, at *22 [hereinafter Brief for HDMA and NACDS]. The Healthcare Distribution 

Management Association (HDMA or HMA)—now known as the Healthcare Distribution Alliance (HDA)—is a 

national, not-for-profit trade association that represents the nation’s primary, full-service healthcare distributors 

whose membership includes, among others: AmerisourceBergen Drug Corporation, Cardinal Health, Inc., and 

McKesson Corporation. See generally HDA, About, https://www.healthcaredistribution.org/about (last visited Aug. 

21, 2017). The National Association of Chain Drug Stores (NACDS) is a national, not-for-profit trade association 

that represents traditional drug stores and supermarkets and mass merchants with pharmacies whose membership 

includes, among others: Walgreen Company, CVS Health, Rite Aid Corporation and Walmart. See generally

NACDS, Mission, https://www.nacds.org/ about/mission/ (last visited Aug. 21, 2017). 

94 See Letter from Joseph T. Rannazzisi, Deputy Assistant Adm’r, Office of Diversion Control, Drug. Enf’t Admin., 

U.S. Dep’t of Justice, to Cardinal Health (Sept. 27, 2006) [hereinafter Rannazzisi Letter] (“This letter is being sent 

to every commercial entity in the United States registered with the Drug Enforcement Agency (DEA) to distribute 

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171. The Distributor Defendants have admitted that they are responsible for reporting 

suspicious orders.95

172. The DEA sent a letter to each of the Distributor Defendants on September 27, 

2006, warning that it would use its authority to revoke and suspend registrations when 

appropriate. The letter expressly states that a distributor, in addition to reporting suspicious 

orders, has a “statutory responsibility to exercise due diligence to avoid filling suspicious orders 

that might be diverted into other than legitimate medical, scientific, and industrial channels.”96 

The letter also instructs that “distributors must be vigilant in deciding whether a prospective 

customer can be trusted to deliver controlled substances only for lawful purposes.”97 The DEA 

warns that “even just one distributor that uses its DEA registration to facilitate diversion can 

cause enormous harm.”98

173. The DEA sent a second letter to each of the Distributor Defendants on December 

27, 2007.99 This letter reminds the Defendants of their statutory and regulatory duties to 

“maintain effective controls against diversion” and “design and operate a system to disclose to 

the registrant suspicious orders of controlled substances.”100 The letter further explains: 

 controlled substances. The purpose of this letter is to reiterate the responsibilities of controlled substance 

distributors in view of the prescription drug abuse problem our nation currently faces.”), filed in Cardinal Health, 

Inc. v. Holder, No. 1:12-cv-00185-RBW (D.D.C. Feb. 10, 2012), ECF No. 14-51. 

95 See Brief for HDMA and NACDS, supra note 85, 2016 WL 1321983, at *4 (“[R]egulations . . . in place for more 

than 40 years require distributors to report suspicious orders of controlled substances to DEA based on information 

readily available to them (e.g., a pharmacy’s placement of unusually frequent or large orders).”). 

96 Rannazzisi Letter, supra note 83, at 2. 

97 Id. at 1. 

98 Id. at 2. 

99 See Letter from Joseph T. Rannazzisi, Deputy Assistant Adm’r, Office of Diversion Control, Drug. Enf’t Admin., 

U.S. Dep’t of Justice, to Cardinal Health (Dec. 27, 2007), filed in Cardinal Health, Inc. v. Holder, No. 1:12-cv00185-RBW (D.D.C. Feb. 10, 2012), ECF No. 14-8. 

100 Id. 

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The regulation also requires that the registrant inform the local DEA Division 

Office of suspicious orders when discovered by the registrant. Filing a monthly 

report of completed transactions (e.g., “excessive purchase report” or “high unity 

purchases”) does not meet the regulatory requirement to report suspicious orders. 

Registrants are reminded that their responsibility does not end merely with the 

filing of a suspicious order report. Registrants must conduct an independent 

analysis of suspicious orders prior to completing a sale to determine whether the 

controlled substances are likely to be diverted from legitimate channels. 

Reporting an order as suspicious will not absolve the registrant of responsibility if 

the registrant knew, or should have known, that the controlled substances were 

being diverted. 

The regulation specifically states that suspicious orders include orders of unusual 

size, orders deviating substantially from a normal pattern, and orders of an 

unusual frequency. These criteria are disjunctive and are not all inclusive. For 

example, if an order deviates substantially from a normal pattern, the size of the 

order does not matter and the order should be reported as suspicious. Likewise, a 

registrant need not wait for a “normal pattern” to develop over time before 

determining whether a particular order is suspicious. The size of an order alone, 

whether or not it deviates from a normal pattern, is enough to trigger the 

registrant’s responsibility to report the order as suspicious. The determination of 

whether an order is suspicious depends not only on the ordering patterns of the 

particular customer, but also on the patterns of the registrant’s customer base and 

the patterns throughout the segment of the regulated industry. 

Registrants that rely on rigid formulas to define whether an order is suspicious 

may be failing to detect suspicious orders. For example, a system that identifies 

orders as suspicious only if the total amount of a controlled substance ordered 

during one month exceeds the amount ordered the previous month by a certain 

percentage or more is insufficient. This system fails to identify orders placed by a 

pharmacy if the pharmacy placed unusually large orders from the beginning of its 

relationship with the distributor. Also, this system would not identify orders as 

suspicious if the order were solely for one highly abused controlled substance if 

the orders never grew substantially. Nevertheless, ordering one highly abused 

controlled substance and little or nothing else deviates from the normal pattern of 

what pharmacies generally order. 

When reporting an order as suspicious, registrants must be clear in their 

communication with DEA that the registrant is actually characterizing an order as 

suspicious. Daily, weekly, or monthly reports submitted by registrant indicating 

“excessive purchases” do not comply with the requirement to report suspicious 

orders, even if the registrant calls such reports “suspicious order reports.” 

Lastly, registrants that routinely report suspicious orders, yet fill these orders 

without first determining that order is not being diverted into other than legitimate 

medical, scientific, and industrial channels, may be failing to maintain effective 

controls against diversion. Failure to maintain effective controls against diversion 

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is inconsistent with the public interest as that term is used in 21 USC 823 and 824, 

and may result in the revocation of the registrant’s DEA Certificate of 

Registration.101

Finally, the DEA letter references the Revocation of Registration issued in Southwood 

Pharmaceuticals, Inc., 72 Fed. Reg. 36,487-01 (July 3, 2007), which discusses the obligation to 

report suspicious orders and “some criteria to use when determining whether an order is 

suspicious.”102

174. The Distributor Defendants admit that they “have not only statutory and 

regulatory responsibilities to detect and prevent diversion of controlled prescription drugs, but 

undertake such efforts as responsible members of society.”103

175. The Distributor Defendants knew they were required to monitor, detect, and halt 

suspicious orders. Industry compliance guidelines established by the Healthcare Distribution 

Management Association, the trade association of pharmaceutical distributors, explain that 

distributors are “[a]t the center of a sophisticated supply chain” and therefore “are uniquely 

situated to perform due diligence in order to help support the security of the controlled 

substances they deliver to their customers.” The guidelines set forth recommended steps in the 

“due diligence” process, and note in particular: If an order meets or exceeds a distributor’s 

threshold, as defined in the distributor’s monitoring system, or is otherwise characterized by the 

distributor as an order of interest, the distributor should not ship to the customer, in fulfillment of 

 

101 Id. 

102 Id. 

103 See Brief of HDMA, supra note 19, 2012 WL 1637016, at *2. 

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that order, any units of the specific drug code product as to which the order met or exceeded a 

threshold or as to which the order was otherwise characterized as an order of interest.104

176. Each of the Distributor Defendants sold prescription opioids, including 

hydrocodone and/or oxycodone, to retailers in Plaintiff’s Community and/or to retailers from 

which Defendants knew prescription opioids were likely to be diverted to Plaintiff’s Community. 

177. Each Distributor Defendant owes a duty to monitor and detect suspicious orders 

of prescription opioids. 

178. Each Distributor Defendant owes a duty under federal and state law to investigate 

and refuse suspicious orders of prescription opioids. 

179. Each Distributor Defendant owes a duty under federal and state law to report 

suspicious orders of prescription opioids. 

180. Each Distributor Defendant owes a duty under federal and state law to prevent the 

diversion of prescription opioids into illicit markets in the State and Plaintiff’s Community. 

181. The foreseeable harm resulting from a breach of these duties is the diversion of 

prescription opioids for nonmedical purposes and subsequent plague of opioid addiction. 

182. The foreseeable harm resulting from the diversion of prescription opioids for 

nonmedical purposes is abuse, addiction, morbidity and mortality in Plaintiff’s Community and 

the damages caused thereby. 

2. The Distributor Defendants Breached their Duties. 

183. Because distributors handle such large volumes of controlled substances, and are 

the first major line of defense in the movement of legal pharmaceutical controlled substances 

from legitimate channels into the illicit market, it is incumbent on distributors to maintain 

 

104 Healthcare Distribution Management Association (HDMA) Industry Compliance Guidelines: Reporting 

Suspicious Orders and Preventing Diversion of Controlled Substances, filed in Cardinal Health, Inc. v. Holder, No. 

12-5061 (D.C. Cir. Mar. 7, 2012), Doc. No. 1362415 (App’x B). 

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effective controls to prevent diversion of controlled substances. Should a distributor deviate from 

these checks and balances, the closed system collapses.105 

184. The sheer volume of prescription opioids distributed to pharmacies in the 

Plaintiff’s Community, and/or to pharmacies from which the Distributor Defendants knew the 

opioids were likely to be diverted into Plaintiff’s Community, is excessive for the medical need 

of the community and facially suspicious. Some red flags are so obvious that no one who 

engages in the legitimate distribution of controlled substances can reasonably claim ignorance of 

them.106 

185. The Distributor Defendants failed to report “suspicious orders” originating from 

Plaintiff’s Community, or which the Distributor Defendants knew were likely to be diverted to 

Plaintiff’s Community, to the federal and state authorities, including the DEA and/or the state 

Board of Pharmacy. 

186. The Distributor Defendants unlawfully filled suspicious orders of unusual size, 

orders deviating substantially from a normal pattern and/or orders of unusual frequency in 

Plaintiff’s Community, and/or in areas from which the Distributor Defendants knew opioids 

were likely to be diverted to Plaintiff’s Community. 

187. The Distributor Defendants breached their duty to monitor, detect, investigate, 

refuse and report suspicious orders of prescription opiates originating from Plaintiff’s 

Community, and/or in areas from which the Distributor Defendants knew opioids were likely to 

be diverted to Plaintiff’s Community. 

 

105 See Rannazzisi Decl. ¶ 10, filed in Cardinal Health, Inc. v. Holder, No. 1:12-cv-00185-RBW (D.D.C. Feb. 10, 

2012), ECF No. 14-2. 

106 Masters Pharmaceuticals, Inc., 80 Fed. Reg. 55,418-01, 55,482 (Sept. 15, 2015) (citing Holiday CVS, L.L.C., 

d/b/a CVS/Pharmacy Nos. 219 and 5195, 77 Fed. Reg. 62,316, 62,322 (2012)). 

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188. The Distributor Defendants breached their duty to maintain effective controls 

against diversion of prescription opiates into other than legitimate medical, scientific, and 

industrial channels. 

189. The Distributor Defendants breached their duty to “design and operate a system to 

disclose to the registrant suspicious orders of controlled substances” and failed to inform the 

authorities including the DEA of suspicious orders when discovered, in violation of their duties 

under federal and state law. 

190. The Distributor Defendants breached their duty to exercise due diligence to avoid 

filling suspicious orders that might be diverted into channels other than legitimate medical, 

scientific and industrial channels.107 

191. The federal and state laws at issue here are public safety laws. 

192. The Distributor Defendants’ violations of public safety statutes constitute prima 

facie evidence of negligence under State law. 

193. The unlawful conduct by the Distributor Defendants is purposeful and intentional. 

The Distributor Defendants refuse to abide by the duties imposed by federal and state law which 

are required to legally acquire and maintain a license to distribute prescription opiates. 

194. The Distributor Defendants acted with actual malice in breaching their duties, i.e., 

they have acted with a conscious disregard for the rights and safety of other persons, and said 

actions have a great probability of causing substantial harm. 

195. The Distributor Defendants’ repeated shipments of suspicious orders, over an 

extended period of time, in violation of public safety statutes, and without reporting the 

suspicious orders to the relevant authorities demonstrates wanton, willful, or reckless conduct or 

 

107 See Cardinal Health, Inc. v. Holder, 846 F. Supp. 2d 203, 206 (D.D.C. 2012). 

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criminal indifference to civil obligations affecting the rights of others and justifies an award of 

punitive damages. 

3. The Distributor Defendants Have Sought to Avoid and Have 

Misrepresented their Compliance with their Legal Duties. 

196. The Distributor Defendants have repeatedly misrepresented their compliance with 

their legal duties under state and federal law and have wrongfully and repeatedly disavowed 

those duties in an effort to mislead regulators and the public regarding the Distributor 

Defendants’ compliance with their legal duties. 

197. Distributor Defendants have refused to recognize any duty beyond reporting

suspicious orders. In Masters Pharmaceuticals, the HDMA, a trade association run the 

Distributor Defendants, and the NACDS submitted amicus briefs regarding the legal duty of 

wholesale distributors. Inaccurately denying the legal duties that the wholesale drug industry has 

been tragically recalcitrant in performing, they argued as follows:

a. The Associations complained that the “DEA has required 

distributors not only to report suspicious orders, but to investigate

orders (e.g., by interrogating pharmacies and physicians) and take 

action to halt suspicious orders before they are filled.”108

b. The Associations argued that, “DEA now appears to have changed 

its position to require that distributors not only report suspicious 

orders, but investigate and halt suspicious orders. Such a change 

in agency position must be accompanied by an acknowledgment of 

the change and a reasoned explanation for it. In other words, an 

agency must display awareness that it is changing position and 

show that there are good reasons for the new policy. This is 

especially important here, because imposing intrusive obligation 

on distributors threatens to disrupt patient access to needed 

prescription medications.”109

 

108 Brief for HDMA and NACDS, supra note 85, 2016 WL 1321983, at *4–5. 

109 Id. at *8 (citations and quotation marks omitted). 

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c. The Associations alleged (inaccurately) that nothing “requires 

distributors to investigate the legitimacy of orders, or to halt 

shipment of any orders deemed to be suspicious.”110 

d. The Association complained that the purported “practical 

infeasibility of requiring distributors to investigate and halt 

suspicious orders (as well as report them) underscores the 

importance of ensuring that DEA has complied with the APA 

before attempting to impose such duties.”111

e. The Associations alleged (inaccurately) that “DEA’s regulations [] 

sensibly impose[] a duty on distributors simply to report

suspicious orders, but left it to DEA and its agents to investigate 

and halt suspicious orders.”112 

f. Also inaccurately, the Associations argued that, “[i]mposing a duty 

on distributors – which lack the patient information and the 

necessary medical expertise – to investigate and halt orders may 

force distributors to take a shot-in-the-dark approach to complying 

with DEA’s demands.”113

198. The positions taken by the trade groups is emblematic of the position taken by the 

Distributor Defendants in a futile attempt to deny their legal obligations to prevent diversion of 

the dangerous drugs.114

199. The Court of Appeals for the District of Columbia recently issued its opinion 

affirming that a wholesale drug distributor does, in fact, have duties beyond reporting. Masters 

Pharm., Inc. v. Drug Enf’t Admin., 861 F.3d 206 (D.C. Cir. 2017). The D.C. Circuit Court 

upheld the revocation of Master Pharmaceutical’s license and determined that DEA regulations 

require that in addition to reporting suspicious orders, distributors must “decline to ship the 

 

110 Id. at *14. 

111 Id. at *22. 

112 Id. at *24–25. 

113 Id. at 26. 

114 See Brief of HDMA, supra note 19, 2012 WL 1637016, at *3 (arguing the wholesale distributor industry “does 

not know the rules of the road because” they claim (inaccurately) that the “DEA has not adequately explained 

them”). 

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order, or conduct some ‘due diligence’ and—if it is able to determine that the order is not likely 

to be diverted into illegal channels—ship the order.” Id. at 212. Master Pharmaceutical was in 

violation of legal requirements because it failed to conduct necessary investigations and filled 

suspicious orders. Id. at 218–19, 226. A distributor’s investigation must dispel all the red flags 

giving rise to suspicious circumstance prior to shipping a suspicious order. Id. at 226. The Circuit 

Court also rejected the argument made by the HDMA and NACDS (quoted above), that, 

allegedly, the DEA had created or imposed new duties. Id. at 220. 

200. Wholesale Distributor McKesson has recently been forced to specifically admit to 

breach of its duties to monitor, report, and prevent suspicious orders. Pursuant to an 

Administrative Memorandum of Agreement (“2017 Agreement”) entered into between 

McKesson and the DEA in January 2017, McKesson admitted that, at various times during the 

period from January 1, 2009 through the effective date of the Agreement (January 17, 2017) it 

“did not identify or report to [the] DEA certain orders placed by certain pharmacies which 

should have been detected by McKesson as suspicious based on the guidance contained in the 

DEA Letters.”115 Further, the 2017 Agreement specifically finds that McKesson “distributed 

controlled substances to pharmacies even though those McKesson Distribution Centers should 

have known that the pharmacists practicing within those pharmacies had failed to fulfill their 

corresponding responsibility to ensure that controlled substances were dispensed pursuant to 

prescriptions issued for legitimate medical purposes by practitioners acting in the usual course of 

their professional practice, as required by 21 C.F.R § 1306.04(a).”116 McKesson admitted that, 

during this time period, it “failed to maintain effective controls against diversion of particular 

 

115 See Administrative Memorandum of Agreement between the U.S. Dep’t of Justice, the Drug Enf’t Admin., and 

the McKesson Corp. (Jan. 17, 2017), https://www.justice.gov/opa/press-release/file/928476/download. 

116 Id. at 4. 

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controlled substances into other than legitimate medical, scientific and industrial channels by 

sales to certain of its customers in violation of the CSA and the CSA’s implementing regulations, 

21 C.F.R. Part 1300 et seq., at the McKesson Distribution Centers” including the McKesson 

Distribution Center located in “Washington Courthouse, Ohio.”117 Due to these violations, 

McKesson agreed that its authority to distribute controlled substances from the Washington 

Courthouse, Ohio facility (among other facilities) would be partially suspended.118 

201. The 2017 Memorandum of Agreement followed a 2008 Settlement Agreement in 

which McKesson also admitted failure to report suspicious orders of controlled substances to the 

DEA.119 In the 2008 Settlement Agreement, McKesson “recognized that it had a duty to monitor 

its sales of all controlled substances and report suspicious orders to DEA,” but had failed to do 

so.120 The 2017 Memorandum of Agreement documents that McKesson continued to breach its 

admitted duties by “fail[ing] to properly monitor its sales of controlled substances and/or report 

suspicious orders to DEA, in accordance with McKesson’s obligations.”121 As a result of these 

violations, McKesson was fined and required to pay to the United States $150,000,000.122

202. Even though McKesson had been sanctioned in 2008 for failure to comply with 

its legal obligations regarding controlling diversion and reporting suspicious orders, and even 

though McKesson had specifically agreed in 2008 that it would no longer violate those 

 

117 Id.

118 Id. at 6. 

119 Id. at 4. 

120 Id.

121 Id.; see also Settlement Agreement and Release between the U.S. and McKesson Corp., at 5 (Jan. 17, 2017) 

[hereinafter 2017 Settlement Agreement and Release] (“McKesson acknowledges that, at various times during the 

Covered Time Period [2009-2017], it did not identify or report to DEA certain orders placed by certain pharmacies, 

which should have been detected by McKesson as suspicious, in a manner fully consistent with the requirements set 

forth in the 2008 MOA.”), https://www.justice.gov/opa/press-release/file/928471/download. 

122 See 2017 Settlement Agreement and Release, supra note 112, at 6. 

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obligations, McKesson continued to violate the laws in contrast to its written agreement not to do 

so.

203. Because of the Distributor Defendants’ refusal to abide by their legal obligations, 

the DEA has repeatedly taken administrative action to attempt to force compliance. For example, 

in May 2014, the United States Department of Justice, Office of the Inspector General, 

Evaluation and Inspections Divisions, reported that the DEA issued final decisions in 178 

registrant actions between 2008 and 2012.123 The Office of Administrative Law Judges issued a 

recommended decision in a total of 117 registrant actions before the DEA issued its final 

decision, including 76 actions involving orders to show cause and 41 actions involving 

immediate suspension orders.124 These actions include the following: 

a. On April 24, 2007, the DEA issued an Order to Show Cause and 

Immediate Suspension Order against the AmerisourceBergen Orlando, 

Florida distribution center (“Orlando Facility”) alleging failure to maintain 

effective controls against diversion of controlled substances. On June 22, 

2007, AmerisourceBergen entered into a settlement that resulted in the 

suspension of its DEA registration; 

b. On November 28, 2007, the DEA issued an Order to Show Cause and 

Immediate Suspension Order against the Cardinal Health Auburn, 

Washington Distribution Center (“Auburn Facility”) for failure to 

maintain effective controls against diversion of hydrocodone; 

c. On December 5, 2007, the DEA issued an Order to Show Cause and 

Immediate Suspension Order against the Cardinal Health Lakeland, 

Florida Distribution Center (“Lakeland Facility”) for failure to maintain 

effective controls against diversion of hydrocodone; 

d. On December 7, 2007, the DEA issued an Order to Show Cause and 

Immediate Suspension Order against the Cardinal Health Swedesboro, 

 

123 Evaluation and Inspections Div., Office of the Inspector Gen., U.S. Dep’t of Justice, The Drug Enforcement 

Administration’s Adjudication of Registrant Actions 6 (2014), https://oig.justice.gov/reports/2014/e1403.pdf. 

124 Id.

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New Jersey Distribution Center (“Swedesboro Facility”) for failure to 

maintain effective controls against diversion of hydrocodone; 

e. On January 30, 2008, the DEA issued an Order to Show Cause and 

Immediate Suspension Order against the Cardinal Health Stafford, Texas 

Distribution Center (“Stafford Facility”) for failure to maintain effective 

controls against diversion of hydrocodone; 

f. On May 2, 2008, McKesson Corporation entered into an Administrative 

Memorandum of Agreement (“2008 MOA”) with the DEA which provided 

that McKesson would “maintain a compliance program designed to detect 

and prevent the diversion of controlled substances, inform DEA of 

suspicious orders required by 21 C.F.R. § 1301.74(b), and follow the 

procedures established by its Controlled Substance Monitoring Program”; 

g. On September 30, 2008, Cardinal Health entered into a Settlement and 

Release Agreement and Administrative Memorandum of Agreement with 

the DEA related to its Auburn Facility, Lakeland Facility, Swedesboro 

Facility and Stafford Facility. The document also referenced allegations by 

the DEA that Cardinal failed to maintain effective controls against the 

diversion of controlled substances at its distribution facilities located in 

McDonough, Georgia (“McDonough Facility”), Valencia, California 

(“Valencia Facility”) and Denver, Colorado (“Denver Facility”); 

h. On February 2, 2012, the DEA issued an Order to Show Cause and 

Immediate Suspension Order against the Cardinal Health Lakeland, 

Florida Distribution Center (“Lakeland Facility”) for failure to maintain 

effective controls against diversion of oxycodone; 

i. On December 23, 2016, Cardinal Health agreed to pay a $44 million fine 

to the DEA to resolve the civil penalty portion of the administrative action 

taken against its Lakeland, Florida Distribution Center; and 

j. On January 5, 2017, McKesson Corporation entered into an 

Administrative Memorandum Agreement with the DEA wherein it agreed 

to pay a $150 million civil penalty for violation of the 2008 MOA as well 

as failure to identify and report suspicious orders at its facilities in Aurora 

CO, Aurora IL, Delran NJ, LaCrosse WI, Lakeland FL, Landover MD, La 

Vista NE, Livonia MI, Methuen MA, Sante Fe Springs CA, Washington 

Courthouse OH and West Sacramento CA. 

 

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204. Rather than abide by their non-delegable duties under public safety laws, the 

Distributor Defendants, individually and collectively through trade groups in the industry, 

pressured the U.S. Department of Justice to “halt” prosecutions and lobbied Congress to strip the 

DEA of its ability to immediately suspend distributor registrations. The result was a “sharp drop 

in enforcement actions” and the passage of the “Ensuring Patient Access and Effective Drug 

Enforcement Act” which, ironically, raised the burden for the DEA to revoke a distributor’s 

license from “imminent harm” to “immediate harm” and provided the industry the right to “cure” 

any violations of law before a suspension order can be issued.125 

205. In addition to taking actions to limit regulatory prosecutions and suspensions, the 

Distributor Defendants undertook to fraudulently convince the public that they were complying 

with their legal obligations, including those imposed by licensing regulations. Through such 

statements, the Distributor Defendants attempted to assure the public they were working to curb 

the opioid epidemic. 

206. For example, a Cardinal Health executive claimed that it uses “advanced 

analytics” to monitor its supply chain, and represented that it was being “as effective and 

efficient as possible in constantly monitoring, identifying, and eliminating any outside criminal 

activity.”126 Given the sales volumes and the company’s history of violations, this executive was 

either not telling the truth, or, if Cardinal Health had such a system, it ignored the results. 

 

125 See Lenny Bernstein & Scott Higham, Investigation: The DEA Slowed Enforcement While the Opioid Epidemic 

Grew Out of Control, Wash. Post, Oct. 22, 2016, https://www.washingtonpost.com/investigations/the-dea-slowedenforcement-while-the-opioid-epidemic-grew-out-of-control/2016/10/22/aea2bf8e-7f71-11e6-8d13-

d7c704ef9fd9_story.html; Lenny Bernstein & Scott Higham, Investigation: U.S. Senator Calls for Investigation of 

DEA Enforcement Slowdown Amid Opioid Crisis, Wash. Post, Mar. 6, 2017, 

https://www.washingtonpost.com/investigations/us-senator-calls-for-investigation-of-dea-enforcementslowdown/2017/03/06/5846ee60-028b-11e7-b1e9-a05d3c21f7cf_story.html; Eric Eyre, DEA Agent: “We Had No 

Leadership” in WV Amid Flood of Pain Pills, Charleston Gazette-Mail, Feb. 18, 2017, 

http://www.wvgazettemail.com/news/20170218/dea-agent-we-had-no-leadership-in-wv-amid-flood-of-pain-pills-. 

126 Lenny Bernstein et al., How Drugs Intended for Patients Ended Up in the Hands of Illegal Users: “No One Was 

Doing Their Job,” Wash. Post, Oct. 22, 2016, https://www.washingtonpost.com/investigations/how-drugs-intendedCase: 2:17-cv-00975-MHW-KAJ Doc #: 1 Filed: 11/06/17 Page: 87 of 171 PAGEID #: 87
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207. Similarly, Defendant McKesson publicly stated that it has a “best-in-class 

controlled substance monitoring program to help identify suspicious orders,” and claimed it is 

“deeply passionate about curbing the opioid epidemic in our country.”127 Again, given 

McKesson’s historical conduct, this statement is either false, or the company ignored outputs of 

the monitoring program. 

208. By misleading the public about the effectiveness of their controlled substance 

monitoring programs, the Distributor Defendants successfully concealed the facts sufficient to 

arouse suspicion of the claims that the Plaintiff now asserts. The Plaintiff did not know of the 

existence or scope of Defendants’ industry-wide fraud and could not have acquired such 

knowledge earlier through the exercise of reasonable diligence. 

209. Meanwhile, the opioid epidemic rages unabated in the Nation, the State, and in 

Plaintiff’s Community. 

210. The epidemic still rages because the fines and suspensions imposed by the DEA 

do not change the conduct of the industry. The distributors, including the Distributor Defendants, 

pay fines as a cost of doing business in an industry that generates billions of dollars in annual 

revenue. They hold multiple DEA registration numbers and when one facility is suspended, they 

simply ship from another facility. 

211. The wrongful actions and omissions of the Distributor Defendants which have 

caused the diversion of opioids and which have been a substantial contributing factor to and/or 

 for-patients-ended-up-in-the-hands-of-illegal-users-no-one-was-doing-their-job/2016/10/22/10e79396-30a7-11e6-

8ff7-7b6c1998b7a0_story.html. 

127 Scott Higham et al., Drug Industry Hired Dozens of Officials from the DEA as the Agency Tried to Curb Opioid 

Abuse, Wash. Post, Dec. 22, 2016, https://www.washingtonpost.com/investigations/key-officials-switch-sides-fromdea-to-pharmaceutical-industry/2016/12/22/55d2e938-c07b-11e6-b527-949c5893595e_story.html. 

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proximate cause of the opioid crisis are alleged in greater detail in Plaintiff’s racketeering 

allegations below. 

212. The Distributor Defendants have abandoned their duties imposed under federal 

and state law, taken advantage of a lack of DEA law enforcement, and abused the privilege of 

distributing controlled substances in the State and Plaintiff’s Community. 

D. THE MANUFACTURER DEFENDANTS’ UNLAWFUL FAILURE 

TO PREVENT DIVERSION AND MONITOR, REPORT, AND 

PREVENT SUSPICIOUS ORDERS. 

213. The same legal duties to prevent diversion, and to monitor, report, and prevent 

suspicious orders of prescription opioids that were incumbent upon the Distributor Defendants 

were also legally required of the Manufacturer Defendants under federal law. 

214. Like the Distributor Defendants, the Manufacturer Defendants were required to 

register with the DEA to manufacture schedule II controlled substances, like prescription 

opioids. See 21 U.S.C. § 823(a). A requirement of such registration is the: 

maintenance of effective controls against diversion of particular controlled 

substances and any controlled substance in schedule I or II compounded 

therefrom into other than legitimate medical, scientific, research, or industrial 

channels, by limiting the importation and bulk manufacture of such controlled 

substances to a number of establishments which can produce an adequate and 

uninterrupted supply of these substances under adequately competitive 

conditions for legitimate medical, scientific, research, and industrial purposes . . 

. . 

21 USCA § 823(a)(1) (emphasis added). 

215. Additionally, as “registrants” under Section 823, the Manufacturer Defendants 

were also required to monitor, report, and prevent suspicious orders of controlled substances: 

The registrant shall design and operate a system to disclose to the registrant 

suspicious orders of controlled substances. The registrant shall inform the Field 

Division Office of the Administration in his area of suspicious orders when 

discovered by the registrant. Suspicious orders include orders of unusual size, 

orders deviating substantially from a normal pattern, and orders of unusual 

frequency. 

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21 C.F.R. § 1301.74. See also 21 C.F.R. § 1301.02 (“Any term used in this part shall have the 

definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.”); 21 

C.F.R. § 1300.01 (“Registrant means any person who is registered pursuant to either section 303 

or section 1008 of the Act (21 U.S.C. 823 or 958).” Like the Distributor Defendants, the 

Manufacture Defendants breached these duties. 

216. The Manufacturer Defendants had access to and possession of the information 

necessary to monitor, report, and prevent suspicious orders and to prevent diversion. The 

Manufacturer Defendants engaged in the practice of paying “chargebacks” to opioid distributors. 

A chargeback is a payment made by a manufacturer to a distributor after the distributor sells the 

manufacturer’s product at a price below a specified rate. After a distributor sells a 

manufacturer’s product to a pharmacy, for example, the distributor requests a chargeback from 

the manufacturer and, in exchange for the payment, the distributor identifies to the manufacturer 

the product, volume and the pharmacy to which it sold the product. Thus, the Manufacturer 

Defendants knew – just as the Distributor Defendants knew – the volume, frequency, and pattern 

of opioid orders being placed and filled. The Manufacturer Defendants built receipt of this 

information into the payment structure for the opioids provided to the opioid distributors. 

217. Federal statutes and regulations are clear: just like opioid distributors, opioid 

manufacturers are required to “design and operate a system to disclose . . . suspicious orders of 

controlled substances” and to maintain “effective controls against diversion.” 21 C.F.R. § 

1301.74; 21 USCA § 823(a)(1). 

218. The Department of Justice has recently confirmed the suspicious order obligations 

clearly imposed by federal law upon opioid manufacturers, fining Mallinckrodt $35 million for 

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failure to report suspicious orders of controlled substances, including opioids, and for violating 

recordkeeping requirements.128

219. In the press release accompanying the settlement, the Department of Justice 

stated: Mallinckrodt did not meet its obligations to detect and notify DEA of suspicious orders of 

controlled substances such as oxycodone, the abuse of which is part of the current opioid 

epidemic. These suspicious order monitoring requirements exist to prevent excessive sales of 

controlled substances, like oxycodone . . . . Mallinckrodt’s actions and omissions formed a link 

in the chain of supply that resulted in millions of oxycodone pills being sold on the street. . . . 

“Manufacturers and distributors have a crucial responsibility to ensure that controlled substances 

do not get into the wrong hands. . . .”129 

220. Among the allegations resolved by the settlement, the government alleged 

“Mallinckrodt failed to design and implement an effective system to detect and report 

‘suspicious orders’ for controlled substances – orders that are unusual in their frequency, size, or 

other patterns . . . [and] Mallinckrodt supplied distributors, and the distributors then supplied 

various U.S. pharmacies and pain clinics, an increasingly excessive quantity of oxycodone pills 

without notifying DEA of these suspicious orders.”130 

221. The Memorandum of Agreement entered into by Mallinckrodt (“2017 

Mallinckrodt MOA”) avers “[a]s a registrant under the CSA, Mallinckrodt had a responsibility to 

 

128 See 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-suspiciousorders 

129 Id. 

130 Id.

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maintain effective controls against diversion, including a requirement that it review and monitor 

these sales and report suspicious orders to DEA.”131

222. The 2017 Mallinckrodt MOA further details the DEA’s allegations regarding 

Mallinckrodt’s failures to fulfill its legal duties as an opioid manufacturer: 

With respect to its distribution of oxycodone and hydrocodone products, 

Mallinckrodt's alleged failure to distribute these controlled substances in a 

manner authorized by its registration and Mallinckrodt's alleged failure to 

operate an effective suspicious order monitoring system and to report suspicious 

orders to the DEA when discovered as required by and in violation of 21 C,F.R. 

§ 1301.74(b). The above includes, but is not limited to Mallinckrodt's alleged 

failure to: 

i. conduct adequate due diligence of its customers; 

ii. detect and report to the DEA orders of unusual size and 

frequency; 

iii. detect and report to the DEA orders deviating substantially from 

normal patterns including, but not limited to, those identified in 

letters from the DEA Deputy Assistant Administrator, Office of 

Diversion Control, to registrants dated September 27, 2006 and 

December 27, 2007: 

1. orders that resulted in a disproportionate amount of a 

substance which is most often abused going to a 

particular geographic region where there was known 

diversion, 

2. orders that purchased a disproportionate amount of a 

substance which is most often abused compared to other 

products, and 

3. orders from downstream customers to distributors who 

were purchasing from multiple different distributors, of 

which Mallinckrodt was aware; 

iv. use "chargeback" information from its distributors to evaluate 

suspicious orders. Chargebacks include downstream purchasing 

information tied to certain discounts, providing Mallinckrodt 

with data on buying patterns for Mallinckrodt products; and 

v. take sufficient action to prevent recurrence of diversion by 

downstream customers after receiving concrete information of 

diversion of Mallinckrodt product by those downstream 

customers.132

 

131 Administrative Memorandum of Agreement between the United States Department of Justice, the Drug 

Enforcement Agency, and Mallinckrodt, plc. and its subsidiary Mallinckrodt, LLC (July 10, 2017), 

https://www.justice.gov/usao-edmi/press-release/file/986026/download. (“2017 Mallinckrodt MOA”). 

132 2017 Mallinckrodt MOA at p. 2-3. 

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223. Mallinckrodt agreed that its “system to monitor and detect suspicious orders did 

not meet the standards outlined in letters from the DEA Deputy Administrator, Office of 

Diversion Control, to registrants dated September 27, 2006 and December 27, 2007.” 

Mallinckrodt further agreed that it “recognizes the importance of the prevention of diversion of 

the controlled substances they manufacture” and would “design and operate a system that meets 

the requirements of 21 CFR 1301.74(b) . . . [such that it would] utilize all available transaction 

information to identify suspicious orders of any Mallinckrodt product. Further, Mallinckrodt 

agrees to notify DEA of any diversion and/or suspicious circumstances involving any 

Mallinckrodt controlled substances that Mallinckrodt discovers.”133

224. Mallinckrodt acknowledged that “[a]s part of their business model Mallinckrodt 

collects transaction information, referred to as chargeback data, from their direct customers 

(distributors). The transaction information contains data relating to the direct customer sales of 

controlled substances to "downstream" registrants.” Mallinckrodt agreed that, from this data, it 

would “report to the DEA when Mallinckrodt concludes that the chargeback data or other 

information indicates that a downstream registrant poses a risk of diversion.”134

225. The same duties imposed by federal law on Mallinckrodt were imposed upon all 

Distributor Defendants. 

226. The same business practices utilized by Mallinckrodt regarding “charge backs” 

and receipt and review of data from opioid distributors regarding orders of opioids were utilized 

 

133 Id. at 3-4. 

134 Id. at p.5. 

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industry-wide among opioid manufacturers and distributors, including, upon information and 

beliefe, the other Distributor Defendants. 

227. Through, inter alia, the charge back data, the Manufacturer Defendants could 

monitor suspicious orders of opioids. 

228. The Manufacturer Defendants failed to monitor, report, and halt suspicious orders 

of opioids as required by federal law. 

229. The Manufacturer Defendants’ failures to monitor, report, and halt suspicious 

orders of opioids were intentional and unlawful. 

230. The Manufacturer Defendants have misrepresented their compliance with federal 

law. 

231. The wrongful actions and omissions of the Manufacturer Defendants which have 

caused the diversion of opioids and which have been a substantial contributing factor to and/or 

proximate cause of the opioid crisis are alleged in greater detail in Plaintiff’s racketeering 

allegations below. 

232. The Manufacturer Defendants’ actions and omissions in failing to effective 

prevent diversion and failing to monitor, report, and prevent suspicious orders have enabled the 

unlawful diversion of opioids into Plaintiff’s Community. 

E. DEFENDANTS’ UNLAWFUL CONDUCT AND BREACHES OF 

LEGAL DUTIES CAUSED THE HARM ALLEGED HEREIN AND 

SUBSTANTIAL DAMAGES. 

233. As the Manufacturer Defendants’ efforts to expand the market for opioids 

increased so have the rates of prescription and sale of their products — and the rates of opioidrelated substance abuse, hospitalization, and death among the people of the State and the 

Plaintiff’s Community. The Distributor Defendants have continued to unlawfully ship these 

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massive quantities of opioids into communities like the Plaintiff’s Community, fueling the 

epidemic. 

234. There is a “parallel relationship between the availability of prescription opioid 

analgesics through legitimate pharmacy channels and the diversion and abuse of these drugs and 

associated adverse outcomes.”135 

235. Opioid analgesics are widely diverted and improperly used, and the widespread 

use of the drugs has resulted in a national epidemic of opioid overdose deaths and addictions.136 

236. The epidemic is “directly related to the increasingly widespread misuse of 

powerful opioid pain medications.”137 

237. The increased abuse of prescription painkillers along with growing sales has 

contributed to a large number of overdoses and deaths.138 

238. As shown above, the opioid epidemic has escalated in Plaintiff’s Community with 

devastating effects. Substantial opiate-related substance abuse, hospitalization and death that 

mirrors Defendants’ increased distribution of opiates. 

239. Because of the well-established relationship between the use of prescription 

opiates and the use of non-prescription opioids, like heroin, the massive distribution of opioids to 

Plaintiffs’ Community and areas from which such opioids are being diverted into Plaintiff’s 

Community, has caused the Defendant-caused opioid epidemic to include heroin addiction, 

abuse, and death. 

 

135 See Dart at al., supra note 11. 

136 See Volkow & McLellan, supra note 1.

137 See Califf et al., supra note 3. 

138 See Press Release, Ctrs. for Disease Control and Prevention, U.S. Dep’t of Health and Human Servs., supra note 

13. 

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240. Prescription opioid abuse, addiction, morbidity, and mortality are hazards to 

public health and safety in the State and in Plaintiff’s Community. 

241. Heroin abuse, addiction, morbidity, and mortality are hazards to public health and 

safety in the State and in Plaintiff’s Community. 

242. Defendants repeatedly and purposefully breached their duties under state and 

federal law, and such breaches are direct and proximate causes of, and/or substantial factors 

leading to, the widespread diversion of prescription opioids for nonmedical purposes into the 

Plaintiff’s Community. 

243. The unlawful diversion of prescription opioids is a direct and proximate cause of, 

and/or substantial factor leading to, the opioid epidemic, prescription opioid abuse, addiction, 

morbidity and mortality in the State and Plaintiff’s Community. This diversion and the epidemic 

are direct causes of foreseeable harms incurred by the Plaintiff and Plaintiff’s Community. 

244. Defendants intentional and/or unlawful conduct resulted in direct and foreseeable, 

past and continuing, economic damages for which Plaintiff seeks relief, as alleged herein. 

Plaintiff also seeks the means to abate the epidemic created by Defendants’ wrongful and/or 

unlawful conduct. 

245. Plaintiff seeks economic damages from the Defendants as reimbursement for the 

costs association with past efforts to eliminate the hazards to public health and safety. 

246. Plaintiff seeks economic damages from the Defendants to pay for the cost to 

permanently eliminate the hazards to public health and safety and abate the temporary public 

nuisance. 

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247. To eliminate the hazard to public health and safety, and abate the public nuisance, 

a “multifaceted, collaborative public health and law enforcement approach is urgently 

needed.”139

248. A comprehensive response to this crisis must focus on preventing new cases of 

opioid addiction, identifying early opioid-addicted individuals, and ensuring access to effective 

opioid addiction treatment while safely meeting the needs of patients experiencing pain.140 

249. These community-based problems require community-based solutions that have 

been limited by “budgetary constraints at the state and Federal levels.”141

250. Having profited enormously through the aggressive sale, misleading promotion, 

and irresponsible distribution of opiates, Defendants should be required to take responsibility for 

the financial burdens their conduct has inflicted upon the Plaintiff and Plaintiff’s Community. 

F. STATUTES OF LIMITATIONS ARE TOLLED AND DEFENDANTS 

ARE ESTOPPED FROM ASSERTED STATUTES OF LIMITATIONS 

AS DEFENSES. 

1. Continuing Conduct. 

251. Plaintiff contends it continues to suffer harm from the unlawful actions by the 

Defendants. 

252. The continued tortious and unlawful conduct by the Defendants causes a repeated 

or continuous injury. The damages have not occurred all at once but have continued to occur and 

have increased as time progresses. The tort is not completed nor have all the damages been 

 

139 See Rudd et al., supra note 20, at 1145. 

140 See Johns Hopkins Bloomberg School of Public Health, The Prescription Opioid Epidemic: An Evidence-Based 

Approach (G. Caleb Alexander et al. eds., 2015), http://www.jhsph.edu/research/centers-and-institutes/center-fordrug-safety-and-effectiveness/research/prescription-opioids/JHSPH_OPIOID_EPIDEMIC_REPORT.pdf. 

141 See Office of Nat’l Drug Control Policy, Exec. Office of the President, Epidemic: Responding to America’s 

Prescription Drug Abuse Crisis (2011), https://www.ncjrs.gov/pdffiles1/ondcp/rx_abuse_plan.pdf. 

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incurred until the wrongdoing ceases. The wrongdoing and unlawful activity by Defendants has 

not ceased. The public nuisance remains unabated. 

2. Equitable Estoppel. 

253. Defendants are equitably estopped from relying upon a statute of limitations 

defense because they undertook efforts to purposefully conceal their unlawful conduct and 

fraudulently assure the public, including the State, the Plaintiff, and Plaintiff’s Community, that 

they were undertaking efforts to comply with their obligations under the state and federal 

controlled substances laws, all with the goal of protecting their registered manufacturer or 

distributor status in the State and to continue generating profits. Notwithstanding the allegations 

set forth above, the Defendants affirmatively assured the public, including the State, the Plaintiff, 

and Plaintiff’s Community, that they are working to curb the opioid epidemic. 

254. For example, a Cardinal Health executive claimed that it uses “advanced 

analytics” to monitor its supply chain, and assured the public it was being “as effective and 

efficient as possible in constantly monitoring, identifying, and eliminating any outside criminal 

activity.”142 

255. Similarly, McKesson publicly stated that it has a “best-in-class controlled 

substance monitoring program to help identify suspicious orders,” and claimed it is “deeply 

passionate about curbing the opioid epidemic in our country.”143

256. Moreover, in furtherance of their effort to affirmatively conceal their conduct and 

avoid detection, the Distributor Defendants, through their trade associations, HDMA and 

 

142 Bernstein et al., supra note 117. 

143 Higham et al., supra note 118. 

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NACDS, filed an amicus brief in Masters Pharmaceuticals, which made the following 

statements:144

a. “HDMA and NACDS members not only have statutory and regulatory responsibilities to 

guard against diversion of controlled prescription drugs, but undertake such efforts as 

responsible members of society.” 

b. “DEA regulations that have been in place for more than 40 years require distributors to 

report suspicious orders of controlled substances to DEA based on information readily 

available to them (e.g., a pharmacy’s placement of unusually frequent or large orders).” 

c. “Distributors take seriously their duty to report suspicious orders, utilizing both computer 

algorithms and human review to detect suspicious orders based on the generalized 

information that is available to them in the ordering process.” 

d. “A particular order or series of orders can raise red flags because of its unusual size, 

frequency, or departure from typical patterns with a given pharmacy.” 

e. “Distributors also monitor for and report abnormal behavior by pharmacies placing 

orders, such as refusing to provide business contact information or insisting on paying in 

cash.” 

Through the above statements made on their behalf by their trade associations, and other similar 

statements assuring their continued compliance with their legal obligations, the Distributor 

Defendants not only acknowledged that they understood their obligations under the law, but they 

further affirmed that their conduct was in compliance with those obligations. 

 

144 Brief for HDMA and NACDS, supra note 85, 2016 WL 1321983, at *3-4, *25. 

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257. The Distributor Defendants have also concealed and prevented discovery of 

information, including data from the ARCOS database, that will confirm their identities and the 

extent of their wrongful and illegal activities. 

258. The Manufacturer Defendants distorted the meaning or import of studies they 

cited and offered them as evidence for propositions the studies did not support. The 

Manufacturer Defendants invented “pseudoaddiction” and promoted it to an unsuspecting 

medical community. Manufacturer Defendants provided the medical community with false and 

misleading information about ineffectual strategies to avoid or control opioid addiction. 

Manufacturer Defendants recommended to the medical community that dosages be increased, 

without disclosing the risks. Manufacturer Defendants spent millions of dollars over a period of 

years on a misinformation campaign aimed at highlighting opioids’ alleged benefits, disguising 

the risks, and promoting sales. The medical community, consumers, the State, and Plaintiff’s 

Community were duped by the Manufacturer Defendants’ campaign to misrepresent and conceal 

the truth about the opioid drugs that they were aggressively pushing in the State and in Plaintiff’s 

Community. 

259. The Plaintiff and Plaintiff’s Community reasonably relied on Defendants’ 

affirmative statements regarding their purported compliance with their obligations under the law 

and consent orders. 

3. Fraudulent Concealment. 

260. The Plaintiff’s claims are further subject to equitable tolling, stemming from 

Defendants’ knowingly and fraudulently concealing the facts alleged herein. As alleged herein, 

Defendants knew of the wrongful acts set forth above, and had material information pertinent to 

their discovery, and concealed them from the Plaintiff and Plaintiff’s community. The Plaintiff 

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did not know, or could not have known through the exercise of reasonable diligence, of its cause 

of action, as a result of Defendants’ conduct. 

261. The purposes of the statutes of limitations period are satisfied because Defendants 

cannot claim prejudice due to a late filing where the Plaintiff filed suit promptly upon 

discovering the facts essential to its claims, described herein, which Defendants knowingly 

concealed. 

262. In light of their statements to the media, in legal filings, and settlements, it is clear 

that Defendants had actual or constructive knowledge that their conduct was deceptive, in that 

they consciously concealed the schemes set forth herein 

263. Defendants continually and secretly engaged in their scheme to avoid compliance 

with their legal obligations. Only Defendants and their agents knew or could have known about 

Defendants’ unlawful actions because Defendants made deliberate efforts to conceal their 

conduct. As a result of the above, the Plaintiff was unable to obtain vital information bearing on 

its claims absent any fault or lack of diligence on its part. 

V. LEGAL CAUSES OF ACTION 

COUNT I 

PUBLIC NUISANCE 

 (Against all Defendants) 

264. Plaintiff incorporates by reference all other paragraphs of this Complaint as if 

fully set forth here, and further alleges as follows. 

265. Ohio Revised Code § 4729.35 provides that “[t]he violation by a ... person of any 

laws of Ohio or of the United States of America or of any rule of the board of pharmacy 

controlling the distribution of a drug of abuse ... constitute[s] a public nuisance[.]” 

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266. Plaintiff alleges that Defendants wrongful and illegal actions have created a 

public nuisance. Each Defendant is liable for public nuisance because its conduct at issue has 

caused an unreasonable interference with a right common to the general public. 

267. The Defendants have intentionally and/or unlawfully created an absolute 

nuisance. 

268. The residents of Plaintiff’s Community have a common right to be free from 

conduct that creates an unreasonable jeopardy to the public health, welfare and safety, and to be 

free from conduct that creates a disturbance and reasonable apprehension of danger to person and 

property. 

269. Defendants intentionally, unlawfully, and recklessly manufacture, market, 

distribute, and sell prescription opioids that Defendants know, or reasonably should know, will 

be diverted, causing widespread distribution of prescription opioids in and/or to Plaintiff’s 

Community, resulting in addiction and abuse, an elevated level of crime, death and injuries to the 

residents of Plaintiff’s Community, a higher level of fear, discomfort and inconvenience to the 

residents of Plaintiff’s Community, and direct costs to Plaintiff’s Community. 

270. Defendants have unlawfully and/or intentionally caused and permitted dangerous 

drugs under their control to be diverted such as to injure the Plaintiff’s Community and its 

residents. 

271. Defendants have unlawfully and/or intentionally distributed opioids or caused 

opioids to be distributed without maintaining effective controls against diversion. Such conduct 

was illegal. Defendants’ failures to maintain effective controls against diversion include 

Defendants’ failure to effectively monitor for suspicious orders, report suspicious orders, and/or 

stop shipment of suspicious orders. 

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272. Defendants have caused a significant and unreasonable interference with the 

public health, safety, welfare, peace, comfort and convenience, and ability to be free from 

disturbance and reasonable apprehension of danger to person or property. 

273. Defendants’ conduct in illegally distributing and selling prescription opioids, or 

causing such opioids to be distributed and sold, where Defendants know, or reasonably should 

know, such opioids will be diverted and possessed and/or used illegally Plaintiff’s Community is 

of a continuing nature. 

274. Defendants’ actions have been of a continuing nature and have produced a 

significant effect upon the public’s rights, including the public’s right to health and safety. 

275. A violation of any rule or law controlling the distribution of a drug of abuse in 

Plaintiff’s Community and the State is a public nuisance. 

276. Defendants’ distribution of opioids while failing to maintain effective controls 

against diversion was proscribed by statute and regulation. 

277. Defendants’ ongoing conduct produces an ongoing nuisance, as the prescription 

opioids that they allow and/or cause to be illegally distributed and possessed in Plaintiff’s 

Community will be diverted, leading to abuse, addiction, crime, and public health costs. 

278. Because of the continued use and addiction caused by these illegally distributed 

opioids, the public will continue to fear for its health, safety and welfare, and will be subjected to 

conduct that creates a disturbance and reasonable apprehension of danger to person and property. 

279. Defendants know, or reasonably should know, that their conduct will have an 

ongoing detrimental effect upon the public health, safety and welfare, and the public’s ability to 

be free from disturbance and reasonable apprehension of danger to person and property. 

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280. Defendants know, or reasonably should know, that their conduct causes an 

unreasonable invasion of the public right to health, safety and welfare and the public’s ability to 

be free from disturbance and reasonable apprehension of danger to person and property. 

281. Defendants are aware, and at a bare minimum certainly should be aware, of the 

unreasonable interference that their conduct has caused in Plaintiff’s Community. Defendants are 

in the business of manufacturing, marketing, selling, and distributing prescription drugs, 

including opioids, which are specifically known to Defendants to be dangerous under federal 

law. See, e.g., 21 U.S.C. § 812 (b)(2). 

282. Defendants’ conduct in marketing, distributing, and selling prescription opioids 

which the defendants know, or reasonably should know, will likely be diverted for nonlegitimate, non-medical use, creates a strong likelihood that these illegal distributions of opioids 

will cause death and injuries to residents in Plaintiff’s Community and otherwise significantly 

and unreasonably interfere with public health, safety and welfare, and with the public’s right to 

be free from disturbance and reasonable apprehension of danger to person and property. 

283. It is, or should be, reasonably foreseeable to defendants that their conduct will 

cause deaths and injuries to residents in Plaintiff’s Community, and will otherwise significantly 

and unreasonably interfere with public health, safety and welfare, and with the public’s right to 

be free from disturbance and reasonable apprehension of danger to person and property. 

284. The prevalence and availability of diverted prescription opioids in the hands of 

irresponsible persons and persons with criminal purposes in Plaintiff’s Community not only 

causes deaths and injuries, but also creates a palpable climate of fear among residents in 

Plaintiff’s Community where opioid diversion, abuse, addiction are prevalent and where diverted 

opioids tend to be used frequently. 

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285. Defendants’ conduct makes it easier for persons to divert prescription opioids, 

constituting a dangerous threat to the public. 

286. Defendants’ actions were, at the least, a substantial factor in opioids becoming 

widely available and widely used for non-medical purposes. Because of Defendants’ special 

positions within the closed system of opioid distribution, without Defendants’ actions, opioid use 

would not have become so widespread, and the enormous public health hazard of prescription 

opioid and heroin overuse, abuse, and addiction that now exists would have been averted. 

287. The presence of diverted prescription opioids in Plaintiff’s Community, and the 

consequence of prescription opioids having been diverted in Plaintiff’s Community, proximately 

results in significant costs to the Plaintiff and to Plaintiff’s Community in order to enforce the 

law, equip its police force and treat the victims of opioid abuse and addiction. 

288. Stemming the flow of illegally distributed prescription opioids, and abating the 

nuisance caused by the illegal flow of opioids, will help to alleviate this problem, save lives, 

prevent injuries and make Plaintiff’s Community a safer place to live. 

289. Defendants’ conduct is a direct and proximate cause of deaths and injuries to the 

residents of Plaintiff’s Community, costs borne by Plaintiff’s Community and the Plaintiff, and a 

significant and unreasonable interference with public health, safety and welfare, and with the 

public’s right to be free from disturbance and reasonable apprehension of danger to person and 

property. 

290. Defendants’ conduct constitutes a public nuisance and, if unabated, will continue 

to threaten the health, safety and welfare of the residents of Plaintiff’s Community, creating an 

atmosphere of fear and addiction that tears at the residents’ sense of well-being and security. 

Plaintiff has a clearly ascertainable right to abate conduct that perpetuates this nuisance. 

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291. Defendants created an absolute nuisance. Defendants’ actions created and 

expanded the abuse of opioids, which are dangerously addictive, and the ensuing associated 

plague of prescription opioid and heroin addiction. Defendants knew the dangers to public 

health and safety that diversion of opioids would create in Plaintiff’s Community, however, 

Defendants intentionally and/or unlawfully failed to maintain effective controls against diversion 

through proper monitoring, reporting and refusal to fill suspicious orders of opioids. Defendants 

intentionally and/or unlawfully distributed opioids or caused opioids to be distributed without 

reporting or refusing to fill suspicious orders or taking other measures to maintain effective 

controls against diversion. Defendants intentionally and/or unlawfully continued to ship and 

failed to halt suspicious orders of opioids, or caused such orders to be shipped. Defendants 

intentionally and/or unlawfully marketed opioids in manners they knew to be false and 

misleading. Such actions were inherently dangerous. 

292. Defendants knew the prescription opioids have a high likelihood of being 

diverted. It was foreseeable to Defendants that where Defendants distributed prescription opioids 

or caused such opioids to be distributed without maintaining effective controls against diversion, 

including monitoring, reporting, and refusing shipment of suspicious orders, that the opioids 

would be diverted, and create an opioid abuse nuisance in Plaintiff’s Community. 

293. Defendants’ actions also created a qualified nuisance. Defendants acted 

recklessly, negligently and/or carelessly, in breach of their duties to maintain effective controls 

against diversion, thereby creating an unreasonable risk of harm. 

294. Defendants acted with actual malice because Defendants acted with a conscious 

disregard for the rights and safety of other persons, and said actions have a great probability of 

causing substantial harm. 

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295. The damages available to the Plaintiff include, inter alia, recoupment of 

governmental costs, flowing from an ongoing and persistent public nuisance which the 

government seeks to abate. Defendants’ conduct is ongoing and persistent, and the Plaintiff 

seeks all damages flowing from Defendants’ conduct. Plaintiff further seeks to abate the 

nuisance and harm created by Defendants’ conduct. 

296. As a direct result of Defendants’ conduct, the Plaintiff and Plaintiff’s Community 

have suffered actual injury and damages including, but not limited to, significant expenses for 

police, emergency, health, prosecution, corrections and other services. The Plaintiff here seeks 

recovery for its own harm. 

297. The Plaintiff and Plaintiff’s Community have sustained specific and special 

injuries because its damages include, inter alia, health services, law enforcement expenditures, 

and costs related to opioid addiction treatment and overdose prevention. 

298. The Plaintiff further seeks to abate the nuisance created by the Defendants’ 

unreasonable, unlawful, intentional, ongoing, continuing, and persistent actions and omissions 

and interference with a right common to the public. 

299. Plaintiff seeks all legal and equitable relief as allowed by law, including inter alia 

abatement, compensatory damages, and punitive damages from the Defendants for the creation 

of a public nuisance, attorney fees and costs, and pre- and post-judgment interest. 

300. Defendants’ intentional and unlawful actions and omissions and unreasonable 

interference with a right common to the public are of a continuing nature. 

301. Defendants are aware, and at a bare minimum certainly should be aware, of the 

unreasonable interference that their conduct has caused in the Plaintiff’s community. Defendants 

are in the business of manufacturing or distributing prescription drugs, including opioids, which 

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are specifically known to Defendants to be dangerous because inter alia these drugs are defined 

under federal and state law as substances posing a high potential for abuse and severe addiction. 

Defendants created an absolute nuisance. Defendants’ actions created and expanded the abuse of 

opioids, drugs specifically codified as constituting severely harmful substances. 

302. The public nuisance created by Defendants’ actions is substantial and 

unreasonable – it has caused and continues to cause significant harm to the community, and the 

harm inflicted outweighs any offsetting benefit. The staggering rates of opioid and heroin use 

resulting from the Defendants’ abdication of their gate-keeping and diversion prevention duties, 

and the Manufacturer Defendants’ fraudulent marketing activities, have caused harm to the entire 

community that includes, but is not limited to: 

a. The high rates of use leading to unnecessary opioid abuse, addiction, overdose, 

injuries, and deaths. 

b. Even children have fallen victim to the opioid epidemic. Easy access to prescription 

opioids made opioids a recreational drug of choice among teenagers. Even infants 

have been born addicted to opioids due to prenatal exposure, causing severe 

withdrawal symptoms and lasting developmental impacts. 

c. Even those residents of Plaintiff’s Community who have never taken opioids have 

suffered from the public nuisance arising from Defendants’ abdication of their gatekeeper duties and fraudulent promotions. Many residents have endured both the 

emotional and financial costs of caring for loved ones addicted to or injured by 

opioids, and the loss of companionship, wages, or other support from family members 

who have used, abused, become addicted to, overdosed on, or been killed by opioids. 

d. The opioid epidemic has increased health care costs. 

e. Employers have lost the value of productive and healthy employees. 

f. Defendants’ conduct created an abundance of drugs available for criminal use and 

fueled a new wave of addiction, abuse, and injury. 

g. Defendants’ dereliction of duties and/or fraudulent misinformation campaign pushing 

dangerous drugs resulted in a diverted supply of narcotics to sell, and the ensuing 

demand of addicts to buy them. More prescription opioids sold by Defendants led to 

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more addiction, with many addicts turning from prescription opioids to heroin. People 

addicted to opioids frequently require increasing levels of opioids, and many turned 

to heroin as a foreseeable result. 

h. The diversion of opioids into the secondary, criminal market and the increased 

number of individuals who abuse or are addicted to opioids increased the demands on 

health care services and law enforcement. 

i. The significant and unreasonable interference with the public rights caused by 

Defendants’ conduct taxed the human, medical, public health, law enforcement, and 

financial resources of the Plaintiff’s Community. 

j. Defendants’ interference with the comfortable enjoyment of life in the Plaintiff’s 

Community is unreasonable because there is little social utility to opioid diversion 

and abuse, and any potential value is outweighed by the gravity of the harm inflicted 

by Defendants’ actions. 

303. The Plaintiff and Plaintiff’s Community have sustained specific and special 

injuries because its damages include inter alia health services and law enforcement expenditures, 

as described in this Complaint. 

304. Plaintiff seeks economic losses (direct, incidental, or consequential pecuniary 

losses) resulting from Defendants’ fraudulent activity and fraudulent misrepresentations. 

Plaintiff does not seek damages for the wrongful death, physical personal injury, serious 

emotional distress, or any physical damage to property caused by Defendants’ actions. 

305. Plaintiff seeks all legal and equitable relief as allowed by law, other than such 

damages disavowed herein, including inter alia injunctive relief, restitution, disgorgement of 

profits, compensatory and punitive damages, and all damages allowed by law to be paid by the 

Defendants, attorney fees and costs, and pre- and post-judgment interest. 

COUNT II 

RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS ACT 

18 U.S.C. 1961, et seq. 

(Against All Defendants) 

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306. Plaintiff incorporates by reference all other paragraphs of this Complaint as if 

fully set forth herein, and further alleges as follows. 

307. Plaintiff brings this Count on behalf of itself against the following Defendants, as 

defined above: Purdue, Cephalon, Janssen, Endo, Mallinckrodt, Actavis, McKesson, Cardinal, 

and AmerisourceBergen (collectively, for purposes of this Count, the “RICO Defendants”). 

308. The RICO Defendants conducted and continue to conduct their business through 

legitimate and illegitimate means in the form of an association-in-fact enterprise and/or a legal 

entity enterprise. At all relevant times, the RICO Defendants were “persons” under 18 U.S.C. § 

1961(3) because they are entities capable of holding, and do hold, “a legal or beneficial interest 

in property.” 

309. Section 1962(c) of RICO makes it unlawful “for any person employed by or 

associated with any enterprise engaged in, or the activities of which affect, interstate or foreign 

commerce, to conduct or participate, directly or indirectly, in the conduct of such enterprise’s 

affairs through a pattern of racketeering activity or collection of unlawful debt.” 18 U.S.C. § 

1962(c); United State v. Turkette, 452 U.S. 576, 580 (1981). 

310. The term “enterprise” is defined as including “any individual, partnership, 

corporation, association, or other legal entity, and any union or group of individuals associated in 

fact although not a legal entity.” 18 U.S.C. § 1961(4); Turkette, 452 U.S. at 580; Boyle v. U.S., 

556 U.S. 938, 944 (2009). The definition of “enterprise” in Section 1961(4) includes legitimate 

and illegitimate enterprises within its scope. Specifically, the section “describes two separate 

categories of associations that come within the purview of an ‘enterprise’ -- the first 

encompassing organizations such as corporations, partnerships, and other ‘legal entities,’ and the 

second covering ‘any union or group of individuals associated in fact although not a legal 

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entity.’” Turkette, 452 U.S. at 577. The second category is not a more generalized description of 

the first. Id. 

311. For over a decade, the RICO Defendants aggressively sought to bolster their 

revenue, increase profit, and grow their share of the prescription painkiller market by unlawfully 

and surreptitiously increasing the volume of opioids they sold. However, the RICO Defendants 

are not permitted to engage in a limitless expansion of their market through the unlawful sales of 

regulated painkillers. As “registrants,” the RICO Defendants operated and continue to operate 

within the “closed-system” created under the Controlled Substances Act, 21 U.S.C. § 821, et seq.

(the “CSA”). The CSA restricts the RICO Defendants’ ability to manufacture or distribute 

Schedule II substances like opioids by requiring them to: (1) register to manufacture or distribute 

opioids; (2) maintain effective controls against diversion of the controlled substances that they 

manufacturer or distribute; (3) design and operate a system to identify suspicious orders of 

controlled substances, halt such unlawful sales, and report them to the DEA; and (4) make sales 

within a limited quota set by the DEA for the overall production of Schedule II substances like 

opioids. 

312. The closed-system created by the CSA, including the establishment of quotas, 

was specifically intended to reduce or eliminate the diversion of Schedule II substances like 

opioids from “legitimate channels of trade” to the illicit market by controlling the quantities of 

the basic ingredients needed for the manufacture of [controlled substances].”145 

313. Finding it impossible to legally achieve their ever increasing sales ambitions, 

members of the Opioid Diversion Enterprise (as defined below) systematically and fraudulently 

 

145 1970 U.S.C.C.A.N. 4566 at 5490; see also Testimony of Joseph T. Rannazzisi before the Caucus on International 

Narcotics Control, United States Senate, May 5, 2015 (available at 

https://www.drugcaucus.senate.gov/sites/default/files/Rannazzisi%20Testimony_0.pdf). 

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violated their statutory duty to maintain effective controls against diversion of their drugs, to 

design and operate a system to identify suspicious orders of their drugs, to halt unlawful sales of 

suspicious orders, and to notify the DEA of suspicious orders.146 As discussed in detail below, 

through the RICO Defendants’ scheme, members of the Opioid Diversion Enterprise repeatedly 

engaged in unlawful sales of painkillers which, in turn, artificially and illegally increased the 

annual production quotas for opioids allowed by the DEA. 147 In doing so, the RICO Defendants 

allowed hundreds of millions of pills to enter the illicit market which allowed them to generate 

obscene profits. 

314. Defendants’ illegal scheme was hatched by an association-in-fact enterprise 

between the Manufacturer Defendants and the Distributor Defendants, and executed in perfect 

harmony by each of them. In particular, each of the RICO Defendants were associated with, and 

conducted or participated in, the affairs of the RICO enterprise (defined below and referred to 

collectively as the “Opioid Diversion Enterprise”), whose purpose was to engage in the unlawful 

sales of opioids, deceive the public and federal and state regulators into believing that the RICO 

Defendants were faithfully fulfilling their statutory obligations. The RICO Defendants’ scheme 

allowed them to make billions in unlawful sales of opioids and, in turn, increase and/or maintain 

high production quotas with the purpose of ensuring unlawfully increasing revenues, profits, and 

market share. As a direct result of the RICO Defendants’ fraudulent scheme, course of conduct, 

and pattern of racketeering activity, they were able to extract billions of dollars of revenue from 

the addicted American public, while entities like the Plaintiff experienced tens of millions of 

dollars of injury caused by the reasonably foreseeable consequences of the prescription opioid 

addiction epidemic. As explained in detail below, the RICO Defendants’ misconduct violated 

 

146 21 U.S.C. § 823(a)(1), (b)(1); 21 C.F.R. § 1301.74(b)-(c). 

147 21 C.F.R. § 1303.11(b); 21 C.F.R. § 1303.23. 

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Section 1962(c) and Plaintiff is entitled to treble damages for its injuries under 18 U.S.C. § 

1964(c). 

315. Alternatively, the RICO Defendants were members of a legal entity enterprise 

within the meaning of 18 U.S.C. § 1961(4), through which the RICO Defendants conducted their 

pattern of racketeering activity in this jurisdiction and throughout the United States. Specifically, 

the Healthcare Distribution Alliance (the “HDA”)148 is a distinct legal entity that satisfies the 

definition of a RICO enterprise. The HDA is a non-profit corporation formed under the laws of 

the District of Columbia and doing business in Virginia. As a non-profit corporation, HDA 

qualifies as an “enterprise” within the definition set out in 18 U.S.C. § 1961(4) because it is a 

corporation and a legal entity. 

316. On information and belief, each of the RICO Defendants is a member, participant, 

and/or sponsor of the HDA and utilized the HDA to conduct the Opioid Diversion Enterprise and 

to engage in the pattern of racketeering activity that gives rise to the Count. 

317. Each of the RICO Defendants is a legal entity separate and distinct from the 

HDA. And, the HDA serves the interests of distributors and manufacturers beyond the RICO 

Defendants. Therefore, the HDA exists separately from the Opioid Diversion Enterprise, and 

each of the RICO Defendants exists separately from the HDA. Therefore, the HDA may serve as 

a RICO enterprise. 

318. The legal and association-in-fact enterprises alleged in the previous and 

subsequent paragraphs were each used by the RICO Defendants to conduct the Opioid Diversion 

Enterprise by engaging in a pattern of racketeering activity. Therefore, the legal and association-

 

148 Health Distribution Alliance, History, Health Distribution Alliance, (last accessed on September 15, 2017), 

https://www.healthcaredistribution.org/about/hda-history. 

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in-fact enterprises alleged in the previous and subsequent paragraphs are pleaded in the 

alternative and are collectively referred to as the “Opioid Diversion Enterprise.” 

A. THE OPIOID DIVERSION ENTERPRISE 

319. Recognizing that there is a need for greater scrutiny over controlled substances 

due to their potential for abuse and danger to public health and safety, the United States 

Congress enacted the Controlled Substances Act in 1970.149 The CSA and its implementing 

regulations created a closed-system of distribution for all controlled substances and listed 

chemicals.150 Congress specifically designed the closed chain of distribution to prevent the 

diversion of legally produced controlled substances into the illicit market.151 As reflected in 

comments from United States Senators during deliberation on the CSA, the “[CSA] is designed 

to crack down hard on the narcotics pusher and the illegal diverters of pep pills and goof 

balls.”152 Congress was concerned with the diversion of drugs out of legitimate channels of 

distribution when it enacted the CSA and acted to halt the “widespread diversion of [controlled 

substances] out of legitimate channels into the illegal market.”153 Moreover, the closed-system 

was specifically designed to ensure that there are multiple ways of identifying and preventing 

diversion through active participation by registrants within the drug delivery chain.154 All 

 

149 Joseph T. Rannazzisi Decl. ¶ 4, Cardinal Health, Inc. v. Eric Holder, Jr., Attorney General, D.D.C. Case No. 12-

cv-185 (Document 14-2 February 10, 2012). 

150 See H.R. Rep. No. 91-1444, 1970 U.S.C.C.A.N. at 4566. 

151 Gonzalez v. Raich, 545 U.S. 1, 12-14 (2005); 21 U.S.C. § 801(20; 21 U.S.C. §§ 821-824, 827, 880; H.R. Rep. 

No. 91-1444, 1970 U.S.C.C.A.N. 4566, 4572 (Sept. 10, 1970). 

152 See H.R. Rep. No. 91-1444, 1970 U.S.C.C.A.N. at 4566; 116 Cong. Rec. 977-78 (Comments of Sen. Dodd, Jan 

23, 1970).

153 See Testimony of Joseph T. Rannazzisi before the Caucus on International Narcotics Control, United State 

Senate, May 5, 2015 (available at 

https://www.drugcaucus.senate.gov/sites/default/files/Rannazzisi%20Testimony_0.pdf). 

154 See Statement of Joseph T. Rannazzisi before the Caucus on International Narcotics Control United States 

Senate, July 18, 2012 (available at 

https://www.justice.gov/sites/default/files/testimonies/witnesses/attachments/07/18/12/07-18-12-dea-rannazzisi.pdf). 

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registrants -- manufacturers and distributors alike -- must adhere to the specific security, 

recordkeeping, monitoring and reporting requirements that are designed to identify or prevent 

diversion.155 When registrants at any level fail to fulfill their obligations, the necessary checks 

and balances collapse.156 The result is the scourge of addiction that has occurred. 

320. In 2006 and 2007, the DEA issued multiple letters to the Distributor Defendants 

reminding them of their obligation to maintain effective controls against diversion of particular 

controlled substances, design and operate a system to disclose suspicious orders, and to inform 

the DEA of any suspicious orders.157 The DEA also published suggested questions that a 

distributor should ask prior to shipping controlled substances, in order to “know their 

customers.”158 

321. Central to the closed-system created by the CSA was the directive that the DEA 

determine quotas of each basic class of Schedule I and II controlled substances each year. The 

quota system was intended to reduce or eliminate diversion from “legitimate channels of trade” 

by controlling the “quantities of the basic ingredients needed for the manufacture of [controlled 

substances], and the requirement of order forms for all transfers of these drugs.”159 When 

evaluating production quotas, the DEA was instructed to consider the following information: 

a. Information provided by the Department of Health and Human Services; 

 

155 Id.

156 Joseph T. Rannazzisi Decl. ¶ 10, Cardinal Health, Inc. v. Eric Holder, Jr., Attorney General, D.D.C. Case No. 

12-cv-185 (Document 14-2 February 10, 2012). 

157 Joseph T. Rannazzisi, In Reference to Registration # RC0183080 (September 27, 2006); Joseph T. Rannazzisi, In 

Reference to Registration # RC0183080 (December 27, 2007).

158 Suggested Questions a Distributor should ask prior to shipping controlled substances, Drug Enforcement 

Administration (available at 

https://www.deadiversion.usdoj.gov/mtgs/pharm_industry/14th_pharm/levinl_ques.pdf). 

159 1970 U.S.C.C.A.N. 4566 at 5490; see also Testimony of Joseph T. Rannazzisi before the Caucus on International 

Narcotics Control, United States Senate, May 5, 2015 (available at 

https://www.drugcaucus.senate.gov/sites/default/files/Rannazzisi%20Testimony_0.pdf). 

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b. Total net disposal of the basic class by all manufacturers; 

c. Trends in the national rate of disposal of the basic class; 

d. An applicant’s production cycle and current inventory position; 

e. Total actual or estimated inventories of the class and of all substances 

manufactured from the class and trends in inventory accumulation; and 

322. Other factors such as: changes in the currently accepted medical use of substances 

manufactured for a basic class; the economic and physical availability of raw materials; yield and 

sustainability issues; potential disruptions to production; and unforeseen emergencies.160

323. It is unlawful for a registrant to manufacture a controlled substance in Schedule II, 

like prescription opioids, that is (1) not expressly authorized by its registration and by a quota 

assigned to it by DEA, or (2) in excess of a quota assigned to it by the DEA.161

324. At all relevant times, the RICO Defendants operated as an association-in-fact 

enterprise formed for the purpose of unlawfully increasing sales, revenues and profits by 

disregarding their statutory duty to identify, investigate, halt and report suspicious orders of 

opioids and diversion of their drugs into the illicit market, in order to unlawfully increase the 

quotas set by the DEA and allow them to collectively benefit from the unlawful formation of a 

greater pool of prescription opioids from which to profit. The RICO Defendants conducted their 

pattern of racketeering activity in this jurisdiction and throughout the United States through this 

enterprise. 

325. The opioid epidemic has its origins in the mid-1990s when, between 1997 and 

2007, per capita purchase of methadone, hydrocodone, and oxycodone increased 13-fold, 4-fold, 

 

160 See Testimony of Joseph T. Rannazzisi before the Caucus on International Narcotics Control, United State 

Senate, May 5, 2015 (available at 

https://www.drugcaucus.senate.gov/sites/default/files/Rannazzisi%20Testimony_0.pdf). 

161 Id. (citing 21 U.S.C. 842(b)). 

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and 9-fold, respectively. By 2010, enough prescription opioids were sold in the United States to 

medicate every adult in the country with a dose of 5 milligrams of hydrocodone every 4 hours 

for 1 month.162 On information and belief, the Opioid Diversion Enterprise has been ongoing for 

at least the last decade.163

326. The Opioid Diversion Enterprise was and is a shockingly successful endeavor. It 

Opioid Diversion Enterprise has been conducting business uninterrupted since its genesis. But, it 

was not until recently that United States and State regulators finally began to unravel the extent 

of the enterprise and the toll that it exacted on the American public. 

327. At all relevant times, the Opioid Diversion Enterprise: (a) had an existence 

separate and distinct from each RICO Defendant; (b) was separate and distinct from the pattern 

of racketeering in which the RICO Defendants engaged; (c) was an ongoing and continuing 

organization consisting of legal entities, including each of the RICO Defendants; (d) 

characterized by interpersonal relationships among the RICO Defendants; (e) had sufficient 

longevity for the enterprise to pursue its purpose; and (f) functioned as a continuing unit. 

Turkette, 452 U.S. at 580; Boyle, 556 U.S. at 944 (2009). Each member of the Opioid Diversion 

Enterprise participated in the conduct of the enterprise, including patterns of racketeering 

activity, and shared in the astounding growth of profits supplied by fraudulently inflating opioid 

sales generated as a result of the Opioid Diversion Enterprise’s disregard for their duty to prevent 

diversion of their drugs into the illicit market and then requesting the DEA increase production 

 

162 Keyes KM, Cerdá M, Brady JE, Havens JR, Galea S. Understanding the rural-urban differences in nonmedical 

prescription opioid use and abuse in the United States. Am J Public Health. 2014;104(2):e52-9. 

163 Matthew Perrone, Pro-Painkiller echo chamber shaped policy amid drug epidemic, The Center for Public 

Integrity (September 19, 2017, 12:01 a.m.), https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echochamber-shaped-policy-amid-drug-epidemic. 

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quotas, all so that the RICO Defendants would have a larger pool of prescription opioids from 

which to profit. 

328. The Opioid Diversion Enterprise also engaged in efforts to lobby against the 

DEA’s authority to hold the RICO Defendants liable for disregarding their duty to prevent 

diversion. Members of the Pain Care Forum (described in greater detail below) and the 

Healthcare Distribution Alliance lobbied for the passage of legislation to weaken the DEA’s 

enforcement authority. The Ensuring Patient Access and Effective Drug Enforcement Act 

significantly reduced the DEA’s ability to issue orders to show cause and to suspend and/or 

revoke registrations164 The HDA and other members of the Pain Care Forum contributed 

substantial amounts of money to political campaigns for federal candidates, state candidates, 

political action committees and political parties. Plaintiff is informed and believes that the Pain 

Care Forum and its members poured at least $3.5 million into lobbying efforts in this jurisdiction 

while the HDA devoted over a million dollars a year to its lobbying efforts between 2011 and 

2016. 

329. The Opioid Diversion Enterprise functioned by selling prescription opioids. While 

there are some legitimate uses and/or needs for prescription opioids, the RICO Defendants, 

through their illegal enterprise, engaged in a pattern of racketeering activity, that involves a 

fraudulent scheme to increase revenue by violating State and Federal laws requiring the 

 

164 See HDMA is now the Healthcare Distribution Alliance, Pharmaceutical Commerce, (June 13, 2016, updated 

July 6, 2016), http://pharmaceuticalcommerce.com/business-and-finance/hdma-now-healthcare-distributionalliance/; Lenny Bernstein & Scott Higham, Investigation: The DEA Slowed Enforcement While the Opioid 

Epidemic Grew Out of Control, Wash. Post, Oct. 22, 2016, https://www.washingtonpost.com/investigations/the-deaslowed-enforcement-while-the-opioid-epidemic-grew-out-of-control/2016/10/22/aea2bf8e-7f71-11e6-8d13-

d7c704ef9fd9_story.html; Lenny Bernstein & Scott Higham, Investigation: U.S. Senator Calls for Investigation of 

DEA Enforcement Slowdown Amid Opioid Crisis, Wash. Post, Mar. 6, 2017, 

https://www.washingtonpost.com/investigations/us-senator-calls-for-investigation-of-dea-enforcementslowdown/2017/03/06/5846ee60-028b-11e7-b1e9-a05d3c21f7cf_story.html; Eric Eyre, DEA Agent: “We Had no 

Leadership” in WV Amid Flood of Pain Pills, Charleston Gazette-Mail, Feb. 18, 2017, 

http://www.wvgazettemail.com/news/20170218/dea-agent-we-had-no-leadership-in-wv-amid-flood-of-pain-pills-. 

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maintenance of effective controls against diversion of prescription opioids, and the identification, 

investigation, and reporting of suspicious orders of prescription opioids destined for the illicit 

drug market. The goal of Defendants’ scheme was to increase profits from opioid sales. But, 

Defendants’ profits were limited by the production quotas set by the DEA, so the Defendants 

refused to identify, investigate and/or report suspicious orders of their prescription opioids being 

diverted into the illicit drug market. The end result of this strategy was to increase and maintain 

artificially high production quotas of opioids so that there was a larger pool of opioids for 

Defendants to manufacture and distribute for public consumption. 

330. The Opioid Diversion Enterprise engaged in, and its activities affected, interstate 

and foreign commerce because the enterprise involved commercial activities across states lines, 

such as manufacture, sale, distribution, and shipment of prescription opioids throughout the 

country and this jurisdiction, and the corresponding payment and/or receipt of money from the 

sale of the same. 

331. Within the Opioid Diversion Enterprise, there were interpersonal relationships 

and common communication by which the RICO Defendants shared information on a regular 

basis. These interpersonal relationships also formed the organization of the Opioid Diversion 

Enterprise. The Opioid Diversion Enterprise used their interpersonal relationships and 

communication network for the purpose of conducting the enterprise through a pattern of 

racketeering activity. 

332. Each of the RICO Defendants had a systematic link to each other through joint 

participation in lobbying groups, trade industry organizations, contractual relationships and 

continuing coordination of activities. The RICO Defendants participated in the operation and 

management of the Opioid Diversion Enterprise by directing its affairs, as described herein. 

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While the RICO Defendants participated in, and are members of, the enterprise, they each have a 

separate existence from the enterprise, including distinct legal statuses, different offices and 

roles, bank accounts, officers, directors, employees, individual personhood, reporting 

requirements, and financial statements. 

333. The RICO Defendants exerted substantial control over the Opioid Diversion 

Enterprise by their membership in the Pain Care Forum, the HDA, and through their contractual 

relationships. 

334. The Pain Care Forum (“PCF”) has been described as a coalition of drugmakers, 

trade groups and dozens of non-profit organizations supported by industry funding. The PCF 

recently became a national news story when it was discovered that lobbyists for members of the 

PCF quietly shaped federal and state policies regarding the use of prescription opioids for more 

than a decade. 

335. The Center for Public Integrity and The Associated Press obtained “internal 

documents shed[ding] new light on how drugmakers and their allies shaped the national response 

to the ongoing wave of prescription opioid abuse.”165 Specifically, PCF members spent over 

$740 million lobbying in the nation’s capital and in all 50 statehouses on an array of issues, 

including opioid-related measures.166

336. Not surprisingly, each of the RICO Defendants who stood to profit from lobbying 

in favor of prescription opioid use is a member of and/or participant in the PCF.167 In 2012, 

membership and participating organizations included the HDA (of which all RICO Defendants 

 

165 Matthew Perrone, Pro-Painkiller echo chamber shaped policy amid drug epidemic, The Center for Public 

Integrity (September 19, 2017, 12:01 a.m.), https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echochamber-shaped-policy-amid-drug-epidemic (emphasis added). 

166 Id. 

167 PAIN CARE FORUM 2012 Meetings Schedule, (last updated December 2011), 

https://assets.documentcloud.org/documents/3108982/PAIN-CARE-FORUM-Meetings-Schedule-amp.pdf 

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are members), Endo, Purdue, Johnson & Johnson (the parent company for Janssen 

Pharmaceuticals), Actavis (i.e., Allergan), and Teva (the parent company of Cephalon).168 Each 

of the Manufacturer Defendants worked together through the PCF to advance the interests of the 

enterprise. But, the Manufacturer Defendants were not alone. The Distributor Defendants 

actively participated, and continue to participate in the PCF, at a minimum, through their trade 

organization, the HDA.169 Plaintiff is informed and believes that the Distributor Defendants 

participated directly in the PCF as well. 

337. The 2012 Meeting Schedule for the Pain Care Forum is particularly revealing on 

the subject of the Defendants’ interpersonal relationships. The meeting schedule indicates that 

meetings were held in the D.C. office of Powers Pyles Sutter & Verville on a monthly basis, 

unless otherwise noted. Local members were “encouraged to attend in person” at the monthly 

meetings. And, the meeting schedule indicates that the quarterly and year-end meetings included 

a “Guest Speaker.” 

338. The 2012 Pain Care Forum Meeting Schedule demonstrates that each of the 

Defendants participated in meetings on a monthly basis, either directly or through their trade 

organization, in a coalition of drugmakers and their allies whose sole purpose was to shape the 

national response to the ongoing prescription opioid epidemic, including the concerted lobbying 

efforts that the PCF undertook on behalf of its members. 

339. Second, the HDA -- or Healthcare Distribution Alliance -- led to the formation of 

interpersonal relationships and an organization between the RICO Defendants. Although the 

 

168 Id. Plaintiff is informed and believes that Mallinckrodt became an active member of the PCF sometime after 

2012. 

169 Id. The Executive Committee of the HDA (formerly the HDMA) currently includes the Chief Executive Officer, 

Pharmaceutical Segment for Cardinal Health, Inc., the Group President, Pharmaceutical Distribution and Strategic 

Global Source for AmerisourceBergen Corporation, and the President, U.S. Pharmaceutical for McKesson 

Corporation. Executive Committee, Healthcare Distribution Alliance (accessed on September 14, 2017), 

https://www.healthcaredistribution.org/about/executive-committee. 

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entire HDA membership directory is private, the HDA website confirms that each of the 

Distributor Defendants and the Manufacturer Defendants named in the Complaint, including 

Actavis (i.e., Allergan), Endo, Purdue, Mallinckrodt and Cephalon were members of the HDA.170

And, the HDA and each of the Distributor Defendants, eagerly sought the active membership and 

participation of the Manufacturer Defendants by advocating that one of the benefits of 

membership included the ability to develop direct relationships between Manufacturers and 

Distributors at high executive levels. 

340. In fact, the HDA touted the benefits of membership to the Manufacturer 

Defendants, advocating that membership included the ability to, among other things, “network 

one on one with manufacturer executives at HDA’s members-only Business and Leadership 

Conference,” “networking with HDA wholesale distributor members,” “opportunities to host and 

sponsor HDA Board of Directors events,” “participate on HDA committees, task forces and 

working groups with peers and trading partners,” and “make connections.”171 Clearly, the HDA 

and the Distributor Defendants believed that membership in the HDA was an opportunity to 

create interpersonal and ongoing organizational relationships between the Manufacturers and 

Defendants. 

341. The application for manufacturer membership in the HDA further indicates the 

level of connection that existed between the RICO Defendants.172 The manufacturer membership 

application must be signed by a “senior company executive,” and it requests that the 

 

170 Manufacturer Membership, Healthcare Distribution Alliance, (accessed on September 14, 2017), 

https://www.healthcaredistribution.org/about/membership/manufacturer. 

171 Manufacturer Membership Benefits, Healthcare Distribution Alliance, (accessed on September 14, 2017), 

https://www.healthcaredistribution.org/~/media/pdfs/membership/manufacturer-membership-benefits.ashx?la=en. 

172 Manufacturer Membership Application, Healthcare Distribution Alliance, (accessed on September 14, 2017), 

https://www.healthcaredistribution.org/~/media/pdfs/membership/manufacturer-membershipapplication.ashx?la=en. 

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manufacturer applicant identify a key contact and any additional contacts from within its 

company. The HDA application also requests that the manufacturer identify its current 

distribution information and its most recent year end net sales through any HDA distributors, 

including but not limited to, Defendants AmerisourceBergen, Cardinal Health, and McKesson.173

342. After becoming members, the Distributors and Manufacturers were eligible to 

participate on councils, committees, task forces and working groups, including: 

a. Industry Relations Council: “This council, composed of distributor and 

manufacturer members, provides leadership on pharmaceutical distribution and 

supply chain issues.”174 

b. Business Technology Committee: “This committee provides guidance to HDA 

and its members through the development of collaborative e-commerce business 

solutions. The committee’s major areas of focus within pharmaceutical 

distribution include information systems, operational integration and the impact of 

e-commerce.” Participation in this committee includes distributors and 

manufacturer members.175

c. Health, Beauty and Wellness Committee: “This committee conducts research, as 

well as creates and exchanges industry knowledge to help shape the future of the 

distribution for health, beauty and wellness/consumer products in the healthcare 

supply chain.” Participation in this committee includes distributors and 

manufacturer members.176

 

173 Id. 

174 Councils and Committees, Healthcare Distribution Alliance, (accessed on September 14, 2017), 

https://www.healthcaredistribution.org/about/councils-and-committees 

175 Id. 

176 Id. 

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d. Logistics Operation Committee: “This committee initiates projects designed to 

help members enhance the productivity, efficiency and customer satisfaction 

within the healthcare supply chain. Its major areas of focus include process 

automation, information systems, operational integration, resource management 

and quality improvement.” Participation in this committee includes distributors 

and manufacturer members.177

e. Manufacturer Government Affairs Advisory Committee: “This committee 

provides a forum for briefing HDA’s manufacturer members on federal and state 

legislative and regulatory activity affecting the pharmaceutical distribution 

channel. Topics discussed include such issues as prescription drug traceability, 

distributor licensing, FDA and DEA regulation of distribution, importation and 

Medicaid/Medicare reimbursement.” Participation in this committee includes 

manufacturer members.178

f. Bar Code Task Force: Participation includes Distributor, Manufacturer and 

Service Provider Members.179 

g. eCommerce Task Force: Participation includes Distributor, Manufacturer and 

Service Provider Members.180 

h. ASN Working Group: Participation includes Distributor, Manufacturer and 

Service Provider Members.181 

 

177 Id. 

178 Id. 

179 Id. 

180 Id. 

181 Id. 

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343. Contracts and Chargebacks Working Group: “This working group explores how 

the contract administration process can be streamlined through process improvements or 

technical efficiencies. It also creates and exchanges industry knowledge of interest to contract 

and chargeback professionals.” Participation includes Distributor and Manufacturer Members.182

344. The councils, committees, task forces and working groups provided the 

Manufacturer and Distributor Defendants with the opportunity to work closely together in 

shaping their common goals and forming the enterprise’s organization. 

345. The HDA also offers a multitude of conferences, including annual business and 

leadership conferences. The HDA, and the Distributor Defendants advertise these conferences to 

the Manufacturer Defendants as an opportunity to “bring together high-level executives, thought 

leaders and influential managers . . . to hold strategic business discussions on the most pressing 

industry issues.”183 The conferences also gave the Manufacturer and Distributor Defendants 

“unmatched opportunities to network with [their] peers and trading partners at all levels of the 

healthcare distribution industry.”184 The HDA and its conferences were significant opportunities 

for the Manufacturer and Distributor Defendants to interact at a high-level of leadership. And, it 

is clear that the Manufacturer Defendants embraced this opportunity by attending and sponsoring 

these events.185

 

182 Id. 

183 Business and Leadership Conference – Information for Manufacturers, Healthcare Distribution Alliance, 

(accessed on September 14, 2017), https://www.healthcaredistribution.org/events/2015-business-and-leadershipconference/blc-for-manufacturers. 

184 Id. 

185 2015 Distribution Management Conference and Expo, Healthcare Distribution Alliance, (accessed on September 

14, 2017), https://www.healthcaredistribution.org/events/2015-distribution-management-conference. 

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346. Third, the RICO Defendants maintained their interpersonal relationships by 

working together and exchanging information and driving the unlawful sales of their opioids 

through their contractual relationships, including chargebacks and vault security programs. 

347. The Manufacturer Defendants engaged in an industry-wide practice of paying 

rebates and/or chargebacks to the Distributor Defendants for sales of prescription opioids.186 As 

reported in the Washington Post, identified by Senator McCaskill, and acknowledged by the 

HDA, there is an industry-wide practice whereby the Manufacturers paid the Distributors rebates 

and/or chargebacks on their prescription opioid sales.187 On information and belief, these 

contracts were negotiated at the highest levels, demonstrating ongoing relationships between the 

Manufacturer and Distributor Defendants. In return for the rebates and chargebacks, the 

Distributor Defendants provided the Manufacturer Defendants with detailed information 

regarding their prescription opioid sales, including purchase orders, acknowledgements, ship 

notices, and invoices.188 The Manufacturer Defendants used this information to gather high-level 

data regarding overall distribution and direct the Distributor Defendants on how to most 

effectively sell the prescription opioids. 

348. The contractual relationships among the RICO Defendants also include vault 

security programs. The RICO Defendants are required to maintain certain security protocols and 

storage facilities for the manufacture and distribution of their opiates. Plaintiff is informed and 

 

186 Lenny Bernstein & Scott Higham, The government’s struggle to hold opioid manufacturers accountable, The 

Washington Post, (April 2, 2017), https://www.washingtonpost.com/graphics/investigations/deamallinckrodt/?utm_term=.b24cc81cc356; see also, Letter from Sen. Claire McCaskill, (July 27, 2017), 

https://www.mccaskill.senate.gov/imo/media/image/july-opioid-investigation-letter-manufacturers.png; Letter from 

Sen. Claire McCaskill, (July 27, 2017), https://www.mccaskill.senate.gov/imo/media/image/july-opioidinvestigation-letter-manufacturers.png; Letters From Sen. Claire McCaskill, (March 28, 2017), 

https://www.mccaskill.senate.gov/opioid-investigation; Purdue Managed Markets, Purdue Pharma, (accessed on 

September 14, 2017), http://www.purduepharma.com/payers/managed-markets/. 

187 Id. 

188 Webinars, Healthcare Distribution Alliance, (accessed on September 14, 2017), 

https://www.healthcaredistribution.org/resources/webinar-leveraging-edi. 

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believes that manufacturers negotiated agreements whereby the Manufacturers installed security 

vaults for Distributors in exchange for agreements to maintain minimum sales performance 

thresholds. Plaintiff is informed and believes that these agreements were used by the RICO 

Defendants as a tool to violate their reporting and diversion duties in order to reach the required 

sales requirements. 

349. Taken together, the interaction and length of the relationships between and among 

the Manufacturer and Distributor Defendants reflects a deep level of interaction and cooperation 

between two groups in a tightly knit industry. The Manufacturer and Distributor Defendants 

were not two separate groups operating in isolation or two groups forced to work together in a 

closed system. The RICO Defendants operated together as a united entity, working together on 

multiple fronts, to engage in the unlawful sale of prescription opioids. The HDA and the Pain 

Care Forum are but two examples of the overlapping relationships, and concerted joint efforts to 

accomplish common goals and demonstrates that the leaders of each of the RICO Defendants 

was in communication and cooperation. 

350. According to articles published by the Center for Public Integrity and The 

Associated Press, the Pain Care Forum -- whose members include the Manufacturers and the 

Distributors’ trade association has been lobbying on behalf of the Manufacturers and Distributors 

for “more than a decade.”189 And, from 2006 to 2016 the Distributors and Manufacturers worked 

together through the Pain Care Forum to spend over $740 million lobbying in the nation’s capital 

and in all 50 statehouses on issues including opioid-related measures.190 Similarly, the HDA has 

 

189 Matthew Perrone, Pro-Painkiller echo chamber shaped policy amid drug epidemic, The Center for Public 

Integrity (September 19, 2017, 12:01 a.m.), https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echochamber-shaped-policy-amid-drug-epidemic. 

190 Id. 

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continued its work on behalf of Distributors and Manufacturers, without interruption, since at 

least 2000, if not longer.191

351. As described above, the RICO Defendants began working together as early as 

2006 through the Pain Care Forum and/or the HDA to promote the common purpose of their 

enterprise. Plaintiff is informed and believes that the RICO Defendants worked together as an 

ongoing and continuous organization throughout the existence of their enterprise. 

B. CONDUCT OF THE OPIOID DIVERSION ENTERPRISE 

352. During the time period alleged in this Complaint, the RICO Defendants exerted 

control over, conducted and/or participated in the Opioid Diversion Enterprise by fraudulently 

failing to comply with their Federal and State obligations to identify, investigate and report 

suspicious orders of opioids in order to prevent diversion of those highly addictive substances 

into the illicit market, to halt such unlawful sales and, in doing so, to increase production quotas 

and generate unlawful profits, as follows: 

353. Defendants disseminated false and misleading statements to the public claiming 

that they were complying with their obligations to maintain effective controls against diversion 

of their prescription opioids. 

354. Defendants disseminated false and misleading statements to the public claiming 

that they were complying with their obligations to design and operate a system to disclose to the 

registrant suspicious orders of their prescription opioids. 

355. Defendants disseminated false and misleading statements to the public claiming 

that they were complying with their obligation to notify the DEA of any suspicious orders or 

diversion of their prescription opioids. 

 

191 HDA History, Healthcare Distribution Alliance, (accessed on September 14, 2017), 

https://www.healthcaredistribution.org/about/hda-history. 

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356. Defendants paid nearly $800 million dollars to influence local, state and federal 

governments through joint lobbying efforts as part of the Pain Care Forum. The RICO 

Defendants were all members of their Pain Care Forum either directly or indirectly through the 

HDA. The lobbying efforts of the Pain Care Forum and its members, included efforts to pass 

legislation making it more difficult for the DEA to suspend and/or revoke the Manufacturers’ 

and Distributors’ registrations for failure to report suspicious orders of opioids. 

357. The RICO Defendants exercised control and influence over the distribution 

industry by participating and maintaining membership in the HDA. 

358. The RICO Defendants applied political and other pressure on the DOJ and DEA 

to halt prosecutions for failure to report suspicious orders of prescription opioids and lobbied 

Congress to strip the DEA of its ability to immediately suspend registrations pending 

investigation by passing the “Ensuring Patient Access and Effective Drug Enforcement Act.”192

359. The RICO Defendants engaged in an industry-wide practice of paying rebates and 

chargebacks to incentivize unlawful opioid prescription sales. Plaintiff is informed and believes 

that the Manufacturer Defendants used the chargeback program to acquire detailed high-level 

data regarding sales of the opioids they manufactured. And, Plaintiff is informed and believes 

that the Manufacturer Defendants used this high-level information to direct the Distributor 

Defendants’ sales efforts to regions where prescription opioids were selling in larger volumes. 

 

192 See HDMA is now the Healthcare Distribution Alliance, Pharmaceutical Commerce, (June 13, 2016, updated 

July 6, 2016), http://pharmaceuticalcommerce.com/business-and-finance/hdma-now-healthcare-distributionalliance/; Lenny Bernstein & Scott Higham, Investigation: The DEA Slowed Enforcement While the Opioid 

Epidemic Grew Out of Control, Wash. Post, Oct. 22, 2016, https://www.washingtonpost.com/investigations/the-deaslowed-enforcement-while-the-opioid-epidemic-grew-out-of-control/2016/10/22/aea2bf8e-7f71-11e6-8d13-

d7c704ef9fd9_story.html; Lenny Bernstein & Scott Higham, Investigation: U.S. Senator Calls for Investigation of 

DEA Enforcement Slowdown Amid Opioid Crisis, Wash. Post, Mar. 6, 2017, 

https://www.washingtonpost.com/investigations/us-senator-calls-for-investigation-of-dea-enforcementslowdown/2017/03/06/5846ee60-028b-11e7-b1e9-a05d3c21f7cf_story.html; Eric Eyre, DEA Agent: “We Had no 

Leadership” in WV Amid Flood of Pain Pills, Charleston Gazette-Mail, Feb. 18, 2017, 

http://www.wvgazettemail.com/news/20170218/dea-agent-we-had-no-leadership-in-wv-amid-flood-of-pain-pills-. 

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360. The Manufacturer Defendants lobbied the DEA to increase Aggregate Production 

Quotas, year after year by submitting net disposal information that the Manufacturer Defendants 

knew included sales that were suspicious and involved the diversion of opioids that had not been 

properly investigated or reported by the RICO Defendants. 

361. The Distributor Defendants developed “know your customer” questionnaires and 

files. This information, compiled pursuant to comments from the DEA in 2006 and 2007 was 

intended to help the the RICO Defendants identify suspicious orders or customers who were 

likely to divert prescription opioids.193 On information and belief, the “know your customer” 

questionnaires informed the RICO Defendants of the number of pills that the pharmacies sold, 

how many non-controlled substances are sold compared to controlled substances, whether the 

pharmacy buys from other distributors, the types of medical providers in the area, including pain 

clinics, general practitioners, hospice facilities, cancer treatment facilities, among others, and 

these questionnaires put the recipients on notice of suspicious orders. 

362. The RICO Defendants refused to identify, investigate and report suspicious orders 

to the DEA when they became aware of the same despite their actual knowledge of drug 

diversion rings. The RICO Defendants refused to identify suspicious orders and diverted drugs 

despite the DEA issuing final decisions against the Distributor Defendants in 178 registrant 

actions between 2008 and 2012194 and 117 recommended decision in registrant actions from The 

Office of Administrative Law Judges. These numbers include 76 actions involving orders to 

 

193 Suggested Questions a Distributor should ask prior to shipping controlled substances, Drug Enforcement 

Administration (available at 

https://www.deadiversion.usdoj.gov/mtgs/pharm_industry/14th_pharm/levinl_ques.pdf); Richard Widup, Jr., 

Kathleen H. Dooley, Esq. Pharmaceutical Production Diversion: Beyond the PDMA, Purdue Pharma and McQuite 

Woods LLC, (available at https://www.mcguirewoods.com/newsresources/publications/lifesciences/product_diversion_beyond_pdma.pdf). 

194 Evaluation and Inspections Div., Office of the Inspector Gen., U.S. Dep’t of Justice, The Drug Enforcement 

Administration’s Adjudication of Registrant Actions 6 (2014), https://oig.justice.gov/reports/2014/e1403.pdf. 

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show cause and 41 actions involving immediate suspension orders -- all for failure to report 

suspicious orders.195

363. Defendants’ scheme had decision-making structure that was driven by the 

Manufacturer Defendants and corroborated by the Distributor Defendants. The Manufacturer 

Defendants worked together to control the State and Federal Government’s response to the 

manufacture and distribution of prescription opioids by increasing production quotas through a 

systematic refusal to maintain effective controls against diversion, and identify suspicious orders 

and report them to the DEA. 

364. The RICO Defendants worked together to control the flow of information and 

influence state and federal governments and political candidates to pass legislation that was proopioid. The Manufacturer and Distributor Defendants did this through their participation in the 

Pain Care Forum and Healthcare Distributors Alliance. 

365. The RICO Defendants also worked together to ensure that the Aggregate 

Production Quotas, Individual Quotas and Procurement Quotas allowed by the DEA stayed high 

and ensured that suspicious orders were not reported to the DEA. By not reporting suspicious 

orders or diversion of prescription opioids, the RICO Defendants ensured that the DEA had no 

basis for refusing to increase or decrease the production quotas for prescription opioids due to 

diversion of suspicious orders. The RICO Defendants influenced the DEA production quotas in 

the following ways: 

a. The Distributor Defendants assisted the enterprise and the Manufacturer 

Defendants in their lobbying efforts through the Pain Care Forum; 

 

195 Id.

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b. The Distributor Defendants invited the participation, oversight and control of the 

Manufacturer Defendants by including them in the HDA, including on the 

councils, committees, task forces, and working groups; 

c. The Distributor Defendants provided sales information to the Manufacturer 

Defendants regarding their prescription opioids, including reports of all opioids 

prescriptions filled by the Distributor Defendants; 

d. The Manufacturer Defendants used a chargeback program to ensure delivery of 

the Distributor Defendants’ sales information; 

e. The Manufacturer Defendants obtained sales information from QuintilesIMS 

(formerly IMS Health) that gave them a “stream of data showing how individual 

doctors across the nation were prescribing opioids.”196 

f. The Distributor Defendants accepted rebates and chargebacks for orders of 

prescription opioids; 

g. The Manufacturer Defendants used the Distributor Defendants’ sales information 

and the data from QuintilesIMS to instruct the Distributor Defendants to focus 

their distribution efforts to specific areas where the purchase of prescription 

opioids was most frequent; 

h. The RICO Defendants identified suspicious orders of prescription opioids and 

then continued filling those unlawful orders, without reporting them, knowing that 

they were suspicious and/or being diverted into the illicit drug market; 

 

196 Harriet Ryan, et al., More than 1 million OxyContin pills ended up in the hands of criminals and addicts. What 

the drugmaker knew, Los Angeles Times, (July 10, 2016), http://www.latimes.com/projects/la-me-oxycontin-part2/ 

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i. The RICO Defendants refused to report suspicious orders of prescription opioids 

despite repeated investigation and punishment of the Distributor Defendants by 

the DEA for failure to report suspicious orders; and 

j. The RICO Defendants withheld information regarding suspicious orders and 

illicit diversion from the DEA because it would have revealed that the “medical 

need” for and the net disposal of their drugs did not justify the production quotas 

set by the DEA. 

366. The scheme devised and implemented by the RICO Defendants amounted to a 

common course of conduct characterized by a refusal to maintain effective controls against 

diversion, and all designed and operated to ensure the continued unlawful sale of controlled 

substances. 

C. PATTERN OF RACKETEERING ACTIVITY. 

367. The RICO Defendants conducted and participated in the conduct of the Opioid 

Diversion Enterprise through a pattern of racketeering activity as defined in 18 U.S.C. § 

1961(B), including mail fraud (18 U.S.C. § 1341) and wire fraud (18 U.S.C. § 1343); and 18 

U.S.C. § 1961(D) by the felonious manufacture, importation, receiving, concealment buying 

selling, or otherwise dealing in a controlled substance or listed chemical (as defined in section 

102 of the Controlled Substance Act), punishable under any law of the United States. 

1. The RICO Defendants Engaged in Mail and Wire Fraud. 

368. The RICO Defendants carried out, or attempted to carry out, a scheme to defraud 

federal and state regulators, and the American public by knowingly conducting or participating 

in the conduct of the Opioid Diversion Enterprise through a pattern of racketeering activity 

within the meaning of 18 U.S.C. § 1961(1) that employed the use of mail and wire facilities, in 

violation of 18 U.S.C. § 1341 (mail fraud) and § 1343 (wire fraud). 

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369. The RICO Defendants committed, conspired to commit, and/or aided and abetted 

in the commission of at least two predicate acts of racketeering activity (i.e. violations of 18 

U.S.C. §§ 1341 and 1343) within the past ten years. The multiple acts of racketeering activity 

that the RICO Defendants committed, or aided and abetted in the commission of, were related to 

each other, posed a threat of continued racketeering activity, and therefore constitute a “pattern 

of racketeering activity.” The racketeering activity was made possible by the RICO Defendants’ 

regular use of the facilities, services, distribution channels, and employees of the Opioid 

Diversion Enterprise. The RICO Defendants participated in the scheme to defraud by using mail, 

telephone and the Internet to transmit mailings and wires in interstate or foreign commerce. 

370. The RICO Defendants used, directed the use of, and/or caused to be used, 

thousands of interstate mail and wire communications in service of their scheme through 

virtually uniform misrepresentations, concealments and material omissions regarding their 

compliance with their mandatory reporting requirements and the actions necessary to carry out 

their unlawful goal of selling prescription opioids without reporting suspicious orders or the 

diversion of opioids into the illicit market. 

371. In devising and executing the illegal scheme, the RICO Defendants devised and 

knowingly carried out a material scheme and/or artifice to defraud by means of materially false 

or fraudulent pretenses, representations, promises, or omissions of material facts. For the purpose 

of executing the illegal scheme, the RICO Defendants committed these racketeering acts, which 

number in the thousands, intentionally and knowingly with the specific intent to advance the 

illegal scheme. 

372. The RICO Defendants’ predicate acts of racketeering (18 U.S.C. § 1961(1)) 

include, but are not limited to: 

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a. Mail Fraud: The RICO Defendants violated 18 U.S.C. § 1341 by sending or 

receiving, or by causing to be sent and/or received, materials via U.S. mail or 

commercial interstate carriers for the purpose of executing the unlawful scheme to 

design, manufacture, market, and sell the prescription opioids by means of false 

pretenses, misrepresentations, promises, and omissions. 

b. Wire Fraud: The RICO Defendants violated 18 U.S.C. § 1343 by transmitting 

and/or receiving, or by causing to be transmitted and/or received, materials by 

wire for the purpose of executing the unlawful scheme to design, manufacture, 

market, and sell the prescription opioids by means of false pretenses, 

misrepresentations, promises, and omissions. 

373. The RICO Defendants’ use of the mail and wires includes, but is not limited to, 

the transmission, delivery, or shipment of the following by the Manufacturers, Distributors, or 

third parties that were foreseeably caused to be sent as a result of the RICO Defendants’ illegal 

scheme, including but not limited to: 

a. The prescription opioids themselves; 

b. Documents and communications that facilitated the manufacture, purchase and 

unlawful sale of prescription opioids; 

c. Defendants’ DEA registrations; 

d. Documents and communications that supported and/or facilitated Defendants’ 

DEA registrations; 

e. Documents and communications that supported and/or facilitated the Defendants’ 

request for higher aggregate production quotas, individual production quotas, and 

procurement quotas; 

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f. Defendants’ records and reports that were required to be submitted to the DEA 

pursuant to 21 U.S.C. § 827; 

g. Documents and communications related to the Defendants’ mandatory DEA 

reports pursuant to 21 U.S.C. § 823 and 21 C.F.R. § 1301.74; 

h. Documents intended to facilitate the manufacture and distribution of Defendants’ 

prescription opioids, including bills of lading, invoices, shipping records, reports 

and correspondence; 

i. Documents for processing and receiving payment for prescription opioids; 

j. Payments from the Distributors to the Manufacturers; 

k. Rebates and chargebacks from the Manufacturers to the Distributors; 

l. Payments to Defendants’ lobbyists through the Pain Care Forum; 

m. Payments to Defendants’ trade organizations, like the HDA, for memberships 

and/or sponsorships; 

n. Deposits of proceeds from Defendants’ manufacture and distribution of 

prescription opioids; and 

o. Other documents and things, including electronic communications. 

374. On information and belief, the RICO Defendants (and/or their agents), for the 

purpose of executing the illegal scheme, sent and/or received (or caused to be sent and/or 

received) by mail or by private or interstate carrier, shipments of prescription opioids and related 

documents by mail or by private carrier affecting interstate commerce, including the following: 

375. Purdue manufactures multiple forms of prescription opioids, including but not 

limited to: OxyContin, MS Contin, Dilaudid/Dilaudid HP, Butrans, Hysingla ER, and Targiniq 

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ER. Purdue manufactured and shipped these prescription opioids to the Distributor Defendants in 

this jurisdiction. 

376. The Distributor Defendants shipped Purdue’s prescription opioids throughout this 

jurisdiction. 

377. Cephalon manufactures multiple forms of prescription opioids, including but not 

limited to: Actiq and Fentora. Cephalon manufactured and shipped these prescription opioids to 

the Distributor Defendants in this jurisdiction. 

378. The Distributor Defendants shipped Teva’s prescription opioids throughout this 

jurisdiction. 

379. Janssen manufactures prescription opioids known as Duragesic. Janssen 

manufactured and shipped its prescription opioids to the Distributor Defendants in this 

jurisdiction. 

380. The Distributor Defendants shipped Janssen’s prescription opioids throughout this 

jurisdiction. 

381. Endo manufactures multiple forms of prescription opioids, including but not 

limited to: Opana/Opana ER, Percodan, Percocet, and Zydone. Endo manufactured and shipped 

its prescription opioids to the Distributor Defendants in Ohio. 

382. The Distributor Defendants shipped Janssen’s prescription opioids throughout the 

this jurisdiction. 

383. Actavis manufactures multiple forms of prescription opioids, including but not 

limited to: Kadin and Norco, as well as generic versions of the drugs known as Kadian, 

Duragesic and Opana. Actavis manufactured and shipped its prescription opioids to the 

Distributor Defendants in this jurisdiction. 

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384. The Distributor Defendants shipped Actavis’ prescription opioids throughout this 

jurisdiction. 

385. Mallinckrodt manufactures multiple forms of prescription opioids, including but 

not limited to: Exalgo and Roxicodone. 

386. The Distributor Defendants shipped Mallinckrodt’s prescription opioids 

throughout this jurisdiction. 

387. The RICO Defendants also used the internet and other electronic facilities to carry 

out their scheme and conceal the ongoing fraudulent activities. Specifically, the RICO 

Defendants made misrepresentations about their compliance with Federal and State laws 

requiring them to identify, investigate and report suspicious orders of prescription opioids and/or 

diversion of the same into the illicit market. 

388. At the same time, the RICO Defendants misrepresented the superior safety 

features of their order monitoring programs, ability to detect suspicious orders, commitment to 

preventing diversion of prescription opioids and that they complied with all state and federal 

regulations regarding the identification and reporting of suspicious orders of prescription opioids. 

389. Plaintiff is also informed and believes that the RICO Defendants utilized the 

internet and other electronic resources to exchange communications, to exchange information 

regarding prescription opioid sales, and to transmit payments and rebates/chargebacks. 

390. The RICO Defendants also communicated by U.S. Mail, by interstate facsimile, 

and by interstate electronic mail and with various other affiliates, regional offices, regulators, 

distributors, and other third-party entities in furtherance of the scheme. 

391. The mail and wire transmissions described herein were made in furtherance of 

Defendants’ scheme and common course of conduct to deceive regulators and the public that 

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Defendants were complying with their state and federal obligations to identify and report 

suspicious orders of prescription opioids all while Defendants were knowingly allowing millions 

of doses of prescription opioids to divert into the illicit drug market. The RICO Defendants’ 

scheme and common course of conduct was intended to increase or maintain high production 

quotas for their prescription opioids from which they could profit. 

392. Many of the precise dates of the fraudulent uses of the U.S. mail and interstate 

wire facilities have been deliberately hidden, and cannot be alleged without access to 

Defendants’ books and records. But, Plaintiff has described the types of, and in some instances, 

occasions on which the predicate acts of mail and/or wire fraud occurred. They include 

thousands of communications to perpetuate and maintain the scheme, including the things and 

documents described in the preceding paragraphs. 

393. The RICO Defendants did not undertake the practices described herein in 

isolation, but as part of a common scheme. These actions violate 18 U.S.C. § 1962(c). Various 

other persons, firms, and corporations, including third-party entities and individuals not named 

as defendants in this Complaint, may have contributed to and/or participated in the scheme with 

the RICO Defendants in these offenses and have performed acts in furtherance of the scheme to 

increase revenues, increase market share, and /or minimize the losses for the RICO Defendants. 

394. The RICO Defendants aided and abetted others in the violations of the above 

laws, thereby rendering them indictable as principals in the 18 U.S.C. §§ 1341 and 1343 

offenses. 

395. The RICO Defendants hid from the general public, and suppressed and/or ignored 

warnings from third parties, whistleblowers and governmental entities, about the reality of the 

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suspicious orders that the RICO Defendants were filling on a daily basis -- leading to the 

diversion of a tens of millions of doses of prescriptions opioids into the illicit market. 

396. The RICO Defendants, with knowledge and intent, agreed to the overall objective 

of their fraudulent scheme and participated in the common course of conduct to commit acts of 

fraud and indecency in manufacturing and distributing prescription opioids. 

397. Indeed, for the Defendants’ fraudulent scheme to work, each of the Defendants 

had to agree to implement similar tactics regarding marketing prescription opioids and refusing 

to report suspicious orders. 

398. As described herein, the RICO Defendants engaged in a pattern of related and 

continuous predicate acts for years. The predicate acts constituted a variety of unlawful 

activities, each conducted with the common purpose of obtaining significant monies and 

revenues from the sale of their highly addictive and dangerous drugs. The predicate acts also had 

the same or similar results, participants, victims, and methods of commission. The predicate acts 

were related and not isolated events. 

399. The predicate acts all had the purpose of generating significant revenue and 

profits for the RICO Defendants while Plaintiff was left with substantial injury to its business 

through the damage that the prescription opioid epidemic caused. The predicate acts were 

committed or caused to be committed by the RICO Defendants through their participation in the 

Opioid Diversion Enterprise and in furtherance of its fraudulent scheme. 

400. The pattern of racketeering activity alleged herein and the Opioid Diversion 

Enterprise are separate and distinct from each other. Likewise, Defendants are distinct from the 

enterprise. 

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401. The pattern of racketeering activity alleged herein is continuing as of the date of 

this Complaint and, upon information and belief, will continue into the future unless enjoined by 

this Court. 

402. Many of the precise dates of the RICO Defendants’ criminal actions at issue here 

have been hidden and cannot be alleged without access to Defendants’ books and records. 

Indeed, an essential part of the successful operation of the Opioids Addiction and Opioid 

Diversion Enterprise alleged herein depended upon secrecy. 

403. Each instance of racketeering activity alleged herein was related, had similar 

purposes, involved the same or similar participants and methods of commission, and had similar 

results affecting similar victims, including consumers in this jurisdiction and the Plaintiff. 

Defendants calculated and intentionally crafted the Opioid Diversion Enterprise and their scheme 

to increase and maintain their increased profits, without regard to the effect such behavior would 

have on consumers in this jurisdiction, its citizens or the Plaintiff. In designing and implementing 

the scheme, at all times Defendants were cognizant of the fact that those in the manufacturing 

and distribution chain rely on the integrity of the pharmaceutical companies and ostensibly 

neutral third parties to provide objective and reliable information regarding Defendants’ products 

and their manufacture and distribution of those products. The Defendants were also aware that 

Plaintiff and the citizens of this jurisdiction rely on the Defendants to maintain a closed system 

and to protect against the non-medical diversion and use of their dangerously addictive opioid 

drugs. 

404. By intentionally refusing to report and halt suspicious orders of their prescription 

opioids, Defendants engaged in a fraudulent scheme and unlawful course of conduct constituting 

a pattern of racketeering activity. 

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405. It was foreseeable to Defendants that refusing to report and halt suspicious orders, 

as required by the CSA and Code of Federal Regulations, would harm Plaintiff by allowing the 

flow of prescriptions opioids from appropriate medical channels into the illicit drug market. 

406. The last racketeering incident occurred within five years of the commission of a 

prior incident of racketeering. 

2. The RICO Defendants Manufactured, Sold and/or Dealt in 

Controlled Substances and Their Crimes Are Punishable as 

Felonies. 

407. The RICO Defendants conducted and participated in the conduct of the affairs of 

the Opioid Diversion Enterprise through a pattern of racketeering activity as defined in 18 U.S.C. 

§ 1961(D) by the felonious manufacture, importation, receiving, concealment, buying, selling, or 

otherwise dealing in a controlled substance or listed chemical (as defined in section 102 of the 

Controlled Substance Act), punishable under any law of the United States. 

408. The RICO Defendants committed crimes that are punishable as felonies under the 

laws of the United States. Specifically, 21 U.S.C. § 483(a)(4) makes it unlawful for any person to 

knowingly or intentionally furnish false or fraudulent information in, or omit any material 

information from, any application, report, record or other document required to be made, kept or 

filed under this subchapter. A violation of section 483(a)(4) is punishable by up to four years in 

jail, making it a felony. 21 U.S.C. § 483(d)(1). 

409. Each of the RICO Defendants qualify as registrants under the CSA. Their status 

as registrants under the CSA requires that they maintain effective controls against diversion of 

controlled substances in schedule I or II, design and operate a system to disclose to the registrant 

suspicious orders of controlled substances., and inform the DEA of suspicious orders when 

discovered by the registrant. 21 U.S.C. § 823; 21 C.F.R. § 1301.74(b). 

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410. Pursuant to the CSA and the Code of Federal Regulations, the RICO Defendants 

were required to make reports to the DEA of any suspicious orders identified through the design 

and operation of their system to disclose suspicious orders. 

411. The RICO Defendants knowingly and intentionally furnished false or fraudulent 

information in their reports to the DEA about suspicious orders, and/or omitted material 

information from reports, records and other document required to be filed with the DEA 

including the Manufacturer Defendants’ applications for production quotas. Specifically, the 

RICO Defendants were aware of suspicious orders of prescription opioids and the diversion of 

their prescription opioids into the illicit market, and failed to report this information to the DEA 

in their mandatory reports and their applications for production quotas. 

412. For example, The DEA and DOJ began investigating McKesson in 2013 

regarding its monitoring and reporting of suspicious controlled substances orders. On April 23, 

2015, McKesson filed a Form-8-K announcing a settlement with the DEA and DOJ wherein it 

admitted to violating the CSA and agreed to pay $150 million and have some of its DEA 

registrations suspended on a staggered basis. The settlement was finalized on January 17, 

2017.197

413. Purdue’s experience in Los Angeles is another striking example of Defendants’ 

willful violation of the CSA and Code of Federal Regulations as it relates to reporting suspicious 

orders of prescription opioids. In 2016, the Los Angeles Times reported that Purdue was aware 

of a pill mill operating out of Los Angeles yet failed to alert the DEA.198 The LA Times 

 

197 McKesson, McKesson Finalizes Settlement with U.S. Department of Justice and U.S. Drug Enforcement 

Administration to Resolve Past Claims, About McKesson / Newsroom / Press Releases, (January 17, 2017(), 

http://www.mckesson.com/about-mckesson/newsroom/press-releases/2017/mckesson-finalizes-settlement-with-dojand-dea-to-resolve-past-claims/. 

198 Harriet Ryan, et al., More than 1 million OxyContin pills ended up in the hands of criminals and addicts. What 

the drugmaker knew, Los Angeles Times, (July 10, 2016), http://www.latimes.com/projects/la-me-oxycontin-part2/. 

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uncovered that Purdue began tracking a surge in prescriptions in Los Angeles, including one 

prescriber in particular. A Purdue sales manager spoke with company officials in 2009 about the 

prescriber, asking “Shouldn’t the DEA be contacted about this?” and adding that she felt “very 

certain this is an organized drug ring.”199 Despite knowledge of the staggering amount of pills 

being issued in Los Angeles, and internal discussion of the problem, “Purdue did not shut off the 

supply of highly addictive OxyContin and did not tell authorities what it knew about Lake 

Medical until several years later when the clinic was out of business and its leaders indicted. By 

that time, 1.1 million pills had spilled into the hands of Armenian mobsters, the Crips gang and 

other criminals.”200

414. Finally, Mallinckrodt was recently the subject of a DEA and Senate investigation 

for its opioid practices. Specifically, in 2011, the DEA targeted Mallinckrodt arguing that it 

ignored its responsibility to report suspicious orders as 500 million of its pills ended up in 

Florida between 2008 and 2012.201 After six years of DEA investigation, Mallinckrodt agreed to 

a settlement involving a $35 million fine. Federal prosecutors summarized the case by saying 

that Mallinckrodt’s response was that everyone knew what was going on in Florida but they had 

no duty to report it.202

415. Plaintiff is informed and believes that the foregoing examples reflect the RICO 

Defendants’ pattern and practice of willfully and intentionally omitting information from their 

mandatory reports to the DEA as required by 21 C.F.R. § 1301.74. This conclusion is supported 

 

199 Id. 

200 Id. 

201 Lenny Bernstein & Scott Higham, The government’s struggle to hold opioid manufacturers accountable, The 

Washington Post, (April 2, 2017), https://www.washingtonpost.com/graphics/investigations/deamallinckrodt/?utm_term=.b24cc81cc356. This number accounted for 66% of all oxycodone sold in the state of 

Florida during that time. 

202 Id.

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by the sheer volume of enforcement actions available in the public record against the Distributor 

Defendants.203 For example: 

416. On April 24, 2007, the DEA issued an Order to Show Cause and Immediate 

Suspension Order against the AmerisourceBergen Orlando, Florida distribution center (“Orlando 

Facility”) alleging failure to maintain effective controls against diversion of controlled 

substances. On June 22, 2007, AmerisourceBergen entered into a settlement that resulted in the 

suspension of its DEA registration; 

417. On November 28, 2007, the DEA issued an Order to Show Cause and Immediate 

Suspension Order against the Cardinal Health Auburn, Washington Distribution Center 

(“Auburn Facility”) for failure to maintain effective controls against diversion of hydrocodone; 

418. On December 5, 2007, the DEA issued an Order to Show Cause and Immediate 

Suspension Order against the Cardinal Health Lakeland, Florida Distribution Center (“Lakeland 

Facility”) for failure to maintain effective controls against diversion of hydrocodone; 

419. On December 7, 2007, the DEA issued an Order to Show Cause and Immediate 

Suspension Order against the Cardinal Health Swedesboro, New Jersey Distribution Center 

(“Swedesboro Facility”) for failure to maintain effective controls against diversion of 

hydrocodone; 

420. On January 30, 2008, the DEA issued an Order to Show Cause and Immediate 

Suspension Order against the Cardinal Health Stafford, Texas Distribution Center (“Stafford 

Facility”) for failure to maintain effective controls against diversion of hydrocodone; 

421. On May 2, 2008, McKesson Corporation entered into an Administrative 

Memorandum of Agreement (“2008 MOA”) with the DEA which provided that McKesson would 

 

203 Evaluation and Inspections Div., Office of the Inspector Gen., U.S. Dep’t of Justice, The Drug Enforcement 

Administration’s Adjudication of Registrant Actions 6 (2014), https://oig.justice.gov/reports/2014/e1403.pdf. 

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“maintain a compliance program designed to detect and prevent the diversion of controlled 

substances, inform DEA of suspicious orders required by 21 C.F.R. § 1301.74(b), and follow the 

procedures established by its Controlled Substance Monitoring Program”; 

422. On September 30, 2008, Cardinal Health entered into a Settlement and Release 

Agreement and Administrative Memorandum of Agreement with the DEA related to its Auburn 

Facility, Lakeland Facility, Swedesboro Facility and Stafford Facility. The document also 

referenced allegations by the DEA that Cardinal failed to maintain effective controls against the 

diversion of controlled substances at its distribution facilities located in McDonough, Georgia 

(“McDonough Facility”), Valencia, California (“Valencia Facility”) and Denver, Colorado 

(“Denver Facility”); 

423. On February 2, 2012, the DEA issued an Order to Show Cause and Immediate 

Suspension Order against the Cardinal Health Lakeland, Florida Distribution Center (“Lakeland 

Facility”) for failure to maintain effective controls against diversion of oxycodone; 

424. On December 23, 2016, Cardinal Health agreed to pay a $44 million fine to the 

DEA to resolve the civil penalty portion of the administrative action taken against its Lakeland, 

Florida Distribution Center; and 

425. On January 5, 2017, McKesson Corporation entered into an Administrative 

Memorandum Agreement with the DEA wherein it agreed to pay a $150,000,000 civil penalty for 

violation of the 2008 MOA as well as failure to identify and report suspicious orders at its 

facilities in Aurora CO, Aurora IL, Delran NJ, LaCrosse WI, Lakeland FL, Landover MD, La 

Vista NE, Livonia MI, Methuen MA, Santa Fe Springs CA, Washington Courthouse OH and 

West Sacramento CA. 

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426. These actions against the Distributor Defendants confirm that the Distributors 

knew they had a duty to maintain effective controls against diversion, design and operate a 

system to disclose suspicious orders, and to report suspicious orders to the DEA. These actions 

also demonstrate, on information and belief, that the Manufacturer Defendants were aware of the 

enforcement against their Distributors and the diversion of the prescription opioids and a 

corresponding duty to report suspicious orders. 

427. The pattern of racketeering activity alleged herein is continuing as of the date of 

this Complaint and, upon information and belief, will continue into the future unless enjoined by 

this Court. 

428. Many of the precise dates of Defendants’ criminal actions at issue herein were 

hidden and cannot be alleged without access to Defendants’ books and records. Indeed, an 

essential part of the successful operation of the Opioid Diversion Enterprise depended upon the 

secrecy of the participants in that enterprise. 

429. Each instance of racketeering activity alleged herein was related, had similar 

purposes, involved the same or similar participants and methods of commission, and had similar 

results affecting similar victims, including consumers in this jurisdiction and the Plaintiff. 

Defendants calculated and intentionally crafted the diversion scheme to increase and maintain 

profits from unlawful sales of opioids, without regard to the effect such behavior would have on 

this jurisdiction, its citizens or the Plaintiff. The Defendants were aware that Plaintiff and the 

citizens of this jurisdiction rely on the Defendants to maintain a closed system of manufacturing 

and distribution to protect against the non-medical diversion and use of their dangerously 

addictive opioid drugs. 

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430. By intentionally refusing to report and halt suspicious orders of their prescription 

opioids, Defendants engaged in a fraudulent scheme and unlawful course of conduct constituting 

a pattern of racketeering activity. 

431. It was foreseeable to Defendants that refusing to report and halt suspicious orders, 

as required by the CSA and Code of Federal Regulations would harm Plaintiff by allowing the 

flow of prescriptions opioids from appropriate medical channels into the illicit drug market. 

432. The last racketeering incident occurred within five years of the commission of a 

prior incident of racketeering. 

D. DAMAGES 

433. The RICO Defendants’ violations of law and their pattern of racketeering activity 

directly and proximately caused Plaintiff injury in its business and property because Plaintiff 

paid for costs associated with the opioid epidemic, as described above in language expressly 

incorporated herein by reference. 

434. Plaintiff’s injuries, and those of her citizens, were proximately caused by 

Defendants’ racketeering activities. But for the RICO Defendants’ conduct, Plaintiff would not 

have paid the health services and law enforcement services and expenditures required as a result 

of the plague of drug-addicted residents. 

435. Plaintiff’s injuries and those of her citizens were directly caused by the RICO 

Defendants’ racketeering activities. 

436. Plaintiff was most directly harmed and there is no other Plaintiff better suited to 

seek a remedy for the economic harms at issue here. 

437. Plaintiff seeks all legal and equitable relief as allowed by law, including inter alia

actual damages, treble damages, equitable relief, forfeiture as deemed proper by the Court, 

attorney’s fees and all costs and expenses of suit and pre- and post-judgment interest. 

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COUNT III 

RACKETEER INFLUENCED AND CORRUPT ORGANIZATIONS ACT 

18 U.S.C. 1962(d), et seq. 

(Against All Defendants)

438. Plaintiff hereby incorporates by reference all other paragraphs of this Complaint 

as if fully set forth herein, and further alleges as follows. 

439. Plaintiff brings this claim on its own behalf against all RICO Defendants. At all 

relevant times, the RICO Defendants were associated with the Opioid Diversion Enterprise and 

agreed and conspired to violate 18 U.S.C. § 1962(c), that is, they agreed to conduct and 

participate, directly and indirectly, in the conduct of the affairs of the Opioid Diversion 

Enterprise through a pattern of racketeering activity in violation of 18 U.S.C. § 1962(d). Under 

Section 1962(d) it is unlawful for “any person to conspire to violate” Section 1962(d), among 

other provisions. 18 U.S.C. § 1962(d). 

440. Defendants conspired to violate Section 1962(c), as alleged more fully above, by 

conducting the affairs of the Opioid Diversion Enterprise through a pattern of racketeering 

activity, as incorporated by reference below. 

A. THE OPIOID DIVERSION ENTERPRISE. 

441. For efficiency and avoiding repetition, for purposes of this claim, Plaintiff 

incorporates by reference Paragraphs 321 through 353 concerning the Opioid Diversion 

Enterprise. 

B. CONDUCT OF THE OPIOID DIVERSION ENTERPRISE. 

442. For efficiency and avoiding repetition, for purposes of this claim, Plaintiff 

incorporates by reference Paragraphs 354 through 368 concerning the Opioid Diversion 

Enterprise. 

C. PATTERN OF RACKETEERING ACTIVITY. 

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443. For efficiency and avoiding repetition, for purposes of this claim, Plaintiff 

incorporates by reference Paragraphs 369 through 434 concerning the Opioid Diversion 

Enterprise. 

D. DAMAGES. 

444. The RICO Defendants’ violations of law and their pattern of racketeering activity 

directly and proximately caused Plaintiff injury in its business and property because Plaintiff 

paid for costs associated with the opioid epidemic, as described above in language expressly 

incorporated herein by reference. 

445. Plaintiff’s injuries, and those of her citizens, were proximately caused by the 

RICO Defendants’ racketeering activities. But for the RICO Defendants’ conduct, Plaintiff 

would not have paid the health services and law enforcement services and expenditures required 

as a result of the plague of drug-addicted residents. 

446. Plaintiff’s injuries and those of her citizens were directly caused by the RICO 

Defendants’ racketeering activities. 

447. Plaintiff was most directly harmed and there is no other Plaintiff better suited to 

seek a remedy for the economic harms at issue here. 

448. Plaintiff seeks all legal and equitable relief as allowed by law, including inter alia 

actual damages, treble damages, equitable relief, forfeiture as deemed proper by the Court, 

attorney’s fees and all costs and expenses of suit and pre- and post-judgment interest. 

COUNT IV 

OHIO CORRUPT PRACTICES ACT 

OHIO REVISED CODE §§ 2923.31, et seq. 

(Against All Defendants) 

449. Plaintiff incorporates by reference all other paragraphs of this Complaint as if 

fully set forth herein, and further alleges as follows. 

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450. The RICO Defendants each operated an enterprise, for purposes that include the 

illegal manufacture and distribution of opioids. As explained herein, each RICO Defendants’ 

conduct involves the commission of criminal offenses, constituting a pattern of corrupt activity, 

and each RICO Defendant participated in the affairs of an enterprise and acquired and 

maintained control of an enterprise. See Universal Coach, Inc. v. New York City Transit Auth., 

Inc., 629 N.E.2d 28, 32 (Ohio Ct. App. 1993) (citation omitted). 

451. Each Defendant is a “person” within the meaning of Ohio Revised Code Section 

2923.31(G) who conducted the affairs of an enterprise through a pattern of racketeering activity, 

in violation of Chapter 2923. 

452. The County is a “person,” as that term is defined in Ohio Revised Code Section 

2923.31(G), which was injured in its business or property as a result of each Defendant’s 

wrongful conduct. “Any person who is injured or threatened with injury by a violation of section 

2923.32 of the Revised Code may institute a civil proceeding in an appropriate court seeking 

relief from any person whose conduct violated or allegedly violated section 2923.32 of the 

Revised Code or who conspired or allegedly conspired to violate that section . . . .” Ohio Rev. 

Code Ann. § 2923.34(A). 

A. THE OPIOID DIVERSION ENTERPRISE. 

453. For efficiency and avoiding repetition, for purposes of this claim, Plaintiff 

incorporates by reference the paragraphs as set forth herein concerning the Opioid Diversion 

Enterprise. 

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454. The RICO Defendants conducted their pattern of racketeering activity under Ohio 

Rev. Code Ann. § 2923.31(C). 

455. The RICO Defendants were members of a legal entity enterprise within the 

meaning of Ohio Rev. Code Ann. § 2923.31(C), through which the RICO Defendants conducted 

their pattern of racketeering activity in this jurisdiction and throughout the United States. 

Specifically, the Healthcare Distribution Alliance (the “HDA”) (formerly known as the 

Healthcare Distribution Management Association or “HDMA”) is a distinct legal entity that can 

serve as a RICO enterprise. The HDA is a non-profit corporation formed under the laws of the 

District of Columbia and doing business in Virginia. As a non-profit corporation, HDA qualifies 

as an “enterprise” within the definition set out in Ohio Rev. Code Ann. § 2923.31(C) because it 

is a corporation and a legal entity. 

B. CONDUCT OF THE OPIOID DIVERSION ENTERPRISE. 

456. For efficiency and avoiding repetition, for purposes of this claim, Plaintiff 

incorporates by reference Paragraphs 354 through 368 concerning the Conduct of the Opioid 

Diversion Enterprise. 

C. CORRUPT ACTIVITY -- I.E., PATTERN OF RACKETEERING 

ACTIVITY. 

457. The RICO Defendants conducted and participated in the conduct of the affairs of 

their Opioid Diversion Enterprise through “corrupt activities” as defined in Ohio Rev. Code 

Ann.§ 2923.31(I). Section 2923.31(I) states that “corrupt activities” means engaging in, 

attempting to engage in, conspiring to engage in, or soliciting, coercing, or intimidating another 

person to engage in any conduct defined as “racketeering activity” under the Organized Crime 

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Control Act of 1970, 84 Stat. 941, 18 U.S.C. 1961(1)(B), (1)(C), (1)(D), and (1)(E), as 

amended.204

458. As previously alleged, the RICO Defendants engaged in a pattern of racketeering 

activity pursuant to 18 U.S.C. § 1961(1)(B) and § 1961(1)(D) by committing mail fraud (18 

U.S.C. § 1341) and wire fraud (18 U.S.C. § 1343), and dealing in a controlled substance which 

crime is punishable as a felony under any law of the United States. The RICO Defendants 

committed a felony by violating Federal Law, including 21 U.S.C. § 843. Plaintiff realleges and 

incorporated herein by this reference all allegations regarding the RICO Defendants’ pattern of 

racketeering as if fully set forth herein. 

D. DAMAGES 

459. The RICO Defendants’ violations of law and their pattern of racketeering activity 

directly and proximately caused Plaintiff injury in its business and property because Plaintiff 

paid for costs associated with the opioid epidemic, as described above in language expressly 

incorporated herein by reference. 

460. Plaintiff’s injuries, and those of her citizens, were proximately caused by the 

RICO Defendants’ racketeering activities. But for the RICO Defendants’ conduct, Plaintiff 

would not have paid the health services and law enforcement services and expenditures required 

as a result of the plague of drug-addicted residents. 

461. Plaintiff’s injuries and those of her citizens were directly caused by the RICO 

Defendants’ racketeering activities. 

462. Plaintiff was most directly harmed and there is no other Plaintiff better suited to 

seek a remedy for the economic harms at issue here. 

 

204 Ohio Rev. Code Ann. § 2923.31(I), 

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463. Plaintiff seeks all legal and equitable relief as allowed by law, including inter alia 

actual damages, treble damages, equitable relief, forfeiture as deemed proper by the Court, 

attorney’s fees and all costs and expenses of suit and pre- and post-judgment interest. 

COUNT V 

INJURY THROUGH CRIMINAL ACTS 

OHIO REVISED CODE § 2307.60 

(Against Distributor Defendants) 

464. Plaintiff incorporates by reference all other paragraphs of this Complaint as if 

fully set forth here, and further alleges as follows. 

465. Ohio Revised Code § 2307.60(A)(1), “by its plain and unambiguous terms, 

creates a statutory cause of action for damages resulting from any criminal act,” unless otherwise 

prohibited by law. Jacobson v. Kaforey, 75 N.E.3d 203, 206 (Ohio 2016). “Anyone injured ... by 

a criminal act has ... a civil action” unless a civil action “is specifically excepted by law.” OHIO 

REV. CODE ANN. § 2307.60(A)(1). 

466. As described above in language incorporated herewith by reference, Plaintiff has 

been injured by the Distributor Defendants’ criminal actions causing the opioid epidemic. 

467. Plaintiff has sustained injuries, inter alia, to its property as a result of the 

Distributor Defendants’ actions and omissions. 

468. Said actions and omissions were criminal and in violation of Ohio Revised Code 

Chapter 2925, and more specifically Section 2925.03(A), which forbids the distribution of 

controlled substances. Distributor Defendants also sold drugs unlawfully pursuant to Ohio 

Revised Code §§ 4729.28, 4729.99(B). 

469. In addition, under Ohio law it is unlawful to “[b]y any means, administer or 

furnish to another or induce or cause another to use a controlled substance, and thereby cause 

serious physical harm to the other person, or cause the other person to become drug dependent.” 

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OHIO REV. CODE ANN. § 2925.02(A)(3). The exemption in this statute only applies when the 

drug wholesaler’s “conduct is in accordance with Chapter[]. . . 4729. . . of the Revised Code.” 

OHIO REV. CODE ANN. § 2925.02(B). Because Defendants failed to inter alia report suspicious 

sales, their conduct is not in compliance, and Defendants have thereby forfeited the protection 

provided by the exception. See OHIO ADMIN. CODE § 4729-9-16. 

470. The Distributor Defendants also acted in violation of 21 U.S.C. § 823(e) and 21 

C.F.R. § 1301.74(b), which are incorporated into Ohio law (OHIO ADMIN. CODE §§ 4729-9-

16(L), 4729-9-28(I)). 

471. Defendants’ further violations of criminal laws are described above, particularly 

in the RICO Count. 

472. Plaintiff seeks all legal and equitable relief as allowed by law, including inter alia

injunctive relief, full compensatory and punitive or exemplary damages, and all damages allowed 

by law to be paid by the Distributor Defendants, attorney fees and costs, and pre- and postjudgment interest. 

COUNT VI 

NEGLIGENCE AND NEGLIGENT MISREPRESENTATION 

 (Against All Defendants) 

473. Plaintiff incorporates by reference all other paragraphs of this Complaint as if 

fully set forth here, and further alleges as follows. 

474. Plaintiff seeks economic damages which were the foreseeable result of 

Defendants’ intentional and/or unlawful actions and omissions. 

475. Under State law, to establish actionable negligence, one must show in addition to 

the existence of a duty, a breach of that duty, and injury resulting proximately therefrom. All 

such essential elements exist here. 

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476. Each Defendant had an obligation to exercise reasonable care in manufacturing, 

marketing, selling, and distributing highly dangerous opioid drugs to the State and Plaintiff’s 

Community. 

477. Each Defendant had an obligation to exercise due care in manufacturing, 

marketing, selling, and distributing highly dangerous opioid drugs in the State and Plaintiff’s 

Community. 

478. The existence of a duty depends on the foreseeability of the injury. Each 

Defendant owed a duty to the Plaintiff and to Plaintiff’s Community because the injuries alleged 

herein was foreseeable, and in fact foreseen, by the Defendants. 

479. Reasonably prudent manufacturers and distributors of prescription opioids would 

have anticipated that the scourge of opioid addiction would wreak havoc on communities, and 

the significant costs which would be imposed upon the governmental entities associated with 

those communities. The closed system of opioid distribution whereby wholesale distributors are 

the gatekeepers between manufacturers and pharmacies, and wherein all links in the chain have a 

duty to prevent diversion, exists for the purpose of controlling dangerous substances such as 

opioids and preventing diversion and abuse. 

480. Reasonably prudent manufacturers of pharmaceutical products would know that 

aggressively pushing highly addictive opioids for chronic pain would result in the severe harm of 

addiction, foreseeably causing patients to seek increasing levels of opioids, frequently turning to 

the illegal drug market as a result of a drug addiction that was foreseeable to the Manufacturer 

Defendants. 

481. Moreover, Defendants were repeatedly warned by law enforcement of the 

unlawfulness and consequences of their actions and omissions. 

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482. The escalating amounts of addictive drugs flowing through Defendants’ 

businesses, and the sheer volume of these prescription opioids, further alerted Defendants that 

addiction was fueling increased consumption and that legitimate medical purposes were not 

being served. 

483. As described above in language expressly incorporated herein, Distributor 

Defendants breached their duties to exercise due care in the business of wholesale distribution of 

dangerous opioids, which are Schedule II Controlled Substances, by failing to monitor for, 

failing to report, and filling highly suspicious orders time and again. Because the very purpose of 

these duties was to prevent the resulting harm – diversion of highly addictive drugs for nonmedical purposes – the causal connection between Defendants’ breach of duties and the ensuing 

harm was entirely foreseeable. 

484. As described elsewhere in the Complaint in language expressly incorporated 

herein, Distributor Defendants misrepresented their compliance with their duties under the law 

and concealed their noncompliance and shipments of suspicious orders of opioids to Plaintiff’s 

Community and destinations from which they knew opioids were likely to be diverted into 

Plaintiff’s Community, in addition to other misrepresentations alleged and incorporated herein. 

485. As described elsewhere in the Complaint in language expressly incorporated 

herein, Manufacturer Defendants breached their duties to exercise due care in the business of 

pharmaceutical manufacturers of dangerous opioids, which are Schedule II Controlled 

Substances, and by misrepresenting the nature of the drugs and aggressively promoting them for 

chronic pain for which they knew the drug were not safe or suitable. 

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486. The Manufacturer Defendants misrepresented and concealed the addictive nature 

of prescription opioids and its lack of suitability for chronic pain, in addition to other 

misrepresentations alleged and incorporated herein. 

487. All Defendants breached their duties to prevent diversion and report and halt 

suspicious orders, and all Defendants misrepresented their compliance with their legal duties. 

488. Defendants’ breaches were intentional and/or unlawful, and Defendants’ conduct 

was willful, wanton, malicious, reckless, oppressive, and/or fraudulent. 

489. The causal connection between Defendants’ breaches of duties and 

misrepresentations and the ensuing harm was entirely foreseeable. 

490. As described above in language expressly incorporated herein, Defendants’ 

breaches of duty and misrepresentations caused, bears a causal connection with, and/or 

proximately resulted in the damages sought herein. 

491. Defendants were selling dangerous drugs statutorily categorized as posing a high 

potential for abuse and severe dependence. Defendants’ knowingly traded in drugs that presented 

a high degree of danger if prescribed incorrectly or diverted to other than medical, scientific, or 

industrial channels. However, Defendants breached their duties to monitor for, report, and halt 

suspicious orders, breached their duties to prevent diversion, and, further, misrepresented what 

their duties were and their compliance with their legal duties. 

492. Defendants’ unlawful and/or intentional actions create a rebuttable presumption 

of negligence under State law. 

493. Plaintiff seeks economic losses (direct, incidental, or consequential pecuniary 

losses) resulting from Defendants’ actions and omissions. Plaintiff does not seek damages for 

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the wrongful death, physical personal injury, serious emotional distress, or any physical damage 

to property caused by Defendants’ actions. 

494. Plaintiff seeks all legal and equitable relief as allowed by law, other than such 

damages disavowed herein, including inter alia injunctive relief, restitution, disgorgement of 

profits, compensatory and punitive damages, and all damages allowed by law to be paid by the 

Defendants, attorney fees and costs, and pre- and post-judgment interest. 

COUNT VII 

NEGLIGENCE PER SE 

 (Against Distributor Defendants) 

495. Plaintiff re-alleges all prior paragraphs of this Complaint as if set forth fully 

herein. 

496. Plaintiff incorporates by reference all other paragraphs of this Complaint as if 

fully set forth here, and further alleges as follows. 

497. Ohio Revised Code §§ 2925.02, 2925.03, 3767.01, 4729.35, and Ohio 

Administrative Code §§ 4729-9-12, 4729-9-16, 4729-9-28, are public safety laws. Each 

Defendant had a duty under, inter alia, these laws maintain effective controls against diversion 

of prescription opioids and to guard against, prevent, and report suspicious orders of opioids. 

498. Defendants’ actions and omissions in violation of the law constitute negligence 

per se. 

499. Defendants’ actions and omissions were intentional and/or unlawful, and 

Defendants acted with actual malice. 

500. It was foreseeable that the breach of duty described herein would result in the 

economic damages for which Plaintiff seeks recovery. 

501. As described above in language expressly incorporated herein, Defendants 

breached their duties to maintain effective controls against diversion of dangerously addictive 

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opioids, including violating public safety statutes requiring that as wholesale drug distributors, 

Defendants could only distribute these dangerous drugs under a closed system – a system 

Defendants were responsible for guarding. 

502. As described above in language expressly incorporated herein, Defendants’ 

breach of statutory and regulatory duties caused, bears a causal connection with, and proximately 

resulted in, harm and damages sought by the Plaintiff. 

503. Plaintiff seeks economic losses (direct, incidental, or consequential pecuniary 

losses) resulting from Defendants’ negligence per se. Plaintiff does not seek damages for the 

wrongful death, physical personal injury, serious emotional distress, or any physical damage to 

property caused by Defendants’ actions. 

504. Plaintiff seeks all legal and equitable relief as allowed by law, except as expressly 

disavowed herein, including inter alia injunctive relief, restitution, disgorgement of profits, 

compensatory and punitive damages, and all damages allowed by law to be paid by the 

Distributor Defendants, attorney fees and costs, and pre- and post-judgment interest. 

COUNT VIII 

DECEPTIVE TRADE PRACTICES 

COMMON LAW AND OHIO REVISED CODE CHAPTER 4165 

(Against All Defendants) 

505. Plaintiff incorporates by reference all other paragraphs of this Complaint as if 

fully set forth here, and further alleges as follows. 

506. Defendants violated Chapter 4165 of the Ohio Revised Code, because they 

engaged in deceptive trade practices in this State. Defendants actions also violated Ohio 

common law. 

507. Defendants committed committing repeated and willful unfair or deceptive acts or 

practices, and unconscionable trade practices, in the conduct of commerce. 

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508. Each Defendant failed to report and/or prevent the diversion of highly addictive 

prescription drugs to illegal sources. 

509. Because of the dangerously addictive nature of these drugs, the Defendants’ 

manufacturing, marketing, sales, and/or distribution practices unlawfully caused an opioid and 

heroin plague and epidemic in the State and Plaintiff’s Community. Each Defendant had a nondelegable duty to guard against and prevent the diversion of prescription opioids to other than 

legitimate medical, scientific, and industrial channels. 

510. The Defendants also omitted material facts, causing confusion or 

misunderstanding as to approval or certification of goods or services. 

511. The Defendants failed to disclose the material facts that inter alia they were not in 

compliance with laws and regulations requiring that they maintain a system to prevent diversion, 

protect against addiction and severe harm, and specifically monitor, investigate, report, and 

refuse suspicious orders. But for these material factual omissions, Defendants would not have 

been able to sell opioids, and the Distributor Defendants would not have been able to receive and 

renew licenses to sell opioids. 

512. As alleged herein, each Manufacturer Defendant wrongfully represented that the 

opioid prescription medications they manufactured, marketed, and sold had characteristics, uses, 

or benefits that they do not have. 

513. The Manufacturer Defendants also wrongfully misrepresented that the opioids 

were safe and effective when such representations were untrue, false, and misleading. 

514. The Manufacturer Defendants also used exaggeration and/or ambiguity as to 

material facts and omitted material facts, which tended to deceive and/or did in fact deceive. 

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515. Because of the dangerously addictive nature of these drugs, which the 

Manufacturer Defendants concealed and misrepresented, they lacked medical value, and in fact 

caused addiction and overdose deaths; therefore, Defendants’ sales and marketing of opioids 

constituted a violation of State law. 

516. The Manufacturer Defendants made deceptive representations about the use of 

opioids to treat chronic non-cancer pain. Each Manufacturer Defendant also omitted or 

concealed material facts and failed to correct prior misrepresentations and omissions about the 

risks and benefits of opioids. Each Defendant’s omissions rendered even their seemingly truthful 

statements about opioids deceptive. 

517. Defendants’ unfair, deceptive, and unconscionable representations, concealments, 

and omissions were reasonably calculated to deceive the State, the public, Plaintiff’s 

Community, and Plaintiff. 

518. As described more specifically above, Defendants’ representations, concealments, 

and omissions constitute a willful course of conduct which continues to this day. 

519. The damages which Plaintiff seeks to recover were sustained as a direct and 

proximate cause of the Manufacturer and Distributor Defendants’ intentional and/or unlawful 

actions and omissions. 

520. Defendants’ actions and omissions in the course of marketing, selling, and 

distributing prescriptions opioids constituted deceptive trade practices under State law. 

521. State law prohibits representing that goods or services have sponsorship, 

approval, characteristics, uses, or benefits that they do not have. State law further prohibits 

representing that goods are of a standard, quality, or grade if they are of another. 

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522. Defendants committed committing repeated and willful unfair or deceptive acts or 

practices, and unconscionable trade practices, in the conduct of commerce in this State. 

523. Each Defendant failed to report and/or prevent the diversion of highly addictive 

prescription drugs. 

524. Because of the dangerously addictive nature of these drugs, the Distributor 

Defendants’ manufacturing, marketing, sales, and distribution practices unlawfully caused an 

opioid and heroin plague and epidemic in the State and Plaintiff’s Community. Each Defendant 

had a non-delegable duty to guard against and prevent the diversion of prescription opioids to 

other than legitimate medical, scientific, and industrial channels. 

525. The Defendants also omitted material facts, causing confusion or 

misunderstanding as to approval or certification of goods or services. 

526. The Defendants failed to disclose the material facts that inter alia they were not in 

compliance with laws and regulations requiring that they maintain a system to prevent diversion, 

protect against addiction and severe harm, and specifically monitor, investigate, report, and 

refuse suspicious orders. But for these material factual omissions, Defendants would not have 

been able to sell opioids, and the Distributor Defendants would not have been able to receive and 

renew licenses to sell opioids. 

527. As alleged herein, each Manufacturer Defendant wrongfully represented that the 

opioid prescription medications they manufactured, marketed, and sold had characteristics, uses, 

or benefits that they do not have. 

528. The Manufacturer Defendants also wrongfully misrepresented that the opioids 

were safe and effective when such representations were untrue, false, and misleading. 

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529. The Manufacturer Defendants also used exaggeration and/or ambiguity as to 

material facts and omitted material facts, which had a tendency to deceive and/or did in fact 

deceive. 

530. Because of the dangerously addictive nature of these drugs, which the 

Manufacturer Defendants concealed and misrepresented, they lacked medical value, and in fact 

caused addiction and overdose deaths; therefore, Defendants’ sales and marketing of opioids 

constituted a violation of State law. 

531. The Manufacturer Defendants made deceptive representations about the use of 

opioids to treat chronic non-cancer pain. Each Manufacturer Defendant also omitted or 

concealed material facts and failed to correct prior misrepresentations and omissions about the 

risks and benefits of opioids. Each Defendant’s omissions rendered even their seemingly truthful 

statements about opioids deceptive. 

532. Defendants acted intentionally and/or unlawfully. 

533. Plaintiff seeks all damages for injuries sustained because of Defendants’ 

violation of Chapter 4165 of the Ohio Revised Code, and all legal and equitable relief as allowed 

by law, including inter alia injunctive relief, restitution, disgorgement of profits, compensatory 

and punitive damages, and all damages allowed by law to be paid by the Defendants, attorney 

fees and costs, and pre- and post-judgment interest. 

 COUNT IX 

CIVIL CONSPIRACY 

(Against All Defendants)

534. Plaintiff incorporates by reference all other paragraphs of this Complaint as if 

fully set forth here, and further alleges as follows. 

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535. As set forth herein, Defendants engaged in a civil conspiracy to create an absolute 

public nuisance in conjunction with their unlawful distribution and diversion of opioids into the 

State and Plaintiff’s Community. 

536. As set forth herein, Defendants engaged in a civil conspiracy to commit fraud and 

misrepresentation in conjunction with their unlawful distribution and diversion of opioids into 

the State and Plaintiff’s Community. 

537. Distributor and Manufacturer Defendants unlawfully failed to act to prevent 

diversion and failed to monitor for, report, and prevent suspicious orders of opioids. 

538. The Manufacturer Defendants further unlawfully marketed opioids in the State 

and Plaintiffs’ Community in furtherance of that conspiracy. 

539. Defendants’ conspiracy and acts in furtherance thereof are alleged in greater 

detail earlier in the complaint, including, without limitation, in Plaintiff’s federal and state law 

racketeering allegations. Such allegations are incorporated herein. 

540. Defendants acted with a common understanding or design to commit unlawful 

acts, as alleged herein, and acted purposely, without a reasonable or lawful excuse, to create the 

injuries alleged herein. 

541. Defendants acted with malice, purposely, intentionally, unlawfully, and without a 

reasonably or lawful excuse. 

542. Defendants’ conspiracy, and Defendants’ actions and omissions in furtherance 

thereof, caused the direct and foreseeable losses alleged herein. 

543. Plaintiff seeks economic losses (direct, incidental, or consequential pecuniary 

losses) resulting from Defendants’ civil conspiracy. Plaintiff does not seek damages for the 

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wrongful death, physical personal injury, serious emotional distress, or any physical damage to 

property caused by Defendants’ actions. 

544. Plaintiff seeks all legal and equitable relief as allowed by law, except as expressly 

disavowed herein, including inter alia injunctive relief, restitution, disgorgement of profits, 

compensatory and punitive damages, and all damages allowed by law to be paid by the 

Distributor Defendants, attorney fees and costs, and pre- and post-judgment interest. 

COUNT X 

FRAUD AND FRAUDULENT MISREPRESENTATION 

(Against All Defendants) 

545. Plaintiff incorporates by reference all other paragraphs of this Complaint as if 

fully set forth here, and further alleges as follows. 

546. Defendants violated their general duty not to actively deceive, and have made 

knowingly false statements and have omitted and/or concealed information which made 

statements Defendants did make knowingly false. Defendants acted intentionally and/or 

unlawfully. 

547. As alleged herein, Defendants made false statements regarding their compliance 

with state and federal law regarding their duties to prevent diversion, their duties to monitor, 

report and halt suspicious orders, and/or concealed their noncompliance with these requirements. 

548. As alleged herein, the Manufacturer Defendants engaged in false representations 

and concealments of material fact regarding the use of opioids to treat chronic non-cancer pain. 

549. As alleged herein, Defendants knowingly and/or intentionally made 

representations that were false. Defendants had a duty to disclose material facts and concealed 

them. These false representations and concealed facts were material to the conduct and actions at 

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issue. Defendants made these false representations and concealed facts with knowledge of the 

falsity of their representations, and did so with the intent of misleading Plaintiff, Plaintiff’s 

community, the public, and persons on whom Plaintiff relied. 

550. These false representations and concealments were reasonably calculated to 

deceive Plaintiff, Plaintiff’s Community, and the physicians who prescribed opioids for persons 

in Plaintiff’s Community, were made with the intent to deceive, and did in fact deceive these 

persons, Plaintiff, and Plaintiff’s Community. 

551. Plaintiff, Plaintiff’s Community, and the physicians who prescribed opioids 

reasonably relied on these false representations and concealments of material fact. 

552. Plaintiff justifiably relied on Defendants’ representations and/or concealments, 

both directly and indirectly. Plaintiff’s injuries were proximately caused by this reliance. 

553. The injuries alleged by Plaintiff herein were sustained as a direct and proximate 

cause of Defendants’ fraudulent conduct. 

554. Plaintiff seeks economic losses (direct, incidental, or consequential pecuniary 

losses) resulting from Defendants’ fraudulent activity, including fraudulent misrepresentations 

and fraudulent concealment. Plaintiff does not seek damages for the wrongful death, physical 

personal injury, serious emotional distress, or any physical damage to property caused by 

Defendants’ actions. 

555. Plaintiff seeks all legal and equitable relief as allowed by law, except as expressly 

disavowed herein, including inter alia injunctive relief, restitution, disgorgement of profits, 

compensatory and punitive damages, and all damages allowed by law to be paid by the 

Distributor Defendants, attorney fees and costs, and pre- and post-judgment interest. 

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PUNITIVE DAMAGES 

556. Plaintiff re-alleges all paragraphs of this Complaint as if set forth fully herein. 

557. By engaging in the above-described unfair acts or practices, Defendants acted 

with actual malice, wantonly, and oppressively. Defendants acted with conscious disregard to the 

rights of others and/or in a reckless, wanton, willful, or gross manner. Defendants acted with a 

prolonged indifference to the adverse consequences of their actions and/or omissions. 

Defendants acted with a conscious disregard for the rights and safety of others in a manner that 

had a great probability of causing substantial harm. 

558. Here, Defendants were selling dangerous drugs statutorily categorized as posing a 

high potential for abuse and severe dependence. Thus, Defendants knowingly traded in drugs 

that presented a high degree of danger if prescribed incorrectly or diverted to other than 

legitimate medical, scientific, or industrial channels. Because of the severe level of danger posed 

by, and indeed visited upon the State and Plaintiff’s Community by, these dangerous drugs, 

Defendants owed a high duty of care to ensure that these drugs were only used for proper 

medical purposes. Defendants chose profit over prudence, and the safety of the community, and 

an award of punitive damages is appropriate, as punishment and a deterrence. 

559. By engaging in the above-described wrongful conduct, Defendants also engaged 

in willful misconduct and exhibited an entire want of care that would raise the presumption of a 

conscious indifference to consequences. 

RELIEF 

WHEREFORE, the Plaintiff respectfully prays that this Court grant the following relief: 

560. Entering Judgment in favor of the Plaintiff in a final order against each of the 

Defendants; 

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561. Enjoining the Defendants and their employees, officers, directors, agents, 

successors, assignees, merged or acquired predecessors, parent or controlling entities, 

subsidiaries, and all other persons acting in concert or participation with it, from engaging in 

unfair or deceptive practices in violation of law and ordering temporary, preliminary or 

permanent injunction; 

562. Order that Defendants compensate the Plaintiff for past and future costs to abate 

the ongoing public nuisance caused by the opioid epidemic; 

563. Order Defendants to fund an “abatement fund” for the purposes of abating the 

opioid nuisance; 

564. Awarding actual damages, treble damages, injunctive and equitable relief, 

forfeiture as deemed proper by the Court, and attorney fees and all costs and expenses of suit 

pursuant to Plaintiff’s racketeering claims; 

565. Awarding the Plaintiff the damages caused by the opioid epidemic, including 

(A) 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; (B) costs for providing treatment, counseling, and rehabilitation services; 

(C) costs for providing treatment of infants born with opioid-related medical conditions; (D) 

costs for providing care for children whose parents suffer from opioid-related disability or 

incapacitation; and (E) costs associated with law enforcement and public safety relating to the 

opioid epidemic. 

566. Awarding judgment against the Defendants requiring Defendants to pay punitive 

damages; 

567. Granting the Plaintiff 

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1. The cost of investigation, reasonable attorneys’ fees, and all costs and expenses; 

2. Pre-judgment and post-judgment interest; and 

3. All other relief as provided by law and/or as the Court deems appropriate and just. 

Respectfully submitted, 

 /s/ James C. Peterson___________________ 

James C. Peterson (Ohio Bar No.0032465) 

Hill, Peterson, Carper, Bee & Deitzler, PLLC

NorthGate Business Park 

500 Tracy Way 

Charleston, WV 25311 

304-345-5667 

304-345-1519 fax 

jcpeterson@hpcbd.com

Paul T. Farrell, Jr. (Ohio Bar No. 0070257) 

(pro hac vice pending)

Greene, Ketchum, Farrell, 

 Bailey & Tweel, LLP 

419 - 11th Street (25701)/ P.O. Box 2389 

Huntington, West Virginia 25724-2389 

Phone: 800.479.0053 or 304.525.9115 

Fax: 304.529.3284 

paul@greeneketchum.com

Peter J. Mougey (pro hac vice pending) 

Levin, Papantonio, Thomas, Mitchell, 

 Rafferty & Proctor, P.A. 

316 S. Baylen Street, Suite 600 

Pensacola, FL 32502-5996 

850.435.7068 (office) 

850.436.6068 (fax) 

pmougey@levinlaw.com

J. Burton LeBlanc, IV (pro hac vice pending)

Baron & Budd, P.C. 

3102 Oak Lawn Avenue, Suite 1100 

Dallas, TX 75219 

Tel.: 214-521-3605 

Fax: 214-520-1181 

bleblanc@baronbudd.com 

Michael J. Fuller, Jr. (Ohio Bar No. 0090250) 

(pro hac vice pending)

McHugh Fuller Law Group, PLLC

97 Elias Whiddon Rd. 

Hattiesburg, MS 39402 

Telephone: 601-261-2220 

Facsimile: 601-261-2481 

mike@mchughfuller.com

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Anthony J. Majestro, Esq. 

(pro hac vice pending) 

Powell & Majestro, PLLC 

405 Capitol Street, Suite P-1200 

Charleston, WV 25301 

304-346-2889 / 304-346-2895 (f) 

Email: amajestro@powellmajestro.com

Michael P. McNamee (Ohio Bar No. 0043861) 

D. Dale Seif, Jr. (Ohio Bar No. 0075924) 

(pro hac vice pending)

Stacy Brooks (Ohio Bar No. 0080986) 

SEIF & MCNAMEE, LLC 

110 East Emmitt Avenue 

Waverly, Ohio 45690 

(740) 947-7277 Phone 

(740) 947-1815 Fax 

mike@mcnameelaw.com 

dseif@law-oh.com 

sbrooks@law-oh.com

Robert R. Miller (Ohio Bar No. 0047186) 

Rebecca D. Louks Waigand 

(OH Bar No. 0087774) 

Oths, Heiser, Miller, 

Waigand & Clagg, LLC 

Sixteen East Broadway 

P.O. Box 309 

Wellston, Ohio 45692 

Phone: 740-384-2111 

Fax: 740-384-5632 

Email: rmiller@ohlaw.com

Email: rlouks@ohlaw.com

 

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