THE UNITED STATES DISTRICT COURT 

FOR THE SOUTHERN DISTRICT OF OHIO 

EASTERN DIVISION 

THE CITY OF COLUMBUS, 

90 W. Broad Street 

Columbus, Ohio 43215 

 Plaintiff, 

v. 

PURDUE PHARMA L.P. 

c/o The Prentice Hall Corporation

2711 Centerville Road

Wilmington, DE 19808 

and

PURDUE PHARMA, INC.

c/o The Prentice Hall Corporation

2711 Centerville Road

Wilmington, DE 19808

and

THE PURDUE FREDERICK COMPANY, 

INC. 

c/o The Prentice Hall Corporation

2711 Centerville Road

Wilmington, DE 19808

and

TEVA PHARMACEUTICALS USA, 

INC. 

c/o Corporate Creations Network Inc.

3411 Silverside Road

Wilmington, DE 19180

and

TEVA PHARMACEUTICAL 

INDUSTRIES, LTD. 

5 Basel Street 

Petach Tikva 49131, Israel 

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Case No. 2:17-cv-1102 

Judge _______________________ 

COMPLAINT OF PLAINTIFF THE 

CITY OF COLUMBUS

JURY DEMAND 

ENDORSED HEREON

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and

CEPHALON, INC. 

c/o Corporate Creations Network Inc. 

3411 Silverside Road 

Wilmington, DE 19180

and

JOHNSON & JOHNSON 

One Johnson & Johnson Plaza 

New Brunswick, NJ 08933 

and 

JANSSEN PHARMACEUTICALS, 

INC. 

116 Pine Street, Suite 320 

Harrisburg, PA 17101 

and 

JANSSEN PHARMACEUTICA INC. 

N/K/A JANSSEN 

PHARMACEUTICALS, INC. 

116 Pine Street, Suite 320 

Harrisburg, PA 17101 

and 

ORTHO-MCNEIL-JANSSEN

PHARMACEUTICALS, INC. N/K/A 

JANSSEN PHARMACEUTICALS, 

INC. 

116 Pine Street, Suite 320 

Harrisburg, PA 17101 

and 

NORAMCO, INC. 

c/o The Corporation Trust Company 

Corporation Trust Center 

1209 Orange Street 

Wilmington, DE 19801 

and 

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ENDO HEALTH SOLUTIONS INC. 

c/o The Corporation Trust Co. 

1209 Orange Street 

Wilmington, DE 19801 

and 

ENDO PHARMACEUTICALS, INC. 

c/o The Corporation Trust Co. 

1209 Orange Street 

Wilmington, DE 19801 

and 

ALLERGAN PLC F/K/A ACTAVIS 

PLC 

CT Corporation System 

4400 Easton Commons Way, Suite 125 

Columbus, OH 43215 

and 

ACTAVIS, INC. F/K/A WATSON 

PHARMACEUTICALS, INC. 

Corporate Creations Network, Inc. 

119 E. Court Street 

Columbus, OH 45202 

and 

WATSON LABORATORIES, INC. 

Corporate Creations Network, Inc. 

119 E. Court Street 

Columbus, OH 45202 

and 

ACTAVIS LLC 

Corporate Creations Network, Inc. 

119 E. Court Street 

Columbus, OH 45202 

and 

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ACTAVIS PHARMA, INC. F/K/A 

WATSON PHARMA, INC. 

Corporate Creations Network, Inc. 

119 E. Court Street 

Columbus, OH 45202 

and 

MCKESSON CORPORATION 

50 West Broad Street, Suite 1330 

Columbus, OH 43215 

and 

CARDINAL HEALTH, INC. 

7000 Cardinal Place 

Dublin, OH 43017 

and 

AMERISOURCEBERGEN DRUG 

CORPORATION 

1300 East Ninth Street 

Cleveland, OH 44114 

and 

RUSSELL PORTENOY 

39 Broadway, 1st Floor 

New York, NY 10006 

and 

PERRY FINE 

615 Arapeen Way, Suite 155 

Salt Lake City, UT 84132 

and 

SCOTT FISHMAN 

2221 Stockton Boulevard 

Sacramento, CA 95817 

and 

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LYNN WEBSTER 

PRA Health Sciences 

3838 S. 700 E. #202 

Salt Lake City, UT 84106 

 Defendants. 

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TABLE OF CONTENTS

INTRODUCTION..........................................................................................................................1 

JURISDICTION AND VENUE ....................................................................................................5 

PARTIES ........................................................................................................................................6 

I. PLAINTIFF ........................................................................................................................6 

II. DEFENDANTS ..................................................................................................................8 

 

A. The Manufacturer Defendants .............................................................................8 

1. Defendants Purdue Pharma L.P.; Purdue Pharma Inc.; and 

The Purdue Frederick Company, Inc. .....................................................8 

2. Defendants Teva Pharmaceuticals USA, Inc.; Teva 

Pharmaceutical Industries, Ltd.; and Cephalon, Inc. ...........................10 

3. Defendants Johnson & Johnson; Janssen Pharmaceuticals, 

Inc.; Janssen Pharmaceutica Inc. n/k/a Janssen 

Pharmaceuticals, Inc.; Ortho-McNeil-Janssen 

Pharmaceuticals, Inc. n/k/a Janssen Pharmaceuticals, Inc.; and 

Noramco, Inc. ............................................................................................11 

4. Defendants Endo Health Solutions Inc. and Endo 

Pharmaceuticals, Inc.................................................................................12 

5. Defendants Allergan plc f/k/a Actavis plc; Actavis, Inc. f/k/a 

Watson Pharmaceuticals, Inc.; Watson Laboratories, Inc.; 

Actavis LLC; Actavis Pharma, Inc. f/k/a Watson Pharma, Inc. ..........13 

B. The Distributor Defendants .................................................................................14 

1. Defendant McKesson Corporation ..........................................................14 

2. Defendant Cardinal Health, Inc. .............................................................14 

3. Defendant AmerisourceBergen Drug Corporation ...............................14 

C. Defendants Russell Portenoy; Perry Fine; Scott Fishman; And Lynn 

Webster ..................................................................................................................15 

1. Defendant Russell Portenoy .....................................................................15 

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2. Defendant Perry Fine ..............................................................................16 

3. Defendant Scott Fishman ........................................................................16 

4. Defendant Lynn Webster ........................................................................16 

FACTS RELEVANT TO ALL CAUSES OF ACTION ...........................................................17 

I. THE OPIOID EPIDEMIC CREATED BY THE MANUFACTURERS, THE 

DISTRIBUTORS AND THE KOLS, CAUSED, AND CONTINUES TO CAUSE, 

DEVASTATION, HARM AND DAMAGES TO COLUMBUS .................................17 

II. THE MANUFACTURERS, DISTRIBUTORS AND KOLS CAUSED THE

OPIOID EPIDEMIC .......................................................................................................20 

A. It Was Generally Accepted That Long-Term Use Of Opioids Was 

Considered Risky .................................................................................................20 

B. Opioids Are Highly Addictive .............................................................................21 

C. There Is No Credible Evidence To Support Long-Term Opioid Use 

For Chronic Pain..................................................................................................22 

D. The Manufacturers’ And KOLs’ Marketing Scheme Changed The 

Perception About, And Prescribing Of, Opioids...............................................24 

1. The Manufacturers directly misrepresented to physicians the 

risks and benefits of prescription opioids ..............................................25 

2. The Manufacturers funded, controlled and operated thirdparty organizations that made misrepresentations to

physicians about the risks and benefits of opioids ................................26 

3. The Manufacturers retained the KOLs to conceal their 

misrepresentations about the risks and benefits of opioids in 

the guise of credentialed medical professionals.....................................28 

E. The Manufacturers’ And KOLs’ Marketing Campaign Is, And 

Always Has Been, Rooted In Scientifically Unsupported Conclusions ...........29 

F. Each Of The Manufacturers And The KOLs Have Made, And 

Continue To Make, False Claims About Opioids .............................................32 

1. The Manufacturers and KOLs misrepresented that the risk of 

opioid addiction was low .........................................................................32 

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2. The Manufacturers and KOLs misrepresented that doctors 

should increase the dosage of opioids for patients that had 

symptoms of addiction .............................................................................37 

3. The Manufacturers and KOLs misrepresented that addiction 

concerns could be minimized by risk-mitigation strategies, 

including tapering ....................................................................................40 

4. The Manufacturers and the KOLs misrepresented that doctors 

and patients could increase opioid dosage indefinitely without 

added risk and failed to disclose the risks associated with 

higher dosages ..........................................................................................43 

5. The Manufacturers misrepresented that reformulated opioids 

can curb addiction and abuse .................................................................46 

6. The Manufacturers misrepresented that opioid use improved 

patients’ function and quality of life ......................................................47 

G. The Manufacturers And KOLs Made False And Misleading 

Statements To Persons, Including Physicians, In Columbus ...........................48 

III. THE MANUFACTURERS’ AND KOLS’ STATEMENTS ABOUT THE 

RISKS AND BENEFITS OF OPIOIDS WERE, AND ARE, FALSE ........................49 

IV. BY FAILING TO REPORT SUSPICIOUS SHIPMENTS, THE 

MANUFACTURERS AND DISTRIBUTORS CAUSED THE OPIOID 

EPIDEMIC .......................................................................................................................51 

A. The Manufacturers And The Distributors Have A Legal Duty to 

Prevent “Suspicious Orders” of Opioids ...........................................................51 

B. The Manufacturers And The Distributors Intentionally And/Or 

Recklessly Breached Their Duties ......................................................................54 

C. The Manufacturers And Distributors Spent Millions Of Dollars 

Lobbying Congress To Weaken DEA Enforcement Efforts Against 

Them......................................................................................................................57 

V. THE MANUFACTURERS’, DISTRIBUTORS’ AND KOLS’ ACTIONS

CAUSED AN ILLICIT OPIOID EPIDEMIC IN COLUMBUS .................................59 

VI. COLUMBUS HAS BEEN, AND WILL CONTINUE TO BE, HARMED 

AND DAMAGED BY THE OPIOID EPIDEMIC CREATED BY THE 

DEFENDANTS ................................................................................................................64 

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A. While The Opioid Epidemic Is A National Issue, The Situation Is 

Particularly Tragic In Columbus .......................................................................64 

B. The Manufacturers’, Distributors’ and KOLs’ Conduct Has 

Increased Columbus’ Health Care Costs. ..........................................................66 

C. The Opioid Epidemic Caused By The Manufacturers, The 

Distributors And The KOLs Has Caused Columbus To Incur 

Damages Providing Increased Human Services In An Effort To Abate 

The Opioid Epidemic ...........................................................................................67 

D. Columbus Already Has Incurred Significant Damages Relating To 

Police And Fire Responses To The Opioid Issues, And Will Continue 

To Do So, In An Effort to Abate The Epidemic ................................................69 

1. The Columbus Division of Fire has incurred significant 

damages responding to opioid issues due to the actions of the 

Manufacturers, the Distributors and the KOLs ...................................69 

2. The Columbus Division of Police has incurred significant 

damages responding to opioid issues due to the actions of the 

Manufacturers, the Distributors and the KOLs ...................................71 

VII. THE MANUFACTURERS, DISTRIBUTORS AND KOLS HAVE REAPED, 

AND WILL CONTINUE TO REAP, ENORMOUS PROFITS WHILE THE 

NATION, AND COLUMBUS, ARE FORCED TO REMEDY AND ABATE 

THE OPIOID EPIDEMIC ..............................................................................................73 

VIII. FRAUDULENT CONCEALMENT ...............................................................................74 

COUNT ONE: PUBLIC NUISANCE (COMMON LAW) 

(AGAINST ALL DEFENDANTS) .............................................................................................76 

COUNT TWO: PUBLIC NUISANCE (O.R.C. § 715.44) 

(AGAINST ALL DEFENDANTS) .............................................................................................80 

COUNT THREE: INJURY THROUGH CRIMINAL ACTS, O.R.C. § 2307.60 

(AGAINST ALL MANUFACTURER AND DISTRIBUTOR DEFENDANTS) ...................84 

COUNT FOUR: FRAUD 

(AGAINST ALL DEFENDANTS) .............................................................................................86 

COUNT FIVE: OHIO CORRUPT PRACTICES ACT, O.R.C. §§ 2923.31, et seq. 

(AGAINST ALL MANUFACTURER AND DISTRIBUTOR DEFENDANTS) ...................87 

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COUNT SIX: CONSPIRACY, OHIO CORRUPT PRACTICES ACT, O.R.C. 

§§ 2923.31, et seq. (AGAINST ALL DEFENDANTS) ..............................................................95 

COUNT SEVEN: VIOLATIONS OF THE RACKETEER INFLUENCED AND 

CORRUPT ORGANIZATIONS ACT (“RICO”), 18 U.S.C. § 1961(c) (AGAINST 

ALL MANUFACTURER AND DISTRIBUTOR DEFENDANTS)........................................97 

COUNT EIGHT: VIOLATIONS OF RICO, 18 U.S.C. § 1961(d) 

(AGAINST ALL DEFENDANTS) ...........................................................................................105 

COUNT NINE: NEGLIGENCE 

(AGAINST ALL DEFENDANTS) ...........................................................................................106 

COUNT TEN: NEGLIGENCE PER SE 

(AGAINST MANUFACTURER AND DISTRIBUTOR DEFENDANTS) ..........................107 

COUNT ELEVEN: DECEPTIVE TRADE PRACTICES ACT, O.R.C. § 4165.01, 

et seq. (AGAINST MANUFACTURER DEFENDANTS AND KOL DEFENDANTS) ......108 

PRAYER FOR RELIEF............................................................................................................111 

JURY DEMAND ........................................................................................................................113 

 

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 Now comes plaintiff the City of Columbus, Ohio (“Plaintiff,” “City,” “Columbus,” or 

“City of Columbus”), by and through its attorney, Richard Pfeiffer, City Attorney, for its 

Complaint against defendants Purdue Pharma L.P.; Purdue Pharma, Inc.; The Purdue Frederick 

Company, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries, Ltd.; 

Cephalon, Inc.; Johnson & Johnson; Janssen Pharmaceuticals, Inc.; Janssen Pharmaceutica Inc. 

n/k/a Janssen Pharmaceuticals, Inc.; Ortho-McNeil-Janssen Pharmaceuticals, Inc. n/k/a Janssen 

Pharmaceuticals, Inc.; Noramco, Inc.; Endo Health Solutions Inc.; Endo Pharmaceuticals, Inc.; 

Allergan plc f/k/a Actavis plc; Actavis, Inc. f/k/a Watson Pharmaceuticals, Inc.; Watson 

Laboratories, Inc.; Actavis LLC; and Actavis Pharma, Inc. f/k/a Watson Pharma, Inc. 

(collectively, the “Manufacturers” or “Manufacturer Defendants”); McKesson Corporation; 

Cardinal Health, Inc.; AmerisourceBergen Drug Corporation (collectively, the “Distributors” or 

“Distributor Defendants”); Russell Portenoy; Perry Fine; Scott Fishman; and Lynn Webster 

(collectively, the “Key Opinion Leaders,” “KOLs,” or “KOL Defendants”) (collectively all of 

the defendants are known as the “Defendants”), alleges as follows: 

INTRODUCTION

1. Opioids are a class of drugs that include the illegal drug heroin and synthetic 

opioids such as fentanyl, oxycodone, hydrocodone, codeine, and many others.1 Over the last two 

decades, opioids have become the most prescribed class of drugs in the United States. In 2016, 

health care providers wrote more than 289 million prescriptions for opioids, or approximately 

one bottle of pills for every adult in America.2

2. The United States, including the City of Columbus, is in the middle of an opioid 

addiction epidemic and crisis. Cities like Columbus have been forced to deal with the effects of 

 

1

See National Institute on Drug Abuse, “Opioids,” https://www.drugabuse.gov/drugs-abuse/opioids. 

2

 Prevalence of Opioid Misuse, BupPractice, https://www.buppractice.com/node/15576. 

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prescription and illicit opioid addiction. The Centers for Disease Control and Prevention 

(“CDC”) estimate that prescription opioid abuse costs the United States $78.5 billion per year. 

This includes, but is not limited to, the costs incurred to abate the affects of addiction and 

addiction-related issues such as increased costs for health care, addiction treatment, and the 

increased cost to the criminal justice system.3

3. The addiction epidemic is the result of a well-developed marketing scheme by the 

Manufacturers and KOLs to sell opioids for the treatment of chronic pain. Despite no credible 

scientific evidence indicating that opioids offer any long-term benefit in treating chronic pain, 

the Manufacturers and KOLs promoted their opioids as a panacea and pushed billions of pills 

into communities, including Columbus. 

4. The Manufacturers and KOLs misrepresented to other physicians and the public 

that opioids were a safe treatment for pain with a low risk for addiction, and/or failed to take 

steps to stem their distribution and flow despite legal duties to do so. 

5. Contrary to the representations of safety made by the Manufacturers and the 

KOLs, there is “[n]o evidence” to show “a long-term benefit of opioids in pain and function 

versus no opioids for chronic pain.”4

 ”Extensive evidence shows the possible harms of opioids 

(including opioid use disorder, overdose, and motor vehicle injury)” and “[o]pioid pain 

medication use presents serious risks, including overdose and opioid use disorder.”5

 

6. The Manufacturers and KOLs spent millions of dollars promoting and marketing 

opioids to doctors, patients, and the public, including through direct marketing, front groups, 

medical journals, and unbranded advertising. The Manufacturers and KOLs touted the purported 

 

3 CDC Foundation’s New Business Pulse Focuses on Opioid Overdose Epidemic, Centers for Disease Control and 

Prevention (Mar. 15, 2017), https://www.cdc.gov/media/releases/2017/a0315-business-pulse-opioids.html. 

4

 Deborah Dowell, M.D., Tamara M. Haegerich, Ph.D., and Roger Chou, M.D., CDC Guideline for Prescribing 

Opioids for Chronic Pain — United States, 2016, Centers for Disease Control and Prevention (Mar. 18, 2016), 

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm (emphasis added). 

5

Id. 

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benefits of opioids to treat pain and downplayed the risks of addiction related to opioid use. 

Their representations included, but are not limited to, that there was a low risk of addiction to the 

Manufacturers’ opioids, more opioids should be prescribed to treat pain, risk-mitigation 

strategies made it safe to prescribe opioids, higher dosages of opioids did not increase risks, 

abuse-deterrent technology minimized risks, and long-term opioid use improved patients’ 

function and quality of life. 

7. The Manufacturers and KOLs generated billions of dollars in sales of opioids. 

Americans consume 80% of the world’s opioid supply and annual prescription opioid sales have 

consistently approached more than $10 billion in recent years. 

8. The Manufacturers and the KOLs are not the only entities that are liable for the 

influx of prescription and illicit opioids into Columbus. Once the Manufacturers and the KOLs 

created the market for opioids, the Distributors helped cause the epidemic by distributing 

prescription opioids in unprecedented numbers. By failing to report “suspicious” orders, as 

required by law, the Distributors fueled the growing opioid epidemic, while their profits 

increased. The Distributors have been suspended and fined multiple times for failing to report 

“suspicious” orders, including, but not limited to:

a. On December 23, 2016, Cardinal Health agreed to pay a 

$44,000,000 fine to the Department of Justice to resolve the civil 

penalty portion of administrative action taken against its Lakeland, 

Florida Distribution Center; 

b. On January 5, 2017, McKesson Corporation entered into an 

Administrative Memorandum of Agreement with the DEA wherein 

it agreed to pay a $150,000,000 civil penalty for violation of the 

2008 Administrative Memorandum of Agreement with the DEA, as 

well as failure to identify and report suspicious orders at its 

facilities in Aurora CO, Aurora IL, Delran NJ, La Crosse WI, 

Lakeland FL, Landover MD, La Vista NE, Livonia MI, Methuen 

MA, Santa Fe Springs CA, Washington Court House OH and West 

Sacramento CA; and 

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c. On January 6, 2017, AmerisourceBergen agreed to pay

$16,000,000 to the State of West Virginia to resolve claims that 

AmerisourceBergen acted negligently and unlawfully while 

engaging in wholesale drug distribution in West Virginia.

9. On September 18, 2017, attorneys general from 41 states announced a joint 

investigation into the Manufacturers’ and Distributors’ manufacture, marketing, and distribution 

of opioids. All eight Manufacturers and Distributors were served with investigative subpoenas 

and document requests relating to the conduct described herein.6

10. As a result of the Defendants’ conduct, Columbus has suffered significant harm 

and damages, including, but not limited to, the breakdown of families, increased health insurance 

costs, increased police and fire usage, increased usage of the criminal justice system and other 

significant harms. Columbus also is faced with a significant addiction problem it must abate and 

remedy. 

11. Columbus brings this action to hold the Defendants liable for their conduct in 

creating and perpetuating the opioid epidemic — conduct that (i) constitutes a public nuisance 

under Ohio common and statutory law; (ii) constitutes deceptive trade practices under Ohio law; 

(iii) has injured Columbus through criminal acts; (iv) constitutes fraud under Ohio law; (v) 

constitutes a pattern of corrupt activity under Ohio law; (vi) constitutes a pattern of racketeering 

activity under federal law; (vii) constitutes negligence under Ohio law, and (viii) constitutes 

negligence per se under Ohio law. 

12. Dr. Andrew Kolodny recently summarized the effect of the Defendants’ unlawful 

scheme: 

I think one of the main reasons that we have failed to respond 

appropriately to the opioid crisis is that it was misframed, and 

 

6

 Nadia Kounang, CNN, 41 state attorneys general subpoena opioid manufacturers (Sept. 20, 2017), 

http://www.cnn.com/2017/09/19/health/state-ag-investigation-opioids-subpoenas/index.html. 

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intentionally so. 

* * * 

From the beginning of the crisis, the way the issue was framed, 

particularly by pain organizations – that were getting funding from 

opioid manufacturers – the way the issue was framed for 

policymakers was as if all of the bad things that we’re hearing 

about, all of the opioid harms, policymakers were told, were 

limited to so called drug abusers, and that millions of patients were 

being helped by the increase in prescribing. 

And so policymakers were told that, your challenge is to try to do 

something about this drug abuse problem without doing something 

to the pain problem – millions of Americans are suffering from 

chronic pain – and if you were to promote any kind of intervention 

that would result in reduced prescribing, you’ll be punishing the 

pain patients for the bad behavior of the drug abusers. So you’ve 

got to balance these two competing problems. 

And the reality is that we don’t have these two distinct groups, and 

opioids are not safe and effective treatments for the vast majority 

of people suffering with chronic pain. Millions of patients with 

pain have become opioid addicted. Thousands of patients have lost 

their lives. 

* * * 

It’s not an abuse crisis, it’s an addiction epidemic. The reason we 

have historically high levels of overdose deaths, the reason we’re 

seeing heroin and fentanyl flood into non-urban areas, the reason 

we’re seeing a soaring increase in infants born opioid-dependent, 

children winding up in the foster care system, outbreaks of 

injection-related infectious diseases, is because we’ve had this 

very sharp increase in the prevalence, the number of Americans 

suffering from opioid addiction.

7

JURISDICTION AND VENUE

13. This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. § 

1331 because the City asserts claims for violations of 18 U.S.C. § 1961, et seq. against all 

 

7

 Dr. Andrew Kolodny, Washington Post Live, Dr. Andrew Kolodny: Opioid crisis ‘not an abuse crisis, it’s an 

addiction epidemic’ (June 21, 2017), https://www.washingtonpost.com/video/postlive/dr-andrew-kolodny-opioidcrisis-not-an-abuse-crisis-its-an-addiction-epidemic/2017/06/21/789fa53c-568a-11e7-840b-512026319da7_video.

html?utm_term=.a6571c16138a (emphasis added). 

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defendants. In addition, pursuant to 28 U.S.C. § 1367, the Court has supplemental jurisdiction 

over Columbus’ state law claims because they are so related to Columbus’ federal claims that 

they are part of the same case or controversy. 

14. 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, consented to the jurisdiction of Ohio when 

obtaining a distributor license, and/or have the requisite minimum contacts with Ohio necessary 

to permit the Court to exercise jurisdiction. 

15. Venue is proper in this District pursuant to 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 the Court that serves a county in which at least one defendant 

resides.” See also 28 U.S.C. § 1391(c). Defendant Cardinal Health 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 this Court. 

Venue is further proper in this District pursuant to 28 U.S.C. §§ 1391, 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). 

PARTIES

I. PLAINTIFF. 

16. The City of Columbus is a municipal corporation organized under Ohio Law. See 

Ohio Constitution, Article XVIII. Columbus has all of the powers of local self-government and 

home rule and all other powers possible for a city to have under the constitution and laws of the 

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State of Ohio, which are exercised in the manner prescribed by the charter of the City of 

Columbus. See Charter of the City of Columbus; O.R.C. § 715.01. 

17. Columbus is the capital and largest city in the State of Ohio, and is located within 

Franklin County, Ohio. It is the fourteenth largest city in the United States, with a population of 

860,090, according to 2016 Census estimates. 

18. Columbus provides a wide range of services on behalf of its residents, including 

services for families and children, public health, public assistance, law enforcement, and 

emergency care. 

19. Columbus has spent, and will continue to spend, significant amounts of taxpayer 

money combating opioid addiction, including substantial costs for prevention, treatment, law 

enforcement, prosecution, emergency medical services, probation, and public works. Nearly 

every department within the City of Columbus, from the Division of Fire to the Recreation and 

Parks Department, has been forced to devote substantial time, money, and resources to the harm 

caused by the opioid epidemic. 

20. The oversaturation of prescription opioids is a continuing public nuisance. It has 

caused opioid abuse, addiction, morbidity, and mortality. Columbus is authorized by law to (a) 

abate any nuisance, (b) prosecute in any court of competent jurisdiction any person who creates, 

continues, contributes to, or suffers such nuisance to exist, and (c) prevent injury and annoyance 

from such nuisance. O.R.C. § 715.44; Cincinnati v. Beretta U.S.A. Corp., 768 N.E.2d 1136 

(Ohio 2002). 

21. Columbus also has standing to recover damages caused by a criminal act. See

O.R.C. §§ 2307.60, 2307.011(F) (“person” includes “political subdivision”), 2744.01(F) 

(municipal corporations are “political subdivisions”). Columbus additionally has standing to 

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bring claims under the Ohio Corrupt Practices Act, and general tort principals. O.R.C. §§ 

2923.31(G) (“persons” include governmental entities), 2923.34(A) (“persons” have standing). 

II. DEFENDANTS. 

A. The Manufacturer Defendants. 

22. The Manufacturer Defendants, also referred to herein as “Manufacturers,” are 

companies whose primary business is the manufacture, marketing and distribution of prescription 

drugs, including opioids. 

23. The Manufacturers have unlawfully orchestrated a marketing and distribution 

campaign designed to increase sales of opioids throughout the United States, including, but not 

limited to, in Columbus. 

24. The Manufacturers are in the chain of distribution of prescription opioids. The 

Manufacturers each sold opioids to distributors, including, but not limited to, the Distributors 

named herein, who distributed them to physicians and pharmacies, including in Columbus. The 

Manufacturers also improperly distributed opioids that ultimately reached Columbus and its 

surrounding areas in unlawfully large quantities. 

1. Defendants Purdue Pharma L.P.; Purdue Pharma, Inc.; and The 

Purdue Frederick Company, Inc. 

25. Defendant Purdue Pharma L.P. is a limited partnership organized under the laws 

of Delaware with its principal place of business in Stamford, Connecticut. Defendant Purdue 

Pharma, Inc. is a Delaware corporation with its principal place of business in Stamford, 

Connecticut. Defendant The Purdue Frederick Company, Inc. is a Delaware corporation with its 

principal place of business in Stamford, Connecticut. These defendants are collectively referred 

to herein as “Purdue.” All Purdue entities acted in concert with one another and acted as agents 

and/or principals of one another in connection with the conduct described herein. 

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26. Purdue manufactures, promotes, and distributes opioids nationally and in 

Columbus, including the following drugs: OxyContin, MS Contin, Dilaudid/Dilaudid HP, 

Butrans, Hysingla ER, and Targiniq ER. 

27. OxyContin, Butrans, and Hysingla ER are Schedule II and III opioids first 

approved in 1995, 2010, and 2014, respectively. 

28. In the 1990s, Purdue patented, obtained FDA approval for and commercially 

released OxyContin, an oral formulation of the opioid oxycodone. Oxycodone is chemically 

related to other opium-derived substances such as morphine, heroin, and hydrocodone. 

29. Similar to other opioids, oxycodone can be a potent painkiller, but it also has an 

extremely high potential to become addictive, particularly when used for other than short term 

use. Because of this, Oxycodone is classified as a Schedule II narcotic under the Controlled 

Substances Act (“CSA”). Other Schedule II controlled substances include cocaine and 

methamphetamine. 

30. The CSA criminalizes, among other things, the unauthorized distribution and 

dispensation of substances classified in any of its five schedules. The five schedules are 

organized from most dangerous (Schedule I) to least dangerous (Schedule V). Classification as 

Schedule II indicates: (A) the drug or other substance has a high potential for abuse; (B) the drug 

or other substance has a currently accepted medical use in treatment in the United States or a 

currently accepted medical use with severe restrictions; and (C) abuse of the drug or other 

substances may lead to severe psychological or physical dependence. 21 U.S.C. § 812(b)(2). 

31. OxyContin was designed to gradually release its oxycodone content over an 

extended period of time, with the purported benefit of providing a longer duration of pain relief 

compared to other oxycodone drugs. Because OxyContin had a higher total oxycodone content 

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than formulations designed for immediate release, however, the potential for misuse and 

addiction posed by OxyContin was tremendous. 

32. OxyContin is Purdue’s largest selling opioid, with national annual sales from 

2009 to the present between approximately $2.5 billion and $3 billion. OxyContin constitutes 

approximately 30% of the entire market for analgesic drugs. The following is a chart of 

OxyContin sales from 1996-2014.8

33. By 2009, 81% of the worldwide annual consumption of oxycodone (the opioid 

used in OxyContin) was used by Americans.9

2. Defendants Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical 

Industries, Ltd.; and Cephalon, Inc. 

34. Defendant Teva Pharmaceuticals USA, Inc. (“Teva USA”) is a Delaware 

corporation with its principal place of business in North Wales, Pennsylvania. Teva USA is a 

wholly owned subsidiary of Defendant Teva Pharmaceutical Industries, Ltd. (“Teva Ltd.”), an 

Israeli corporation. Defendant Cephalon, Inc. (“Cephalon”) is a Delaware corporation with its 

principal place of business in Frazer, Pennsylvania. In 2011, Teva Ltd. acquired Cephalon. 

 

8

 John Fauber and Ellen Gabler, Milwaukee Journal Sentinel, What happened to the poster children of OxyContin?, 

http://archive.jsonline.com/watchdog/watchdogreports/what-happened-to-the-poster-children-of-oxycontin-r65r0lo169056206.html/; Los Angeles Times Graphics, OxyContin Sales, 1996-2014 (May 5, 2016), 

http://www.latimes.com/projects/oxycontin-part1/. 

9

 John Fauber and Ellen Gabler, Milwaukee Journal Sentinel, What happened to the poster children of OxyContin?, 

http://archive.jsonline.com/watchdog/watchdogreports/what-happened-to-the-poster-children-of-oxycontin-r65r0lo169056206.html/. 

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Collectively, these Defendants are referred to herein as “Teva.” 

35. All Teva entities acted in concert with one another and acted as agents and/or 

principals of one another in connection with the conduct described herein. 

36. Teva manufactures several opioids, including Actiq and Fentora, and it promotes, 

markets, and sells its opioids in Columbus, Ohio. 

37. Actiq and Fentora are fentanyl-based opioids. Fentanyl is a synthetic opioid that 

is 50-100 times more potent than morphine, and 25-50 times more potent than heroin. As a 

result, Actiq and Fentora are only approved for limited purposes – that is, to treat pain from 

cancer. 

38. Upon information and belief, Teva generates substantial sales from its opioids. In 

2005, for example, Teva sold over $410 million worth of Actiq.10

3. Defendants Johnson & Johnson; Janssen Pharmaceuticals, Inc.; 

Janssen Pharmaceutica Inc. n/k/a Janssen Pharmaceuticals, Inc.; 

Ortho-McNeil-Janssen Pharmaceuticals, Inc. n/k/a Janssen 

Pharmaceuticals, Inc.; and Noramco, Inc. 

39. Defendant Janssen Pharmaceuticals, Inc. is a Pennsylvania corporation with its 

principal place of business in Titusville, New Jersey, and is a wholly-owned subsidiary of 

Defendant Johnson & Johnson, a New Jersey corporation with its principal place of business in 

New Brunswick, 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. Defendant Ortho-McNeil-Janssen Pharmaceuticals, Inc., now known as 

Janssen Pharmaceuticals, Inc., is a Pennsylvania corporation with its principal place of business 

in Titusville, New Jersey. Noramco, Inc. (“Noramco”) is a Delaware company with its principal 

place of business in Wilmington, Delaware, and was a wholly-owned subsidiary of Johnson & 

 

10 John Carreyrou, The Wall Street Journal, “Narcotic ‘Lollipop’ Becomes Big Seller Despite FDA Curbs” (Nov. 3, 

2006), https://www.wsj.com/articles/SB116252463810112292. 

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Johnson until July 2016. Collectively, these entities are referred to herein as “Janssen.” 

40. All Janssen entities acted in concert with one another and acted as agents and/or 

principals of one another in connection with the conduct described herein. 

41. Johnson & Johnson owns more than 10% of Janssen Pharmaceuticals, Inc., and, 

upon information and belief, communicates with the FDA regarding the drugs manufactured by 

Janssen Pharmaceuticals, Inc. Upon information and belief, Johnson & Johnson controls the sale 

and development of the drugs manufactured by Janssen Pharmaceuticals, Inc. 

42. Janssen manufactures, promotes, sells, markets, and distributes opioids such as 

Duragesic, Nucynta, and Nucynta ER in the United States, including in Columbus, Ohio. 

43. Janssen stopped manufacturing Nucynta and Nucynta ER in 2015. 

44. Duragesic and Nucynta ER are Schedule II opioids first approved in 1990 and 

2011, respectively. 

45. Janssen generates substantial revenue from its opioids. Janssen sold more than $1 

billion of Duragesic in 2009, and sold $172 million worth of Nucynta and Nucynta ER in 2014. 

4. Defendants Endo Health Solutions Inc. and Endo Pharmaceuticals, 

Inc. 

46. Defendant Endo Pharmaceuticals, Inc. is a wholly owned subsidiary of Defendant 

Endo Health Solutions Inc. Both are Delaware corporations with their principal place of 

business in Malvern, Pennsylvania. Collectively, these entities are referred to as “Endo.” 

47. Each Endo entity acted in concert with one another and acted as agents and/or 

principals of one another in connection with the conduct described herein. 

48. Endo manufactures, promotes, sells, markets, and distributes opioids such as 

Percocet, Percodan, Opana, and Opana ER in the United States, including in Columbus. 

49. Endo generates substantial revenue from its opioids. Endo sold more than $400 

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million in 2012, and sold more than $1 billion of Opana ER 2010 to 2013. 

5. Defendants Allergan plc f/k/a Actavis plc; Actavis, Inc. f/k/a Watson 

Pharmaceuticals, Inc.; Watson Laboratories, Inc.; Actavis LLC; and 

Actavis Pharma, Inc. f/k/a Watson Pharma, Inc.

50. Defendant Allergan plc f/k/a Actavis 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 March 2015. 

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 to Actavis plc 

in October 2013. Defendant 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. Defendant Actavis LLC is a Delaware limited 

liability company with its principal place of business in Parsippany, New Jersey. Defendant 

Actavis Pharma, Inc. f/k/a Actavis, Inc. is a Delaware corporation with its principal place of 

business in New Jersey and was formerly known as Watson Pharma, Inc. Collectively, these 

entities are referred to as the “Actavis Defendants” or “Actavis.” 

51. Each Actavis entity acted in concert with one another and acted as agents and/or 

principals of one another in connection with the conduct described herein. Upon information 

and belief, Allergan plc exercises control over these marketing and sales efforts, and profits from 

the sale of Actavis products ultimately inure to its benefit. 

52. Actavis manufactures, promotes, sells, markets, and distributes opioids such as

Kadian and Norco, and several generic opioids, and it promotes, markets, and sells its opioids in 

Columbus. 

53. Upon information and belief, Actavis generates substantial sales from its opioids. 

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B. The Distributor Defendants. 

54. The Distributor Defendants, also collectively referred to herein as the 

“Distributors,” are in the chain of distribution of prescription opioids, namely hydrocodone and 

oxycodone. Upon information and belief, the Distributors have distributed the Manufacturers’ 

opioids to Columbus physicians and pharmacies. 

1. Defendant McKesson Corporation. 

55. Defendant McKesson Corporation (“McKesson”) is registered with the Ohio 

Secretary of State as a Delaware corporation and may be served through its registered agent for 

service of process, Corporation Service Company, 50 West Broad Street, Suite 1330, Columbus, 

Ohio 43215. McKesson’s principal place of business is located in San Francisco, California. 

McKesson operates distribution centers in Ohio, including in Washington Court House, Ohio. 

2. Defendant Cardinal Health, Inc. 

56. Defendant Cardinal Health, Inc. is registered with the Ohio Secretary of State as 

an Ohio corporation, with its principal place of business located in Dublin, Ohio, and may be 

served through its registered agent for service of process, CT Corporation System, 4400 Easton 

Commons Way, Suite 125, Columbus, Ohio 43219. Cardinal Health operates distribution 

centers nationwide and in Ohio, including in Groveport, Ohio and in Zanesville, Ohio. 

3. Defendant AmerisourceBergen Drug Corporation. 

57. Defendant AmerisourceBergen Drug Corporation (“AmerisourceBergen”) is 

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

its registered agent for service of process, CT Corporation System, 4400 Easton Commons Way, 

Suite 125, Columbus, Ohio 43219. AmerisourceBergen’s principal place of business is located 

in Chesterbrook, Pennsylvania. AmerisourceBergen operates distribution centers in Ohio, 

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including in Lockbourne, Ohio. 

C. Defendants Russell Portenoy; Perry Fine; Scott Fishman; And Lynn 

Webster. 

58. Defendants Russell Portenoy; Perry Fine; Scott Fishman; and Lynn Webster are 

Key Opinion Leaders or “KOLs.” “Key Opinion Leaders” is a pharmaceutical industry term of 

art meaning “physicians who influence their peers’ medical practice, including but not limited to 

prescribing behavior.”11

59. The KOLs were paid by the Manufacturers to tout misrepresentations regarding 

the risks and benefits of opioids. The KOLs knowingly misrepresented that opioids could be 

used effectively to treat conditions such as chronic pain, and downplayed the risks of addiction 

and abuse. 

1. Defendant Russell Portenoy. 

60. Defendant Russell Portenoy, M.D., is a citizen of New York. Dr. Portenoy is a 

physician licensed to practice medicine in the state of New York. Dr. Portenoy promoted 

opioids for sale and distribution nationally and in Columbus. 

61. For the past two decades, multiple Manufacturers have paid Dr. Portenoy to make 

representations regarding opioids and addiction in general.12

62. Dr. Portenoy served on the American Pain Society (“APS”)/American Academy 

of Pain Medicine (“AAPM”) Guidelines Committees, which misrepresented the use of opioids as 

 

11 See Pharma Marketing Network, The Pharma Marketing Glossary, “Key Opinion Leader (KOL)” (2014), 

http://www.pharma-mkting.com/glossary/keyopinionleader.htm. 

12 Peter Whoriskey, The Washington Post, Rising painkiller addiction shows damage from drugmakers’ role in 

shaping medical opinion (Dec. 30, 2012), 

https://www.washingtonpost.com/business/economy/2012/12/30/014205a6-4bc3-11e2-b709-

667035ff9029_story.html?utm_term=.351a72fdd485 (As of 2002, Dr. Portenoy “reported involvements on contracts 

and grants with Parke-Davis, Boehringer Ingelheim, Elan, Ortho Biotech, Endo, Ametek, Medtronic, Purdue 

Pharma, Pfizer, Janssen, Abbott, Curatech, Ortho-McNeil and Searle.”); see also Janice Lynch Schuster, MedPage 

Today, Portenoy Opioid Talk Sparks Controversy (Sept. 28, 2014), 

https://www.medpagetoday.com/painmanagement/painmanagement/47855. Additionally, Dr. Portenoy received 

payments from Teva Pharmaceuticals in 2015. See, e.g., Open Payments federal database, 

https://openpaymentsdata.cms.gov/physician/886802/payment-information. 

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an effective treatment for chronic pain. 

63. Dr. Portenoy also was a member of the board of the American Pain Foundation 

(“APF”), an organization funded by the Manufacturers. He served as the director of APF in the 

late 1990s, and campaigned to make pain the “fifth vital sign” that doctors needed to monitor, 

along with blood pressure, temperature, breathing, and heartbeat.

2. Defendant Perry Fine. 

64. Defendant Perry Fine, M.D., is a citizen of Utah. Dr. Fine promoted opioids for 

sale and distribution nationally and in Columbus. 

65. Dr. Fine served on the board of directors of APF alongside Defendant Scott 

Fishman. APF was financed by Manufacturers and issued education guides that promoted the 

benefits of opioids for chronic pain, while trivializing their risks, particularly the risk of 

addiction. 

3. Defendant Scott Fishman. 

66. Defendant Scott Fishman, M.D., is a citizen of California. Dr. Fishman promoted 

opioids for sale and distribution nationally and in Columbus. 

67. Dr. Fishman authored Responsible Opioid Prescribing: A Physician’s Guide, a 

book funded, at least in part, by certain of the Manufacturers, including Endo. Those 

Manufacturers attempted to distribute the book to all 700,000 doctors in the United States.13

4. Defendant Lynn Webster. 

68. Defendant Lynn Webster, M.D., is an anesthesiologist and a citizen of Utah. Dr. 

Webster promoted opioids for sale and distribution nationally and in the city of Columbus. 

69. Dr. Webster is a current board member of AAPM, a front group that supports 

 

13Milwaukee Journal Sentinel, Drug company influence: A case study, 

http://archive.jsonline.com/features/health/drug-company-influence-a-case-study-139610013.html. 

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chronic opioid therapy. 

70. Like Dr. Portenoy, multiple Manufacturers used Dr. Webster as a KOL and 

provided him with funding and consultant fees. Dr. Webster authored numerous Continuing 

Medical Education (“CME”) materials sponsored by Teva, Endo, and Purdue. At the same time, 

Dr. Webster received significant funding from the Manufacturers (including nearly $2 million 

from Teva).14

71. Dr. Webster also promoted the concept of “pseudoaddiction” as a theory that 

addictive behaviors were indications of undertreated pain, and should not be viewed as warnings 

of addiction. According to Dr. Webster, in a book he co-authored entitled Avoiding Opioid 

Abuse While Managing Pain, when faced with “drug seeking behavior,” the “clinician’s first 

response” should be to increase the dose.15 

FACTS RELEVANT TO ALL CAUSES OF ACTION

I. THE OPIOID EPIDEMIC CREATED BY THE MANUFACTURERS, THE 

DISTRIBUTORS AND THE KOLS, CAUSED, AND CONTINUES TO CAUSE, 

DEVASTATION, HARM AND DAMAGES TO COLUMBUS. 

72. Opioids are a class of drugs used to treat pain. They are derived in whole or in 

part from the opium poppy, the same plant from which morphine and heroin are made. Some 

opioids also are completely synthetic, but nevertheless contain the same properties as morphine 

and heroin. 

73. The term “opioid” refers to natural, synthetic, and semi-synthetic opioids. The 

Manufacturers manufacture synthetic and semi-synthetic opioids. Opium and morphine are 

examples of natural opioids. 

 

14 Kristen Stewart & Jennifer Dobner, The Salt Lake Tribune, Utah doctors paid $25.8 million by drug companies

(March 12, 2013), http://archive.sltrib.com/article.php?id=55962410&itype=CMSID (Noting “[o]nly three other 

doctors in the country received more [money] from [Teva]” than Dr. Webster.) 

15 Webster, Lynn R., and Beth Dove. “Chapter III.” Avoiding Opioid Abuse While Managing Pain: a Guide for 

Practitioners, Sunrise River Press, 2007. 

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74. Opioids are highly addictive, habit-forming drugs, something the medical 

community has understood for centuries. Until the 1990s, medical professionals employed 

opioid-based drugs with caution, prescribing them in limited circumstances to patients with 

cancer, terminal illnesses, or acute short-term pain. 

75. Opioid use has increased in the last twenty years. Opioids are now commonly 

prescribed for general pain. One in every five patients with non-cancer pain symptoms or painrelated diagnoses is prescribed opioids.16

76. Over the past two decades, annual opioid prescription sales have increased from 

approximately $1 billion to $10 billion:17

 

77. Between 1991 and 2011, opioid prescriptions in the U.S. tripled, from 76 million 

to 219 million per year.18 In 2016, there were more than 289 million prescriptions for opioids 

filled in the U.S.19

 

 

16 Deborah Dowell, M.D., Tamara M. Haegerich, Ph.D., and Roger Chou, M.D., CDC Guideline for Prescribing 

Opioids for Chronic Pain — United States, 2016, Centers for Disease Control and Prevention (Mar. 18, 2016), 

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

17 David Crow, Drugmakers hooked on $10bn opioid habit, Financial Times (Aug. 10, 2016), 

https://www.ft.com/content/f6e989a8-5dac-11e6-bb77-a121aa8abd95?mhq5j=e1. 

18 Nora D. Volkow, MD, America’s Addiction to Opioids: Heroin and Prescription Drug Abuse, Appearing before 

the Senate Caucus on International Narcotics Control, NIH National Institute on Drug Abuse (May 14, 2014), 

https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/americas-addiction-toopioids-heroin-prescription-drug-abuse. 

19 Prevalence of Opioid Misuse, BupPractice, https://www.buppractice.com/node/15576 (last visited Sept. 7, 2017). 

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78. By 2012, one in three opioid users was prescribed dosages of opioids that 

rendered them more potent than morphine.20

 

79. The Manufacturers and the KOLs aggressively pushed the use of opioids to 

physicians in general. The majority of medical professionals who prescribe opioids are not pain 

specialists. A 2014 study concluded that of the more than half million prescribers of opioids 

during that time period, only 385 were identified as pain specialists.21

 

80. The increase in opioid prescriptions has caused a national epidemic and nuisance. 

From 1999 to 2015, the number of opioid overdose deaths increased from approximately 4,030 

to more than 33,000.22

 

81. More than 183,000 deaths from prescription opioids have been reported in the

United States since 1999.23 Someone in the U.S. dies from an overdose of a prescription opioid 

every sixteen minutes.24

82. Between 2000 and 2015, life expectancy in the United States increased overall, 

but drug-poisoning deaths, mostly related to opioids, contributed to reducing life expectancy.25 

 

20 America’s opioid epidemic is worsening, the Economist (Mar. 6, 2017), 

https://www.economist.com/blogs/graphicdetail/2017/03/daily-chart-3. 

21 A Nation in Pain, Express Scripts (Dec. 9, 2014), http://lab.express-scripts.com/lab/publications/a-nation-in-pain. 

22 Overdose Death Rates, NIH National Institute on Drug Abuse, https://www.drugabuse.gov/related-topics/trendsstatistics/overdose-death-rates (revised Jan. 2017). The actual number of opioid-related deaths is likely much 

higher. As much as 25 percent of the time, death certificates do not record the drug responsible for an overdose. See

Centers for Disease Control and Prevention, Opioid Data Analysis (Feb. 9, 2017), https://www.cdc.gov/

drugoverdose/data/analysis.html (“[A]ll the numbers are likely to underestimate the true burden given the large 

proportion of overdose deaths where the type of drug is not listed on the death certificate.”); Alexandra Sifferlin, 

Time, “Dying From an Opioid Overdose Is More Common Than You Think” (Aug. 7, 2017), http://time.com/

4890536/opioid-heroin-overdose-deaths/ (“Between 20%-25% of the overdose death certificates Ruhm studied 

did not have any drug specified, suggesting that statewide estimates of deaths linked to opioids could be 

significantly off.”). 

23 Understanding the Epidemic, Centers for Disease Control and Prevention, 

https://www.cdc.gov/drugoverdose/epidemic/index.html (last updated Aug. 30, 2017). 

24 Katelyn Newman, U.S. News, From Punishing Users to Treating a Disease (May 18, 2017), 

https://www.usnews.com/news/national-news/articles/2017-05-18/the-opioid-epidemic-from-punishing-users-totreating-a-disease. 

25 Rachel Becker, The Verge, The opioid epidemic is so bad it’s driving down life expectancy in the US, https://

www.theverge.com/2017/9/19/16333126/opioid-epidemic-deaths-us-national-life-expectancy-emergency-cdc-jamaresearch. 

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The rising death rate from drug overdoses during the same time period cut the average life 

expectancy in the United States by more than three months – roughly the same reduction 

attributable to rising death rates from injuries, Alzheimer’s disease, suicide, chronic liver disease,

and sepsis combined.

26

83. Unintentional drug overdoses are the leading cause of injury-related death in 

Ohio, ahead of motor vehicle traffic crashes. This trend began in 2007.27 Of the 4,050 Ohioans 

who died of unintentional drug overdoses in 2016, 86.3% overdosed on opioids – far above the 

national average.28 Persons addicted to opioids are less productive. 

84. The total economic loss attributable to prescription opioids is at least $78.5 billion 

per year.29 At least one quarter of these costs – approximately $20 billion per year – are borne 

by the public sector, including by municipalities like Columbus.30

 

II. THE MANUFACTURERS, DISTRIBUTORS AND KOLS CAUSED THE OPIOID 

EPIDEMIC. 

85. The safe and effective treatment of chronic pain requires physicians to weigh the 

risks of prescribing opioids against the benefits, as well as the risks and benefits of alternative 

treatments. Thus, physicians need to be given accurate information about opioids. 

A. It Was Generally Accepted That Long-Term Use Of Opioids Was 

Considered Risky. 

86. The DEA has regulated opioids as controlled substances since 1970. 

87. In the 1970s, 1980s and prior, it was the generally accepted view throughout the 

medical community that opioids should not be used for long-term treatment of chronic pain 

 

26 Id.

27 Ohio Department of Health, 2016 Ohio Drug Overdose Data: General Findings (2016), https://www.odh.ohio.

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

28 Id.

29 CDC Foundation’s New Business Pulse Focuses on Opioid Overdose Epidemic, Centers for Disease Control and 

Prevention (Mar. 15, 2017), https://www.cdc.gov/media/releases/2017/a0315-business-pulse-opioids.html. 

30 Wolters Kluwer Health: Lippincott Williams and Wilkins, Costs of US prescription opioid epidemic estimated at 

$78.5 billion, Science Daily (Sept. 14, 2016), https://www.sciencedaily.com/releases/2016/09/160914105756.htm. 

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because opioids were not effective and did not improve function. Patients also developed 

tolerance and addiction issues.31

88. As a result, before the 1990s, long held and generally accepted standards of 

medicine dictated that opioids only should be used short-term, for acute pain, pain relating to 

recovery from surgery, or for cancer or palliative (end-of-life) care. The use of opioids to treat 

chronic pain was discouraged or prohibited because there was: (a) a lack of evidence that opioids 

improved patients’ ability to overcome pain and still function; (b) evidence of greater pain 

complaints as patients developed tolerance to opioids over time; and (c) serious risk of addiction 

and other side effects. In addition to physical and psychological dependency, it was believed 

that chronic therapy produced greater psychological distress, poorer outcomes, and impaired 

cognition.32

 

B. Opioids Are Highly Addictive. 

89. Prescribing opioids, even for short term pain, risks addiction. 

90. 30% to 40% of long-term users of opioids experience opioid use disorders.33 

According to the Substance Abuse and Mental Health Services Administration (“SAMHSA”), 

symptoms of opioid use disorders include a “strong desire for opioids, inability to control or 

reduce use, continued use despite interference with major obligations or social functioning, use 

of larger amounts over time, development of tolerance, spending a great deal of time to obtain 

and use opioids, and withdrawal symptoms that occur after stopping or reducing use, such as 

 

31 Sonia Moghe, CNN, Opioid History: From ‘wonder drug’ to abuse epidemic (Oct. 14, 2016), 

http://www.cnn.com/2016/05/12/health/opioid-addiction-history/index.html (“By the mid- and late-1970s, when 

Percocet and Vicodin came on the market, doctors had long been taught to avoid prescribing highly addictive 

opioids to patients.”). 

32 See, e.g., Maruta, T. and Swanson, D.W., Problems With The Use Of Oxycodone Compound In Patients With 

Chronic Pain, Pain, 11 (1981), 389-396. 

33 Joseph A. Boscarino et al., Risk factors for drug dependence among out-patients on opioid therapy in a large US 

health-care system, 105(10) Addiction 1776 (2010), 

http://www.thblack.com/links/RSD/Addiction2010_105_1776_RiskFactors4Depend.pdf. 

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negative mood, nausea or vomiting, muscle aches, diarrhea, fever, and insomnia.”34

91. After taking opioids for a period of time, patients develop a tolerance to their pain 

relieving effects. As a result, patients typically require increased doses to achieve the original 

pain relief. These doses can become “frighteningly high.”35 As doses increase, the withdrawal 

symptoms increase, making a patient more susceptible to addiction. Patients can even overdose 

on recommended doses. Fear of withdrawal symptoms can force a patient to seek additional 

opioids to avoid the adverse consequences of withdrawal.36

C. There Is No Credible Evidence To Support Long-Term Opioid Use For 

Chronic Pain. 

92. There are no credible studies that support the long-term effectiveness of opioids 

for patients with chronic non-cancer pain.37

93. By 2009, the Journal of Pain (the official journal of the APS) noted: 

Critical research gaps on use of opioids for chronic noncancer pain 

include: lack of effectiveness studies on long-term benefits and 

harms of opioids (including drug abuse, addiction, and diversion); 

insufficient evidence to draw strong conclusions about optimal 

approaches to risk stratification, monitoring, or initiation and 

titration of opioid therapy; and lack of evidence on the utility of 

informed consent and opioid management plans, the utility of 

opioid rotation, the benefits and harms specific to methadone or 

higher doses of opioids, and treatment of patients with chronic 

noncancer pain at higher risk for drug abuse or misuse.

38

94. Studies have shown that there is no, or limited, efficacy for the use of opioids to 

 

34 Substance Abuse and Mental Health Services Administration, “Substance Use Disorders” (Oct. 27, 2015),

https://www.samhsa.gov/disorders/substance-use. 

35 M. Katz, Long-term Opioid Treatment of Nonmalignant Pain: A Believer Loses His Faith, 170(16) Archives of 

Internal Med. 1422 (2010). 

36 See, e.g., Geordan Omand, The Globe and Mail, Longtime opioid users motivated by fear of withdrawal (Last 

updated March 24, 2017), https://www.theglobeandmail.com/news/british-columbia/longtime-opioid-usersmotivated-by-fear-of-withdrawal/article33360222/ (“[O]ne of the primary motivators for people to continue using 

drugs is to relieve or avoid withdrawal.”). 

37 Roger Chou, et al., Journal of Pain, Volume 10, Issue 2, 149-155, Research Gaps on Use of Opioids for Chronic 

Noncancer Pain: Findings From a Review of the Evidence for an American Pain Society and American Academy of 

Pain Medicine Clinical Practice Guide (Feb. 2009), http://www.jpain.org/article/S1526-5900(08)00830-4/fulltext. 

38 Id. 

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treat chronic back pain, non-cancer pain, and headaches.39 

95. Opioids do not improve patients’ function. “For functional outcomes, the other 

analgesics were significantly more effective than were opioids.”40 

96. Contrary to his later work for the Manufacturers, in 1986, Defendant Dr. Russell 

Portenoy, a KOL and top spokesperson for the Manufacturers, published an article reporting that 

“[f]ew substantial gains in employment or social function could be attributed to the institution of 

opioid therapy.”41

97. Also contrary to his later work for the Manufacturers, upon information and 

belief, in 1994, Dr. Portenoy described the dangers of long-term use of opioids, including 

problems with drug seeking behavior and addiction. 

98. Also contrary to his later work for Manufacturers, upon information and belief, 

 

39 K.C. Brennan, et al., Neurology, Symptom Codes And Opioids: Disconcerting Headache Practice Patterns In 

Academic Primary Care (April 8, 2015), abstract 

http://www.neurology.org/content/82/10_Supplement/S41.003.short; Robert P. Cowan, MD, American Migraine 

Foundation, “Opioid Narcotics and Headache” (July 29, 2015), 

https://americanmigrainefoundation.org/understanding-migraine/opioid-narcotics-and-headache/; Bridget A. Martell 

et al., Annals of Internal Medicine, Systematic Review: Opioid Treatment for Chronic Back Pain: Prevalence, 

Efficacy, and Association with Addiction (2007), 

https://www.researchgate.net/profile/Robert_Kerns/publication/6574580_Systematic_Review_Opioid_Treatment_fo

r_Chronic_Back_Pain_Prevalence_Efficacy_and_Association_with_Addiction/links/00b7d530c87b9ea0d4000000/S

ystematic-Review-Opioid-Treatment-for-Chronic-Back-Pain-Prevalence-Efficacy-and-Association-withAddiction.pdf (“On the basis of recent attention to the treatment for pain and concerns regarding the adverse effects 

of nonsteroidal anti-inflammatory medications, it would be expected that an increasing number of patients with 

chronic back pain will receive opioid medications. The findings in this review suggest that clinicians should 

reconsider treating chronic back pain with opioid medications, and consider other treatments with similar benefit yet 

fewer long-term adverse effects.”). 

40 Andrea D. Furlan, et al., Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects, 

174(11) Can. Med. Ass’n J. 1589 (2006), 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1459894/pdf/20060523s00017p1589.pdf. This same study 

revealed that efficacy studies do not typically include data on opioid addiction. In many cases, patients who may be 

more prone to addiction are prescreened out of the study pool. This does not reflect how doctors actually prescribe 

the drugs, because even patients who have past or active substance use disorders tend to receive higher doses of 

opioids. Karen H. Seal, Association of Mental Health Disorders With Prescription Opioids and High-Risk Opioids 

in US Veterans of Iraq and Afghanistan, 307(9) J. Am. Med. Ass’n 940 (2012), 

https://www.researchgate.net/publication/221683297_Association_of_Mental_Health_Disorders_With_Prescription

_Opioids_and_High-Risk_Opioid_Use_in_US_Veterans_of_Iraq_and_Afghanistan; Andrea Rubenstein, Are we 

making pain patients worse?, Sonoma Medicine (Fall 2009), http://www.nbcms.org/about-us/sonoma-countymedical-association/magazine/sonoma-medicine-are-we-making-pain-patients-worse.aspx?pageid=144&tabid=747. 

41 Russell K. Portenoy & Kathleen M. Foley, Chronic Use of Opioid Analgesics in Non-Malignant Pain: Report of 

38 Cases, 25(2) Pain 171 (1986). 

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Dr. Portenoy stated that there was a lack of evidence supporting the safety and efficacy of opioid 

therapy for long-term chronic non-cancer pain as of 1994.

99. The longer a patient uses opioids, the more likely they are to suffer mental health 

conditions, experience increased psychological distress, and seek medical attention more 

frequently. 

D. The Manufacturers’ And KOLs’ Marketing Scheme Changed The 

Perception About, And Prescribing Of, Opioids.

100. Prior to the conduct of the Manufacturers and the KOLs described herein, 

generally accepted medical standards held that opioids only should be used short-term or for 

cancer or palliative care. 

101. Internal Purdue documents reveal, for example, that even before OxyContin was 

released, Purdue’s goal was clear: “we do not want to niche OxyContin just for cancer pain.”42

 

Purdue also insisted that “there is a big non-cancer marketplace for OxyContin.”43

102. Upon information and belief, Actavis commissioned a consulting report in 2005, 

in anticipation of releasing Kadian to the market. Upon information and belief, that report 

concluded that two challenges facing opioid manufacturers were: (1) overcoming concerns of 

opioids; and (2) that physicians are hesitant to change prescribing patterns without supporting 

data. Upon information and belief, Actavis designed its marketing of Kadian to circumvent these 

two challenges. 

103. Notwithstanding their actual and constructive knowledge of the negative impact 

of opioids, the Manufacturers and the KOLs used multiple means to mislead doctors and the 

general public into believing that long-term use of opioids was an effective and safe treatment 

 

42 Los Angeles Times, OxyContin Files, “Launch Team Meeting 3/31/95 Minutes,” (April 4, 1995) 

http://documents.latimes.com/oxycontin-launch-1995/ (emphasized in original). 

43 Id. 

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for chronic pain. As a spokesperson for the National Institute on Drug Abuse (NIDA), a 

component of the National Institutes of Health (NIH), testified before Congress, “aggressive 

marketing by pharmaceutical companies” is a cause of the opioid abuse problem.44

1. The Manufacturers directly misrepresented to physicians the risks 

and benefits of prescription opioids. 

104. The Manufacturers communicated directly to doctors through in-person 

communications from sales representatives, CMEs, and other written literature. 

105. The Manufacturers spent hundreds of millions of dollars to communicate their 

misleading messages to doctors.45 The Manufacturers employed sales representatives to present 

their message to doctors and to increase both the volume of opioids sold and promote the 

prescription of higher doses of opioids.46 Purdue increased its internal sales force from 318 to 

671 and almost doubled its physician call list from 1996 to 2000.47 The Manufacturers provided 

substantial bonuses to their salespersons to increase their sales. For example, Purdue paid $40 

million in bonuses to its salespersons in 2001.48

 

106. The Manufacturers also invited doctors to attend free pain conferences at resorts 

in warm-weather locations. More than 5,000 medical professionals attended those trips from 

1996-2001.49 At these conferences, the Manufacturers promoted the long-term use of opioids for 

long-term treatment of chronic pain. These free trips and seminars influenced doctors to increase 

 

44 Nora D. Volkow, MD, America’s Addiction to Opioids: Heroin and Prescription Drug Abuse, Appearing before 

the Senate Caucus on International Narcotics Control, NIH National Institute on Drug Abuse (May 14, 2014), 

https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/americas-addiction-toopioids-heroin-prescription-drug-abuse. 

45 Mike Mariani, How the American opiate epidemic was started by one pharmaceutical company, The Week (Mar. 

4, 2015), http://theweek.com/articles/541564/how-american-opiate-epidemic-started-by-pharmaceutical-company. 

46 Los Angeles Times, Letter to Sales Reps, 1996, May 5, 2016, http://documents.latimes.com/letter-sales-reps1996/. At the time, 40mg was the largest pill of OxyContin available. 

47 Art Van Zee, M.D., The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, 

99(2) Am J Public Health 221-27 (Feb. 2009), 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2622774/pdf/221.pdf. 

48 Id.

49 Id.

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the number of prescriptions of opioids for chronic pain. Doctors attending the seminars were 

twice as likely to write prescriptions for opioids as those who did not.50

 

107. The Manufacturers also spent, upon information and belief, hundreds-ofthousands, if not millions, of dollars to review and analyze data from IMS Health Holdings, Inc. 

to determine which doctors prescribed opioids and the volume of those prescriptions. The use 

and analysis of the data became the bedrock of the Manufacturers’ marketing campaigns and 

allowed the Manufacturers to tailor their communications with each doctor.51 Upon information 

and belief, the Manufacturers continue to employ the same marketing practices today. 

108. The Manufacturers targeted family and primary care doctors that were susceptible 

to their marketing campaigns because they were not pain specialists and were more likely to rely 

on the information provided by the Manufacturers.52 As a result of the Manufacturers’ 

marketing campaign, doctors relied on the materials provided by the Manufacturers and 

prescribed opioids for chronic pain. 

2. The Manufacturers funded, controlled and operated third-party 

organizations that made misrepresentations to physicians about the 

risks and benefits of opioids. 

109. The Manufacturers funded and controlled organizations that communicated to 

doctors, patients, and the public about the purported benefits of opioids to treat chronic pain. 

These organizations were known as “Front Groups” and they published prescribing guidelines, 

unbranded materials, and other programs that promoted opioids for chronic pain. The Front 

Groups sought to influence not only doctors and patients, but lawmakers as well, to increase the 

number of opioid prescriptions written. 

 

50 Harriet Ryan, Lisa Girion and Scott Glover, OxyContin goes global — “We’re only just getting started”, Los 

Angeles Times (Dec. 18, 2016), http://www.latimes.com/projects/la-me-oxycontin-part3/. 

51 Art Van Zee, M.D., The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy, 

99(2) Am J Public Health 221-27 (Feb. 2009), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2622774/pdf/221

.pdf. 

52 Id.

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110. For example, APF received more than $10 million from opioid drug 

manufacturers, including, upon information and belief, Purdue, Endo, Teva, and Janssen, 

between 2007 and 2012.53 APF’s operating budget was comprised almost entirely of 

contributions from prescription opioid manufacturers. Not only did the Manufacturers control 

APF’s finances, its board of directors was full of doctors who were on the Manufacturers’ 

payrolls.54 APF also lobbied against federal and state proposals to limit opioid use.55 

111. The AAPM, which received more than $2.2 million in funding since 2009 from 

opioid drug manufacturers, including, upon information and belief, Purdue, Endo, Teva, and 

Actavis, held itself out as an independent and non-biased advocacy group representing 

physicians practicing in the field of pain medicine.

56 In fact, the AAPM simply was another 

Front Group used by the Manufacturers.57 The AAPM participated in issuing guidelines in 2009 

entitled “Guideline for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain – 

Evidence Review” (“2009 Guidelines”), which misrepresented that opioids were “safe and 

effective” for treating chronic pain. The 2009 Guideline is still available online today.58

 

112. The Manufacturers realized treatment guidelines can “change prescribing 

practices,” by falsely giving the appearance that it was an unbiased source of evidence-based 

information, even though they were really marketing materials. 

 

53 Charles Ornstein and Tracy Weber, The Champion of Painkillers, ProPublica (Dec. 23, 2011), 

https://www.propublica.org/article/the-champion-of-painkillers. 

54 Id. 

55 See Matthew Perrone, The Center For Public Integrity, Pro-painkiller echo chamber shaped policy amid drug

epidemic (December 15, 2016), https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chambershaped-policy-amid-drug-epidemic. 

56 Larry McShane, NY Daily News, “How Big Tobacco-style marketing propels U.S. opioid crisis” (June 24, 2017), 

http://www.nydailynews.com/news/national/big-tobacco-style-marketing-propels-u-s-opioid-crisis-article1.3274960. 

57 Tracy Weber and Charles Ornstein, Two Leaders in Pain Treatment Have Long Ties to Drug Industry, ProPublica 

(Dec. 23, 2011), https://www.propublica.org/article/two-leaders-in-pain-treatment-have-long-ties-to-drug-industry. 

58 Clinical Guideline for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain, American Pain Society, 

http://americanpainsociety.org/uploads/education/guidelines/chronic-opioid-therapy-cncp.pdf (last visited Sept. 7, 

2017). 

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113. Upon information and belief, the Manufacturers participated in the Pain Care 

Forum, a coalition of drug makers, trade groups, and nonprofit organizations, which spent more 

than $740 million lobbying in the nation’s capital and all fifty states on an array of issues, 

including opioid-related measures.59 

114. Another group, a University of Wisconsin-based organization known as the Pain 

& Policy Studies Group, received about $2.5 million from pharmaceutical companies, including, 

but not limited to, Purdue, to promote opioid use and discourage the passing of regulations 

against opioid use in medical practice.60 The Pain & Policy Studies Group wields considerable 

influence over the nation’s medical schools.61 Purdue was the largest contributor to the Pain & 

Policy Studies Group, paying approximately $1.6 million between 1999 and 2010.62 

115. The Manufacturers also engaged in unbranded advertising to generally tout the 

benefits of opioids without specifically naming a particular brand of opioid. Unbranded 

marketing promotes a type of treatment generally, and is typically not reviewed by the FDA. 

3. The Manufacturers retained the KOLs to conceal their 

misrepresentations about the risks and benefits of opioids in the guise 

of credentialed medical professionals. 

116. The Manufacturers compensated the KOLs, who misrepresented the benefits of 

opioid use for chronic pain at CME seminars and conferences. The KOLs misrepresented that 

they were independent of the Manufacturers. In fact, the KOLs served on advisory boards of the 

Manufacturers, on the boards of certain Front Groups, and on committees that helped develop 

 

59 Matthew Perrone and Ben Wieder, Pro-painkiller echo chamber shaped policy amid drug epidemic, AP News 

(Sept. 19, 2016), https://apnews.com/3d257452c24a410f98e8e5a4d9d448a7/pro-painkiller-echo-chamber-shapedpolicy-amid-drug. 

60 John Fauber, Journal Sentinel, UW group ends drug firm funds (April 20, 2011), 

http://archive.jsonline.com/watchdog/watchdogreports/120331689.html/. 

61 The Role of Pharmaceutical Companies in the Opioid Epidemic, Addictions.com, https://www.addictions.com/

opiate/the-role-of-pharmaceutical-companies-in-the-opioid-epidemic/ (last visited Sept. 7, 2017). 

62 John Fauber, UW group ends drug firm funds, Journal Sentinel (Apr. 20, 2011), 

http://archive.jsonline.com/watchdog/watchdogreports/120331689.html. 

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guidelines relating to opioids, including the AAPM’s 2009 Guideline described above. 

E. The Manufacturers’ And KOLs’ Marketing Campaign Is, And Always Has 

Been, Rooted In Scientifically Unsupported Conclusions. 

117. Each of the Manufacturers and the KOLs made false and misleading statements 

about opioids. Each Manufacturer and KOL knew, or should have known, that such statements, 

as described herein, were false at the time they were made. 

118. The medical community’s understanding of opioids has not fundamentally 

changed in the past thirty years, and recent studies confirm that the Manufacturers’ and the 

KOLs’ statements about the risks and benefits of opioids are false. 

119. For example, the Manufacturers and the KOLs cited a one-paragraph letter-to-theeditor published in the New England Journal of Medicine (“NEJM”) in 1980 (hereafter, the 

“1980 NEJM Letter-to-the-Editor”) that “conclude[d]...the development of addiction is rare in 

medical patients with no history of addiction:”63

120. The study referenced in the 1980 NEJM Letter-to-the-Editor merely analyzed 

patients whom were not given long-term opioid prescriptions for use at home. Instead, they were 

 

63 Jane Porter and Herschel Jick, MD, Addiction Rare in Patients Treated with Narcotics, 302(2) N Engl J Med. 123 

(Jan. 10, 1980), http://www.nejm.org/doi/pdf/10.1056/NEJM198001103020221. 

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prescribed opioids under in-patient doctor supervision at hospitals. The 1980 NEJM Letter-tothe-Editor also provided no evidence to support its conclusions. 

121. The Manufacturers and the KOLs repeatedly cited the 1980 NEJM Letter-to-theEditor to support their claim that patients treated with opioids rarely became addicted.64

122. The 1980 NEJM Letter-to-the-Editor was cited at least 608 times.65 The number 

of citations notably increased after OxyContin was introduced in 1995.66  

123. Of those 608 articles, 72.2% cited it “as evidence that addiction was rare in 

patients treated with opioids,” and 80.8% “did not note that the patients who were described in 

 

64 Jane Porter and Herschel Jick, MD, Addiction Rare in Patients Treated with Narcotics, 302(2) N Engl J Med. 123 

(Jan. 10, 1980), http://www.nejm.org/doi/pdf/10.1056/NEJM198001103020221. 

65 Pamela T.M. Leung, et al., New England Journal of Medicine, A 1980 Letter on the Risk of Opioid Addiction

(June 1, 2017), http://www.nejm.org/doi/pdf/10.1056/NEJMc1700150; see also Harrison Jacobs, Business Insider, 

This one-paragraph letter may have launched the opioid epidemic (May 26, 2016), 

http://www.businessinsider.com/porter-and-jick-letter-launched-the-opioid-epidemic-2016-5. 

66 Pamela T.M. Leung, et al., New England Journal of Medicine, A 1980 Letter on the Risk of Opioid Addiction

(June 1, 2017), http://www.nejm.org/doi/pdf/10.1056/NEJMc1700150 see also Harrison Jacobs, Business Insider, 

This one-paragraph letter may have launched the opioid epidemic (May 26, 2016), 

http://www.businessinsider.com/porter-and-jick-letter-launched-the-opioid-epidemic-2016-5. 

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the letter were hospitalized at the time they received the prescription.”67

124. The misleading citation to the 1980 NEJM Letter-to-the-Editor became so 

pervasive that even Time magazine cited it as a “landmark study” and claimed it demonstrated 

that the “exaggerated fear that patients would become addicted [to opioids]...[was] basically 

unwarranted.”68 

125. The representations based on the 1980 NEJM Letter-to-the-Editor were false 

because the 1980 NEJM Letter-to-the-Editor “does not speak to the level of addiction in 

outpatients who take these drugs for chronic pain.”69

126. Despite knowing the limited scope of the study, the Manufacturers’ and the 

KOLs’ misrepresentations based on this letter included claims that less than one percent of 

opioid users become addicted.70

127. In 2017, the NEJM published a follow-up letter-to-the-editor in which it 

concluded that the misleading citations of the 1980 NEJM Letter-to-the-Editor “contributed to 

the North American opioid crisis by helping to shape a narrative that allayed prescribers’ 

concerns about the risk of addiction associated with long-term opioid therapy.”71

128. The Manufacturers and the KOLs contributed to the opioid epidemic by 

representing that the risk of addiction was low when opioids were prescribed to treat chronic 

pain. Defendant Dr. Russell Portenoy, a KOL, recently described the campaign of 

 

67 Id.

68 Sam Allis Boston, Time, Less Pain, More Gain (June 24, 2001), 

http://content.time.com/time/magazine/article/0,9171,158154,00.html. 

69 Harrison Jacobs, Business Insider, This one-paragraph letter may have launched the opioid epidemic (May 26, 

2016), http://www.businessinsider.com/porter-and-jick-letter-launched-the-opioid-epidemic-2016-5. 

70 See, e.g., Mike Mariani, The Week, “How the American opiate epidemic was started by one pharmaceutical 

company” (March 4, 2015), http://theweek.com/articles/541564/how-american-opiate-epidemic-started-bypharmaceutical-company (“Through an array of promotional materials, including literature, brochures, videotapes, 

and Web content, Purdue proudly asserted that the potential for addiction was very small, at one point stating it to be 

‘less than 1 percent.’”). 

71 Pamela T.M. Leung, B.Sc. Pharm., Erin M. Macdonald, M.Sc., Matthew B. Stanbrook, M.D., Ph.D., Irfan Al 

Dhalla, M.D., David N. Juurlink, M.D., Ph.D., A 1980 Letter on the Risk of Opioid Addiction, 376 N Engl J Med 

2194-95 (June 1, 2017), http://www.nejm.org/doi/full/10.1056/NEJMc1700150#t=article (emphasis added). 

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misinformation: 

I gave so many lectures to primary care audiences in which the 

[1980 NEJM letter] was just one piece of data that I would then 

cite – and I would then cite six, seven, maybe ten different avenues 

of thought, or avenues of evidence, none of which represented real 

evidence. 

And yet, what I was trying to do, was to create a narrative so that 

the primary care audience would look at this information in toto 

and feel more comfortable about opioids, in a way they hadn’t 

before. In essence, this was education to destigmatize, and 

because the primary goal was to destigmatize [opioids], we often 

left evidence behind.”72

F. Each Of The Manufacturers And The KOLs Have Made, And Continue To 

Make, False Claims About Opioids. 

129. Each Manufacturer and KOL knew, or should have known, that its statements 

about the low risk of addiction were false at the time they were made, and remain false today, as 

recent studies have confirmed. Each has failed to correct its false and misleading statements. 

130. The Manufacturers and KOLs made material misrepresentations concerning the 

following subject matters, each of which is discussed in detail below: (1) the risk of addiction to 

opioids was low; (2) increased dosage of opioids should be used to treat pain; (3) there were 

effective strategies to reduce the risk of addiction and abuse; (4) higher dosages of opioids did 

not pose serious risks; (5) abuse-deterrent technology existed to reduce the risks of abuse; and 

(6) patient functionality and quality of life improved through the long-term use of opioids. 

1. The Manufacturers and KOLs misrepresented that the risk of opioid 

addiction was low. 

131. The Manufacturers and KOLs have made false statements related to the risk of 

opioid addiction. 

132. To expand the market for OxyContin, Purdue engaged in a campaign to 

 

72 Andrew Kolodny, Opioids for Chronic Pain: Addiction is NOT Rare, 

https://www.youtube.com/watch?v=DgyuBWN9D4w (last visited October 11, 2017). 

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exaggerate the benefits of, and need for, OxyContin, while minimizing the known risks of 

OxyContin, including addiction, misuse, and diversion. 

133. According to an internal Purdue document from 1990, drafted by Dr. Robert F. 

Kaiko, Purdue was aware before developing OxyContin that “in the State of Connecticut and 

perhaps other states, the substance abuse officials consider oxycodone combinations among the 

most abused Schedule II narcotic analgesic drugs.”73 Dr. Kaiko noted oxycodone’s reputation as 

a “sleeping giant” among analgesics, “in that among all of the opioid analgesics utilized in fixed 

combinations, oxycodone is the only one with an analgesic potential comparable to that of 

morphine.”74

134. Dr. Portenoy, the paid KOL described above, stated in a Purdue promotional 

video 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.”75

135. Dr. Alan Spanos, a pain specialist paid by Purdue,76 purporting to rely on the 

1980 NEJM Letter-to-the-Editor stated in a Purdue promotional video: “In fact, the rate of 

addiction amongst pain patients who are treated by doctors is much less than 1%. They don’t 

wear out, they go on working, they do not have serious medical side effects....”77 Purdue 

distributed this video to 15,000 doctors.78 

136. In reliance on the 1980 NEJM Letter-to-the-Editor, Purdue’s “Partners Against 

 

73 Robert F. Kaiko, Ph.D., Purdue Pharma Memo, Controlled-Release Oxycodone (July 16, 1990), 

http://documents.latimes.com/purdues-need-new-painkiller-1990/. 

74 Id.

75 Thomas Catan and Evan Perez, A Pain-Drug Champion Has Second Thoughts, The Wall Street Journal (Dec. 17, 

2012), https://www.wsj.com/articles/SB10001424127887324478304578173342657044604. 

76 John Fauber and Ellen Gabler, Milwaukee Journal Sentinel and MedPage Today, Anatomy of an Epidemic: The 

Opioid Movie (Sept. 9, 2012), https://www.medpagetoday.com/neurology/painmanagement/34650. 

77 Our Amazing World, Purdue Pharma OxyContin Commercial, https://www.youtube.com/watch?v=Er78Dj5hyeI

(last visited Sept. 7, 2017) (emphasis added). 

78 U.S. General Accounting Office, Report to Congressional Requesters, OxyContin Abuse and Diversion and 

Efforts to Address the Problem (Dec. 2003), http://www.gao.gov/new.items/d04110.pdf. 

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Pain” website claimed that the addiction risk with OxyContin was very low.79 

137. Purdue misrepresented that there was no need to worry about addiction if taking 

opioids for legitimate, “medical” purposes: 

Drug addiction means using a drug to get “high” rather than to 

relieve pain. You are taking opioid pain medication for medical 

purposes. The medical purposes are clear and the effects are 

beneficial, not harmful.80

138. With Purdue’s actual or constructive knowledge, and at Purdue’s direction, 

Purdue sales representatives misrepresented the low risk for addiction to doctors across the 

country.81 Purdue also marketed OxyContin for a wide variety of conditions and to doctors who 

were not adequately trained in pain management.82 

139. Endo also made misrepresentations about the low risk of addiction. For instance, 

it sponsored a website, PainKnowledge.com, on which it claimed that “[p]eople who take opioids 

as prescribed usually do not become addicted.”83 The website has since been taken down. In 

another website, PainAction.com, still available online, Endo claimed that “most chronic pain 

patients do not become addicted to the opioid medications that are prescribed for them.”84

140. Endo began selling an opioid, oxymorphone, in 2005. That opioid, marketed 

under the brand name Opana, was chemically identical to a previous opioid, Numorphan. In 

1974, a report by the National Institute of Drug Abuse entitled “Drugs and Addict Lifestyle,” 

 

79 Art Van Zee, M.D., The OxyContin Abuse Problem: Spotlight on Purdue Pharma’s Marketing (Aug. 22, 2001), 

https://www.fda.gov/ohrms/dockets/dockets/01n0256/c000297-A.pdf. 

80 Opioids.com, The Marketing of Opioids (accessed Oct. 20, 2017), 

https://www.opioids.com/oxycodone/oxycontin.htm. 

81 Barry Meier, In Guilty Plea, OxyContin Maker to Pay $600 Million, The New York Times (May 10, 2007), 

http://www.nytimes.com/2007/05/10/business/11drug-web.html. 

82 U.S. General Accounting Office, Report to Congressional Requesters, OxyContin Abuse and Diversion and 

Efforts to Address the Problem (Dec. 2003), http://www.gao.gov/new.items/d04110.pdf. 

83 German Lopez, US officials are starting to treat opioid companies like Big Tobacco—and suing them, Vox (Aug. 

9, 2017), https://www.vox.com/policy-and-politics/2017/6/7/15724054/opioid-companies-epidemic-lawsuits. 

84 Opioid medication and addiction, Pain Action (Aug. 17, 2017), https://www.painaction.com/opioid-medicationaddiction/. 

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revealed the popularity of Numorphan.85 According to the report, Numorphan’s oral tablets were 

about twice as potent as morphine, and many addicts said they preferred the drug over heroin 

because it was “about 10 times more potent than morphine upon parenteral administration” [nonoral means of administration, including by injection].86 In 1979, Endo agreed with the FDA to 

take Numorphan off the market following two decades of abuse by addicts.87 Endo publically 

stated the removal was for “commercial reasons.” 

141. Despite knowing the high potential for abuse inherent in oxymorphone, Endo 

sought FDA approval of Opana in 2003. During preliminary clinical trials of Opana, several 

patients overdosed on the drug and had to be revived with emergency doses of naloxone.88 Endo 

promptly conducted new clinical trials using the concept of “enriched enrollment,” a clinical trial 

method that permitted Endo to remove anyone from the study who didn’t respond well to the 

drug.89

 

142. The concept of “enriched enrollment” arose from the Initiative on Methods, 

Measurements, and Pain Assessment in Clinical Trials (“IMMPACT”).90 Throughout the 2000s, 

IMMPACT hosted annual meetings where representatives of drug manufacturers – including 

Purdue, Endo, Janssen, Teva, and Actavis – could discuss clinical trial design with FDA 

officials.91 These meetings were by invitation only.92

 

85 Patricia Ferguson, et al., National Institute on Drug Abuse, Drugs and Addict Lifestyle at 238, https://assets.

documentcloud.org/documents/2074330/dalopana.pdf (noting “widespread abuse of Numorphan as both a 

preference drug and as a drug to supplement other narcotics” and a belief that “tolerance to Numorphan builds very 

rapidly.”). 

86 Id. at 237. 

87 John Fauber, Milwaukee Journal Sentinel, FDA seeks to remove a power opioid from the market for the second 

time (June 9, 2017), https://www.usatoday.com/story/news/2017/06/09/xxxxxx/384827001/. 

88 John Fauber and Kristina Fiore, Milwaukee Journal Sentinel/MedPage Today, “A Look Back: Abandoned 

Painkiller Makes a Comeback” (June 9, 2017), https://www.medpagetoday.com/psychiatry/addictions/65916. 

89 Id.

90 John Fauber and Kristina Fiore, Milwaukee Journal Sentinel, Opana gets FDA approval despite history of abuse, 

limited effectiveness in trials (May 9, 2015), http://archive.jsonline.com/watchdog/watchdogreports/opana-gets-fdaapproval-despite-history-of-abuse-limited-effectiveness-in-trials-b99494132z1-303198321.html/. 

91 Id.

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143. Relying on an “enriched enrollment” trial, the FDA approved Opana, even though 

the FDA acknowledged that “one could argue that the results [of the clinical trials with “enriched 

enrollment”] may not be generalizable to the wider chronic pain population.”93

144. In June 2017, after twelve years on the market, the FDA expressed its “concern 

that the benefits of [Opana] may no longer outweigh the risks,” and asked Endo to remove 

Opana from the market.94 The FDA based its decision “on a review of all available 

postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER 

from nasal to injection following the product’s reformulation.”95

145. Janssen currently states that concerns about opioid addiction are “overestimated” 

and that “true addiction occurs only in a small percentage of patients.”96 Janssen also claimed 

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

management of chronic pain.”97

 

146. Upon information and belief, Actavis created sales training materials that 

contained misinformation about the risks and benefits of Kadian, particularly related to abuse 

and addiction. Upon information and belief, Actavis misrepresented that the risk of addiction 

was limited to chronic pain patients and/or patients already predisposed to abuse, addiction, 

and/or dysfunctional behavior. Upon information and belief, Actavis’ training materials 

specifically omitted information about the serious risks associated with high dose opioid therapy 

and/or long term opioid therapy. Upon information and belief, Actavis’ sales representatives 

 

92 Id.

93 Id.

94 U.S. Food & Drug Administration, Press Release, FDA requests removal of Opana ER for risks related to abuse

(June 8, 2017), https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm. 

95 Id.

96 Keith Candiotti, M.D., Use of Opioid Analgesics in Pain Management, Prescribe Responsibly, 

http://www.prescriberesponsibly.com/articles/opioid-pain-management (last modified Jul. 2, 2015). 

97 German Lopez, US officials are starting to treat opioid companies like Big Tobacco—and suing them, Vox (Aug. 

9, 2017), https://www.vox.com/policy-and-politics/2017/6/7/15724054/opioid-companies-epidemic-lawsuits. 

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then passed these misrepresentations on to physicians. 

147. In addition, the Manufacturers used third parties and the Front Groups to advance 

their false and misleading statements about the safety of opioids. Dr. John D. Giglio, Executive 

Director of the APF, stated that “opioids are safe and effective, and only in rare cases lead to 

addiction.”98 In a 2007 publication titled “Treatment Options: A Guide for People Living with 

Pain,” funded by Teva and Purdue, APF claimed: “Restricting access to the most effective 

medications for treating pain is not the solution to drug abuse or addiction.” APF also tried to 

normalize the dangers of opioids by listing opioids as one of several “[c]ommon drugs that can 

cause physical dependence,” including steroids, certain heart medications, and caffeine. 

148. The statements made by the Manufacturers and the KOLs constituted 

misrepresentations and were false and misleading. 

2. The Manufacturers and KOLs misrepresented that doctors should 

increase the dosage of opioids for patients that had symptoms of 

addiction. 

149. The Manufacturers and KOLs also developed the false concept of 

“pseudoaddiction” and even reformulated the meaning of the word “addiction” altogether to 

convince doctors that their patients did not actually suffer from opioid addiction. 

150. Dr. David Haddox – who later became a Senior Medical Director for Purdue – 

created the term “pseudoaddiction,” which he defined as “the iatrogenic syndrome of abnormal 

behavior developing as a direct consequence of inadequate pain management.”99 In other words, 

Dr. Haddox asserted that persons who presented with signs of addiction were not actually 

addicted to opioids, but, instead, merely suffered from improperly managed pain. Dr. Haddox 

 

98 Oxycontin: Balancing Risks and Benefits: Hearing of the S. Comm. on Health, Education, Labor and Pensions, 

107th Cong. 2 (Feb. 12, 2002) (testimony of John D. Giglio, M.A., J.D., Executive Director, American Pain 

Foundation), https://www.help.senate.gov/imo/media/doc/Giglio.pdf. 

99 David E. Weissman and J. David Haddox, Opioid pseudoaddiction--an iatrogenic syndrome, 36(3) Pain 363-66 

(Mar. 1989), https://www.ncbi.nlm.nih.gov/pubmed/2710565. 

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recommended that such patients be prescribed more opioids. 

151. The Manufacturers seized on Dr. Haddox’s statements and used them as part of 

their marketing campaigns. The Front Groups, including APF and the Federation of State 

Medical Boards (another national group funded by the Manufacturers), repeated Dr. Haddox’s 

claims in their literature.100 

152. APF also asserted that: “Physical dependence is normal; any patient who is taking 

an opioid on a regular basis for a few days should be assumed to be physically dependent. This 

does NOT mean you are addicted.”101 APF advised that drug seeking behavior did not mean a 

patent was addicted, but only that the patient needed a larger dose because the patient’s pain was 

more severe or the cause of the pain had changed: 

153. Purdue used Dr. Haddox’s statements to encourage doctors to treat patients 

 

100 John Fauber, Milwaukee Journal Sentinel, Painkiller boom fueled by networking, 

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

101 Treatment Options: A Guide for People Living with Pain, American Pain Foundation, 

https://assets.documentcloud.org/documents/277605/apf-treatmentoptions.pdf (last visited Sept. 7, 2017) (emphasis 

in original). 

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exhibiting signs of addiction by increasing their dosages of opioids, noting that “chronic pain has 

been historically undertreated.”102

 

154. Purdue represented to doctors and patients that “[b]ehaviors that suggest drug 

abuse exist on a continuum, and pain-relief seeking behavior can be mistaken for drug-seeking 

behavior.”103 Purdue’s statements were false and misleading. 

155. Endo used the National Initiative on Pain Control (“NIPC”) – a program it 

controlled and funded – to promote the concept of pseudoaddiction and advised doctors that 

aberrant drug seeking behavior was the result of untreated pain.104 In addition, a doctor affiliated 

with Janssen published a study claiming that “[m]any patients presenting to a doctor’s office 

asking for pain medications are accused of drug seeking. In reality, most of these patients may 

be undertreated for their pain syndrome.”105 

156. Janssen also promoted the concept of pseudoaddiction. A Janssen-sponsored 

website similarly stated that pseudoaddiction is different from true addiction “because such 

behaviors can be resolved with effective pain management.”106 One of Janssen’s current 

websites, PrescribeResponsibly.com, defines pseudoaddiction as “a syndrome that causes 

patients to seek additional medications due to inadequate pharmacotherapy being prescribed. 

 

102 Oxycontin: Its Use and Abuse: Hearing Before the H. Subcomm. on Oversight and Investigations of the Comm. 

On Energy and Commerce, 107th Cong. 1 (Aug. 28, 2001) (statement of Michael Friedman, Executive Vice 

President, Chief Operating Officer, Purdue Pharma, L.P.), https://www.gpo.gov/fdsys/pkg/CHRG107hhrg75754/html/CHRG-107hhrg75754.htm (Noting that “surveys still show that half of the patients in this 

country with chronic pain are undertreated.”) 

103 OxyContin Risk Evaluation and Mitigation Strategy, Purdue Pharma L.P., 

https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM

220990.pdf (last modified Nov. 2010). 

104 See, e.g., Wayback Machine, PainKnowledge.com (as of Feb. 10, 2004), 

https://web.archive.org/web/20120119124921/http://www.painknowledge.org/aboutpaink.aspx (“Unfortunately, less 

than optimal training of physicians in pain disorders has led to the underassessment and undertreatment of patients 

who are living with pain.”). 

105 Howard A. Heit, MD, FACP, FASAM, The truth about pain management: the difference between a pain patient 

and an addicted patient, 5 European Journal of Pain 27-29 (2001), http://www.med.uottawa.ca/courses/totalpain/

pdf/doc-34.pdf. 

106 Chris Morran, Ohio: Makers Of OxyContin, Percocet & Other Opioids Helped Fuel Drug Epidemic By 

Misleading Doctors, Patients, Consumerist (May 31, 2017), https://consumerist.com/2017/05/31/ohio-makers-ofoxycontin-percocet-other-opioids-helped-fuel-drug-epidemic-by-misleading-doctors-patients/. 

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Typically, when the pain is treated appropriately, the inappropriate behavior ceases.”107 

157. Upon information and belief, Actavis trained its sales representatives to 

emphasize the signs of “pseudoaddiction” to doctors. 

158. The Manufacturers’ use of the concept of pseudoaddiction was not, and is not, 

supported by evidence. Even Dr. Portenoy recognized that “[t]he term [pseudoaddiction] has 

taken on a bit of a life of its own . . . That’s a mistake.”108

3. The Manufacturers and KOLs misrepresented that addiction 

concerns could be minimized by risk-mitigation strategies, including 

tapering. 

159. The Manufacturers and KOLs minimized the concerns regarding addiction by 

falsely asserting that addiction could be avoided and resolved through screening tools that 

 

107 Howard A. Heit, MD, FACP, FASAM and Douglas L. Gourlay, MD, MSc, FRCPC, FASAM, What a Prescriber 

Should Know Before Writing the First Prescription, Prescribe Responsibly, http://www.prescriberesponsibly.com/

articles/before-prescribing-opioids#pseudoaddiction (last modified July 2, 2015). 

108 John Fauber, Milwaukee Journal Sentinel/MedPage Today, Chronic Pain Fuels Boom in Opioids (Feb. 19, 

2012), https://www.medpagetoday.com/neurology/painmanagement/31254. 

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allowed doctors to identify risks and safely prescribe opioids to patients. In addition, the 

Manufacturers and KOLs advised doctors that tapering opioid doses would allow patients to 

safely cease opioid treatment.109

160. Purdue advised doctors that patients should be screened to determine their 

potential to abuse or become addicted to opioids. Purdue represented that such screening would 

reduce incidences of addiction.110 

161. Purdue currently represents to the public that certain patients have higher risk of 

opioid addiction because they have a history of substance abuse or mental illness. Purdue’s 

representation downplays the risk of addiction for all patients and implies that it is the patients 

that are the cause of addiction and not opioids:111 

162. Purdue also claims that opioid dependence can be resolved easily by using a 

 

109 See, e.g., Joseph Rasor, PT, OMS IV, The Journal of the American Osteopathic Association, “Using Opioids for 

Patients With Moderate to Severe Pain,” September 2007, Vol. 107, ES4-ES10, 

http://jaoa.org/article.aspx?articleid=2093482 (CME publication, funded by Purdue, discussing a 12-week taper 

program); Bill H. McCarberg, MD, CME: Opioid Analgesia: Practical Treatment of the Patient With Chronic Pain 

(2003), https://www.medscape.org/viewarticle/469428 (CME presentation, funded by Endo, instructing doctors to 

“start withdrawing the patient from the medication – tapering the dosage....once you start patients on medications, 

getting them off those drugs is hard...it is much easier when you have done it that way.”). 

110 OxyContin Risk Evaluation and Mitigation Strategy, Purdue Pharma L.P., 

https://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM

220990.pdf (last modified Nov. 2010). 

111 OxyContin, https://www.oxycontin.com/index.html (last visited Sept. 7, 2017). 

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tapering schedule when stopping opioid treatment.112 Purdue instructed doctors to taper 

someone off of OxyContin to prevent problems associated with withdrawal in patients who were 

physically dependent on opioids.113 Purdue did not warn doctors or patients that tapering may 

be inadequate to safely end opioid treatment. 

163. Endo represented that assessment tools can assess risks for addiction and even 

“[t]he potential for these risks should not, however, prevent proper management of pain in any 

given patient.”114 Before taking down its website for Opana, Endo also instructed doctors and 

patients that “[w]hen discontinuing OPANA ER, gradually taper the dosage.”115 

164. Janssen likewise represents to doctors and the general public that opioid addiction 

“can usually be managed” and that written agreements between a doctor and patient that 

facilitate informed consent can reduce the risk of addiction and misuse of opioids.116 

165. Upon information and belief, Actavis misrepresented via its sales representatives 

that the physical symptoms of opioid withdrawal could be adequately addressed by tapering. 

166. The Manufacturers’ and KOLs’ representations were false. There are no reliable 

screening tests or questions to determine whether someone has the propensity to become 

addicted. Anyone can become addicted to opioids, even when using them as prescribed by a 

physician.117

 

112 OxyContin, https://www.oxycontin.com/index.html (last visited Sept. 7, 2017); OxyContin Full Prescribing 

Information, Purdue Pharma LP, http://app.purduepharma.com/xmlpublishing/pi.aspx?id=o (last visited Sept. 7, 

2017). 

113 Purdue Pharma, Dear Healthcare Professional (Oct. 4, 2010), http://webcache.googleusercontent.com/search?

q=cache:Yhi3TrVHeGIJ:www.purduepharma.com/pdfs/DearHCPLetter.pdf+&cd=1&hl=en&ct=clnk&gl=us (last 

visited Nov. 29, 2017). 

114 Opana ER, http://www.opana.com (last visited Sept. 7, 2017). 

115 Id.

116 Prescribe Responsibly, “What a Prescriber Should Know Before Writing the First Prescription” (last modified 

July 2, 2015), https://www.prescriberesponsibly.com/articles/before-prescribing-opioids. 

117 Walter Ling, et al., “Prescription opioid abuse, pain and addiction: Clinical issues and implications,” Drug 

Alcohol Rev. 2011 May ; 30(3): 300–305, 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4170948/pdf/nihms617787.pdf (“Pain may contribute to the 

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167. Each Manufacturer’s and KOL’s statements about tapering misrepresented that 

gradual tapering would be sufficient to alleviate any risk of withdrawal or addiction while taking 

opioids. 

4. The Manufacturers and the KOLs misrepresented that doctors and 

patients could increase opioid dosage indefinitely without added risk 

and failed to disclose the risks associated with higher dosages. 

168. The Manufacturers and the KOLs, directly or through Front Groups, made false 

and misleading statements regarding dosage that have contributed to the opioid epidemic. 

169. In 2012, APF claimed on its website that there was no “ceiling dose” for opioids 

for chronic pain.118 APF also made this claim in a guide sponsored by Purdue, which is still 

available online. 

170. A Purdue regional manager instructed that representatives should “convinc[e] the 

physician that there is no need” for prescribing OxyContin in shorter intervals than the 

recommended 12-hour interval and, instead, the solution is prescribing higher doses. The 

manager directed representatives to discuss with physicians that there is “no[] upward limit” for 

dosing and to ask “if there are any reservations in using a dose of 240mg-320mg of 

OxyContin.”119

 

171. Teva promoted Actiq for use in non-cancer patients to treat such conditions as 

migraines, sickle-cell pain crises, and other injuries.120 Teva also made statements promoting 

Actiq for use in patients who were not yet opioid-tolerant, and targeted such statements towards 

 

development of opioid abuse and addiction, which may emerge after a period of legitimate use of opioids as 

prescribed for analgesia.”). 

118 Noah Nesin, M.D., FAAFP, Responsible Opioid Prescribing, PCHC 

https://www.mainequalitycounts.org/image_upload/Keynote-%20Managing%20Chronic%20Pain%20and%20

Opioids_Nesin.pdf (last visited Sept. 7, 2017). 

119 Sales manager on 12-hour dosing, Los Angeles Times (May 5, 2016), http://documents.latimes.com/salesmanager-on12-hour-dosing-1996/. 

120 United States Department of Justice, “Pharmaceutical Company Cephalon To Pay $425 Million For Off-Label 

Drug Marketing” (Sept. 29, 2008), 

https://www.justice.gov/sites/default/files/civil/legacy/2014/01/09/Cephalon%20Press%20Release.pdf.

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physicians other than oncologists, including general practitioners.121 In so doing, Teva 

knowingly targeted patients for whom Actiq could have life-threatening results.122

172. The FDA warned Teva about its online marketing, finding that companysponsored links on Internet search engines such as Google misrepresented the efficacy of Fentora 

without communicating any risk information.123

173. Upon information and belief, Endo published a patient handout that assured 

patients that “[j]ust because you are tolerant and need more medication does not mean that you 

are addicted.”124 The website on which Endo made this misrepresentation, PainKnowledge.com, 

described itself as “a one-stop repository for print materials, educational resources, and physician 

tools across the broad spectrum of pain assessment, treatment, and management approaches,” but 

failed to disclose its association with Endo.125 Dr. Perry Fine was on the website’s “Steering 

Committee.”126 PainKnowledge.com is no longer an active website.127

174. In a publication titled “Understanding Your Pain: Taking Oral Opioid 

Analgesics,” Endo assures opioid users that concern about developing tolerance to the drugs’ 

pain-relieving effect is “not a problem,” and that “[t]he dose can be increased” and “[y]ou won’t 

‘run out’ of pain relief.”128

175. Janssen discussed the disadvantages of dosage limits for pain medicines in a 2009 

 

121 Id.

122 Id. 

123 Lynne Taylor, Pharma Times, “Big Pharma firms warned over Internet drug ads” (April 7, 2009), 

http://www.pharmatimes.com/news/big_pharma_firms_warned_over_internet_drug_ads_985134. 

124 See Wayback Machine, PainKnowledge.com PAIN Opioid Therapy Patient Handout, 

https://web.archive.org/web/20101007083722/http://painknowledge.org/patiented/pdf/B697_%20Patient%20Hando

ut_FINAL.pdf

125 See Wayback Machine, About PainKnowledge.com, 

https://web.archive.org/web/20120119124921/http://www.painknowledge.org/aboutpaink.aspx. 

126 See Wayback Machine, Steering Committee, 

https://web.archive.org/web/20120119103221/http://www.painknowledge.org/facultypk/faculty.aspx. 

127 http://painknowledge.com/. 

128 Understanding Your Pain: Taking Oral Opioid Analgesics, Endo Pharmaceuticals (2004), 

http://www.thblack.com/links/RSD/Understand_Pain_Opioid_Analgesics.pdf. 

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patient education guide, but failed to address the risks of dosage increases.129

176. Upon information and belief, Actavis’ training materials specifically omitted 

information about the serious risks associated with high dose opioid therapy and/or long term 

opioid therapy. Upon information and belief, Actavis’ paid physician speakers in turn made 

misrepresentations about addiction risk profiles to other prescribing physicians and omitted 

information about the serious risks associated with high dose opioid therapy and/or long term 

opioid therapy. 

177. The FDA sent Actavis a “Warning Letter” regarding Actavis’ promotion of 

Kadian.130 The FDA identified two documents, a “Co-Pay Assistance Program” brochure for 

Kadian and a “PK to PK Comparison Detailer for Kadian”, and determined they “[were] false or 

misleading because they omit and minimize the serious risks associated with the drug, broaden 

and fail to present the limitations to the approved indication of the drug, and present 

unsubstantiated superiority and effectiveness claims.”131 The FDA warned Actavis against 

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

misleadingly suggest[] that Kadian is safer than has been demonstrated,” because such 

promotional materials “fail to reveal warnings regarding potentially fatal abuse of opioids, use by 

individuals other than the patient for whom the drug was prescribed.”132

 

129 See Vasudevan, Sridhar V. Multidisciplinary Management of Chronic Pain: a Practical Guide for Clinicians, 

Springer, 2015, p. 77, 

https://books.google.com/books?id=AFh1CgAAQBAJ&pg=PA77&lpg=PA77&dq=2009+%22Finding+Relief:+Pai

n+Management+for+Older+Adults%22&source=bl&ots=DqFa-RL1OE&sig=bsMgaPXrX1ZVdC6sK4GdhtBjBQ&hl=en&sa=X&ved=0ahUKEwjatdyAivPXAhVs34MKHXLTBLoQ6AEIOjAD#v=onepage&q=2009%20%22Fi

nding%20Relief%3A%20Pain%20Management%20for%20Older%20Adults%22&f=false. 

130 Warning Letter from Thomas Abrams, Director Division of Drug Marketing, Advertising and Communications, 

U.S. Food and Drug Administration, to Doug Boothe, Chief Executive Officer, Actavis US (Feb. 18, 2010), 

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

131 Id.

132 Id. 

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5. The Manufacturers misrepresented that reformulated opioids can 

curb addiction and abuse. 

178. The Manufacturers have made, and continue to make, misrepresentations about 

the purported abuse-deterrent properties of reformulated pills. 

179. Purdue misrepresented that “abuse resistant products can reduce the incidence of 

abuse.”133 Its current website claims abuse-deterrent properties “can make a difference.”134

 

180. On August 17, 2015, Purdue announced the launch of a new website, “Team 

Against Opioid Abuse,” which it said was “designed to help healthcare professionals and 

laypeople alike learn about different abuse-deterrent technologies and how they can help in the 

reduction of misuse and abuse of opioids.”135 This website appears to no longer be active. 

181. A study, whose authors included doctors formerly working for Purdue, stated that 

“[a]buse-deterrent formulations of opioid analgesics can reduce abuse.”136 A 2016 study, which 

includes at least one doctor affiliated with Purdue as an author, claims that abuse decreased by as 

much as 99% in some situations after abuse-deterrent formulations were introduced.137 

182. Endo changed its formula for Opana ER to one with purported abuse-deterrent 

properties. Although the FDA determined the data did not back up Endos’ claims that the new 

formula could reduce abuse, Endo advertised its reformulated pills as “crush resistant” and 

directed its sales representatives to state the same. Endo agreed with the Attorney General of the 

 

133 Art Van Zee, M.D., The OxyContin Abuse Problem: Spotlight on Purdue Pharma’s Marketing (Aug. 22, 2001), 

https://www.fda.gov/ohrms/dockets/dockets/01n0256/c000297-A.pdf. 

134 Opioids with Abuse-Deterrent Properties, Purdue, http://www.purduepharma.com/healthcareprofessionals/responsible-use-of-opioids/opioids-with-abuse-deterrent-properties/ (last visited Sept. 7, 2017). 

135 Purdue Pharma L.P. Launches TeamAgainstOpioidAbuse.com, Purdue (Aug. 17, 2015), 

http://www.purduepharma.com/news-media/2015/08/purdue-pharma-l-p-launches-teamagainstopioidabuse-com/. 

136 Paul M. Coplan, Hrishikesh Kale, Lauren Sandstrom, Craig Landau, and Howard D. Chilcoat, Changes in 

oxycodone and heroin exposures in the National Poison Data System after introduction of extended-release 

oxycodone with abuse-deterrent characteristics, 22 (12) Pharmacoepidemiol Drug Saf. 1274-82 (Sept. 30, 2013), 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4283730/. 

137 Paul M. Coplan, Howard D. Chilcoat, Stephen Butler, Edward M. Sellers, Aditi Kadakia, Venkatesh 

Harikrishnan, J. David Haddox, and Richard C. Dart, The effect of an abuse-deterrent opioid formulation

(OxyContin) on opioid abuse-related outcomes in the postmarketing setting, 100 Clin. Pharmacol. Ther., 275-86 

(June 22, 2016), http://onlinelibrary.wiley.com/doi/10.1002/cpt.390/full. 

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State of New York that it would discontinue making such statements.138

6. The Manufacturers misrepresented that opioid use improved 

patients’ function and quality of life. 

183. The Manufacturers misrepresented that there was a significant upside to long-term 

opioid use, including restoration or improvement of function and quality of life. 

184. Purdue sponsored the development and distribution of a 2011 APF guide which 

claimed that “multiple clinical studies have shown that opioids are effective in improving daily 

function, psychological health, and health-related quality of life for chronic pain patients.” This 

guide is still available today. 

185. Upon information and belief, Purdue and Endo paid for, at least in part, and 

disseminated Dr. Webster’s book, Avoiding Opioid Abuse While Managing Pain, that claims 

opioids improved patients’ function. The book remains for sale online today. 

186. Endo’s advertisements suggested Opana ER allowed patients to engage in 

construction. Its Opana ER ads depicted Opana ER users as healthy and unimpaired. 

187. Endo’s NIPC website claimed that by taking 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.” 

188. Endo sponsored CMEs through NIPC that claimed chronic opioid therapy has 

been “shown to reduce pain and improve depressive symptoms and cognitive functioning.”

189. Endo helped publish guidelines stating that “Opioid Medications are a powerful 

and often highly effective tool in treating pain,” and “they can help restore comfort, function, and 

 

138 Press Release, Attorney General Eric T. Schneiderman, A.G. Schneiderman Announces Settlement with Endo 

Health Solutions Inc. & Endo Pharmaceuticals Inc. Over Marketing of Prescription Opioid Drugs (Mar. 3, 2016), 

https://ag.ny.gov/press-release/ag-schneiderman-announces-settlement-endo-health-solutions-inc-endopharmaceuticals. 

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quality of life.”139

190. Teva and Purdue funded an APF publication entitled “Treatment Options: A 

Guide for People Living with Pain,” which represented to pain patients that, when used properly, 

opioids “can be life savers and give all of us a quality of life we deserve.”140 This publication is 

still available online.141

191. Janssen assisted in publishing patient guides in which it stated that “opioids may 

make it easier for people to live normally,” including sleeping through the night, returning to 

work, recreation, sex, walking and climbing stairs.

192. Upon information and belief, Janssen assisted with a website which claimed 

opioids allowed a patient to “continue to function.”

193. Upon information and belief, Actavis trained its sales representatives to 

misrepresent that opioids would improve patients’ function. 

194. The Manufacturers’ sales representatives communicated, and continue to 

communicate, the message that opioids will improve patients’ function, without appropriate 

disclaimers. 

G. The Manufacturers And KOLs Made False And Misleading Statements To 

Persons, Including Physicians, In Columbus. 

195. Upon information and belief, the Manufacturers and KOLs made each of the 

specific misrepresentations set forth Section II.F, above, to persons and physicians in Columbus 

and the surrounding areas. As a result, persons in Columbus and the surrounding areas were 

prescribed significant amounts of opioids.

196. Upon information and belief, Manufacturers sent sales representatives to 

 

139 Informed Consent for Using Opioids to Treat Pain, Painknowledge.org (2007), 

https://www.mainequalitycounts.org/image_upload/Opioid%20Informed%20Consent%20Formatted_1_23_2008.pdf 

140 American Pain Foundation, “Treatment Options: A Guide for People Living with Pain,” 

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

141 Id.

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Columbus and its surrounding areas to tout the asserted benefits and low risks of opioid use to 

treat chronic pain. The Manufacturers and KOLS knew or should have known that doctors in 

Columbus and the surrounding areas would rely on the Manufacturers’ and KOLs’ statements 

and prescribe opioids to treat chronic pain. 

197. In addition, the Manufacturers and KOLs have made, and continue to make, 

payments to doctors in Columbus for marketing these drugs. For example, according to publicly 

available records, Purdue paid at least one Columbus doctor over $30,000 in consulting and 

promotional speaking fees between August 2013 and December 2015 relating to Butrans, 

Hysingla ER, and OxyContin.142

III. THE MANUFACTURERS’ AND KOLS’ STATEMENTS ABOUT THE RISKS 

AND BENEFITS OF OPIOIDS WERE, AND ARE, FALSE. 

198. The CDC issued its CDC Guideline for Prescribing Opioids for Chronic Pain on 

March 15, 2016 (the “2016 CDC Guideline” or “Guideline”).143 The recommendations in the 

2016 CDC Guideline were further made “on the basis of a systematic review of the best available 

evidence.”144 The findings in the 2016 CDC Guideline confirmed scientific evidence regarding 

the questionable efficacy of opioid use.

199. The 2016 CDC Guideline confirmed that “[e]xtensive evidence shows the 

possible harms of opioids (including opioid use disorder, overdose, and motor vehicle injury)” 

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

disorder.”145 The Guideline further confirms the existence of opioid withdrawal. 

200. The 2016 CDC Guideline states that there is “[n]o evidence” to show “a long-

 

142 ProPublica, Dollars for Docs, Gladstone C. McDowell, 

https://projects.propublica.org/docdollars/doctors/pid/242959. 

143 Deborah Dowell, Tamara M. Haegerich, and Roger Chou, Centers for Disease Control and Prevention, CDC 

Guideline for Prescribing Opioids for Chronic Pain – United States, 2016 (March 15, 2016), 

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

144 Id.

145 Id.

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term benefit of opioids in pain and function versus no opioids for chronic pain . . .” The 

Guideline also states that “continuing opioid therapy for 3 months substantially increases the risk 

of opioid use disorder.”146 The Guideline further indicates that “[p]atients who do not 

experience clinically meaningful pain relief early in treatment . . . are unlikely to experience pain 

relief with longer-term use,” and that physicians should “reassess[] pain and function within 1 

month” to decide whether to “minimize risks of long-term opioid use by discontinuing 

opioids.”147 

201. The 2016 CDC Guideline finds that “[a]lthough opioids can reduce pain during 

short-term use, the clinical evidence review found insufficient evidence to determine whether 

pain relief is sustained and whether function or quality of life improves with long-term opioid 

therapy.”148 The CDC further finds that “evidence is limited or insufficient for improved pain or 

function with long-term use of opioids for several chronic pain conditions for which opioids are 

commonly prescribed, such as low back pain, headache, and fibromyalgia.”149 

202. The 2016 CDC Guideline finds that “[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.”150 The CDC also finds that there is an “increased risk[] for opioid use 

disorder, respiratory depression, and death at higher dosages.”151 The CDC advised doctors to 

“avoid increasing dosage” above 90 morphine milligram equivalents per day.152 

203. The 2016 CDC Guideline indicates that available risk screening tools “show 

insufficient accuracy for classification of patients as at low or high risk for [opioid] abuse or 

 

146 Id. 

147 Id. 

148 Id. (emphasis added). 

149 Id. 

150 Id. 

151 Id. 

152 Id. 

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misuse” and counsels that doctors “should not overestimate the ability of these tools to rule out 

risks from long-term opioid therapy.”153

204. The 2016 CDC Guideline additionally states that “[n]o studies” support the notion 

that “abuse-deterrent technologies [are] a risk mitigation strategy for deterring or preventing 

abuse.” The CDC found such technologies “do not prevent opioid abuse through oral intake, the 

most common route of opioid abuse, and can still be abused by nonoral routes.”154

 

IV. BY FAILING TO REPORT SUSPICIOUS SHIPMENTS, THE 

MANUFACTURERS AND DISTRIBUTORS CAUSED THE OPIOID EPIDEMIC. 

A. The Manufacturers And Distributors Have A Legal Duty to Prevent 

“Suspicious Orders” of Opioids. 

205. In 1970, Congress devised a “closed” chain of distribution specifically designed 

to prevent legally produced controlled substances from being diverted into the illegal market. 

Gonzales v. Raich, 525 U.S. 1, 12-14 (2005); 21 U.S.C. §§ 801(2), 821-824, 827, 880; H.R. Rep. 

No. 91-1444, 1970 U.S.C.C.A.N. 4566, 4572 (Sept. 10, 1970). The term “controlled substance” 

means “a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or 

V” of the Controlled Substances Act, as discussed above. 21 U.S.C. § 801(6). 

206. Federal law mandates that Manufacturers and the Distributors “shall inform the 

Field Division Office of the Administration in his area of suspicious orders [of controlled 

substances] when discovered by the registrant [Manufacturers and Distributors]. 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). Thus, under this closed system, the 

Manufacturers and Distributors have the duty to monitor, identify, halt, and report “suspicious 

orders” of controlled substances. Masters Pharm., Inc. v. Drug Enf’t Admin., 861 F.3d 206 

 

153 Id. 

154 Id. 

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(D.C. Cir. 2017). 

207. “Suspicious orders” are not determined by any one test. An order that deviates 

substantially from a normal pattern – no matter the size of the order – must be reported as 

suspicious. Deviation from normal patterns relates to patterns of ordering from particular 

customers, from the entirety of the wholesale distributor’s customer base or the relevant segment 

of the wholesale distributor industry. Deviation from a pattern is not the sole factor to consider 

in determining whether an order is suspicious. The size of an order is enough to trigger the 

wholesale distributor’s responsibility to report the order as suspicious. Masters Pharm., Inc., at 

215 (“DEA regulations expressly provide that deviations in size, frequency, or pattern are the 

sort of indicia that give rise to a suspicion and, unless the suspicion is dispelled, the obligation to 

report.”) (emphasis added). 

208. Federal law requires that Manufacturers and Distributors maintain “effective 

control against diversion of particular controlled substances into other than legitimate medical, 

scientific, and industrial channels.” See 21 U.S.C. §§ 823(a) (1), 823(b)(1). Each Manufacturer 

and Distributor was required to register with the DEA, pursuant to the federal Controlled 

Substance Act. See 21 U.S.C. § 823; 21 C.F.R. § 1301.11(a) (“Every person who manufactures, 

distributes, imports, or exports any controlled substances...shall obtain a registration”).

209. Ohio incorporates the above described federal requirements through statutes and 

regulations promulgated by the Ohio Board of Pharmacy, which mandate that “[w]holesale drug 

distributors shall operate in compliance with applicable federal, state, and local laws and 

regulations.” O.A.C. § 4729-9-16(L); see also § 4729-9-28(I); O.R.C. § 4729.26 (“The state 

board of pharmacy may adopt rules in accordance with Chapter 119 of the Revised Code, not 

inconsistent with the law, as may be necessary to carry out the purposes of and to enforce the 

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provisions of this chapter.”). Ohio requires the Manufacturers and Distributors to “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.” O.A.C. § 4729-9-16(H). 

210. Ohio requires the Manufacturers and Distributors to “first obtain a license as a 

wholesaler of controlled substances from the state board of pharmacy.” O.R.C. § 3719.021. 

Each Manufacturer and Distributor is licensed by the Ohio Board of Pharmacy and is a 

“registrant” as a wholesale distributor in the chain of distribution of Schedule II controlled 

substances and assumes a duty to comply with all requirements imposed by the Board of 

Pharmacy. 

211. Ohio independently requires the Manufacturers and Distributors to report 

“suspicious orders” 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. 

O.A.C. § 4729-9-16(H)(1)(e); see also 4729-9-12(G); 4729-9-28(E). 

212. In addition to federal and Ohio law, industry compliance guidelines from the 

Healthcare Distribution Management Association (now known as the Healthcare Distribution 

Alliance) further indicate that the Manufacturers and Distributors, as the entities “[a]t the center 

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of a sophisticated supply chain,” must monitor, detect, report and refuse to fill suspicious orders. 

The Healthcare Distribution Management Association advised that distributors should perform 

due diligence and create monitoring systems to ensure that they do not ship suspicious orders 

referred to as “orders of interest.”155

213. In sum, the Manufacturers and Distributors are “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.”156

214. The Manufacturers and the Distributors are a major line of defense to prevent the 

excessive sales of legal pharmaceutical controlled substances. Therefore, federal and Ohio law 

mandate that the Manufacturers and the Distributors maintain effective controls to prevent 

oversaturation of opioids. Should a Manufacturer or Distributor deviate from these checks and 

balances, the closed system collapses.157

B. The Manufacturers And The Distributors Intentionally And/Or Recklessly 

Breached Their Duties. 

215. The DEA repeatedly has taken administrative action to force compliance. The 

United States Department of Justice, Office of the Inspector General, Evaluation and Inspections 

 

155 “Prescribing Drug Diversion: Combating the Scourge” (March 1, 2012), 

https://archive.org/stream/gov.gpo.fdsys.CHRG-112hhrg80861/CHRG-112hhrg80861_djvu.txt. 

156See U.S. Department of Justice, Drug Enforcement Administration, letter to Cardinal Health dated September 27, 

2006 (“This letter is being sent to every commercial entity in the United States registered with the Drug 

Enforcement Agency (DEA) to distribute 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.”) (a copy of letter is filed at Cardinal Health, Inc. v. Holder, No. 1:12-cv-00185-RBW, Doc. 14-51 

(filed therein in D.D.C. on February 20, 2012)).

157See Declaration of Joseph Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug 

Enforcement Agency, United States Department of Justice, ¶ 10, Cardinal Health, Inc. v. Holder, No. 1:12-cv00185-RBW, Doc. 14-2 (filed in D.D.C. on February 20, 2012). 

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Division, reported that the DEA issued final decisions in 178 registrant actions between 2008 

and 2012. 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.158 

216. Defendants Cardinal Health and McKesson were fined millions of dollars and 

issued Orders to Show Cause by the DEA for failing to maintain effective controls to prevent the 

diversion of controlled substances for illicit purposes. In addition, Defendant 

AmerisourceBergen was the subject of a criminal investigation concerning “its oversight of 

painkiller sales” in 2012. AmerisourceBergen settled with the state of West Virginia on January 

10, 2017 for $16 million.159

 

217. In response to the fines, lawsuits and Orders to Show Cause, the Distributors 

purported to create greater controls to identify and prevent the shipment of suspicious orders of 

Opioids.

218. For example, Cardinal Health claims 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.”160 Similarly, 

McKesson claims that it has a “best-in-class controlled substance monitoring program to help 

identify suspicious orders,” and is “deeply passionate about curbing the opioid epidemic in our 

 

158The Drug Enforcement Administration’s Adjudication of Registrant Actions, United States Department of Justice, 

Office of the Inspector General, Evaluation and Inspections Divisions, I-2014-003 (May 2014), available at 

https://oig.justice.gov/reports/2014/e1403.pdf. 

159 Kyla Asbury, West Virginia Record, “Cardinal Health, AmerisourceBergen settle pain pill lawsuit for $36 

million” (Jan. 10, 2017), https://wvrecord.com/stories/511071502-cardinal-health-amerisourcebergen-settle-painpill-lawsuit-for-36-million. 

160Lenny Bernstein et al., How drugs intended for patients ended up in the hands of illegal users: ‘No one was doing 

their job’, The Washington Post( October 22, 2016), available at https://www.washingtonpost.com/investigations/

how-drugs-intended-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?utm_term=.744e85035bdc.

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country.”161 AmerisourceBergen also claims to use “a sophisticated set of algorithms and data 

analytics” and recently announced its continued investment in a “best-in-class Diversion Control 

Team, comprised of internal and external experts including former law enforcement 

professionals, diversion investigators, pharmacists, and pharmacy technicians that maintains an 

ongoing order monitoring program, conducts customer site visits, participates in surveillance 

activities, reviews customer policies and identifies and reports suspicious orders.”162

219. Despite the Distributors’ claims about their monitoring and detection capabilities, 

opioids have flooded Columbus in such numbers that either the controls are illusory and the 

Distributors intentionally ignored suspicious orders, or, the Distributors negligently shipped 

suspicious orders.

220. Upon information and belief, the volume of opioids distributed into Columbus 

and the surrounding area exceeded the medical need of the community and the Distributors 

should have known they were filling suspicious orders. 

221. Based on this volume, upon information and belief, the Manufacturers and 

Distributors unlawfully filled and failed to report suspicious orders of opioids that were delivered 

and/or diverted into Columbus and its surrounding areas. 

222. Each Manufacturer and Distributor breached its duties to monitor, detect, 

investigate, refuse to fill, and report suspicious orders of prescription opioids headed to 

Columbus and its surrounding areas. 

223. The Manufacturers’ and the Distributors’ continued and repeated shipments of 

 

161Scott Higham et al., Drug industry hired dozens of officials from the DEA as the agency tried to curb opioid 

abuse, The Washington Post (December 22, 2016), available at 

https://www.washingtonpost.com/investigations/key-officials-switch-sides-from-dea-to-pharmaceuticalindustry/2016/12/22/55d2e938-c07b-11e6-b527-949c5893595e_story.html?utm_term=.68a58d17478e.

162 “AmerisourceBergen Announces Operating Commitments to Address Opioid Diversion and Abuse” (Dec. 7, 

2017), https://www.businesswire.com/news/home/20171207005566/en/. 

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suspicious orders was wanton, willful, or reckless conduct or criminal indifference to civil 

obligations affecting the rights of others and justifies an award of punitive damages.

C. The Manufacturers And Distributors Spent Millions Of Dollars Lobbying 

Congress To Weaken DEA Enforcement Efforts Against Them. 

224. While the Manufacturers and Defendants publicly stated that they had increased 

their efforts to detect, monitor and prevent suspicious orders, the Manufacturers and Distributors 

also developed another strategy to prevent fines and investigation by the DEA – spend millions 

of dollars lobbying Congress to weaken the DEA’s ability to enforce federal regulations against 

the Manufacturers and Defendants. 

225. Upon information and belief, the Manufacturers and the Distributors have spent 

the past decade lobbying Congress to decrease the number of immediate suspension orders 

issued by the DEA.163 An immediate suspension order is a DEA tool used to freeze a distributor 

from distributing drugs. 

226. Overall, the drug industry, including the Manufacturers and the Distributors, spent 

$102 million lobbying Congress on the Effective Drug Enforcement Act and other legislation 

between 2014 and 2016.164

227. The Manufacturers’ and the Distributors’ lobbying efforts to minimize immediate 

suspension orders has been successful: the DEA issued 65 such orders in 2011, and that number 

 

163 Scott Higham and Lenny Bernstein, The Washington Post, The Drug Industry’s Triumph Over The DEA (Oct. 15, 

2017), available at: https://www.washingtonpost.com/graphics/2017/investigations/dea-drug-industry-congress/

?utm_term=.37b4a0d6ae33; Lenny Bernstein and Scott Higham, The Washington Post, Investigation: The DEA 

slowed enforcement while the opioid epidemic grew out of control (October 22, 2016), https://www.washingtonpost.

com/investigations/the-dea-slowed-enforcement-while-the-opioid-epidemic-grew-out-of-control/2016/10/22/

aea2bf8e-7f71-11e6-8d13-d7c704ef9fd9_story.html?utm_term=.7ba890887d7b; Lenny Bernstein and Scott 

Higham, The Washington Post, Investigation: U.S. senator calls for investigation of DEA enforcement slowdown 

amid opioid crisis (March 6, 2017), https://www.washingtonpost.com/investigations/the-dea-slowed-enforcementwhile-the-opioid-epidemic-grew-out-of-control/2016/10/22/aea2bf8e-7f71-11e6-8d13-d7c704ef9fd9_story.html

?utm_term=.83d382cede93; Eric Eyre, Charleston Gazette, DEA agent: ‘We had no leadership’ in WV amid flood of 

pain pills (February 18, 2017), 

http://www.wvgazettemail.com/news/20170218/dea-agent-we-had-no-leadership-in-wv-amid-flood-of-pain-pills-.

164Id. 

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dropped to only 6 throughout the first ten months of 2017.165

228. Not a single immediate suspension order has targeted a distributor or 

manufacturer of opioids since late 2015. 

229. The Manufacturers’ and the Distributors’ lobbying efforts led to, among other 

things, the Ensuring Patient Access and Effective Drug Enforcement Act (the “Effective Drug 

Enforcement Act”), PL 114-145, April 19, 2016, 130 Stat. 354, passed by Congress in 2016. 

230. Despite the DEA’s resistance to the Effective Drug Enforcement Act, Congress 

passed the bill unanimously.166 One DEA official is quoted as noting that Congress “would have 

passed [the bill] with us or without us . . . Our point was that this law was completely 

unnecessary.”167

231. According to DEA Chief Administrative Law Judge John J. Mulrooney II, the bill 

does not live up to its name. In a draft 115-page article pending publication by the Marquette 

Law Review, ALJ Mulrooney wrote that, “[a]t a time when, by all accounts, opioid abuse, 

 

165Id. 

166Id.

167Id. 

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addiction and deaths were increasing markedly ... [the new law] imposed a dramatic diminution 

of the [DEA’s] authority.”168 ALJ Mulrooney noted it was now “all but logically impossible” 

for the DEA to suspend a drug company’s operations for failing to comply with federal law.169 

ALJ Mulrooney further stated: “[i]f it had been the intent of Congress to completely eliminate 

the DEA’s ability to ever impose an immediate suspension on distributors or manufacturers, it 

would be difficult to conceive of a more effective vehicle for achieving that goal.”170

V. THE MANUFACTURERS’, DISTRIBUTORS’ AND KOLS’ ACTIONS CAUSED 

AN ILLICIT OPIOID EPIDEMIC IN COLUMBUS. 

232. As a direct result of opioid abuse, individuals who have become addicted to 

opioids – but cannot afford their increased costs or are unable to secure a prescription – have 

turned to cheaper, more potent, and dangerous alternatives, including heroin and fentanyl, 

fueling a related epidemic directly attributable to prescription opioid abuse. 

233. Columbus is the largest city in the state of Ohio. It also is the largest city in the 

five-state region of Indiana, Michigan, Ohio, Kentucky, and West Virginia, and the fifth-largest 

city in the United States east of the Mississippi River.171

234. Columbus is located at the center of the most densely populated area of the United 

States: approximately 45 percent of the United States population lives within a ten hour drive of 

Columbus, more than any other city in the country.172

 

168 John J. Mulrooney II & Katherine E. Legel, Current Navigation Points in Drug Diversion Law: Hidden Rocks in 

Shallow, Murky, Drug-Infested Waters, 101 MARQ. L. REV. (forthcoming Feb. 2018). 

169 Scott Higham and Lenny Bernstein, The Washington Post, The Drug Industry’s Triumph Over The DEA (Oct. 15, 

2017), available at: https://www.washingtonpost.com/graphics/2017/investigations/dea-drug-industrycongress/?utm_term=.37b4a0d6ae33. 

170Id. 

171 United States Census Bureau, “The 15 Most Populous Cities: July 1, 2016” (July 1, 2016), 

https://www.census.gov/content/dam/Census/newsroom/releases/2017/cb17-81-table3-most-populous.pdf. 

172 Columbus 2020, “The Region with Reach,” http://columbusregion.com/doing-business/transportationinfrastructure/ (accessed on October 18, 2017). 

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235. By the early 2000s, Columbus had become a major crossroad in America’s opioid 

epidemic, as the Manufacturers’, the Distributors’ and the KOLs’ efforts to increase the number 

of opioid prescriptions, and failures to properly monitor shipments, intersected with Columbus’ 

size, location and distribution channels.173

236. At the same time as the Manufacturers, Distributors and KOLs were marketing 

and distributing opioids throughout Columbus, illicit drug dealers in Columbus identified a 

significant opportunity, and began offering persons addicted to prescription opioids black tar 

heroin – a less expensive product with the same (or even stronger) narcotic effect – in an attempt 

to recruit more customers.

237. Black tar heroin is a semi-processed form of heroin – heroin acetate – that 

primarily came to Columbus from the Pacific coast of Mexico. It can be injected or smoked, and 

it offers the user an inexpensive, potent opioid effect similar to that derived from the 

Manufacturers’ opioids. 

238. Columbus became the center of the black tar heroin drug market east of the 

 

173 See Quinones, Sam. Dreamland: the True Tale of America’s Opiate Epidemic. Dreamland: the True Tale of 

America's Opiate Epidemic, Bloomsbury Press, 2016, Chapter 12 (“Collision: Ground Zero”). 

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Mississippi River and was transformed into a major black tar heroin trafficking hub for 

supplying other U.S. geographical regions, including the Northeast, the Great Lakes, the 

Midwest, and Appalachia.

239. The rise of black tar heroin in Columbus was caused by the oversaturation of 

prescription opioids in Columbus.

240. The Manufacturers, Distributors and KOLs knew, or should have known, about 

the sequence of addiction that leads a pain patient to heroin: as a pain patient takes prescription 

opioids, their body develops a tolerance such that the dosage regularly needs to be increased; as 

dosages increase, opioids become more expensive; because opioids are often prescribed for daily 

use, patients taking prescription opioids quickly spend hundreds, and then thousands, of dollars 

simply managing their pain.174 Alternatively, patients may no longer be able to obtain 

prescriptions for the opioids to which they have become addicted. The Manufacturers, 

Distributors and KOLs knew or should have known that, because heroin offers a pain patient 

similar effect to that offered by opioids, and heroin costs far less, a high percentage of patients 

taking prescription opioids were vulnerable to pivoting their opioid addiction into a heroin 

addiction. 

241. One study revealed that 65% of heroin abusers in Ohio between 18 and 30 entered 

into heroin use from prescription opioids. While a majority of heroin abusers are former opioid 

abusers, the inverse is not true: according to a national survey, less than 4% of prescription pain 

medicine abusers had started by using heroin within five years.175 The NEJM published an 

 

174 Nicole Makris, Healthline, “Prescription Drugs Are Leading to Heroin Addictions” (Feb. 26, 2016), 

https://www.healthline.com/health-news/prescription-drugs-lead-to-addiction#1 (Quoting a family care physician 

who has observed that “[a] lot of people get addicted to the [opioid] pills and then progress to heroin because they 

can’t afford the [opioid] pills.”). 

175 National Institute on Drug Abuse, “Heroin” (Revised July 2017), https://www.drugabuse.gov/publications/

drugfacts/heroin#ref, citing Muhuri PK, Gfroerer JC, Davies MC., Associations of Nonmedical Pain Reliever Use 

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article examining the relationship between opioids and heroin use. The article concluded that 

“75% of [heroin] users initiated opioid use with prescription opioids.”176 These studies draw a 

direct line between the Manufacturers’, Distributors’ and KOLs’ conduct and the heroin 

epidemic in the United States, including in Columbus. 

242. As opioids have become less available, their price has risen; the inverse is true for 

heroin.177 And, as deaths related to prescription opioid medications are starting to fall, deaths 

related to heroin overdoses are rising.178

243. Consumers also substituted from prescription opioids to synthetic opioids such as 

fentanyl.179 Fentanyl is a synthetic opioid that is 50-100 times more potent than morphine, and 

25-50 times more potent than heroin.180 Because of its higher potency, it takes much less

fentanyl for a user to experience the opioid effect – making it far more likely that a user will 

overdose.181 Fentanyl is so dangerous that China recently banned it.182

 

244. The United States government does not track death rates for every drug. The 

National Center for Health Statistics (“NCHS”) at the CDC does collect information on many of 

the more commonly used drugs. The information collected shows a 5.9-fold increase in the total 

number of deaths from heroin and non-methadone synthetics (including illicit synthetic opioids 

 

and Initiation of Heroin Use in the United States. Rockville, MD: Substance Abuse and Mental Health Services 

Administration; 2013.

176 Wilson M. Compton, M.D., M.P.E., Christopher M. Jones, Pharm. D., M.P.H., and Grant T. Baldwin, Ph.D., 

M.P.H., 374 N Engl J Med 154-63 (Jan. 14, 2106), http://www.nejm.org/doi/full/10.1056/NEJMra1508490#ref41. 

177 See, e.g., Eugene Richards, The New Yorkers, The Addicts Next Door (June 5, 2017), 

https://www.newyorker.com/magazine/2017/06/05/the-addicts-next-door (“In West Virginia, many addicts told me, 

an oxycodone pill now sells for about eighty dollars; a dose of heroin can be bought for about ten.”).

178 Josh Katz, The New York Times, Short Answers to Hard Questions About The Opioid Crisis (Aug. 10, 2017), 

https://www.nytimes.com/interactive/2017/08/03/upshot/opioid-drug-overdose-epidemic.html#question-3. 

179 Abby Albert et al., National Board of Economic Research, Supply-Side Drug Policy in the Presence of 

Substitutes: Evidence from the Introduction of Abuse-Deterrent Opioids (January 2017), 

http://www.nber.org/papers/w23031. 

180 Alice G. Walton, Forbes, Why Fentanyl Is So Much More Deadly Than Heroin (April 9, 2016), https://www.

forbes.com/sites/alicegwalton/2016/04/09/why-fentanyl-is-so-much-more-deadly-than-heroin/#670fcc3a7f6a. 

181 Id.

182 Sara Ganim, CNN, China’s fentanyl ban a ‘game-changer’ for opioid epidemic, DEA officials say (Feb. 16, 

2017), http://www.cnn.com/2017/02/16/health/fentanyl-china-ban-opioids/index.html. 

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such as fentanyl) from 2002 to 2015, as well as a 6.2-fold increase in the total number of deaths 

from heroin since 2002 to 2015.183

245. The dramatic rise of this epidemic is illustrated by the fact that between 2005 and 

2009, Mexican heroin production increased by more than 600%. And between 2010 and 2014, 

 

183 National Institute on Drug Abuse, “Overdose Death Rates,” Revised September 2017, 

https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates. 

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the amount of heroin seized at the U.S.-Mexico border more than doubled. Overall, global 

poppy cultivation has hit its highest level since the 1930s.184

246. The average life span of someone addicted to heroin is approximately fifteen (15) 

years less than the average person.185

VI. COLUMBUS HAS BEEN, AND WILL CONTINUE TO BE, HARMED AND 

DAMAGED BY THE OPIOID EPIDEMIC CREATED BY DEFENDANTS. 

247. As a result of the Manufacturers’, Distributors’ and KOLs’ actions, Columbus has 

suffered significant and ongoing harm and damages. 

A. While The Opioid Epidemic Is A National Issue, The Statistics Are 

Particularly Tragic In Columbus. 

248. While the opioid epidemic is affecting communities throughout the country, 

Columbus has felt its impact, and will continue to feel its impact, more than others. 

249. Columbus is the fourteenth largest city in the United States. 

250. The State of Ohio leads the nation in deaths related to heroin and synthetic 

opioids, despite being only the seventh most populous state. Approximately one in nine heroin 

deaths across the U.S. happened in Ohio (1,208 out of 10,574), and approximately one in 

fourteen synthetic opioid deaths happened in Ohio (590 deaths out of 5,544).186

251. In Franklin County, Columbus’ home county, there has been a 396% increase in 

residents who have died from unintentional drug overdoses from 2003 to 2016.187 Over 300 

residents of Franklin County died from unintentional drug overdoses in 2016 alone, surpassing 

 

184 New York Times, “The Numbers Behind America’s Heroin Epidemic” (Oct. 30, 2015), 

https://www.nytimes.com/interactive/2015/10/30/us/31heroin-deaths.html?mcubz=0. 

185 Breda Smith, et al., Journal of Addictive Diseases, Life Expectancy and Productivity Loss Among Narcotics 

Addicts Thirty-Three Years After Index Treatment, 2006, https://aran.library.nuigalway.ie/bitstream/handle/

10379/2342/2006_ja_smyth_narcotics_j_of_addictive_diseases.pdf?sequence=1&isAllowed=y. 

186 Catherine Candisky and Alan Johnson, Ohio Leads Nation In Overdose Deaths, Columbus Dispatch (Nov. 29, 

2016), http://www.dispatch.com/news/20161129/ohio-leads-nation-in-overdose-deaths/1. 

187 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, April-June 2017” (Oct. 2017), available 

at https://www.columbus.gov/publichealth/programs/Office-of-Epidemiology/Harm-Reduction/. 

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the number of deaths in 2015.188

252. For every opioid-related death, 10 people are admitted for treatment, 32 people 

visited the emergency room, 130 people are classified as abusers or drug-dependent, and 825 

people use opioids for non-medical purposes.189

253. A study by the Ohio Department of Health revealed a 97.9% correlation between 

the number of opioids prescribed in Ohio and the number of accidental drug overdoses 

(including from prescription opioids and heroin).190 From this information, statisticians 

approximate that for every two months’ worth of opioids that Defendants marketed and 

distributed into Columbus, someone died.191

254. The opioid addiction epidemic is directly devastating the children of Columbus. 

It is estimated that more than 5,000 children in Franklin County between the ages of 12 and 17 

have used prescription medication such as opioids for non-medical use.192 Further, from July 

2016 to June 2017, 268 babies were treated in Franklin County for neonatal abstinence 

syndrome, a syndrome associated with opioid withdrawal.193

255. Related to the devastation to families is the devastation to neighborhoods. 

Neighborhoods have been devastated by the crisis and need to be revitalized through various 

methods, including the creation of Community Centers. 

256. Treatment is complex and needs to be customized to meet individuals needs, 

 

188 Id.

189 City of Columbus and Franklin County, “Franklin County Opiate Action Plan” (2017), 

https://www.myfcph.org/pdfs/OpiateReports/Opiate%20Action%20Plan_0617.pdf. 

190 Emma Ockerman, The Post, Ohio In Crisis, http://projects.thepostathens.com/SpecialProjects/opioid-epidemicohio-in-crisis/index.html. 

191 Quinones, Sam. Dreamland: the True Tale of America's Opiate Epidemic. Dreamland: the True Tale of 

America's Opiate Epidemic, Bloomsbury Press, 2016, p. 252. 

192 City of Columbus and Franklin County, “Franklin County Opiate Action Plan” (2017), 

https://www.myfcph.org/pdfs/OpiateReports/Opiate%20Action%20Plan_0617.pdf, citing Journal of Addictive 

Diseases, Nonmedical Use of Prescription Opioids Among Adolescents: Subtypes Based on Motivation for Use

(2012). 

193 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, April-June 2017” (Oct. 2017), available 

at https://www.columbus.gov/publichealth/programs/Office-of-Epidemiology/Harm-Reduction/. 

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including, but not limited to, housing, employment, education, care for affected family members, 

physical and mental health issues, support groups such as Narcotics Anonymous and faith based 

support. 

257. Columbus also needs to be able to treat the persons addicted and affected by 

opioids, including, but not limited to, through the funding, implementation and/or construction of 

treatment centers and facilities, medication assisted treatment, recovery support, community 

based support and through funding, equipping and educating existing health care facilities. 

B. The Manufacturers’, Distributors’ And KOL’s Conduct Has Increased 

Columbus’ Health Care Costs. 

258. The Manufacturers’, Distributors’ and KOL’s misrepresentations regarding the 

purported safety and efficacy of opioids, and their failure to properly limit shipments, have 

increased Columbus’s health care costs. Columbus provides health insurance to its employees 

and their beneficiaries, and has administrative services-only agreements with two different 

insurers. This means that when anyone covered by Columbus’s health insurance program visits 

a doctor, fills a prescription or otherwise incurs covered health-related costs, Columbus pays a 

portion of those costs directly. 

259. Columbus provides health insurance to more than 8,200 people. 194 From 2010 to 

2016, Columbus health insurance costs increased from $107 million to $177.2 million, a 65.6 

percent increase.195 In 2016, Columbus’s prescription drug coverage made up $40.4 million of 

the total insurance cost.196 

260. Columbus incurs increased costs for its employees’ prescriptions for opioids that 

would have not been prescribed but for the misrepresentations made by the Manufacturers and 

 

194 Lucas Sullivan, The Columbus Dispatch, Health costs jump 11.5% to cover Columbus city employees (Jan. 13, 

2016), available at: http://www.dispatch.com/content/stories/local/2016/01/13/11-5-jump-in-health-costs-okd.html. 

195 Id.

196 Id. 

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KOLs to doctors in Columbus. The direct costs of filling employees’ opioid prescriptions is a 

part of the total cost to Columbus for prescriptions of opioids, which includes, but is not limited 

to, costs for doctors’ visits and lab work. Had Defendants told the truth about the risks and 

benefits of opioids, and/or properly reported suspicious orders, Columbus would not have had to 

pay for these drugs or the costs related to their prescription.

C. The Opioid Crisis Caused By The Manufacturers, The Distributors And The 

KOLs Has Caused Columbus To Incur Damages Providing Human Services 

In An Effort To Abate The Opioid Epidemic. 

261. The effects of the opioid epidemic reach across Columbus, imposing additional 

human and financial costs at all levels. For example, Columbus has spent, and will continue to 

spend, significant resources helping its homeless population by directly providing key services or 

funding programs run by charitable organizations. Such human services include housing, 

shelters, and mental health counseling, among others. 

262. Over the past decade, the homeless population in Columbus has grown. From 

2010 to 2014, for example, overall family homelessness fell 15 percent nationwide – but rose 7.6 

percent in Columbus.197

263. The increase in Columbus has been caused, at least in part, by the opioid 

epidemic, as people addicted to opioids often find it difficult to hold down jobs, which ultimately 

pushes them on to the street and places a huge burden onto the City. Providing the homeless 

population in Columbus with shelter, treatment, and other services is an expensive undertaking, 

made dramatically more so now that the homeless population has grown and is comprised of a 

large number of addicts. 

264. For many persons, a valid prescription for opioids was the first step to addiction 

 

197 Rick Rouan, The Columbus Dispatch, Number of homeless families rising in Franklin County, report says (Sept. 

22, 2015), http://www.dispatch.com/content/stories/local/2015/09/22/Report_shows_more_homeless_families.html. 

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and drug abuse, which ultimately led to the loss of their homes. Some young people living on 

the streets of Columbus today ran away from homes that had fallen apart because a parent had 

become addicted to opioids. According to the Public Children Services Association of Ohio, 

70% of children under the age of one who are in custody of Children Services have opioidinvolved parents.198

265. The oversaturation of prescription opioids has not only helped to fuel the 

homeless crisis, but it has made it immeasurably more difficult for Columbus to address. Mental 

health services, for example, are critical for many in the homeless population. Unfortunately, 

opioid use and addiction can make it more difficult to provide effective mental health treatment. 

Those who need help most often turn to opioids to self-medicate, and avoid getting treatment and 

care that might lead to long-term success. As a result, Columbus needs to provide additional 

mental health facilities and treatment options. 

266. Because opioid addition is highly prevalent in Columbus, the City has had to 

invest significant resources in addiction programs and other human services, which are widely 

used by all residents of Columbus, whether homeless or not. 

267. Columbus also is investing heavily in prevention work, running programs at local 

schools and sponsoring events aimed at teaching people how to avoid becoming addicted to 

opioids and how to help friends and family do the same. 

268. For example, the Columbus Department of Public Health works with City Schools 

and community centers in regard to prevention. 

 

198 City of Columbus and Franklin County, “Franklin County Opiate Action Plan: Building the Bridge to 

Tomorrow,” https://www.myfcph.org/pdfs/OpiateReports/Opiate%20Action%20Plan_0617.pdf, citing Public 

Children Services Association of Ohio, The Opioid Epidemic’s Impact on Children Services in Ohio 2017. 

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D. Columbus Already Has Incurred Significant Damages Relating To Police 

And Fire Responses To The Opioid Issues, And Will Continue To Do So, In 

An Effort to Abate The Epidemic. 

269. The Columbus Department of Public Safety acts as a response unit to specific 

issues caused by the opioid epidemic. It includes both the Columbus Division of Fire and the 

Columbus Division of Police. 

1. The Columbus Division of Fire has incurred significant damages 

responding to opioid issues due to the actions of the Manufacturers, 

the Distributors and the KOLs. 

270. The Columbus Division of Fire provides emergency medical services in the City 

of Columbus. The Division of Fire responds to emergency calls, dispatching emergency medical 

service personnel, including emergency medical technicians, or EMTs, in ambulances or fire 

trucks. 

271. Although providing emergency medical services is expensive, it is one of the 

most critical services the City provides its citizens. The Division of Fire is the front-line 

responder for a wide range of medical emergencies, from heart attacks and strokes to mental 

health emergencies and drug overdoses. 

272. Over the past decade, the number of opioid-related emergency calls to which the 

Fire Department has responded has risen sharply. For example, in 2016, the Division of Fire 

administered over 3,800 doses (over ten doses per day) of naloxone, a powerful medicine given 

to counteract an opioid-related overdose.199 This rate, over ten doses per day, has increased 

 

199 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, Jan.-March 2016” (August 2016), 

http://www.myfcph.org/pdfs/OpiateReports/DrugOD_Q1_01-03_16.pdf; Columbus Department of Public Health, 

“Opiate Crisis Quarterly Report, April-June 2016” (September 2016), http://www.myfcph.org/pdfs/OpiateReports

/DrugOD_Q2_04-06_16.pdf; Columbus Department of Public Health, “Opiate Crisis Quarterly Report, July-Sept. 

2016” (December 2016), http://www.myfcph.org/pdfs/OpiateReports/DrugOD_Q3_12_21_16.pdf; Columbus 

Department of Public Health, “Opiate Crisis Quarterly Report, Oct.-Dec. 2016” (March 2017), http://www.myfcph.

org/pdfs/OpiateReports/OpiateQuarterly_Q4_3_27_17.pdf. 

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dramatically since 2011, when the average number of doses administered per day was 6.55.200 

273. From July 2016 through June 2017, the Division of Fire reported 3,115 patients 

with drug overdoses who were treated by EMS with at least one dose of naloxone.201

274. In the last four years, the number of times the Division of Fire was dispatched for 

an emergency drug overdose increased by more than 20 percent.202 The Division of Fire also 

established the Rapid Response Emergency Addiction and Crisis Team (RREACT) to assist 

overdose patients with accessing treatment and other social services. 

275. Responding to opioid overdoses is expensive; it involves sending ambulances, 

engines, and specially-trained staff to the emergency. People who have overdosed on opioids 

typically require at least one, if not several, doses of naloxone, each of which carries a significant

price tag. Then the patient must be transported to the emergency room where City employees 

typically must wait while the patient is treated. The costs of materials, maintenance, medication, 

and time are significant. Additional resources are needed to pay for the emergency services costs 

caused by the opioid epidemic. 

276. In 2016, the Division of Fire administered naloxone over 3,800 times.203 That 

means that nearly every two hours, Columbus EMTs saved the life of someone who had 

overdosed on opioids. And the overall increase in the volume of calls means each first responder 

is responding to ever-increasing numbers of emergency incidents. This dramatic rise in the 

number and intensity of emergency incidents has significant effects on the emergency 

responders. 

 

200 City of Columbus and Franklin County, “Franklin County Opiate Action Plan” at 8, 

https://octf.franklincountyohio.gov/CRNR-OCTFwebsite/media/Documents/2017%20Opiate%20Action%20Plan/2017-Opiate-Action-Plan-Web.pdf 

201 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, April-June 2017” (Oct. 2017), available 

at https://www.columbus.gov/publichealth/programs/Office-of-Epidemiology/Harm-Reduction/. 

202 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, Jan.-March 2017” (June 2017), citing 

Columbus Division of Fire statistics. 

203 See supra note 205. 

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2. The Columbus Division of Police has incurred significant damages 

responding to opioid issues due to the actions of the Manufacturers, 

the Distributors and the KOLs. 

277. Because not all addicts receive the help they need, opioid addiction is killing 

Columbus’ citizens at an alarming rate. For example, fentanyl kills at least one person every day 

in Franklin County.204

 

278. Fentanyl’s deadly presence is caused by those who are addicted seeking 

alternatives to prescription opioids once they no longer can obtain them. From 2013 to 2015, the 

number of law enforcement drug seizures of fentanyl increased more than thirty-five fold, from 

110 in 2013 to 3,882 in 2015.205

279. The opioid epidemic has forced the Columbus Division of Police to expend 

significant resources fighting drug trafficking in Columbus. In the 2000s, as prescription opioids 

and heroin became the kings of the drug trade, illegal drug trafficking in Columbus rose 

significantly. Combating this rise in drug trafficking has forced the City to put more officers on 

the street and assign more detectives to work these drug cases in an effort to abate the epidemic. 

280. Columbus is just beginning to experience the full impact of Defendants’ actions, 

as addicted persons inevitably turn to heroin and fentanyl. Columbus’ injury is ongoing, and 

promises to continue for many years before it is abated. 

281. Increased illegal drug trafficking also has caused a rise in other criminal activities 

in Columbus. The price of prescription opioids on the black market is significant, forcing many 

addicts to turn to burglary or other property crimes in order to pay for their addiction. 

282. Not only does the opioid epidemic impair the quality of life for everyone in 

 

204 Alan Johnson and Catherine Candisky, The Columbus Dispatch, Fentanyl, a ruthless, indiscriminate killer, 

taking a big toll in Ohio (April 23, 2017), http://www.dispatch.com/news/20170423/fentanyl-ruthlessindiscriminate-killer-taking-big-toll-in-ohio. 

205 City of Columbus and Franklin County, “Franklin County Opiate Action Plan” at 8, 

https://octf.franklincountyohio.gov/CRNR-OCTFwebsite/media/Documents/2017%20Opiate%20Action%20Plan/2017-Opiate-Action-Plan-Web.pdf. 

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Columbus, the City is forced to address these crimes, expending police, surveillance, field 

testing, lab and investigatory resources and additional manpower, all of which have direct costs 

to the City. For example, from 2009 through 2015, both property crimes and retail theft 

increased. In 2015, central Ohio shoplifters stole a record amount of merchandise from 

retailers.206 In 2009, 58 percent of theft charges involved repeat offenders; by 2015, that number 

had risen to 81 percent.207 The increase in property crime has been attributed to the heroin and 

opioid addiction epidemic.208

283. As Columbus expends significant resources to address increased drug trafficking 

and property crimes, it has had to divert resources from other public safety issues. 

284. The opioid epidemic also has increased public safety costs and needs in other 

aspects. For example, Columbus bears significant costs related to an increased number of arrests 

for opioid-related crimes. This alone has placed a serious strain on Columbus’ police resources, 

and individuals who are addicted to opioids present special challenges to law enforcement. 

285. Often, individuals in active use of opioids may need medical care, including, but 

limited to, transportation to a medical center. This requires removing an officer from her or his 

beat to take the individual to the hospital and wait there during a recovery period, thus 

effectively removing that officer from the remainder of her or his shift. 

286. Additional harm has been caused to Columbus in the form of additional costs to, 

and needs of, the City’s Justice system. Many more opioid related or caused cases now fill the 

court’s dockets. Diversion programs are needed to assist with the excess. Additionally, due to 

the damage done to families, domestic issues have increased. The creation of Community 

 

206 Tim Feran, The Columbus Dispatch, Shoplifting a plague on central Ohio in 2015 (Jan. 15, 2016), 

http://www.dispatch.com/content/stories/business/2016/01/15/shoplifting-a-plague-on-central-ohio-in-15.html. 

207 Id.

208 Id. 

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Liaison Officers and partnerships with local domestic courts and Family Services agencies are 

needed to address the problems created by the opioid epidemic. 

287. The opioid epidemic created by the Defendants has caused Columbus serious and 

ongoing harm. The City’s costs for public safety, human and public services, and law 

enforcement have all risen dramatically, and the City as a community has suffered serious and 

tragic consequences as a result. 

288. The opioid epidemic also will cause Columbus to incur significant damages going 

forward in an effort to end, alleviate and abate the issues caused by the epidemic. 

VII. THE MANUFACTURERS, DISTRIBUTORS AND KOLS HAVE REAPED, AND 

WILL CONTINUE TO REAP, ENORMOUS PROFITS WHILE THE NATION, 

AND COLUMBUS, ARE FORCED TO REMEDY AND ABATE THE OPIOID 

EPIDEMIC. 

289. The Manufacturers, Distributors and KOLs have reaped enormous profits from 

the addiction epidemic they spawned. 

290. The Distributors generate substantial revenue from the distribution of opioids. In 

2015, for example, U.S. revenues from the Distributors’ respective drug distribution divisions 

totaled $378.4 billion, a 14.8% increase from 2014.209 The Distributors’ collective drug 

distribution revenues totaled approximately $406.5 billion in 2016, and are expected to reach 

$424.9 billion in 2017.210 Broken down for 2016, McKesson’s revenues in 2016 totaled $153.8 

billion; AmerisourceBergen’s revenues in 2016 totaled $142.1 billion; and Cardinal Health’s 

revenues totaled $110.5 billion.211 The Distributors account for roughly 90% of all revenues 

from drug distributions in the United States.212

 

209 Brian McCullough, Daily Local News, AmerisourceBergen draws heat for opioid distributions (March 6, 2017), 

http://www.dailylocal.com/article/DL/20170306/BUSINESS/170309882. 

210 Adam J. Fein, Ph.D., MDM, “MDM Market Leaders | Top Pharmaceutical Distributors,” 

https://www.mdm.com/2017-top-pharmaceuticals-distributors. 

211 Id.

212 Id.

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291. The Manufacturers also are reaping billions of dollars from opioids. In 2014 

alone, the American opioid market generated $11 billion in revenue for individuals and 

companies like Manufacturers – a number expected to rise to $17.7 billion by 2021.213

292. In fact, Purdue has generated estimated sales of more than $35 billion from 

opioids since 1996, while making profits of more than $3 billion in 2015 alone. 

293. Purdue’s annual opioid sales of $3 billion in 2015 represent a four-fold increase 

from its 2006 sales of $800 million. 

294. Endo has also profited massively from the sale of opioids. Opioids accounted for 

more than $400 million in 2012, and Opana ER alone generated more than $1 billion in revenue 

for Endo from 2010 to 2013. 

295. Janssen also generates substantial sales from its opioids. For example, Duragesic 

accounted for more than $1 billion in sales in 2009, and Nucynta and Nucynta ER accounted for 

$172 million in sales in 2014. 

296. The Manufacturers, the Distributors and the KOLs will continue to reap enormous 

profits. 

VIII. FRAUDULENT CONCEALMENT. 

297. At all times relevant to this Complaint, the Manufacturers, Distributors and KOLs 

took steps to avoid detection of, and fraudulently conceal, their conduct. 

298. The Manufacturers and KOLs disguised their own roles in the deceptive 

marketing of chronic opioid therapy by funding and working through the Front Groups. The 

Manufacturers and KOLs purposefully hid behind these organizations to avoid regulatory 

scrutiny and to prevent doctors and the public from discounting their messages. 

 

213 Alyangka Francheska Manalo, GuruFocus, Companies Aiming for the Billion-Dollar Opioid Addiction Market

(March 18, 2017), https://www.gurufocus.com/news/493086/companies-aiming-for-the-billiondollar-opioidaddiction-market. 

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299. While the Manufacturers and KOLs were listed as sponsors of many of the 

publications described in this Complaint, they never disclosed their role in shaping, editing, and 

exerting final approval over their content. The Manufacturers and KOLs exerted their 

considerable influence on these promotional and “educational” materials. 

300. In addition to hiding their own role in generating the deceptive content, the 

Manufacturers and KOLs manipulated their promotional materials and the scientific literature to 

make it appear as if they were accurate, truthful, and supported by substantial scientific evidence. 

The Manufacturers and KOLs distorted the meaning or import of studies they cited and offered 

them as evidence for propositions they did not actually support. The true lack of support for 

Manufacturers’ and KOLs’ deceptive messages was not apparent to the medical professionals 

who relied upon them in making treatment decisions, nor could they have been detected by 

Columbus. 

301. The Manufacturers and KOLs, in furtherance of their respective marketing 

strategies, intentionally concealed their own role in causing the opioid epidemic. The 

Manufacturers and KOLs successfully concealed from the medical community, patients, and 

health care payers facts sufficient to arouse suspicion of the existence of claims that Columbus 

now asserts. Columbus was not alerted to the existence and scope of the Manufacturers’ and 

KOLs’ industry-wide misrepresentations and could not have acquired such knowledge earlier 

through the exercise of reasonable diligence. 

302. The Distributors also concealed their role in the epidemic. Initially, they 

represented that they were complying with all applicable laws. In regard to the various 

settlements and consent orders discussed above, the Distributors nowhere admitted liability or 

wrongdoing. In fact, to this day, the Distributors claim they currently, and always have, 

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followed the law. It is only recently that their liability and wrongdoing have come to light. 

303. The Distributors knew, or should have known, their conduct was not in 

compliance with the law. 

304. Columbus has acted diligently at all times in investigating and bringing this suit. 

305. Through their public statements, marketing, and advertising, and concealment of 

their wrongdoing, the Manufacturers’, Distributors’, and KOLs’ deceptions deprived Columbus 

of actual or presumptive knowledge of facts sufficient to put them on notice of potential claims. 

COUNT ONE: PUBLIC NUISANCE (COMMON LAW)

(AGAINST ALL DEFENDANTS)

306. Columbus incorporates by reference paragraphs 1 through 305 of this Complaint 

as if fully set forth herein, and further alleges as follows. 

307. Columbus brings this claim under Ohio common law for recovery related to the 

abatement of the continuing public nuisance created by the Defendants. As a direct result of the 

Defendants’ conduct, Columbus has suffered actual injury and damages related to abating the 

nuisance caused by the Defendants. Columbus seeks recovery for its own harm. Columbus does 

not seek damages in this Count for death, physical injury to person, emotional distress and/or 

physical damages to property. 

308. The Defendants individually, and in conjunction with each other, have caused a 

significant and unreasonable interference with the public health, safety, welfare, peace, comfort 

and convenience, as well as the ability for Columbus residents to be free from disturbance and 

reasonable apprehension of danger to person or property. 

309. The Defendants intentionally, unlawfully, and recklessly manufactured, 

distributed, marketed, and sold prescription opioids, and continue to do so, in a manner and in 

quantities that the Defendants knew, or reasonably should have known, would result in the 

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oversaturation of opioids throughout the Columbus, addiction, drug abuse, an elevated level of 

crime, death and injuries to Columbus residents, a higher level of fear, discomfort and 

inconvenience to the residents of Columbus, and direct costs to the City itself. 

310. The nuisance and harm caused to Columbus as a direct result of the Defendants’ 

conduct described above, includes, but is not limited to: 

a. It is estimated that in calendar year 2016 alone, health care 

providers wrote more than 289 million prescriptions for opioid 

pain medication, i.e., enough for every adult in the United States 

to have more than one bottle of pills. This has in turn caused an 

epidemic of addiction, as well as crime, broken families and 

devastation to communities, including Columbus. 

b. 300 residents of Franklin County died from unintentional drug 

overdoses in 2016 alone.214 Related to this, generally, for every 

opioid-related death, 10 people are admitted for treatment, 32 

people visit the emergency room, 130 people are classified as 

abusers or drug-dependent, and 825 people use opioids for nonmedical purposes.215

c. It is estimated that more than 5,000 children in Franklin County 

between the ages of 12 and 17 have used prescription medication 

such as opioids for non-medical use. On information and belief, 

the majority of these children are from Columbus.216 

d. According to the Public Children Services Association of Ohio, 

70% of children under the age of one who are in custody of 

Children Services have opioid-involved parents.217

e. From July 2016 to June 2017, 268 babies were treated in Franklin 

County for neonatal abstinence syndrome, a condition associated 

with opioid withdrawal. On information and belief, the majority of 

these children were from the Columbus.218

 

214 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, Jan-March 2017” (June 2017), 

http://www.myfcph.org/pdfs/OpiateReports/OpiateQuarterly_2017Q1.PDF. 

215 City of Columbus and Franklin County, “Franklin County Opiate Action Plan” (2017), 

https://www.myfcph.org/pdfs/OpiateReports/Opiate%20Action%20Plan_0617.pdf. 

216 Id., citing Journal of Addictive Diseases, Nonmedical Use of Prescription Opioids Among Adolescents: Subtypes 

Based on Motivation for Use, 2012) 

217 City of Columbus and Franklin County, “Franklin County Opiate Action Plan: Building the Bridge to 

Tomorrow,” https://www.myfcph.org/pdfs/OpiateReports/Opiate%20Action%20Plan_0617.pdf, citing Public 

Children Services Association of Ohio, The Opioid Epidemic’s Impact on Children Services in Ohio 2017. 

218 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, Jan.-March 2017” (June 2017). 

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f. Neighborhoods have been devastated. 

g. Persons in Columbus and surrounding communities are addicted 

to, and affected by, opioids. 

i. Columbus has lost employee and resident productivity. 

j. The homeless population has increased, as has the resulting 

necessity to provide housing, shelters, treatment and mental health 

counseling. From 2010 to 2014, for example, overall family 

homelessness fell 15 percent nationwide – but rose 7.6 percent in 

Columbus.219

k. Individuals who have become addicted to prescription opioids, but 

cannot afford their increased costs or are unable to secure a 

prescription, have turned to cheaper, more potent, and more 

dangerous alternatives, including heroin and fentanyl. While a 

majority of heroin abusers are former opioid abusers, the inverse is 

not true: according to a national survey, less than 4% of 

prescription pain medicine abusers had started by using heroin.220

l. A mental health crisis has been created. 

m. Increased demands have been created on the Columbus Division of 

Fire. In 2016 alone, the Division of Fire administered over 3,800 

doses (over ten doses per day) of naloxone, a powerful medicine 

given to counteract an opioid-related overdose.221 From July 2016 

through June 2017, the Division of Fire reported 3,115 patients 

with drug overdoses who were treated by EMS with at least one 

dose of naloxone.222

 

219 Rick Rouan, The Columbus Dispatch, Number of homeless families rising in Franklin County, report says (Sept. 

22, 2015), http://www.dispatch.com/content/stories/local/2015/09/22/Report_shows_more_homeless_families.html. 

220 National Institute on Drug Abuse, “Heroin” (Revised July 2017), 

https://www.drugabuse.gov/publications/drugfacts/heroin#ref, citing Muhuri PK, Gfroerer JC, Davies MC., 

Associations of Nonmedical Pain Reliever Use and Initiation of Heroin Use in the United States. Rockville, MD: 

Substance Abuse and Mental Health Services Administration; 2013.

221 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, Jan.-March 2016” (August 2016), 

http://www.myfcph.org/pdfs/OpiateReports/DrugOD_Q1_01-03_16.pdf; Columbus Department of Public Health, 

“Opiate Crisis Quarterly Report, April-June 2016” (September 2016), http://www.myfcph.org/pdfs/OpiateReports

/DrugOD_Q2_04-06_16.pdf; Columbus Department of Public Health, “Opiate Crisis Quarterly Report, July-Sept. 

2016” (December 2016), http://www.myfcph.org/pdfs/OpiateReports/DrugOD_Q3_12_21_16.pdf; Columbus 

Department of Public Health, “Opiate Crisis Quarterly Report, Oct.-Dec. 2016” (March 2017), 

http://www.myfcph.org/pdfs/OpiateReports/OpiateQuarterly_Q4_3_27_17.pdf. 

222 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, April-June 2017” (Oct. 2017), available 

at https://www.columbus.gov/publichealth/programs/Office-of-Epidemiology/Harm-Reduction/ 

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n. Increased demands have been created on the Columbus Division of 

Police. As opioid-addicted persons turn to heroin and fentanyl to 

fuel their needs, the harm to Columbus is ongoing and promises to 

continue for many years. Increased illegal drug trafficking has 

caused a rise in other criminal activities in Columbus. Not only 

does this impair the quality of life for everyone in Columbus, 

Columbus is forced to address these crimes through police work, 

surveillance, field testing, lab and investigatory resources, 

prosecution, diversion programs, and additional manpower. 

311. The Defendants’ ongoing conduct produces a continuing nuisance, leading to 

abuse, misuse, addiction, crime, and public health issues which must be abated to prevent injury 

and annoyance. The Defendants’ conduct directly impacted, and continues to impact, persons in 

Columbus, and is likely to cause significant harm in the future. 

312. The Defendants knew, or reasonably should have known, that their conduct 

described in this Complaint would cause addiction, and otherwise significantly and unreasonably 

interfere with public health, safety and welfare, and with the public’s right to be free from 

disturbance. But for the Defendants’ individual and/or combined conduct, these harms would not 

have occurred. 

313. The Defendants knew, or reasonably should have known, that persons would rely 

to their detriment on the Defendants’ misrepresentations, omissions and other statements 

described in this Complaint. 

314. It is, or should be, reasonably foreseeable to the Defendants that their conduct will 

continue to cause harm to Columbus in the future, and, unless abated, will otherwise 

significantly and unreasonably interfere with public health, safety and welfare, and with the 

public’s right to be free from disturbance. 

315. The Defendants acted with actual malice because the Defendants acted 

intentionally and/or with a conscious disregard for the rights and safety of other persons, and said 

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actions have a great probability of causing substantial harm and have created an absolute 

nuisance. 

316. The damages available to Columbus include, inter alia, recoupment of damages 

flowing from an ongoing and persistent public nuisance that the government seeks to abate. The 

Defendants’ conduct is ongoing and persistent, and Columbus seeks all damages flowing from 

the Defendants’ conduct. Columbus further seeks to abate the continuing nuisance and harm 

created by the Defendants’ conduct into the future.

317. Columbus seeks all legal and equitable relief as allowed by law, including inter 

alia, abatement, abatement costs, available compensatory damages, and available punitive 

damages related to the absolute and continuing public nuisance the Defendants created, 

attorneys’ fees and costs, and pre- and post-judgment interest. 

COUNT TWO: PUBLIC NUISANCE (O.R.C. § 715.44)

(AGAINST ALL DEFENDANTS)

318. Columbus incorporates by reference paragraphs 1 through 317 of this Complaint 

as if fully set forth herein, and further alleges as follows. 

319. Columbus brings this claim pursuant to O.R.C. § 715.44 for recovery related to 

the abatement of the continuing public nuisance created by the Defendants. As a direct result of 

the Defendants’ conduct, Columbus has suffered actual injury and damages related to abating the 

nuisance caused by the Defendants. Columbus seeks recovery for its own harm. Columbus does 

not seek damages in this Count for death, physical injury to person, emotional distress and/or 

physical damage to property. 

320. The Defendants individually, and in conjunction with each other, have caused a 

significant and unreasonable interference with public health, safety, welfare, peace, comfort and 

convenience, as well as the ability for Columbus residents to be free from disturbance and 

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reasonable apprehension of danger to person or property. 

321. The Defendants intentionally, unlawfully, and recklessly manufactured, 

distributed, marketed, and sold prescription opioids, and continue to do so, in a manner and in 

quantities that the Defendants knew, or reasonably should have known, would result in the 

oversaturation of opioids throughout the Columbus, addiction, drug abuse, an elevated level of 

crime, death and injuries to Columbus residents, a higher level of fear, discomfort and 

inconvenience to the residents of Columbus, and direct costs to the City itself. 

322. The nuisance and harm caused to Columbus as a direct result of the Defendants’ 

conduct described above, includes, but is not limited to: 

a. It is estimated that in calendar year 2016 alone, health care 

providers wrote more than 289 million prescriptions for opioid 

pain medication, i.e., enough for every adult in the United States 

to have more than one bottle of pills. This has in turn caused an 

epidemic of addiction, as well as crime, broken families and 

devastation to communities, including Columbus. 

b. 300 residents of Franklin County died from unintentional drug 

overdoses in 2016 alone.223 Related to this, generally, for every 

opioid-related death, 10 people are admitted for treatment, 32 

people visit the emergency room, 130 people are classified as 

abusers or drug-dependent, and 825 people use opioids for nonmedical purposes.224

c. It is estimated that more than 5,000 children in Franklin County 

between the ages of 12 and 17 have used prescription medication 

such as opioids for non-medical use. On information and belief, 

the majority of these children are from Columbus.225

 

d. According to the Public Children Services Association of Ohio, 

70% of children under the age of one who are in custody of 

 

223 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, Jan-March 2017” (June 2017), 

http://www.myfcph.org/pdfs/OpiateReports/OpiateQuarterly_2017Q1.PDF. 

224 City of Columbus and Franklin County, “Franklin County Opiate Action Plan” (2017), 

https://www.myfcph.org/pdfs/OpiateReports/Opiate%20Action%20Plan_0617.pdf. 

225 Id., citing Journal of Addictive Diseases, Nonmedical Use of Prescription Opioids Among Adolescents: Subtypes 

Based on Motivation for Use, 2012. 

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Children Services have opioid-involved parents.226

e. From July 2016 to June 2017, 268 babies were treated in Franklin 

County for neonatal abstinence syndrome, a condition associated 

with opioid withdrawal. On information and belief, the majority of 

these children were from the Columbus.227

f. Neighborhoods have been devastated. 

g. Persons in Columbus and surrounding communities are addicted 

to, and affected by, opioids. 

ii. Columbus has lost employee and resident productivity. 

j. The homeless population has increased, as has the resulting 

necessity to provide housing, shelters, treatment and mental health 

counseling. From 2010 to 2014, for example, overall family 

homelessness fell 15 percent nationwide – but rose 7.6 percent in 

Columbus.228

k. Individuals who have become addicted to prescription opioids, but 

cannot afford their increased costs or are unable to secure a 

prescription, have turned to cheaper, more potent, and more 

dangerous alternatives, including heroin and fentanyl. While a 

majority of heroin abusers are former opioid abusers, the inverse is 

not true: according to a national survey, less than 4% of 

prescription pain medicine abusers had started by using heroin.229

l. A mental health crisis has been created. 

m. Increased demands have been created on the Columbus Division of 

Fire. In 2016 alone, the Division of Fire administered over 3,800 

doses (over ten doses per day) of naloxone, a powerful medicine 

given to counteract an opioid-related overdose.230 From July 2016 

 

226 City of Columbus and Franklin County, “Franklin County Opiate Action Plan: Building the Bridge to 

Tomorrow,” https://www.myfcph.org/pdfs/OpiateReports/Opiate%20Action%20Plan_0617.pdf, citing Public 

Children Services Association of Ohio, The Opioid Epidemic’s Impact on Children Services in Ohio 2017. 

227 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, Jan.-March 2017” (June 2017). 

228 Rick Rouan, The Columbus Dispatch, Number of homeless families rising in Franklin County, report says (Sept. 

22, 2015), http://www.dispatch.com/content/stories/local/2015/09/22/Report_shows_more_homeless_families.html. 

229 National Institute on Drug Abuse, “Heroin” (Revised July 2017), https://www.drugabuse.gov/publications/

drugfacts/heroin#ref, citing Muhuri PK, Gfroerer JC, Davies MC., Associations of Nonmedical Pain Reliever Use 

and Initiation of Heroin Use in the United States. Rockville, MD: Substance Abuse and Mental Health Services 

Administration; 2013.

230 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, Jan.-March 2016” (August 2016), 

http://www.myfcph.org/pdfs/OpiateReports/DrugOD_Q1_01-03_16.pdf; Columbus Department of Public Health, 

“Opiate Crisis Quarterly Report, April-June 2016” (September 2016), 

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through June 2017, the Division of Fire reported 3,115 patients 

with drug overdoses who were treated by EMS with at least one 

dose of naloxone.231

n. Increased demands have been created on the Columbus Division of 

Police. As opioid-addicted persons turn to heroin and fentanyl to 

fuel their needs, the harm to Columbus is ongoing and promises to 

continue for many years. Increased illegal drug trafficking has 

caused a rise in other criminal activities in Columbus. Not only 

does this impair the quality of life for everyone in Columbus, 

Columbus is forced to address these crimes through police work, 

surveillance, field testing, lab and investigatory resources, 

prosecution, diversion programs, and additional manpower. 

323. The Defendants’ ongoing conduct produces a continuing nuisance, leading to 

abuse, misuse, addiction, crime, and public health issues which must be abated to prevent injury 

and annoyance. The Defendants’ conduct directly impacted, and continues to impact, persons in 

Columbus, and is likely to cause significant harm in the future. 

324. The Defendants knew, or reasonably should have known, that their conduct 

described in this Complaint would cause addiction, and otherwise significantly and unreasonably 

interfere with public health, safety and welfare, and with the public’s right to be free from 

disturbance. But for the Defendants’ individual and/or combined conduct, these harms would not 

have occurred. 

325. The Defendants knew, or reasonably should have known, that persons would rely 

to their detriment on the Defendants’ misrepresentations, omissions and other statements 

described in this Complaint. 

326. It is, or should be, reasonably foreseeable to the Defendants that their conduct will 

 

http://www.myfcph.org/pdfs/OpiateReports/DrugOD_Q2_04-06_16.pdf; Columbus Department of Public Health, 

“Opiate Crisis Quarterly Report, July-Sept. 2016” (December 2016), http://www.myfcph.org/pdfs/OpiateReports

/DrugOD_Q3_12_21_16.pdf; Columbus Department of Public Health, “Opiate Crisis Quarterly Report, Oct.-Dec. 

2016” (March 2017), http://www.myfcph.org/pdfs/OpiateReports/OpiateQuarterly_Q4_3_27_17.pdf. 

231 Columbus Department of Public Health, “Opiate Crisis Quarterly Report, April-June 2017” (Oct. 2017), available 

at https://www.columbus.gov/publichealth/programs/Office-of-Epidemiology/Harm-Reduction/. 

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continue to cause harm to Columbus in the future, and, unless abated, will otherwise 

significantly and unreasonably interfere with public health, safety and welfare, and with the 

public’s right to be free from disturbance. 

327. The Defendants acted with actual malice because the Defendants acted 

intentionally and/or with a conscious disregard for the rights and safety of other persons, and said 

actions have a great probability of causing substantial harm and have created an absolute 

nuisance. 

328. The damages available to Columbus include, inter alia, recoupment of damages 

flowing from an “ongoing and persistent” public nuisance “which the government seeks to 

abate.” Beretta, 768 N.E.2d at 1149-50. The Defendants’ conduct is ongoing and persistent, and 

Columbus seeks all damages flowing from the Defendants’ conduct. Columbus further seeks to 

abate the continuing nuisance and harm created by the Defendants’ conduct into the future. 

329. Columbus seeks all legal and equitable relief as allowed by law, including inter 

alia, abatement, abatement costs, available compensatory damages, and available punitive 

damages related to the absolute and continuing public nuisance the Defendants created, 

attorneys’ fees and costs, and pre- and post-judgment interest. 

COUNT THREE: INJURY THROUGH CRIMINAL ACTS, O.R.C. § 2307.60

(AGAINST MANUFACTURER AND DISTRIBUTOR DEFENDANTS)

330. Columbus incorporates by reference paragraphs 1 through 329 of this Complaint 

as if fully set forth herein, and further alleges as follows.

331. O.R.C. § 2307.60(A)(1) “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.” O.R.C. § 2307.60(A)(1).

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332. As described above, Columbus has been injured by all Defendants’ actions that 

caused the opioid epidemic.

333. Defendants’ actions and omissions were criminal and in violation of O.R.C. 

Chapter 2925, and more specifically Section 2925.03(A), which forbids the distribution of 

controlled substances.

334. 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,” unless 

an exception applies. O.R.C. § 2925.02(A)(3). The exception only applies when the drug 

wholesaler’s “conduct is in accordance with Chapter[]. . . 4729. . . of the Revised Code.” O.R.C. 

§ 2925.02(B). Because the Manufacturers and Distributors (a) caused other persons to become 

drug dependent and (b) failed to inter alia report suspicious sales, their conduct is not in 

compliance with Chapter 4729, and the Manufacturers and Distributors have thereby forfeited 

the protection provided by the exception. See O.R.C. § 4729.26; O.A.C. § 4729-9-16. 

335. The Manufacturers and Distributors 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 (O.A.C. §§ 4729-9-16(L), 

4729-9-28(I)).

336. The Manufacturers’ and Distributors’ further violations of criminal laws are 

described above.

337. Columbus has sustained injuries, inter alia, as a result of the Manufacturers’ and 

Distributors’ actions and omissions.

338. Columbus 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 

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allowed by law to be paid by the Manufacturer and Distributors, attorneys’ fees and costs, and 

pre- and post-judgment interest.

COUNT FOUR: FRAUD

(AGAINST ALL DEFENDANTS)

339. Columbus incorporates by reference paragraphs 1through 338 of this Complaint 

as if fully set forth herein, and further alleges as follows. 

340. Each Defendant individually, and in concert with each other, made 

misrepresentations and/or omissions of facts material to Columbus, physicians treating residents 

of Columbus, residents of Columbus and others in order to cause them to purchase, prescribe, 

administer, take, consume or provide opioids as described above. 

341. The Defendants had a duty not to make misrepresentations or omissions of 

material fact. 

342. Defendants knew at the time they made the misrepresentations they were false 

and at the time they made the omissions they created falsity, or made the misrepresentations with 

utter disregard and recklessness as to their falsity. 

343. The Defendants intended that Columbus, physicians treating residents of 

Columbus, residents of Columbus and others would rely on the misrepresentations and 

omissions. 

344. Columbus, physicians treating residents of Columbus, residents of Columbus and 

others justifiably relied on the Defendants’ misrepresentations and omissions. 

345. Despite the exercise of due diligence, Columbus failed to discover the facts 

identified herein. 

346. Columbus and its citizens were damaged by each Defendant’s intentional and 

fraudulent misrepresentations and omissions of material facts. 

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347. Columbus seeks all legal and equitable relief as allowed by law, including, inter 

alia, full compensatory and punitive or exemplary damages, and all damages allowed by law to 

be paid by all Defendants, attorneys’ fees and costs, and pre- and post-judgment interest.

COUNT FIVE: OHIO CORRUPT PRACTICES ACT, O.R.C. §§ 2923.31, et seq.

(AGAINST ALL MANUFACTURER AND DISTRIBUTOR DEFENDANTS)

348. Columbus incorporates by reference paragraphs 1 through 347 of this Complaint 

as if fully set forth herein, and further alleges as follows. 

349. This count is against each Manufacturer and each Distributor. 

350. At all relevant times, each Manufacturer and each Distributor is and has been a 

“person” within the meaning of O.R.C. § 2923.31(G) who conducted the affairs of an enterprise 

through a pattern of corrupt activity, in violation of Chapter 2923. 

351. Columbus is a “person,” as that term is defined in O.R.C. §2923.31(G), that 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 . . . .” O.R.C. § 2923.34(A). 

352. Manufacturers, Distributors, the KOLs, and certain Front Groups, including but 

not limited to (a) the American Pain Foundation, including its employees and agents; (b) the 

American Academy of Pain Medicine, including its employees and agents; and (c) the American 

Pain Society, including its employees and agents (collectively, the “Front Groups”) are an 

association-in-fact enterprise (the “Opioid Enterprise”) within the meaning of O.R.C. 

2923.31(C). 

353. Based on the facts alleged above, the Opioid Enterprise has been in existence for 

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more than 20 years, and continues through the present. The Opioid Enterprise, pursued and 

continues to pursue, a common purpose of causing the prescription of opioids to treat chronic 

pain. The Manufacturers manufactured the opioids. The Manufacturers also marketed and 

promoted the purported safe use of opioids to treat chronic pain through their own efforts, and 

through enlisting the KOLs and Front Groups. The Manufacturers enlisted the Distributors to 

distribute the opioids. 

354. Each Manufacturer and each Distributor agreed to and did conduct and participate 

in the conduct of the Opioid Enterprise’s affairs through a pattern of corrupt activity under 

O.R.C. § 2923.31(I), for the unlawful purpose of illegally selling and distributing opioids (the 

“Scheme”). Specifically, each Manufacturer and each Distributor engaged in dealing “in a 

controlled substance or listed chemical (as defined in section 102 of the Controlled Substances 

Act), which is chargeable under State law and punishable by imprisonment for than one year.” 

18 U.S.C. §1961(1)(A). In addition, each Manufacturer and each Distributor violated 18 U.S.C. 

§§ 1341 and 1342 (i.e., mail and wire fraud), which constitutes corrupt activity under O.R.C. § 

2923.31. 

355. Each Manufacturer violated O.R.C. §2925.02(A), which provides: 

No person shall knowingly do any of the following: 

(1) By force, threat, or deception, administer to another or induce or 

cause another to use a controlled substance; 

(2) By any means, administer or furnish to another or induce or cause 

another to use a controlled substance with purpose to cause serious 

physical harm to the other person, or with purpose to cause the 

other person to become drug dependent; 

(3) By 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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356. Each Manufacturer violated O.R.C. §2925.02(A) by deceptively inducing citizens 

of Columbus to use opioids, inducing and causing citizens of Columbus to use opioids for the 

purpose of causing them to be dependent on opioids, inducing and causing residents of 

Columbus to use opioids and causing those persons to become drug dependent. Each Distributor 

violated O.R.C. § 2925.02(A)(3) because it knew or had reasonable cause to know that opioids 

that it sold were intended for sale or resale through illegal means. 

357. Each Manufacturer and each Distributor violated O.R.C. § 2925.03(A), which 

provides: 

No person shall knowingly do any of the following: 

(1) Sell or offer to sell a controlled substance or a controlled substance 

analog; 

(2) Prepare for shipment, ship, transport, deliver, prepare for 

distribution, or distribute a controlled substance or a controlled 

substance analog, when the offender knows or has reasonable 

cause to believe that the controlled substance or a controlled 

substance analog is intended for sale or resale . . . .” 

358. Each Manufacturer and each Distributor violated O.R.C. § 2925.03(A) by selling 

and distributing opioids in Columbus and because they knew or had reasonable cause to believe 

that the opioids they sold and distributed would be illegally resold. 

359. The Manufacturers and Distributors are not protected by any exception to O.R.C. 

§§ 2925.02 and 2925.03 because their conduct did not comply with O.R.C. § 4729. Specifically, 

as set forth in the Complaint above, the Manufacturers and Distributors violated O.A.C. Section 

4729-9-16 by failing to report suspicious orders. See O.A.C. § 4729-9-16(H)(1)(e)(i) (“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, 

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are of unusual size, unusual frequency, or deviate substantially from established buying 

patterns.”). Any violation of Section 2925.03 is defined as “corrupt activity.” O.R.C. § 

2923.31(I)(2)(c).

360. In addition, the Opioid Enterprise conducted its affairs through predicate acts of 

racketeering, as defined by 18 U.S.C. § 1961(1), constituting corrupt activity under O.R.C. § 

2923.31, through: 

a. Mail Fraud: The members of the Opioid Enterprise violated 18 

U.S.C. § 1341 by sending or receiving, or by causing to be sent 

and/or received, fraudulent materials via U.S. mail or commercial 

interstate carriers for the purpose of selling opioids. 

b. Wire Fraud: The members of the Opioid Enterprise violated 18 

U.S.C. § 1343 by transmitting and/or receiving, or by causing to be 

transmitted and/or received, fraudulent materials by wire for the 

purpose of selling opioids. 

361. Each particular instance of mail and/or wire fraud cannot be alleged. The precise 

dates and times that the Manufacturers and Distributors used the U.S. Mail and interstate wire 

facilities are known only to the Manufacturers and Defendants. However, based on the volume 

of communications that would be necessary to market opioids for sale, each Manufacturer used 

the U.S. Mail and interstate wire facilities to perpetrate the Scheme by, among other things: 

a. Sending marketing materials that touted the benefit of opioids to 

treat chronic pain and minimizing the risks of addiction to 

physicians, KOLs and Front Groups; 

b. Conducting telephone calls with Front Groups and KOLs to 

discuss the use of opioids for chronic pain; 

c. Sending thousands of e-mails to Front Groups, KOLs, doctors, 

medical groups, and other persons and entities involved in the 

distribution and marketing chains for opioids; 

d. Sending by U.S. Mail and e-mail drafts of, or comments to, 

publications, guidelines, or other material relating to the marketing 

and sale of opioids; 

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e. Sending by U.S. Mail and email literature to physicians that cited 

the 1980 NEJM Letter-to-the-Editor as support for the contention 

that opioids were safe to treat chronic pain; 

f. Sending by U.S. Mail and email by the Manufacturers’ sales 

representatives to physicians communications indicating that 

opioids were safe for use in treating patients for chronic pain, had 

low risk of addiction or other aberrant behavior and would improve 

patients’ function; 

g. Sending communications directed to federal and State agencies 

and others in Ohio that misrepresented the benefits and risks of 

opioid use for the treatment of chronic pain; and 

h. Receiving monies through wire transfers relating to the sales of 

opioids. 

362. In addition, each of the following Manufacturers used the U.S. Mail or interstate 

wire facilities to make the specific statements in furtherance of their Scheme. 

363. Purdue: Defendant Purdue made false or misleading claims in violation of 18 

U.S.C. §§ 1341 and 1343 including, but not limited to: (1) a 1998 video that cited a 1980 NEJM 

letter in support of the use of opioids to treat chronic pain; (2) statements made on its 2000 

“Partners Against Pain” website that represented that the addiction risk of OxyContin was 

extremely small; (3) statements in Purdue’s Risk Evaluation and Mitigation Strategy for 

OxyContin indicating that “[b]ehaviors that suggest drug abuse exist on a continuum, and painrelief seeking behavior can be mistaken for drug-seeking behavior”; (4) statements made on 

Purdue’s website and in a 2010 “Dear Healthcare Professional” letter instructing doctors to taper 

someone off of OxyContin to prevent problems associated with withdrawal in patients who were 

physically dependent opioids; (5) statements included in a 1996 sales strategy memo indicating 

that there is no ceiling dose for opioids for chronic pain; (6) statements on its website that abuseresistant products can prevent opioid addiction; and (7) statements made in advertising and a 

2007 book indicating that pain relief from opioids improve patients’ function and quality of life.. 

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364. Teva: Defendant Teva made false or misleading claims in violation of 18 U.S.C. 

§§ 1341 and 1343 including, but not limited to: (1) statements made regarding Actiq and Fentora 

as safe and effective treatments for chronic pain, when neither drug has been approved by the 

FDA for treatment of chronic pain; (2) statements made promoting Actiq for use in non-cancer 

patients to treat such conditions as migraines, sickle-cell pain crises, and other injuries; (3) 

statements made promoting Actiq for use in patients who were not yet opioid-tolerant, despite its 

FDA-approved label indicating that the drug was for “opioid tolerant cancer patients with 

breakthrough cancer pain, to be prescribed by oncologist or pain specialists familiar with 

opioids”; (4) statements deliberately made to physicians other than oncologists, including general 

practitioners, promoting Actiq for off-label uses; (5) representations to pain patients that, when 

used properly, opioids “can be life savers and give all of us a quality of life we deserve”; (6) 

representations through sponsored links on Internet search engines that misrepresented the 

efficacy of Fentora without communicating any risk information. 

365. Endo: Defendant Endo made false or misleading claims in violation of 18 U.S.C. 

§§ 1341 and 1343 including, but not limited to: (1) statements made, beginning in at least 2009, 

on an Endo-sponsored website, PainKnowledge.com, indicating that patients “who take opioids 

as prescribed usually do not become addicted”; (2) statements made on another Endo-sponsored 

website, PainAction.com, indicating that “most chronic pain patients do not become addicted to 

opioid medications that are prescribed for them”; (3) statements made on the Endo-run website, 

Opana.com, indicating that opioid use does not result in addiction; (4) statements made on the 

Endo-run website, Opana.com, indicating that opioid dependence can be addressed by dosing 

methods such as tapering; and (6) statements made in a publication entitled “Understanding Your 

Pain: Taking Oral Opioid Analgesics” suggesting that opioid doses “can be increased” 

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indefinitely, because “[y]ou won’t ‘run out’ of pain relief”. 

366. Janssen: Defendant Janssen made false or misleading claims in violation of 18 

U.S.C. §§ 1341 and 1343 including but not limited to: (1) statements on its website, 

PrescribeResponsibly.com, indicating that concerns about opioid addiction are “overestimated,” 

and that “true addiction occurs only in a small percentage of patients”; (2) statements included 

on a 2009 Janssen-sponsored website promoting the concept of opioid pseudoaddiction; (3) 

statements on its website, PrescribeResponsibly.com, advocating the concept of opioid 

pseudoaddiction; (4) statements on its website, PrescribeResponsibly.com, indicating that opioid 

addiction can be managed; and (5) statements in its 2009 patient education guide indicating the 

risks associated with limiting the dosages of pain medicines. 

367. Actavis: Defendant Actavis made false or misleading claims in violation of 18 

U.S.C. §§ 1341 and 1343 including but not limited to: (1) statements that “omit and minimize the 

serious risks associated with Kadian”; (2) statements that “misleadingly suggest[] that Kadian is 

safer than has been demonstrated”; (3) statements that “fail to reveal warnings regarding 

potentially fatal abuse of opioids, use by individuals other than the patient for whom the drug 

was prescribed[.]”; (4) statements that falsely conveyed that the risk of addiction was limited to 

chronic pain patients and/or patients already predisposed to abuse, addiction, and/or 

dysfunctional behavior; (5) statements that instructed physicians to look for signs of 

“pseudoaddiction” in patients; and (6) statements which suggested that the physical symptoms of 

opioid withdrawal could be adequately addressed by tapering. 

368. Distributors: The Distributors violated 18 U.S.C. §§ 1341 and 1343 by sending 

or receiving into Columbus, or by causing to be sent and/or received into Columbus, opioids. In 

addition, upon information and belief, each of the Distributors falsely reported to various state 

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and federal government authorities that they were in compliance with state and federal laws 

concerning suspicious orders. Upon information and belief, these reports were transmitted by 

mail and/or wire. Distributors further violated 18 U.S.C. § 1341 and § 1343 by: (1) using the 

mail to send suspicious shipments to doctors and pharmacies in the City; (2) using the mail 

and/or wire communications to send invoices to doctors and pharmacies relating to the 

suspicious statements; and (3) using the mail and/or wire communications to send reports falsely 

stating that it was in compliance with federal laws concerning the distribution of opioids. 

369. All of the dates of the fraudulent uses of the U.S. mail and interstate wire facilities 

are not yet known, but, on information and belief , based on the volume of opioid sales by the 

Opioid Enterprise, the number of fraudulent uses of the mail and interstate wire number in tens 

of thousands and continue to today. 

370. The actions set forth in the Complaint above constitute a pattern of corrupt 

activity pursuant to O.R.C. § 2323.31. 

371. The Manufacturers and Distributors have directly and indirectly conducted and 

participated in the conduct of the Opioid Enterprise’s affairs through the pattern of corrupt 

activity described above, in violation of O.R.C. § 2923.32. Each of the Manufacturers 

orchestrated the affairs of the Enterprise and exerted substantial control over the Enterprise by, at 

least: (1) manufacturing the opioids; (2) determining pricing for the opioids; (3) making 

misleading statements about the purported benefits, efficacy, and risks of opioids to doctors, 

patients, the public, and others, in the form of telephonic and electronic communications, CME 

programs, medical journals, advertisements, and websites; (4) employing sales representatives or 

detailers to promote the use of opioid medications; (5) purchasing and utilizing sophisticated 

marketing data (e.g., IMS data) to coordinate and refine the sale and distribution of opioids; (6) 

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employing doctors to serve as speakers at or attend all-expense paid trips to programs 

emphasizing the benefits of prescribing opioid medications; (7) funding, controlling, and 

operating the Front Groups to target doctors, patients, and lawmakers and provide a veneer of 

legitimacy to the Scheme; (8) retaining KOLs to tout the benefits of opioid medicines; and (9) 

concealing the true nature of their relationship with the other members of the Enterprise, 

including the Front Groups and the KOLs. 

372. Each Distributor orchestrated the affairs of the Opioid Enterprise and exerted 

substantial control over the Enterprise by, at least: (1) shipping significant doses of opioids in 

Columbus, the sheer volume of which should have, or actually did, put them on notice to 

investigate and report such orders; (2) refusing to report such suspicious orders; (3) refusing to 

report suspicious prescribers; (4) failing to refuse to fill suspicious orders; (5) affirmatively 

misrepresenting the efforts they were taking to curb the growing epidemic; and (6) concealing 

the true nature of their relationship with the other members of the Enterprise. 

373. As a direct and proximate result of the Manufacturers’ and Distributors’ corrupt 

activities and violations of O.R.C. § 2923.32, Columbus has been injured in its business and 

property in the manner set forth in the manner described above in the Complaint above. 

374. Columbus seeks all legal and equitable relief as allowed by law, including, inter 

alia, injunctive relief, full compensatory and punitive or exemplary damages, including treble 

damages, and all damages allowed by law to be paid by all Defendants, attorneys’ fees and costs, 

and pre- and post-judgment interest.

COUNT SIX: CONSPIRACY, OHIO CORRUPT PRACTICES ACT,

O.R.C. §§ 2923.01, 2923.31, et seq.

(AGAINST ALL DEFENDANTS)

375. Plaintiff incorporates by reference paragraphs 1 through 374 of this Complaint, as 

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if fully set forth herein, and further alleges as follows. 

376. This Count is against all Defendants. 

377. Defendants agreed and conspired to violate O.R.C. § 2923.32(A)(1). Specifically, 

the Manufacturers entered into various agreements with the KOLs pursuant to which the KOLs 

would falsely promote the safety of opioids to treat chronic pain. The KOLS agreed to 

knowingly facilitate the activities of the Manufacturers and/or Distributors. The Distributors 

entered into agreements with the Manufacturers to distribute the opioids. The Distributors 

agreed to knowingly facilitate the activities of the Manufacturers by distributing opioids in 

violation of state and federal rules regarding suspicious orders. 

378. Defendants have intentionally conspired and agreed to directly or indirectly 

conduct and participate in the conduct of the affairs of the enterprise through a pattern of corrupt 

activity. Defendants knew that their predicate acts were part of a pattern of corrupt activity and 

agreed to the commission of the schemes described above. The conduct constitutes a conspiracy 

to violate O.R.C. § 2923.32(A)(1), and constitutes a conspiracy to engage in a pattern of corrupt 

activity under O.R.C. § 2923.32(B), in violation of O.R.C. § 2923.01(A).

379. As direct and proximate result of the Defendants’ conspiracy, the overt action 

taken in furtherance of that conspiracy, and violations of O.R.C. §§ 2923.01(A) and 

2923.32(A)(1), Columbus has been injured in its business and property in the manner set forth in 

the Complaint above.

380. Columbus seeks all legal and equitable relief as allowed by law, including, inter 

alia, injunctive relief, full compensatory and punitive or exemplary damages, including treble 

damages, and all damages allowed by law to be paid by all Defendants, attorneys’ fees and costs, 

and pre- and post-judgment interest.

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COUNT SEVEN: VIOLATIONS OF THE RACKETEER INFLUENCED AND 

CORRUPT ORGANIZATIONS ACT (“RICO”), 18 U.S.C. § 1961(c)

(AGAINST ALL MANUFACTURER AND DISTRIBUTOR DEFENDANTS)

381. Plaintiff incorporates by reference paragraphs 1 through 380 of this Complaint, as 

if fully set forth herein, and further alleges as follows. 

382. This count is against each Manufacturer and each Distributor. 

383. At all relevant times, each Manufacturer and each Distributor is and has been a 

“person” within the meaning of 18 U.S.C. § 1961(3), because they are capable of holding, and do 

hold, “a legal or beneficial interest in property.”

384. Columbus is a “person,” as that term is defined in 18 U.S.C. § 1961(3), and has 

standing to sue as it was and is injured in its business and/or property as a result of the 

Defendants’ wrongful conduct described herein. 

385. Manufacturers, Distributors, the KOLs, and the Front Groups are an associationin-fact enterprise (the “Opioid Enterprise”) within the meaning of 18 U.S.C. § 1961(4). 

386. Based on the facts alleged above, the Opioid Enterprise has been in existence for 

more than 20 years, and continues through the present. The Opioid Enterprise, pursued and 

continues to pursue, a common purpose of causing the prescription of opioids to treat chronic 

pain. Manufacturers also marketed and promoted the purported safe use of opioids to treat 

chronic pain through their own efforts, and through enlisting the KOLs and Front Groups. 

Manufacturers enlisted the Distributors to distribute the opioids to pharmacies and doctors. 

387. The Opioid Enterprise engaged in, and its activities affected, interstate and 

foreign commerce because it involved commercial activities across state boundaries, including 

but not limited to: (1) the marketing, promotion, and advertisement of opioids; (2) the advocacy 

at the state and federal level for change in the law governing the use and prescription of opioids; 

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(3) the distribution of suspicious shipments of opioids; (4) the issuance of prescriptions and 

prescription guidelines for opioids; and (5) the issuance of fees, bills, and statements demanding 

payment for prescriptions of opioids. 

388. Each Manufacturer and each Distributor agreed to and did conduct and participate 

in the conduct of the Opioid Enterprise’s affairs through a pattern of racketeering activity and for 

the unlawful purpose of illegally selling and distributing opioids (the “Scheme”). Specifically, 

each Manufacturer and each Distributor in dealing “in a controlled substance or listed chemical 

(as defined in section 102 of the Controlled Substances Act), which is chargeable under State law 

and punishable by imprisonment for than one year.” 18 U.S.C. §1961(1)(A). In addition, each 

Manufacturer and each Distributor violated 18 U.S.C. §§ 1341 and 1342 (i.e., mail and wire 

fraud). 

389. Each Manufacturer violated O.R.C. §2925.02(A), which provides: 

No person shall knowingly do any of the following: 

(1) By force, threat, or deception, administer to another or induce or 

cause another to use a controlled substance; 

(2) By any means, administer or furnish to another or induce or cause 

another to use a controlled substance with purpose to cause serious 

physical harm to the other person, or with purpose to cause the 

other person to become drug dependent; 

(3) By 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[.] 

390. Each Manufacturer violated O.R.C. §2925.02(A) by deceptively inducing citizens 

of Columbus to use opioids, inducing and causing citizens of Columbus to use opioids for the 

purposes causing them to be dependent on opioids, inducing and causing citizens of Columbus to 

use opioids and causing those persons to become drug dependent. Each Distributor violated 

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O.R.C. §2925.02(A)(3) because it knew or had reasonable cause to know that opioids that it sold 

were intended for sale or resale through illegal means. 

391. Each Manufacturer and each Distributor violated O.R.C. § 2925.03(A), which 

provides: 

No person shall knowingly do any of the following: 

(1) Sell or offer to sell a controlled substance or a controlled substance 

analog; 

(2) Prepare for shipment, ship, transport, deliver, prepare for 

distribution, or distribute a controlled substance or a controlled 

substance analog, when the offender knows or has reasonable 

cause to believe that the controlled substance or a controlled 

substance analog is intended for sale or resale . . . .” 

392. Each Manufacturer and each Distributor violated O.R.C. § 2925.03(A) by selling 

and distributing opioids in Columbus and because they know or had reasonable cause to believe 

that the opioids they sold and distributed would be illegally resold. 

393. The Manufacturer and Distributors are not protected by any exception to O.R.C. 

§§ 2925.02 and 2925.03 because their conduct did not comply with O.R.C. § 4729. Specifically, 

as set forth in the Complaint above, the Manufacturers and Distributors violated O.A.C. Section 

4729-9-16 by failing to report suspicious orders. See O.A.C. § 4729-9-16(H)(1)(e)(i) (“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.”). Any violation of Section 2925.03 is defined as “racketeering activity.” O.R.C. § 

2923.31(I)(2)(c). 

394. In addition, the Opioid Enterprise conducted its affairs through predicate acts of 

racketeering (18 U.S.C. § 1961(1)) through: 

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a. Mail Fraud: The members of the Opioid Enterprise violated 18 

U.S.C. § 1341 by sending or receiving, or by causing to be sent 

and/or received, fraudulent materials via U.S. mail or commercial 

interstate carriers for the purpose of opioids. 

b. Wire Fraud: The members of the Opioid Enterprise violated 18 

U.S.C. § 1343 by transmitting and/or receiving, or by causing to be 

transmitted and/or received, fraudulent materials by wire for the 

purpose of selling opioids. 

395. Each particular instance of mail and/or wire fraud cannot be alleged. The precise 

dates and times that the Manufacturers and Distributors used the U.S. Mail and interstate wire 

facilities are known only to the Manufacturers and Defendants. However, based on the volume 

of communications that would be necessary to market opioids for sale, each Manufacturer used 

the U.S. Mail and interstate wire facilities to perpetrate the Scheme by, among other things: 

a. Sending marketing materials that touted the benefit of opioids to 

treat chronic pain and minimizing the risks of addiction to 

physicians, KOLs and Front Groups; 

b. Conducting telephone calls with Front Groups and KOLs to 

discuss the use of opioids for chronic pain; 

c. Sending thousands of e-mails to Front Groups, KOLs, doctors, 

medical groups, and other persons and entities involved in the 

distribution and marketing chains for opioids; 

d. Sending by U.S. Mail and e-mail drafts of, or comments to, 

publications, guidelines, or other material relating to the market 

and sale of opioids; 

e. Sending by U.S. Mail and email literature to physicians that cited 

the 1980 NEJM Letter-to-the-Editor as support for the contention 

that opioids were safe to treat chronic pain; 

f. Sending by U.S. Mail and email by the Manufacturers’ sales 

representatives to physicians communications indicating that 

opioids were safe for use in treating patients for chronic pain, had 

low risk of addiction or other aberrant behavior and would improve 

patients’ function; 

g. Sending communications directed to federal and State agencies 

and others in Ohio that misrepresented the benefits and risks of 

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opioid use for the treatment of chronic pain; and 

h. Receiving monies through wire transfers relating to the sales of 

opioids. 

396. In addition, each of the following Manufacturers used the U.S. Mail or interstate 

wire facilities to make the specific statements in furtherance of their Scheme. 

397. Purdue: Defendant Purdue made false or misleading claims in violation of 18 

U.S.C. §§ 1341 and 1343 including but not limited to: (1) a 1998 video that cited a 1980 NEJM 

letter in support of the use of opioids to treat chronic pain; (2) statements made on its 2000 

“Partners Against Pain” website that represented that the addiction risk of OxyContin was 

extremely small; (3) statements in Purdue’s Risk Evaluation and Mitigation Strategy for 

OxyContin indicating that “[b]ehaviors that suggest drug abuse exist on a continuum, and painrelief seeking behavior can be mistaken for drug-seeking behavior”; (4) statements made on 

Purdue’s website and in a 2010 “Dear Healthcare Professional” letter instructing doctors to taper 

someone off of OxyContin to prevent problems associated with withdrawal in patients who were 

physically dependent opioids; (5) statements included in a 1996 sales strategy memo indicating 

that there is no ceiling dose for opioids for chronic pain; (6) statements on its website that abuseresistant products can prevent opioid addiction; and (7) statements made in advertising and a 

2007 book indicating that pain relief from opioids improve patients’ function and quality of life.. 

398. Teva: Defendant Teva made false or misleading claims in violation of 18 U.S.C. 

§§ 1341 and 1343 including but not limited to: (1) statements made regarding Actiq and Fentora 

as safe and effective treatments for chronic pain, when neither drug has been approved by the 

FDA for treatment of chronic pain; (2) statements made promoting Actiq for use in non-cancer 

patients to treat such conditions as migraines, sickle-cell pain crises, and other injuries; (3) 

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statements made promoting Actiq for use in patients who were not yet opioid-tolerant, despite its 

FDA-approved label indicating that the drug was for “opioid tolerant cancer patients with 

breakthrough cancer pain, to be prescribed by oncologist or pain specialists familiar with 

opioids”; (4) statements deliberately made to physicians other than oncologists, including general 

practitioners, promoting Actiq for off-label uses; (5) representations to pain patients that, when 

used properly, opioids “can be life savers and give all of us a quality of life we deserve”; (6) 

representations through sponsored links on Internet search engines that misrepresented the 

efficacy of Fentora without communicating any risk information. 

399. Endo: Defendant Endo also made false or misleading claims in violation of 18 

U.S.C. §§ 1341 and 1343 including but not limited to: (1) statements made, beginning in at least 

2009, on an Endo-sponsored website, PainKnowledge.com, indicating that patients “who take 

opioids as prescribed usually do not become addicted”; (2) statements made on another Endosponsored website, PainAction.com, indicating that “most chronic pain patients do not become 

addicted to opioid medications that are prescribed for them”; (3) statements made on the Endorun website, Opana.com, indicating that opioid use does not result in addiction; (4) statements 

made on the Endo-run website, Opana.com, indicating that opioid dependence can be addressed 

by dosing methods such as tapering; and (6) statements made in a publication entitled 

“Understanding Your Pain: Taking Oral Opioid Analgesics” suggesting that opioid doses “can be 

increased” indefinitely, because “[y]ou won’t ‘run out’ of pain relief”. 

400. Janssen: Defendant Janssen made false or misleading claims in violation of 18 

U.S.C. §§ 1341 and 1343 including but not limited to: (1) statements on its website, 

PrescribeResponsibly.com, indicating that concerns about opioid addiction are “overestimated,” 

and that “true addiction occurs only in a small percentage of patients”; (2) statements included 

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on a 2009 Janssen-sponsored website promoting the concept of opioid pseudoaddiction; (3) 

statements on its website, PrescribeResponsibly.com, advocating the concept of opioid 

pseudoaddiction; (4) statements on its website, PrescribeResponsibly.com, indicating that opioid 

addiction can be managed; and (5) statements in its 2009 patient education guide indicating the 

risks associated with limiting the dosages of pain medicines. 

401. Actavis: Defendant Actavis made false or misleading claims in violation of 18 

U.S.C. §§ 1341 and 1343 including but not limited to: (1) statements that “omit and minimize the 

serious risks associated with Kadian”; (2) statements that “misleadingly suggest[] that Kadian is 

safer than has been demonstrated”; (3) statements that “fail to reveal warnings regarding 

potentially fatal abuse of opioids, use by individuals other than the patient for whom the drug 

was prescribed[.]”; (4) statements that falsely conveyed that the risk of addiction was limited to 

chronic pain patients and/or patients already predisposed to abuse, addiction, and/or 

dysfunctional behavior; (5) statements that instructed physicians to look for signs of 

“pseudoaddiction” in patients; and (6) statements which suggested that the physical symptoms of 

opioid withdrawal could be adequately addressed by tapering. 

402. Distributors: The Distributors violated 18 U.S.C. §§ 1341 and 1343 by sending 

or receiving into Columbus, or by causing to be sent and/or received into Columbus, opioids, 

which have little to no demonstrated efficacy for the pain they are purported to treat in the 

majority of persons prescribed them. In addition, upon information and belief, each of the 

Distributors falsely reported to various state and federal government authorities that they were in 

compliance with state and federal laws concerning suspicious orders. Upon information and 

belief, these reports were transmitted by mail and/or wire. Distributors further violated 18 

U.S.C. § 1341 and § 1343 by: (1) using the mail to send suspicious shipments to doctors and 

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pharmacies in the City; (2) using the mail and/or wire communications to send invoices to 

doctors and pharmacies relating to the suspicious statements; and (3) using the mail and/or wire 

communications to send reports falsely stating that the Distributor was in compliance with 

federal laws concerning the distribution of opioids. 

403. All of the dates of the fraudulent uses of the U.S. mail and interstate wire facilities 

are not yet known, but on information and belief based on the volume of opioid sales by the 

Opioid Enterprise, the number of fraudulent uses of the mail and interstate wire number in tens 

of thousands and continue to today. 

404. The acts set forth in the Complaint above constitute a pattern of racketeering 

activity pursuant to 18 U.S.C. § 1961(5). 

405. The Manufacturers and Distributors have directly and indirectly conducted and 

participated in the conduct of the Opioid Enterprise’s affairs through the pattern of racketeering 

and activity described above, in violation of 18 U.S.C. § 1962(c). Each of the Manufacturers 

orchestrated the affairs of the Enterprise and exerted substantial control over the Enterprise by, at 

least: (1) manufacturing the opioids; (2) determining pricing for the opioids; (3) making 

misleading statements about the purported benefits, efficacy, and risks of opioids to doctors, 

patients, the public, and others, in the form of telephonic and electronic communications, CME 

programs, medical journals, advertisements, and websites; (4) employing sales representatives or 

detailers to promote the use of opioid medications; (5) purchasing and utilizing sophisticated 

marketing data (e.g., IMS data) to coordinate and refine the sale and distribution of opioids; (6) 

employing doctors to serve as speakers at or attend all-expense paid trips to programs 

emphasizing the benefits of prescribing opioid medications; (7) funding, controlling, and 

operating the Front Groups to target doctors, patients, and lawmakers and provide a veneer of 

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legitimacy to the Scheme; (8) retaining KOLs to tout the benefits of opioid medicines; and (9) 

concealing the true nature of their relationship with the other members of the Enterprise, 

including the Front Groups and the KOLs.

406. Each Distributor orchestrated the affairs of the Opioid Enterprise and exerted 

substantial control over the Enterprise by, at least: (1) shipping significant doses of opioids in 

Columbus, the sheer volume of which should have, or actually did, put them on notice to 

investigate and report such orders; (2) refusing to report such suspicious orders; (3) refusing to 

report suspicious prescribers; (4) failing to refuse to fill suspicious orders; (5) affirmatively 

misrepresenting the efforts they were taking to curb the growing epidemic; and (6) concealing 

the true nature of their relationship with the other members of the Enterprise. 

407. As a direct and proximate result of the Manufacturer and Distributors’ 

racketeering activities and violations of 18 U.S.C. § 1962(c), Columbus has been injured in its 

business and property in the manner set forth in the Complaint above. 

408. Columbus seeks all legal and equitable relief as allowed by law, including, inter 

alia, injunctive relief, full compensatory and punitive or exemplary damages, including treble 

damages, and all damages allowed by law to be paid by all Defendants, attorneys’ fees and costs, 

and pre- and post-judgment interest.

COUNT EIGHT: VIOLATIONS OF RICO, 18 U.S.C. § 1961(d)

(AGAINST ALL DEFENDANTS)

409. Plaintiff incorporates by reference paragraphs 1 through 408 of this Complaint as 

if fully set forth here, and further alleges as follows. 

410. This Count is against all Defendants. 

411. Defendants agreed and conspired to violate 18 U.S.C. § 1962(c). Specifically, the 

Manufacturers entered into various agreements with the KOLs pursuant to which the KOLs 

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would falsely promote the safety of opioids to treat chronic pain. The KOLS agreed to 

knowingly facilitate the activities of the Manufacturer and Distributors. The Distributors entered 

into agreements with the Manufacturers to distribute the opioids. The Distributors agreed to 

knowingly facilitate the activities of the Manufacturers by distributing opioids in violation of 

state and federal rules regarding suspicious orders. 

412. Defendants have intentionally conspired and agreed to directly or indirectly 

conduct and participate in the conduct of the affairs of the enterprise through a pattern of 

racketeering activity. Defendants knew that their predicate acts were part of a pattern of 

racketeering activity and agreed to the commission of to further the schemes described above. 

The conduct constitutes a conspiracy to violate 18 U.S.C. §1962(c), in violation of 18 U.S.C. 

§1962(d).

413. As direct and proximate result of the Defendants’ conspiracy, the overt action 

taken in furtherance of that conspiracy, and violations of 18 U.S.C. §1962(d), Columbus has 

been injured in its business and property in the manner set forth in the Complaint above.

414. Columbus seeks all legal and equitable relief as allowed by law, including, inter 

alia, injunctive relief, full compensatory and punitive or exemplary damages, including treble 

damages, and all damages allowed by law to be paid by all Defendants, attorneys’ fees and costs, 

and pre- and post-judgment interest.

COUNT NINE: NEGLIGENCE

(AGAINST ALL DEFENDANTS)

415. Plaintiff incorporates by reference paragraphs 1 through 414 of this Complaint as 

if fully set forth here, and further alleges as follows. 

416. Each Defendant had an obligation to exercise due care in distributing opioids to 

Columbus and its surrounding areas. 

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417. Each Defendant owed a duty to Columbus and its surrounding areas, and to the 

public health and safety in Columbus, because the injury was foreseeable, and in fact foreseen. 

418. Reasonably prudent manufacturers, physicians, and distributors would have 

anticipated that the widespread use of opioids would cause addiction and would wreak havoc on 

communities. 

419. The Manufacturers, the Distributors and the KOLs breached their duties to 

exercise due care in the business of manufacturing, promoting, and distributing opioids. Because 

the very purpose of these duties was to prevent the resulting harm – addiction to opioids – the 

causal connection between the Defendants’ breach of duties and the ensuing harm was entirely 

foreseeable. 

420. The Defendants’ breach of duty caused, bears a causal connection with, and/or 

proximately resulted in, harm and damages to Columbus. 

421. Defendants acted with actual malice or were reckless. 

422. Columbus seeks all legal and equitable relief as allowed by law, including inter 

alia, injunctive relief, compensatory and punitive damages, and all damages allowed by law to 

be paid by the Defendants, attorneys’ fees and costs, and pre- and post-judgment interest. 

COUNT TEN: NEGLIGENCE PER SE 

(AGAINST MANUFACTURER AND DISTRIBUTOR DEFENDANTS)

423. Plaintiff incorporates by reference paragraphs 1 through 422 of this Complaint as 

if fully set forth herein, and further alleges as follows. 

424. O.R.C. §§ 2925.02, 2925.03, 3767.01, 4729.35, and O.A.C. §§ 4729-9-12, 4729-

9-16, 4729-9-28, are public safety laws. Each Manufacturer and Distributor had a duty under, 

inter alia, these laws to maintain effective controls against diversion of prescription opioids and 

to guard against, prevent, and report suspicious orders of opioids. The Manufacturer’s and 

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Distributors’ violations of the law constitute negligence per se. 

425. It was foreseeable that the breach of their duties would result in the damages 

sustained by Columbus. 

426. The Manufacturers and Distributors breached their duties. 

427. The Manufacturers’ and Distributors’ breach of statutory and regulatory duties 

caused, bears a causal connection with, and proximately resulted in, harm and damages to 

Columbus.

428. The Manufacturers and Distributors acted with actual malice or were reckless.

429. Columbus seeks all legal and equitable relief as allowed by law, including inter 

alia injunctive relief, compensatory and punitive damages, and all damages allowed by law to be 

paid by the Manufacturers and Distributors, attorneys’ fees and costs, and pre- and postjudgment interest.

COUNT ELEVEN: DECEPTIVE TRADE PRACTICES ACT, O.R.C. § 4165.01, et seq. 

(AGAINST MANUFACTURER DEFENDANTS AND KOL DEFENDANTS)

430. Columbus incorporates by reference paragraphs 1 through 429 of this Complaint 

as if fully set forth herein, and further alleges as follows.

431. The Manufacturers and KOLs have committed deceptive trade practices by 

causing a likelihood of confusion or misunderstanding as to affiliation, or connection with 

another, in violation of O.R.C. § 4165.02(A)(3).

432. The Manufacturers and KOLs have also committed deceptive trade practices by 

representing, and continuing to represent, that the Manufacturers’ opioids have characteristics, 

uses, or benefits that they do not have, in violation of O.R.C. § 4165.02(A)(7).

433. Purdue’s deceptive trade practices include, but are not limited to, (1) making 

misleading statements; (2) funding, controlling, and operating the Front Groups, including the 

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American Pain Foundation and the Pain & Policy Studies Group; (3) participating in the Pain 

Care Forum, a coalition of drug makers, trade groups, and nonprofit organizations that, 

collectively, spent hundreds of millions of dollars lobbying against opioid-related measures; (4) 

retaining the KOLs to tout the benefits of opioid medicines; and (5) concealing the true nature of 

its relationship with the other Manufacturers and KOLs.

434. Teva’s deceptive trade practices include, but are not limited to, (1) making 

misleading statements, particularly regarding the promotion of opioids for off-label uses; (2) 

funding, controlling, and operating the Front Groups, including the American Pain Foundation 

and the Pain & Policy Studies Group; (3) sponsoring a series of CME programs which claimed 

that opioid therapy has been shown to reduce pain and depressive symptoms; (4) supporting and 

sponsoring guidelines indicating that opioid medications are effective and can restore patients’ 

quality of life; (5) participating in the Pain Care Forum, a coalition of drug makers, trade groups, 

and nonprofit organizations that, collectively, spent hundreds of millions of dollars lobbying 

against opioid-related measures; (6) retaining the KOLs to tout the benefits of opioid medicines; 

and (7) concealing the true nature of its relationship with the other Manufacturers and KOLs.

435. Endo’s deceptive trade practices include, but are not limited to, (1) making 

misleading statements; (2) sponsoring a 2009 National Initiative on Pain Control CME program 

which promoted the concept of pseudoaddiction; (3) funding, controlling, and operating the 

Front Groups, including the American Pain Foundation and the Pain & Policy Studies Group; (3) 

sponsoring a series of CME programs which claimed that opioid therapy has been shown to 

reduce pain and depressive symptoms; (4) supporting and sponsoring guidelines indicating that 

opioid medications are effective and can restore patients’ quality of life; (5) participating in the 

Pain Care Forum, a coalition of drug makers, trade groups, and nonprofit organizations that, 

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collectively, spent hundreds of millions of dollars lobbying against opioid-related measures; (6) 

retaining the KOLs to tout the benefits of opioid medicines; and (7) concealing the true nature of 

its relationship with the other Manufacturers and KOLs.

436. Janssen’s deceptive trade practices include, but are not limited to, (1) making 

misleading statements; (2) funding, controlling, and operating Front Groups, including the Pain 

& Policy Studies Group; (3) supporting and sponsoring guidelines indicating that opioid 

medications are effective and can restore patients’ quality of life; (4) sponsoring, funding, and 

editing a website which features an interview indicating that opioid medications can improve 

patients’ function; (5) participating in the Pain Care Forum, a coalition of drug makers, trade 

groups, and nonprofit organizations that, collectively, spent hundreds of millions of dollars 

lobbying against opioid-related measures; (6) retaining the KOLs to tout the benefits of opioid 

medicines; and (7) concealing the true nature of its relationship with the other Manufacturers and 

KOLs.

437. Actavis’ deceptive trade practices include, but are not limited to, (1) making 

misleading statements; (2) funding, controlling, and operating the Front Groups, including the 

American Pain Foundation and the Pain & Policy Studies Group; (3) sponsoring a series of CME 

programs which claimed that opioid therapy has been shown to reduce pain and depressive 

symptoms; (4) supporting and sponsoring guidelines indicating that opioid medications are 

effective and can restore patients’ quality of life; (5) retaining the KOLs to tout the benefits of 

opioid medicines; and (6) concealing the true nature of its relationship with the other 

Manufacturers and KOLs.

438. The KOLs’ deceptive trade practices include, but are not limited to, (1) making 

misleading statements about the purported benefits, efficacy, and low risks of opioids; (2) 

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holding themselves out as independent, when in fact there are systematically linked to and 

funded by opioid drug manufacturers; and (3) concealing the true nature of their relationship 

with the Manufacturers.

439. Columbus and its residents have been injured by reason of the Manufacturers’ and 

the KOLs’ violations of O.R.C. Chapter 4165.

440. Columbus seeks 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 Manufacturers and the KOLs, attorneys’ fees 

and costs, and pre- and post-judgment interest.

PRAYER FOR RELIEF

WHEREFORE, Plaintiff respectfully prays that this Court grant the following relief:

1. Enter Judgment in favor of the City of Columbus in a final order against each of 

the Defendants;

2. Enjoin 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 them, from engaging in the unlawful 

manufacture, marketing, distribution and sales of prescription opioid pills and ordering a 

permanent injunction;

3. Order that the Defendants compensate the City for its past and future costs to 

abate the continuing and absolute public nuisance caused by the opioid epidemic;

4. Impose an award of actual and triple the actual damages the City has sustained as 

a result of Defendants’ violations of the Ohio Corrupt Practices Act and the Racketeer Influenced 

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and Corrupt Organizations Act, and an award of the City’s reasonable Attorney’s’ fees incurred 

in prosecuting those violations;

5. Award the City its damages caused by abating the opioid epidemic, and to be 

incurred, including, but not limited to, (a) costs for providing medical care, additional therapeutic 

and prescription drug purchases, and other treatments/services for patients suffering from opioidrelated 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 associated with law enforcement and public safety 

relating to the opioid epidemic; and (e) any other costs, expenses or damages caused by the 

Defendants’ conduct described above;

6. Order the Defendants to fund an “abatement fund” for the purposes of abating the 

opioid nuisance;

7. Order Defendants to fund a “treatment fund” for the purposes of treating those 

throughout Columbus who have become addicted or otherwise injured as a result of the 

oversaturation of opioids created by the Defendants;

8. Award judgment requiring Defendants to pay punitive and exemplary damages; 

and 

9. Grant Columbus court costs, including reasonable attorneys’ fees, pre-judgment 

and post-judgment interest, and all other relief as provided by law and/or as the Court deems 

appropriate and just. 

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CITY OF COLUMBUS, DEPARTMENT OF LAW 

RICHARD C. PFEIFFER, JR., CITY ATTORNEY 

By: s/Michael H. Carpenter 

Michael H. Carpenter (0015733) (Trial Attorney) 

Timothy R. Bricker (0061872) 

CARPENTER LIPPS AND LELAND LLP 

280 Plaza, Suite 1300 

280 North High Street 

Columbus, OH 43215 

E-mail:carpenter@carpenterlipps.com

bricker@carpenterlipps.com

 Special Counsel for Plaintiff 

The City of Columbus 

Joshua T. Cox (0029860) 

Chief Counsel 

Columbus City Attorney’s Office 

77 N. Front Street, 4th Floor 

Columbus, Ohio 43215 

(614) 645-7385 telephone 

(614) 645-6949 facsimile 

jtcox@columbus.gov

JURY DEMAND

Columbus demands that this case be tried to a jury comprised of the maximum number 

permitted by law. 

 s/Michael H. Carpenter

 One of the Attorneys for the 

City of Columbus 

 

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