Case: 1:20-op-45229-DAP Doc #: 1 Filed: 08/10/20 1 of 67. PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF OHIO
`EASTERN DIVISION
`
`CASE NO.: _______________________
`
`COMPLAINT
`
`JURY TRIAL DEMANDED
`
`WAYNE FARMS , LLC,
`Plaintiff,
`
`v.
`
`MCKESSON CORPORATION;
`CARDINAL HEALTH, INC.;
`AMERISOURCEBERGEN CORPORATION;
`TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.;
`TEVA PHARMACEUTICALS USA, INC.;
`CEPHALON, INC.;
`JOHNSON & JOHNSON;
`JANSSEN PHARMACEUTICALS, INC.;
`ORTHO-MCNEIL-JANSSEN
`PHARMACEUTICALS, INC. n/k/a
`JANSSEN PHARMACEUTICALS, INC.;
`JANSSEN PHARMACEUTICA INC. n/k/a
` JANSSEN PHARMACEUTICALS, INC.;
`ENDO HEALTH SOLUTIONS INC.;
`
`ENDO PHARMACEUTICALS, INC.;
`ALLERGAN PLC f/k/a ACTAVIS PLC;
`ALLERGAN FINANCE, LLC;
`
`WATSON PHARMACEUTICALS, INC.
`n/k/a ACTAVIS, INC.;
`WATSON LABORATORIES, INC.;
`ACTAVIS LLC; ACTAVIS PHARMA, INC.
`f/k/a WATSON PHARMA, INC.;
`MALLINCKRODT, PLC d/b/a
`
`MALLINCKRODT PHARMACEUTICALS;
`MALLINCKRODT, LLC;
`CVS HEALTH CORPORATION;
`RITE-AID OF MARYLAND, INC.;
`RITE-AID CORP;
`WALGREENS BOOTS ALLIANCE, INC.;
`WAL-MART INC.;
`John Does 1-100;
`
`Defendants.
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`Case: 1:20-op-45229-DAP Doc #: 1 Filed: 08/10/20 2 of 67. PageID #: 2
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`COMPLAINT
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`The Plaintiff, Wayne Farms LLC, a company providing health and welfare benefits to its
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`employees and their families, (hereinafter referred to as “Wayne Farms”), by and through its
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`attorneys, files this Complaint against the Defendants as follows:
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`
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`1.
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`
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`
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`
`
`INTRODUCTION
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`The addiction epidemic of prescription opioid abuse in the United States has
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`caused businesses, including Wayne Farms, extraordinary economic damages. This opioid
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`epidemic has financially damaged Wayne Farms. Wayne Farms seeks, in part,
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`reimbursement of losses incurred as a result of the opioid epidemic including without
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`limitation medical care, opioid-related illnesses, workers compensations and disability
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`premium increases, employee downtime, employee retraining, employee counseling, and
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`other costs.
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`2.
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`Prescription opioids are deadlier than heroin, with related drug overdose
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`deaths surpassing car accident deaths in the United States. The direct costs incurred by
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`health and welfare funds, including Wayne Farms, are overwhelming.
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`3.
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`This epidemic and its consequences could have been, and should have been,
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`prevented by the Defendants who control the U.S. drug distribution industry and the Defendants
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`who manufacture prescription opioids. These Defendants have profited greatly by allowing the
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`geographic area that Wayne Farms serves to become flooded with prescription opioids.
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`4.
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`The drug distribution industry is supposed to serve as a "check" in the drug delivery
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`system by securing and monitoring opioids at every step of the stream of commerce, protecting
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`them from theft and misuse, and refusing to fulfill suspicious or unusual orders by downstream
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`pharmacies, doctors, clinics, or patients. Defendants woefully failed in this duty by consciously
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`ignoring known or knowable problems and data in their custody, control, and/or possession.
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`5.
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`Defendants thus intentionally and negligently created conditions in which vast
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`amounts of opioids have overflowed freely from and through the Defendants to innocent patients
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`who became addicted, to opioid abusers, and even to illicit drug dealers.
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`6.
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`Defendants’ wrongful conduct has allowed millions of opioid pills to be diverted
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`from legitimate channels of distribution into the illicit black market in quantities that have fueled
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`the opioid epidemic in the Wayne Farms area – where the participants of Wayne Farms and their
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`families live and work. This is "opioid diversion." Acting against their common law and statutory
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`duties, Defendants have caused a black market in opioid pills and other opioid drugs in which
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`opioid diversion is rampant.
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`7.
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`For years, Defendants and their agents have had the ability to substantially reduce
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`the death toll and adverse economic consequences of opioid diversion, including the deaths and
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`health ruination of hundreds of thousands of citizens. Substantial expenditures by Wayne Farms
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`in dealing with the problem have gone un-recouped and unreimbursed. All the Defendants share
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`responsibility for perpetuating the epidemic.
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`8.
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`Defendants have foreseeably caused damages to Wayne Farms, including the
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`unreimbursed and/or un-recouped costs from the over-prescription of opioids.
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`9.
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`Wayne Farms brings this civil action for injunctive relief, compensatory damages,
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`statutory damages, and any other relief allowed by law against the Defendant opioid drug
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`distributors, retailers, and manufacturers that, by their actions and omissions, knowingly or
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`negligently have distributed, dispensed, and/or over-prescribed prescription opioid drugs in a
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`manner that foreseeably injured, and continues to injure, Wayne Farms.
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`10.
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`Plaintiff has strived to hold and manage its resources and assets and to only pay
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`reasonable expenses. To succeed and flourish Plaintiff strives to prevent waste or to otherwise
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`prohibit asset dilution. As a result of the misconduct of Defendants, Plaintiff has suffered
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`unnecessary and wasteful diversion and diminution of its assets.
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`PARTIES
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`11.
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`The Plaintiff is a company and an employer providing health and welfare benefits
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`and other benefits to its employees and their families. At all relevant times, Plaintiff’s costs have
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`increased directly or indirectly due to Defendants’ Misconduct. Plaintiff has sustained injury as a
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`result of Defendants’ illegal and wrongful conduct alleged herein, including but not limited to,
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`incurring unreimbursed costs related to the over-prescription of opioids.
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`12. McKesson Corporation ("McKesson”) has its principal place of business in San
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`Francisco, California, and is incorporated under the laws of Delaware. During all relevant times,
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`McKesson has distributed substantial amounts of prescription opioids to providers and retailers in
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`the geographic area of participants of Wayne Farms.
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`13. Cardinal Health, Inc. ("Cardinal”) has its principal place of business in Ohio and is
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`incorporated under the laws of Ohio. During all relevant times, Cardinal has distributed substantial
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`amounts of prescription opioids to providers and retailers in the geographic area of participants of
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`Wayne Farms.
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`14.
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`AmerisourceBergen Corporation has its principal place of business in Pennsylvania
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`and is incorporated under the laws of Delaware. During all relevant times, AmerisourceBergen has
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`distributed substantial amounts of prescription opioids to providers and retailers in the geographic
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`area of the participants of Wayne Farms.
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`15. McKesson, Cardinal, and AmerisourceBergen are collectively referred to
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`hereinafter as “Distributor Defendants.”
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`16.
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`Cephalon, Inc. (“Cephalon”) is a Delaware corporation with its principal place of
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`business in Frazer, Pennsylvania. Cephalon manufactures, promotes, sells, and distributes opioids
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`such as Actiq and Fentora in the U.S., and Georgia. Actiq and Fentora have been approved by the
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`FDA only for the “management of breakthrough cancer pain in patients 16 years of age and older
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`who are already receiving and who are tolerant to opioid therapy for their underlying persistent
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`cancer pain.” In 2008, Cephalon pled guilty to a criminal violation of the Federal Food, Drug and
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`Cosmetic Act for its misleading promotion of Actiq and two other drugs and agreed to pay $425
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`million.
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`17.
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`Teva Pharmaceutical Industries, Ltd. (“Teva Ltd.”) is an Israeli corporation with its
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`principal place of business in Petah Tikva, Israel. Teva Pharmaceuticals USA, Inc. (“Teva USA”)
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`is a wholly-owned subsidiary of Teva Ltd. and is a Delaware corporation with its principal place
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`of business in Pennsylvania. Teva USA acquired Cephalon in October 2011.
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`18.
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`Teva Ltd., Teva USA, and Cephalon collaborate to market and sell Cephalon
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`products in the U.S. Teva Ltd. conducts all sales and marketing activities for Cephalon in the U.S.
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`through Teva USA. Teva Ltd. and Teva USA publicize Actiq and Fentora as Teva products. Teva
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`USA sells all former Cephalon branded products through its “specialty medicines” division. The
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`FDA-approved prescribing information and medication guide, which is distributed with Cephalon
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`opioids marketed and sold in Georgia, discloses that the guide was submitted by Teva USA, and
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`directs physicians to contact Teva USA to report adverse events. Teva Ltd. has directed Cephalon
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`to disclose that it is a wholly-owned subsidiary of Teva Ltd. on prescription savings cards
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`distributed in Georgia, indicating Teva Ltd. would be responsible for covering certain co-pay costs.
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`All of Cephalon’s promotional websites, including those for Actiq and Fentora, prominently
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`display Teva Ltd.’s logo. Teva Ltd.’s financial reports list Cephalon’s and Teva USA’s sales as its
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`own. Through interrelated operations like these, Teva Ltd. operates in Georgia, and the rest of
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`the U.S. through its subsidiaries Cephalon and Teva USA. The U.S. is the largest of Teva Ltd.’s
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`global markets, representing 53% of its global revenue in 2015, and, were it not for the existence
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`of Teva USA and Cephalon, Inc., Teva Ltd. would conduct those companies’ business in the
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`United States itself. Upon information and belief, Teva Ltd. directs the business practices of
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`Cephalon and Teva USA, and their profits inure to the benefit of Teva Ltd. as controlling
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`shareholder. (Teva Ltd., Teva USA, and Cephalon, Inc. are hereinafter collectively referred to as
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`“Cephalon.”)
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`19.
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`Janssen Pharmaceuticals, Inc. is a Pennsylvania corporation with its principal place
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`of business in Titusville, New Jersey, and is a wholly-owned subsidiary of Johnson & Johnson
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`(J&J), a New Jersey corporation with its principal place of business in New Brunswick, New
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`Jersey. Ortho-McNeil-Janssen Pharmaceuticals, Inc., now known as Janssen Pharmaceuticals,
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`Inc., is a Pennsylvania corporation with its principal place of business in Titusville, New Jersey.
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`Janssen Pharmaceutica Inc., now known as Janssen Pharmaceuticals, Inc., is a Pennsylvania
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`corporation with its principal place of business in Titusville, New Jersey. J&J is the only company
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`that owns more than 10% of Janssen Pharmaceuticals’ stock, and corresponds with the FDA
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`regarding Janssen’s products. Upon information and belief, J&J controls the sale and development
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`of Janssen Pharmaceuticals’ drugs and Janssen’s profits inure to J&J’s benefit. (Janssen
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`Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica, Inc.,
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`and J&J hereinafter are collectively referred to as “Janssen.”). Janssen manufactures, promotes,
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`sells, and distributes drugs in the U.S., and Georgia, including the opioid Duragesic. Until January
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`2015, Janssen developed, marketed, and sold the opioids Nucynta and Nucynta ER.
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`20.
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`Endo Health Solutions Inc. is a Delaware corporation with its principal place of
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`business in Malvern, Pennsylvania. Endo Pharmaceuticals Inc. is a wholly-owned subsidiary of
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`Endo Health Solutions Inc. and is a Delaware corporation with its principal place of business in
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`Malvern, Pennsylvania. (Endo Health Solutions Inc. and Endo Pharmaceuticals Inc. hereinafter
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`are collectively referred to as “Endo.”) Endo develops, markets, and sells prescription drugs,
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`including the opioids Opana/Opana ER, Percodan, Percocet, and Zydone, in the U.S., and Georgia.
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`Endo also manufactures and sells generic opioids such as oxycodone, oxymorphone,
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`hydromorphone, and hydrocodone products in the U.S., and Georgia, by itself and through its
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`subsidiary, Qualitest Pharmaceuticals, Inc.
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`21.
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`Allergan PLC is a public limited company incorporated in Ireland with its principal
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`place of business in Dublin, Ireland. Actavis PLC acquired Allergan PLC in March 2015, and the
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`combined company changed its name to Allergan PLC in January 2013. Before that, Watson
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`Pharmaceuticals, Inc. acquired Actavis, Inc. in October 2012, and the combined company changed
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`its name to Actavis, Inc. as of January 2013, later to Actavis PLC in October 2013. Watson
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`Laboratories, Inc. is a Nevada corporation with its principal place of business in Corona,
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`California, and is a wholly-owned subsidiary of Allergan PLC (f/k/a Actavis, Inc. f/k/a Watson
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`Pharmaceuticals, Inc.). Actavis Pharma, Inc. (f/k/a Actavis, Inc.) is a Delaware corporation with
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`its principal place of business in New Jersey and was formerly known as Watson Pharma, Inc.
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`Actavis LLC is a Delaware limited liability company with its principal place of business in
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`Parsippany, New Jersey. Each of these defendants is owned by Allergan PLC, which uses them to
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`market and sell its drugs in the United States. Upon information and belief, Allergan PLC exercises
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`control over and derives financial benefit from the marketing, sales, and profits of
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`Allergan/Actavis products. Allergan Finance, LLC is a wholly-owned subsidiary of Allergan plc,
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`which markets and sells Allergan plc’s drugs in the United States. Allergan plc and Allergan
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`Finance, LLC are collectively referred to herein as “Allergan.” Allergan PLC, Allergan Finance,
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`LLC, Actavis PLC, Actavis, Inc., Actavis LLC, Actavis Pharma, Inc., Watson Pharmaceuticals,
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`Inc., Watson Pharma, Inc., and Watson Laboratories, Inc. hereinafter are referred to collectively
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`as “Actavis.” Actavis manufactures, promotes, sells, and distributes opioids, including the branded
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`drugs Kadian and Norco, a generic version of Kadian, and generic versions of Duragesic and
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`Opana, in the U.S., and Georgia. Actavis acquired the rights to Kadian from King
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`Pharmaceuticals, Inc. on December 30, 2008, and began marketing Kadian in 2009.
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`22. Mallinckrodt, PLC, an alien company, doing business as Mallinckrodt
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`Pharmaceuticals with its principal place of business in the United States in St. Louis, Missouri.
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`Mallinckrodt, LLC is a Delaware limited liability company, also doing business as Mallinckrodt
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`Pharmaceuticals, with its principal place of business in the United States in Hazelwood, Missouri.
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`Mallinckrodt plc and Mallinckrodt LLC are collectively referred to herein as “Mallinckrodt.”
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`Malinckrodt is one of the largest manufacturers of the generic opioid oxycodone.
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`23. Cephalon, Janssen, Endo, Actavis, and Mallinckrodt are collectively referred to
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`hereinafter as the “Pharmaceutical Defendants.”
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`24.
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`Defendant CVS Health Corporation (“CVS”) is a Delaware corporation with its
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`principal place of business in Rhode Island. CVS, through its various DEA registered subsidiaries
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`and affiliated entities, conducts business as a licensed wholesale distributor. At all times relevant
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`to this Complaint, CVS distributed prescription opioids throughout the United States.
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`25.
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`Defendant Rite-Aid of Maryland, Inc., d/b/a Rite Aid Mid Atlantic Customer
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`Support Center, Inc. and Rite Aid Corp. (“Rite Aid”), are a Delaware corporation with its principal
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`office located in Camp Hill, Pennsylvania. Rite Aid, through its various DEA registered
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`subsidiaries and affiliated entities, conducts business as a licensed wholesale distributor. At all
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`times relevant to this Complaint, Rite Aid, through its various DEA registered subsidiaries and
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`affiliated entities, distributed prescription opioids throughout the United States.
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`26.
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`Defendant Walgreen Boots Alliance, Inc., also known as Walgreen Co.
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`(“Walgreens”) is a Delaware corporation with its principal place of business in Illinois. Walgreens,
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`through its various DEA registered subsidiaries and affiliated entities, conducts business as a
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`licensed wholesale distributor. At all times relevant to this Complaint, Walgreens distributed
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`prescription opioids throughout the United States.
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`27.
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`Defendant Wal-Mart, Inc., formerly known as Wal-Mart Stores, Inc. (“Wal-Mart”),
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`is a Delaware corporation with its principal place of business in Bentonville, Arkansas. Wal-Mart,
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`through its various DEA registered subsidiaries and affiliated entities, conducts business as a
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`licensed wholesale distributor. At all times relevant to this Complaint, Wal-Mart distributed
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`prescription opioids throughout the United States.
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`28.
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`The Plaintiff presently lacks information sufficient to specifically identify the true
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`names or capacities, whether individual, corporate or otherwise, of the Defendants sued herein
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`under the fictitious names, DOES 1 through 100 inclusive. The Plaintiff will amend this Complaint
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`to show their true names and capacities if and when they are ascertained. The Plaintiff is informed
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`and believes, and on such information and belief alleges, that each of the Defendants named as a
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`DOE is responsible in some manner for the events and occurrences alleged in this Complaint and
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`is liable for the relief sought herein.
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`JURISDICTION AND VENUE
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`29.
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`The Plaintiff brings this civil action in In Re: National Prescription Opiate
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`Litigation, MDL 2804, and files directly in the Northern District of Ohio as permitted in Paragraph
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`6(a) of this Court’s Case Management Order No. 1 dated April 11, 2018 (Doc. # 232).
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`30.
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`Jurisdiction of this Court arises under the laws of the United States 28 U.S.C. §
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`1392 as the parties are citizens of different states and the amount in controversy exceeds
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`$75,000.00, exclusive of attorney’s fees and costs. This Court has supplemental jurisdiction over
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`the Plaintiff’s state law claims pursuant to 28 U.S.C. § 1367.
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`31.
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`Defendants have engaged in conduct and activities over a long time, systematically,
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`individually, jointly, and severally, in the geographic area served by Wayne Farms that have
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`caused all of the Plaintiff’s damages and all of which form the bases of the causes of action in this
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`Complaint as against Defendants. Defendants have committed multiple torts and breaches within
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`the geographic areas in which Wayne Farms serves, repeatedly and systematically. Defendants,
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`for a long time, repeatedly and systematically, have substantial contacts and business relationships
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`with Wayne Farms, some or all of which form the basis of the causes of action in this Complaint
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`as against Defendants.
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`32.
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`The U.S. District Court, Northern District of Georgia, has personal jurisdiction over
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`Defendants, each of which has substantial contacts and business dealings throughout by virtue of
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`the distribution, dispensing, and sales of prescription opioids within Georgia. All causes of action
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`herein relate to Defendants’ wrongful actions, conduct, and omissions within Georgia and
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`consequences and damages related to said wrongful actions, conduct, and omissions.
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`33.
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`Venue is proper in the U.S. District Court, Northern District of Georgia because
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`many of the Defendants’ acts and omissions that gave rise to the causes of action of this Complaint
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`occurred in this judicial District. Plaintiff states that, but for the Order permitting direct filing into
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`the Northern District of Ohio pursuant to Case Management Order No. 1, dated April 11, 2018,
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`Plaintiff would have filed in the U.S. District Court, Northern District of Georgia.
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`BACKGROUND FACTS
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`34.
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`Opioid means "opium-like," and the term includes all drugs derived in whole or in
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`part from the opium poppy.
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`35.
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`The United States Food and Drug Administration’s website describes this class of
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`drugs as follows: "Prescription opioids are powerful pain-reducing medications that include
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`prescription oxycodone, hydrocodone, and morphine, among others, and have both benefits as well
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`as potentially serious risks. These medications can help manage pain when prescribed for the right
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`condition and when used properly. But when misused or abused, they can cause serious harm,
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`including addiction, overdose, and death."
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`36.
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`Prescription opioids with the highest potential for addiction are categorized under
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`Schedule II of the Controlled Substances Act. They include non-synthetic derivatives of the opium
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`poppy (such as codeine and morphine, which are also called "opiates”), partially synthetic
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`derivatives (such as hydrocodone and oxycodone), or fully synthetic derivatives (such as fentanyl
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`and methadone).
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`37.
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`Before the epidemic of Defendants’ prescription opioids, the generally accepted
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`standard of medical practice was that opioids should only be used short-term for acute pain, pain
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`relating to recovery from surgery, or for cancer or palliative (end-of-life) care. Due to the lack of
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`evidence that opioids improved patients’ ability to overcome pain and function, coupled with
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`evidence of greater pain complaints as patients developed tolerance to opioids over time and the
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`serious risk of addiction and other side effects, the use of opioids for chronic pain was discouraged
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`or prohibited. As a result, doctors generally did not prescribe opioids for chronic pain.
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`38.
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`To establish and exploit the lucrative market of chronic pain patients, each
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`Pharmaceutical Defendant developed a well-funded, sophisticated, and deceptive marketing
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`and/or distribution scheme targeted at consumers and physicians. These Defendants used direct
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`marketing, as well as veiled advertising by seemingly independent third parties to spread false and
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`deceptive statements about the risks and benefits of long-term opioid use – statements that created
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`the “new” market for prescription opioids, upended the standard medical practice, and benefited
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`other Defendants and opioid manufacturers. These statements were unsupported by and contrary
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`to the scientific evidence. These statements were also contrary to pronouncements by and guidance
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`from the FDA and CDC based on that evidence. They also targeted susceptible prescribers and
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`vulnerable patient populations, including those in the geographic area served by Wayne Farms.
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`39.
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`The Pharmaceutical Defendants spread their false and deceptive statements by
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`marketing their branded opioids directly to doctors and patients in Georgia. Defendants also
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`deployed seemingly unbiased and independent third parties that they controlled to spread their
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`false and deceptive statements about the risks and benefits of opioids for the treatment of chronic
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`pain throughout geographic areas served by Wayne Farms.
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`40.
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`The Pharmaceutical Defendants’ direct and branded ads deceptively portrayed the
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`benefits of opioids for chronic pain. For example, Endo distributed and made available on its
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`website opana.com a pamphlet promoting Opana ER with photographs depicting patients with
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`physically demanding jobs, misleadingly implying that the drug would provide long-term pain
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`relief and functional improvement. While Endo agreed in 2015-16 to stop these particularly
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`misleading representations in New York, they continued to disseminate them in Georgia.
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`41.
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`The Pharmaceutical Defendants also promoted the use of opioids for chronic pain
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`through “detailers” – sophisticated and specially trained sales representatives who visited
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`individual doctors and medical staff and fomented small-group speaker programs. In 2014, for
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`instance, these Defendants spent almost $200 million on detailing branded opioids to doctors.
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`42.
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`The FDA has cited at least one of these Defendants for deceptive promotions by its
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`detailers and direct-to-physician marketing. In 2010 an FDA-mandated “Dear Doctor” letter
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`required Actavis to inform doctors that “Actavis sales representatives distributed . . . promotional
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`materials that . . . omitted and minimized serious risks associated with [Kadian],” including the
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`risk of “[m]isuse, [a]buse, and [d]iversion of [o]pioids” and, specifically, the risk that “[o]pioid[s]
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`have the potential for being abused and are sought by drug abusers and people with addiction
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`disorders and are subject to criminal diversion.”
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`43.
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`The Pharmaceutical Defendants invited doctors to participate, for payment and
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`other remuneration, on and in speakers’ bureaus and programs paid for by these Defendants. These
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`speaker programs were designed to provide incentives for doctors to prescribe opioids, including
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`recognition and compensation for being selected as speakers. These speakers give the false
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`impression that they are providing unbiased and medically accurate presentations when they are,
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`in fact, presenting a script prepared by these Defendants. On information and belief, these
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`presentations conveyed misleading information, omitted material information, and failed to correct
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`Defendants’ prior misrepresentations about the risks and benefits of opioids.
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`44.
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`The Pharmaceutical Defendants’ detailing to doctors was highly effective in the
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`national proliferation of prescription opioids. Defendants used sophisticated data mining and
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`intelligence to track and understand the rates of initial prescribing and renewal by individual
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`doctors, allowing specific and individual targeting, customizing, and monitoring of their
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`marketing.
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`45.
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`The Pharmaceutical Defendants have had unified marketing plans and strategies
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`from state to state, including Georgia. This unified approach ensures that Defendants’ messages
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`were and are consistent and effective across all their marketing efforts.
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`46.
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`The Pharmaceutical Defendants deceptively marketed opioids in Georgia through
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`unbranded advertising that promoted opioid use generally, yet silent as to a specific opioid. This
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`advertising was ostensibly created and disseminated by independent third parties, but funded,
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`directed, coordinated, edited, and distributed, in part or whole, by these Defendants and their public
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`relations firms and agents.
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`47.
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`The Pharmaceutical Defendants used putative third-party, unbranded advertising to
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`avoid regulatory scrutiny as such advertising is not submitted to or reviewed by the FDA. These
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`Defendants used third-party, unbranded advertising to create the false appearance that the
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`deceptive messages came from an independent and objective source.
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`48.
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`The Pharmaceutical Defendants’ deceptive unbranded marketing also contradicted
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`their branded materials reviewed by the FDA.
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`49.
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`The Pharmaceutical Defendants marketed opioids through a small circle of doctors
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`who were vetted, selected, funded, and promoted by these Defendants because their public
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`positions supported the use of prescription opioids to treat chronic pain. These doctors became
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`known as “key opinion leaders” or “KOLs.” These Defendants paid KOLs to serve in a number of
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`doctor-facing and public-facing capacities, all designed to promote a pro-opioid message and to
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`promote the opioid industry pipeline, from manufacture to distribution to retail.
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`50.
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`These Defendants entered into and/or benefitted from arrangements with seemingly
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`unbiased and independent organizations or groups that generated treatment guidelines, unbranded
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`materials, and programs promoting chronic opioid therapy, including the American Pain Society
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`(“APS”), American Geriatrics Society (“AGS”), the Federation of State Medical Boards
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`(“FSMB”), American Chronic Pain Association (“ACPA”), American Society of Pain Education
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`(“ASPE”), National Pain Foundation (“NPF”), and Pain & Policy Studies Group (“PPSG”).
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`51.
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`The Pharmaceutical Defendants collaborated,
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`through
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`the aforementioned
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`organizations and groups, to spread deceptive messages about the risks and benefits of long-term
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`opioid therapy.
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`52.
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`To convince doctors and patients in Georgia that opioids can and should be used to
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`treat chronic pain, these Defendants had to persuade them that long-term opioid use is both safe
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`and helpful. Knowing that they could do so only by deceiving those doctors and patients about the
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`risks and benefits of long-term opioid use, these Defendants made claims that were not supported
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`by or were contrary to the scientific evidence and which were contradicted by data.
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`53.
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`To convince doctors and patients that opioids are safe, the Pharmaceutical
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`Defendants deceptively trivialized and failed to disclose the risks of long-term opioid use,
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`particularly the risk of addiction, through a series of misrepresentations that have been
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`conclusively debunked by the FDA and CDC. These misrepresentations – which are described
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`below – reinforced each other and created the dangerously misleading impression that: (a) starting
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`patients on opioids was low- risk because most patients would not become addicted, and because
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`those who were at greatest risk of addiction could be readily identified and managed; (b) patients
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`who displayed signs of addiction probably were not addicted and, in any event, could easily be
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`weaned from the drugs; (c) the use of higher opioid doses, which many patients need to sustain
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`pain relief as they develop tolerance to the drugs, do not pose special risks; and (d) abuse-deterrent
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`opioids both prevent abuse and overdose and are inherently less addictive. Defendants have not
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`only failed to correct these misrepresentations; they continue to make them today.
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`54.
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`The Pharmaceutical Defendants falsely claimed that the risk of opioid addiction is
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`low and that addiction is unlikely to develop when opioids are prescribed, as opposed to obtained
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`illicitly; and failed to disclose the greater risk of addiction with prolonged use of opioids. Some
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`examples of these false and deceptive claims by opioid manufacturers are: (a) Actavis employed
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`a patient education brochure that falsely claimed opioid addiction is “less likely if you have never
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`had an addiction problem”; (b) Cephalon sponsored APF’s Treatment Options: A Guide for
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`People Living with Pain, falsely claiming that addiction is rare and limited to extreme cases of
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`unauthorized doses; (c) Endo sponsored a website, Painknowledge.com, which falsely claimed
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`that “[p]eople who take opioids as prescribed usually do not become addicted”; (d) Endo
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`distributed a pamphlet with the Endo logo entitled Living with Someone with Chronic Pain, which
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`stated that: “most people do not develop an addiction problem”; (e) Janssen distributed a patient
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`education guide entitled Finding Relief: Pain Management for Older Adults which described as
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`“myth” the claim that opioids are addictive; (f) a Janssen website falsely claimed that concerns
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`about opioid addiction are “overestimated.”
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`55.
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`These claims are contrary to longstanding scientific evidence, as the FDA and CDC
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`have conclusively declared. As noted in the 2016 CDC Guideline endorsed by the FDA, there is
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`“extensive evidence” of the “possible harms of opioids (including opioid use disorder [an
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`alternative term for opioid addiction]).” The Guideline points out that “[o]pioid pain medication
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`use presents serious risks, including . . . opioid use disorder” and that “continuing opioid therapy
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`for three (3) months substantially increases risk for opioid use disorder.”
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`56.
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`The FDA further exposed the falsity of the Pharmaceutical Defendants’ claims
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`about the low risk of addiction when it announced changes to the labels for certain opioids in 2013
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`and for other opioids in 2016. In its announcements, the FDA