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. Author manuscript; available in PMC: 2020 Sep 9.
Published in final edited form as: N Engl J Med. 2017 Dec 14;377(24):2301–2305. doi: 10.1056/NEJMp1710756

High-Profile Settlements against Opioid Companies, 2004–2017.*

Case Key Dates Allegations Settlement Details
State and Local Government Suits
West Virginia v. Purdue Pharma Nov. 5, 2004 (settled) • Aggressively marketing OxyContin to state residents, many of whom became addicted.
• Concealing from prescribers the extent to which OxyContin’s qualities could lead to addiction.
• $10 million paid over 4 yr to support drug abuse and education programs, law-enforcement initiatives, and medical programs on drug abuse.
• No fault admitted.
26 states and District of Columbia v. Purdue Pharma May 8, 2007 (settled) • Unlawfully marketing OxyContin for off-label uses.
• Misbranding OxyContin as “less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medications.”
• $19.5 million
• Purdue pledged not to promote OxyContin for off-label uses.
• Requires Purdue to maintain abuse- and diversion-detection program, report problem prescribing, and have field sales personnel undergo special training before selling OxyContin
• No fault admitted.
Kentucky v. Purdue Pharma Oct. 4, 2007 (filed)
Dec. 23, 2015 (settled)
• Committing Medicaid fraud by misrepresenting the risks and benefits of OxyContin, thereby costing Kentucky Medicaid millions in drug and treatment costs.
• Engaging in false advertising by means of false and misleading package inserts, promotion, and marketing.
• Reaping unjust enrichment by profiting from OxyContin while state paid associated medical and drug costs.
• $24 million paid over 8 yr, to be spent on addiction treatment.
• No fault admitted.
• Judge granted media request to unseal the court documents to make Purdue practices known to the public.
West Virginia v. Cardinal Health June 26, 2012 (filed)
Jan. 9, 2017 (settled)
• Violating West Virginia Controlled Substances Act by failing to diligently respond to suspicious orders.
• Engaging in unfair and deceptive practices, in violation of the West Virginia Consumer Credit and Protection Act.
• Creating a public nuisance because diversion of drugs led to increased crime and consumption of law-enforcement and health care resources.
• Reaping unjust enrichment while state expended substantial resources on prescription opioid epidemic.
• $20 million paid by Cardinal Health (distributor).
• $16 million paid by AmerisourceBergen (distributor).
• $2.4 million paid by Miami-Luken (distributor).
• No fault admitted.
California v. Purdue Pharma May 21, 2014 (filed)
May 24, 2017 (settled with Teva)
• Engaging in false advertising by deceptively marketing opioid drugs meant for short-term use as appropriate for chronic pain.
• Engaging in unfair competition, in violation of the California Unfair Competition Law.
• Creating a public nuisance under California law, by engaging in deceptive marketing that led to an epidemic of opioid abuse.
• $1.6 million paid by Teva Pharmaceuticals, to be spent on combatting the ongoing opioid epidemic impacts in Santa Clara and Orange Counties.
• Bars Teva from deceptive marketing.
• No fault admitted by Teva.
• Charges against Purdue, Endo Health Solutions, Janssen, and Actavis remain unresolved, although litigation was stayed by state court judge pending the outcome of FDA studies related to the risks of long-term opioid treatment.
Federal Government Suits
U.S. v. Purdue Frederick May 10, 2007 (filed)
June 25, 2007 (settled)
• Violating the FDCA by misbranding OxyContin with the intent to defraud or mislead. • $600 million paid by Purdue.
• $34 million paid by 3 of Purdue’s top executives.
• Parties admitted they misled physicians and patients about the product’s addictiveness and misbranded it as abuse resistant.
U.S. v. Cardinal Healthcare Dec. 23, 2016 (settled) • Violating the CSA by failing to report suspicious orders of controlled substances to pharmacies in Maryland, Florida, and New York.
• Violating Washington record-keeping laws.
• $44 million
• Cardinal admitted failure to report suspicious orders to the DEA.
U.S. v. McKesson Corporation Jan. 5, 2017 (settled) • Violating the CSA by failing to maintain effective controls against diversion of controlled substances, including opioids, and to report suspicious orders to the DEA.
• Violating a 2008 administrative agreement with the federal government to monitor sales and report suspicious orders to the DEA.
• $150 million
• Requires McKesson to suspend sales of controlled substances from distribution centers in Colorado, Ohio, Michigan, and Florida for 3, 2, 2, and 1 years, respectively.
• Because McKesson admitted failure to report suspicious pharmacy orders, it agreed to enhanced compliance with earlier 2008 agreement (which had also included a $13.25 million settlement).
U.S. v. Mallinckrodt July 11, 2017 (settled) • Violating the CSA by failing to notify DEA of suspicious orders, as well as to implement an effective system to detect such orders. • $35 million
• Allows DEA to analyze data Mallinckrodt collects on orders from customers.
• No fault admitted.
Foreign Suits
Canada v. Purdue Pharma (class action) June 8, 2007 (commenced)
Aug. 24, 2017 (settlement approved)
• Failing to disclose the known risk of addiction and withdrawal associated with OxyContin and OxyNEO to a class of persons who were prescribed and ingested these products from Jan. 1, 1996 through Feb. 28, 2017. • $20 million (Canadian) settlement proposed and accepted by 3 of 4 jurisdictions overseeing the cases, consisting of:
 ○ $2 million to provincial health providers,
 ○ $4.5 million in legal fees, and
 ○ ∼$13,000–$17,000/class member (varies on the basis of many factors).
*

CSA denotes Controlled Substances Act; DEA, Drug Enforcement Agency; FDCA, Food Drug and Cosmetic Act; and FDA, Food and Drug Administration.