List of largest pharmaceutical settlements

The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2013, ordered by the size of the total settlement. The settlement amount includes both the civil (False Claims Act) settlement and criminal fine. Glaxo's $3 billion settlement included the largest civil False Claims Act settlement on record, and Pfizer’s $2.3 billion ($3.5 billion in 2022) settlement including a record-breaking $1.3 billion criminal fine. Legal claims against the pharmaceutical industry have varied widely over the past two decades, including Medicare and Medicaid fraud, off-label promotion, and inadequate manufacturing practices.Almashat, S et al. Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 – 2010. Public Citizen’s Health Research Group. December 16, 2010 With respect to off-label promotion, specifically, a federal court recognized off-label promotion as a violation of the False Claims Act for the first time in Franklin v. Parke-Davis, leading to a $430 million settlement.

Year Company Settlement Violation(s) Product(s) Laws violated (if applicable)2012 GlaxoSmithKlineformed in 2000 by merger of Glaxo Wellcome and SmithKline Beecham $3 billion ($1B criminal, $2B civil) Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex False Claims Act, FDCA2009 Pfizer $2.3 billion Off-label promotion, kickbacks Bextra, Geodon, Zyvox, Lyrica False Claims Act, FDCA2013 Johnson & Johnson $2.2 billion Off-label promotion, kickbacks Risperdal, Invega, Nesiritide False Claims Act, FDCA2012 Abbott Laboratories $1.5 billion Off-label promotion Depakote False Claims Act, FDCA2009 Eli Lilly $1.4 billion Off-label promotion Zyprexa False Claims Act, FDCA2001 TAP Pharmaceutical Products $875 million Medicare fraud, kickbacks Lupron False Claims Act, Prescription Drug Marketing Act2012 Amgen $762 million Off-label promotion, kickbacks Aranesp False Claims Act, FDCA2010 GlaxoSmithKline $750 million Poor manufacturing practices Kytril, Bactroban, Paxil CR, Avandamet False Claims Act, FDCA2005 Serono $704 million Off-label promotion, kickbacks, monopolistic practices Serostim False Claims Act2008 Merck $650 million Medicare fraud, kickbacks Zocor, Vioxx, Pepsid False Claims Act, Medicaid Rebate Statute2007 Purdue Pharma $601 million Off-label promotion Oxycontin False Claims Act2010 Allergan $600 million Off-label promotion Botox False Claims Act, FDCA2010 AstraZeneca $520 million Off-label promotion, kickbacks Seroquel False Claims Act2007 Bristol-Myers Squibb $515 million Off-label promotion, kickbacks, Medicare fraud Abilify, Serzone False Claims Act, FDCA2002 Schering-Plough $500 million Poor manufacturing practices Claritin FDA Current Good Manufacturing Practices2006Mylan $465 million Misclassification under the Medicaid Drug Rebate ProgramEpiPen (epinephrine) False Claims Act2006 Schering-Plough $435 million Off-label promotion, kickbacks, Medicare fraud Temodar, Intron A, K-Dur, Claritin RediTabs False Claims Act, FDCA2004 Pfizer $430 million Off-label promotion Neurontin False Claims Act, FDCA2008 Cephalon $425 million Off-label promotion Actiq, Gabitril, Provigil False Claims Act, FDCA2010 Novartis $423 million Off-label promotion, kickbacks Trileptal False Claims Act, FDCA2003 AstraZeneca $355 million Medicare fraud Zoladex Prescription Drug Marketing Act2004 Schering-Plough $345 million Medicare fraud, kickbacks Claritin False Claims Act, Anti-Kickback Statute

See also Vaccine hesitancy Pharmaceutical fraud List of off-label promotion pharmaceutical settlements

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