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 1991 to 2012, ordered by the size of the total settlement. The settlement amount includes both the civil 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 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. 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.
YearCompanySettlementViolationProductLaws allegedly violated
2012GlaxoSmithKline$3 billion 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, Wellbutrin,
Paxil, Advair,
Lamictal, Zofran,
Imitrex, Lotronex,
Flovent, Valtrex;		False Claims Act/FDCA
2009Pfizer$2.3 billionOff-label promotion/kickbacksBextra/Geodon/
Zyvox/Lyrica		False Claims Act/FDCA
2013Johnson & Johnson$2.2 billionOff-label promotion/kickbacksRisperdal/Invega/
Nesiritide		False Claims Act/FDCA
2012Abbott Laboratories$1.5 billionOff-label promotionDepakoteFalse Claims Act/FDCA
2009Eli Lilly$1.4 billionOff-label promotionZyprexaFalse Claims Act/FDCA
2001TAP Pharmaceutical Products$875 millionMedicare fraud/kickbacksLupronFalse Claims Act/
Prescription Drug Marketing Act
2012Amgen$762 millionOff-label promotion/kickbacksAranespFalse Claims Act/FDCA
2010GlaxoSmithKline$750 millionPoor manufacturing practicesKytril/Bactroban/
Paxil CR/Avandamet		False Claims Act/FDCA
2005Serono$704 millionOff-label promotion/
kickbacks/monopoly practices		SerostimFalse Claims Act
2008Merck$650 millionMedicare fraud/kickbacksZocor/Vioxx/PepsidFalse Claims Act/
Medicaid Rebate Statute
2007Purdue Pharma$601 millionOff-label promotionOxycontinFalse Claims Act
2010Allergan$600 millionOff-label promotionBotoxFalse Claims Act/FDCA
2010AstraZeneca$520 millionOff-label promotion/kickbacksSeroquelFalse Claims Act
2007Bristol-Myers Squibb$515 millionOff-label promotion/
kickbacks/Medicare fraud		Abilify/SerzoneFalse Claims Act/FDCA
2002Schering-Plough$500 millionPoor manufacturing practicesClaritinFDA Current
Good Manufacturing Practices
2006Mylan$465 millionMisclassification under the Medicaid Drug Rebate ProgramEpiPen False Claims Act
2006Schering-Plough$435 millionOff-label promotion/
kickbacks/Medicare fraud		Temodar/ Intron A/K-Dur/
Claritin RediTabs		False Claims Act/FDCA
2004Pfizer$430 millionOff-label promotionNeurontinFalse Claims Act/FDCA
2008Cephalon$425 millionOff-label promotionActiq/Gabitril/ProvigilFalse Claims Act/FDCA
2010Novartis$423 millionOff-label promotion/kickbacksTrileptalFalse Claims Act/FDCA
2003AstraZeneca$355 millionMedicare fraudZoladexPrescription Drug Marketing Act
2004Schering-Plough$345 millionMedicare fraud/kickbacksClaritinFalse Claims Act/
Anti-Kickback Statute