The following is a list of the 21 largest civil settlements, reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2017, ordered by the size of the total civil settlement. Some of these matters also resolved criminal fines and penalties, listed in parentheses, but these amounts are not considered when ranking these settlements as some of the settlements listed did not have a criminal component. Thus, this article provides the most accurate list of the largest civil-only portion of settlements between pharmaceutical companies and the Department of Justice. Because this article focuses on civil portions of settlements, some of the larger total settlements do not make the list. For example, Purdue Pharmaceuticals entered an agreement with the United States, pleading guilty to felony misbranding of OxyContin with intent to defraud and mislead under sections 33 1(a) and 333(a)(2) of the FD&C Act and agreed to pay more than $600 million, but only $160 million was allocated to resolve civil claims under the False Claims Act, while the remainder was allocated to resolve criminal claims and private claims.
Legal claims against the pharmaceutical industry have varied widely over the past two decades, including Medicare and Medicaid fraud driven by 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 that bills submitted to Medicare or Medicaid driven by 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. The civil portion of this settlement was $190 million, and it is the last settlement included in the below table.
YearRank (by total)Rank (by civil component) Product(s) Company Total Settlement (with any criminal and other components) Settlement (civil component only) Violation(s) Laws allegedly violated (if applicable)201211 Avandia, Wellbutrin, Paxil, Advair, Lamictal, Zofran,Imitrex, Lotronex, Flovent, Valtrex; GlaxoSmithKline$3,000,000,000 $2B civil Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to physicians, making false and misleadingstatements concerning the safety of Avandia, reporting false bestprices and underpaying rebates owed under the Medicaid Drug Rebate Program False Claims Act/FDCA201332 Risperdal/Invega/ Nesiritide Johnson & Johnson$2,200,000,000 $1.72 billion civil ($2.2 billion with criminal component) Off-label promotion/kickbacks False Claims Act/FDCA200923 Bextra/Geodon/ Zyvox/Lyrica Pfizer$2,300,000,000 $1 billion civil ($2.3 billion with criminal component) Off-label promotion/kickbacks False Claims Act/FDCA201244 (tie) Depakote Abbott Laboratories$1,500,000,000 $800 million civil ($1.5 billion with criminal component) Off-label promotion False Claims Act/FDCA200954 (tie) Zyprexa Eli Lilly$1,450,000,000 $800 million civil ($1.45 billion with criminal component) Off-label promotion False Claims Act/FDCA 2008105 Zocor/Vioxx/Pepsid Merck$650,000,000 $650 million civil (no criminal component) Medicare fraud/kickbacks False Claims Act/ Medicaid Rebate Statute201296 Aranesp Amgen$672,000,000 $612 million civil ($762 million with criminal component) Off-label promotion/kickbacks False Claims Act/FDCA201077 Kytril/Bactroban/ Paxil CR/Avandamet GlaxoSmithKline$750,000,000 $600 million civil ($750 million with criminal component) Poor manufacturing practices False Claims Act/FDCA200588 Serostim Serono$704,000,000 $567 million civil ($704 million with criminal component) Off-label promotion/ kickbacks/monopoly practices False Claims Act200169 Lupron TAP Pharmaceutical Products$875,000,000 $559 million civil ($875 million with criminal component) Medicare fraud/kickbacks False Claims Act/ Prescription Drug Marketing Act20101310 Seroquel AstraZeneca$520,000,000 $520 million (civil only) Off-label promotion/kickbacks False Claims Act20071211 Abilify/Serzone Bristol-Myers Squibb$540,000,000 $515 million ($25 million in civil disgorgement) Off-label promotion/ kickbacks/Medicare fraud False Claims Act/FDCA201614 (tie)12EpiPen (epinephrine)Mylan$465,000,000 $465 million (civil only)Misclassification under the Medicaid Drug Rebate Program False Claims Act201014 (tie)13 Trileptal Novartis$465,000,000 $390 million ($465 million with co-defendant settlements) Off-label promotion/kickbacks False Claims Act/FDCA20081714 Actiq/Gabitril/Provigil Cephalon$425,000,000 $375 million civil ($425 million with criminal component) Off-label promotion"Cephalon pays $425 million to settle whistleblower off-label marketing case", Phillips & Cohen LLP Press Release, September 29, 2008. False Claims Act/FDCA20041915 Claritin Schering-Plough$345,000,000 $290 million civil ($345 million with criminal component) Medicare fraud/kickbacks False Claims Act/ Anti-Kickback Statute20172016 Thalomid/ RevlimidCelgene Corporation$280,000,000 $280 million (civil only; non-intervened) Off-label promotion/ kickbacks/Medicare fraud False Claims Act/FDCA20031817 Zoladex AstraZeneca$355,000,000 $266 million ($355 million with criminal component) Medicare fraud Prescription Drug Marketing Act20061518 Temodar/ Intron A/K-Dur/ Claritin RediTabs Schering-Plough$435,000,000 $255 million civil ($435 million with criminal component) Off-label promotion/ kickbacks/Medicare fraud False Claims Act/FDCA20101119 Botox Allergan$600,000,000 $225 million civil ($600 million with criminal component) Off-label promotion False Claims Act/FDCA20041620 Neurontin Pfizer$430,000,000 $190 million civil ($430 million with criminal component) Off-label promotion False Claims Act/FDCA
See also Pharmaceutical fraud List of off-label promotion pharmaceutical settlements
References