# List of largest civil only pharmaceutical settlements

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. 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.
| Year | Rank (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) |
| 2012 | 1 | 1 | 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 misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program | False Claims Act/FDCA |
| 2013 | 3 | 2 | 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/FDCA |
| 2009 | 2 | 3 | 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/FDCA |
| 2012 | 4 | 4 (tie) | Depakote | Abbott Laboratories | $1,500,000,000 | $800 million civil ($1.5 billion with criminal component) | Off-label promotion | False Claims Act/FDCA |
| 2009 | 5 | 4 (tie) | Zyprexa | Eli Lilly | $1,450,000,000 | $800 million civil ($1.45 billion with criminal component) | Off-label promotion | False Claims Act/FDCA |
| 2008 | 10 | 5 | Zocor/Vioxx/Pepsid | Merck | $650,000,000 | $650 million civil (no criminal component) | Medicare fraud/kickbacks | False Claims Act/ Medicaid Rebate Statute |
| 2012 | 9 | 6 | Aranesp | Amgen | $672,000,000 | $612 million civil ($762 million with criminal component) | Off-label promotion/kickbacks | False Claims Act/FDCA |
| 2010 | 7 | 7 | Kytril/Bactroban/ Paxil CR/Avandamet | GlaxoSmithKline | $750,000,000 | $600 million civil ($750 million with criminal component) | Poor manufacturing practices | False Claims Act/FDCA |
| 2005 | 8 | 8 | Serostim | Serono | $704,000,000 | $567 million civil ($704 million with criminal component) | Off-label promotion/ kickbacks/monopoly practices | False Claims Act |
| 2001 | 6 | 9 | Lupron | TAP Pharmaceutical Products | $875,000,000 | $559 million civil ($875 million with criminal component) | Medicare fraud/kickbacks | False Claims Act/ Prescription Drug Marketing Act |
| 2010 | 13 | 10 | Seroquel | AstraZeneca | $520,000,000 | $520 million (civil only) | Off-label promotion/kickbacks | False Claims Act |
| 2007 | 12 | 11 | Abilify/Serzone | Bristol-Myers Squibb | $540,000,000 | $515 million ($25 million in civil disgorgement) | Off-label promotion/ kickbacks/Medicare fraud | False Claims Act/FDCA |
| 2016 | 14 (tie) | 12 | EpiPen (epinephrine) | Mylan | $465,000,000 | $465 million (civil only) | Misclassification under the Medicaid Drug Rebate Program | False Claims Act |
| 2010 | 14 (tie) | 13 | Trileptal | Novartis | $465,000,000 | $390 million ($465 million with co-defendant settlements) | Off-label promotion/kickbacks | False Claims Act/FDCA |
| 2008 | 17 | 14 | Actiq/Gabitril/Provigil | Cephalon | $425,000,000 | $375 million civil ($425 million with criminal component) | Off-label promotion | False Claims Act/FDCA |
| 2004 | 19 | 15 | Claritin | Schering-Plough | $345,000,000 | $290 million civil ($345 million with criminal component) | Medicare fraud/kickbacks | False Claims Act/ Anti-Kickback Statute |
| 2017 | 20 | 16 | Thalomid/ Revlimid | Celgene Corporation | $280,000,000 | $280 million (civil only; non-intervened) | Off-label promotion/ kickbacks/Medicare fraud | False Claims Act/FDCA |
| 2003 | 18 | 17 | Zoladex | AstraZeneca | $355,000,000 | $266 million ($355 million with criminal component) | Medicare fraud | Prescription Drug Marketing Act |
| 2006 | 15 | 18 | 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/FDCA |
| 2010 | 11 | 19 | Botox | Allergan | $600,000,000 | $225 million civil ($600 million with criminal component) | Off-label promotion | False Claims Act/FDCA |
| 2004 | 16 | 20 | Neurontin | Pfizer | $430,000,000 | $190 million civil ($430 million with criminal component) | Off-label promotion | False Claims Act/FDCA |