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List of largest pharmaceutical settlements

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Summary

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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, 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.

YearCompanySettlementViolation(s)Product(s)Laws violated
(if applicable)
2012date=2 July 2012title=GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Dataurl=https://www.justice.gov/opa/pr/2012/July/12-civ-842.htmlurl-status=livearchive-url=https://web.archive.org/web/20240714112314/https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-reportarchive-date=2024-07-14accessdate=25 August 2012publisher=justice.gov}}$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 ProgramAvandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, ValtrexFalse Claims Act, FDCA
2009url=https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-historytitle=Justice Department Announces Largest Health Care Fraud Settlement in Its Historypublisher=justice.govdate=2 September 2009accessdate=12 June 2024}}$2.3 billionOff-label promotion, kickbacksBextra, Geodon, Zyvox, LyricaFalse Claims Act, FDCA
2013url=https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigationstitle=Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigationspublisher=justice.govdate=4 November 2013accessdate=5 March 2015}}$2.2 billionOff-label promotion, kickbacksRisperdal, Invega, NesiritideFalse 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, AvandametFalse Claims Act, FDCA
2005Serono$704 millionOff-label promotion, kickbacks, monopolistic practicesSerostimFalse 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 fraudAbilify, SerzoneFalse Claims Act, FDCA
2002Schering-Plough$500 millionPoor manufacturing practicesClaritinFDA Current Good Manufacturing Practices
2006Mylan$465 millionMisclassification under the Medicaid Drug Rebate ProgramEpiPen (epinephrine)False Claims Act
2006Schering-Plough$435 millionOff-label promotion, kickbacks, Medicare fraudTemodar, Intron A, K-Dur, Claritin RediTabsFalse 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

References

References

  1. Medicare and Medicaid fraud]], [[Off-label use. off-label]] promotion, and inadequate manufacturing practices.Almashat, S ''et al''. [http://www.citizen.org/documents/rapidlyincreasingcriminalandcivilpenalties.pdf Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 – 2010]. Public Citizen’s Health Research Group. December 16, 2010
  2. Katie Thomas, Michael S. Schmidt. (2 July 2012). "Glaxo Agrees to Pay $3 Billion in Fraud Settlement". [[The New York Times]].
  3. Lavoie, Denise. (5 December 2007). "Drug Whistleblower Collects $24M". cbsnews.com.
  4. (2 July 2012). "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data". justice.gov.
  5. formed in 2000 by merger of Glaxo Wellcome and SmithKline Beecham
  6. (2 September 2009). "Justice Department Announces Largest Health Care Fraud Settlement in Its History". justice.gov.
  7. (4 November 2013). "Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations". justice.gov.
  8. (7 May 2012). "Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote". justice.gov.
  9. (15 January 2009). "Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa". justice.gov.
  10. (3 October 2001). "TAP Pharmaceutical Products Inc. and Seven Others Charged with Health Care Crimes; Company Agrees to Pay $875 Million to Settle Charges". justice.gov.
  11. (19 December 2012). "Amgen Inc. Pleads Guilty to Federal Charge in Brooklyn, NY.; Pays $762 Million to Resolve Criminal Liability and False Claims Act Allegations". justice.gov.
  12. (26 October 2010). "GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant". justice.gov.
  13. (17 October 2005). "Serono to Pay $704 Million for the Illegal Marketing of AIDS Drug". justice.gov.
  14. (7 February 2008). "Merck to Pay More than $650 Million to Resolve Claims of Fraudulent Price Reporting and Kickbacks". justice.gov.
  15. (7 November 2008). "Office of the Deputy Attorney General". justice.gov.
  16. (1 September 2010). "Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®". justice.gov.
  17. (27 April 2010). "Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing". justice.gov.
  18. (28 September 2007). "Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing". justice.gov.
  19. (18 May 2002). "$500 million fine for Schering-Plough". [[The Philadelphia Inquirer]].
  20. (October 7, 2016). "For ripping off Medicaid, EpiPen maker Mylan pays Feds $465 million".
  21. (29 August 2006). "Schering to Pay $435 Million for the Improper Marketing of Drugs and Medicaid Fraud". justice.gov.
  22. (13 May 2004). "Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion". United States Department of Justice.
  23. (29 September 2008). "Biopharmaceutical Company, Cephalon, to Pay $425 Million & Enter Plea to Resolve Allegations of Off-Label Marketing".
  24. (30 September 2010). "Novartis Pharmaceuticals Corporation, a US subsidiary of Novartis AG, reaches settlement agreement with US Attorney's Office". novartis.com.
  25. Petersen, Melody. (21 June 2003). "AstraZeneca Pleads Guilty In Cancer Medicine Scheme". nytimes.com.
  26. (30 July 2004). "Schering-Plough to Pay $345 Million to Resolve Criminal and Civil Liabilities for Illegal Marketing of Claritin". justice.gov.
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