The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2012, 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,[1] and Pfizer’s $2.3 billion ($3.5 billion in 2022) settlement including a record-breaking $1.3 billion criminal fine.[2] 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.[3][4] 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.[5]

Year Company Settlement Violation(s) Product(s) Laws violated
(if applicable)
2012 GlaxoSmithKline[1][6] $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, FDCA
2009 Pfizer[2] $2.3 billion Off-label promotion, kickbacks Bextra, Geodon, Zyvox, Lyrica False Claims Act, FDCA
2013 Johnson & Johnson[7] $2.2 billion Off-label promotion, kickbacks Risperdal, Invega, Nesiritide False Claims Act, FDCA
2012 Abbott Laboratories[8] $1.5 billion Off-label promotion Depakote False Claims Act, FDCA
2009 Eli Lilly[9] $1.4 billion Off-label promotion Zyprexa False Claims Act, FDCA
2001 TAP Pharmaceutical Products[10] $875 million Medicare fraud, kickbacks Lupron False Claims Act, Prescription Drug Marketing Act
2012 Amgen[11] $762 million Off-label promotion, kickbacks Aranesp False Claims Act, FDCA
2010 GlaxoSmithKline[12] $750 million Poor manufacturing practices Kytril, Bactroban, Paxil CR, Avandamet False Claims Act, FDCA
2005 Serono[13] $704 million Off-label promotion, kickbacks, monopolistic practices Serostim False Claims Act
2008 Merck[14] $650 million Medicare fraud, kickbacks Zocor, Vioxx, Pepsid False Claims Act, Medicaid Rebate Statute
2007 Purdue Pharma[15] $601 million Off-label promotion Oxycontin False Claims Act
2010 Allergan[16] $600 million Off-label promotion Botox False Claims Act, FDCA
2010 AstraZeneca[17] $520 million Off-label promotion, kickbacks Seroquel False Claims Act
2007 Bristol-Myers Squibb[18] $515 million Off-label promotion, kickbacks, Medicare fraud Abilify, Serzone False Claims Act, FDCA
2002 Schering-Plough[19] $500 million Poor manufacturing practices Claritin FDA Current Good Manufacturing Practices
2006 Mylan[20] $465 million Misclassification under the Medicaid Drug Rebate Program EpiPen (epinephrine) False Claims Act
2006 Schering-Plough[21] $435 million Off-label promotion, kickbacks, Medicare fraud Temodar, Intron A, K-Dur, Claritin RediTabs False Claims Act, FDCA
2004[22] Pfizer $430 million Off-label promotion Neurontin False Claims Act, FDCA
2008 Cephalon[23] $425 million Off-label promotion[23] Actiq, Gabitril, Provigil False Claims Act, FDCA
2010 Novartis[24] $423 million Off-label promotion, kickbacks Trileptal False Claims Act, FDCA
2003 AstraZeneca[25] $355 million Medicare fraud Zoladex Prescription Drug Marketing Act
2004 Schering-Plough[26] $345 million Medicare fraud, kickbacks Claritin False Claims Act, Anti-Kickback Statute

See also

References

  1. ^ a b "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data". justice.gov. 2 July 2012. Retrieved 25 August 2012.
  2. ^ a b "Justice Department Announces Largest Health Care Fraud Settlement in Its History". justice.gov. 2 September 2009. Retrieved 25 August 2012.
  3. ^ 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
  4. ^ Katie Thomas, Michael S. Schmidt (2 July 2012). "Glaxo Agrees to Pay $3 Billion in Fraud Settlement". The New York Times. Retrieved 25 August 2012.
  5. ^ Lavoie, Denise (5 December 2007). "Drug Whistleblower Collects $24M". cbsnews.com. Retrieved 25 August 2012.
  6. ^ formed in 2000 by merger of Glaxo Wellcome and SmithKline Beecham
  7. ^ "Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations". justice.gov. 4 November 2013. Retrieved 5 March 2015.
  8. ^ "Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote". justice.gov. 7 May 2012. Retrieved 25 August 2012.
  9. ^ "Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa". justice.gov. 15 January 2009. Retrieved 25 August 2012.
  10. ^ "TAP Pharmaceutical Products Inc. and Seven Others Charged with Health Care Crimes; Company Agrees to Pay $875 Million to Settle Charges". justice.gov. 3 October 2001. Retrieved 25 August 2012.
  11. ^ "Amgen Inc. Pleads Guilty to Federal Charge in Brooklyn, NY.; Pays $762 Million to Resolve Criminal Liability and False Claims Act Allegations". justice.gov. 19 December 2012. Retrieved 20 December 2012.
  12. ^ "GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant". justice.gov. 26 October 2010. Retrieved 25 August 2012.
  13. ^ "Serono to Pay $704 Million for the Illegal Marketing of AIDS Drug". justice.gov. 17 October 2005. Archived from the original on 2 November 2013. Retrieved 25 August 2012.
  14. ^ "Merck to Pay More than $650 Million to Resolve Claims of Fraudulent Price Reporting and Kickbacks". justice.gov. 7 February 2008. Retrieved 25 August 2012.
  15. ^ "Office of the Deputy Attorney General" (PDF). justice.gov. 7 November 2008. Retrieved 25 August 2012.
  16. ^ "Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®". justice.gov. 1 September 2010. Retrieved 25 August 2012.
  17. ^ "Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing". justice.gov. 27 April 2010. Retrieved 25 August 2012.
  18. ^ "Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing". justice.gov. 28 September 2007. Retrieved 25 August 2012.
  19. ^ "$500 million fine for Schering-Plough". The Philadelphia Inquirer. 18 May 2002. Retrieved 25 August 2012.
  20. ^ Mole, Beth (October 7, 2016). "For ripping off Medicaid, EpiPen maker Mylan pays Feds $465 million". Ars Technica. Retrieved December 3, 2016.
  21. ^ "Schering to Pay $435 Million for the Improper Marketing of Drugs and Medicaid Fraud" (PDF). justice.gov. 29 August 2006. Retrieved 25 August 2012.
  22. ^ "Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion". usdoj.gov. United States Department of Justice. 13 May 2004. Retrieved 30 July 2017.
  23. ^ a b "Biopharmaceutical Company, Cephalon, to Pay $425 Million & Enter Plea to Resolve Allegations of Off-Label Marketing". U.S. Department of Justice. 29 September 2008. Retrieved 30 July 2017.
  24. ^ "Novartis Pharmaceuticals Corporation, a US subsidiary of Novartis AG, reaches settlement agreement with US Attorney's Office". novartis.com. 30 September 2010. Archived from the original on 17 October 2013. Retrieved 25 August 2012.
  25. ^ Petersen, Melody (21 June 2003). "AstraZeneca Pleads Guilty In Cancer Medicine Scheme". nytimes.com. Retrieved 25 August 2012.
  26. ^ "Schering-Plough to Pay $345 Million to Resolve Criminal and Civil Liabilities for Illegal Marketing of Claritin". justice.gov. 30 July 2004. Retrieved 25 August 2012.
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