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
- ^ 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.
- ^ a b "Justice Department Announces Largest Health Care Fraud Settlement in Its History". justice.gov. 2 September 2009. Retrieved 12 June 2024.
- ^ 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
- ^ 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.
- ^ Lavoie, Denise (5 December 2007). "Drug Whistleblower Collects $24M". cbsnews.com. Retrieved 25 August 2012.
- ^ formed in 2000 by merger of Glaxo Wellcome and SmithKline Beecham
- ^ "Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations". justice.gov. 4 November 2013. Retrieved 5 March 2015.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ "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.
- ^ "Office of the Deputy Attorney General" (PDF). justice.gov. 7 November 2008. Retrieved 25 August 2012.
- ^ "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.
- ^ "Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing". justice.gov. 27 April 2010. Retrieved 25 August 2012.
- ^ "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.
- ^ "$500 million fine for Schering-Plough". The Philadelphia Inquirer. 18 May 2002. Retrieved 25 August 2012.
- ^ Mole, Beth (October 7, 2016). "For ripping off Medicaid, EpiPen maker Mylan pays Feds $465 million". Ars Technica. Retrieved December 3, 2016.
- ^ "Schering to Pay $435 Million for the Improper Marketing of Drugs and Medicaid Fraud" (PDF). justice.gov. 29 August 2006. Retrieved 25 August 2012.
- ^ "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.
- ^ 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.
- ^ "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.
- ^ Petersen, Melody (21 June 2003). "AstraZeneca Pleads Guilty In Cancer Medicine Scheme". nytimes.com. Retrieved 25 August 2012.
- ^ "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.