List of largest pharmaceutical settlements

The following is a list of the 20 largest settlements reached between the United States Department of Justice and pharmaceutical companies from 1991 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 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 allegedly violated (if applicable)
2012	GlaxoSmithKline[1]	$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, Wellbutrin, Paxil, 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[6]	$2.2 billion	Off-label promotion/kickbacks	Risperdal/Invega/ Nesiritide	False Claims Act/FDCA
2012	Abbott Laboratories[7]	$1.5 billion	Off-label promotion	Depakote	False Claims Act/FDCA
2009	Eli Lilly[8]	$1.4 billion	Off-label promotion	Zyprexa	False Claims Act/FDCA
2001	TAP Pharmaceutical Products[9]	$875 million	Medicare fraud/kickbacks	Lupron	False Claims Act/ Prescription Drug Marketing Act
2012	Amgen[10]	$762 million	Off-label promotion/kickbacks	Aranesp	False Claims Act/FDCA
2010	GlaxoSmithKline[11]	$750 million	Poor manufacturing practices	Kytril/Bactroban/ Paxil CR/Avandamet	False Claims Act/FDCA
2005	Serono[12]	$704 million	Off-label promotion/ kickbacks/monopoly practices	Serostim	False Claims Act
2008	Merck[13]	$650 million	Medicare fraud/kickbacks	Zocor/Vioxx/Pepsid	False Claims Act/ Medicaid Rebate Statute
2007	Purdue Pharma[14]	$601 million	Off-label promotion	Oxycontin	False Claims Act
2010	Allergan[15]	$600 million	Off-label promotion	Botox	False Claims Act/FDCA
2010	AstraZeneca[16]	$520 million	Off-label promotion/kickbacks	Seroquel	False Claims Act
2007	Bristol-Myers Squibb[17]	$515 million	Off-label promotion/ kickbacks/Medicare fraud	Abilify/Serzone	False Claims Act/FDCA
2002	Schering-Plough[18]	$500 million	Poor manufacturing practices	Claritin	FDA Current Good Manufacturing Practices
2006	Mylan[19]	$465 million	Misclassification under the Medicaid Drug Rebate Program	EpiPen (epinephrine)	False Claims Act
2006	Schering-Plough[20]	$435 million	Off-label promotion/ kickbacks/Medicare fraud	Temodar/ Intron A/K-Dur/ Claritin RediTabs	False Claims Act/FDCA
2004	Pfizer[21]	$430 million	Off-label promotion	Neurontin	False Claims Act/FDCA
2008	Cephalon[22]	$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

• Pharmaceutical fraud
• List of off-label promotion pharmaceutical settlements

References

1. "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. "JUSTICE DEPARTMENT ANNOUNCES LARGEST HEALTH CARE FRAUD SETTLEMENT IN ITS HISTORY" (PDF). 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. "Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations". justice.gov. 4 November 2013. Retrieved 5 March 2015.
7. "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.
8. "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.
9. "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.
10. "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.
11. "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.
12. "SERONO TO PAY $704 MILLION FOR THE ILLEGAL MARKETING OF AIDS DRUG". justice.gov. 17 October 2005. Retrieved 25 August 2012.
13. "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.
14. "Office of the Deputy Attorney General" (PDF). justice.gov. 7 November 2008. Retrieved 25 August 2012.
15. "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.
16. "Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing". justice.gov. 27 April 2010. Retrieved 25 August 2012.
17. "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.
18. "$500 million fine for Schering-Plough". The Philadelphia Inquirer. 18 May 2002. Retrieved 25 August 2012.
19. Mole, Beth (October 7, 2016). "For ripping off Medicaid, EpiPen maker Mylan pays Feds $465 million". Ars Technica. Retrieved December 3, 2016.
20. "SCHERING TO PAY $435 MILLION FOR THE IMPROPER MARKETING OF DRUGS AND MEDICAID FRAUD" (PDF). justice.gov. 29 August 2006. Retrieved 25 August 2012.
21. "Franklin v. Parke-Davis: First Off-Label Case Under False Claims Act". greenellp.com. Retrieved 25 August 2012.
22. "September 29 2008" (PDF). quitam-lawyer.com. 29 September 2008. Retrieved 25 August 2012.
23. "Cephalon pays $425 million to settle whistleblower off-label marketing case", Phillips & Cohen LLP Press Release, September 29, 2008.
24. "Novartis Pharmaceuticals Corporation, a US subsidiary of Novartis AG, reaches settlement agreement with US Attorney's Office". novartis.com. 30 September 2010. 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.