List of largest pharmaceutical settlements

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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 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 Schering-Plough[19] $435 million Off-label promotion/
kickbacks/Medicare fraud		 Temodar/ Intron A/K-Dur/
Claritin RediTabs		 False Claims Act/FDCA
2004 Pfizer[20] $430 million Off-label promotion Neurontin False Claims Act/FDCA
2008 Cephalon[21] $425 million Off-label promotion[22] Actiq/Gabitril/Provigil False Claims Act/FDCA
2010 Novartis[23] $423 million Off-label promotion/kickbacks Trileptal False Claims Act/FDCA
2003 AstraZeneca[24] $355 million Medicare fraud Zoladex Prescription Drug Marketing Act
2004 Schering-Plough[25] $345 million Medicare fraud/kickbacks Claritin False Claims Act/
Anti-Kickback Statute

See also

References

  1. ↑ 1.0 1.1 Lua error in package.lua at line 80: module 'strict' not found.
  2. ↑ 2.0 2.1 Lua error in package.lua at line 80: module 'strict' not found.
  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. ↑ Lua error in package.lua at line 80: module 'strict' not found.
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  13. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  14. ↑ Lua error in package.lua at line 80: module 'strict' not found.
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  20. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  21. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  22. ↑ "Cephalon pays $425 million to settle whistleblower off-label marketing case", Phillips & Cohen LLP Press Release, September 29, 2008.
  23. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  24. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  25. ↑ Lua error in package.lua at line 80: module 'strict' not found.
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