List of largest pharmaceutical settlements
Updated: 11/6/2025, 12:32:50 AM Wikipedia source
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, and Pfizer’s $2.3 billion ($3.5 billion in 2022) settlement including a record-breaking $1.3 billion criminal fine. 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. 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.
Tables
2012
2012
Year
2012
Company
GlaxoSmithKline
Settlement
$3 billion ($1B criminal, $2B civil)
Violation(s)
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
Product(s)
Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex
Laws violated (if applicable)
False Claims Act, FDCA
2009
2009
Year
2009
Company
Pfizer
Settlement
$2.3 billion
Violation(s)
Off-label promotion, kickbacks
Product(s)
Bextra, Geodon, Zyvox, Lyrica
Laws violated (if applicable)
False Claims Act, FDCA
2013
2013
Year
2013
Company
Johnson & Johnson
Settlement
$2.2 billion
Violation(s)
Off-label promotion, kickbacks
Product(s)
Risperdal, Invega, Nesiritide
Laws violated (if applicable)
False Claims Act, FDCA
2012
2012
Year
2012
Company
Abbott Laboratories
Settlement
$1.5 billion
Violation(s)
Off-label promotion
Product(s)
Depakote
Laws violated (if applicable)
False Claims Act, FDCA
2009
2009
Year
2009
Company
Eli Lilly
Settlement
$1.4 billion
Violation(s)
Off-label promotion
Product(s)
Zyprexa
Laws violated (if applicable)
False Claims Act, FDCA
2001
2001
Year
2001
Company
TAP Pharmaceutical Products
Settlement
$875 million
Violation(s)
Medicare fraud, kickbacks
Product(s)
Lupron
Laws violated (if applicable)
False Claims Act, Prescription Drug Marketing Act
2012
2012
Year
2012
Company
Amgen
Settlement
$762 million
Violation(s)
Off-label promotion, kickbacks
Product(s)
Aranesp
Laws violated (if applicable)
False Claims Act, FDCA
2010
2010
Year
2010
Company
GlaxoSmithKline
Settlement
$750 million
Violation(s)
Poor manufacturing practices
Product(s)
Kytril, Bactroban, Paxil CR, Avandamet
Laws violated (if applicable)
False Claims Act, FDCA
2005
2005
Year
2005
Company
Serono
Settlement
$704 million
Violation(s)
Off-label promotion, kickbacks, monopolistic practices
Product(s)
Serostim
Laws violated (if applicable)
False Claims Act
2008
2008
Year
2008
Company
Merck
Settlement
$650 million
Violation(s)
Medicare fraud, kickbacks
Product(s)
Zocor, Vioxx, Pepsid
Laws violated (if applicable)
False Claims Act, Medicaid Rebate Statute
2007
2007
Year
2007
Company
Purdue Pharma
Settlement
$601 million
Violation(s)
Off-label promotion
Product(s)
Oxycontin
Laws violated (if applicable)
False Claims Act
2010
2010
Year
2010
Company
Allergan
Settlement
$600 million
Violation(s)
Off-label promotion
Product(s)
Botox
Laws violated (if applicable)
False Claims Act, FDCA
2010
2010
Year
2010
Company
AstraZeneca
Settlement
$520 million
Violation(s)
Off-label promotion, kickbacks
Product(s)
Seroquel
Laws violated (if applicable)
False Claims Act
2007
2007
Year
2007
Company
Bristol-Myers Squibb
Settlement
$515 million
Violation(s)
Off-label promotion, kickbacks, Medicare fraud
Product(s)
Abilify, Serzone
Laws violated (if applicable)
False Claims Act, FDCA
2002
2002
Year
2002
Company
Schering-Plough
Settlement
$500 million
Violation(s)
Poor manufacturing practices
Product(s)
Claritin
Laws violated (if applicable)
FDA Current Good Manufacturing Practices
2006
2006
Year
2006
Company
Mylan
Settlement
$465 million
Violation(s)
Misclassification under the Medicaid Drug Rebate Program
Product(s)
EpiPen (epinephrine)
Laws violated (if applicable)
False Claims Act
2006
2006
Year
2006
Company
Schering-Plough
Settlement
$435 million
Violation(s)
Off-label promotion, kickbacks, Medicare fraud
Product(s)
Temodar, Intron A, K-Dur, Claritin RediTabs
Laws violated (if applicable)
False Claims Act, FDCA
2004
2004
Year
2004
Company
Pfizer
Settlement
$430 million
Violation(s)
Off-label promotion
Product(s)
Neurontin
Laws violated (if applicable)
False Claims Act, FDCA
2008
2008
Year
2008
Company
Cephalon
Settlement
$425 million
Violation(s)
Off-label promotion
Product(s)
Actiq, Gabitril, Provigil
Laws violated (if applicable)
False Claims Act, FDCA
2010
2010
Year
2010
Company
Novartis
Settlement
$423 million
Violation(s)
Off-label promotion, kickbacks
Product(s)
Trileptal
Laws violated (if applicable)
False Claims Act, FDCA
2003
2003
Year
2003
Company
AstraZeneca
Settlement
$355 million
Violation(s)
Medicare fraud
Product(s)
Zoladex
Laws violated (if applicable)
Prescription Drug Marketing Act
2004
2004
Year
2004
Company
Schering-Plough
Settlement
$345 million
Violation(s)
Medicare fraud, kickbacks
Product(s)
Claritin
Laws violated (if applicable)
False Claims Act, Anti-Kickback Statute
| Year | Company | Settlement | Violation(s) | Product(s) | Laws violated (if applicable) |
| 2012 | GlaxoSmithKline | $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 | billion | Off-label promotion, kickbacks | Bextra, Geodon, Zyvox, Lyrica | False Claims Act, FDCA |
| 2013 | Johnson & Johnson | billion | Off-label promotion, kickbacks | Risperdal, Invega, Nesiritide | False Claims Act, FDCA |
| 2012 | Abbott Laboratories | billion | Off-label promotion | Depakote | False Claims Act, FDCA |
| 2009 | Eli Lilly | billion | Off-label promotion | Zyprexa | False Claims Act, FDCA |
| 2001 | TAP Pharmaceutical Products | $875 million | Medicare fraud, kickbacks | Lupron | False Claims Act, Prescription Drug Marketing Act |
| 2012 | Amgen | $762 million | Off-label promotion, kickbacks | Aranesp | False Claims Act, FDCA |
| 2010 | GlaxoSmithKline | $750 million | Poor manufacturing practices | Kytril, Bactroban, Paxil CR, Avandamet | False Claims Act, FDCA |
| 2005 | Serono | $704 million | Off-label promotion, kickbacks, monopolistic practices | Serostim | False Claims Act |
| 2008 | Merck | $650 million | Medicare fraud, kickbacks | Zocor, Vioxx, Pepsid | False Claims Act, Medicaid Rebate Statute |
| 2007 | Purdue Pharma | $601 million | Off-label promotion | Oxycontin | False Claims Act |
| 2010 | Allergan | $600 million | Off-label promotion | Botox | False Claims Act, FDCA |
| 2010 | AstraZeneca | $520 million | Off-label promotion, kickbacks | Seroquel | False Claims Act |
| 2007 | Bristol-Myers Squibb | $515 million | Off-label promotion, kickbacks, Medicare fraud | Abilify, Serzone | False Claims Act, FDCA |
| 2002 | Schering-Plough | $500 million | Poor manufacturing practices | Claritin | FDA Current Good Manufacturing Practices |
| 2006 | Mylan | $465 million | Misclassification under the Medicaid Drug Rebate Program | EpiPen (epinephrine) | False Claims Act |
| 2006 | Schering-Plough | $435 million | Off-label promotion, kickbacks, Medicare fraud | Temodar, Intron A, K-Dur, Claritin RediTabs | False Claims Act, FDCA |
| 2004 | Pfizer | $430 million | Off-label promotion | Neurontin | False Claims Act, FDCA |
| 2008 | Cephalon | $425 million | Off-label promotion | Actiq, Gabitril, Provigil | False Claims Act, FDCA |
| 2010 | Novartis | $423 million | Off-label promotion, kickbacks | Trileptal | False Claims Act, FDCA |
| 2003 | AstraZeneca | $355 million | Medicare fraud | Zoladex | Prescription Drug Marketing Act |
| 2004 | Schering-Plough | $345 million | Medicare fraud, kickbacks | Claritin | False Claims Act, Anti-Kickback Statute |
References
- "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data"https://www.justice.gov/opa/pr/2012/July/12-civ-842.html
- "Justice Department Announces Largest Health Care Fraud Settlement in Its History"https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history
- Almashat, S et al. Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 –http://www.citizen.org/documents/rapidlyincreasingcriminalandcivilpenalties.pdf
- The New York Timeshttps://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all
- "Drug Whistleblower Collects $24M"https://www.cbsnews.com/news/drug-whistleblower-collects-24m/
- 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"https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations
- "Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote"https://www.justice.gov/opa/pr/2012/May/12-civ-585.html
- "Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa"https://www.justice.gov/opa/pr/2009/January/09-civ-038.html
- "TAP Pharmaceutical Products Inc. and Seven Others Charged with Health Care Crimes; Company Agrees to Pay $875 Million to Settle Charges"https://www.justice.gov/opa/pr/2001/October/513civ.htm
- "Amgen Inc. Pleads Guilty to Federal Charge in Brooklyn, NY.; Pays $762 Million to Resolve Criminal Liability and False Claims Act Allegations"https://www.justice.gov/opa/pr/2012/December/12-civ-1523.html
- "GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant"https://www.justice.gov/opa/pr/2010/October/10-civ-1205.html
- "Serono to Pay $704 Million for the Illegal Marketing of AIDS Drug"https://web.archive.org/web/20131102113937/http://www.justice.gov/opa/pr/2005/October/05_civ_545.html
- "Merck to Pay More than $650 Million to Resolve Claims of Fraudulent Price Reporting and Kickbacks"https://www.justice.gov/opa/pr/2008/February/08_civ_094.html
- "Office of the Deputy Attorney General"https://www.justice.gov/usao/eousa/foia_reading_room/usab5701.pdf
- "Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®"https://www.justice.gov/opa/pr/2010/September/10-civ-988.html
- "Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing"https://www.justice.gov/opa/pr/2010/April/10-civ-487.html
- "Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing"https://www.justice.gov/opa/pr/2007/September/07_civ_782.html
- The Philadelphia Inquirerhttps://web.archive.org/web/20140101053436/http://articles.philly.com/2002-05-18/business/25345918_1_schering-plough-clarinex-schering-stock
- Ars Technicahttps://arstechnica.com/science/2016/10/for-ripping-off-medicaid-epipen-maker-mylan-pays-feds-465-million/
- "Schering to Pay $435 Million for the Improper Marketing of Drugs and Medicaid Fraud"https://www.justice.gov/usao/ma/news/Schering-Plough/press%20release.pdf
- usdoj.govhttps://www.justice.gov/archive/opa/pr/2004/May/04_civ_322.htm
- U.S. Department of Justicehttps://www.justice.gov/archive/opa/pr/2008/September/08-civ-860.html
- "Novartis Pharmaceuticals Corporation, a US subsidiary of Novartis AG, reaches settlement agreement with US Attorney's Office"https://web.archive.org/web/20131017111251/http://www.novartis.com/newsroom/media-releases/en/2010/1448151.shtml
- nytimes.comhttps://www.nytimes.com/2003/06/21/business/astrazeneca-pleads-guilty-in-cancer-medicine-scheme.html
- "Schering-Plough to Pay $345 Million to Resolve Criminal and Civil Liabilities for Illegal Marketing of Claritin"https://www.justice.gov/opa/pr/2004/July/04_civ_523.htm