# 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 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.
| 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 | $2.3 billion | Off-label promotion, kickbacks | Bextra, Geodon, Zyvox, Lyrica | False Claims Act, FDCA |
| 2013 | Johnson & Johnson | $2.2 billion | Off-label promotion, kickbacks | Risperdal, Invega, Nesiritide | False Claims Act, FDCA |
| 2012 | Abbott Laboratories | $1.5 billion | Off-label promotion | Depakote | False Claims Act, FDCA |
| 2009 | Eli Lilly | $1.4 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 |