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Published 9 September 2009
WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.
Wikipedia snapshot from 9 March 2021:
| Year | Company | Settlement | Violation(s) | Product(s) | Laws allegedly 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 |
$3 billion GSK settlement. On 2 July 2012, GlaxoSmithKline pleaded guilty to criminal charges and agreed to a $3 billion settlement of the largest health-care fraud case in the U.S. and the largest payment by a drug company. The settlement is related to the company’s illegal promotion of prescription drugs, its failure to report safety data, bribing doctors, and promoting medicines for uses for which they were not licensed. The drugs involved were Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label, non-covered uses. Those and the drugs Imitrex, Lotronex, Flovent, and Valtrex were involved in the kickback scheme. The government investigation of GSK was launched largely on the basis of information provided by four whistleblowers who filed two qui tam (whistleblower) lawsuits against the company under the False Claims Act. GSK settled the whistleblowers’ lawsuits for a total of $1.017 billion out of the $3 billion settlement, the largest civil False Claims Act settlement to date.
Pfizer $2.3 billion settlement: Pfizer settled multiple civil and criminal allegations for $2.3 billion in the largest case of pharmaceutical and health care fraud in US history. The drugs involved were Bextra (an anti-inflammatory drug), Geodon (an anti-psychotic drug), Lipitor (a cholesterol drug), Norvasc (anti-hypertensive drug), Viagra (erectile dysfunction), Zithromax (antibiotic), Zyrtec (antihistamine), Zyvox (an antibiotic), Lyrica (an anti-epileptic drug), Relpax (anti-migraine drug), Celebrex (anti-inflammatory drug), and Depo-provera (birth control).
Merck $650 million settlement: Merck settled a nominal pricing fraud case in which the company was accused of taking kickbacks and violating Medicaid best price regulations for various drugs.
United States et al., ex rel. Jim Conrad and Constance Conrad v. Forest Pharmaceuticals, Inc, et al. involved a drug manufacturer selling a drug, Levothroid, that had never been approved by the FDA. These allegations settled for $42.5 million due to multiple whistleblowers stepping forward to provide detailed information on the alleged fraud. The collective reward to the relators in this case was over $14.6 million.
Wikipedia snapshot from 28 January 2021: