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Justice Department Announces Largest Health Care Fraud Settlement in Its History – US Department of Justice

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.

https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history

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List of largest pharmaceutical settlements – Wikipedia

Wikipedia snapshot from 9 March 2021:

YearCompanySettlementViolation(s)Product(s)Laws allegedly violated
(if applicable)
2012GlaxoSmithKline[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, ValtrexFalse Claims Act, FDCA
2009Pfizer[2]$2.3 billionOff-label promotion, kickbacksBextra, Geodon, Zyvox, LyricaFalse Claims Act, FDCA
2013Johnson & Johnson[7]$2.2 billionOff-label promotion, kickbacksRisperdal, Invega, NesiritideFalse Claims Act, FDCA
2012Abbott Laboratories[8]$1.5 billionOff-label promotionDepakoteFalse Claims Act, FDCA
2009Eli Lilly[9]$1.4 billionOff-label promotionZyprexaFalse Claims Act, FDCA
2001TAP Pharmaceutical Products[10]$875 millionMedicare fraud, kickbacksLupronFalse Claims Act, Prescription Drug Marketing Act
2012Amgen[11]$762 millionOff-label promotion, kickbacksAranespFalse Claims Act, FDCA
2010GlaxoSmithKline[12]$750 millionPoor manufacturing practicesKytril, Bactroban, Paxil CR, AvandametFalse Claims Act, FDCA
2005Serono[13]$704 millionOff-label promotion, kickbacks, monopolistic practicesSerostimFalse Claims Act
2008Merck[14]$650 millionMedicare fraud, kickbacksZocor, Vioxx, PepsidFalse Claims Act, Medicaid Rebate Statute
2007Purdue Pharma[15]$601 millionOff-label promotionOxycontinFalse Claims Act
2010Allergan[16]$600 millionOff-label promotionBotoxFalse Claims Act, FDCA
2010AstraZeneca[17]$520 millionOff-label promotion, kickbacksSeroquelFalse Claims Act
2007Bristol-Myers Squibb[18]$515 millionOff-label promotion, kickbacks, Medicare fraudAbilify, SerzoneFalse Claims Act, FDCA
2002Schering-Plough[19]$500 millionPoor manufacturing practicesClaritinFDA Current Good Manufacturing Practices
2006Mylan[20]$465 millionMisclassification under the Medicaid Drug Rebate ProgramEpiPen (epinephrine)False Claims Act
2006Schering-Plough[21]$435 millionOff-label promotion, kickbacks, Medicare fraudTemodar, Intron A, K-Dur, Claritin RediTabsFalse Claims Act, FDCA
2004[22]Pfizer$430 millionOff-label promotionNeurontinFalse Claims Act, FDCA
2008Cephalon[23]$425 millionOff-label promotion[23]Actiq, Gabitril, ProvigilFalse Claims Act, FDCA
2010Novartis[24]$423 millionOff-label promotion, kickbacksTrileptalFalse Claims Act, FDCA
2003AstraZeneca[25]$355 millionMedicare fraudZoladexPrescription Drug Marketing Act
2004Schering-Plough[26]$345 millionMedicare fraud, kickbacksClaritinFalse Claims Act, Anti-Kickback Statute

http://archive.today/2021.05.05-122141/https://en.wikipedia.org/wiki/List_of_largest_pharmaceutical_settlements

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Pharmaceutical fraud – Wikipedia

$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:

http://archive.today/WZkcB