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词条 List of largest pharmaceutical settlements
释义

  1. See also

  2. References

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.[1][2] 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.[3]

Year Company SettlementViolation(s) Product(s) Laws allegedly violated
(if applicable)
2012 GlaxoSmithKline[4][5]$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[6]$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/monopoly 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
2006Mylan[20]$465 millionMisclassification under the Medicaid Drug Rebate ProgramEpiPen (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

See also

  • Pharmaceutical fraud
  • List of off-label promotion pharmaceutical settlements

References

1. ^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
2. ^{{cite news|author=Katie Thomas, Michael S. Schmidt|url=https://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?pagewanted=all|title=Glaxo Agrees to Pay $3 Billion in Fraud Settlement|date=2 July 2012|publisher=The New York Times|accessdate=25 August 2012}}
3. ^{{cite news|last=Lavoie|first=Denise|url=http://www.cbsnews.com/2100-204_162-617223.html|title=Drug Whistleblower Collects $24M|date=5 December 2007|publisher=cbsnews.com|accessdate=25 August 2012}}
4. ^1 {{cite web|url=http://www.justice.gov/opa/pr/2012/July/12-civ-842.html|title=GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data|date=2 July 2012|publisher=justice.gov|accessdate=25 August 2012}}
5. ^formed in 2000 by merger of Glaxo Wellcome and SmithKline Beecham
6. ^1 {{cite web|url=http://www.justice.gov/usao/ma/news/Pfizer/Pfizer%20-%20PR%20(Final).pdf|title=Justice Department Announces Largest Health Care Fraud Settlement in Its History|publisher=justice.gov|date=2 September 2009|accessdate=25 August 2012}}
7. ^{{cite web|url=http://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations|title=Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations|publisher=justice.gov|date=4 November 2013|accessdate=5 March 2015}}
8. ^{{cite web|url=http://www.justice.gov/opa/pr/2012/May/12-civ-585.html|title=Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote|date=7 May 2012|publisher=justice.gov|accessdate=25 August 2012}}
9. ^{{cite web|url=http://www.justice.gov/opa/pr/2009/January/09-civ-038.html|title=Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa|date=15 January 2009|publisher=justice.gov|accessdate=25 August 2012}}
10. ^{{cite web|url=http://www.justice.gov/opa/pr/2001/October/513civ.htm|title=TAP Pharmaceutical Products Inc. and Seven Others Charged with Health Care Crimes; Company Agrees to Pay $875 Million to Settle Charges|date=3 October 2001|publisher=justice.gov|accessdate=25 August 2012}}
11. ^{{cite web|url=http://www.justice.gov/opa/pr/2012/December/12-civ-1523.html|title=Amgen Inc. Pleads Guilty to Federal Charge in Brooklyn, NY.; Pays $762 Million to Resolve Criminal Liability and False Claims Act Allegations|date=19 December 2012|publisher=justice.gov|accessdate=20 December 2012}}
12. ^{{cite web|url=http://www.justice.gov/opa/pr/2010/October/10-civ-1205.html|title=GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant|date=26 October 2010|publisher=justice.gov|accessdate=25 August 2012}}
13. ^{{cite web|url=http://www.justice.gov/opa/pr/2005/October/05_civ_545.html |title=Serono to Pay $704 Million for the Illegal Marketing of AIDS Drug |date=17 October 2005 |publisher=justice.gov |accessdate=25 August 2012 |deadurl=yes |archiveurl=https://web.archive.org/web/20131102113937/http://www.justice.gov/opa/pr/2005/October/05_civ_545.html |archivedate=2 November 2013 |df= }}
14. ^{{cite web|url=http://www.justice.gov/opa/pr/2008/February/08_civ_094.html|title=Merck to Pay More than $650 Million to Resolve Claims of Fraudulent Price Reporting and Kickbacks|date=7 February 2008|publisher=justice.gov|accessdate=25 August 2012}}
15. ^{{cite web|url=http://www.justice.gov/usao/eousa/foia_reading_room/usab5701.pdf|title=Office of the Deputy Attorney General|date=7 November 2008|publisher=justice.gov|accessdate=25 August 2012}}
16. ^{{cite web|url=http://www.justice.gov/opa/pr/2010/September/10-civ-988.html|title=Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®|date=1 September 2010|publisher=justice.gov|accessdate=25 August 2012}}
17. ^{{cite web|url=http://www.justice.gov/opa/pr/2010/April/10-civ-487.html|title=Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing|date=27 April 2010|publisher=justice.gov|accessdate=25 August 2012}}
18. ^{{cite web|url=http://www.justice.gov/opa/pr/2007/September/07_civ_782.html|title=Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing|date=28 September 2007|publisher=justice.gov|accessdate=25 August 2012}}
19. ^{{cite news|url=http://articles.philly.com/2002-05-18/business/25345918_1_schering-plough-clarinex-schering-stock|title=$500 million fine for Schering-Plough|date=18 May 2002|publisher=The Philadelphia Inquirer|accessdate=25 August 2012}}
20. ^{{cite news|last1=Mole|first1=Beth|title=For ripping off Medicaid, EpiPen maker Mylan pays Feds $465 million|url=https://arstechnica.com/science/2016/10/for-ripping-off-medicaid-epipen-maker-mylan-pays-feds-465-million/|accessdate=December 3, 2016|publisher=Ars Technica|date=October 7, 2016}}
21. ^{{cite web|url=http://www.justice.gov/usao/ma/news/Schering-Plough/press%20release.pdf|title=Schering to Pay $435 Million for the Improper Marketing of Drugs and Medicaid Fraud|date=29 August 2006|publisher=justice.gov|accessdate=25 August 2012}}
22. ^{{cite web|title=Warner-Lambert to Pay $430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion|url=https://www.justice.gov/archive/opa/pr/2004/May/04_civ_322.htm|website=usdoj.gov|publisher=United States Department of Justice|accessdate=30 July 2017|date=13 May 2004}}
23. ^1 {{cite web|title=Biopharmaceutical Company, Cephalon, to Pay $425 Million & Enter Plea to Resolve Allegations of Off-Label Marketing|url=https://www.justice.gov/archive/opa/pr/2008/September/08-civ-860.html|website=U.S. Department of Justice|accessdate=30 July 2017|date=29 September 2008}}
24. ^{{cite web|url=http://www.novartis.com/newsroom/media-releases/en/2010/1448151.shtml|title=Novartis Pharmaceuticals Corporation, a US subsidiary of Novartis AG, reaches settlement agreement with US Attorney's Office|date=30 September 2010|publisher=novartis.com|accessdate=25 August 2012}}
25. ^{{cite news|last=Petersen|first=Melody|url=https://www.nytimes.com/2003/06/21/business/astrazeneca-pleads-guilty-in-cancer-medicine-scheme.html|title=AstraZeneca Pleads Guilty In Cancer Medicine Scheme|date=21 June 2003|publisher=nytimes.com|accessdate=25 August 2012}}
26. ^{{cite web|url=http://www.justice.gov/opa/pr/2004/July/04_civ_523.htm|title=Schering-Plough to Pay $345 Million to Resolve Criminal and Civil Liabilities for Illegal Marketing of Claritin|date=30 July 2004|publisher=justice.gov|accessdate=25 August 2012}}

7 : Product liability|Lists of lawsuits|Medical controversies|Pharmaceutical industry in the United States|Drug advertising|Drug policy of the United States|Social problems in medicine
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