The following is a list of the 21 largest civil settlements, reached between the United States Department of Justice and pharmaceutical companies from 2001 to 2017, ordered by the size of the total civil settlement. Some of these matters also resolved criminal fines and penalties, listed in parentheses, but these amounts are not considered when ranking these settlements as some of the settlements listed did not have a criminal component. Thus, this article provides the most accurate list of the largest civil-only portion of settlements between pharmaceutical companies and the Department of Justice. Because this article focuses on civil portions of settlements, some of the larger total settlements do not make the list. For example, Purdue Pharmaceuticals entered an agreement with the United States, pleading guilty to felony misbranding of OxyContin with intent to defraud and mislead under sections 33 1(a) and 333(a)(2) of the FD&C Act and agreed to pay more than $600 million, but only $160 million was allocated to resolve civil claims under the False Claims Act, while the remainder was allocated to resolve criminal claims and private claims.[1]
Legal claims against the pharmaceutical industry have varied widely over the past two decades, including Medicare and Medicaid fraud driven by off-label promotion, and inadequate manufacturing practices.[2][3] With respect to off-label promotion, specifically, a federal court recognized that bills submitted to Medicare or Medicaid driven by 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.[4] The civil portion of this settlement was $190 million, and it is the last settlement included in the below table.
| Year | Rank (by total) | Rank (by civil component) | Product(s) | Company | Total Settlement (with any criminal and other components) | Settlement (civil component only) | Violation(s) | Laws allegedly violated (if applicable) |
|---|---|---|---|---|---|---|---|---|
| 2012 | 1 | 1 | Avandia, Wellbutrin, Paxil, Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex; |
GlaxoSmithKline[5] | $3,000,000,000 | $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 |
False Claims Act/FDCA |
| 2013 | 3 | 2 | Risperdal/Invega/ Nesiritide |
Johnson & Johnson[6] | $2,200,000,000 | $1.72 billion civil ($2.2 billion with criminal component) | Off-label promotion/kickbacks | False Claims Act/FDCA |
| 2009 | 2 | 3 | Bextra/Geodon/ Zyvox/Lyrica |
Pfizer[7] | $2,300,000,000 | $1 billion civil ($2.3 billion with criminal component) | Off-label promotion/kickbacks | False Claims Act/FDCA |
| 2012 | 4 | 4 (tie) | Depakote | Abbott Laboratories[8] | $1,500,000,000 | $800 million civil ($1.5 billion with criminal component) | Off-label promotion | False Claims Act/FDCA |
| 2009 | 5 | 4 (tie) | Zyprexa | Eli Lilly[9] | $1,450,000,000 | $800 million civil ($1.45 billion with criminal component) | Off-label promotion | False Claims Act/FDCA |
| 2008 | 10 | 5 | Zocor/Vioxx/Pepsid | Merck[10] | $650,000,000 | $650 million civil (no criminal component) | Medicare fraud/kickbacks | False Claims Act/ Medicaid Rebate Statute |
| 2012 | 9 | 6 | Aranesp | Amgen[11] | $672,000,000 | $612 million civil ($762 million with criminal component) | Off-label promotion/kickbacks | False Claims Act/FDCA |
| 2010 | 7 | 7 | Kytril/Bactroban/ Paxil CR/Avandamet |
GlaxoSmithKline[12] | $750,000,000 | $600 million civil ($750 million with criminal component) | Poor manufacturing practices | False Claims Act/FDCA |
| 2005 | 8 | 8 | Serostim | Serono[13] | $704,000,000 | $567 million civil ($704 million with criminal component) | Off-label promotion/ kickbacks/monopoly practices |
False Claims Act |
| 2001 | 6 | 9 | Lupron | TAP Pharmaceutical Products[14] | $875,000,000 | $559 million civil ($875 million with criminal component) | Medicare fraud/kickbacks | False Claims Act/ Prescription Drug Marketing Act |
| 2010 | 13 | 10 | Seroquel | AstraZeneca[15] | $520,000,000 | $520 million (civil only) | Off-label promotion/kickbacks | False Claims Act |
| 2007 | 12 | 11 | Abilify/Serzone | Bristol-Myers Squibb[16] | $540,000,000 | $515 million ($25 million in civil disgorgement) | Off-label promotion/ kickbacks/Medicare fraud |
False Claims Act/FDCA |
| 2016 | 14 (tie) | 12 | EpiPen (epinephrine) | Mylan[17] | $465,000,000 | $465 million (civil only) | Misclassification under the Medicaid Drug Rebate Program | False Claims Act |
| 2010 | 14 (tie) | 13 | Trileptal | Novartis[18] | $465,000,000 | $390 million ($465 million with co-defendant settlements) | Off-label promotion/kickbacks | False Claims Act/FDCA |
| 2008 | 17 | 14 | Actiq/Gabitril/Provigil | Cephalon[19] | $425,000,000 | $375 million civil ($425 million with criminal component) | Off-label promotion[20] | False Claims Act/FDCA |
| 2004 | 19 | 15 | Claritin | Schering-Plough[21] | $345,000,000 | $290 million civil ($345 million with criminal component) | Medicare fraud/kickbacks | False Claims Act/ Anti-Kickback Statute |
| 2017 | 20 | 16 | Thalomid/ Revlimid | Celgene Corporation[22][23] | $280,000,000 | $280 million (civil only; non-intervened) | Off-label promotion/ kickbacks/Medicare fraud |
False Claims Act/FDCA |
| 2003 | 18 | 17 | Zoladex | AstraZeneca[24] | $355,000,000 | $266 million ($355 million with criminal component) | Medicare fraud | Prescription Drug Marketing Act |
| 2006 | 15 | 18 | Temodar/ Intron A/K-Dur/ Claritin RediTabs |
Schering-Plough[25] | $435,000,000 | $255 million civil ($435 million with criminal component) | Off-label promotion/ kickbacks/Medicare fraud |
False Claims Act/FDCA |
| 2010 | 11 | 19 | Botox | Allergan[26] | $600,000,000 | $225 million civil ($600 million with criminal component) | Off-label promotion | False Claims Act/FDCA |
| 2004 | 16 | 20 | Neurontin | Pfizer[27] | $430,000,000 | $190 million civil ($430 million with criminal component) | Off-label promotion | False Claims Act/FDCA |
See also edit
References edit
- ^ Girard, Vicki (2009). "Punishing Pharmaceutical Companies for Unlawful Promotion of Approved Drugs: Why the False Claims Act Is the Wrong Rx" (PDF). digitalcommons.law.umaryland.edu. Retrieved 2019-07-03.
- ^ 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
- ^ Katie Thomas, Michael S. Schmidt (2 July 2012). "Glaxo Agrees to Pay $3 Billion in Fraud Settlement". The New York Times. Retrieved 25 August 2012.
- ^ Lavoie, Denise (5 December 2007). "Drug Whistleblower Collects $24M". cbsnews.com. Retrieved 25 August 2012.
- ^ "GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data". justice.gov. 2 July 2012. Retrieved 25 August 2012.
- ^ "Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations". justice.gov. 4 November 2013. Retrieved 5 March 2015.
- ^ "JUSTICE DEPARTMENT ANNOUNCES LARGEST HEALTH CARE FRAUD SETTLEMENT IN ITS HISTORY" (PDF). justice.gov. 2 September 2009. Retrieved 25 August 2012.
- ^ "Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote". justice.gov. 7 May 2012. Retrieved 25 August 2012.
- ^ "Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa". justice.gov. 15 January 2009. Retrieved 25 August 2012.
- ^ "Merck to Pay More than $650 Million to Resolve Claims of Fraudulent Price Reporting and Kickbacks". justice.gov. 7 February 2008. Retrieved 25 August 2012.
- ^ "Amgen Inc. Pleads Guilty to Federal Charge in Brooklyn, NY.; Pays $762 Million to Resolve Criminal Liability and False Claims Act Allegations". justice.gov. 19 December 2012. Retrieved 20 December 2012.
- ^ "GlaxoSmithKline to Plead Guilty & Pay $750 Million to Resolve Criminal and Civil Liability Regarding Manufacturing Deficiencies at Puerto Rico Plant". justice.gov. 26 October 2010. Retrieved 25 August 2012.
- ^ "SERONO TO PAY $704 MILLION FOR THE ILLEGAL MARKETING OF AIDS DRUG". justice.gov. 17 October 2005. Archived from the original on 2 November 2013. Retrieved 25 August 2012.
- ^ "TAP PHARMACEUTICAL PRODUCTS INC.AND SEVEN OTHERS CHARGED WITH HEALTH CARE CRIMES;COMPANY AGREES TO PAY $875 MILLION TO SETTLE CHARGES". justice.gov. 3 October 2001. Retrieved 25 August 2012.
- ^ "Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing". justice.gov. 27 April 2010. Retrieved 25 August 2012.
- ^ "Bristol-Myers Squibb to Pay More Than $515 Million to Resolve Allegations of Illegal Drug Marketing and Pricing". justice.gov. 28 September 2007. Retrieved 25 August 2012.
- ^ Mole, Beth (October 7, 2016). "For ripping off Medicaid, EpiPen maker Mylan pays Feds $465 million". Ars Technica. Retrieved December 3, 2016.
- ^ "Manhattan U.S. Attorney Announces $370 Million Civil Fraud Settlement Against Novartis Pharmaceuticals For Kickback Scheme Involving High-Priced Prescription Drugs, Along With $20 Million Forfeiture Of Proceeds From The Scheme". www.justice.gov. November 20, 2015.
- ^ "September 29, 2008" (PDF). quitam-lawyer.com. 29 September 2008. Archived from the original (PDF) on 9 July 2012. Retrieved 25 August 2012.
- ^ "Cephalon pays $425 million to settle whistleblower off-label marketing case", Phillips & Cohen LLP Press Release, September 29, 2008.
- ^ "SCHERING-PLOUGH TO PAY $345 MILLION TO RESOLVE CRIMINAL AND CIVIL LIABILITIES FOR ILLEGAL MARKETING OF CLARITIN". justice.gov. 30 July 2004. Retrieved 25 August 2012.
- ^ "Celgene Agrees to Pay $280 Million to Resolve Fraud Allegations Related to Promotion of Cancer Drugs For Uses Not Approved by FDA". U.S. Department of Justice. 24 July 2017.
- ^ PLLC, Guttman, Buschner & Brooks. "Bio Pharma Giant -- Celgene -- Settles Case Alleging Marketing Violations For $280 Million". www.prnewswire.com.
{{cite web}}: CS1 maint: multiple names: authors list (link) - ^ Petersen, Melody (21 June 2003). "AstraZeneca Pleads Guilty In Cancer Medicine Scheme". nytimes.com. Retrieved 25 August 2012.
- ^ "SCHERING TO PAY $435 MILLION FOR THE IMPROPER MARKETING OF DRUGS AND MEDICAID FRAUD" (PDF). justice.gov. 29 August 2006. Retrieved 25 August 2012.
- ^ "Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botox®". justice.gov. 1 September 2010. Retrieved 25 August 2012.
- ^ "Franklin v. Parke-Davis: First Off-Label Case Under False Claims Act". greenellp.com. Retrieved 25 August 2012.