Year
|
Company
|
Settlement
|
Violation(s)
|
Product(s)
|
Laws 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
|