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/
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
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