British drug maker GlaxoSmithKline (GSK) has agreed to pay
$3 billion US in criminal and civil fines and plead guilty to misdemeanor
criminal charges related to the sale and marketing of its antidepressants Paxil
and Wellbutrin and the diabetes drug Avandia in the largest health-care fraud
settlement in U.S. history.
The case was brought against GSK under the federal
government’s whistle-blower law,
known as the False Claims Act.
Whistle-blowers get a share of any money received by the federal
government. The case stems from claims
made by four employees of GSK, including a former senior marketing development
manager for the company and a regional vice president, who informed the
government about a range of improper practices from the late 1990s to the mid
2000s.
The British drug maker admitted, as part of its settlement,
that it misbranded antidepressants Paxil and Wellbutrin. It also admitted to
marketing them for uses not approved by the FDA including treatment of children
for depression and treatment for obesity, addition, ADHD and anxiety. The
company also admitted that it failed to inform the FDA that its diabetes drug
Avandia might cause heart problems.
GlaxoSmithKline will pay $1 billion in criminal fines and
forfeitures and the remaining $2 billion will go to settle state and federal
civil allegations regarding false claims that it submitted to the federal
health care programs. According to the Michigan Attorney General Bill Schuette,
Michigan is in line to get $23.8 million as part of the settlement, as Michigan
was among the states that sued GSK.
If you have any questions relating to health care fraud,
contact Mark Mandell or Tariq Hafeez at (248) 380-0000.
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