WASHINGTON (AP) — Irish pharmaceutical manufacturer Elan
Corporation PLC and its U.S.
subsidiary have agreed to pay more than $203 million for alleged illegal
promotion of the epilepsy drug Zonegran, the Justice Department said Wednesday.
The department said Japanese drug marketer Eisai Inc., which
bought the drug from Elan, will pay $11 million for so-called off-label
marketing of Zonegran.
Elan has agreed to plead guilty to a misdemeanor for
allegedly promoting Zonegran for a wide variety of improper uses, including
mood stabilization, migraine headaches, eating disorders and weight loss.
The Food and Drug administration approved Zonegran as an
anti-epileptic drug, but not for other uses.
Elan will pay a criminal fine of $97 million, will pay
$102.3 million to resolve civil allegations and will forfeit $3.6 million in
This settlement is part of the government’s emphasis on
combating health care fraud. One of the most powerful tools in that effort is
the False Claims Act, which the Justice Department has used to recover more
than $5 billion since January 2009 in cases involving fraud against federal
health care programs. The Justice Department’s total recoveries in False Claims
Act cases since January 2009 have topped $6 billion.
The settlement resolves a whistle-blower lawsuit filed by a Massachusetts physician.
The law allows citizens with knowledge of fraud to file civil actions on behalf
of the United States
and share in any recovery.
The Justice Department says it has recovered more than $5
billion since January 2009 in cases involving fraud against federal health care