Nov 22 (Reuters) - Merck & Co will pay roughly $950 million
to settle criminal and civil charges that it promoted the
painkiller Vioxx for an unapproved use, the U.S. Justice Department said Tuesday.
The fine will conclude a long-running investigation into
Merck's promotion of its one-time blockbuster drug, which was
withdrawn from the market in September 2004 after being linked
to heart risks.
The Justice Department alleged that Merck promoted the drug
for treating rheumatoid arthritis before it had been approved
for that condition by the U.S. Food and Drug Administration.
The case is one of the largest settlements by a major
pharmaceutical company over marketing drugs in the United
States for uses that have not been approved by the FDA, known
as off-label promotion.
"We will not hesitate to pursue those who skirt the proper
drug approval process and make misleading statements about the
safety and efficacy of their products," said Tony West, the
Justice Department's assistant attorney general for the civil
division, in a statement.
Merck pled guilty to a misdemeanor charge and will pay a
$321.6 million criminal fine for introducing the misbranded
drug Vioxx into interstate commerce.
It also agreed to pay an additional $628.4 million civil
settlement to resolve additional allegations regarding its
off-label marketing of Vioxx and alleged false statements about
the pill's heart safety. The U.S. government will recover $426
million of that amount, while the remainder will go to the
states in the lawsuit.
HEART RISKS
The Justice Department said Merck also agreed to a
corporate integrity agreement to strengthen oversight over its
marketing. Merck said the settlement does not mean it admits
liability or wrongdoing.
"We believe that Merck acted responsibly and in good faith
in connection with the conduct at issue in these civil
settlement agreements, including activities concerning the
safety profile of Vioxx," said Bruce Kuhlik, executive vice
president and general counsel of Merck, in a statement.
The large American drugmaker had already told investors in
Oct. 2010 it was taking a $950 million charge related to the
U.S. government probe.
The civil settlement agreement is signed with the United
States and individually with 43 states and the District of
Columbia, but previously disclosed litigation with seven states
is still unresolved, Merck said.
States have said the company misled regulators about the
dangers associated with Vioxx, which has been linked in
lawsuits to increasing users' risk of heart attacks and other
serious cardiovascular side effects.
In 2007, Merck also agreed to pay $4.85 billion to settle
lawsuits filed by thousands of former Vioxx users, who alleged
the pill caused heart attacks.
(Reporting by Sarah N. Lynch and Anna Yukhananov)
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