BOSTON - Merck, Sharp & Dohme Inc. has agreed to plead
guilty to a criminal misdemeanor and to pay $950 million to resolve criminal
charges and civil claims stemming from its marketing of the painkiller Vioxx a
decade ago, the U.S. Department of Justice announced yesterday (United
States v. Merck Sharp & Dohme Corp., 1:11-cr-10384, D. Mass.).
The company's guilty plea in
the U.S. District Court for the District of Massachusetts, on a single
misdemeanor criminal charge, is for interstate commerce in a misbranded
product. The U.S. Food and Drug Administration did not approve Vioxx for
the treatment of rheumatoid arthritis until April 2002, the government says,
but Merck promoted Vioxx for that indication before then, resulting in an FDA
warning letter in September 2001. With the guilty plea, Merck will pay a
criminal fine of more than $321 million, the government said.
Merck also will enter a civil
settlement entailing more than $628 million to resolve additional allegations
of off-label marketing of Vioxx and false statements about the drug's
cardiovascular safety, the government said. Of that sum, $426 million
will go to the federal government, with nearly $202 million to be distributed
among participating Medicaid states.
A letter outlining the plea
agreement is dated Nov. 7 but was docketed at the same time as the criminal
information, which is dated Nov. 22. As part of the settlement, Merck
agrees to enter into an "expansive corporate integrity agreement" with the
Office of Inspector General of the Department of Health and Human Services,
which will impose oversight procedures on the company.
The government is represented
by U.S. Attorney Carmen M. Ortiz and Assistant U.S. Attorneys for the District
of Massachusetts Susan G. Winkler, Jeremy M. Sternberg and Zachary A. Cunha,
all in Boston, and Assistant Attorney General Tony West of the U.S. Department
of Justice and Jill P. Furman of the Justice Department Office of Consumer
Litigation, both in Washington, D.C. Merck is represented by Theodore V.
Wells Jr. of Paul, Weiss, Rifkind, Wharton and Garrison in New
York and R.J. Cinquegrana of Choate, Hall & Stewart in Boston.
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