US Judge imposes nearly $322 million fine on Merck & Co for illegal marketing

US drug giant Merck & Co (NYSE: MRK) was sentenced by US District Court Judge Patti Saris in Boston to pay a criminal fine in the amount of $321,636,000 in connection with its guilty plea related to its promotion and marketing of the painkiller Vioxx (rofecoxib), the Justice Department announced yesterday. In December 2011, Merck pleaded guilty to violating the Food, Drug, and Cosmetic Act (FDCA) for introducing a misbranded drug, Vioxx (which was withdrawn from the market in 2004 because of serious side effects), into interstate commerce.

Merck’s guilty plea was part of a global resolution involving its illegal promotional activity. In November 2011, Merck entered into a civil settlement agreement under which it will pay $628,364,000 to resolve additional allegations regarding off-label marketing of Vioxx and false statements about the drug’s cardiovascular safety. Of the total civil settlement, $426,389,000 will be recovered by the USA, and the remaining share of $201,975,000 will be distributed to the participating Medicaid states. The settlement and yesterday’s sentencing conclude a long-running investigation of Merck’s promotion of Vioxx, which was withdrawn from the marketplace in September 2004.

Merck’s criminal plea related to the misbranding of Vioxx by promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration. The FDA approved Vioxx for three indications in May 1999, but did not approve its use for rheumatoid arthritis until April 2002. In the interim, for nearly three years, Merck promoted Vioxx for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001.