Merck has agreed to plead guilty to introducing a misbranded drug into interstate commerce in connection with its illegal marketing of Vioxx.  Merck will pay a criminal fine of $321,636,000 and $628,264,000 to resolve related civil allegations.

The criminal plea relates to Merck’s marketing of Vioxx for rheumatoid arthritis.  Although the drug was not approved for that purpose until 2002, according to the criminal plea, Merck promoted Vioxx as a treatment for rheumatoid arthritis for three ears prior to its approval.  The drug was taken off the market all together in 2004.  In addition to the conduct covered in the criminal plea, the settlement also resolves allegations that Merck made inaccurate, unsupported, or misleading statements about the cardiovascular safety of the drug in order to increase sales.  Merck also allegedly made false statements regarding the safety of Vioxx to state Medicaid agencies which caused them to cover the drug.  Several product liability cases have been brought by patients injured by Vioxx; many have prevailed in jury trials.

As part of the settlement, Merck has also agreed to enter into a Corporate Integrity Agreement with the Health and Human Services Office of the Inspector General (HHS-OIG).

Read the press release, “U.S. Pharmaceutical Company Merck Sharp & Dohme to Pay Nearly One Billion Dollars Over Promotion of Vioxx”