Merck had pled guilty to pushing its Vioxx painkiller as a treatment for rheumatoid arthritis without approval from the U.S. Food and Drug Administration. The drug maker also settled additional civil claims for making false statements to state Medicaid agencies about Vioxx's cardiovascular safety.
Of the nearly billion-dollar settlement, Merck will pay a $321.6 million criminal penalty, $426.4 million in civil fines to the U.S. and $202 million to states. The Justice Department said that the settlement ends a long-running investigation into Vioxx, which was yanked from the market in 2004.
No Liability, No Wrongdoing Admitted
When a pharmaceutical company ignores FDA rules aimed at keeping our medicines safe and effective, that company undermines the ability of health care providers to make the best medical decisions on behalf of their patients, Tony West, assistant attorney general for the Justice Department's Civil Division.
Merck said in a statement that the company did not admit liability or wrongdoing in settling the civil claims.
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 N. Kuhlik, executive vice president and general counsel of Merck, in a statement.