Drug giant Merck & Co. has agreed to plead guilty and pay $950 million to settle criminal and civil charges over the marketing of the arthritis painkiller Vioxx, which studies showed increased the risk of strokes and heart attacks, the U.S. Justice Department has announced.
Merck, based in New Jersey, pulled Vioxx from the market in September 2004.
The company pleaded guilty to a single misdemeanor charge of violating the Food Drug and Cosmetic Act for introducing a misbranded drug and will pay $321.6 million.
Merck will also pay $628.3 million to settle civil charges for off-label marketing of the drug and making false statements about its cardiovascular safety. The federal government will get $426.3 million and $201.9 million will be distributed to 43 states for Medicaid.
Read the full news release.
"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," said Tony West, Assistant Attorney General for the Civil Division . "As this plea agreement and civil settlement make clear, 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."
In its statement, Merck emphasized the civil settlement first, noting that it "does not constitute any admission by Merck of any 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 N. Kuhlik, the company's executive vice president and general counsel. He did not comment on the criminal charge.
Merck's release also notes that "the United States acknowledged that there was no basis for a finding of high-level management participation in the violation."
Tuesday, November 22, 2011
Finally! - Merck to plead guilty, pay $950 million over Vioxx marketing | The Town Talk | thetowntalk.com