One of the country’s largest drugmakers, Merck, will pay nearly $1 billion to settle criminal and civil charges related to its marketing of the painkiller Vioxx the Justice Department announced Tuesday.
Merck has agreed to plead guilty to a misdemeanor for illegally promoting Vioxx and to pay a criminal fine of $321,636,000. Additionally, the pharmaceutical company agreed to pay a civil settlement of $628,364,000, of which $426,389,000 will go to the federal government and $201,975,000 will be split among 43 states and the District of Columbia.
Merck voluntarily withdrew Vioxx from the market in September 2004 after a study found the drug posed an increased risk of heart attacks and strokes. The company has been battling a massive number of lawsuits – by some counts in the tens of thousands – ever since.
Tuesday’s settlements were related to thel company’s marketing of the drug. The Justice Department said in its press release about the settlement that Merck advertised the use of Vioxx for rheumatoid arthritis for three years before the FDA approved it for use for the disorder and that Merck representatives “made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug.”
“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 Justice Department’s Civil Division, in a press release. “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.”
The civil settlement does not constitute any admission by Merck of any liability or wrongdoing said the company in a statement in response to the settlement announcement.
"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 the company’s press release.
Also as part of the settlement, Merck has entered into a corporate integrity agreement (CIA) with the Office of the Inspector General of the Department of Health and Human Services. The CIA, noted the Justice Department’s press release, serves to establish ongoing monitoring of Merck in order to “deter and detect similar conduct in the future.”
In Merck’s statement, the company said the new CIA replaces its current one and builds upon the company’s existing compliance program.
“Merck recognizes the importance of robust compliance programs and is committed to adhering to the law and to our fundamental values and standards,” Kuhlik said in the company’s statement. “We believe that the settlement of this lengthy investigation is in the best interests of our stakeholders, and we look forward to focusing on our mission to save and improve lives around the world.”
Follow HFN associate editor Stephanie Bouchard on Twitter @SBouchardHFN.