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Merck reaches $950 million settlement over off-label marketing of Vioxx

The drug company will plead guilty, resolve criminal and civil charges

Pharmaceutical giant Merck & Co. agreed Tuesday to pay $950 million to settle criminal and civil charges surrounding the alleged false promotion of its painkiller Vioxx, which was withdrawn from the marketplace after claims of heart attacks and other injuries surfaced.

The U.S. Justice Department (DOJ) said the company used illegal off-label marketing to promote Vioxx as a drug for treating rheumatoid arthritis before approval by the Food and Drug Administration.

According to the DOJ’s news release, Merck will plead guilty to a misdemeanor offense and pay $321.6 million for violating the Food, Drug, and Cosmetic Act. The company will also enter a civil settlement and pay $628 million to resolve additional allegations.

“We will not hesitate to pursue those who skirt the proper drug approval process and make misleading statements about the safety and efficacy of our products,” said Tony West, assistant attorney general for the Civil Division of the DOJ.

Merck will also enter into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services (HHS-OIG), aimed to toughen the company’s system of reviews and monitor its conduct.

“Merck recognizes the importance of robust compliance programs and is committed to adhering to the law and to our fundamental values and standards,” said Merck Executive Vice President and General Counsel Bruce N. Kuhlik.

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