The justice department announced that the US pharmaceutical company Merck & Co. has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx.
The criminal charges relate to off-label marketing of Vioxx. Under the agreement, Merck will plead guilty to a misdemeanor for its illegal promotional activity and will pay a $321,636,000 criminal fine. Vioxx was approved for three indications in 1999, but not approved for use in rheumatoid arthritis patients until 2002. However, Merck marketed the painkiller for use in rheumatoid arthritis patients between 1999 and 2002 and received a Warning Letter from FDA in November 2001, for the practice.
Merck has also agreed to a civil settlement under which it will pay $628,364,000 to resolve additional allegations regarding off-label marketing of Vioxx and false statements about the drug’s cardiovascular safety. The settlement resolves allegations that Merck representatives made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug, resulting in payments by the federal government. According to a press release from Merck, as a result of the settlement, the US and the participating states have released Merck from civil liability related to the government’s allegations regarding the sale and marketing of Vioxx in the US, They also state that the civil settlement does not constitute any admission by Merck of any liability or wrongdoing. However, previously disclosed litigation with seven states remains outstanding.
Finally, as part of the settlement, Merck has also agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services (HHS-OIG), which will strengthen the system of reviews and oversight procedures imposed on the company. Although Vioxx was voluntarily withdrawn from the market in 2004, this ongoing monitoring of Merck’s conduct is aimed to deter and detect similar conduct in the future.
Bruce N. Kuhlik, executive vice-president and general counsel of Merck, said in the company press release, “Merck recognizes the importance of robust compliance programs and is committed to adhering to the law and to our fundamental values and standards. 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.”