Merck to pay $950 million in Vioxx suit, plead guilty
Merck agreed to pay $950 million to resolve criminal charges and a lawsuit alleging that the company illegally marketed Vioxx, the painkiller that was pulled from the market in 2004. Merck, based in Whitehouse Station, N.J., will plead guilty to a misdemeanor for illegal promotion activity related to Vioxx and pay a $321.6 million criminal fine. In an agreement with prosecutors, Merck admits misbranding Vioxx by promoting the drug to physicians as a treatment for rheumatoid arthritis during a three-year period in which it was not approved by the Food and Drug Administration for that indication. Vioxx was approved by the FDA in 1999; it was approved as an indication for rheumatoid arthritis in 2002. The company also will enter a $628.4 million civil settlement agreement that resolves allegations of off-label marketing and false statements about the drug’s safety. The U.S. will recover $426 million from the civil settlement and the remaining $202 million will be distributed to the Medicaid programs that participated in the suit. Merck will enter a corporate integrity agreement with the HHS’ inspector general’s office. Top executives will be required to complete annual compliance certifications, and Merck will be required to post information about physician payments on its website, according to the news release. Merck said in a news release that the “civil settlement does not constitute any admission by Merck of any liability or wrongdoing.” The company said Vioxx litigation with seven states remains outstanding.