Merck, Sharp & Dohme (MSD) [the U.S. operating company for the pharmaceutical business formerly conducted by Merck & Co.] agreed to pay $950 million to resolve criminal and civil claims related to its promotion and marketing of the painkiller Vioxx. MSD agreed to plead guilty to a one-count information charging a single misdemeanor violation of the Food Drug and Cosmetic Act (FDCA) and pay a $321,636,000 criminal fine. (Merck & Co. simultaneously entered into a non-prosecution agreement with the Department of Justice.) MSD also entered into a civil settlement agreement to pay $628,364,000 to resolve additional allegations regarding off-label marketing of Vioxx and false statements about the drug’s cardiovascular safety. The criminal plea related to the misbranding of Vioxx between May 1999 and April 2002 by promoting the drug for treating rheumatoid arthritis before that use was approved by the Food and Drug Administration (FDA). The civil settlement covered a broader range of allegations, including making inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug and making false statements to state Medicaid agencies about the cardiovascular safety of Vioxx.