The Department of Justice announced a $950 million settlement with the second-largest U.S. drugmaker, Merck, Sharp & Dohme for its illegal promotion of its Vioxx painkiller in 2004. The drug, rofecoxib, was pulled from store shelves seven years ago when studies linked increased risks of heart attacks and strokes, even after patients stop taking the medicine.
Under the agreement, Merck will plead guilty for marketing Vioxx as a treatment for rheumatoid arthritis, before that use was approved by the Food and Drug Administration. This misbranded marketing of the rofecoxib drug, a misdemeanor offense of the Food Drug and Cosmetic Act, resulted in a $321,636,000 criminal fine.
The remaining $628,364,000 under the Justice Dept. settlement covers Merck's off-label marketing of Vioxx and false statements about the prescription drug's safety. Nearly $202,000,000 of that civil settlement will go toward various state Medicare agencies involved in the Merck Vioxx investigation.