Merck to Plead Guilty, Pay $950M in U.S. Vioxx Probe.

Merck Sharp & Dohme will plead guilty to one count of misbranding Vioxx, the company and U.S. prosecutors said yesterday. The company will pay a $321.6 million criminal fine and $628.3 million to resolve civil claims that it sold Vioxx for unapproved uses and made false statements about its cardiovascular safety.

Before that approval, the company touted Vioxx to physicians for rheumatoid arthritis, prompting the FDA to send a warning letter on Sept. 17, 2001. The letter said Merck made a misleading claim suggesting that “Vioxx is effective for the treatment of rheumatoid arthritis when this has not been demonstrated,” according to the criminal charge that Merck Sharp & Dohme will admit in federal court in Boston.

Former Vioxx users who sued in state and federal courts claimed Merck didn’t adequately disclose safety data to the FDA, failed to properly warn doctors and patients of the drug’s risks, and misrepresented the potential harm in marketing materials.

They accused Merck officials of withholding data in 2000 about a clinical trial that found Vioxx caused five times more heart attacks than another painkiller and publishing misleading and inaccurate information about the drug’s health risks.


http://www.bloomberg.com/news/2011-11-22/merck-agrees-to-pay-950-million-to-settle-u-s-government-s-vioxx-probe.html