Merck assessed additional fine in Vioxx case

Pharmaceutical giant Merck & Co. has been ordered to pay a $321.6 million criminal fine for marketing the painkiller Vioxx for rheumatoid arthritis before the Food and Drug Administration had approved the medication for that use. The fine, ordered by US District Judge Patti B. Saris, will be added to a $628 million civil settlement between Merck and a number of federal and state authorities.

Merck did not attempt to deny the allegations, pleading guilty in December to violating federal law by marketing Vioxx for an unapproved use. The drug was originally approved in 1999, but the FDA’s approval did not include prescribing Vioxx as a treatment for rheumatoid arthritis. The FDA did not formally approve the drug as a rheumatoid arthritis treatment until 2002; thus, for a three-year period, Merck was in violation of the Food, Drug and Cosmetic Act. In addition, prosecutors said, the FDA had issued a letter to Merck in 2001 specifically warning the company about its actions.

Vioxx proved a profitable drug for Merck, earning billions before it was taken off the market in 2004, when long-term use of the drug was found to increase patients’ risk of stroke and heart attack.

The full report from Courthouse News Service can be found here.