BOSTON (CN) – A federal judge ordered Merck & Co. to pay a criminal fine of $321.6 million for marketing its Vioxx painkiller for rheumatoid arthritis before it was approved for that – this on top of a $628 million civil settlement between Merck, Uncle Sam and several states.
In the criminal case, Merck pleaded guilty in December to violating the Food, Drug and Cosmetic Act by introducing the misbranded drug into commerce. U.S. District Judge Patti B. Saris sentenced the company on Thursday.
The Food & Drug Administration approved Vioxx in May 1999, but did not approve it for rheumatoid arthritis until April 2002.
In the interim, Merck promoted Vioxx for rheumatoid arthritis for 3 years, conduct for which it was admonished in an FDA warning letter issued in September 2001, prosecutors said.
The drug made billions of dollars for Merck as a top-selling arthritis and pain medication, but was withdrawn in 2004 due to fears of increased risk of heart disease and stroke after prolonged use.
In the related civil settlement in November, Merck agreed to pay the federal government and several states more than $628 million.