Merck & Co will pay roughly $950 million to settle criminal and civil charges that it promoted the painkiller drug Vioxx for an unapproved use, the U.S. Justice Department said on Tuesday.
The fine will conclude a long-running investigation into Merck's promotion of the drug, which was withdrawn from the market in September 2004. The Justice Department had alleged that Merck promoted the drug for treating rheumatoid arthritis before it had been approved for that condition by the Food and Drug Administration.
Merck had previously disclosed to investors the anticipated $950 million charge ahead of the government announcement.
Merck said the settlement does not constitute an admission of any liability or wrongdoing.
The FDA approved Vioxx in 1999, but the government did not initially approve the drug for use in rheumatoid arthritis. That meant doctors could write prescriptions for Vioxx for rheumatoid arthritis patients, but Merck could not promote the drug for that use. The Justice Department said Merck promoted Vioxx for rheumatoid arthritis for three years and continued to do so after getting an FDA warning letter in 2001. The drug was approved as a treatment for rheumatoid arthritis in April 2002.
Merck stopped selling Vioxx in 2004 after evidence showed the drug doubled the risk of heart attack and stroke. In 2007, the company paid $4.85 billion to settle around 50,000 Vioxx-related lawsuits.
The government will get $426.4 million from the new settlement, and $202 million will be distributed to state Medicaid programs for 43 states and the District of Columbia.
