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Shots - Health Blog
Tue November 22, 2011
Remember Vioxx? Merck Settles Marketing Charges From Way Back
Originally published on Wed November 23, 2011 11:44 am
Drugmaker Merck took the painkiller Vioxx off the market in 2004, citing an increased risk of heart attacks among people taking the medicine.
Today, seven years later, the Justice Department said Merck had agreed to pay $950 million to settle charges the company went too far in marketing the drug.
The company pleaded guilty to a misdemeanor that it illegally promoted the drug for the treatment of rheumatoid arthritis a decade ago. The Food and Drug Administration didn't approve Vioxx for rheumatoid arthritis until 2002, three years after the drug got the green light for the relief of acute pain, treatment of osteoarthritis and menstrual pain.
In between, the Justice Department said Merck marketed the drug for rheumatoid arthritis anyway, even after the FDA warned the company about doing so. Merck pleaded guilty to a misdemeanor criminal charge covering that behavior and is paying a fine of $322 million.
Merck agreed to settle other civil charges, including claims that it made misleading and inaccurate claims about the cardiovascular safety of the medicine between April 2000 and Sept. 30, 2004, when the drug was yanked.
The settlement of those charges "does not constitute any admission by Merck of any liability or wrongdoing," the company said in a statement. "We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx," Bruce N. Kuhlik, Merck's general counsel, said in the statement.
The settlement has been expected for a while. Merck set aside money to cover the cost more than a year ago.