NEW YORK (Legal Newsline) - New York Attorney General Eric Schneiderman secured a settlement Friday with Merck Sharp & Dohme Corp. to resolve civil and criminal charges over the marketing of the drug Vioxx.
Merck allegedly marketed Vioxx for uses that the FDA did not approve and misrepresented the drug's cardiovascular safety. As part of a multi-state and federal agreement, the company will pay $615 million in civil damages and penalties to compensate Medicaid, Medicare and other government healthcare programs, with New York set to receive $61 million of the settlement.
Vioxx was withdrawn from the worldwide market in 2004 after Merck cited an increase in the incidence of heart attacks and strokes in patients taking the drug. The increase prompted litigation by New York and other states.
"To make a profit, Merck put the lives of New Yorkers in danger by misrepresenting the safety of Vioxx," Schneiderman said. "The settlement holds this pharmaceutical giant accountable for its deceptive marketing practices and ripping off our state's taxpayers. Our office will continue to root out this kind of reckless corporate behavior on behalf of the people of New York."
According to Schneiderman's civil action, filed in conjunction with the New York City Corporation Counsel's office, Merck made false or misleading representations from May 1999 through September 2004 about the cardiovascular safety of Vioxx, a non-steroidal anti-inflammatory medication, in the drug's sale, marketing, advertising and promotion.
Merck's alleged misrepresentations caused physicians to prescribe Vioxx that otherwise would not have been written, causing the state's Medicaid program to reimburse them for prescriptions they otherwise would not have.
The resolution's criminal component centers on the illegal marketing and promotion of Vioxx as a treatment for rheumatoid arthritis. The drug was not approved to treat rheumatoid arthritis until 2002 despite being on the market since 1999. Federal law prohibits manufacturers from promoting a drug for uses not approved by the FDA>
Merck, under terms of the settlement, will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company's future marketing and sales practices.
The settlement was reached in November but has not been made public until the disposition of a related criminal manner.