|Merck continues to pay up due to faults related to Vioxx. Source: The People’s Pharmacy|
Merck agreed Tuesday to pay $58 million to 29 states and Washington, D.C., to settle civil allegations under the state consumer protection laws that the company’s ads for the once-popular pain killer Vioxx intentionally played down the health risks.
Merck will also be required to submit all new pharmaceutical television commercials to the FDA for review.
Vioxx (rofecoxib) was approved for use as an anti-inflammatory drug in 1999, and became a blockbuster for Merck with annual sales of $2.5 billion. In 2004, the FDA ordered the painkiller off the market after an analysis of patients using Vioxx linked the drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003.
“Merck remains committed to communications that help patients and their physicians choose medicines based on accurate, fair and balanced information,” said Bruce Kuhlik, executive vice president and general counsel of Merck. “Today's agreement enables Merck to put this matter behind us and focus on what Merck does best, developing new medicines.”
In March, Merck settled a nationwide claim totaling $649 million, plus $22 million in interest, to 49 states, Washington, D.C., and the federal government, for failing to pay rebates to state Medicaid programs and overcharging government health programs for its drugs.
To further add to Merck’s Vioxx woes, a case study published in the April 16 issue of the Journal of the American Medical Association, uncovered that clinical trial manuscripts related to Vioxx were authored by Merck employees, but attributed to academic investigators, who did not always disclose industry financial support.
Thousands of wrongful death and injury lawsuits sprang out of the Vioxx case, most of which are expected to be settled with $4.85 billion offer from Merck last November.
The Whitehouse, N.J.-based Merck said it does not admit any wrongdoing under the current settlement.