By PBN Staff
PROVIDENCE – Rhode Island will receive $917,453 as part of a $950 million settlement with pharmaceutical giant, Merck Sharp & Dohme Corp.
Merck is settling civil and criminal allegations that it marketed its drug Vioxx for uses not approved by the U.S. Food and Drug Administration; misrepresented the cardiovascular safety issues related to the drug; and other false and misleading representations.
Vioxx, a non-steroidal anti-inflammatory medication, for treating osteoarthritis, acute pain conditions and dysmenorrhea, was withdrawn from the market on Sept. 30, 2004, due to an “increase in the incidence of adverse cardiovascular events” in those taking the drug.
The company will pay $628.3 million to resolve civil claims to federal health care programs “for harm suffered as a result of this conduct.”
Merck has also agreed to plead guilty to violating the Food, Drug and Cosmetic Act and pay a fine of $321.6 million for illegal marketing of Vioxx as a treatment of rheumatoid arthritis. It was not approved by the FDA for treatment of the disease until 2002 but was introduced into the market in 1999.
The civil settlements are contingent on the U.S. District Court for the District of Massachusetts accepting Merck’s guilty plea. A hearing date has not yet been scheduled.
“Pharmaceutical companies are driven to off-label marketing of prescription drugs, like Vioxx, to boost profits despite the potential risks to patients’ health and safety,” said R.I. Attorney General Peter Kilmartin. “Merck’s false representations concerning the safety of Vioxx diverted Medicaid funds from legitimate programs to corporate profits to the detriment of taxpayers and patients.”