The pharmaceutical company will pay Oregon more than $1.6 million to resolve off-label marketing allegations related to the drug Vioxx
Attorney General John Kroger today announced an approximately $950 million national agreement with Merck Sharp & Dohme Corp. (Merck) to resolve civil and criminal allegations that Merck illegally promoted and misrepresented the safety of its anti-inflammatory drug Vioxx.
“It’s important that everyone follows the law,” said Keith Dubanevich, Chief of Staff at the Oregon Department of Justice. “This case shows that companies that break the rules will be held accountable.”
Oregon joined 42 other states and the federal government to reach a settlement agreement over allegations that Merck marketed Vioxx for uses not approved by the U.S. Food and Drug Administration (FDA), failed to disclose cardiovascular safety risks related to its use and otherwise made false and misleading representations about Vioxx.
Vioxx (generic name rofecoxib) is a non-steroidal anti-inflammatory medication that was approved by the FDA in 1999 for the treatment of osteoarthritis, acute pain conditions and dysmenorrhea. On September 30, 2004, Merck voluntarily withdrew Vioxx from the market worldwide, citing an increase in the incidence of adverse cardiovascular events in patients taking the drug.
Today’s settlement resolves numerous allegations, including that Merck illegally promoted Vioxx for the treatment of rheumatoid arthritis. Although Vioxx was introduced into the market in 1999, it was not approved by the FDA as an indication for rheumatoid arthritis until 2002. While it is not illegal for a physician to prescribe a drug for an unapproved use, federal law prohibits a manufacturer from promoting a drug for such usage.
Merck was also accused of making false claims about the safety of Vioxx, which Medicaid programs relied upon in making formulary and prior authorization decisions with respect to the drug. Physicians also relied upon allegedly false and misleading promotional claims in prescribing Vioxx, and thereby caused the Medicaid to pay for prescriptions that should not have been reimbursed by the program.
Under today’s agreement Merck will pay a total of $628 million in civil damages and penalties to compensate Medicaid, Medicare and other federally-subsidized healthcare programs. Merck will also plead guilty to federal criminal charges, pay a fine and forfeit more than $321 million. Oregon’s share of approximately $1,650,000 is contingent upon the acceptance of Merck’s guilty plea by the U.S. District Court for the District of Massachusetts.
As a condition of the settlement Merck will also enter into a Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.
Attorney General John Kroger leads the Oregon Department of Justice. The Department’s mission is to fight crime and fraud, protect the environment, improve child welfare, promote a positive business climate, and defend the rights of all Oregonians.