Merck Sharp & Dohme Corporation (Merck) has settled the Vioxx lawsuit with the state of Georgia, 42 other states and the federal government. Merck will be paying $15 million to settle civil and criminal allegations by Georgia Medicaid that Merck made false and misleading representations about its drug Vioxx.
 
Specifically, the allegations claim that Merck marketed Vioxx for uses not approved by the United States Food and Drug Administration (FDA) and misrepresented the cardiovascular safety issues relating to the drug.
 
Merck will pay the states and the federal government a total of $615 million in civil damages and penalties to compensate Medicaid, Medicare and other federal healthcare programs for harm suffered as a result of this conduct. Georgia Medicaid will receive $15,648,300.46 in state and federal dollars and the state portion of that amount is $6,822,077.81.
 
In addition, Merck has agreed to plead guilty to a violation of the Food, Drug, and Cosmetic Act and to pay a criminal fine and forfeiture of more than $300 million. The criminal component of the resolution centers on the illegal marketing and promotion of Vioxx for the treatment of rheumatoid arthritis. Vioxx was introduced into the market in 1999 but was not approved by the FDA as an indication for rheumatoid arthritis until 2002.
 
The civil settlements are contingent upon the acceptance of Merck’s guilty plea by the U.S. District Court for the District of Massachusetts. A hearing date for this proceeding has not yet been scheduled.
 
Vioxx 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 Vioxx.
 
The State of Georgia alleges that Merck made false representations concerning the safety of Vioxx to its Medicaid program, and the Medicaid program relied on that information to its detriment in making formulary and prior authorization decisions with respect to the drug.
 
Georgia also alleges that Merck made false or misleading representations about Vioxx in its marketing, advertising and promotion of the drug that caused physicians to write prescriptions or Vioxx that they otherwise would not have written, and thereby caused the Medicaid program to pay for prescriptions that should not have been reimbursed.