Merck Caves, Agrees To $4.85 Billion Vioxx Settlement
November 13, 2007
Pain reliever raised risk of heart attack, stroke
Vioxx, et al
After insisting it would contest each of the thousands of product liability law suits over Vioxx, pharmaceutical giant Merck, Inc. has agreed to settle claims over the withdrawn painkiller for $4.85 billion.
Merck withdrew Vioxx from the market in September 2004 after tests indicated the highly popular arthritis drug increased the risk of heart attack and stroke in patients taking it. More than 27,000 consumers or their family members filed suit against Merck as a result.
In the last three years, only a handful of the cases have gone to trial.
Merck has won some of the more recent trials, but pressure mounted on company executives to do something to stem the escalating legal costs of defending those cases. Judges in California, New Jersey, and Louisiana, who have heard most of the cases, also pressed both sides to reach a settlement.
Under the terms of the agreement, 85 percent of the plaintiffs must sign off on it for it to become binding. Plaintiffs would receive payments depending on the severity of their injuries and the length of time they took the drug.
If finalized, it would become the largest settlement in the U.S. this year and could rank among the largest in U.S. history. Prior to its withdrawal from the market, millions of consumers were taking Vioxx for arthritis and other pain. Merck’s Vioxx sales totaled $2.5 billion in 2003.
A New NSAID
FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by FDA.
Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.
At the time that Vioxx and other Cox-2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs, such as ibuprofen and naproxen. Vioxx was the only NSAID demonstrated to have a lower rate of these side effects.
Merck contacted FDA on September 27, 2004, to request a meeting and to advise the agency that the long-term study of Vioxx in patients at increased risk of colon polyps had been halted.
Merck and FDA officials met the next day, September 28, and during that meeting the company informed FDA of its decision to remove Vioxx from the market voluntarily.