There will be no single class action lawsuit against Merck's Vioxx, a federal judge has ruled. But U.S. District Court Judge Eldon Fallon left open the possibility that thousands of individual lawsuits against the pharmaceutical giant may be lumped into a series of class actions.
Merck is likely to view the ruling as a victory.
It has resisted settlement overtures and has insisted on contesting each of the product liability suits on an individual basis. To date the company has won about as many cases as it has lost.
Thousands of consumers who took the popular arthritis pain killer have sued Merck, saying it should have known there were problems with the drug sooner.
In late 2004 Merck withdrew Vioxx from the market after unrelated clinical trials showed those taking the drug faced a higher risk of stroke or heart attacks.
A group of plaintiffs had pushed for the class action, saying it was only logical that the cases should all be tried in New Jersey, where the company is based. They based their argument on the expectation that companies are required to abide by the laws in which their corporate offices reside.
The FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults 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. Vioxx quickly became one of Merck's biggest selling drugs.
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 those 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.
Subsequent studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. FDA said it was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market.
