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The US drug company Merck announced last week that it will pay $4.85bn (£2.3bn; €3.3bn) to settle 26600 lawsuits, representing 47000 plaintiffs, in addition to 265 possible class action cases, arising out of the use of rofecoxib (Vioxx).
The agreement is to cover cases filed in federal and state courts, and depends on 85% of all plaintiffs dropping their cases. The money will be paid into a settlement fund for claims that qualify. In a statement the company said, “This is not a class action settlement. Claims will be evaluated on an individual basis.”
Chris Seeger, one of six lawyers for the plaintiffs who helped to negotiate the settlement, said that it was the largest ever in the drug industry.
Rofecoxib was approved by the US Food and Drug Administration in 1999 for the relief of the symptoms of osteoarthritis, management of acute pain in adults, and treatment of menstrual pain. The company withdrew the drug from the market in 2004, when a study that it had funded showed that patients taking rofecoxib had twice the risk of heart attack and stroke (New England Journal of Medicine 2005;352:1092-102; see BMJ 2004;329:816 doi: 10.1136/bmj.329.7470.816-a).
In February 2005 the FDA concluded that rofecoxib and similar drugs posed cardiovascular risks but that they could remain on sale. Later that year, in the first Vioxx trial, a Texas jury awarded $253.4m (later reduced to about $26m) to the widow of a man who had died in May 2001. Other legal cases followed, some of which resulted in millions of dollars in damages awarded to the plaintiffs (BMJ 2005;331:471 doi: 10.1136/bmj.331.7515.471) and others ruling that Merck had not been responsible for heart attacks experienced by people taking rofecoxib (BMJ 2005;331:1101 doi: 10.1136/bmj.331.7525.1101-a).
Despite winning recent individual cases, Merck agreed the settlement last week to stop further hearings. Ken Frazier, executive vice president of Merck, said, “Without this settlement the litigation might very well stretch on for years,” adding that the agreement was “responsible and reasonable.” To qualify for part of the settlement, people adversely affected as a result of taking rofecoxib must have filed their claims by Thursday 8 November 2007 and met several strict medical criteria, including proof that they had had a heart attack or stroke.