Texas court dismisses Vioxx lawsuit
NEW YORK (Reuters) - A Texas judge overseeing lawsuits against Merck & Co. over its withdrawn pain drug Vioxx on Friday dismissed a case brought by a woman, rejecting her claim that she was not properly informed of the medicine's health risks, according to court papers.
Judge Randy Wilson held that to prevail under Texas law the plaintiff would have to show that Merck withheld required, material and relevant information from the U.S. Food and Drug Administration that would have led to a different decision regarding warnings on the approved labeling for Vioxx.
Wilson, of the U.S. District Court of Harris County, Texas, ruled in the case of Ruby Ledbetter vs Merck that such a determination can only be made by the FDA, not a Texas jury.
"There is no question but that the FDA has not made a determination that material and relevant information was either withheld or misrepresented concerning Vioxx," Wilson wrote in his decision.
Wilson certified the decision for an expedited appeal to the Texas Court of Civil Appeals.
More than 1,300 Vioxx cases were filed in Texas after the 2003 law Wilson cited in his ruling was enacted. Merck has sought to dismiss all such failure-to-warn claims under Texas law.
"The Texas Legislature enacted its law to ensure that jurors are not asked to second-guess the doctors and scientists at the FDA who conduct an extensive review," Merck attorney Ted Mayer said in a statement.
In September 2004 Merck withdrew the arthritis and pain drug, which once had sales of $2.5 billion a year, after a study showed it doubled the risk of heart attack and stroke in long-term users.
The company is facing more than 27,000 lawsuits brought by people who claim to have been harmed by the medicine.
Many of the suits are based on claims that the drugmaker failed to provide adequate warnings of the health risks associated with the drug. In several already completed trials plaintiffs' attorneys have alleged that Merck knew of the risks long before it pulled the drug but put profit ahead of patient safety.
Merck has maintained that it acted responsibly in marketing the drug and in providing warnings to patients and physicians, and that it withdrew Vioxx as soon as it had definitive proof of the increased heart risks.
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