Posted Apr 23, 2007 03:12 pm CDT
A Texas judge has ruled that state juries may not decide whether Vioxx manufacturer Merck & Co. withheld information from the Food and Drug Administration.
That determination may be made only by the FDA, Judge Randy Wilson said in granting partial summary judgment to Merck.
Vioxx was withdrawn from the market in 2004 after a study showed it increased risks of heart problems. The FDA had approved the Vioxx warning that was later deemed inadequate by plaintiffs in 1,000 consolidated cases in Texas.
A Texas law says an FDA-approved warning creates a presumption that there is no liability, but the presumption can be rebutted with evidence that the defendant withheld information about a drug.
Wilson ruled that U.S. Supreme Court precedent establishes it is the FDA’s exclusive responsibility to determine whether Merck withheld any required information.
Wilson certified his decision for an expedited appeal.
“Merck acted responsibly by providing the FDA with the required data and updating the label with FDA-approved language to reflect what was known at the time,” said Ted Mayer of Hughes, Hubbard & Reed, counsel for Merck, in a press release.
A hat tip to Law Blog, published by the Wall Street Journal, which posted the April 20 ruling (PDF).