New Orleans – The Food and Drug Administration's approval of warnings on a drug label doesn't clear the manufacturer of claims that the warnings were inadequate, a judge ruled Tuesday in a decision affecting thousands of federal lawsuits against Merck over the painkiller Vioxx.
"The FDA's current view on the question of immunity for prescription-drug manufacturers is entirely unpersuasive," U.S. District Judge Eldon E. Fallon wrote.
Fallon rejected Merck's attempt to throw out lawsuits brought in the cases of two people who began taking Vioxx after April 2002, when the FDA approved a label warning that the drug might increase the chance of heart attacks and other cardiovascular problems.
Lene Arnold, who had a heart attack in December 2003, and the family of Joe G. Gomez, who died of one in January 2003, claim that the warning was inadequate.
"Failure to warn" is a state claim, but where there is no parallel federal law, federal courts apply state laws in the jurisdiction where a suit is filed.
In a preamble to rules set in 2006, the FDA contends that its requirements set the limits for prescription-drug labels, pre-empting state claims that a company failed to warn users of a danger.
However, Fallon wrote, "Because there are no federal remedies for individuals harmed by prescription drugs, a finding of implied pre-emption in these cases would abolish state-law remedies and would, in effect, render legally impotent those who sustain injuries from defective prescription drugs."
Had Merck won, it could have challenged claims brought by thousands of other plaintiffs.