U.S. Food and Drug Administration approval of a drug label doesn't release the manufacturer of claims that its warnings are inadequate.

This rule of law was properly applied in a decision affecting thousands of federal lawsuits against Merck & Co. involving Vioxx.

"The FDA's current view on the question of immunity for prescription drug manufacturers is entirely unpersuasive," U.S. District Judge Eldon Fallon wrote in the opinion handed down last month. Judge Fallon, who is presiding over the Vioxx multi-district litigation (MDL) cases, correctly rejected Merck's attempt to have lawsuits brought by two people who began taking Vioxx after April 2002 dismissed, because the FDA had approved a label warning that the drug might increase the risk of heart attacks and related problems.

Like thousands of others, Lene Arnold, who had a heart attack in December 2003, and the family of Joe G. Gomez, who died of a heart attack in January 2003, say the warning was inadequate. The Arnold case was filed in federal court in New Orleans, while the Gomez case originated in Texas.

A "failure to warn" claim is a state law claim, but where there is no parallel federal law, federal courts apply state laws in the jurisdiction where a suit is filed.

The FDA wrongly contends its requirements, which were placed in a preamble to rules set in 2006, set limits for prescription drug labels, preempting state claims that a company failed to warn users of a danger. Judge Fallon stated in his opinion:

Because there are no federal remedies for individuals harmed by prescription drugs, a finding of implied preemption in these cases would abolish state-law remedies and would, in effect, render legally impotent those who sustain injuries from defective prescription drugs.

This is a powerful order that will have tremendous ramifications. The claim of federal preemption over state law in failure to warn cases simply cannot be successfully argued in any court – state or federal – for a number of reasons. It flies in the face of the states' rights position usually argued by conservatives. It also totally ignores established rules of law dealing with the preemptive issue.



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