LawyersUSA

A state law claim against the maker of the antidepressant Paxil for failing to warn of an increased suicide risk is not preempted by federal law, a U.S. District Court in Indiana has ruled.

The plaintiff's brother committed suicide after taking Paxil. She sued on behalf of his estate for wrongful death. She claimed the manufacturer's failure to warn of the increased suicide risk violated state law.

The manufacturer argued her claim was preempted by the Food and Drug Act because the labeling she claimed was required would result in a label that violated an existing FDA order on Paxil's labeling.

The court disagreed.

"FDA regulations allow a manufacturer to modify pharmaceutical labels unilaterally and immediately, without prior FDA approval, when the manufacturer has reasonable evidence of a serious hazard. …

"If the FDA exercises its power to disapprove the revised label, the FDA's disapproval is not retroactively illegal; the manufacturer simply stops distributing the new label. … Thus, prior FDA approval need not be obtained, nor will a product be deemed misbranded, if the manufacturer voluntarily or even unilaterally strengthens the warnings, precautions or potential adverse reactions listed on a label previously approved by the FDA pursuant to its powers under 21 C.F.R. §314.70(c) and §201.80."

Here, "the FDA's [ordered] revisions were not necessarily the final word on Paxil's label and did not put the [manufacturer] into a position where it was impossible for [it] to comply with both state and federal law."

U.S. District Court for the Southern District of Indiana. Tucker v. SmithKline Beecham Corp., No. 1:04-cv-1748-DFH-WTL. July 18, 2008. Lawyers USA No. 99310356. Click here for the full text of this opinion.