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Pre-Empted by FDA's Public Stance

April 9, 2008

Suicide Warning Suits Pre-Empted; Makers of Paxil, Zoloft Win

In a significant victory for drug manufacturers, the 3rd U.S. Circuit Court of Appeals has ruled that the makers of Paxil and Zoloft cannot be sued for failing to warn of a risk of suicide because the Food & Drug Administration has explicitly refused to order such warnings.

Voting 2-1 in a pair of cases where the lower courts issued conflicting rulings, the 3rd Circuit found that such lawsuits must be pre-empted because they directly conflict with action already taken by the FDA. Writing for the majority, 3rd Circuit Judge Dolores K. Sloviter said the FDA has “actively monitored” the possible risk of suicide from taking the class of antidepressant drugs known as selective serotonin re-uptake inhibitors, or SSRIs, for two decades, and concluded that the suicide warnings demanded by plaintiffs “are without scientific basis and would therefore be false and misleading.”

But Sloviter, who was joined by visiting Judge Jane A. Restani of the U.S. Court of International Trade, emphasized that the ruling was a narrow one. “Our holding is limited to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires,” Sloviter wrote in Colacicco v. Apotex Inc.

In dissent, 3rd Circuit Judge Thomas L. Ambro said he would have allowed both cases to go forward. “The FDA has for over three-quarters of a century viewed state tort law as complementary to its warning regulations. Only for the last two years has it claimed otherwise,” Ambro wrote.

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