Wednesday, April 9, 2008
The Legal Intelligencer (via law.com) reports on a decision filed yesterday by the United States Court of Appeals for the Third Circuit holding that claims that the manufacturers of Paxil and Zoloft failed to warn of a risk of suicide were preempted. The court issued a narrow decision based on the fact that the FDA expressly had refused to order the very suicide warnings that plaintiffs argued were necessary:
"We do not decide whether the FDA's mere approval of drug labeling is sufficient to pre-empt state-law claims alleging that the labeling failed to warn of a given danger," Sloviter wrote. Likewise, Sloviter said, the court would not address "whether FDA approval of drug labeling constitutes minimum standards in the absence of the FDA's express rejection of a specific warning."
On the narrow question, Sloviter found that since both plaintiffs were suing over warnings that the FDA had explicitly refused to order, their failure-to-warn claims "conflict with, and are therefore pre-empted by, the FDA's regulatory actions."
Beck & Herrmann have a break-down of the decision's "high points." Judge Thomas L. Ambro dissented from the majority opinion.