In a case brought by surviving spouse against the makers of Paxil and its generic equivalent for failure to warn of increased risk of suicide, Judge Baylson of the Eastern Distrit of Pennsylvania found implied preemption based upon the approval of the FDA. In an amicus brief filed by the FDA in the case, as well as the 2006 “Preemption Preamble” [71 Fed. Register 3934-3925], the FDA specifically rejected the notions that: (i) the FDCA imposes only minimum standards for labeling, and (ii) drug manufacturers have the ability to strengthen warnings without FDA approval. Disputing the argument that 21 C.F.R. 314.70(c) permits a manufacturer to strengthen a warning unilaterally, the FDA took the position that the dissemination of unsupported warnings “would deprive patients of efficacious treatment, thereby chilling the drug’s otherwise beneficial use.” While concluding that the Preamble was “interpretive” and could therefore be applied retroactively, the court noted that, given the amicus brief, prospective-only application of the Preamble would not change the result. It is not clear to what extent the decision is limited by the case-specific aspects: (a) that the agency had repeatedly determined that there was inadequate evidence of an association between adult use of SSRIs and suicidality, hence such a warning would have (arguably) been “false and misleading”; and/or, (b) at least with respect to the generic manufacturer, that this defendant was required to use the same warning label as the brand namufacturer, under the relaxed approval standards of the Hatch-Waxman Amendments. Additional claims sounding in negligence and strict liability were dismissed on other grounds. See Colacicco v. Apotex, 432 F.Supp.2d 514 (E.D.Pa. 2006).
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