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This post is entirely Bexis’ work – for the best reason in the world. Co-blogger Herrmann is victorious counsel for the defendant in the case we’re describing.
Hot off the presses, is Dobbs v. Wyeth Pharmaceuticals, No. CIV-04-1762-D (W.D. Okla. Jan. 17 2008), copy here (now reported at 530 F. Supp.2d 1275). Briefly, the court holds that failure to warn claims about suicide risk as of 12/2002 (the suicide date) are preempted by FDA decisions that there wasn’t then (and isn’t now) any scientifically valid evidence supporting a suicide risk in adults. It’s a well written, even scholarly, 25-page opinion that goes through all the issues regarding deference to the FDA’s positions (amicus briefs and 2006 Final Rule), both generally and with specific reference to SSRI suicidality (pp.5-22). The court sides with those courts that grant the FDA “considerable deference” (p.21), but ultimately decides the case on impossibility, since the FDA had rejected the exact type of warning plaintiff was advocating (pp. 23-24).
Kudos to Herrmann for bringing home the preemption bacon.