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We posted on the adverse preemption decision, Knipe v. SmithKline Beecham Corp., 2008 WL 4090995 (E.D. Pa. Aug. 28, 2008), shortly after it was decided. Well, the other day the court denied reconsideration, but granted an interlocutory appeal to the Third Circuit of the preemption question. See Knipe v. SmithKline Beecham Corp., 2008 U.S. Dist. Lexis 87448 (E.D. Pa. Oct. 29, 2008).
A couple of substantive things:
First, in denying reconsideration, the court now changes its tune with respect to the Kallas FDA amicus brief (in which the FDA took a clear public position on preemption in a pediatric suicide SSRI case). Before, as we pointed out, the court misapplied the Fellner case to ignore the brief entirely. Now the court claims it didn’t do that, but instead “took full notice of the FDA’s factual and scientific determinations,” and determined that it was “entitled” to however much “deference” it deserved. 2008 U.S. Dist. Lexis 87448, at *34-35. Having read both opinions, that sounds like revisionist history to us.
Second, in denying reconsideration, the court also makes the statement, “[b]oth FDA regulations and state tort law ask only whether the manufacturer knows or has reasonable evidence of an association between a drug and the complained-of adverse effect.” Id. at *31 (emphasis added). That’s hard to square with the court’s statement in the prior opinion, “[b]ecause the standard for adding a warning under a CBE requires only reasonable evidence of association of a serious risk with the drug, and because state failure to warn claims under New Jersey law require the more stringent proof of causation between the drug and the injury, only a drug manufacturer who, in fact, possessed such reasonable evidence, yet failed to add a warning, would be potentially liable under state law.” 2008 WL 4090995, at *25. So much for the defendant being protected by the greater stringency of state law.
There’s more, but we have to get back to work. Suffice it to say, we think the defendant in Knipe will have plenty to tell the Third Circuit on appeal – hopefully after a favorable result in Levine.