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Preemption 2.0

By James M. Beck and Mark Herrmann

Defense counsel considering whether they still have good preemption arguments in drug product liability matters after Levine would do well to review preemption briefs recently filed by defendants in major product liability litigation. The litigation involves two fact patterns that we have previously mentioned as candidates for preemption even after Levine. FDA regulatory activity on the order of (but not necessarily identical to) what is addressed in these briefs is what defendants will need to advance preemption successfully in drug cases after Levine. We encourage you to compare your regulatory records to what's described in these briefs.

Yesterday, in the Colacicco (SSRI) remand before the Third Circuit, defendant Pfizer filed its preemption brief. It addresses the factual situation where the FDA has (both before and after the injury in the case) considered and rejected the warning that the plaintiff advocated as scientifically unsubstantiated. In addition to addressing these facts, the third argument in the brief deals with the Congressional intent and FDA deference aspects of Levine. We haven't seen the brief filed by the defense (GSK/Apotex) in the other half of Colacicco yet. Full disclosure: Bexis has past (but not present) involvement in the defense of the Colacicco case.

Earlier, in the Seroquel (atypical antipsychotic) MDL litigation, defendant AstraZeneca filed revised, post-Levine preemption briefs (initial and reply). These deal with the factual situation where the FDA undertook its own analysis of several companies' pooled data (data proprietary to each company) and then the FDA undertook to write the warning it considered appropriate as to the risk at issue. In addition, they address a claim that an indication considered and approved by the FDA should have been contraindicated. Full disclosure: Bexis is a member of the team that represents the defense in Seroquel.

Full post as published by Drug and Device Law on April 17, 2009 (boomark / email).