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Colacicco v. Apotex: A New Era in Prescription Drug Pre-emption

By Donald C. Le Gower
October 30, 2006

Prescription drug manufacturers have unsuccessfully asserted pre-emption as a defense to product liability claims for decades. A new FDA final rule and the first federal case interpreting that rule indicate that the tide may be turning. On May 25, 2006, Judge Baylson of the U.S. District Court for the Eastern District of Pennsylvania issued his opinion in Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006). The decision is the first federal court opinion discussing the pre-emptive effect of the preamble to the FDA's final rule on prescription drug labeling (the 'preamble'). See 71 Fed. Reg. 3922, 3934 (Jan. 24, 2006). See Lasker article infra at 5.

In Colacicco, the court dismissed the plaintiff's failure-to-warn claims against generic and brand name drug companies, based on its determination that it was required to defer to the FDA's statements on pre-emption in the preamble and in an amicus brief filed in the case. In a notable alternative holding, the court also found that a brand name drug manufacturer owes no duty to a plaintiff who took only the generic version of a prescription drug. The lengthy, detailed opinion, which is currently on appeal to the Third Circuit, has been labeled 'profoundly wrong' by members of plaintiffs' bar and is certain to be widely cited in prescription drug cases around the country. See Brief of Amicus Curiae the Pennsylvania Trial Lawyers Association in Opposition to Defendant's Motion for Summary Judgment (Pre-emption), Woodward v. Pfizer, Inc., No. 05-CV-3764, at 3 (E.D. Pa. filed June 8, 2006). To understand the court's reasoning and the scope of the opinion, it is necessary to discuss the FDA preamble and history of the case.

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