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Prescription Drug Litigation Pre-emption: A Continuing Status Report From the Defense Perspective

By Eric G. Lasker

Since the Food and Drug Administration ('FDA') set forth its pre-emption analysis in the preamble to its Jan. 24, 2006 drug-labeling rule, there has been a flood of judicial opinions analyzing the scope and applicability of the pre-emption defense in prescription drug litigation. The cases have been sharply divided, and the defense now appears likely to be a key issue that will be addressed in all cases going forward. In this continuing coverage, I summarize the pre-emption opinions that have been handed down since my last article in the November 2006 issue of this newsletter. For an analysis of the legal arguments in support of pre-emption and the FDA preamble, see Eric G. Lasker, Prescription Drug Litigation Pre-emption Following the FDA Preamble, LJN's Product Liability Law & Strategy, Vol. 25, No. 4 (October 2006).

At the time of my November 2006 article, a clear majority of courts that had considered the FDA preamble had affirmed the pre-emption defense. Since then, however, the sides have balanced out, as a number of courts have departed from the FDA's analysis as follows:

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