Since the Food and Drug Administration 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 a November 2006 article in Product Liability Law & Strategy, I found that 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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