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Wyeth v. Levine

By Christopher Thomas, Kevin Saunders and Timothy Broshears

If all the world's a stage, as Shakespeare professed, then surely one of the great dramas playing in the theater of American jurisprudence is the epic struggle that roils pharmaceutical labeling. Pitting state-law causes of action against a federal agency's regulatory authority, the storylines are stark. Simply put, the labeling issue confronting the Supreme Court this term is: Who decides the adequacy of drug labeling ' the Food and Drug Administration (FDA) or a jury of plaintiff's peers? Both sides have plenty to gain ' and lose.

In 2006, after years of filing amicus briefs, the FDA finally adopted clear rules that set forth its position on the question of the preemptive effect of its labeling determinations. Indeed, the preamble to the 2006 rules states that “the government's long-standing views on preemption” take precedence; namely that, “under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law.” Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922 (Jan. 24, 2006)(21 C.F.R. pts. 201, 313, 601).

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