Recently, the U.S. Food and Drug Administration announced in a preamble to its new drug labeling rules that, in its view, failure to warn and some other tort claims against drug manufacturers by injured patients are pre-empted by federal law. 71 Fed. Reg. 3922 (Jan. 24, 2006).

Drug companies, their lawyers and some commentators have lauded this announcement as the latest, greatest development in the fight against tort liability, opining that courts will almost certainly defer to the FDA’s views on pre-emption. This is a good thing, they argue, because tort claims alleging inadequate drug labels conflict with — and undermine — the federal government’s exclusive authority to regulate drug labels and create an incentive for drug makers to overlabel drugs.

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