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: Drug and Device LawLatest Supreme Court Preemption Moves
By James M. Beck and Mark Herrmann
The Court also invited the SG to "express the view of the United States" in the Mensing case (Supreme Court Nos. 09-993, 09-1039. That means that the Court has at least some interest in the preemption issues presented by generic drug manufacturers. Our preemption scorecard briefly summarizes the prior result in Mensing:
Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. Nov. 27, 2009), finding no preemption of warning claims in case involving generic metoclopramide. Regardless of CBE requirements the common law could impose a duty upon generic drug manufacturers to alert the FDA and to seek a stronger warning for both generic and brand name labeling or to have the agency issue a "Dear Doctor" letter, in light of evolving knowledge. Nothing in Hatch-Waxman evinces a congressional intent to preempt state law.
Full post as published by Drug and Device Law on May 25, 2010 (boomark / email).
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