Wyeth v. Levine: Implied Preemption Cases are Fact Intensive

By March 4, 2009General

Victor Schwartz, general counsel for the American Tort Reform Association (who has also represented the NAM on occasion), issued a statement in reaction to the Supreme Court’s ruling in Wyeth v. Levine. From ATRA:

Personal injury lawyers will applaud today’s Supreme Court decision, but we caution against any over-reading of the Court’s ruling. As the Court’s decision makes clear, implied preemption cases are fact-intensive, turning on what information the agency considered in a specific instance.

The Supreme Court’s decision focuses more attention on the flipside of the federal preemption coin. Several states have already determined, through courts or legislatures, that due deference should be given to the FDA in assessing the validity of a medicine’s warnings, particularly when there has been no wrongdoing by the defendant. The unfortunate truth is that all medicines come with risks. States should pick up the baton left for them today and join these other states in yielding to FDA scientists when, after years of earnest study, the FDA stamps a drug as safe and effective when accompanied by warnings explaining a medicine’s known risks.


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