Monday, March 23, 2009
Cause of action alleging drug so dangerous no possible warning is adequate is still preempted
Since the Supreme Court decided Wyeth v Levine, a number of cases have been remanded by appeals courts to be reviewed in light of the ruling in that decision. One such case was Longs v. Wyeth, 536 F. Supp.2d 843 (N.D. Ohio 2008), a fen-phen decision in which the plaintiffs argued that the drug in question was so dangerous that there was no adequate warning that could make it "safe" enough for state tort law. That’s the same thing as saying that, as far as state law is concerned, notwithstanding the FDA’s approval, the defendant should never have sold the product at all. The court originally held that the claim was preempted by the FDA's action and last week, on reconsideration after Wyeth v. Levine, the same judge held that nothing had changed. Drug and Device Law Blog has the story here.