Sixth Circuit Allows State Law Negligence Claims

Last year, the Supreme Court decided Wyeth v. Levine [PDF], stating that Congress, through the FDCA, did not intend to preempt state law failure to warn claims. The Sixth Circuit extended Levine in Wimbush v. Wyeth, No.09-3380, 2010 WL 3256029 (6th Cir. Aug. 18, 2010) [PDF], and reasoned that a plaintiff could pursue negligence claims relating to a manufacturer’s decision to bring a drug to market, i.e., a pre-labeling, pre-approval claim.

Mary Buchanan, the Plaintiff’s decedent, developed primary pulmonary hypertension, allegedly caused by her ingestion of Redux, a weight-control drug pulled from the market in 1997. The pulmonary hypertension was the alleged cause of death. It’s unlikely, at least in Ohio, that there would be many more claims like the plaintiff’s. Ohio statutory law would now preempt any negligence claims based on products liability, but Buchanan filed her claim before the statute became effective. Therefore, Wimbush brings us into a strange scenario where, although the drug manufacturer can successfully defend the failure to warn claim, there are other state law claims that are not preempted and allowed by state tort law.

After explaining why the state law negligence claim would be allowed under state law, the Sixth Circuit reversed the district court’s grant of summary judgment in favor of Wyeth. The Court, leaning heavily on Levine, noted that Congress had never enacted an express preemption provision throughout the 70-year history of the FDCA. In light of the history of the scheme, there could be no preemption of state law claims, express or implied. Nevertheless, the Sixth Circuit acknowledged that its decision was breaking new ground:

Finally, we are aware of no federal appeals court decision since Levine concluding that FDA regulation preempts any aspect of state tort law, though we admit that, until today, there is also no post-Levine court of appeals authority for the proposition that the Levine rationale extends beyond the realm of failure-to-warn claims to apply to all pre-approval state law claims.

Wimbush may be used to open a door in other jurisdictions to allow other state law negligence claims in jurisdictions where the standards, statutes of limitations, or venire may be plaintiff-oriented. Look for plaintiffs’ attorneys to test the state law waters with inventive tort actions. I’m sure that there are all manner of pre-approval state law claims that are about to be manufactured.

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