Fulgenzi v. Plever asks if a claim against a generic drug manufacturer for failure to update warnings claims is preempted by FDA regulation. The 6th Circuit says NO, correctly in my view applying Ohio law. (see excerpt below.) (For the full text go to Prof. Bernabe's Torts Blog, above.)
[T]he result of this violation does raise concerns that [plaintiff] is simply attempting to enforce a federal-law violation through state litigation. Where, as here, the statute specifically excludes a private cause of action, 21 U.S.C. §337(a), state tort suits premised on violations of federal law may be impliedly preempted . . . if the claims "exist solely by virtue of” the regulatory scheme . . . . Here, [plaintiff's] suit is not even premised on violation of federal law, but rather on an independent state duty. The alleged breach arises from the same act, but the legal basis is different. This is simply not grounds for preemption. The federal duty of sameness is not a "critical element" in [plaintiff's] case. Failure to update from one adequate warning to another would violate the FDCA, but not Ohio law. Her suit instead relies upon the adequacy of the warnings and the causation of her injuries.
'via Blog this'
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