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FDA recognizes that FDA’s regulation of drug labeling will not preempt all State law actions. The Supreme Court has held that certain State law requirements that parallel FDA requirements may not be preempted (Medtronic, Inc. v. Lohr, 518 U.S. 4790, 495 (1996)) (holding that the presence of a State law damages remedy for violations of FDA requirements does not impose an additional requirement upon medical device manufacturers but “merely provides another reason for manufacturers to comply with *** federal law”).

The analogy to Medtronic v. Lohr is flawed. FDA’s reference to the Supreme Court’s holding in Medtronic v. Lohr has no application to the issue of federal preemption in prescription drug cases.

Lohr concerned the express preemption language in the Medical Device Amendment. Lohr did not involve implied preemption or conflict preemption.

Tomorrow: A conclusion or two

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