Doctors, FDA Compliance and Regulations

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

TBI was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state law, a “warning”-based cause of action against a manufacturer of an FDA-regulated prescription drug or medical device for allegedly failing to report adverse events to the FDA.

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A Thorny PMA Preemption Decision from Rhode Island

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