2014, Doctors, FDA and FDA Compliance

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

Plaintiff had surgery in 2014 in which the clips were used. Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements. In 2021, a CT scan revealed the clips had migrated.

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A Thorny PMA Preemption Decision from Rhode Island

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