FDA Approval, FDA Compliance and Trials

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

Plaintiff did not allege that the design of the clips deviated from the FDA approved design. Nor did plaintiff allege that the clips were manufactured in a way not approved by the FDA. We do not believe that the trial justice abused her discretion in so ruling. So, both claims were expressly preempted.

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A Thorny PMA Preemption Decision from Rhode Island

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