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A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

It involves allegations against the manufacturer and distributor of surgical clips used in tubal ligation surgery—Class III Pre-Market Approved (“PMA”) medical devices. Coopersurgical, Inc. 2024 WL 1109055 (D.R.I. 14, 2024). Plaintiff had surgery in 2014 in which the clips were used.

FDA 52