Polypropylene Safety Claims in Prolift TVM Case Not Preempted, W. Va. Federal Judge Rules

CHARLESTON, W. Va. — A West Virginia federal judge has denied Ethicon Inc. summary judgment as to claims that its use of polypropylene in its Prolift transvaginal mesh device rendered the device defective or negligently designed, ruling that such claims are not preempted.

In a Nov. 24 order, Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia held that because the Prolift device only went through the less stringent 510(k) clearance process, rather than the rigorous premarket approval process, such claims are not preempted by the Food, Drug and Cosmetic Act.

In this …