U.S. High Court Won’t Review Exclusion Of 510(k) Defense In Pelvic Mesh Case

Mealey's (October 2, 2017, 11:14 AM EDT) -- WASHINGTON, D.C. — The U.S. Supreme Court on Oct. 2 said that it will not review federal multidistrict litigation court and federal circuit court rulings that evidence about a pelvic mesh device’s approval through the less-stringent 510(k) process cannot be used to show Food and Drug Administration approval of the devices for safety and efficacy (Ethicon, Inc., et al. v. Jo Huskey, et vir., No. 16-1399, U.S. Sup., U.S. S.Ct. Briefs LEXIS 2913)....

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