FDA 510(k) Marketing Clearance Evidence
Inadmissible in Ethicon Pelvic Mesh Case

May 19, 2014, 8:48 PM

Marketing clearance evidence under the FDA’s 510(k) process is irrelevant and inadmissible in another case surrounding alleged faulty pelvic mesh devices, the U.S. District Court for the Southern District of West Virginia held (Huskey v. Ethicon, Inc., S.D.W. Va., No. 2:12-cv-05201).

“Ethicon has not identified any cases, statutes, or other authorities indicating that 510(k) clearance, which focuses on equivalence, not safety, is relevant in determining whether a product is unreasonably dangerous under the law applicable in this case,” the district court overseeing the federal multidistrict litigation said.

Here, Jo Huskey and other plaintiffs sought to exclude evidence relating ...

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