AdvaMed Amicus Brief Urges Supreme Court to Review 510(k) Verdict

AdvaMed filed an amicus brief asking the U.S. Supreme Court to overturn a jury verdict against J&J subsidiary Ethicon dealing with pelvic mesh devices — in a case that featured the admissibility of evidence from a 510(k) review.

In the January decision, the U.S. Court of Appeals for the Fourth Circuit, upheld a $3.27 million district court judgment in favor of plaintiff Jo Huskey, who claimed severe pain from use of pelvic mesh devices manufactured by Ethicon. The Fourth Circuit upheld the district court’s exclusion of all evidence of the Ethicon device’s 510(k) clearance.

Decisions to exclude this evidence “prevent juries from hearing the full story, which is fundamentally unfair,” said AdvaMed’s legal committee chair, Ann Bunnenberg, president and COO of Electrical Geodesics.