Ethicon Mesh MDL Judge Excludes FDA 501(k) Evidence in Bellwether Case

CHARLESTON, W.Va. — The judge overseeing the Ethicon pelvic mesh multidistrict litigation has excluded evidence of the 510(k) approval process in a bellwether case, explaining that it does not does not go to safety or efficacy of medical devices and has the potential to mislead and confuse the jury.

On May 12, Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia found that the evidence is not relevant to Illinois’ consumer-expectation and risk-utility tests.

Jo Huskey and her husband sued Ethicon Inc. and Johnson & Johnson, alleging various injuries caused by the Ethicon …