Bard May Not Present Evidence of 510(k) Compliance in Upcoming Transvaginal Mesh Trial, Judge Rules

CHARLESTON, W. Va. — A West Virginia federal judge has ruled that C.R. Bard may not present evidence in an upcoming transvaginal mesh trial that it complied with the 510(k) clearance process, explaining that such evidence is irrelevant as to whether the Avaulta system was safe and effective.

However, in the Feb. 6 order, Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia ruled that Bard may present evidence of lawsuits the plaintiff has filed against her implanting surgeon or evidence concerning injuries arising out of the surgeon’s care, finding it is relevant …