Boston Scientific Denied Summary Judgment on Design Defect, Warning Claims in Pinnacle Transvaginal Mesh Case

CHARLESTON, W. Va. — A West Virginia federal judge has allowed claims of design defect to proceed against Boston Scientific Corp. in a transvaginal mesh case, ruling that the claims are not barred by the “government rules defense” because the 510(k) process through which the device was approved is focused on equivalence, not safety.

In an Oct. 5 order, Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia also allowed the plaintiff’s failure-to-warn claims to proceed, finding questions of fact exist as to the adequacy of BSC’s warnings.

Florida resident Patricia Wolford was …