Comment k Applies to Medical Devices, Del. Judge Rules in BSC Pelvic Mesh Action

WILMINGTON, Del. — A Delaware judge has dismissed design and manufacturing defect claims from a Boston Scientific Corp. pelvic mesh case, ruling that the “unavoidably safe products” exception to comment k extends to medical devices.

However, in a May 12 order, Judge Francis J. Jones Jr. of the Delaware Superior Court refused to dismiss the plaintiffs’ claims for failure to warn, breach of warranty and punitive damages.

Alabama resident Zelda Gunter was implanted with BSC’s Advantage Fit pelvic mesh device in February 2018. Nine months later, on Nov. 5, 2018, she underwent surgery to remove mesh from the device that …