Fourth Circuit Affirms Judgment for Boston Scientific

In a unanimous published decision, the U.S. Court of Appeals for the Fourth Circuit affirmed a lower court’s decision to dismiss a transvaginal surgical mesh patient’s failure to warn claim against Boston Scientific. In 2015, a North Carolina jury found the plaintiff failed to prove design defect or breach of warranty claims against the company; the trial court entered summary judgment on her failure to warn claim. The appeals panel also affirmed the trial court’s decision not to reconsider its summary judgment ruling. 


The appeals court agreed that Martha Carlson failed to prove that she or her treating physician relied on the allegedly inadequate warnings in the product’s directions for use (DFU), but proof of reliance is required to establish proximate cause. The plaintiff “cited zero evidence establishing that either she or Dr. [Michael] Kennelly so much as read the allegedly inadequate warning,” the panel said. The plaintiff proffered portions of the physician’s testimony in an attempt to establish the alleged inadequacy of the warnings, but “importantly, those portions did not indicate that if the DFU included an adequate warning, Dr. Kennelly would have read it.” [emphasis in original]

Shook, Hardy & Bacon Partner Dan Rogers, with co-counsel Ellis & Winters LLP, represented Boston Scientific before the Fourth Circuit. Partner Jon Strongman led Shook’s trial team with assistance from associates Chris Kaufman and Curtis Moore

Carlson v. Boston Scientific, No. 15-2440 (4th Cir. May 9, 2017).