Boston Scientific had sought to have the suit — brought by the Jean Penland estate — dismissed based on the Supreme Court’s decade-old Riegel v. Medtronic decision. The Riegel ruling found that federal medical device regulation laws provide lawsuit protections for devices with FDA premarket approval, and Watchman received a PMA in 2015.
However, Penland’s estate and its executor Donna Shook argued that their claims involve a clear and specific manufacturing and assembly defect. They want to hold Boston Scientific’s medical device to the performance characteristics and functional principles presented to and approved by the FDA.
A Watchman broke free of the core wire during implantation surgery and eventually lodged in her mitral valve, Judge Max O. Cogburn Jr. said in the order filed yesterday. Penland underwent 77 minutes of cardiopulmonary bypass for device retrieval and died in 2018 following months of severe respiratory distress and injuries.
Cogburn denied Boston Scientific’s motion to dismiss and allowed discovery in the case to proceed.
“In so holding, the court makes no determination on federal preemption at this time. Rather, the court has determined that plaintiff has merely sufficiently pleaded enough facts to overcome a motion to dismiss as to the preemption issue,” Cogburn said.