Gretchen Bish vs. Sofamor

These are consolidated interlocutory appeals of products liability suits against the manufacturers of spinal fixation devices. The trial court dismissed plaintiffs' negligence per se claims based on the alleged violation of the Food, Drug and Cosmetics Act (FDCA) and the Medical Device Amendments (MDA). In one of the cases, the trial court also granted defendants' motion in limine to exclude all Federal Drug Administration (FDA) regulatory evidence information and documents concerning the fixation devices. Plaintiffs appeal the rulings of the trial court.