Medtronic, Inc. v. Lohr

Lora Lohr (plaintiff) was injured when her Medtronic, Inc. (defendant) pacemaker failed, allegedly due to a defective lead, and she sued in Florida state court for negligence and strict products liability; Medtronic removed to federal court and argued the Medical Device Amendments preempted her claims. Medtronic's pacemaker had reached the market through an FDA process for devices substantially equivalent to existing products, bypassing full premarket approval and subjecting it only to general manufacturing-practice regulations rather than device-specific federal requirements. The trial court ultimately found all claims preempted, but the court of appeals held only the manufacturing-defect and failure-to-warn claims preempted, and both sides sought Supreme Court review.