Riegel v. Medtronic, Inc.

Charles Riegel and his wife (plaintiffs) sued Medtronic (defendant) after a Medtronic balloon catheter ruptured in Charles's coronary artery during surgery. The catheter had gone through the FDA's rigorous premarket approval process, which bars the manufacturer from changing the device's safety-relevant design without FDA permission. The Riegels brought New York common-law claims alleging defective design, labeling, and manufacture. The trial court granted Medtronic summary judgment, finding the claims preempted by the federal Medical Device Amendments (MDA), which bar states from imposing device-safety requirements different from or in addition to federal ones; the Second Circuit affirmed.