Supreme Court Limits Lawsuits Over Medical Devices

The Supreme Court today issued their decision in Riegel v. Medtronic, IncAt issue before the Court was whether the pre-emption clause in the Medical Device Amendments of 1976, 21 U. S. C. §360k, bars state law claims challenging the safety and effectiveness of a medical device approved by the federal Food and Drug Administration. The plaintiff in the case (who died while the case was still on appeal) had suffered serious injuries when a catheter manufactured by Medtronic burst during a medical procedure. In an 8-1 decision, the Court held that state lawsuits are barred to the extent they would impose requirements that are different from federal requirements.