The U.S. Supreme Court

In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that a 1976 federal law, the Medical Device Amendments (MDA),  granting the FDA authority to regulate medical devices also limits the rights of consumers to sue device manufacturers for injuries due to defective products.   

Charles Riegel was seriously injured when a balloon catheter burst during an angioplasty procedure.  He sued the manufacturer of the catheter, Medtronic, in state court claiming that the company should be liable for his injuries caused by the defective product.  Medtronic argued that because the product was FDA approved, states could not “preempt” FDA’s federal authority and impose different, higher standards on device performance.  The Supreme Court agreed with Medtronic, ruling 8-1 in their favor.  The Syllabus association with the Court's ruling stated, "The MDA's pre-emption clause bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA."     

Consumer advocates believe the Court's decision significantly curtails medical device manufacturers product liability.  As such, it serves to reduce consumer protections and to reduce manufacturer incentives to develop and manufacture safe products.    This decision has led Congress to hold hearings on the impact of the ruling.  Legislation has been introduced in both the House and the Senate to overrule the Court's Riegel v. Medtronic decision. 

Click here to go to the Supreme Court website.

Click here to read the Medtronic v. Riegel decision.