SW Legal studies in Business

FDA Approved Medical Device Makers Cannot Be Sued in Common Law

Supreme Court held that the maker of a medical device approved for marketing by the FDA is, under the Medical Device Amendments, subject to suit for violating FDA standards, but federal law expressly pre-empts state common law suits against the device maker.


Consumer Protection

Key Words

FDA Approval; Medical Devices; Pre-emption

C A S E   S U M M A R Y

Riegel suffered an injury when a catheter made by Medtronic ruptured during a heart-bypass operation. The catheter is a Class III device that received FDA premarket approval under the Medical Device Amendments (MDA). Riegal sued Medtronic, contending that the device was designed, labeled, and made in a manner that violated New York contract and tort common law. The federal district court held that the MDA pre-empted the common law claims. Suit must be based on a violation of federal law. The federal appeals court affirmed; Riegel appealed.


Affirmed. The MDA’s pre-emption clause bars common-law contract and tort claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. Plaintiff must bring suit based on a violation of FDA safety and effectiveness standards.


Riegel v. Medtronic, Inc., 128 S.Ct. 999 (Sup. Ct., 2008)

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