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(Mar 02, 2008) The Supreme Court ruled on February 20 that because the Medical Device Amendments of 1976 (MDA) preempts state regulation of medical devices that were approved by the Food and Drug Administration (FDA), persons injured by such devices may not pursue lawsuits under state law causes of action.

The MDA provides that a state shall not establish "any requirement . . . different from, or in addition to" federal requirements with respect to the safety or effectiveness of a medical device approved by the FDA. Metronic, Inc. manufactured a catheter that received FDA approval. After a Metronic catheter ruptured in her husband Charles Riegel's coronary artery during heart surgery, Donna Riegel sued Medtronic, alleging that the device was designed, labeled and manufactured in a manner that made Medtronic liable under New York common law theories of strict liability, implied warranty, and negligence. The lower federal courts ruled that the MDA preempted the state law claims. The Supreme Court agreed. The Court found that common law claims such as those raised by Riegel would impose "requirements" under the ordinary meaning of that term as it appears in the MDA, and therefore the MDA's preemption provision bars such state causes of action. (Riegel v. Medtronic, Inc., No. 06-179 (Feb. 20, 2008) available at http://www.supremecourtus.gov/opinions/07pdf/06-179.pdf.)

Author: Luis Acosta More by this author
Topic: Workers safety and health More on this topic
Jurisdiction: United States More about this jurisdiction

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Last updated: 03/02/2008