The Supreme Court has ruled 8-1 that a party can't file suit under state law against the manufacturer of a medical device approved by the FDA. The case (Riegel v. Medtronic, 06-179) may have important implications for the nexus of state and federal courts as well as for the medical device industry.

The case involved a patient, Charles Riegel, who suffered injuries after his heart catheter burst. The device had cleared the FDA's rigorous approval process. However, the family claimed that the catheter, which is no longer produced, had a design flaw. Mr. Riegel died in 2004 and his family/estate carried the case forward.

At issue before the Supreme Court was whether the estate could sue a company under state law over a device previously cleared for sale by federal regulators. The court ruling affirms that the answer is no in this case.
"Today's (2/20/08) ruling is a win for patients and public health and safety," said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed). "It reaffirms what two previous lower court rulings in this case have already made clear -- the Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetic Act (FFDCA) expressly provide for the U.S. Food and Drug Administration's ultimate regulatory authority over medical devices."

The Bush administration supported the industry position. Justice Ruth Bader Ginsburg dissented. Some Democratic lawmakers plan to enact legislation allowing such suits, the New York Times reported.

Read previous DOTmed News coverage at:
https://www.dotmed.com/news/story/5191/
https://www.dotmed.com/news/story/4956/

Read Medtronic's comments at:
http://aami.org/news/2008/022108.medtronic.html

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