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Recent News and Articles on the Keywords: justices + 0.31 + web  Related to the article below (Last Update: 8/5/2008)

Le Fonds de revenu Great Lakes Hydro annonce des r?sultats records ...
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[CITATION] Federalism in the European Union The View From Below (If There Is Such a Thing)?
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Source: Google Scholar

US justices weigh medical-device makers' liability

Last Updated: 2007-12-05 12:03:44 -0400 (Reuters Health)

WASHINGTON - U.S. Supreme Court justices questioned on Tuesday if patients can sue medical-device manufacturers in state court over harm from a device that has approval from federal regulators.

The case involves a New York man who was injured when a doctor inflated a Medtronic Inc balloon catheter during an artery-clearing procedure. The court's decision could have implications for other device companies and drug makers.

In oral arguments on Tuesday, attorney Allison Zieve argued the man had a right to sue Medtronic because the catheter should have been designed differently and the instructions for its use were misleading.

While the Food and Drug Administration makes a judgment about whether a product is safe and effective before granting approval, "very often problems and hazards come to light only after the device is in widespread use," Zieve said.

Several justices questioned Zieve's position that a state jury could decide if a company should be liable for injury from an FDA-approved product.

"Because of the judgment of that one jury, the manufacturer is placed at risk in selling a device that scientists at the FDA have said is OK. I find that extraordinary," said Justice Antonin Scalia.

Attorney Theodore Olson, arguing on behalf of Medtronic, said Congress "made it explicitly clear that any requirement that is different or in addition to the federal requirement is preempted if it has to do with the safety or effectiveness of the device."

"The FDA is the right place for these decisions to be made," Olson told the court.

Medtronic has said the doctor in the case used the catheter contrary to labeling instructions and in a patient for whom it was not recommended. The company no longer makes that specific catheter.

A lower court in Albany, New York, dismissed the lawsuit, and an appeals court upheld that decision.

The case is Riegel v. Medtronic.

Copyright © 2007 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

 
 
 
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