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US Supreme Court Could Protect Medical Equipment Manufacturers from Law Suits

not have used the balloon catheter because of Mr. Riegels condition and that the surgeon used the device in a manner inconsistent with its labeling.

Both a Federal District Court and a Federal Appeals Court in New York dismissed most of the Riegels claims. Those courts concluded that because the FDA had approved the balloon catheter after a rigorous review and before it went to market, injured patients could not file claims against Medtronic under state law.

The medical devices amendment forbids a state from adopting any requirement which is different from, or in addition to, any requirement in federal law.

Federal courts around the nation have taken different views of whether that provision bars state law damage claims against medical devices approved by the FDA.

The issue has so confounded the courts that three appeals courts reviewing the same medical device made by the same company have reached two different conclusions about whether patients could bring a lawsuit.

Lawyers involved in the Medtronic case say they expect the court to hear from manufacturers and business groups in support of Medtronic, as well as from states and consumer organizations on behalf of the patient who was injured. The case, Riegel v. Medtronic, No. 06-179, is expected to be heard by the court in the fall.

Significantly, a group of similar cases involving drugs is also moving through the courts.


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Each handle is designed to fit a specific trephine size.
Medtronic Ophthalmics offers a comprehensive selection of corneal trephine,blades and handles. Handcrafted, sharp, uniform blade edges promote a,symetrical and vertical cut of all corneal layers.
Medtronic Ophthalmics offers a comprehensive selection of corneal trephine,blades and handles. Handcrafted, sharp, uniform blade edges promote a,symetrical and vertical cut of all corneal layers.
Each handle is designed to fit a specific trephine size.
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