The ruling came in a case filed by Charles Riegel and his wife on Medtronic alleging faulty design. Riegel who died in 2004, sustained a serious injury when a Medtronic balloon catheter burst during an angioplasty procedure in 1996.

Mr Riegel alleged the design of the device was faulty and that Medtronic was liable because the labeling on the catheter was also deficient. However the Court did not side with him and ruled 8 to 1 that medical devices that have passed the Food and Drug Administration's pre-market approval process could not be held liable.

Justice Ruth Bader Ginsburg was the only dissenter in this case and wrote that the pre-emption of liability clause in federal laws was not included "to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices."

Medtronic said it was not liable as the doctor in question had not used the balloon catheter properly and had elected to use it in a patient who was not fit for receiving the device.

Medtronic Chief Executive Bill Hawkins hailed the decision in a statement and said it "ensures that patients continue to have appropriate access to innovative, life-saving medical devices."

However the company has now stopped manufacturing the balloon catheter specified in the lawsuit.
 

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