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US court rules for Medtronic, bars some state suits
Law Firm News | 2008/02/20 21:46

The U.S. Supreme Court handed a victory to Medtronic Inc on Wednesday, ruling that patients cannot sue medical-device manufacturers in state court over harm from a device that has approval from federal regulators.

By an 8-1 vote, the court ruled a 1976 law creating federal safety oversight for medical devices bars state-law claims challenging safety or effectiveness of devices that have won premarket approval from the U.S. Food and Drug Administration.

The decision was the Supreme Court's first ruling on the legal effect of the FDA's approval of a medical device on liability lawsuits, Medtronic said.

The ruling could benefit other device makers, who have argued that the FDA's judgment that a product is safe and effective should protect companies from being sued for liability in state court.

The Medtronic case involved a New York man who was injured in 1996 when a doctor inflated a balloon catheter during an artery-clearing procedure.

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 federal trial court in Albany, New York, dismissed the lawsuit, finding the patient was not entitled to state law remedies because of the FDA's prior approval of the device.

A U.S. appeals court agreed that the lawsuit was pre-empted by federal law, and the Supreme Court upheld that decision.



Top US court rejects spying case
Law Firm News | 2008/02/19 21:48

The US Supreme Court has dismissed a legal challenge to a domestic anti-terrorism eavesdropping programme.
President George W Bush authorised the monitoring, without a court order, of international phone calls and e-mails of US citizens after the 9/11 attacks.

The American Civil Liberties Union argued that Mr Bush did not have the constitutional authority to order the programme, which ended last year.

The Supreme Court gave no explanation for its ruling.

Legality questioned

The domestic spying programme was denounced by Democrats and rights activists when it was disclosed in 2005.

A group of civil liberties activists, journalists, academics and lawyers challenged the spying programme in the courts, arguing it violated a 1978 rule prohibiting surveillance of American citizens on US soil without a warrant.

In July last year, an appeals court struck down a lower court's ruling that found the programme to be unconstitutional.

The appeals court, based in Cincinnati, dismissed the case because the plaintiffs had failed to show that their communications had been monitored.

But the Cincinnati judges did not rule on the legality or otherwise of the programme.

The president rejected claims that he broke the law by ordering surveillance without first securing warrants. He argued the eavesdropping programme was necessary and was targeted against al-Qaeda.

The Bush administration has so far refused to release documents about the programme that might reveal who was under surveillance.




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