Health Highlights: Feb. 20, 2008

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Wednesday, February 20, 2008; 12:00 AM

Here are some of the latest health and medical news developments, compiled by editors ofHealthDay:

Supreme Court: FDA-Approved Medical Devices Not Subject to State Lawsuits

State courts are not the proper place to sue medical device companies if their product has federal approval, the U.S. Supreme Court has ruled.

According to theNew York Times, the top court overwhelmingly rejected an appeal by a man who claimed that a defective catheter used on him during a 1996 angioplasty violated New York state law.

The device, made by Minneapolis-based Medtronic, had received U.S. Food and Drug Administration approval, making it exempt from liability under individual state laws, theTimesreported. The Wednesday U.S. Supreme Court ruling confirmed federal appeals courts' decisions that denied the plaintiff's standing to sue in the NY state court system.

Charles Riegel was severely injured in 1996 while undergoing an angioplasty when the catheter burst. Riegel and his wife maintained that the device's design violated New York State law. Riegel died a number of years after the injury, but his wife continued the lawsuit, theTimessaid.

Medtronic was protected under the Medical Device Amendments of 1976, Justice Antonin Scalia wrote in the majority decision, according to theTimes. The federal law keeps states from imposing on medical devices "any requirement which is different from, or in addition to, any requirement applicable under this chapter," Scalia wrote.

The reason for this, Scalia added, was because the FDA sometimes has to weigh some possible bad outcomes against a device or drug's overall benefits, the newspaper said. "It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives," he wrote. He cited one case where the F.D.A. approved a ventricular device for children "even though the survival rate of children using the device was less than 50 percent."

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Bird Flu Outbreak Puts Vietnam on High Alert

A new H5N1 bird flu outbreak that has killed thousands of birds in three northern provinces in Vietnam has put the country on high alert. Seven of Vietnam's 64 provinces and municipalities that have reported H5N1 virus outbreaks within the past 21 days are now on the watchlist,Agence France-Pressereported.

"We will go on nationwide red alert on the risk of bird flu over the next few days," Bui Ba Bong, Vietnam's Deputy Minister of Agriculture and Rural Development, was quoted as telling theThanh Niendaily newspaper.


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