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Friday, August 1, 2008

Bill would limit immunity for medical device makers

Legislation was introduced in the U.S. Senate today that would make it more difficult for medical device manufacturers to claim immunity from lawsuits.

According to a press release from the American Association for Justice, the bill, The Medical Device and Safety Act, is a response to the recent U.S. Supreme Court ruling in Riegel v. Medtronic.

In that case, Charles Riegel and his wife, petitioner Donna Riegel, brought suit against Medtronic after a Medtronic catheter ruptured in Charles’ coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. The Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law.

The Supreme Court, affirming both a federal District Court judge and the 2nd U.S. Circuit Court of Appeals, found that the pre-emption clause in the Medical Device Amendments Act of 1976 bars common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received pre-market approval from the FDA.

The Medical Device and Safety Act was introduced by Senator Edward M. Kennedy, D-Mass. (Pictured here.) The House of Representatives introduced a similar bill in June.

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