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.