Friday, April 17, 2009

Industry Opposes Legislation Allowing Patients to Sue Medical Device Makers

CQ HealthBeat reports that, according to the Advanced Medical Technology Association (AdvaMed), "legislation easing lawsuits for patients injured by advanced medical devices would significantly curtail innovation." AdvaMed president and CEO Stephen Ubl said that "patients could lose access to the most promising medical technology." The legislation comes "in response to a February 2008 Supreme Court decision that said FDA approval of" devices "that require the filing...of a 'PMA,' or premarket approval application," preempts "certain state lawsuits for injuries." The ruling was "condemned" by "key congressional Democrats" who argued that it "strips consumers of the rights they've had for decades." Rep. Henry Waxman (D-CA) claims that "consumers should be able to seek compensation for injuries, medical expenses, or lost wages resulting from injuries caused by defective PMA devices or inadequate safety warnings." But, Ubl contends that the legislation, however, "would create a patchwork of 50 different and potentially conflicting state laws related to PMA devices."

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