The court ruled 8 to 1 that a state lawsuit against a device company is barred if federal regulators had already approved the device for sale and determined it was both safe and effective.
Federal law requires the U.S. Food and Drug Administration to sign off on a device before it can be marketed and sold. But the court said state lawsuits, if accepted, would be detrimental because they would impose requirements different from federal requirements.
Justice Ruth Bader Ginsburg dissented saying Congress never intended federal law to trump state lawsuits over injuries caused by "defectively designed or labeled medical devices."
But a Massachusetts medical device industry leader said the decision affirms the meticulous review process that medical device companies go through to get a product approved.
"In bringing a medical product to market in this country, medical device manufacturers comply with the most-rigorous review process in the world," said Thomas Sommer, president of the Massachusetts Medical Device Industry Council. "Approval of medical products and technology by the FDA is considered to be the 'gold standard' in the global marketplace. Today's ruling confirms that the current review system is the most appropriate for establishing the safety and effectiveness of medical devices."
The Supreme Court Case involved a specific lawsuit from a patient who suffered serious injuries when a Medtronic Inc. catheter burst during a medical procedure. The man used the catheter to unclog an artery and was left disabled before dying in 2004, according to press reports.
