A Sensible Standard for Medical Devices

By February 20, 2008Briefly Legal, Health Care

A good ruling from the U.S. Supreme Court in a product liability case, Riegel v. Medtronic, Inc. From Reuters:

WASHINGTON (Reuters) – The Supreme Court handed a victory to Medtronic Inc on Wednesday, ruling that patients cannot sue medical-device manufacturers in state court over harm from a device that has approval from federal regulators.

By an 8-1 vote, the court ruled a 1976 law creating federal safety oversight for medical devices bars state-law claims challenging safety or effectiveness of devices that have won premarket approval from the U.S. Food and Drug Administration.

To function in any sort of predictable, profitable way, medical device manufacturers have to rely on a reasonable approval process that provides some level of certainty. Congress has determined that FDA, that is, federal approval is the proper way to achieve that certainty, logically enough given the interstate commerce considerations. You simply cannot change the standards every time there’s a lawsuit.

In his majority opinion, Justice Antonin Scalia argued, “State tort law that requires a manufacturer’s catheters to be safer, but hence less effective, than a model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect.” He suggested that tort law, applied by juries, is “less deserving of preservation” than statutory law or regulations, because juries, unlike federal or state officials, do not take into account the benefits of a particular product design along with its risks.

Here’s the the NAM summary of the case notes. More on Riegel and several other federal pre-emption cases from The Jurist. The Supreme Court’s opinion is available here.

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