Supreme Court Backs Medical-Device Manufacturers

By Anna Boyd
11:03, February 21st 2008
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Supreme Court Backs Medical-Device Manufacturers

The Supreme Court today ruled that patients could not sue medical-device manufacturers in state court over harm from a device that has approval from federal regulators.

The Supreme Court Case involved a specific lawsuit from a patient, named Charles Riegel, who suffered serious injuries when a Medtronic Inc. catheter burst during a medical procedure. Riegel used the catheter to unclog an artery and was left disabled before dying in 2004. He argued that the catheter was not designed properly and sued the manufacturer. Medtronic no longer manufactures the catheter.

However, the court ruled that because the device received final approval from the Food and Drug Administration, Medtronic could not be sued over the catheter’s design flaws. The court ruled 8 to 1 in favor of a law that was established back in 1976 that protects medical device manufacturers from legal action being taken against them by patients, who are hurt or otherwise injured from using approved medical devices.

Justice Antonin Scalia noted for the court majority that the FDA spends an average of 1,200 hours (nearly a year) reviewing each device application and grants approval only if it finds there is a “reasonable assurance” of the device’s “safety and effectiveness,” the New York Times reported.

The ruling is “a victory for a national system designed to maximize the benefits to patients” from exhaustive review by government experts, Theodore Olson, lawyer for Medtronic said. He argued no product is perfectly safe, and suggested a reasonable risk should be accepted while the majority of patients have received benefits from the medical device.

Medtronic Chief Executive Bill Hawkins said, in a statement, that the ruling was “a very important decision, which ensures that patients continue to have appropriate access to innovative, life-saving medical devices,” Reuters reported.

Allison Zieve of the Public Citizen Litigation Group, Riegel’s lawyer said the decision was “potentially dangerous for patients,” because the prospect of damages against manufacturers is an incentive for safety.

The ruling was one of three yesterday in which the justices affirmed the supremacy of federal laws or regulations over often-tougher state laws aimed at protecting consumers.



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