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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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