Supreme Court Rules Against State Lawsuits Over FDA Approved Medical Devices


Yesterday the United States Supreme Court ruled against an injured man and in favor of a medical device manufacture in an 8-1 ruling. The basis of the ruling was that the Food & Drug Administration (FDA) had approved the device so that consumers are not allowed to sue under state law claiming that the device was defective or that the warning was inadequate.

The excellent Washington Post article by Robert Barnes summarizes the case:

The court ruled 8 to 1 against the estate of a New York man who was seriously injured when a balloon catheter manufactured by Medtronic burst during an angioplasty in 1996. Charles Riegel, who died three years ago, and his wife sued under New York law, alleging that the device’s design was faulty and its labeling deficient.

Justice Antonin Scalia, writing for the majority, said federal law preempts the imposition of liability under state laws for devices that have undergone the Food and Drug Administration’s pre-market approval process, the most rigorous of the FDA’s testing procedures.

Justice Ruth Bader Ginsburg was the lone dissenter. Congress did not intend the preemption clause, Ginsburg wrote, “to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.”

The Washington Post article notes the basis for the majority’s opinion (authored by Scalia) is

Allowing juries to award damages when something goes wrong, Scalia wrote, would be unfair. A jury “sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court,” Scalia wrote. Patients “would suffer without new medical devices if juries were allowed to apply the tort law of 50 states to all innovations.”

We are pleasantly surprised at the reaction among congress –

“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” said Rep. Henry A. Waxman of California, the chairman of the House Committee on Oversight and Government Reform. “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

The whole issue of federal preemption of state law is very active one that we will continue to watch as the more the courts find preemption the more state law claims are swept away without normally any federal claim being put in its place to compensate injured citizens of Alabama and other states.

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