The plaintiff in the underlying suit was Charles R. Reigel who suffered severe and permanent injuries when a balloon catheter, manufactured by Minneapolis based Medtronic, burst while Reigel was undergoing an angioplasty. Reigel alleged that the catheter was manufactured in a way that violated New York state laws, and he brought suit in Federal Court. On appeal, the Second Circuit Court of Appeals dismissed, stating that the catheter had been approved by the F.D.A., and therefore was protected from liability under state law by the Medical Device Amendments of 1976.
The Supreme Court upheld, with Scalia writing the opinion. He stated devices only receive F.D.A. approval if there is a "reasonable assurance" of the device's "safety and effectiveness." Thus, medical device manufacturers are encouraged to produce devices that, while they may introduce great risk to the patient, have the potential to offer a greater benefit than "safer" alternatives. Scalia also said jurors were in a poor position to measure the benefits and dangers of medical devices. The court sided with medical experts who testified that leaving medical device manufacturers subject to liability would "discourage the marketing of products that might save our lives." Medtronic, the company shielded in this case, reported $12.3B in revenues in its last fiscal year.
The lone dissenter on the court, Ginsburg, argued in favor of states' authority to develop their own common-law aimed at compensating for injuries caused by defectively designed or labeled medical devices. Both the House of Representative and the Senate have vowed to enact new legislation to allow lawsuits against medical device manufacturers. Henry Waxman said, "This isn't what Congress intended and we'll pass legislation as quickly as possible to fix this nonsensical situation." While Edward Kennedy said, "Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices."
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