In the case Riegel v. Medtronic, Inc. the U.S. Supreme Court ruled that the manufacturer of the medical device could not be sued under state law when the device causes an injury. What this means for patients is that it is now harder to file an Illinois product liability lawsuit against a maker of medical device that is FDA approved.
FDA recall video of the leads used in Medtronics pacemakers.
In its decision the Supreme Court relied on the Medical Device Amendments of 1976 (MDA) which holds that a state cannot establish regulations that are different than established by the FDA, or that are in addition to the federal requirements. Nor can state regulations supersede those laid out by the FDA regarding safety and effectiveness.
In Riegel v. Medtronic, the Riegels sued the manufacturer after a Medtronic catheter burst in Charles Riegel’s coronary artery during heart surgery. The relevant catheter had premarket FDA approval. In their claim against Medtronic the Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. However, because their claim was based on violations of New York law and not federal law, the court dismissed the Riegels’ claim.
So despite the fact that the medical device had caused severe and permanent injuries to Riegel there is no legal recourse for them. As long as the medical device in question adequately meets all federal regulations and has federal approval then your legal options are limited.
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