The United States Supreme Court held 8-1 that Food and Drug Administration (FDA) pre-market approval of medical devices barred state court lawsuits by patients injured by such devices. The Medical Device Amendments of 1976 called for federal oversight of medical devices, and provided that states were not to establish or continue in effect any requirement “different from, or in addition to, any requirement” applicable to the device under federal law and which relates to, among other things, safety and effectiveness of the device. The Riegel court determined that common law negligence principles, as applied to medical device manufacture and design, constituted impermissible requirements under the statute.
Justice Ginsberg dissented, stating, “Congress, in my view, did not intend 360k(a) to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.” However, the majority explicitly stated that this was precisely what the pre-emption, by its very terms, had done.
The Supreme Court’s decision has effectively terminated an injured person’s ability to recover compensation for injuries caused by unsafe and defective medical devices. It will take legislation from Congress to undo this damage to the rights of injured people.