On Tuesday, December 4, the U.S. Supreme Court heard oral arguments in Riegel v. Medtronic, Inc. The case is an appeal of the Second Circuit’s decision finding that the Food and Drug Administration’s extensive pre-market approval process for Class III medical devices pre-empts state law causes of action for injuries allegedly caused by those devices. The Circuit Courts are currently split on the question.
During the proceedings, Justice Ginsburg compared the medical devices to new drugs, which also undergo an extensive pre-market approval. Tort suits relating to new drugs are generally not preempted by FDA approval. Justice Scalia stated that without preemption, a jury may decide that some alternative design would have been safer, thereby putting a manufacturer at risk for selling a product approved by FDA scientists. Justice Scalia described such a hypothetical outcome as “extraordinary.”