To understand the concerns raised by preemption, it is important to understand the United States Supreme Court decision in Riegel v. Medtronics which upheld federal preemption in medical device design defect cases.
In Riegel, the plaintiff underwent heart surgery and during the procedure a balloon catheter ruptured while his doctor was attempting to dilate his coronary artery that had been partially blocked. The device was blamed and a question of law arose as to what impact the approval by the Food and Drug Administration (FDA) should have.
Specifically, the Court addressed whether the FDA’s approval of a product preempted state common law tort claims. In an 8-1 decision, the Court held that a state-law-based claim against a manufacturer for a defective medical device was preempted by the Medical Device Amendments of 1976 if the alleged defective product had been approved by the FDA. The Court reasoned that state regulatory laws and state tort law that made devices “safer, but less effective” than the FDA’s approved model would disrupt the federal scheme and should be preempted.
While the ruling is a major setback to consumers, the language of the opinion appears to be limited to “design defect” claims, leaving open the possibility of recovery in cases involving manufacturing defect-based claims, which would remain viable. However, with preemption now recognized, the ability to prosecute these cases has been made much more difficult.
