Medtronic & the Supreme Court

A suit against Medtronic was heard by the Supreme Court this week. To jog your memory: Riegel v. Medtronic began when a balloon catheter manufactured by Medtronic burst, causing injury to Mr. Riegel. This may sound like a common product liability design-defect case - except that the catheter's design was FDA-approved. Thus, the issue in the case is whether FDA approval of a design may preempt state law product liability claims.

Medtronic argued that the FDA is charged with evaluating the safety and effectiveness of a medical device, and that puts the FDA scientists in a better position to make determinations about safety than a jury. To allow the plaintiffs claim would essentially allow juries to second-guess the FDA. Several justices appeared to agree, expressing concern that a jury could better assess safety than the FDA, and concern that the Food, Drug and Cosmetic Act expressly put such decisions in the hands of experts.

Attorneys for the plaintiff cited products that were recalled with design defects, and questioned whether Congress really intended to limit liability in those cases.

You can read the transcript of the oral arguments here.