Lora Lohr, et Vir v. Medtronic, Inc.

Opinion summary

Etalia.ai summary of the majority opinion

The case involved a lawsuit by Lora Lohr against Medtronic, Inc., a manufacturer of medical devices. The issue was whether the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act preempted state law claims for negligence and strict liability regarding defective design and labeling of medical devices that had received FDA approval through its 'substantial equivalence' process. The Supreme Court held that federal law did not preempt these state common-law claims because the MDA's express preemption provision only applied when there were specific federal requirements applicable to a particular device. Since Medtronic’s pacemaker went through an expedited review process without detailed scrutiny under substantial equivalence, it did not impose such specific requirements on this device type.