In 1976, Congress enacted the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act in response to concerns over defective devices such as the Dalkon Shield intrauterine contraceptive.
The amendments established a regulatory framework classifying devices into three classes based on risk, with Class III devices like pacemakers requiring premarket approval unless they qualified for an exemption. In October 1982, Medtronic, Inc. notified the FDA that its Model 4011 pacemaker lead was substantially equivalent to pre-1976 devices, and the FDA cleared it for marketing under the §510(k) process.
In 1982, Lora Lohr underwent surgery in Florida to receive a Medtronic pacemaker equipped with the Model 4011 lead. Five years later, on December 30, 1990, the device failed, allegedly causing a complete heart block that required emergency surgery; her physician attributed the failure to a defect in the lead. Lohr and her husband subsequently filed suit in Florida state court in 1993, asserting claims for negligent design, negligent manufacture, failure to warn, and strict liability based on an unreasonably dangerous product.
Medtronic removed the action to the United States District Court for the Middle District of Florida. The district court initially denied Medtronic's motion for summary judgment but later dismissed the entire complaint after the Eleventh Circuit's decision in a related case, concluding that the claims were preempted by the MDA. On appeal, the Court of Appeals for the Eleventh Circuit affirmed in part and reversed in part, holding that the design defect claims were not preempted while the manufacturing and failure-to-warn claims were preempted by general federal regulations.
The Lohrs and Medtronic both petitioned for certiorari, and the Supreme Court granted review to address the conflict among the circuits regarding the preemptive scope of the MDA's preemption provision. The case was argued on April 23, 1996, and decided on June 26, 1996.
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