Medtronic, Inc. v. Lohr
Citation and Court
518 U.S. 470 (1996), Supreme Court of the United States
Facts
Lora Lohr was injured when her Medtronic pacemaker failed. She sued Medtronic under Florida common law, alleging negligent design, manufacture, and failure to warn. Medtronic argued that the Medical Device Amendments of 1976 (MDA) expressly preempted state tort claims related to medical devices that had received FDA clearance through the § 510(k) premarket notification process.
Issue
Whether the MDA’s express preemption clause preempts state common law tort claims against a medical device manufacturer whose device received § 510(k) clearance.
Holding
The Supreme Court held that the MDA’s express preemption clause did not preempt Lohr’s common law tort claims because the § 510(k) process does not establish specific federal requirements that would be the subject of preemption; it merely establishes “substantial equivalence” to a predicate device rather than setting particular safety requirements.
Rule / Doctrine
Express preemption clauses are read narrowly and do not preempt state law unless the federal requirements are specific and detailed enough to conflict with particular state requirements. A general federal clearance process that does not impose specific substantive requirements does not establish the kind of federal “requirement” that can preempt state common law tort duties. There is also a presumption against preemption in areas traditionally governed by state law such as tort law.
Significance
Medtronic v. Lohr is a landmark preemption case holding that the FDA’s § 510(k) clearance process does not preempt state tort claims, preserving an important avenue of recovery for injured patients. It established the narrow reading of the MDA preemption clause and was later partially limited by Riegel v. Medtronic, Inc. (2008) for devices approved through the more rigorous premarket approval process.