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MEDTRONIC, INC. v. LOHR Case Brief
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Case Brief Summary & Legal Analysis
tl;dr: A patient sued a pacemaker manufacturer under state tort law for injuries from a defective device. The Supreme Court held that the federal Medical Device Amendments did not pre-empt her state-law claims, allowing the product liability suit to proceed.
Legal Significance: This case narrowly interpreted the Medical Device Amendments’ express pre-emption clause, preserving state common-law tort remedies for victims of defective medical devices that were approved through the less-rigorous § 510(k) “substantial equivalence” process, rather than full premarket approval (PMA).
MEDTRONIC, INC. v. LOHR Law School Study Guide
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Case Facts & Court Holding
Key Facts & Case Background
Lora Lohr suffered a complete heart block when her pacemaker, manufactured by Medtronic, Inc., failed. The failure was allegedly caused by a defect in the pacemaker’s lead component. Lohr and her husband sued Medtronic in Florida state court, asserting common-law claims for negligence (in design, manufacturing, and warning) and strict liability. The specific pacemaker lead had not undergone the Food and Drug Administration’s (FDA) rigorous premarket approval (PMA) process. Instead, Medtronic had marketed the device under the § 510(k) process of the Medical Device Amendments of 1976 (MDA), which allows marketing of devices found “substantially equivalent” to products already on the market before 1976. The FDA’s § 510(k) clearance letter explicitly stated it was not an approval of the device’s safety or effectiveness. Medtronic moved for summary judgment, arguing that the MDA’s express pre-emption provision, 21 U.S.C. § 360k(a), barred all of the Lohrs’ state-law tort claims. The Eleventh Circuit held the design claims were not pre-empted but the manufacturing and failure-to-warn claims were.
Court Holding & Legal Precedent
Issue: Does the express pre-emption provision of the Medical Device Amendments of 1976 bar state common-law tort claims alleging negligent design, negligent manufacturing, and failure to warn against the manufacturer of a medical device cleared for market under the § 510(k) “substantial equivalence” process?
No, the MDA does not pre-empt the Lohrs’ state common-law tort claims. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in re
IRAC Legal Analysis
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Legal Issue
Does the express pre-emption provision of the Medical Device Amendments of 1976 bar state common-law tort claims alleging negligent design, negligent manufacturing, and failure to warn against the manufacturer of a medical device cleared for market under the § 510(k) “substantial equivalence” process?
Conclusion
This case significantly limited the pre-emptive scope of the MDA for devices Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in re
Legal Rule
Under the Medical Device Amendments of 1976, a state "requirement" is pre-empted Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit
Legal Analysis
The Court, in a fractured opinion, narrowly construed the scope of the Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in
Flash-to-Full Case Opinions
Flash Summary
- The Medical Device Amendments (MDA) do not broadly preempt state common-law