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Medtronic, Inc. v. Lohr | 518 U.S. 470 (1996)

Seeing a need to regulate medical devices, in nineteen seventy six, Congress added the Medical Device Amendments to the Food and Drug Act of Nineteen Oh Six. In Medtronic versus Lohr, the Supreme Court probed the boundaries of this law’s preemption of state law claims.

The act classifies medical devices into three categories. Class Three devices, which include pacemakers, are devices that are necessary for sustaining human life or for preventing impairment of health. Before a Class Three device can go on the market, the manufacturer must prove that the device is safe and effective through a rigorous process of premarket approval. Some devices, however, are allowed to enter the market without this process because they’re grandfathered in, or they’re substantially equivalent to existing devices that already have approval.

Lora Lohr received a Medtronic pacemaker in nineteen eighty seven. This pacemaker was approved through the substantially equivalent pathway. In nineteen ninety, the pacemaker failed. Lohr’s heart formed a blockage, and she needed emergency surgery. Lohr’s physician blamed the pacemaker’s lead, the part that transmits electricity from the device to the heart.

Lohr sued Medtronic in Florida state court, alleging common law claims of negligent design, negligent manufacture, and negligent failure to warn. Medtronic removed the case to federal district court, where it argued that state common law claims were preempted by the Medical Device Amendments.

The district court dismissed Lohr’s claims.

The Eleventh Circuit held that the claims based on negligent design weren’t preempted, but the claims based on negligent manufacture and failure to warn were. It reversed the dismissal of Lohr’s negligent design claim.

The United States Supreme Court granted cert.

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