Citation. 518 U.S. 470, 116 S. Ct. 2240,135 L. Ed. 2d 700, 1996 U.S.
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Brief Fact Summary.
The Plaintiff, Lora Lohr (Plaintiff), required emergency surgery when a pacemaker manufactured by the Defendant, Medtronic, Inc. (Defendant), failed. Plaintiff sued under state laws alleging negligence and strict liability. Defendant answered by moving the case to federal court and claiming preemption of state law by a federal act.
Synopsis of Rule of Law.
A federal law enacted by Congress will not be held to preempt existing state law unless is the clear intent of Congress to legislate exclusively in the area.
The Plaintiff was equipped with a pacemaker made by the Defendant. Three years later, the pacemaker failed due to a defect in the lead, requiring emergency surgery. Plaintiff filed suit in a Florida State Court, alleging negligence and strict liability. Defendant removed the case to federal court and filed a motion for summary judgment, claiming that 21 U.S.C. Section: 360k(a) preempted the state common law claims. The trial court dismissed the entire complaint. The 11th Circuit affirmed in part and reversed in part. Both parties sought review by the United States Supreme Court (Supreme Court).
Does the Medical Device Amendments of 1976 (the Act) [90 Stat. 539 (1976)] preempt a state common law negligence action against the manufacturer of an allegedly defective medical device?
No. Affirmed in part and reversed in part.
* The states have traditionally exercised their police powers to protect the health of their citizens. However, the Federal Government has increasingly played a role in health protection. The Act requires rigorous pre-market approval for products such as the pacemaker in question. However, the Act grandfathered in devices on the market before 1976 and permitted devices that are substantially equivalent to pre-existing devices to avoid approval. The pacemaker at issue in this case was a device deemed substantially equivalent.
* This Supreme Court is presented with the task of interpreting a statutory provision that preempts state law. In doing so, we follow two presumptions. First, when Congress is preempting a law in a field generally governed by the states, the Supreme Court assumes that the powers of the state are not to be preempted unless that was the clear purpose of Congress. Second, the scope of the preemption statute must reflect a clear understanding of congressional purpose.
* Defendant’s argument that Congress intended to bar all common law claims based on medical devices with the Act is implausible. This interpretation would provide complete immunity for design defect liability for the entire industry. The legislative history of the Act in no way supports this argument.
* Plaintiff claims that the Act does not preempt her negligent design claim because the Act imposes no requirement on the design of Defendant’s pacemaker. In the alternative, Plaintiff claims that even if the Act does provide requirements, it does not preempt state rules that duplicate these federal requirements.
* The Plaintiff’s common law claims are not preempted by the Act. These claims are general state common-law requirements that every manufacturer use due care to avoid foreseeable dangers in its products and inform users of potentially dangerous risks involved in their use. These general requirements in no way reflect the concerns Congress expressed regarding regulation of specific devices in the Act.
If Congress had clearly intended to preempt state law, the Supreme Court would have no choice and the manufacturer would only have to abide by the federal law. In this case, the Supreme Court determined that Congress had not expressed a clear intention to preempt these state common laws.