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.
Issue. 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?
Held. 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.
The federal requirements reflect important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation which the statute or regulations were designed to protect from potentially contradictory state requirements.View Full Point of Law