Medtronic, Inc. v. Lohr

Facts

Medtronic (D) took advantage of § 510(k)'s expedited process in October 1982, when it notified the FDA that it intended to market its Model 4011 pacemaker lead as a device that was “substantially equivalent” to devices already on the market. On November 30, 1982, the FDA found that the model was “substantially equivalent to devices introduced into interstate commerce” prior to the effective date of the Act, and advised D that it could, therefore, market its device subject only to the general control provisions of the Act, which could be found in the Code of Federal Regulations. Lohr (P) is dependent on a pacemaker for the proper functioning of her heart. P was implanted with a Medtronic pacemaker equipped with one of the company's Model 4011 pacemaker leads. On December 30, 1990, the pacemaker failed, allegedly resulting in a “complete heart block” that required emergency surgery. According to her physician, a defect in the lead was the likely cause of the failure. P and her husband filed this action in a Florida state court. Their complaint contained both a negligence count and a strict-liability count. The negligence count alleged a breach of D's “duty to use reasonable care in the design, manufacture, assembly, and sale of the subject pacemaker” in several respects, including the use of defective materials in the lead and a failure to warn or properly instruct the plaintiff or her physicians of the tendency of the pacemaker to fail, despite knowledge of other earlier failures. A strict-liability count alleged that the device was in a defective condition and unreasonably dangerous to foreseeable users at the time of its sale. D removed the case to Federal District Court, where it filed a motion for summary judgment arguing that both the negligence and strict-liability claims were pre-empted by 21 U.S.C. § 360k(a). The District Court initially denied D's motion, finding nothing in the statute to support the company's argument that the MDA entirely exempted from liability a manufacturer who had allegedly violated the FDA's regulations. The United States Court of Appeals for the Eleventh Circuit concluded that § 360k required pre-emption of at least some common-law claims brought against the manufacturer of a medical device. After reconsidering the District Court reversed its earlier decision and dismissed P's entire complaint. The Court of Appeals reversed in part and affirmed in part. It held that pre-emption could not be avoided by merely alleging that the negligence flowed from a violation of federal standards. Under these regulations, the court concluded, it was not necessary that the federal regulation specifically deal with pacemakers, but only that the federal requirement “should, in some way, be ‘restricted by nature’ to a particular process, procedure, or device and should not be completely open-ended,” and that the specific device at issue should be subject to its requirements. The court concluded that P's negligent design claims were not pre-empted. It rejected D's argument that the FDA's finding of “substantial equivalence” had any significance with respect to the pacemaker's safety, or that the FDA's continued surveillance of the device constituted a federal “requirement” that its design be maintained. The court then concluded that the negligent manufacturing and failure to warn claims were pre-empted by FDA's general “good manufacturing practices” regulations, which establish general requirements for most steps in every device's manufacture and by the FDA labeling regulations, which require devices to bear various warnings. It held that under the strict-liability claims, there was no pre-emption insofar as P alleged an unreasonably dangerous design, but they could not revive the negligent manufacturing or failure to warn claims under a strict-liability theory. D filed a petition for certiorari.

Issues

Rule of Law

Holding and Decision

Legal Analysis

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