Cite as: 518 U. S. 470 (1996)
Opinion of the Court
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.
In 1993 Lohr 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 Medtronic'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. Complaint ¶ 5. The strict-liability count alleged that the device was in a defective condition and unreasonably dangerous to foreseeable users at the time of its sale. Id., ¶ 11. (A third count alleging breach of warranty was dismissed for failure to state a claim under Florida law.)
Medtronic 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 preempted by 21 U. S. C. § 360k(a). That section, which is at the core of the dispute between the parties in this suit, provides:
"§ 360k. State and local requirements respecting devices "(a) General rule
"Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
"(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
481
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