472
Syllabus
where a particular state requirement threatens to interfere with a specific federal interest. State requirements must be "with respect to" medical devices and "different from, or in addition to," federal requirements. They must also relate "to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device," and the regulations provide that state requirements of general applicability are pre-empted only where they have "the effect of establishing a substantive requirement for a specific device." Federal requirements must be "applicable to the device" in question, and, according to the regulations, pre-empt state law only if they are "specific counterpart regulations" or "specific" to a "particular device." The federal manufacturing and labeling requirements at issue 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. Similarly, Florida's common-law requirements were not specifically developed "with respect to" medical devices and, thus, are not the kinds of requirements that Congress and the FDA feared would impede implementation and enforcement of specific federal requirements. Pp. 497-502.
Justice Stevens, joined by Justice Kennedy, Justice Souter, and Justice Ginsburg, concluded in Part IV that Medtronic's argument that any common-law cause of action is a "requirement" under § 360k(a) is implausible, for it would grant complete immunity from design defect liability to an entire industry that, in Congress' judgment, needed more stringent regulation. It would take language much plainer than § 360k's text to do that. The word "requirement," which appears to presume that the State is imposing a specific duty upon the manufacturer, would be an odd term to use to indicate the sweeping pre-emption Medtronic urges here. Cipollone, 505 U. S., at 521-522, distinguished. The legislation's basic purpose and history entirely support the rejection of such an extreme position. Pp. 486-491.
Justice Breyer concluded that, although the MDA will sometimes pre-empt a state-law tort suit, it does not pre-empt the claims at issue here. First, since the MDA's pre-emption provision is highly ambiguous, Congress must have intended that courts look elsewhere for help as to just which federal requirements pre-empt just which state requirements, as well as just how they might do so. Second, in the absence of a clear congressional command as to pre-emption, courts may infer that the relevant administrative agency possesses a degree of leeway to determine which rules, regulations, or other administrative actions will have pre-emptive effect. See Hillsborough County v. Automated Medical Laboratories, Inc., 471 U. S. 707, 721. Third, the FDA's regula-
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