effectiveness.15
If the applicant wishes to make such a
change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application.16
[citations omitted] Te Supreme Court undertook a two-part analysis in
determining the question at hand: (1) because the MDA expressly preempted only those state requirements which were “different from, or in addition to, any requirement applicable to the device” under federal law, 21 U.S.C. § 360k(a)(1), it sought to determine whether the federal government had established requirements applicable to Medtronic’s catheter; (2) if such requirements had been established, the next inquiry was “whether the Riegels' common-law claims were based upon New York requirements that, with respect to the device that are “different from, or in addition to” the federal ones, and that relate to safety and effectiveness.” 21 U.S.C. § 360k(a).17 As in Medtronic, Inc. v. Lohr,18
the Supreme Court interpreted
the MDA’s preemption clause to be “substantially informed” by the implementing federal regulation, 21 CFR §808.1(d), which provides that preemption of state requirements is required when the FDA “has established specific counterpart regulations or there are other specific requirements applicable to a particular device” under federal law.19
In contrast to the facts
before it in Lohr -- in which the Supreme Court held that general federal manufacturing and labeling requirements20 applicable to almost all medical devices did not preempt the common law strict liability and negligence claims at issue -- the Supreme Court determined that the federal government had established “requirements applicable” to Medtronic’s catheter within the meaning of § 360k(a)(1) in the form of pre-market approval of the catheter.21
It urged, “Unlike
general labeling duties [Lohr], pre-market approval is specific to individual devices. And it is in no sense an exemption from federal safety review-it is federal safety review.”22 “equivalence, not safety” was at issue in Lohr;23 it concerned “safety, not equivalence.”24 Lohr, the Supreme Court concluded:
the case before Again contrasting
15 552 U.S. 312, 128 S.Ct. at 1004 (citing 21 U.S.C. § 360e(d)(6)(A)(i)). 16 552 U.S. 312, 128 S.Ct. at 1004 (citing 21 U.S.C. § 360e(d)(6); 21 CFR § 814.39(c)). 17 552 U.S. 312, 128 S.Ct. at 1007. 18 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). 19 552 U.S. 312, 128 S.Ct. at 1006-1007 (emphasis added). 20 In Riegel, the Supreme Court made clear that while it had disclaimed the notion, in Lohr, that general federal requirements could never pre-empt, or general state duties never be pre-empted, it had held that no pre-emption occurred in the case at hand based on a careful comparison between the state and federal duties at issue. 552 U.S. 312, 128 S.Ct. at 1006-1007 (citing Lohr, 518 U.S. at 500-501, 116 S.Ct. 2240).
21 552 U.S. 312, 128 S. Ct. at 1006 (citing Lohr, 518 U.S. at 495, 500-501, 116 S.Ct. 2240). 22 552 U.S. 312, 128 S.Ct. at 1007 (emphasis in original). 23 Lohr involved “substantial equivalence” review under 21 U.S.C. § 510(k). In Lohr, the Supreme Court rejected the argument that § 510(k) approval imposed device-specific “requirements.” It regarded the fact that products entering the market through § 510(k) may be marketed only so long as they remain substantial equivalents of the relevant pre-1976 devices as a qualification for an exemption rather than a requirement. Id., at 493-494, 116 S.Ct. 2240; see also Id., at 513, 116 S.Ct. 2240 (O'Connor, J., concurring in part and dissenting in part). 24 552 U.S. 312, 128 S.Ct. at 1007.
In its view,
While devices that enter the market through § 510(k) have “never been formally reviewed under the MDA for safety or efficacy,” the FDA may grant pre-market approval only after it determines that a device offers a reasonable assurance of safety and effectiveness, § 360e(d). And while the FDA does not “‘require’” that a device allowed to enter the market as a substantial equivalent “take any particular form for any particular reason,” the FDA requires a device that has received pre- market approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness. [citations omitted]25
With respect to the second prong of its analysis, the
Supreme Court held that the Riegels’ common law claims were preempted because they were based upon New York “requirements” as to Medtronic’s device that were “different from, or in addition to” federal requirements, and that they related to safety and effectiveness.26
it reiterated the view of the five Justices27
in Lohr that common-law causes of action for negligence and strict liability “do impose ‘requirement[s]’ and would
25 Id. 26 552 U.S. 312, 128 S.Ct. at 1007-1011. 27 Lohr was a plurality decision.
Trial Reporter / Winter 2010 35
As to the former point, who concluded
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