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Quality Healthcare providers specializing in the treatment of patients injured in automobile accidents and on the job since the 1980’s.


be preempted by federal requirements specific to a medical device.”28


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clauses precluding the imposition of “any requirements” “in addition to” or “different from” those specified in federal law to preempt state common law actions,32


and the absence of


any explicit Congressional statutory direction otherwise, it rejected the dissent’s argument that Congress could not have intended, “without comment, [to] remove all means of judicial recourse”33


for consumers injured by FDA-approved devices.34


Te Supreme Court recognized that §360k(a) did not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case “parallel,” rather than add to, federal requirements, but it declined to address the Riegels’ argument that the lawsuit raised “parallel” claims that were not preempted by 21 U.S.C. § 360k as permitted under Lohr because it had failed to raise those issues below.35


Other Views In a vigorous dissent, Justice Ruth Bader Ginsburg


urged that § 360k(a) did not preempt the Riegels’ state actions: “Congress, in my view, did not intend §360k(a) to effect a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.”36


Te Court’s construction of Te Court rejected the Riegels’ contention that


state tort claims do not establish “requirements” within the meaning of the MDA because they are not requirements maintained “with respect to devices,”29


stating, “Nothing


in the statutory text suggests that the preempted state requirement must apply only to the relevant device, or only to medical devices and not to all products and all actions in general.”30


In its view, “Te MDA provides that no State


“may establish or continue in effect with respect to a device ... any requirement” relating to safety or effectiveness that is different from, or in addition to, federal requirements.”31 Relying on other decisions interpreting statutory preemption


28 552 U.S. 312, 128 S.Ct. at 1007 (citing, 518 Lohr U.S., at 512, 116 S.Ct. 2240)(opinion of O'Connor, J., joined by Rehnquist, C. J., and Scalia and Tomas, JJ.).


29 Te Riegels relied for their position on the text of an FDA regulation, 21 CFR § 808.1(d)(1), which stated that the MDA preemption clause did not apply to certain duties, including “[s]tate or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.” 21 CFR § 808.1(d)(1). Te regulation, in the Supreme Court’s view, did not provide “unambiguous” support for the Riegels’ position. Moreover, while “less than compelling,” the FDA had taken the position that the regulation did not exclude general tort duties from pre-emption requirements; only those incidental to medical devices such as fire codes. In the end, it ignored the FDA’s distinction between preempted general duties and non- preempted incidental requirements: “All in all, we think that § 808.1(d)(1) can add nothing to our analysis but confusion. Neither accepting nor rejecting the proposition that this regulation can properly be consulted to determine the statute's meaning; and neither accepting nor rejecting the FDA's distinction between general requirements that directly regulate and those that regulate only incidentally; the regulation fails to alter our interpretation of the text insofar as the outcome of this case is concerned.” 552 U.S. 312, 128 S. Ct. at 1009.


30 552 U.S. 312, 128 S.Ct. at 1009-1010. Tat the Riegels’ state law claims were related to the safety of the devices was assumed. Id. at 1006 (“Safety and effectiveness are the very subjects of the Riegels' common-law claims, so the critical issue is whether New York's tort duties constitute “requirements” under the MDA.”).


31 552 U.S. 312, 128 S.Ct. at 1010 (quoting 21 U.S.C. § 360k(a) (emphasis in original)). 36 Trial Reporter / Winter 2010


the clause, in her view, had the “‘perverse effect’ of granting broad immunity ‘to an entire industry that, in the judgment of Congress, needed more stringent regulation[.]’”37


Justice


Ginsburg took issue with the Court’s statement that, “Absent other indication, reference to a state’s ‘requirements’ includes its common-law duties.”38 such “other indications.”39


Regarding the MDA, there were In stark contrast to the majority,


which refused to go beyond what it considered to be the unambiguous language of §360k(a), Justice Ginsburg cited to the legislative history of the MDA’s preemption clause. Congress' reason for enacting § 360k(a) was “evident” – it was a response to the Dalkon shield cases, other defective medical product cases, and state premarket regulation of medical devices in the absence of federal premarket regulation of such devices. Section 360k(a) responded to that state regulation by


32 552 U.S. at 312, 128 S.Ct. at 1007-1108, relying on Bates v. Dow Agrosciences LLC, 544 U.S. 431, 433, 125 S.Ct. 1788, 161 L.Ed.2d 687 (2005)(common law actions preempted by provision in Federal Insecticide, Fungicide, and Rodenticide Act specifying that States “‘shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this subchapter.’"; Cipollone v. Liggett Group, Inc., 505 U.S. 504, 523, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992) (plurality opinion), which held common-law actions pre-empted by a provision of the Public Health Cigarette Smoking Act of 1969 stating, that “[n]o requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes” whose packages were labeled in accordance with federal law.


33 552 U.S. 312, 128 S.Ct. at 1008-1009 (citing Id. at 1015; Ginsburg, J., dissenting). 34 Justice Scalia urged, “It is not our job to speculate upon congressional motives. If we were to do so, however, the only indication available -- the text of the statute -- suggests that the solicitude for those injured by FDA-approved devices, which the dissent finds controlling, was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations. 552 U.S. 312, 128 S.Ct. at 1009, and fn. 5. Congress did not apply the preemption clause to “the entire FDCA…but instead wrote a preemption clause that applies only to medical devices.” Id.


35 552 U.S. 312, 128 S.Ct. at 1011 (citing Lohr, supra, at 495, 513, 116 S.Ct. 2240). 36 552 U.S. 312, 128 S.Ct. at 1012 (Ginsburg, J. dissenting) 37 552 U.S. 312, 128 S.Ct. at 1016 (quoting Lohr, 518 U.S., at 487, 116 S.Ct. 2240)(plurality opinion).


38 552 U.S. 312, 128 S.Ct. at 1014 (Ginsburg, J. dissenting) 39 552 U.S. 312, 128 S.Ct. at 1014 (Ginsburg, J. dissenting)


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