preempting State initiatives absent FDA permission.40
Given
that awareness, and the consumer safety orientation of the MDA’s sponsors,41
Justice Ginsburg found “informative the
absence of any sign of a legislative design to preempt state common-law tort actions.” 42 Judge Ginsburg took little solace in the majority’s
recognition that § 360k(a) did not preclude state damages remedies for violations of FDA regulations, noting that preemption of other state common law actions would result in “’the loss of a significant layer of consumer protection’:”43
Tat remedy, although important, does not help consumers injured by devices that receive FDA approval but nevertheless prove unsafe. Te MDA's failure to create any federal compensatory remedy for such consumers further suggests that Congress did not intend broadly to preempt state common-law suits grounded on allegations independent of FDA requirements. It is “difficult to believe that Congress would, without comment, remove all means of judicial recourse” for large numbers of consumers injured by defective medical devices. Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 251, 104 S.Ct. 615, 78 L.Ed.2d 443 (1984).44
Of particular note -- given the decision in Wyeth v. Levine
to follow a year later --Justice Ginsburg urged that Congress’ experience regulating drugs and additives “cast[] doubt” on Medtronic’s policy argument that Congress did not intend for juries to override FDA determinations that medical devices were safe and effective when used as directed, a point found persuasive to the majority.45
In the four decades preceding the
MDA’s enactment in 1976, she noted, “common-law claims for drug labeling and design defects had continued unabated despite nearly four decades of FDA regulation,” despite extensive federal premarket regulation of drugs and additives since 1938. Congressional approval of a preemption clause in the MDA was not motivated by concern that similar court actions might be brought regarding medical devices, but by
40 552 U.S. 312, 128 S.Ct. at 1013 (Ginsburg, J. dissenting). 41 552 U.S. 312, 128 S.Ct. at 1014, 1015, fn. 4, 7 (Ginsburg, J. dissenting) 42 Indeed, Justice Ginsburg referenced the Lohr plurality’s earlier statement that, “[N]othing in the hearings, the Committee Reports, or the debates, suggest[ed] that any proponent of the legislation intended a sweeping pre-emption of traditional common-law remedies against manufacturers and distributors of defective devices. If Congress intended such a result, its failure even to hint at it is spectacularly odd, particularly since Members of both Houses were acutely aware of ongoing product liability litigation.” 552 U.S. 312, 128 S.Ct. at 1015, fn. 7 (quoting Lohr, 518 U.S., at 491, 116 S.Ct. 2240).
While Justice Stevens agreed with Justice Ginsburg’s description of the MDA’s actual legislative history and concurred that there was nothing to indicate that Congress “thought state court remedies had impeded the development of medical devices,” he was persuaded that the statutory text did preempt state law requirements that differ. 128 S.Ct. at 1011 (Stevens, J., concurring in part, and concurring in judgment). Te MDA provided an “example of a statute whose text and general objective cover territory not envisioned by its authors[.]” Id.
43 552 U.S. 312, 128 S.Ct. at 1015 (quoting Porter, Te Lohr Decision: FDA Perspective and Position, 52 Food & Drug L.J. 7, 11 (1997)).
44 552 U.S. 312, 128 S.Ct. at 1015 (Ginsburg, J., dissenting)(emphasis added). 45 While not all common law actions qualified as “requirements,” Justice Stevens, in his concurrence, agreed that the actions at issue imposed “requirements” that were preempted by federal requirements specific to a medical device. Id. Notably, he disagreed that the verdicts of juries who obey rules are not “requirements;” “[w]hile a jury’s finding of liability may induce a defendant to alter its device or label, this does not render the finding a ‘requirement’ within the meaning of the MDA.” 128 S.Ct. at [insert] at fn.1 (J. Stevens, concurring).
Trial Reporter / Winter 2010 37
a desire “to empower the FDA to exercise control over state premarket approval systems installed at a time when there was no preclearance at the federal level.”46 Justice Ginsberg was prescient about the Supreme
Court’s reaction to the jury override argument in Wyeth v. Levine. One year later, the Levine Court soundly rejected this policy argument in the context of prescription drug labeling.
The Giving: Wyeth v. Levine Decision (6-3)
Petitioner Diana Levine suffered gangrene and
amputation following intravenous push (“IV-push”) administration of Phenergan, an anti-nausea drug, during treatment for migraines. Te existing drug label, approved by the FDA, referenced the methods by which Phenergan could be administered: intravenous drip (“IV-drip”) or IV-push.47
46 552 U.S. 312, 128 S.Ct. at 1017 (Ginsburg, J., dissenting).See also id. at 1012 (J. Stevens, concurring) (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 489, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996)(“[W] hen Congress enacted § 360k, it was primarily concerned with the problem of specific, conflicting state statutes and regulations rather than the general duties enforced by common-law actions”)). Justice Ginsburg stated that little deference should be accorded to the FDA’s “new” position that such actions were preempted, given its former, longstanding position on the limited preemptive effect of § 360k, and a wealth of authority adhering to a presumption against Congressional preemption of state law causes of action which is heightened when federal law is claimed to bar state action in fields of “traditional state regulation.” 552 U.S. 312, 128 S.Ct. at 1016, fn. 8 (relying on Good Samaritan Hospital v. Shalala, 508 U.S. 402, 417, 113 S.Ct. 2151, 124 L.Ed.2d 368 (1993) (“[T]he consistency of an agency's position is a factor in assessing the weight that position is due.”). Te MDA “cut deeply into a domain historically occupied by state law.” 47 555 U.S. ---, 129 S.Ct. at 1991.
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