implied preemption doctrines and the majority’s reliance on extra-textual considerations as to Congress’ intentions.72 Justice Alito, joined by the Chief Justice and Justice Scalia (author of Riegel), dissented. After a detailed examination of the regulatory history of Phenergan, the dissent urged that a state court jury should not be able to “countermand the FDA’s considered judgment” that Phenergan’s FDA- mandated, detailed warning label rendered its IV-push use safe.
FDA’s cost-benefit-balancing function” as they focus on the risk of a particular product rather than its benefits. 73
Decisions Following Riegel & Levine Post-Riegel In the face of the Riegel decision, drug manufacturers
have brazenly advertised that medical device manufacturers should willingly seek PMA approval by the FDA of their devices in order to claim, under Riegel, that state claims are preempted.74
Medical device cases following Riegel have
uniformly found preemption of state claims related to Class III75
medical devices.76
notice of proposed rule making specified that the rule did not contain policies “to preempt state laws,” and because the FDA finalized the rules with a contrary preamble without giving interested parties notice or opportunity for comment.69 Te Court noted as well that the preamble reversed the “FDA’s own longstanding position without providing a reasoned explanation . . . of how state law has interfered with the FDA’s regulation of drug labeling during decades of co- existence.”70
Finally, the Court commented on the FDA’s
“limited resources” to monitor 11,000 drugs on the market; the superior access of manufacturers to information about new risks emerging in the post-marketing phase; and the fact that “state tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.”71
Other Views Justice Breyer concurred, writing only to express his
view that specific FDA regulations could potentially have preemptive effect, and to iterate that such a regulation was not at issue in the case before it.
Justice Tomas concurred in the judgment only, stating his objections to “overly broad”
69 555 U.S. ---, 129 S.Ct. at 1200-1204. 70 555 U.S. ---, 129 S.Ct. at 1201-1202. 71 555 U.S. ---, 129 S.Ct. at 1202-1203.
40 Trial Reporter / Winter 2010 However, the practitioner should be alert to arguments that Riegel does not apply:
1. “Parallel” claims As noted above, “Parallel” claims – state remedies for FDA violations
- persist 360k(a) does not prevent a state
following Riegel. Section from providing a
damages remedy for claims premised on a violation of federal (FDA) regulations.77
72 555 U.S. ---, 129 S.Ct. at 1204 (Breyer, J., concurring) 73 Te dissent further urged that the Court’s decision was contrary to its prior decision in Geier v. American Honda Motor Co., in which the Court had held preempted state law suits viewed to be obstacles to a formal rulemaking of the FDA related to a planned phase-in of passive restraint devices. 555 U.S. ---, 128 S. Ct. at 1217-1226 (dissenting opinion). 74 "Te Changing Landscape of U.S. State Tort Liability for FDA-approved Drugs and Medical Devices," Corporate Liability, Federated Press, at 848.
75 Riegel concerned only the medical devices subject to Class III subject to pre-market approval, a small percentage of the total number of medical devices on the market. It is unclear how the courts will treat a device initially classified and subject to pre-market approval as a Class III device but later re-classified at a lower level. Pre-Riegel cases generally found that the preemption analysis remained the same as that for the Class III devices. See, e.g., Scott v. Pfizer Inc., 249 F.R.D. 248, 254 fn. 8 (E.D.Tex.2008) (treating bone cement as Class III rather than Class II because the cement at issue in the case was manufactured and distributed during the time of the Class III classification); Southard v. Temple Univ. Hosp., 566 Pa. 335, 781 A.2d 101 (Pa.2001). So, too, have post-Riegel decisions. See, e.g., Colombini v. Westchester County Health Care Corp. 24 Misc.3d 1222(A), Slip Copy, 2009 WL 2170230.
76 See, e.g., Wolicki-Gables v. Arrow Intern., Inc., ---
F.Supp.2d ----, 2009 WL 21900 (M.D.Fla.,2009) (actions alleging design defects, failure to warn and strict liability manufacturing defect claim preempted); Williams v. Cyberonics, Inc. ---F. Supp. 2d ---, 2009 WL 2914414 (E.D. Pa. 2009) (preempting claims related to nerve stimulation device); Covert v. Stryker Corp., ---F. Supp. 2d ---, 2009 WL 2424559 (M.D.N.C. 2009); In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592
F.Supp.2d 1147, 1161 (D.Minn.2009) (“In the [ ] months following Riegel, courts across the country have applied Section 360k(a) broadly, preempting all manner of claims ....”) (finding breach of express and implied warranty claims, fraud claims and claims for deceptive trade practices preempted); see also Heisner v. Genzyme Corp., No. 08-C-593, 2009 WL 1210633 (
N.D.Ill. Apr.30, 2009) (breach of express warranty claim preempted); Horowitz v. Stryker Corp., No. CV- 07-1572(DGT), 2009 WL 436406 (E.D.N.Y. Feb.20, 2009) (breach of express warranty, implied warranty of fitness and implied warranty of merchantability claims, as well as state-law claim for deceptive trade practices preempted); Parker v. Stryker Corp., 584
F.Supp.2d 1298 (
D.Colo.2008) (breach of express warranty, implied warranty of fitness and implied warranty of merchantability claims preempted); Adkins v. Cytyc Corp., No. 4:07CV00053, 2008 WL 2680474 (
W.D.Va. July 3, 2008) (express and implied warranty claims preempted);Weston v. Kim’s Dollar Store, ---S.E.2d ---, 2009 WL 2136707 (S.C. App. 2009)(contact lens claims preempted); but cf. Hofts v. Howmedica Osteonics Corp., 597
F.Supp.2d 830 (
S.D.Ind.2009) (no preemption found, despite Riegel's overt criticism of § 808.1(d)(1)).
77 Schronk v. City of Burleson, --- S.W.3d ----, 2009 WL 2215081 (Tex.App. 2009)(because Plaintiffs seek only to enforce federal regulations for medical device in their suit, their product liability claims are not preempted by the FDCA). As to differing views as to what constitutes a “parallel claim,”
Juries, in its view, were “ill-equipped to perform the
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