Conclusion Te only credible explanation for the opposite conclusions
in Riegel and Levine is the presence of a preemption clause in the MDA and the absence of one in the FDCA. But for that fact, the underlying policy considerations should have compelled similar conclusions in both decisions. In both cases, Congress had approved far-reaching premarket approval regimes. Levine and post-Levine decisions, finding no preemption of state claims involving prescription drugs, refer to “the limited resources of the FDA and the extensive assortment of pharmaceutical products on the market, and the further fact that “the FDA [has] traditionally regarded state law as a complementary form of drug regulation.”80
Hatch-Waxman Amendment was devised to allow generic drug manufacturers to get their drugs to market both cheaply and quickly, this purpose was to be achieved by permitting manufacturers to forego duplicative clinical trials. It was not to be achieved by permitting manufacturers to engage in negligent activities.”); Kellogg v. Wyeth, 612
F.Supp.2d 437 (D.Vt. 2009)(“[A]lthough the Levine decision did not definitively dispose of the issues in this case, its statement that “[f ]ailure-to- warn actions, in particular, lend force to the FDCA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times,” Levine, 129 S.Ct. at 1202, does not appear to permit the caveat, “except for generic drug manufacturers.” Schrock v. Wyeth, Inc., 601
F.Supp.2d 1262, 1265-66 (W.D.Okla.2009)(claims based on failure to warn of long term side effects of generic form of Reglan not preempted); Tucker v. SmithKline Beecham Corp., 596
F.Supp.2d 1225 (
S.D.Ind.2008)(same).
Preempted: See, e.g., Mending v. Wyeth, 562
F.Supp.2d 1056 (D.Minn.2008) (pre-Levine, finding state law preempted). A separate statute expressly exempts strict liability and negligent design defect claims as to certain childhood vaccines. See, e.g., Bruesewitz v. Wyeth Inc. 561 F.3d 233C.A.3 (Pa.),2009, discussing National Childhood Vaccine Injury Act).
80 See, e.g., In re Prempro Products Liability Litigation, ---F.3d --- 2009, WL 3518245 (8th Cir. 2009) (quoting Levine at 1202).
Te Supreme Court, however, gave nary a consideration in Riegel to those limited resources and the States’ pre-MDA role with respect to medical devices, except as the catalyst for adoption of a preemption clause. If the FDA’s “limited resources” and the existence of state tort suits to “uncover unknown drug hazards,” supported a determination of non- preemption as to drugs, surely the FDA’s limited resources and the historic existence of state tort suits identifying defects in medical devices should be of paramount consideration. Both decisions referenced the well-established presumption against preemption in fields historically occupied by the states. In one case that presumption was given lip service (Riegel); in another it was held up as an honored and guiding principle (Levine). In Levine, the Supreme Court expressed its concern that the manufacturer's argument would leave injured parties with no remedy, because injured parties have no cause of action under the FDCA.81
Te same could have
been said in Riegel (and was said by the dissent). Te Riegel majority gave it short shrift. In neither case did the legislative history of the enactments at issue indicate a Congressional intent to preempt the field of state common law actions. Tat fact was roundly ignored in Riegel. Sadly, the decisions
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