Opinion ID: 1161575
Heading Depth: 2
Heading Rank: 3

Heading: Medtronic Inc. v. Lohr (1996) 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700

Text: Although the Court of Appeal does not mention Medtronic, Inc. v. Lohr (1996) 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (Medtronic ), plaintiffs contend that under its reasoning common law tort claims involving a `failure to warn' of the dangers of a pesticide are no longer preempted at all. Medtronic does not undermine the conclusion that FIFRA preempts state failure-to-warn claims. The overwhelming majority of the courts that have examined the question have so held. (See Lescs v. William R. Hughes, Inc. (4th Cir. Jan. 4, 1999, No. 97-2278) 1999 WL 12913; Grenier v. Vermont Log Bldgs., Inc., supra, 96 F.3d 559; Oliver v. Reckitt & Colman, Inc. (M.D.Fla.1998) 12 F.Supp.2d 1287; Hawkins v. Leslie's Poolmart (D.N.J.1997) 965 F.Supp. 566; Kuiper v. American Cyanamid Co. (E.D.Wis.1997) 960 F.Supp. 1378; Koch v. Shell Oil Co. (D.Kan.1997) 173 F.R.D. 288; Ackerman v. American Cyanamid Co. (Iowa 1998) 586 N.W.2d 208; Ackles v. Luttrell (1997) 252 Neb. 273, 561 N.W.2d 573, cert. den. (1997) 522 U.S. 928, 118 S.Ct. 329, 139 L.Ed.2d 255; Didier v. Drexel Chemical Co. (1997) 86 Wash.App. 795, 938 P.2d 364; Lewis v. American Cyanamid Co. (1998) 155 N.J. 544, 715 A.2d 967; Sherman v. Claire Manufacturing Co. (N.Y.App.Div.1997) 239 A.D.2d 487, 657 N.Y.S.2d 453.) In Medtronic, supra, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700, the high court construed the preemption provision of the Medical Device Amendments of 1976. (21 U.S.C. § 360k(a)(MDA).) Section 360k(a) of title 21 of the United States Code provides that no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement [¶] (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and [¶] (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. The manufacturer argued, in essence, that the plain language of the statute preempts any and all common law claims brought by an injured plaintiff against a manufacturer of medical devices. ( Medtronic, supra, 518 U.S. at p. 486, 116 S.Ct. 2240.) Rejecting this sweeping interpretation of the statute, the plurality opinion held that § 360(k) simply was not intended to pre-empt most, let alone all, general common law duties enforced by damages actions. (518 U.S. at p. 491, 116 S.Ct. 2240.) Medtronic is distinguishable on the ground Congress gave the federal Food and Drug Administration (FDA) a unique role in determining the scope of preemption under the MDA. Unlike the statute construed in Cipollone, for instance, preemption under the MDA does not arise directly as a result of the enactment of the statute; rather, in most cases a state law will be pre-empted only to the extent that the FDA has promulgated a relevant federal `requirement.' ... Congress explicitly delegated to the FDA the authority to exempt state regulations from the preemptive effect of the MDAan authority that necessarily requires the FDA to assess the pre-emptive effect that the Act and its own regulations will have on state laws.... The ambiguity in the statute and the congressional grant of authority to the agency on the matter contained within itprovide a `sound basis,' ... for giving substantial weight to the agency's view of the statute.... [¶] The regulations promulgated by the FDA expressly support the conclusion that § 360k `does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.' ( Medtronic, supra, 518 U.S. at pp. 496-497, 116 S.Ct. 2240 (plur. opn. of Stevens, J.); see also id. at p. 506, 116 S.Ct. 2240 (cone. opn. of Breyer, J.) [emphasizing the FDA's exercise of its explicitly designated power to exempt state requirements from pre-emption].) Congress did not give the EPA an analogous role in implementing FIFRA. (See Oliver v. Reckitt & Colman, Inc., supra, 12 F.Supp.2d at p. 1291 [[T]he Court's decision in Medtronic was influenced by the authority given to the FDA, an authority not given to the EPA.]; Kuiper v. American Cyanamid Co., supra, 960 F.Supp. at p. 1384 [FIFRA does not have a corresponding federal regulation which limits its preemptive effect.... Such a regulation, along with the MDA's particular statutory language, was critical to the Court's opinion in Medtronic.].)