National Bank of Commerce ex rel. Estate of Wilson v. Kimberly-Clark Corp.

38 F.3d 988, 1994 U.S. App. LEXIS 29616, 1994 WL 580798
CourtCourt of Appeals for the Eighth Circuit
DecidedOctober 25, 1994
DocketNo. 93-3012
StatusPublished
Cited by1 cases

This text of 38 F.3d 988 (National Bank of Commerce ex rel. Estate of Wilson v. Kimberly-Clark Corp.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Eighth Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
National Bank of Commerce ex rel. Estate of Wilson v. Kimberly-Clark Corp., 38 F.3d 988, 1994 U.S. App. LEXIS 29616, 1994 WL 580798 (8th Cir. 1994).

Opinions

HEANEY, Senior Circuit Judge.

Margaret Armón Wilson allegedly died as a result of toxic shock syndrome (TSS) caused by her use of tampons manufactured by Kimberly-Clark Corporation. The administrator of her estate, National Bank of Commerce of El Dorado, sued Kimberly-Clark for wrongful death, asserting that Kimberly-Clark failed to test, design, manufacture, and label its tampons adequately. Kimberly-Clark moved for summary judgment on the ground that all of these claims were preempted by the Medical Devices Amendments Act of 1976 (MDA), in which Congress delegated the regulation of medical devices to the Food and Drug Administration (FDA). The district court granted Kimberly-Clark’s motion and National Bank appeals.

I

The only question before the court is the scope of the MDA’s statutory preemption provision, codified at 21 U.S.C. § 360k(a), which 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—
[990]*990(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.

As the agency charged with administering the MDA, the FDA has issued an interpretive regulation that deals specifically with the question of preemption. See 21 C.F.R. § 808.1. Two sections of that regulation cast light on the issues presented by this ease. First, the FDÁ indicated that the statute was intended to preempt any state requirement “whether established by statute, ordinance, regulation, or court decision,” id. § 808.1(b); and second, such “State or local requirements are preempted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act....” Id. § 808.1(d).

Under the MDA, a medical device receives one of three classifications depending on the level of regulation or control deemed necessary to provide reasonable assurance of the safety and effectiveness of that device. Devices requiring the least regulation are placed in class I, and those requiring the most are placed in class III. See 21 U.S.C. § 360c. Tampons have been placed in class II, see 21 C.F.R. §§ 884.5460, 884.5470, which means that the FDA may impose “performance standards,” or may require, for example, “postmarket surveillance” or “patient registries.” 21 U.S.C. § 360c(a)(l)(B).

Beyond classifying tampons as class II medical devices, the FDA has issued only one regulation involving tampons. Under 21 C.F.R. § 801.430, tampons must be labeled in such a way as to inform consumers of (1) the dangers of TSS, (2) means by which women may avoid or reduce the risk of contracting tampon-associated TSS, and (3) the absorbency rating of the particular tampon as measured by a test method prescribed by the FDA. The FDA mandates only the content of the warning and, to some extent, its location on the packaging, but premarket approval of the actual design of the warning is not required.

II

Following the First Circuit decision in King v. Collagen Corp., 983 F.2d 1130 (1st Cir.) (“Collagen Corp.”), cert. denied, — U.S. —, 114 S.Ct. 84, 126 L.Ed.2d 52 (1993), the district court held that National Bank’s entire cause of action was preempted. See National Bank of Commerce of El Dorado v. Kimberly-Clark Corp., No. 91-1068, slip op. at 3 (W.D.Ark. July 16, 1993). National Bank argues that none of its cause of action is preempted because the FDA has only imposed minimum requirements on tampon labeling. If any of its claim is preempted, it argues, it can only be for failure to warn, and if so, only to the extent that any potential state law requiremént would exceed that imposed by the FDA.

It is clear to us, as it has been clear to every court that has published a decision on the issue, that to the extent National Bank’s claim against Kimberly-Clark seeks to impose any warning requirement beyond that imposed by 21 C.F.R. § 801.430, it is preempted by 21 U.S.C. § 360k(a). See Moore v. Kimberly-Clark Corp., 867 F.2d 243 (5th Cir.1989); Bejarano v. International-Playtex, Inc., 750 F.Supp. 443 (D.Idaho 1990); Krause v. Kimberly-Clark Corp., 749 F.Supp. 164 (W.D.Mich.1990); Northrip v. International Playtex, Inc., 750 F.Supp. 402 (W.D.Mo.1989); Lindquist v. Tambrands, Inc., 721 F.Supp. 1058 (D.Minn.1989); Cornelison v. Tambrands, Inc., 710 F.Supp. 706 (D.Minn.1989); Meyer v. International Playtex, Inc., 724 F.Supp. 288 (D.N.J.1988); Lavetter v. International Playtex, 706 F.Supp. 722 (D.Ariz.1988); Rinehart v. International Playtex, Inc., 688 F.Supp. 475 (S.D.Ind.1988); Edmondson v. International Playtex, Inc., 678 F.Supp. 1571 (N.D.Ga.1987); Stewart v. International Playtex, Inc., 672 F.Supp. 907 (D.S.C.1987); Poloney v. Tambrands, Inc., 260 Ga. 850, 412 S.E.2d 526 (1991); Lulov v. Tambrands, Inc., 198 A.D.2d 479, 604 N.Y.S.2d 206 (App.Div.1993); Berger v. Personal Prods., Inc., 115 Wash.2d 267, 797 P.2d 1148 (1990), cert. denied, 499 U.S. 961, 111 S.Ct. 1584, 113 L.Ed.2d 649 (1991). National Bank acknowledges the weight of these authorities, but argues that [991]*991these decisions reflect nothing more than a “follow the leader” mentality.1 In National Bank’s view, each of these decisions fails adequately to address its argument that the labeling requirements in 21 C.F.R. § 801.430 represent a floor rather than a ceiling; that the FDA has simply imposed the minimum requirements a manufacturer must meet, to which states may add additional requirements through their respective tort laws.

National Bank’s argument fails for two reasons. First, the “requirements” that section 360k(a) preempts include those imposed by state tort law. The FDA understands the statute to preempt state tort law, see 21 C.F.R. § 808.1(b), and its interpretation of a statute it administers is controlling so long as that interpretation is a reasonable one, as it is in this instance. See Chevron U.S.A., Inc. v.

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38 F.3d 988, 1994 U.S. App. LEXIS 29616, 1994 WL 580798, Counsel Stack Legal Research, https://law.counselstack.com/opinion/national-bank-of-commerce-ex-rel-estate-of-wilson-v-kimberly-clark-corp-ca8-1994.