CHARLENE K. REECE, Individually and as Guardian, Appellant, v. GOOD SAMARITAN HOSI'ITAL, ET AL., Defendants, TAMBRANDS, INC., Respondent.
[1] Appear- Disposition of Cause - Affirmance on Other Grounds - In General. An appellate court may affirm a judgment on any ground.- supported by the record.
[2] Statutes - Construction - Federal Statutes - Preemption of State Law - Actual Conflict. Under the Supremacy Clause of the United States Constitution, a state law that actually conflicts with a federal law is preempted by the federal law and has no effect.
[3] Constitutional Law - Police Power - Preemption by Federal Law - Test. Federal law does not preempt the State from legislating in a particular field under its historic police powers to provide for the health, safety, and welfare of its citizens unless preemption is clearly and manifestly intended by Congress.
[4] Statutes - Construction - Federal Statutes - Preemption of State Law - Defined Reach - Effect. When a federal statute expressly defines its preemptive reach, matters beyond that reach are not preempted.
[5] Statutes - Construction - Federal Statutes - Preemption of State Law - Undefined Reach - Effect. When the preemptive reach of a federal statute is not explicitly defined by Congress, the statutory context surrounding the statute's preemption clause and the purpose Congress sought to achieve by enacting the statute determine the extent, to which state law is prompted by the statute.
[6] Statutes - Construction - Federal Statutes - Preemption of State Law - Implicit Preemption - Absence of Express Preemption Language - Effect. In the absence of express language in a federal statute, a court will not consider whether the federal statute implicitly preempts a particular field.
[7] Statutes - Construction - Federal Statutes - Preemption of State Law - Presumption - Burden of Overcoming. A party claiming that federal law preempts state law in a field of regulation has I he burden of overcoming the presumption that the State s historic police powers are not to be superseded by federal law unless that is the clear and manifest purpose of Congress.
[8] Statutes - Construction - Federal Statutes - Preemption of State Law - Explicit Nonregulation - What Constitutes - Rejection of Regulatory Standard. For purposes of determining if federal law preempts state law in a field of regulation, a
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federal agency's rejection of a proposed regulatory standard does not necessarily constitute explicit nonregulation.
[9] Products Liability - Warnings - Instructions - Tampons - Toxic Shock Syndrome - Preemption of State Law. Under 21 U.S.C. § 360k(a), federal law preempts state tort action based upon claims of inadequate warnings and instructions about the risk of contracting toxic shock syndrome from using tampons, if the tampon manufacturer complies with federal labeling requirements of 21 C.F.R. § 801.430.
[10] Products Liability - Defect - Design - Tampons - Federal Regulation - Preemptive Effect. A state law tort claim against a tampon manufacturer alleging defective tampon design is not preempted by the federal government's regulation of tampon package labels and warnings and absorbency ratings (as codified at 21 C.F.R. § 801.430 (1997)).
[11] Products Liability - Tampons - Federal Regulation - Scope. The tampon regulations promulgated by the Federal Food and Drug Administration and codified at 21 C.F.R. § 801.430 (1997) do not govern the design and manufacture of tampons.
[12] Products Liability - Defect - Design - Tests. Manufacturer liability for defective product design is established by (1) proving that the likelihood and seriousness of harm by the product outweighs (a) the burden on the manufacturer to design a product that would have prevented the harm and (b) any adverse effect that an alternative design would have on the product's usefulness (the risk-utility test) or (2) showing that the product was unsafe to an extent beyond that which would reasonably be contemplated by the ordinary consumer (the consumer expectations test).
[13] Products Liability - Defect - Design - Consumer Expectations Test - Adequate Warnings - Effect. A design defect claim against a product manufacturer cannot be sustained under the "consumer expectations" test for liability if the manufacturer has adequately warned consumers of the risks associated with the product's use.
[14] Appeal - Assignments of Error - Argument - Authority - Necessity. An appellate court may decline to consider a claim or issue that is unsupported by clear argument or citation to authority
[15] Warranties - Express Warranties - Statement in Advertisement - Justifiable Reliance - Necessity. A product manufacturer's advertisement will not support a breach of express warranty claim unless the claimant demonstrates that a statement in the advertisement was justifiably relied on.
Nature of Action: A woman injured from using high
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absorbency tampons sought damages from the tampon manufacturer on theories of negligent or defective design, failure to warn, and breach of express and implied warranties.
Superior Court: The Superior Court for Pierce County, No. 93-2-12620-0, Terry D. Sebring, J., on May 13, 1996, entered a summary judgment dismissing the action.
Court of Appeals: Holding that federal law preempted the claim of failure to warn; that federal law did not preempt the claim of negligent or defective design; that the design defect claims were actionable under the "risk-utility" test of liability, but not the "consumer expectation" test; that the express warranty claim was not actionable; and that the implied warranty claim was not reviewable, the court affirms the judgment in part, reverses it in part, and remands the case for further proceedings.
John S. Moceri of Mama Moceri, P.S., for appellant.
Ronald C. Gardner of Gardner Bond Trabolsi (Roger E. Podesta of Debevoise & Plimpton, of counsel), for respondent.
HUNT, J. - Charlene Reece appeals summary judgment in favor of defendants Tambrands, Inc. Reece brought a products liability action after she used Tampax Super Plus Tampons and developed toxic shock syndrome (TSS), in December 1990. The trial court granted the defendants' motion for summary judgment on grounds that federal law preempts Reece's claims of "negligent or defective tampon design, to the extent such design claims are based on tampon absorbency or fiber composition." After the Court of Appeals denied discretionary review, the trial court
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granted Tambrands' motion for summary judgment and dismissed Reece's remaining claims that Tambrands violated express and implied warranties concerning its tampon. We reverse summary judgment on the design defect claim and affirm on the express warranty, implied warranty, and failure to warn claims.
I
FACTS
Reece developed TSS as a result of using Tambrands' "super plus" tampons. Both her feet and portions of all of her fingers and thumbs were amputated. She also suffered respiratory distress syndrome and acute renal failures, which necessitated dialysis.
II
ISSUES
1) Has the Federal Food and Drug Administration (FDA) regulated the design and manufacturing of tampons so as to preempt a state cause of action for negligent and defective tampon design and manufacturing?
2) Are Reece"s claims of breach of express and/or implied warranties preempted by federal regulation?
III
ANALYSIS
A. Standard of review
[1] When reviewing a summary judgment order, the appellate court engages in the same inquiry as the trial court and reviews the evidence de novo. Tanner Elec. Coop. v. Puget Sound Power & Light, 128 Wn.2d 656, 668, 911 P.2d 1301 (1996). A summary judgment motion should be granted if, after considering all the submissions and all reasonable inferences drawn therefrom in favor of the nonmoving party, there is no genuine issue of material fact and "the moving party is entitled to judgment as a matter of
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law." Tanner Elec., 128 Wn.2d at 668 (citations omitted). The trial court can be affirmed on any grounds supported by the record. Syrovy v. Alpine Resources, Inc., 80 Wn. App. 50, 906 P.2d 377 (1995), review denied, 129 Wn.2d 1012 (1996).
B. Federal Preemption
[2-7] Reece asserts that there is no FDA preemption of state product liability law for defective tampon design and manufacturing. She argues that such preemption is limited to warning and labeling requirements. Tambrands counters that Reece's defective design claims based on absorbency of Tampax Super Plus tampons, whether cast in terms of strict liability, negligence, or breach of implied warranty, are preempted by federal law.
The doctrine of preemption is rooted in the Supremacy Clause of the United States Constitution. [U.S. CONST. art. VI]. A state law is without effect when it conflicts with federal law. But the. historic police powers of states to provide for the health, safety, and welfare of their citizens are not preempted unless that is the clear and manifest purpose of Congress.
When Congress expressly defines the preemptive reach of a statute, matters beyond that reach are not preempted. When, as here, the reach of a preemptive federal law is not explicitly defined, it depends on the statutory context surrounding the preemption clause, and the purpose Congress sought to achieve by the statute.
Backer v. U.S. Marine Co., 88 Wn. App. 103, 107-08, 943 P.2d 700 (1997) (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S. Ct. 2240, 2250, 135 L. Ed. 2d 700 (1996); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516-17, 112 S. Ct. 2608, 2617, 120 L. Ed. 2d 407 (1992)) (footnote omitted).«1» In the absence of express statutory language, the court will
«1» See also 21 C.F.R. § 808.1(d); Berger v. Personal Prods., Inc., 115 Wn.2d 267, 273, 797 P.2d 1148 (1990) (citing Moore v. Kimberly-Clark Corp., 867 F.2d 243, 244-45 (5th Cir. 1989); National Bank of Commerce v. Kimberly-Clark Corp., 38 F.3d 988, 997 (8th Cir. 1994)) (state or local "requirements" are preempted only when the FDA has specifically regulated a particular device).
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not consider whether preemption is implied. National Bank of Commerce L: Kimberly-Clark Corp., 38 P.3d 988, 991 (8th Cir. 1994). The party claiming federal preemption bears a heavy burden of overcoming "the presumption that the historic police powers of the states are not to be superseded by federal law unless that is the clear and manifest purpose of Congress." Wutzke v. Schwaegler, 86 Wn. App. 898, 903, 940 P.2d 1386 (1997) (citing Lohr, 116 S. Ct. at 2250).«2»
In 1976 Congress enacted the Medical Device Amendments (MDA), granting the Food and Drug Administration power to regulate all medical devices intended for human use. 21 U.S.C. § 360c-k (1994). There are three classes of medical devices under the MDA, of which Tampons are a Class II. 21 C.F.R. §§ 884.5460, 884.5470 (1996). A Class II medical device is one that poses some risk of injury to the user, so the manufacturers of these devices must comply with federal performance regulations known as "special controls." 21 U.S.C. § 360c(a)(1)(B) (1994) (as amended in 1990).
Section 360k(a) of the MDA provides:
(a) General rule
Except as provided in subsection (b) of this section, 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.
«2» See also the newly proposed FDA rule on federal preemption regarding state and local requirements applicable to medical devices:
This action is being taken to clarify and codify the agency's longstanding position that available legal remedies, including State common law tort claims, generally are not preempted under the Federal Food, Drug, and Cosmetic Act
. . . .
Medical Devices; Preemption of State Product Liability Claims, 62 Fed. Reg. 65,384 (1997) (to be codified at 21 C.F.R. pt. 808).
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21 U.S.C. § 360k(a) (1994). The question here is what "requirements," if any, has the federal government established with respect to tampon manufacture and sale.
1. Explicit Nonregulation
Tambrands argues that the FDA studied tampon absorbency and specifically declined to set minimum or maximum limits, choosing instead to inform consumers of the relative risks and allow them to decide for themselves how to balance the enhanced convenience of higher absorbency against the greater risk of TSS. Although the C.F.R. demonstrates that the FDA undertook various studies to test for absorbency ratings, there is no conclusive indication that the FDA considered and rejected regulating the design and manufacture of tampons. Menstrual Tampons; User Labeling, 47 Fed. Reg. 26,982, 26,984 (1982) (to be codified at 21 C.F.R. pt. 801) notes as follows:
FDA has determined that absorbency is not a basis upon which to exclude any style or brand of tampon from the requirements of the final rule. Nonetheless, because the risk of TSS appears to decrease as tampon absorbency decreases, the final rule requires that product labeling advise women to use tampons with the minimum absorbency needed to control menstrual flow.
. . . Even if tampons with a particular fiber, ingredient, material, design, construction, or functional characteristic were shown to exhibit significantly dissimilar risk characteristics and consumers could identify those tampons from product labeling, application of the final rule to them would still be necessary to protect the public health and minimize the serious effects of TSS because all tampons are associated with TSS.
The report goes on to note that one study has found a detectable association between TSS and tampon absorbency. 47 Fed. Reg. at 26,984. The FDA apparently also considered, but rejected, reclassification of tampons from class II to class III. Even in successive years, the focus remained on standardizing absorbency and package labeling. As indicated in the September 23, 1988, Federal Register, vol. 53,
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no. 185, the FDA did not seek to set upper and lower absorbency limits on tampons. Rather the FDA presumed that no one would manufacture a tampon with absorbency below four grams because of its ineffectiveness. The FDA also did not expect manufacturers to exceed 18 grams, but mentioned creating a new absorbency range "F" if such a product were produced.
[8] Tambrands cannot establish federal preemption on these bases. See Becker, 88 Wn. App. at 110-11 (noting that a federal agency's "formal consideration and rejection of a proposed regulation will preempt state tort claims as the feature or structure considered," but finding no history or sufficient evidence in that case to prove "explicit nonregulation" by the federal government). The FDA has not engaged in "explicit non-regulation" of tampon design or upper limits of absorbency, other than establishing a standardized absorbency rating and labeling system.
2. Warning Labels
In 1982, the FDA determined that in order "[t]o protect the public and to minimize the serious adverse effects of TSS, menstrual tampons shall be labeled"«3» to inform the public of the statistical risk of developing TSS, the warning signs of the disease, and the need to seek medical attention if symptoms occur. 21 C.F.R. § 801.430(b), (d) (1997).
[9] It has already been decided that "federal law preempts a state tort action based on the claims of inade