Reece v. Good Samaritan Hosp.

• Decision Date: 27 March 1998
• Docket Number: No. 20781-8-II,20781-8-II
• Citation: 90 Wn.App. 574,953 P.2d 117
• Court: Washington Court of Appeals
• Parties: , Prod.Liab.Rep. (CCH) P 15,237 Charlene K. REECE, individually and as Guardian Ad Litem for Chelsie I. Reece, a minor child, Appellant, v. GOOD SAMARITAN HOSPITAL, a Washington Corporation; Vernon J. Nessan, M.D., and "Jane Doe" Nessan, husband and wife, and the marital community comprised thereof; Thomas A. Barale, P.A., and "Jane Doe" Barale, husband and wife, and the marital community comprised thereof; Wayne E. Larson, M.D. and "Jane Doe" Larson, husband and wife and the marital community comprised thereof; "John Does" 1 through 4, M.D.'s, nurses, employees, agents of Good Samaritan Hospital, Defendants, Tambrands, Inc., a New York Corporation, Respondent.

Page 574

90 Wn.App. 574

953 P.2d 117, Prod.Liab.Rep. (CCH) P 15,237

Charlene K. REECE, individually and as Guardian Ad Litem for Chelsie I. Reece, a minor child, Appellant, v. GOOD SAMARITAN HOSPITAL, a Washington Corporation; Vernon J. Nessan, M.D., and "Jane Doe" Nessan, husband and wife and the marital community comprised thereof; Thomas A Barale, P.A., and "Jane Doe" Barale, husband and wife, and the marital community comprised thereof; Wayne E. Larson M.D. and "Jane Doe" Larson, husband and wife and the marital community comprised thereof; "John Does" 1 through 4 M.D.'s, nurses, employees, agents of Good Samaritan Hospital, Defendants, Tambrands, Inc., a New York Corporation, Respondent.

No. 20781-8-II.

Court of Appeals of Washington, Division 2.

March 27, 1998.

John S. Moceri, Manza, Moceri PS, Tacoma, for Appellant.

William L. Holder, Reed, McClure, Reed P. Schifferman, Lane, Powell, Spears, Lubersky, Seattle, for Defendants.

Ronald C. Gardner, Gardner, Bond, Trabolsi, Seattle, Roger E. Podesta, Debevoise & Plimpton, New York, NY, for Respondents.

John S. Moceri, Manza, Moceri PS, Tacoma, for Minor.

HUNT, Judge.

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

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

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 Wash.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

                law."   Tanner Elec., 128 Wash.2d at 668, 911 P.2d 1301 (citations omitted).  The trial court can be affirmed on any grounds supported by the record.  Syrovy v. Alpine Resources, Inc., 80 Wash.App. 50, 906 P.2d 377 (1995), review denied, 129 Wash.2d 1012, 917 P.2d 130 (1996)
                

B. Federal Preemption

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. 6]. 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.

Becker v. U.S. Marine Co., 88 Wash.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 In 1976 Congress enacted the Medical Device Amendments (MDA), granting the Food and Drug Administration (FDA), 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).

not consider whether preemption is implied. National Bank of Commerce v. Kimberly-Clark Corp., 38 F.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 Wash.App. 898, 903, 940 P.2d 1386 (1997) (citing Lohr, 518 U.S. at ----, 116 S.Ct. at 2250). ²

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.

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 Non-Regulation

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 Tambrands cannot establish federal preemption on these bases. See Becker, 88 Wash.App. at 110-11, 943 P.2d 700 (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 non-regulation" 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.

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.

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) and (d) (1997).

It has already been decided that "federal law preempts a state tort action based on the claims of inadequate warnings and instructions about the...