Papike v. Tambrands Inc.

• Decision Date: 20 February 1997
• Docket Number: No. 95-55173,95-55173
• Citation: 107 F.3d 737
• Parties: , Prod.Liab.Rep. (CCH) P 14,875, 97 Cal. Daily Op. Serv. 1184, 97 Daily Journal D.A.R. 1789 Kandis L. PAPIKE, Plaintiff-Appellant, v. TAMBRANDS INC., Defendant-Appellee.
• Court: U.S. Court of Appeals — Ninth Circuit

Page 737

107 F.3d 737

65 USLW 2580, Prod.Liab.Rep. (CCH) P 14,875,

97 Cal. Daily Op. Serv. 1184,

97 Daily Journal D.A.R. 1789

Kandis L. PAPIKE, Plaintiff-Appellant, v. TAMBRANDS INC., Defendant-Appellee.

No. 95-55173.

United States Court of Appeals Ninth Circuit.

Argued and Submitted Oct. 8, 1996.

Decided Feb. 20, 1997.

Tom Riley, Charles C. Brown, Jr. and T. Todd Becker, Cedar Rapids, IA, for the plaintiff-appellant.

Roger E. Podesta, Debevoise & Plimpton, New York City, for the defendant-appellee.

Appeal from the United States District Court for the Central District of California, William J. Rea, District Judge, Presiding. D.C. No. CV-93-05114-WJR.

Before: O'SCANNLAIN, T.G. NELSON and HAWKINS, Circuit Judges.

T.G. NELSON, Circuit Judge:

Kandis Papike appeals from the district court's summary judgment dismissal of her diversity products liability action against Tambrands Inc. for injuries she sustained when she contracted Toxic Shock Syndrome ("TSS") while using Tampax Original Regular tampons. The primary issue on appeal is whether Papike's state law claim for failure to warn of the risk of TSS related to tampon use is preempted by the Medical Devices Amendments of 1976 ("MDA"), 90 Stat. 539 (codified as amended at 21 U.S.C. §§ 360, 360c-360l (Supp.1996)). We hold that the claim is preempted. We also hold that the district court properly concluded that Tambrands' warnings complied with federal requirements, and properly dismissed the design defect, negligence, breach of warranty, and punitive damages claims. We affirm the grant of summary judgment to Tambrands.

I

In this action Papike contends, inter alia, that Tampax tampons are defective because they contain viscose rayon; that Tambrands failed to adequately warn her about an established association between Tampax tampons and TSS; and failed to comply with federal requirements for TSS warnings. Papike's action was dismissed through a series of summary judgment rulings.

The district court agreed with Tambrands that "any state law causes of action for failure to warn are preempted by the comprehensive federal regulatory scheme covering tampons and TSS." The court found Tambrands' warnings, "which track the language of the federal regulations almost verbatim, constitute sufficient warning as a matter of law."

The design defect claim was later dismissed because it failed both the "consumer expectation" test and the "risk benefit" test under California law. The court concluded that the affidavit of Dr. Tierno, a microbiologist who has conducted TSS-related testing of tampons, failed to raise an issue of triable fact concerning a causal connection between Tampax Original Regular tampons and TSS.

The court later dismissed the complaint when it granted Tambrands' summary judgment motion on the remaining claims of negligence, breach of express and implied warranties, and punitive damages. The court denied Papike's motion for reconsideration, and she timely appeals. The district court had diversity jurisdiction under 28 U.S.C. § 1332. We have jurisdiction under 28 U.S.C. § 1291.

II

Our review of the district court's summary judgment order is de novo. Bagdadi v. Nazar, 84 F.3d 1194, 1197 (9th Cir.1996). In reviewing the court's order we must view the evidence in the light most favorable to Papike and determine whether there are any genuine issues of material fact and whether the court correctly applied the relevant substantive law. Id.

III

We first consider whether the preemption provision of the Medical Devices Amendments to the federal Food, Drug & Cosmetics Act, 21 U.S.C. § 360k(a), and the tampon labeling regulations promulgated thereunder, 21 C.F.R. § 801.430, preempt state tort law claims for failure to warn.

A

The Food and Drug Administration ("FDA") has broad powers under the MDA to classify and regulate medical devices. See 21 U.S.C. § 360c(b)-(f); 21 U.S.C. § 371(a). Tampons are "Class II" medical devices under the MDA. 21 C.F.R. §§ 884.5460, 884.5470 (1996). Use of Class II devices involves some risk of injury, so manufacturers of these devices must comply with federal regulations known as "special controls." 21 U.S.C. § 360c(a)(1)(B) (Supp.1996); 21 C.F.R. § 860.3(c)(2) (1996). The FDA has promulgated regulations concerning tampon labeling "[t]o protect the public and to minimize the serious adverse effects of TSS." 21 C.F.R. § 801.430(b). For example, a tampon manufacturer must label tampons with

the following consumer information prominently and legibly, in such terms as to render the information likely to be read and understood by the ordinary individual under customary conditions of purchase and use:

(1)(i) Warning signs of TSS, e.g., sudden fever (usually 102 [degrees] or more) and vomiting, diarrhea, fainting or near fainting when standing up, dizziness, or a rash that looks like a sunburn;

(ii) What to do if these or other signs of TSS appear, including the need to remove the tampon at once and seek medical attention immediately;

(2) The risk of TSS to all women using tampons during their menstrual period, especially the reported higher risks to women under 30 years of age and teenage girls, the estimated incidence of TSS of 1 to 17 per 100,000 menstruating women and girls per year, and the risk of death from contracting TSS;

(3) The advisability of using tampons with the minimum absorbency needed to control menstrual flow in order to reduce the risk of contracting TSS;

(4) Avoiding the risk of getting tampon-associated TSS by not using tampons, and reducing the risk of getting TSS by alternating tampon use with sanitary napkin use during menstrual periods; and

(5) The need to seek medical attention before again using tampons if TSS warning signs have occurred in the past, or if women have any questions about TSS or tampon use.

21 C.F.R. § 801.430(d). If this information is included as a package insert (rather than on the tampon box), an alert statement must be "prominently and legibly" placed on the package label:

ATTENTION: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare but serious disease that may cause death. Read and save the enclosed information.

21 C.F.R. § 801.430(c).

The MDA contains an express, but "highly ambiguous" provision for the preemption of state law. Medtronic, Inc. v. Lohr, --- U.S. ----, ----, 116 S.Ct. 2240, 2260, 135 L.Ed.2d 700 (1996) (Breyer, J., concurring in part and concurring in the judgment), which provides that:

[N]o 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) (1984) (emphasis added).

The FDA interprets this preemption provision in 21 C.F.R. § 808.1(d), which provides that:

State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements.

21 C.F.R. § 808.1(d) (1996) (emphasis added). Section 808.1(d)(1) provides that "State or local requirements of general applicability " are not preempted

where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.

21 C.F.R. § 808.1(d)(1) (1996) (emphasis added).

The Supreme Court "[has] long presumed that Congress does not cavalierly pre-empt state-law causes of action." Medtronic, --- U.S. at ----, 116 S.Ct. at 2250. "The purpose of Congress is the ultimate touchstone" in a preemption case. Retail Clerks Int'l Ass'n v. Schermerhorn, 375 U.S. 96, 103, 84 S.Ct. 219, 223, 11 L.Ed.2d 179 (1963).

B

In this case, the FDA has promulgated a regulation mandating the specific substantive content of the TSS warnings on tampon boxes and/or tampon package inserts. 21 C.F.R. § 801.430. The regulation is not only device-specific (tampons), but also disease-specific (TSS). This fact distinguishes Papike's case from prior relevant MDA preemption cases, including Medtronic, --- U.S. at ----, 116 S.Ct. at 2258 (general federal labeling and manufacturing requirements reflecting "important but entirely generic concerns about device regulation generally," not pacemakers specifically); Committee of Dental Amalgam Mfrs. and Distribs. v. Stratton, 92 F.3d 807, 812-13 (9th Cir.1996) (no specific FDA regulations relating to dental amalgam), cert. denied, --- U.S. ----, 117 S.Ct. 754, 136 L.Ed.2d 690 (1997); Kennedy v. Collagen Corp., 67 F.3d 1453, 1459 (9th Cir.1995) (premarket approval process for Class III devices is not a " 'specific requirement applicable to a particular device' "), cert. denied, --- U.S. ----, 116 S.Ct. 2579, 135 L.Ed.2d 1094 (1996); and Anguiano v. E.I. Du Pont De Nemours & Co., 44 F.3d 806, 809-10 (9th Cir.1995) (no specific FDA regulations regarding carbon material used in jaw implants).

In Medtronic, a divided Supreme Court addressed the extent to which state common-law claims of negligence and strict liability against the manufacturer of a failed pacemaker were preempted. --- U.S. at ----, ----, 116 S.Ct. at 2248, 2250. Significantly, the manufacturer contended that the plaintiff's claims were preempted by the FDA's "general 'good manufacturing practices' regulations, which establish general requirements for most steps in every device's manufacture, and by the FDA labeling regulations,...