Source: http://openjurist.org/107/f3d/737/papike-v-tambrands-inc
Timestamp: 2015-08-29 00:36:43
Document Index: 719723357

Matched Legal Cases: ['§ 360', '§ 1332', '§ 1291', '§ 360', '§ 801', '§ 360', '§ 371', '§ 884', '§ 360', '§ 860', '§ 801', '§ 801']

107 F3d 737 Papike v. Tambrands Inc | OpenJurist
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107 F3d 737 Papike v. Tambrands Inc 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.
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.
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.
* 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.
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.
* 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;
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:
21 C.F.R.