Kаndis 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 (сodified as amended at 21 U.S.C. §§ 360, 360c-360i (Supp.1996)). We hold that the claim is preempted. We also hold that the district court properly concluded that Tam-brands’ 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 contаin 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 rеgulatory scheme covering tampons and TSS.” The court found Tam-brands’ 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 cоnducted 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 recоnsideration, 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.
*845 II
Our review of the district court’s summary judgment order is
de novo. Bagdadi v. Nazar,
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 somе risk of injury, so manufacturers of these devices must comply with federal regulations known as “special controls.” 21 U.S.C. § 360c(a)(l)(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 rendеr the information likely to be read and understood by the ordinary individual under customary conditions of purchase and use:
(l)(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” plaсed 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. —,—,
[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
*844 (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 рrovides 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 cоdes, 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—,
B
In this ease, the FDA has promulgated a regulation mandating the sрecific 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 eases, including
Medtronic,
— U.S. at — ,
In
Medtronic,
a divided Supreme Court addressed the extent to which state common-law claims of negligеnce and strict liability against the manufacturer of a failed pacemaker were preempted. — U.S. at —,—,
The Justices were unanimous in
Medtronic
in holding that there can be no preemption
*843
under the MDA unless there is an FDA regulation that is in some manner applicable to the device.
Id.
at—,—,
Unlike the general federal requirements in
Medtronic,
the warning requirements here reflect “the sort of concerns regarding a specific device or field of device regulation which the ... regulations were designed to protect from potentially contradictoiy state requiremеnts.”
See Medtronic,
— U.S. at —,
Papike contends that the tampon labeling regulation is too general to warrant preemption because it allows tampon manufacturers “broad latitude in the wording, style, and placement of the consumer information.” We disagree. Although the regulation provides some flexibility to the manufacturer, it mandates the specific substantive content of the TSS warning. Preemption results in this case because the FDA has еstablished specific counterpart regulations with respect to labeling tampons.
See
21 C.F.R. § 808.1(d).
Accord, Medtronic,
— U.S. at—, —,
That the state “requirement” in this case arises out of a state common-law cause of action for failure to warn, rather than a specific state statute, does not save Papike’s claim from preemption. The plurality in
Medtronic
stops short of declaring that common law duties are never “requirements” under § 360k, finding it unnecessary to reach this issue.
Id.
at—-—,
We must next consider whether Papike’s warning claim is saved from preemption because it arises under “generally applicable” principles of state tort law.
See
21 C.F.R. § 808.1(d)(1). Papike contends that we must look not only at the specificity of the federal requirements, but also at whether or not the state lаw being preempted was “specifically developed ‘with respect to’ medical devices.”
See Medtronic,
— U.S. at—,
escape pre-emption, not because the source of the duty is a judge-made common-law rule, but because their generality *842 leaves them outside the category of requirements that § 360k envisioned to be “with respect to” specific devices such as pacemakers.
Id.
Although Justice Breyer joined in Section V, a fair reading of that Section and of Justice Breyer’s separate opinion does not support Papike’s claim that tampon manufacturers must comply both with FDA labeling requirements and state common-law labeling duties. In Section V, the Court evaluates the specificity of the general state common-lаw requirements, but only after concluding that the federal labeling and manufacturing requirements at issue were not specific to pacemakers.
Id.; see also id.
at—,
As counsel for Tambrands pointed out at oral argument, it makes little sense to argue that Justice Breyer would write separately to make clear his position that duties arising under state common law can constitute state law “requirements” which can be preempted by the MDA, and then agree that because tort law consists of generally applicable рrinciples, it is always preempted, even in the face of specific federal requirements. Instead, in
Medtronic
Justice Breyer found “no actual conflict between any federal requirement and any of the liability-ereating-premis-es of the plaintiffs’ state law tort suit.”
Id.
at —,
In summary, preemption is triggered by and “the scopе of preemption is limited to instances where there are specific FDA requirements applicable to a particular device.”
Anguiano,
IV
We next consider Papike’s claim that the district court erred when it concluded that Tambrands’ warnings were sufficient under federal law. She contends that , a jury could find that the warnings here violated 21 U.S.C. § 352(c) (general misbranding statute addressing prominence of label information), 21 C.F.R. § 801.15(a) (general regulation addressing prominence of label statements on *841 medical devices), and the specific tampon labeling regulation, 21 C.F.R. § 801.430.
We find no error. First, Tambrands’ warnings comply with the tampon labeling regulation. The alert statement on the package complies with § 801.430(c), including the prominence requirement.
See Lindquist v. Tambrands, Inc.,
Second, arguing that the more general statute and regulation on “prominenсe” of medical device warnings could require something else or something additional does not create a material issue of fact sufficient to preclude summary judgment in the face of compliance with the specific tampon labeling requirements.
See, e.g., Beecher v. Tambrands, Inc.,
V
We next consider Papike’s argument that the district court erred in dismissing her design defect claim. She contends thаt the Tampax Original Regular tampon was defectively designed because it contains a layer of viscose rayon, which she alleges amplifies toxin production. Under California law, a product is defectively designed if it fails to meet an ordinary consumer’s expectations, or if injury is attributable to a specific design feature of the product and the risks associated with the design outweigh its benefits.
Barker v. Lull Eng’g Co.,
Tambrands’ warnings met the federal requirements and Papike’s design defect claim therefore fails the “consumer expectation” test. To rule otherwise would allow the anomalous circumstance that a consumer is entitled to expect a product to perform mоre safely than its government-mandated warnings indicate.
The district court properly concluded that Tambrands established the benefits of their tampon’s design outweighed the risks inherent in the design. We disagree with Papike’s contention that in evaluating the “risk-benefit” test, the district court improperly weighed the evidence when it rejected the affidavit of Dr. Tierno, a microbiologist who has conducted tampon/TSS testing.
The district court properly determined that the Tiemo affidavit was insufficient to preclude summary judgment because his test results do not establish a causal connection between the composition of Tampax Original Regular tampons and TSS. As the court observed, Dr. Tierno’s research in part supported Tambrands’ position, because his 1985 tests detected no toxin with the Tampax Original Regular tampon (the same result he obtained with his 100 percent cotton control). Dr. Tiemo’s affidavit was simply insufficient to meet Papike’s burden of establishing a design defect. The district court’s rejection of the affidavit was not an invasion of the province of the jury, but rather part of the district court’s duty to evaluate Papike’s showing of the existence of some significant probative evidence.
See Anderson v. Liberty Lobby, Inc., 477
U.S. 242, 249,
VI
Lastly, we consider Papike’s claim that the district сourt erred in dismissing her remaining claims of negligence, breach of express and implied warranties, and for punitive damages. Papike alleged negligence based on inadequate warning and defective design. She does not allege negligent manufacture. The district court properly dismissed the failure to warn claims based on
*840
state and federal law. The court also properly ruled that Papike fadеd to meet the “consumer expectations” test for her design defect claim. The court explained that because the “consumer expectations” strict liability test is synonymous with the “reasonableness” test in negligence claims, Papike’s negligent design claim must also fail.
See Barker,
The court also properly found that the legally-adequate warnings, which give notice to consumers of the possibility of contracting TSS, foreclosed Papike’s claims for breach of warranty.
See Temple v. Velcro USA Inc.,
VII
The judgment of the district court is affirmed.
AFFIRMED.