Court Opinion

ID: 9410442
Source: CourtListenerOpinion
Date Created: 2023-07-21 14:00:55.328561+00
Date Added: 2024-06-11T17:20:57.701165
License: Public Domain

USCA11 Case: 21-12085    Document: 35-1      Date Filed: 07/21/2023   Page: 1 of 22

                                                            [PUBLISH]
                                    In the
                 United States Court of Appeals
                         For the Eleventh Circuit

                           ____________________

                                 No. 21-12085
                           ____________________

        TERRANCE NELSON CATES,
                                                       Plaintiﬀ-Appellant,
        versus
        ZELTIQ AESTHETICS, INC.,

                                                     Defendant-Appellee.

                           ____________________

                  Appeal from the United States District Court
                       for the Middle District of Florida
                   D.C. Docket No. 6:19-cv-01670-PGB-LRH
                           ____________________

        Before ROSENBAUM, BRANCH, and BRASHER, Circuit Judges.
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        2                      Opinion of the Court                 21-12085

        BRASHER, Circuit Judge:
               This appeal arises from a dispute about CoolSculpting, a
        medical device intended to minimize the appearance of fat. When
        Terrance Cates tried CoolSculpting, he developed a rare condition
        called Paradoxical Adipose Hyperplasia (“PAH”), which enlarges
        the targeted fat tissue. Needless to say, Cates was unhappy that
        CoolSculpting maximized the fat he wanted to minimize. So Cates
        sued Zeltiq Aesthetics, Inc., the manufacturer of the CoolSculpting
        system, for failure to warn and design defect under Florida law.
               The district court granted Zeltiq summary judgment. On
        failure to warn, the district court concluded that Zeltiq’s warnings
        about PAH were adequate as a matter of law. On design defect, the
        court determined that Cates failed to provide expert testimony that
        the risk of CoolSculpting outweighed its utility. Cates challenges
        both of the district court’s rulings on appeal.
                As to his failure to warn claim, Cates argues Zeltiq’s warn-
        ings were legally inadequate because they did not demonstrate the
        severity of PAH. We disagree. Zeltiq warned medical providers in
        its user manual and training sessions about the exact condition
        Cates experienced: PAH is an increase of adipose tissue in the treat-
        ment area that may require surgery to correct. Accordingly, the
        district court properly concluded Zeltiq’s warnings were adequate
        as a matter of law.
                As to his design defect claim, Cates argues the district court
        should have applied the consumer expectations test, not the risk-
        utility test, under Florida law. We are convinced that Cates’s design
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        21-12085               Opinion of the Court                        3

        defect claim fails under either test. So we need not decide which
        Florida-law test applies to a design defect claim about a medical
        device like CoolSculpting.
              After reviewing the record, and with the benefit of oral ar-
        gument, we cannot conclude that the district court erred in grant-
        ing summary judgment to Zeltiq. Accordingly, we affirm.
                                       I.

                                       A.

               CoolSculpting is a medical device that purports to freeze
        away fat without surgery. Zeltiq, the manufacturer of the
        CoolSculpting system, cleared its product with the FDA as a Class
        II prescription medical device in 2010. As a Class II medical device,
        CoolSculpting is sold to companies with a physician or medical di-
        rector, not directly to consumers. Even so, Zeltiq advertises its
        product to consumers, and many consumers frequent dermatology
        offices, plastic surgery offices, and medical spas specifically for
        CoolSculpting services.
                CoolSculpting works through “cryolipolysis”: applying cold
        applicators to the body to induce “lipolysis” or the breakdown of
        fat cells. Medical providers apply the device to the patient’s target
        areas, such as the lower stomach and hips, in applications or “cy-
        cles.” When CoolSculpting is effective, it minimizes the appear-
        ance of fat that may not otherwise respond to diet or exercise. But
        in rare instances, patients develop PAH in the months following
        CoolSculpting. PAH produces the opposite of the intended result—
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        4                      Opinion of the Court                 21-12085

        visibly enlarged tissue volume in the treatment areas. The condi-
        tion gets its name from the “paradoxical” result of fat cells (adipose
        tissue) growing (hyperplasia) rather than shrinking. Patients who
        develop PAH often require liposuction or other surgery.
               PAH is exactly what happened to Terrance Cates. In Febru-
        ary 2018, Cates visited a medical spa in Orlando, Florida to receive
        CoolSculpting. Isis Bucci—an advanced registered nurse practi-
        tioner authorized to perform CoolSculpting under the supervision
        of Dr. Ayyaz Shaha—administered eight cycles of CoolSculpting to
        Cates. He received four cycles to his lower stomach and two on
        each hip. Cates returned in May 2018 for two more cycles to each
        hip. Then in July, Cates noticed a mass forming in his lower stom-
        ach. Cates returned to the medical spa in October, where Dr. Shaha
        diagnosed Cates with PAH.
                After the diagnosis, additional masses formed on both of
        Cates’s hips. Cates consulted two plastic surgeons, both of whom
        confirmed he had PAH. Dr. Max Polo described Cates’s condition
        as mild “subcutaneous adiposity” or fat residing under the skin
        where he received CoolSculpting treatments and “bulging contour
        with slightly firm fat on palpitation.” Similarly, Dr. Gregory Neil
        described Cates’s PAH as three “well-defined masses” of “hyper-
        plastic fat.” Both surgeons recommended liposuction.
               Cates contends Nurse Practitioner Bucci never explained to
        him the risk of PAH before administering his CoolSculpting treat-
        ments. In fact, Nurse Practitioner Bucci later testified in a deposi-
        tion that she believed patients who did not assiduously follow post-
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        21-12085                  Opinion of the Court                                5

        treatment procedures had “more chance” of developing PAH.
        Even so, Nurse Practitioner Bucci knew that PAH was a possible
        side effect of CoolSculpting that may require surgery to correct.
        She recounted that a coworker of hers developed PAH after a
        CoolSculpting procedure before Cates’s CoolSculpting procedure.
        And according to Nurse Practitioner Bucci, that coworker required
        plastic surgery to correct the problem. Still, Nurse Practitioner
        Bucci deemed PAH “rare,” given that it had occurred a handful of
        times in the 2,000 to 4,000 CoolSculpting procedures she had per-
        formed.
               For his part, Cates signed a CoolSculpting consent form
        warning about the risk of PAH. 1 That form described PAH as a
        “rare side effect” consisting of “an enlargement of fat in the service
        area of varying size and shape,” which “may occur in the months
        to year following the treatment.” The consent form added that
        PAH is “unlikely [to] resolve on its own” but “can be removed
        through liposuction or related surgery.”
                Zeltiq also warns healthcare providers that administer
        CoolSculpting cycles about PAH. Under “Rare Adverse Events” in
        its CoolSculpting manual, Zeltiq includes, “Paradoxical hyper-
        plasia: Visibly enlarged tissue volume within the treatment area,
        which may develop two to five months after treatment. Surgical

        1 Cates alleged that he was not given the consent form until thirty-five minutes
        into his first two of eight CoolSculpting procedures. Even assuming this to be
        true, as we must, that means he still voluntarily underwent several more
        CoolSculpting procedures after signing the consent form.
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        6                       Opinion of the Court                  21-12085

        intervention may be required.” Zeltiq also conducts training ses-
        sions that incorporate a slide on PAH. That slide describes PAH as
        “[l]ocal increases in subcutaneous adipose tissue” that “[p]resents
        as a demarcated border between treated and non treated area.” The
        training describes the “affected tissue” as “firm compared to non
        treated [sic] tissue” and concedes that “[t]here is no evidence of
        spontaneous resolution of PAH and surgical intervention may be
        required.”
                                        B.

                Cates sued Zeltiq, asserting five claims: (1) strict product li-
        ability based on failure to warn, (2) strict product liability based on
        design defect, (3) negligence, (4) negligent misrepresentation, and
        (5) fraudulent misrepresentation and concealment. Zeltiq sought
        summary judgment on all claims, which the district court granted.
                First, the court dismissed Cates’s failure to warn claim be-
        cause Zeltiq “provided accurate, clear, and unambiguous warnings
        of the exact injury [Cates] experienced . . . sufficient to educate a
        reasonable CoolSculpting provider that the procedure carries the
        risk of patients developing permanent, visibly enlarge, hardened
        tissue in the treatment area.”
              Second, for Cates’s design defect claim, the district court de-
        termined that Florida’s “consumer expectations test” (which asks
        what a reasonable consumer would expect) did not govern the
        claim because the CoolSculpting device “is a complex medical de-
        vice available to an ordinary consumer only as an incident to a
        medical procedure.” Cavanaugh v. Stryker Corp., 308 So. 3d 149, 156
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        21-12085               Opinion of the Court                        7

        (Fla. 4th DCA 2020). Instead, it concluded that the risk utility test
        (which asks whether the risk of a design outweighs its utility) ap-
        plied. And given that Cates’s experts gave no opinion about the de-
        vice’s risk or utility, the court dismissed the claim. Alternatively,
        the court concluded that, even if the consumer expectations test
        applied, summary judgment for Zeltiq was proper because Cates
        provided no expert testimony that the CoolSculpting device was
        defective.
              Third, the court dismissed Cates’s remaining three claims as
        “simply repurposed failure-to-warn” arguments. Consequently,
        the court entered a final judgment for Zeltiq.
              Cates timely appealed.
                                       II.

               “We review a district judge’s granting summary judgment
        de novo.” Chapman v. Procter & Gamble Distrib., LLC, 766 F.3d 1296,
        1312 (11th Cir. 2014). Summary judgment is proper when “there is
        no genuine dispute as to any material fact and the movant is enti-
        tled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). When
        the plaintiff fails to provide “a sufficient showing to establish the
        existence of an element” of his claim, “there is no genuine dispute
        regarding a material fact.” Chapman, 766 F.3d at 1312 (internal quo-
        tation omitted). We may “affirm a grant of summary judgment on
        any alternative ground fairly supported by the record.” Rozar v.
        Mullis, 85 F.3d 556, 564 (11th Cir. 1996). In this diversity action,
        Florida law applies. See Salinero v. Johnson & Johnson, 995 F.3d 959,
        964 (11th Cir. 2021).
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        8                      Opinion of the Court                 21-12085

                                       III.

              Cates argues that the district court erred in granting sum-
        mary judgment on his failure to warn and design defect claims. We
        take up each claim in turn.
                                       A.

                A failure to warn claim under Florida law requires a plaintiff
        to demonstrate “(1) that the product warning was inadequate; (2)
        the inadequacy proximately caused [his] injury; and (3) that [he] in
        fact suffered an injury from using the product.” Eghnayem v. Bos.
        Sci. Corp., 873 F.3d 1304, 1321 (11th Cir. 2017) (citing Hoffmann-La
        Roche Inc. v. Mason, 27 So. 3d 75, 77 (Fla. 1st DCA 2009)). Zeltiq
        argues, and the district court held, that Cates’s claim fails on the
        first element. Cates argues there is a genuine dispute of material
        fact as to the adequacy of Zeltiq’s PAH warnings. We agree with
        the district court that Zeltiq’s warnings are legally adequate.
               We must first address whom a product manufacturer must
        warn. In cases involving medical devices like CoolSculpting, the
        device manufacturer has a duty to warn “the physician who pre-
        scribes the device.” Salinero, 995 F.3d at 964 (quoting Buckner v. Al-
        lergan Pharms., Inc., 400 So. 2d 820, 823 (Fla. 5th DCA 1981) (cleaned
        up)). The duty is owed, not to the consumer, but to the physician
        or medical professional because the medical professional is a
        “learned intermediary.” See id. Under Florida’s learned intermedi-
        ary doctrine, a learned intermediary is one who weighs “the poten-
        tial benefits of a device against the dangers in deciding whether to
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        21-12085               Opinion of the Court                          9

        recommend it to meet the patient’s needs.” Eghnayem, 873 F.3d at
        1321 (citing Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102, 104 (Fla.
        1989)).
                The question becomes, therefore, whether Zeltiq’s warn-
        ings were legally adequate to warn the medical professionals who
        administer CoolSculpting about PAH. “While in many instances
        the adequacy of warnings . . . is a question of fact,” the Florida Su-
        preme Court held that this question can be resolved as “a question
        of law where the warning is accurate, clear, and unambiguous.”
        Felix, 540 So. 2d at 105. A warning is adequate as a matter of law
        when it “make[s] apparent the potential harmful consequences” of
        the product. Farias v. Mr. Heater, Inc., 684 F.3d 1231, 1233 (11th Cir.
        2012) (quoting Scheman–Gonzalez v. Saber Mfg. Co., 816 So. 2d 1133,
        1139 (Fla. 4th DCA 2002)). Warning the learned intermediary is
        “somewhat easier” than warning consumers given that the warn-
        ing “will be read and considered by a trained expert.” Eghnayem,
        873 F.3d at 1321−22 (quoting Hayes v. Spartan Chem. Co., 622 So. 2d
        1352, 1354 (Fla. 2nd DCA 1993)).
                To conduct this inquiry, we put ourselves in the shoes of a
        “reasonable person,” setting aside any individual’s “subjective ap-
        preciation of the danger.” Id. at 1233–34 (internal quotation omit-
        ted). In Upjohn Company v. MacMurdo, for instance, the Florida Su-
        preme Court determined a product label for contraception was ad-
        equate as a matter of law when it put a reasonable medical profes-
        sional on notice for the symptoms experienced by the plaintiff—
        abnormal bleeding. 562 So. 2d 680, 683 (Fla. 1990). The warning
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        10                     Opinion of the Court                  21-12085

        did not require greater specificity (i.e., that bleeding may be “exces-
        sive, continuous or prolonged”), in part, because medical literature
        did not support such a characterization. Id. at 683 n.4.
                With this background in mind, we ask whether Zeltiq’s
        warnings were objectively “accurate, clear, and unambiguous,” see
        Felix, 540 So. 2d at 105, to warn medical professionals about the
        “apparent potential harmful consequences” of PAH, Farias, 684
        F.3d at 1234. The answer is “yes.”
               Zeltiq warned medical professionals about PAH and its po-
        tential consequences in both its CoolSculpting user manual and its
        training session materials. The manual warned that CoolSculpting
        carried the risk of a “Rare Adverse Event[]” of “Paradoxical hyper-
        plasia,” which it defined as “[v]isibly enlarged tissue volume within
        the treatment area, which may develop two to five months after
        treatment.” The manual also warns, “[s]urgical intervention may
        be required,” which is the exact consequence Cates now faces.
        Zeltiq’s training presentation similarly included a slide on PAH, de-
        scribing it as “[l]ocal increases in subcutaneous adipose tissue” that
        “[p]resents a demarcated border between treated and non treated
        area” and is “firm compared to non treated [sic] tissue.” Again,
        Zeltiq warned of the possibility that “surgical intervention may be
        required.” Therefore, Zeltiq’s warnings accurately, clearly, and un-
        ambiguously describe PAH and its consequences. See Felix, 540 So.
        2d at 105; Farias, 684 F.3d at 1233.
              Cates argues that the warnings about PAH were insufficient
        for two reasons: (1) the warnings fail to accurately reflect the
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        21-12085                   Opinion of the Court                                11

        “severity of the risk,” and (2) the warnings were insufficient to
        warn Nurse Practitioner Bucci given her alleged misunderstanding
        of PAH. We disagree.
                First, Cates asserts that Zeltiq’s warnings failed to alert med-
        ical providers about the severity of PAH because PAH is not “a
        mere increase in fat cells.” Cates posits that PAH “is fibroplasia” or
        firm, scar-like tissue. But here, as in Upjohn, there is hardly any sup-
        port in the record that PAH “is fibroplasia.” See Upjohn Co., 562 So.
        2d at 683 n.4. In fact, none of the five medical articles Cates prof-
        fered to oppose summary judgment link CoolSculpting to fibropla-
        sia or suggest that fibroplasia causes PAH.2 On this record, we see

        2 See Scott A. Seaman et al., Paradoxical Adipose Hyperplasia and Cellular Effects
        after Cryolipolysis: A Case Report, 36(1) AESTHETIC SURGERY J. 6, 7 (2016) (“The
        precise pathogenesis of PAH”—or the manner of development—“is not well
        understood.”); Selina M. Singh et al., Paradoxical Adipose Hyperplasia Secondary
        to Cryolipolysis: An Underreported Entity?, 47 LASERS IN SURGERY & MED. 476, 478
        (2015) (“The etiology of paradoxical adipose hyperplasia is unknown.”); Mis-
        bah Khan, Complications of Cryolipolysis: Paradoxical Adipose Hyperplasia (PAH)
        and Beyond, AESTHETIC SURGERY J. 6−7 (2018) (“Although the exact pathophys-
        iology of the formation of PAH remains a mystery, a multi-factorial etiology
        has been speculated: hypertrophy of the preexisting adipocytes in response to
        cold injury, tissue hypoxia, reduction in sympathetic innervation, recruitment
        of preadipocytes, and/or stem cell population.”); Derek Ho & Jared Jagdeo, A
        Systematic Review of Paradoxical Adipose Hyperplasia (PAH) Post-Cryolipolysis,
        16(1) J. OF DRUGS IN DERM. 62, 64 (2017) (“The exact pathoetiology of PAH
        remains to be elucidated, but researchers have proposed several mechanisms
        of PAH development.”); Michael E. Kelly et al., Treatment of Paradoxical Adi-
        pose Hyperplasia following Cryolipolysis: A Single-Center Experience, PLASTIC AND
        RECONSTRUCTIVE SURGERY 17e−22e (July 2018) (refraining from addressing
        the cause of PAH).
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        12                        Opinion of the Court                      21-12085

        no legally significant distinction between a warning about PAH,
        which Zeltiq provided, and a warning about fibroplasia, which
        Zeltiq did not provide.
                Moreover, after Cates’s initial PAH diagnosis, he visited two
        plastic surgeons who did not diagnose him with fibroplasia, but in-
        stead, described Cates’s masses as “subcutaneous adiposity” and
        “hyperplastic fat.” And both recommended liposuction to remove
        the masses. In other words, both doctors concluded that Cates’s
        masses were fat cells 3 and recommended liposuction to resolve the
        problem. Zeltiq’s warnings were, thus, legally sufficient as directed
        to trained medical professionals to warn about the condition Cates
        experienced. See Eghnayem, 873 F.3d at 1321−22; accord Felix, 540
        So. 2d at 105 (determining, “as to physicians, the warnings concern-
        ing the dangerous side effects” were “quite clear,” even if the aver-
        age consumer would not fully appreciate them).
                Second, Cates argues that Zeltiq’s warnings were inade-
        quate to inform Nurse Practitioner Bucci, specifically, about the
        risk of PAH. In her deposition, Nurse Practitioner Bucci incorrectly
        attributed PAH to CoolSculpting patients’ failure to adhere to post-
        treatment procedures. Cates relies on the principle that “a manu-
        facturer may not be reasonable in relying on an intermediary” if it

        3 “Adiposity refers to the amount of adipose (fat) tissue in the body.” José M.
        Luchsinger, M.D. M.P.H., & Deborah R. Gustafson, M.S. Ph.D., Adiposity and
        Alzheimer’s Disease, Curr. Opin. Clin. Nutr. Metab. Care, Jan. 2009,
        https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2771208/.
        [https://perma.cc/5USW-4CZ4].
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        21-12085               Opinion of the Court                         13

        “did not adequately convey the danger to the intermediary or take
        steps to ensure that the intermediary would adequately warn the
        end user.” Aubin v. Union Carbide Corp., 177 So. 3d 489, 515 (Fla.
        2015). Cates contends that Nurse Practitioner Bucci’s misunder-
        standing about PAH is evidence that Zeltiq’s warnings were inade-
        quate to fully convey to her the danger of PAH.
               But Nurse Practitioner Bucci’s “subjective appreciation of
        the danger” is not dispositive to the adequacy of the warning. Far-
        ias, 684 F.3d at 1233–34 (internal quotation omitted). Whether the
        warning is legally adequate is based on the “reasonable person” or,
        here, the reasonable medical provider. Id. at 1233. And nothing in
        Zeltiq’s user manual or training session materials suggests that
        PAH develops when patients fail to adhere to post-CoolSculpting
        protocols.
               To be sure, whether the individual medical provider subjec-
        tively “fully understood” a warning is relevant to the element of
        proximate cause. See Felix, 540 So. 2d at 105. For example, if the med-
        ical professional testifies that she “fully understood the warnings”
        and would use the product even if the warning had been different,
        then the warning cannot be the proximate cause of the patient’s
        injury. Id. But as to the warning’s adequacy, our analysis under Flor-
        ida law is objective.
               Cates relies on the Florida Supreme Court’s decision in
        Aubin, 177 So. 3d 489, but it provides Cates no assistance. The court
        in Aubin was concerned with whether the learned intermediary
        doctrine applied in the first place. Id. at 514−15. There, the
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        14                    Opinion of the Court                21-12085

        manufacturer of an asbestos product argued the learned interme-
        diary doctrine applied when the manufacturer supplied its product
        through intermediary manufacturers. Id. at 514. Accordingly, the
        court zeroed in on “the critical inquiry”: “whether the manufac-
        turer was reasonable in relying on the intermediary to relay warn-
        ings to the end user.” Id. But here, whether the learned intermedi-
        ary doctrine applies is not at issue. Manufacturers of medical prod-
        ucts, like the CoolSculpting system, are reasonable in directing
        warnings to medical providers because medical providers use their
        expertise to decide “whether to recommend [the device] to meet
        the patient’s needs.” Eghnayem, 873 F.3d at 1321 (citing Felix, 540
        So. 2d at 104). Any misunderstanding by Nurse Practitioner Bucci
        (i.e., whether PAH results from evading post-CoolSculpting proce-
        dures) does not render it unreasonable for Zeltiq to rely on learned
        intermediaries.
               A patient might understandably be frustrated when a
        learned intermediary never relays a warning that a manufacturer
        gave the learned intermediary. But it is not the manufacturer’s job
        to ensure the patient gave “informed consent” to a medical proce-
        dure when a learned intermediary is involved. Buckner, 400 So. 2d
        at 824. In other words, when the warning is legally adequate to in-
        form the learned intermediary, the learned intermediary’s failure
        to warn the patient does “not give rise to a duty in the manufac-
        turer.” Id.
              In any event, Zeltiq itself warned patients about PAH along
        with medical professionals. Zeltiq provided—and Cates signed—
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        21-12085                   Opinion of the Court                                15

        consent forms that warned patients about the risk of PAH. That
        form described PAH as “an enlargement of fat in the service area”
        that is “unlikely [to] resolve on its own” and “can be removed
        through liposuction or related surgery.” Together with Zeltiq’s
        product manual and training presentation, the CoolSculpting
        warnings accurately, clearly, and unambiguously described PAH
        and its consequences. See Felix, 540 So. 2d at 105; Farias, 684 F.3d at
        1233.
                                            B.

                We turn now to Cates’s design defect claim. A design defect
        claim under Florida law requires “[f]irst, that the product is defec-
        tive; and second, that such defect caused plaintiff’s injuries.” Liggett
        Grp., Inc. v. Davis, 973 So. 2d 467, 475 (Fla. 4th DCA 2007) (citing
        Jennings v. BIC Corp., 181 F.3d 1250, 1255 (11th Cir. 1999)). Applying
        the risk utility test, the district court determined no genuine dis-
        pute of material fact existed for whether Zeltiq’s CoolSculpting sys-
        tem was defective. 4 Cates argues we should reverse because the
        district court employed the wrong test under Florida law. Zeltiq
        argues, and we agree, that Cates’s claim fails under any Florida law
        standard for assessing a design defect.

        4 The district court reasoned, in part, that Cates’s design defect claim fails un-
        der the risk utility test for lack of supporting expert opinion. But we are satis-
        fied that Cates did not provide evidence of defect—expert or otherwise. Ac-
        cordingly, we express no opinion about whether expert testimony is necessary
        to establish the element of defect.
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        16                       Opinion of the Court                    21-12085

                We begin with some background on design defect claims
        under Florida law. Two different tests determine whether a prod-
        uct is defective: (1) the consumer expectations test and (2) the risk
        utility test. The consumer expectations test, found in the Second
        Restatement, “considers whether a product is unreasonably dan-
        gerous because it failed to perform as safely as an ordinary con-
        sumer would expect when used as intended or in a reasonably fore-
        seeable manner.” Aubin, 177 So. 3d at 503 (citing Restatement (Sec-
        ond) of Torts § 402A (1965)). The risk utility test from the Third
        Restatement requires a plaintiff demonstrate “the foreseeable risks
        of harm posed by the product could have been reduced or avoided
        by the adoption of a reasonable alternative design . . . , and the
        omission of the alternative design renders the product not reason-
        ably safe.” Id. at 505 (emphasis omitted) (quoting Restatement
        (Third) of Torts: Products Liability § 2 (1998)). The main difference
        between the two tests is that the risk utility test requires that the
        plaintiff prove a “reasonable alternative design.” Id.
               As between the two tests, the consumer expectations test is
        the default under Florida law. Id. at 510. In Aubin, the Florida Su-
        preme Court held that, “in approaching design defects claims,”
        Florida law “adhere[s] to the consumer expectations test as set
        forth in the Second Restatement and reject[s] the categorical adop-
        tion of the Third Restatement and its reasonable alternative design
        requirement.” Id. Aubin involved a product with asbestos used in
        the plaintiff’s construction business. Id. at 495. Among the reasons
        Aubin rejected the risk utility test is that it “fails to consider the cru-
        cial link between a manufacturer establishing the reasonable
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        21-12085               Opinion of the Court                         17

        expectations of a product that in turn cause consumers to demand
        that product” and “places upon the plaintiff an additional burden-
        some element of proof, requiring the injured consumer to step into
        the shoes of a manufacturer and prove that a reasonable alternative
        design was available to the manufacturer.” Id. at 506−07. The con-
        sumer expectations test, on the other hand, acknowledges that “a
        manufacturer plays a pivotal role in crafting the image of a product
        and establishing the consumers’ expectations for that product, a
        portrayal which in turns motivates consumers to purchase that par-
        ticular product,” id. at 511, and places the “burden of compensating
        victims of unreasonably dangerous products . . . on the manufac-
        turers, who are most able to protect against the risk of harm,” id.
        at 510.
                But five years later, Florida’s Fourth District Court of Appeal
        distinguished Aubin and applied the risk utility test to a design de-
        fect claim involving a “complex product.” Cavanaugh, 308 So. 3d at
        155. The Fourth District reasoned, “Aubin did not decide whether
        the consumer expectations test can logically be applied to a com-
        plex medical device accessible to a consumer only through a med-
        ical professional.” Id. The court in Cavanaugh then held that the
        consumer expectations test does not apply to design defect claims
        for medical devices because “medical device manufacturers gener-
        ally do not market their products to ‘ordinary consumers.’” Id. For
        example, the medical device in Cavanaugh was the “Neptune 2,” a
        device the physician used during lung removal surgery to suction
        blood and surgical fluid waste. Id. at 151. The device was ancillary
        to the patient’s surgery. See id. The court reasoned that the one of
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        18                     Opinion of the Court                  21-12085

        the “rationale[s] for the consumer expectations test—that a manu-
        facturer plays a central role in establishing the consumers’ expecta-
        tions for a particular product, which in turn motivates consumers
        to purchase the product—simply does not apply to the Neptune 2
        device.” Id. at 155.
                The parties dispute whether we should follow the Florida
        Supreme Court’s holding in Aubin—consumer expectations—or
        the Fourth District’s reasoning in Cavanaugh—risk utility. For its
        part, the district court was persuaded by Cavanaugh and applied the
        risk utility test. Cates asks us to distinguish Cavanaugh, arguing that
        CoolSculpting is an unusual medical device that is marketed di-
        rectly to consumers who seek medical care only to access the de-
        vice. Indeed, unlike the medical device in Cavanaugh, CoolSculpt-
        ing is not ancillary to another surgery; it is the primary service con-
        sumers seek. See Cavanaugh, 308 So. 3d at 155. So, even if the risk
        utility test were appropriate for most medical products, Cates ar-
        gues that the consumer expectations test should be used to evalu-
        ate this particular device.
               We need not decide which of the two design defect tests ap-
        plies to medical devices under Florida law, however, because
        Cates’s claim fails under either test. The problem is that Cates has
        not identified a defect in the design of CoolSculpting; he has merely
        pointed to a known, but rare, side effect.
               If we apply the risk utility test, we agree with the district
        court that Cates failed to demonstrate a design defect. As discussed
        above, the risk utility test requires a plaintiff demonstrate “the
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        21-12085               Opinion of the Court                         19

        foreseeable risks of harm posed by the product could have been
        reduced or avoided by the adoption of a reasonable alternative de-
        sign . . . , and the omission of the alternative design renders the
        product not reasonably safe.” Aubin, 177 So. 3d at 505 (quoting Re-
        statement (Third) of Torts: Products Liability § 2 (1998)). But Cates
        fails to present any evidence of an alternative design for the
        CoolSculpting system that could have reduced or avoided PAH and
        its effects. Instead, Cates’s hired expert testified that CoolSculpting
        is “safe and effective when we understand the potential risks and
        benefits.” That reinforces that Cates’s issue with the CoolSculpting
        system is not the alleged design defect but the alleged failure to
        provide adequate warnings. If the risk utility test applies, summary
        judgment for Zeltiq is warranted.
               If we apply the consumer expectations test, we also con-
        clude that Cates failed to demonstrate a design defect. Under the
        consumer expectations test, a product is defective if “it failed to
        perform as safely as an ordinary consumer would expect when
        used as intended or in a reasonably foreseeable manner.” Id. at 503
        (citing Restatement (Second) of Torts § 402A (1965)). Even so, “a
        manufacturer is not under a duty in strict liability to design a prod-
        uct which is totally incapable of injuring” consumers. Grieco v.
        Daiho Sangyo, Inc., 344 So. 3d 11, 19 (Fla. 4th DCA 2022) (quoting
        Husky Indus., Inc. v. Black, 434 So. 988, 991 (Fla. 4th DCA 1983)).
        Whether a product is “unreasonable dangerous” is “based on an
        objective standard and not the viewpoint of any particular cus-
        tomer.” Liggett Grp., 973 So. 2d at 475 (citing Jennings, 181 F.3d at
        1255).
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        20                     Opinion of the Court                21-12085

               The parties agree that, in a medical device case in which the
        consumer expectations test applies, a court must assess the expec-
        tations of the learned intermediary, not the end user. Cavanaugh,
        308 So. 3d at 156. Assuming without deciding that we evaluate the
        expectations of the healthcare provider in applying this test under
        Florida law, Cates’s design defect claim fails. Cates has produced
        no evidence that an objectively reasonable medical provider would
        believe that PAH is not a potential side effect of CoolSculpting. In-
        stead, his own expert conceded that it is a known side effect that
        should be discussed with the patient before the procedure. In short,
        PAH was within the realm of known (albeit rare) side effects of
        CoolSculpting.
               Cates argues that Nurse Practitioner Bucci’s misconceptions
        about PAH are proof that the CoolSculpting system failed to meet
        her expectations. Not so. Nurse Practitioner Bucci’s apparently er-
        roneous notion that PAH develops in patients who fail to adhere
        to post-procedure care is irrelevant for two reasons. One—Nurse
        Practitioner Bucci understood that PAH was a possible side effect
        of CoolSculpting that may require surgery to correct, regardless of
        whether she understood its mechanism. Her deposition testimony
        does not support the conclusion that she was unaware of PAH or,
        said differently, that PAH was outside the realm of expectations of
        CoolSculpting. Two—Nurse Practitioner Bucci’s subjective expec-
        tations about the CoolSculpting system are not definitive. We eval-
        uate an “objective” medical provider’s expectations, not Nurse
        Practitioner Bucci’s in particular. Liggett Grp., 973 So. 2d at 475.
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        21-12085                Opinion of the Court                         21

               Assuming, however, that the relevant expectations are those
        of the patient, we likewise conclude that there is no genuine issue
        of material fact that the CoolSculpting system performed as rea-
        sonably expected. “The consumer expectations test intrinsically
        recognizes a manufacturer’s central role in crafting the image of a
        product and establishing the consumers’ expectations for that prod-
        uct.” Aubin, 177 So. 3d at 507. And we believe Cates’s injury was
        well within the range of side effects that Zeltiq’s messaging would
        lead a reasonable consumer to expect. In light of Zeltiq’s many
        warnings about the possibility of PAH, including in the consent
        form that Cates signed, we cannot say the CoolSculpting system
        “failed to perform as safely as an ordinary consumer would ex-
        pect.” Aubin, 177 So. 3d at 503.
                Cates contends that the CoolSculpting system failed to meet
        his expectation that the procedure would reduce the appearance of
        fat “without damage to his tissue and without the need for invasive
        surgery.” We do not doubt that Cates did not subjectively antici-
        pate developing PAH. He would not have engaged in CoolSculpt-
        ing if he had known that he would be one of the few CoolSculpting
        customers who experience PAH as a side effect. But the consumer
        expectations test is an objective test. Liggett Grp., 973 So. 2d at 475.
        And PAH is the kind of outcome that Zeltiq’s messaging would
        lead an objective person to expect as a potential side effect of
        CoolSculpting.
             In sum, under either test, Cates failed to meet his burden of
        demonstrating a genuine issue of material fact as to design defect.
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        22                   Opinion of the Court             21-12085

        The district court did not err in granting summary judgment for
        Zeltiq.
                                    IV.

              The district court is AFFIRMED.