Terrance Nelson Cates v. Zeltiq Aesthetics, Inc.

[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 R OSENBAUM , 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) A ESTHETIC S URGERY 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 L ASERS IN S URGERY & MED . 476, 478
(2015) (“The etiology of paradoxical adipose hyperplasia is unknown.”); Mis-
bah Khan, Complications of Cryolipolysis: Paradoxical Adipose Hyperplasia (PAH)
and Beyond, A ESTHETIC S URGERY 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 D RUGS IN D ERM . 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
R ECONSTRUCTIVE S URGERY 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 cells3 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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“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.
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