Terrance Nelson Cates v. Zeltiq Aesthetics, Inc., 73 F.4th 1342

CoolSculpting is a Class II prescription medical device that uses cryolipolysis to reduce fat; a rare adverse effect is paradoxical adipose hyperplasia (PAH), which enlarges treated fat and often requires surgery.
Terrance Cates received multiple CoolSculpting cycles in 2018; months later he developed PAH confirmed by physicians who recommended liposuction.
Zeltiq warned medical providers in its user manual and training slides about PAH (describing enlarged, firm adipose tissue that may require surgical intervention) and provided a patient consent form warning of PAH that Cates signed.
Cates sued Zeltiq in Florida state law claims for failure to warn, design defect, negligence, negligent misrepresentation, and fraud; the district court granted summary judgment for Zeltiq on all claims.
The Eleventh Circuit affirmed: it held Zeltiq’s warnings were legally adequate as directed to learned intermediaries and that Cates failed to show a design defect under either consumer-expectations or risk-utility frameworks.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Failure to warn — adequacy of warnings about PAH	Cates: warnings were legally inadequate because they did not convey the severity/nature of PAH and Nurse Practitioner Bucci misunderstood the risk	Zeltiq: warnings in manual, training, and patient consent accurately, clearly, and unambiguously described PAH and the need for possible surgery; warnings are directed to learned intermediaries	Warning was adequate as a matter of law; learned intermediary doctrine applies; nurse practitioner's misunderstanding does not make manufacturer's warnings unreasonable
Design defect — applicable test and proof of defect	Cates: consumer expectations test should apply (CoolSculpting marketed to consumers), and device failed his expectations	Zeltiq: risk-utility applies to complex/medical devices and, in any event, Cates has no evidence of a reasonable alternative design or other proof of defect	Court did not decide which test governs medical devices but held Cates’s claim fails under either test — no evidence of design defect or alternative design; summary judgment affirmed

Felix v. Hoffmann-LaRoche, 540 So. 2d 102 (Fla. 1989) (warning may be adjudicated adequate as a matter of law when "accurate, clear, and unambiguous")
Eghnayem v. Bos. Sci. Corp., 873 F.3d 1304 (11th Cir. 2017) (learned intermediary rule: duty to warn physicians who prescribe/use device)
Upjohn Co. v. MacMurdo, 562 So. 2d 680 (Fla. 1990) (label adequate where it put reasonable medical professional on notice of plaintiff’s symptoms)
Aubin v. Union Carbide Corp., 177 So. 3d 489 (Fla. 2015) (Florida favors consumer-expectations test over categorical adoption of Third Restatement risk-utility)
Cavanaugh v. Stryker Corp., 308 So. 3d 149 (Fla. 4th DCA 2020) (distinguished Aubin for complex/medical devices and applied risk-utility for device accessible only through medical professionals)
Farias v. Mr. Heater, Inc., 684 F.3d 1231 (11th Cir. 2012) (objective "reasonable person" standard governs warning adequacy)