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

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No. 21-12085 ____________________

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

Defendant-Appellee.

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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. USCA11 Case: 21-12085 Document: 35-1 Date Filed: 07/21/2023 Page: 2 of 22

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 USCA11 Case: 21-12085 Document: 35-1 Date Filed: 07/21/2023 Page: 3 of 22

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