In Cates v. Zeltiq Aesthetics, Inc., 73 F.4th 1342, 2023 WL 4671283 (11th Cir. July 21, 2023), the Eleventh Circuit affirmed the summary judgment victory of Zeltiq Aesthetics, Inc. in a failure-to-warn and design defect lawsuit regarding its CoolSculpting medical device and found that a health care provider’s misunderstanding of an adverse effect did not bear on the adequacy of the product’s warning. Zeltiq’s CoolSculpting machine applies cold to fat in order to destroy fat cells in a process called “cryolipolysis.” Zeltiq has included warnings, including in its device manual and training sessions, that CoolSculpting patients may develop an adverse effect known as paradoxical adipose hyperplasia (PAH). This adverse effect causes patients to experience an enlargement rather than a reduction of fat.
Here, Plaintiff received multiple cycles of CoolSculpting from a nurse practitioner who performed the treatment under the supervision of a doctor and later developed PAH. The nurse practitioner allegedly never warned Plaintiff of the potential PAH side effect, but stated she knew it was one. Moreover, Plaintiff signed a consent form that included a warning of PAH as a “rare side effect.” Plaintiff sued Zeltiq in Florida under failure-to-warn and design defect theories. Under Florida’s the learned-intermediary doctrine, Zeltiq owed a duty to warn the medical professionals of the CoolSculpting device’s adverse effects rather than Plaintiff. The 11th Circuit observed that the adequacy of a warning under Florida law can also “be resolved as ?a question of law where the warning is accurate, clear, and unambiguous.”‘ Further, “[a] warning is adequate as a matter of law when it ?make[s] apparent the potential harmful consequences’ of the product.” And lastly, Florida assesses adequacy in light of how a reasonable practitioner would understand the warning.
The 11th Circuit assessed Plaintiffs’ claims under both the risk-utility and the consumer-expectations tests, and determined that Plaintiff could not show a genuine issue under either test. Thus, the Court concluded that the district court had not erred in granting summary judgment.