The First Department, reversing Supreme Court, determined defendant Zeltiq, the manufacturer of a system for treating burns (CoolSculpting Systems), could not be held liable for injury allegedly caused by the application of ice packs after the CoolSculpting treatment. The complaint alleged a failure to warn of the the danger of using ice packs. The use of ice packs was not part of the CoolSculpting treatment:
Zeltiq also had no duty to warn plaintiffs of any risks associated with using ice packs after treatment with the CoolSculpting System. Because the CoolSculpting System is a FDA Class II medical device that requires a prescription, Zeltiq’s duty to warn runs to physicians, not directly to patients … . Thus, in this case, Zeltiq’s duty ran to Silverstein’s [plaintiff’s] treating physician, Dr. Brauer. However, there is no duty to warn of risks that are obvious, including risks that are well-known to physicians because of their medical training … . Dr. Brauer testified that through his education and training, he was aware of and knew of the dangers of placing ice on bare skin, and that those dangers were basic medical knowledge … . Plaintiffs’ expert does not dispute that these dangers are basic knowledge in the medical community and, in fact, opines that it is a deviation from the standard of care to place ice packs on bare skin.
In addition, given Dr. Brauer’s awareness of the risk, his status as a “responsible intermediary” breaks the chain of proximate cause between any failure to warn by Zeltiq and the harm to Silverstein … . Silverstein v Coolsculpting Zeltiq Aesthetics, Inc., 2025 NY Slip Op 01183, First Dept 2-27-25
Practice Point: Here the application of ice packs to bare skin was not part of the defendant manufacturer’s burn-treatment system. The use of the burn-treatment system is by prescription only, so the duty to warn owed by the manufacturer runs to the physician, not the patient. Here the dangers of applying ice packs to bare skin are well known to physicians, so the use of ice packs by plaintiff’s physician broke the chain of proximate cause re: the defendant manufacturer.