A manufacturer produces a medical device for physicians to use to administer a particular type of treatment to their patients. When does that manufacturer have a duty under New York state law to warn a physician of risks posed by using another product — made by another manufacturer — to mitigate side effects that may result from treatment with the medical device? A Harris Beach Murtha team, working with co-counsel from Butler Snow LLP, recently persuaded a New York state intermediate appellate court to recognize that the medical device manufacturer’s duty to warn is generally limited to warnings regarding risks associated with the use of its medical device -- and does not extend to risks associated with the use of products made by third parties.
The Underlying Facts
In Silverstein v. Zeltiq Aesthetics, Inc., a patient visited a Manhattan medical clinic to obtain “CoolSculpting” treatment on her abdomen and sides: treatment, performed by a physician using the CoolSculpting device manufactured by Zeltiq Aesthetics, Inc. (later acquired by AbbVie Pharmaceuticals), designed to freeze subcutaneous fat cells and cause them to be excreted from the body. A physician performed the treatment, which concluded without incident. Before leaving the clinic, the patient expressed concerns about potential swelling. A nurse, under the physician’s supervision, placed several ice packs (not made by Zeltiq) directly on the areas of the patient’s skin that had undergone the CoolSculpting treatment, and used gauze to wrap the ice packs securely in place. That evening, the patient removed the ice packs and saw that the skin beneath them had become red. Later, she experienced a burning sensation and blistering in the ice pack-covered areas.
The patient sued the medical clinic, the physician who performed the treatment, the nurse who assisted him, and Zeltiq, in New York state court. The patient’s claims against the clinic and providers sounded largely in medical malpractice. Against Zeltiq, however, the patient alleged the company owed a duty to warn physicians that the use of ice packs on bare skin following CoolSculpting treatment can cause adverse effects like those experienced by the patient in this case, and that the company had not issued such a warning. Zeltiq moved for summary judgment dismissing the lawsuit against it, but the court denied the motion.
The Appellate Court Decision
On appeal, the New York State Supreme Court Appellate Division, First Department — the New York state intermediate appellate court based in Manhattan — reversed the lower-court decision and dismissed the case against Zeltiq in its entirety.
The First Department emphasized that the set of circumstances in which a manufacturer has a duty to warn of dangers associated with another manufacturer’s product is unusually narrow: “the manufacturer of a product has a duty to warn of the danger arising from the known and reasonably foreseeable use of its product in combination with a third-party product which, as a matter of design, mechanics or economic necessity, is necessary to enable the manufacturer’s product to function as intended.” The court then observed that there was no evidence indicating that the CoolSculpting device depended upon the post-treatment use of ice packs in that “synergistic” manner.
Namely, “ice packs were not necessary in any way for the CoolSculpting device to function as intended. Indeed, the device functioned without incorporating ice packs, and the ice packs were not included as supplies with the CoolSculpting device. The user manual for the CoolSculpting device also does not suggest or recommend the use of ice packs. Rather, the ice packs were considered for use only after the treatment was completed. Nor is there any evidence in the record that Zeltiq derived any economic benefit from posttreatment use of ice packs.”
The First Department also determined that, even had the CoolSculpting device, on the one hand, and ice packs, on the other hand, been found to have had a synergistic relationship, Zeltiq still would not have been required to warn physicians of the risks associated with the use of ice packs on bare skin because those risks were so well known. “[T]here is no duty to warn of risks that are obvious, including risks that are well-known to physicians because of their medical training,” the court explained. And the physician who performed the treatment “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.” Additionally, the doctor that the patient called as an expert witness “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.”
Important Takeaways
The First Department’s decision in Silverstein establishes significant precedent recognizing the highly circumscribed nature of a medical device manufacturer’s duty to warn physicians administering treatment with that manufacturer’s device of risks associated with the use of other products, made by other manufacturers, to address potential side effects. However, as the court’s opinion reflects, every case depends heavily on the particular facts established therein, so medical device manufacturers faced with claims similar to those brought in Silverstein should take care to place before the court the most favorable evidence available, such as evidence affirmatively demonstrating that their devices function independently of products used to mitigate side effects. The manufacturer should also investigate whether the particular risks at issue are well known throughout the medical profession — like the risks of applying ice packs to bare skin — and put any evidence to that effect before the court, as well.
