Silverstein v. CoolSculpting – Zeltiq Aesthetics, Inc.

William M. Janssen*

Why It Made the List

James Barr Ames was Dean of the Harvard Law School until 1910, a devotee of Langdell’s casebook method for teaching law,[1] and an intriguing speaker. During a guest lecture one day at Cincinnati’s law school, Ames riveted his audience about the law’s approach to a “duty to rescue”:

As I am walking over a bridge a man falls into the water. He cannot swim and calls for help. I am strong and a good swimmer, or, if you please, there is a rope on the bridge, and I might easily throw him an end and pull him ashore. I neither jump in nor throw him the rope, but see him drown. . . . Am I guilty of a crime, and must I make compensation to the widow and children of the man drowned . . . ?[2]

Ames then probed his own question: “As the law stands today there would be no legal liability, either civilly or criminally” since “[t]he law does not compel active benevolence between man and man. It is left to one’s conscience whether he shall be the good Samaritan or not.”[3] But, Ames mused, is this proper? Wouldn’t we “all be better satisfied if the man who refuses to throw a rope to a drowning man . . . could be punished and be made to compensate the widow of the man drowned?”[4]

Imposing new legal duties is a controversial (and, often, morally challenging) undertaking. It zeros in on the balance the law must strike between actor autonomy and utilitarianism, or whether, for example, “one human being, seeing a fellow man in dire peril” can “sit on the dock, smoke his cigar, and watch the other drown.”[5] The existence of a legal duty to “volunteer” and rescue has been so long debated that it may now be considered a canonical feature of every first-year torts class. And there, it does good service, because novel attempts to recalibrate the law’s balance by pronouncing new duties will continue unabated.

In early 2025, the Appellate Division of New York’s Supreme Court rebuffed one such request in Silverstein v. CoolSculpting – Zeltiq Aesthetics, Inc., where a plaintiff argued that a body-sculpting device’s manufacturer owed her a duty to warn about the risks posed by ice pack treatments her providers placed on her body once that treatment had concluded.[6] The duty of one manufacturer to warn about risks posed by another manufacturer’s product is a nuanced inquiry. The Appellate Division’s crisp navigation of that journey, and the legal standard it applied while doing so, qualifies this decision as one of the top food and drug cases of the year.

Discussion

Plaintiff Liana Silverstein filed a product liability and medical malpractice lawsuit in New York State court seeking compensation for serious burns she sustained to her abdomen following a “CoolSculpting” procedure.[7]

“CoolSculpting” is the patented trade name for cryolipolysis,[8] a non-invasive body contouring technique (commonly known as “fat freezing”) that uses cold temperatures to break down “a localized fat bulge that has persisted despite diet and exercise.”[9] The procedure draws a “targeted area of pinchable fat” into an applicator device using vacuum pressure, where the pinched area is then cooled for a period of time. “Because fat cells are uniquely sensitive to cold,” this “controlled cooling” aims “to kill the fat cells” without freezing the skin.[10] Thereafter, “[t]he fat released from the damaged fat cells is slowly cleared by the body’s immune system, usually within two to three months. This causes the fat bulge to become smaller over time.”[11] The American Society of Plastic Surgeons ranks cryolipolysis as “one of the most popular nonsurgical fat reduction treatments.”[12] According to the manufacturer, “CoolSculpting” is “the leading fat freezing treatment” and the one “doctors use most for fat reduction without surgery,” with more than 17 million treatments performed since 2009.[13] The device is FDA-cleared.[14] The manufacturer lists “typical side effects” from the procedure as including “temporary redness, swelling, blanching, bruising, firmness, stinging, tenderness, cramping, skin inflammation, and aching,” as well as “[s]ensory alteration (itching, skin sensitivity, tingling, and numbness) [which] can persist up to several weeks after treatment.”[15]

Ms. Silverstein apparently received seventy minutes of CoolSculpting treatment, after which the administering medical staff wrapped four ice packs directly against the skin of her abdomen and sent her home. Once home, Ms. Silverstein claimed that she attempted to remove the ice packs, but “they were stuck to her skin and ‘just didn’t come off.’”[16] When second degree burns developed, she sued her healthcare providers for medical negligence and, later, the CoolSculpting device manufacturer for product liability.[17]

In pressing her products claim, Ms. Silverstein evidently acknowledged that her injuries were not caused by a malfunction of the CoolSculpting device, nor were they caused during the CoolSculpting treatment or from the device’s placement against her body.[18] Rather, Ms. Silverstein’s theory was that the device manufacturer breached its duty to warn about the risks of placing ice packs directly on a patient’s skin after a CoolSculpting treatment.[19] The ice packs used with Ms. Silverstein were not supplied by the device manufacturer.[20]

The manufacturer moved for summary judgment on Ms. Silverstein’s products claim on several grounds. First, it asserted that the risks of prolonged use of ice packs directly on human tissue were commonly known. Second, because those risks were not ones “associated with the use of the Coolsculpting device,” the manufacturer insisted they were not risks that gave rise to a duty to warn on its part.[21]

The trial court denied the manufacturer’s motion. It began by noting New York’s foreboding summary judgment standard: “The drastic remedy of summary judgment, which deprives a party of his day in court, should not be granted where there is any doubt as to the existence of triable issues or the issue is even ‘arguable.’”[22] The court then cited to several facts from the summary judgment record that, it ruled, supported a denial of defendant’s motion: (a) the device’s user manual contained no warnings related to ice packs on bare skin after CoolSculpting treatments; (b) a slide from the manufacturer—entitled “Mitigating Late Onset Pain”—depicted “the use of ice packs to affected areas post treatment”; and (c) testimony by a manufacturer witness created doubt whether the manufacturer “viewed ice packs as contraindicated” or as “a part of its indicated protocol or treatment” for post-administration care.[23]

On appeal, a unanimous five-member panel of the Appellate Division (First Department) reversed, directing that the summary judgment motion be granted and that the complaint be dismissed against the CoolSculpting device manufacturer.[24] The appeals panel rested its decision on three grounds. First, the panel held that the manufacturer had no warning duty to Ms. Silverstein; because the CoolSculpting device was a Class II medical device requiring a prescription, any duty owed would run to prescribers and not to patients directly.[25] Second, under New York tort law, there was no duty to warn of well-known, obvious risks—which Ms. Silverstein’s treating physician conceded included the risks of placing ice on bare skin.[26] Third, the panel ruled that the manufacturer would have had no duty to warn of the risks posed by the use of ice packs, as it was a product manufactured by someone else.[27] This third and last ground for reversal merits further discussion.

The appeals panel noted that New York has recognized a duty on the part of a manufacturer to warn about another company’s product, but only under certain circumstances. “[T]he 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.”[28] But that third-party product warning duty did not apply in this dispute, the appeals panel found. Ice packs “were not necessary in any way for the CoolSculpting device to function as intended.”[29] Ice packs were not included with the device as supplies (essential or otherwise), were not suggested or recommended by the device’s user’s manual, and did not produce “any economic benefit” for the manufacturer that had been shown by record evidence.[30] The appeals court discounted the probative value of the “training slide” because it never depicted ice packs being used “simultaneously or in conjunction with” a CoolSculpting treatment, did not offer manufacturer advice but only “recommendations” from “clinicians,” and even that advice concerned just “late onset pain” (which occurs not during CoolSculpting treatment, but “develops days or weeks” later).[31] Accordingly, the appeals panel concluded that no duty to warn arose on the part of the CoolSculpting device’s manufacturer to caution about ice packs supplied by a different company.

Impact

Imposing on a manufacturer an additional duty to warn when a consumer uses its product in tandem with another company’s product evokes, in some quarters, a visceral sense of injustice—as though the venerable moral/legal joust over a legal duty to rescue or to volunteer has been renewed. On first glance, such a duty seems at odds with settled, foundational products liability theory. The New York Appellate Division’s ruling in Silverstein v. CoolSculpting – Zeltiq Aesthetics, Inc. confronts that impression.

At the very core of products law lies the notion of “defectiveness.” It has been that way for millennia—from ancient Roman law, through the ecclesiastical law of the middle ages, then to English law, and on to colonial and post-colonial law in America.[32] “[T]he essence of accountability in products liability law,” writes the legendary products scholar Davd G. Owen, “is that the defendant supplied a product that was deficient in some respect”; indeed, “[r]egardless of the underlying cause of action, plaintiffs in products liability cases normally must establish that something was wrong with the product” that the defendant supplied.[33]

But this attribute is more than just the core of products law: it is also its grounding logic. When Justice Roger Traynor penned his court’s pioneering adoption of strict products liability in 1963, he expressed his and his colleagues’ reasoning in just these sorts of terms: “Implicit in” a product’s “presence on the market” is “a representation that it would safely do the jobs for which it was built.”[34] Liability followed when that representation proved to be mistaken: when a product’s “own appearance of excellence . . . belied the defect lurking beneath the surface.”[35] Or, put another way: “To establish the manufacturer’s liability it was sufficient that plaintiff proved that he was injured while using the [product] in a way it was intended to be used as a result of a defect in design and manufacture of which plaintiff was not aware that made the [product] unsafe for its intended use.”[36]

The American Law Institute has endorsed the law’s emphasis on product “defect” for more than half a century, and continues to endorse it today. Section 2 of the Third Restatement of Torts advises that a product is defective “when, at the time of sale or distribution, it contains . . . inadequate instructions or warnings,” and instructions or warnings are inadequate when failing to provide them “renders the product not reasonably safe.”[37]

The recurring theme is the defining focus on something wrong with the product. It is the product that the law is testing for a “defect.” The product must suffer from some sort of deficiency “lurking beneath the surface” that, when encountered, results in injury to someone while they were in the act of “using” the product “in the way it was intended to be used.” If the product is not defective, but its use in combination with another product causes an injury, why should there be failure-to-warn liability on the part of the non-defective product’s manufacturer?

The appeals panel in Silverstein v. CoolSculpting – Zeltiq Aesthetics, Inc. decided Ms. Silverstein’s case by applying a standard announced a decade earlier by New York’s Court of Appeals. In that earlier case, In re New York City Asbestos Litigation, the court announced a standard that it had reframed, but its essence had long been applied by the State’s appellate courts.[38] In fact, the court wrote, so settled was this existing precedent that the In re New York City Asbestos Litigation reframing “adds but a note to a familiar anthem in failure-to-warn jurisprudence.”[39] Still, the court’s formulation did supply a further bit of precision: “[T]he 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.”[40]

On closer inspection, this standard does not undermine or contradict core product theory. It aligns with it. The standard supposes a very particular factual setting: that the manufacturer is supplying a product it knows (or could reasonably foresee) cannot function as intended unless and until some third-party’s product is added to it. Put another way, in this setting, it is the manufacturer’s product that is incomplete, inoperable, nonfunctional without the third-party’s add-on. That addition isn’t an “extra” in those circumstances; it is essential. It is there, and only there, that this new duty to warn arises.

To be sure, the Court of Appeals carefully cabined its standard. Mere foreseeability of harm is not enough to create this duty, nor is a weighing of equities, symmetry, and sympathy.[41] Instead, courts must assess, on a case-by-case basis, whether the manufacturer in question is in a superior position, when compared to users, “to know of and warn against” the new danger created by the combined use.[42] To users, the court explained, a modern product may often seem to be “a most sophisticated and even mysterious article,” well insulated from an ordinary consumer’s practical ability to detect dangers—a situation only magnified when two incomprehensibly complex products are combined during a joint use “because he or she rarely has access to sufficient technical information about both products to anticipate the perils of their joint use.”[43] This is especially true when the third-party’s add-on product is a fungible one that deteriorates and must be replaced; there, users are “more likely to interact with the durable product over an extended period of time, and hence he or she is more likely to inspect warnings on that item or in associated documentation than to review warnings supplied by the maker of the ‘wear item.’”[44]

The imposing of this added duty of care, admonished the Court of Appeals, hinges in part on “whether the manufacturer’s product can function without the other product.”[45] This is the duty’s trigger because “it would be unfair to allow a manufacturer to avoid the minimal cost of including a warning about the perils of the joint use of the products when the manufacturer knows that the combined use is both necessary and dangerous.”[46] And that is not unfair to the manufacturer, the court concluded, because when “a manufacturer creates a product that cannot be used without another product,” that manufacturer “has a substantial, albeit indirect, role in placing the third-party product in the stream of commerce” and thus “derives a benefit from the sale of the essential third-party product, as the manufacturer is able to sell its own product to customers precisely because the third party has sold to those customers another item that is essential to the product’s function.”[47]

A simple example helps illustrate the court’s standard. If the manufacturer’s vehicle requires diesel (not gasoline) or gasoline (not diesel), the In re New York City Asbestos Litigation standard would impose upon the manufacturer a legal duty to warn the vehicle’s user against filling up with the wrong type of fuel—if doing so would create a foreseeable danger.

Applying its standard to the facts in In re New York City Asbestos Litigation was simple for the Court of Appeals in that case.[48] That defendant manufactured valves for use in high-pressure, high-temperature steam pipes, but those valves could not function practically without gaskets, insulation, and packing around the valve stems. The defendant manufacturer knew this. It specified the use of asbestos-containing components for that valve-stem-surrounding purpose, packaged new valves it sold with asbestos-containing gaskets, and marketed a sheet of asbestos-based material for users when the aging gaskets wore out and needed to be replaced. The Court of Appeals ruled, on those facts, that the valve manufacturer owed a duty to warn about the risks of using asbestos materials with its valves.[49]

Ms. Silverstein’s case seemed equally easy to resolve for the Appellate Division of the New York Supreme Court; the ruling took only two brief paragraphs. Ice packs were not necessary or essential for the CoolSculpting device to operate; to the contrary, while the CoolSculpting treatment was underway, there apparently was no ice pack involvement of any sort. The CoolSculpting device’s manufacturer did not supply ice packs with its product, nor does the user’s manual suggest that ice packs were required “as a matter of design, mechanics, or economic necessity . . . to enable the manufacturer’s product to function as intended.”[50] Unlike the asbestos gaskets needed for the high-pressure stem valves to function, ice packs played no role—essential or otherwise—in the operation of the CoolSculpting device. Pivotally, the ice packs were applied to Ms. Silverstein’s torso by her medical professionals only after the CoolSculpting treatment had finished and she was discharged to go home. By any measure, the standard announced in In re New York City Asbestos Litigation was found to be plainly inapplicable.

The Appellate Division’s task was made easier in several further respects. First, the ice packs used with Ms. Silverstein were not “a most sophisticated and even mysterious article” that defied common appreciation; to the contrary, Ms. Silverstein’s treaters (and, one could surmise, laypersons in general) readily understood how ice packs worked and the risks they posed to bare skin. Second, the ice packs were not wrapped around Ms. Silverstein’s body by the CoolSculpting manufacturer, but by her treating medical professionals who were making personalized treatment decisions about how best to care for her. Third, in the trial court’s retelling of Ms. Silverstein’s allegations, the ice packs were not the true culprit here. According to the lawsuit, the injury-causing error wasn’t the decision to use ice packs, but to place them directly on Ms. Silverstein’s bare skin (“the ice packs should have been wrapped in gauze or paper towels before application to her skin”)—an alleged error in professional technique.[51] Fourth, ice packs were not a fungible, degradable commodity that could not support a warning or be accompanied by a written one supplied by the treaters. Fifth, there was no economic synergy of any sort between the CoolSculpting device manufacturer and the ice packs maker.

*  *  *

Enterprising lawyers will never cease attempting to press the boundaries of duty theory in products cases. Nor should they. Legal creativity is the engine of change. A century ago, Dean Ames aspirationally characterized “the spirit of reform” as a quest to bring “our system of law more and more into harmony with moral principles.”[52] Yet, the balance between autonomy and utilitarianism will never be perfectly fixed, and the law needs clear and certain benchmarks to set duty theory fairly. In Silverstein v. CoolSculpting – Zeltiq Aesthetics, Inc., the New York appeals court added a valuable new chapter to that task.

 

*   William M. Janssen is a professor of law at the Charleston School of Law in Charleston, South Carolina, where he teaches products liability, mass torts, civil procedure, and constitutional law.

[1]   See Joseph H. Beale, James Barr Ames—His Life and Character, 23 Harv. L. Rev. 325, 328 (1910) (“He promised his colleagues again and again to give up the making of case-books and get down to serious work—after just one more.”).

[2]   James Barr Ames, Law and Morals, 22 Harv. L. Rev. 97, 112 (1908).

[3]   Id. See generally Restatement (Second) of Torts § 314 (1965) (“The fact that the actor realizes or should realize that action on his part is necessary for another’s aid or protection does not of itself impose upon him a duty to take such action.”).

[4]   James Barr Ames, supra note 2, at 112–13. See also Restatement (Second) of Torts § 314 cmt c (1965) (though “condemned by legal writers as revolting to any moral sense,” such cases “remain the law”).

[5]   Id.

[6]   Silverstein v. CoolSculpting – Zeltiq Aesthetics, Inc., 229 N.Y.S.3d 44, 45 (N.Y. Sup. Ct. App. Div. 2025).

[7]   See Silverstein v. CoolSculpting – Zeltiq Aesthetics, Inc., 2024 WL 3255440, at *1 (N.Y. Sup. Ct. July 1, 2024) [hereinafter, Silverstein I], rev’d, 229 N.Y.S.3d 44 (N.Y. Sup. Ct. App. Div. 2025).

[8]   See Fat Freezing (Cryolipolysis), Cleveland Clinic, https://my.clevelandclinic.org/‌‌ health/‌treatments/‌21060-fat-freezing-cryolipolysis (last visited Feb. 25, 2026).

[9]   See Reasons patients want cryolipolysis—Nonsurgical Fat Reduction: Minimally Invasive Procedures, Am. Soc’y of Plastic Surgeons, https://www.plasticsurgery.org/cosmetic-procedures/nonsurgical-fat-reduction/cryolipolysisns (last visited Feb. 25, 2026).

[10] See Non-Invasive Body Contouring Technologies—Thermal: Cold (Cryolipolysis or Fat Freezing), FDA, https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/non-invasive-body-contouring-technologies (last visited Feb. 25, 2026). See generally User Manual for CoolSculpting® Elite System, https://www.rxabbvie.com/pdf/coolsculptingelite_manual.pdf.

[11] Id.

[12] See What Is Cryolipolysis—Nonsurgical Fat Reduction: Minimally Invasive Procedures, Am. Soc’y of Plastic Surgeons, https://www.plasticsurgery.org/cosmetic-procedures/nonsurgical-fat-reduction/cryolipolysisns (last visited Feb. 25, 2026).

[13] See id.

[14] See How It Works, CoolSculpting.com, https://www.coolsculpting.com/how-it-works/faq (last visited Feb. 26, 2026).

[15] See What are the Side Effects of CoolSculpting?, CoolSculpting.com, https://www.coolsculpting.com/how-it-works/faq (last visited Feb. 26, 2026).

[16] See Silverstein I, 2024 WL 3255440, at *1.

[17] See Priscilla DeGregory, Fat ‘Freezing’ Procedure Leaves NYC Woman With Third-Degree Burns: Suit, N.Y. Post (Dec. 18, 2019), https://nypost.com/2019/12/18/fat-freezing-procedure-leaves-nyc-woman-with-third-degree-burns-suit/ (last visited Feb. 28, 2026).

[18] Silverstein I, 2024 WL 3255440, at *1–*2.

[19] Id.

[20] See Silverstein v. CoolSculpting – Zeltiq Aesthetics, Inc., 229 N.Y.S.3d 44, 45 (N.Y. Sup. Ct. App. Div. 2025) [hereinafter Silverstein II].

[21] Id. at *2.

[22] Id. (citation omitted).

[23] Id. at *3.

[24] See Silverstein II, 229 N.Y.S.3d at 45.

[25] Id. at 46.

[26] Id. (noting that the treating physician “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”).

[27] Id. at 45–46.

[28] Id. at 45 (quoting In re New York City Asbestos Litig., 59 N.E.3d 458, 463 (N.Y. 2016)).

[29] Id.

[30] Id.

[31] Id.

[32] See generally David G. Owen, Products Liability Law 341 (4th ed. 2022).

[33] Id. The qualifier “normally” acknowledges compensable claims anchored on attributes such as non-conformity, like breach of warranty or fraud, where a non-defective product might nonetheless still be actionable.

[34] Greenman v. Yuba Power Prods., Inc., 377 P.2d 897, 901 (Cal. 1963).

[35] Id.

[36] Id.

[37] Restatement (Third) of Torts: Prod. Liab. § 2(c) (1998).

[38] In re New York City Asbestos Litig., 59 N.E.3d 458, 463 (N.Y. 2016) (the court summarized this settled precedent this way: “a manufacturer has a duty to warn about the dangers resulting from the combined use of its product with another product that is essential to the intended function of the manufacturer’s product”).

[39] Id. at 476.

[40] Id. at 463, 474.

[41] Id. at 469–70.

[42] Id. at 471–72.

[43] Id. at 473 (citations omitted).

[44] Id. at 472.

[45] Id. at 474. In the different but analytically similar context of component parts, the law may hold component part suppliers liable “for harm to persons or property caused by a product into which the component is integrated if” the component is defective or the integration causes a defect. See Restatement (Third) of Torts: Prod. Liab. § 5 (1998) (emphasis added). Again, incorporation into the product is the point of liability.

[46] Id.

[47] Id.

[48] The Court of Appeals ruling came in a consolidated case; the facts recounted in this paragraph concern just the first of the two consolidated factual settings.

[49] Id. at 463–78.

[50] Id. at 463, 474.

[51] Silverstein I, 2024 WL 3255440 at *1.

[52] James Barr Ames, supra note 2, at 113.