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What follows is another “guest post” by our sixth (actually seventh)-man poster, Dean Balaes.  It features litigation that the good guys won the old-fashioned way – with warnings that were adequate as a matter of law.  Take it away Dean.


Legal professionals know all too well that building a healthy and active lifestyle is not easy.  For further illustration, please see a tyranny of cat gifs.  For these reasons (and many others), it is understandable why individuals turn to weight loss solutions.  One of these—cryotherapy—was at issue in Cates v. Zeltiq Aesthetics, Inc., No. 6:19-cv-1670-PGB-LRH, __F.Supp.3d__, 2021 WL 1808583 (M.D. Fla. April 19, 2021).

Under Florida law, the defendant successfully sought summary judgment, arguing that its warnings were adequate as a matter of law, there was no evidence that the device was defective, and the remainder of plaintiff’s claims must fail because “they are all predicated upon the inadequacy of [d]efendant’s warnings.”  Cates, 2021 WL 1808583, at *2.  The finding in Cates that the defendant’s warning is adequate as a matter of law is one of the best outcomes possible, and was fully justified by the record before the court.

The defendant manufactured CoolSculpting technology, a Class II prescription “medical device that supplies intense cooling to targeted areas of the body to induce lipolysis (i.e., the breakdown of subcutaneous fat cells).”  Id. at *1.  After lipolysis, fat cells are removed from the body through its normal processes.  Id.

The fly in the ointment, and the basis of the Cates litigation, is a known side effect of this treatment, paradoxical hyperplasia (“PH”).  Id.  Paradoxical hyperplasia is “an enlargement and hardening of tissue in the treated area.”  Id.  Of course, the plaintiff alleged that he experienced PH after his treatments, and asserted strict product liability claims based on defective design, strict liability based on failure to warn, negligence, and fraudulent misrepresentation and concealment.  Id.

The court held that the defendant provided “accurate, clear, and unambiguous” warnings to learned intermediaries about the exact injury the plaintiff alleged.  Id. at *6.  This meant the product label made “apparent the potential harmful consequences.”  Id. at *3.  In addition, the defendant warned the “prescribing physician of the possibility that the [device] may cause the injury alleged”—that is, PH.  Id.  That was enough, because “[w]hen a warning is designed to inform a learned intermediary, it is somewhat easier to establish the adequacy of the warning because it will be read and considered by the trained expert.”  Id.

The record reflected that the product manual “contain[ed] a section discussing common and rare adverse side effects,” of which the very first one was PH, and cited four published papers discussing the risks and symptoms of PH.  Id. at *4.  In addition, the defendant provided in-person training to the plaintiff’s providers, which included a PowerPoint presentation with a section devoted exclusively to PH.  The slide included the following information:

[1] Local increase in subcutaneous adipose tissue; [2] Generally develops four to five months post treatment but can be seen as early [as] two months after; [3] Presents as a demarcated border between treated and non-treated area; [4] The affected tissue is firm compared to non-treated tissue; [and 5] There is no evidence of spontaneous resolution of PAH and surgical intervention may be required.

Id.  The same slide also contained “a picture of a PH patient’s midsection” and referenced a JAMA Dermatology article entitled “Paradoxical Adipose Hyperplasia after Cryolipolysis.”  Id.  The defendant even supplied physician users with a sample patient consent form—a form almost identical to the form that the plaintiff’s own provider had used.  Id.

The other side attempted to dispute the accuracy of the warnings by arguing that the defendant (like any product seller) “was highly motivated to downplay the severity, permanency, and frequency of the adverse effect.”  Id. at *5.  The court, however, disagreed, for three reasons:  (1) the plaintiff’s contentions are directly contradicted by the scientific articles cited by the plaintiff; (2) the articles indicate that most PH cases require a single corrective surgery; and (3) every authority cited by the plaintiff describes the frequency of PH as “rare,” which is the same term used in the defendant’s warnings.  Id.  The court held defendant’s warnings to be accurate:  “[t]hese warnings enabled providers to weigh the risks and benefits before making a treatment recommendation.”  Id.

Aside from warnings, the plaintiff’s design defect claim failed under the risk utility test, as “neither of [p]laintiff’s experts offered any opinion that the device’s design was defective.”  Id. at *7.  Indeed, the plaintiff’s own expert admitted a day before her deposition that she had used the same product “on a patient earlier that week” and that she “would not offer [it] if [she] didn’t believe it was safe and effective for the patients [she] chose to offer it for.”  Id.  That’s right—the plaintiff’s expert.  Consequently, the court found that the plaintiff failed “to present evidence that the risk of danger in [device’s] design outweighs its benefits.”  Id.

As to the remainder of plaintiff’s claims, the court agreed with defendant’s arguments as to negligence, negligent misrepresentation, and fraud claims:  “No matter how he dresses them up, Plaintiff’s counts of general negligence, negligent misrepresentation, and fraud are simply repurposed failure-to-warn claims.”  Id. at *7.  Altogether, Cates is well written and worth the read.