Image: Prada

Supermodel Linda Evangelista has filed a new $50 million-plus lawsuit against ZELTIQ Aesthetics, Inc., accusing the subsidiary of pharma giant Allergan of destroying her “quality of life [and] her career,” and causing her to suffer from “severe and permanent personal injuries and disfigurement” as a result of the company’s failure to adequately alert consumers about the harmful potential side effects of its CoolSculpting cosmetic treatment. In the newly-filed suit, Evangelista claims that Delaware-based ZELTIQ is on the hook for products liability, negligence, breach of warranty, and various types of fraud, among other claims, in connection with its willfully “deceptive acts and practices and false and misleading advertising.”

According to the 54-page complaint that she filed in a New York federal court on Tuesday, Evangelista asserts that between August 2015 and February 2016, she underwent CoolSculpting treatments, an “effective, non-invasive alternative to liposuction surgery for contouring small areas of the body … based on ZELTIQ’s representations that CoolSculpting was safe.” The famous model claims that she was unaware of the potential dangers associated with the procedure, including the risk of paradoxical adipose hyperplasia (“PAH”)  – which is “a known serious adverse effect where the targeted fat cells increase in number and size (and actually grow larger) after CoolSculpting treatment and form hard, bulging masses under the skin” – because ZELTIQ’s direct-to-consumer advertising “misrepresented to consumers that the CoolSculpting System was safe and effective for its intended use and intentionally omitted material information by failing to disclose known health risks and serious adverse effects.” 

To make matters worse, Evangelista claims that ZELTIQ was “aware of the actual incidence and occurrence of PAH, and other serious, adverse effects, and knew the liability it faced as a result at least as early as March 2013.” Despite such “clear knowledge of the incidence and occurrence of PAH after use of the CoolSculpting System,” the complaint states that ZELTIQ “failed to inform (or adequately warn) consumers, including Ms. Evangelista, of the known risk of developing PAH as a result of using the CoolSculpting System.” 

In fact, Evangelista argues that ZELTIQ did the opposite, and “continuously made affirmative representations in its direct-to- consumer advertising and marketing that the CoolSculpting System … [has] proven to be a safe and effective treatment for non-surgical fat reduction.” In doing so, she claims that ZELTIQ “failed to adequately warn and intentionally omitted and/or concealed material information about the serious health risks and adverse effects” even though, as the manufacturer of the CoolSculpting System, the company “had a duty to warn of all known health risks and adverse effects associated with use of the CoolSculpting System, particularly the incidence and occurrence of PAH.” 

After receiving multiple CoolSculpting treatments, Evangelista says that she has “suffered severe and permanent physical injuries and disfigurement as a direct and proximate result.” All the while, she claims that she continues to suffer from “other severe and personal injuries that are permanent and lasting in nature, severe physical pain and suffering, emotional distress, mental anguish, diminished enjoyment of life, medical expenses, and a complete loss of income as a result of the physical injuries and permanent disfigurement that she suffered as a direct and proximate result of using ZELTIQ’s CoolSculpting System.” 

Had ZELTIQ “properly disclosed and adequately warned consumers, including Ms. Evangelista, of the known health risks and serious adverse effects associated with use of its CoolSculpting System,” Evangelista says that she “would not have undergone any treatment using the CoolSculpting System.” 

With the foregoing in mind, the model argues that ZELTIQ is “strictly liable in tort … for designing, developing, manufacturing, marketing, distributing, advertising, promoting, and/or selling a defective product in the form of its CoolSculpting System,” and sets out claims of strict products liability, negligence, breach of express and implied warranties (including warranties that CoolSculpting is “safe and effective”), fraudulent and negligent misrepresentation, fraudulent concealment (of information about the risks of the treatment, which it had a duty to disclose), fraud and deceit, and violations of New York General Business Law, which prohibits “unconscionable commercial practices.” 

In addition to compensatory damages in the amount of $50 million, Evangelista claims that she is also entitled to “punitive and/or exemplary damages for the wanton, willful, fraudulent, reckless acts of ZELTIQ which demonstrated a complete disregard and reckless indifference for the safety and welfare of the general public and to Ms. Evangelista in an amount sufficient to punish ZELTIQ and deter future similar conduct.” 

Evangelista addressed the newly-filed suit in a statement on Instagram on Thursday, stating that “with this lawsuit, I am moving forward to rid myself of my shame, and going public with my story.” 

The case is Evangelista v. Zeltiq Aesthetics, Inc., 1:21-cv-07889 (SDNY).