Inside the Fat
By Andrea Marks
Since September, Nineties supermodel Linda Evangelista has been embroiled in a lawsuit over a cosmetic procedure that she said did the opposite of what it advertised, and ruined her famous physique. Evangelista is suing Zeltiq, the company that markets CoolSculpting, claiming the so-called fat-freezing treatment left her "permanently disfigured."
CoolSculpting is a cosmetic procedure designed to reduce the appearance of fat bulges without surgery. Its advertising says it "literally freezes and kills fat cells" and that it's "FDA-cleared" to treat fat under the chin and jaw, as well as on thighs, the stomach, and back, among other places. In the lawsuit, Evangelista claims that after receiving seven CoolSculpting treatments between 2015 and 2016, she developed a condition known as paradoxical adipose hyperplasia, or PAH, which court documents describe as "a serious adverse effect where the targeted fat cells increase in number and size (and actually grow larger) after treatment and form hard, bulging masses under the skin." In a recent People article, Evangelista said that because of hard protrusions at the top of her inner thighs, which she claims were caused by the treatment, she couldn't wear dresses without a girdle underneath or her bare thighs would chafe to the point of "almost bleeding."
The lawsuit further claims that Zeltiq, the company that invented and markets the procedure, knew about the risk of PAH since at least 2013, based on an annual report for investors that acknowledged the liability risk of people potentially suing them because of the side effect. Despite this, Evangelista claims, they did not adequately warn her or the dermatologist who performed the procedure about the risk.
Zeltiq's lawyers said in court documents that the company fulfilled its obligation to warn Evangelista of the risk when she signed paperwork that included information about the possibility of PAH. Beyond that, they argue her claims fail for other reasons concerning consumer law, statutes of limitations, and whether a proclamation like "safe and effective" can legally be considered a warranty. The company filed a motion to dismiss the case in December. A judge has yet to rule on it. A lawyer for Evangelista said he was unable to comment on the case at this time.
A spokesperson for CoolSculpting provided a statement from the company, saying, "CoolSculpting has been well studied with more than 100 scientific publications and more than 11 million treatments performed worldwide. Rare reported side effects can include paradoxical hyperplasia, severe pain or late-onset pain, and continue to be well-documented in the CoolSculpting information for patients and health care providers and sample consent form given to health care providers to use with patients." The spokesperson added that a warning about rare side effects, including paradoxical hyperplasia, is included in the complete safety information, a link to which can be found on the website for the procedure. The warning says the condition occurs in about one in 3,000 treatments, and describes it as "the gradual development of a visibly enlarged tissue volume, of varying size and shape, in the treatment area." The condition won't go away on its own, it reads, adding, "Surgical intervention may be required."
Personal injury lawyer Louiza Tarassova, who specializes in cosmetic procedure cases and has represented multiple clients about CoolSculpting, says in one sense, lawsuits like Evangelista's are to be expected. Companies like Zeltiq — and its parent pharmaceutical companies Allergan and AbbVie — have to anticipate legal action and plan for it. "The more popular the product is, the more they’re going to be exposed to various claims and lawsuits," she says. At the same time, she condemns Zeltiq's handling of the discovery of PAH, which, as the "paradoxical" in its name suggests, creates the complete opposite effect of what CoolSculpting is supposed to do. "It's such a severe, permanent, adverse effect," she says, noting that she's spoken to some people who underwent surgery for the condition only to see it return. "The way they handled it was so beyond any normal decent behavior, any morality. They didn't take any particular steps. They described in a vague, two-line way that would mislead practitioners."
Evangelista is not the only person who has brought legal action against Zeltiq. Others have claimed in federal court that they experienced adverse side effects from the same procedure.
In 2015, an Ohio doctor sued Zeltiq for breach of contract, among other charges. She claimed she had purchased a CoolSculpting machine for her office after having the procedure demonstrated on herself. She claimed a representative from the company told her any side effects would be "minimal in nature and had only a rare chance of occurring." Shortly after the procedure and subsequent purchase, however, she began experiencing "severe and prolonged pain and numbness," with some numbness becoming permanent. Her case was dismissed later that same year. In 2016, a 39-year-old woman from New York claimed the CoolSculpting machine was "defective" and left her with a "growth in both of her thighs." She dismissed the case later that year.
In 2019, a man from the Bahamas, represented by Tarassova, sued the company saying that a few months after getting CoolSculpting treatments in 2018, he developed a hard mass "the shape and size of a bowling ball" above his navel. He claimed he had not been sufficiently warned about the side effect or the difficulty of reversing it. In 2021, a judge ruled in favor of Zeltiq, saying the company's warnings were legally "adequate," that the man had signed a waiver acknowledging risk of injury. Tarassova and her client have appealed the ruling. "Unfortunately, the judge did not allow the case to go to a jury trial," she tells Rolling Stone. "He ruled that based on his opinion the warnings about PAH by Zeltiq were adequate to warn doctors of the condition. The court's ruling is now under appeal. We are asking the appellate court to review whether the evidence should have been presented to the jury for the jury to decide whether Zeltiq's conduct was wrong."
Beyond lawsuits claiming CoolSculpting harmed people, the company has also faced legal action for its business practices. One med spa sued Zeltiq in 2021, alleging unfair and deceptive trade practices. They claimed the company had sold them a CoolSculpting machine, telling them it would be constantly in use and bring in business while knowing it would in fact be "barely profitable" for such providers. That action is ongoing.
Evangelista's high-profile case is still in process, but one thing is certain: Zeltiq and its owners will not go quietly. Tarassova says companies like theirs are "notorious" for aggressively and expertly defending themselves in court. "These pharmaceutical companies make billions and part of their business is litigation," she says. "They’re very experienced litigators and they have multiple firms working on each case at a time. They have a product to protect."