May 11, 2022 – CoolSculpting Body Deformity Class Action Dismissed
On April 21, 2022, the proposed class action detailed on this page was dismissed with leave to amend the case.
In a 10-page order, U.S. District Judge Yvonne Gonzalez Rogers granted AbbVie’s motion to dismiss the case on the grounds that the plaintiffs failed to provide sufficient evidence showing that the court had personal jurisdiction over the lawsuit. The plaintiffs failed to adequately establish, essentially, that AbbVie was the correct party to sue and that California was the correct state in which to do it, the order relays.
In order for a court to have personal jurisdiction over a dispute, there must exist a connection between the forum state, in this case California, and the underlying controversy, the order explains.
Although AbbVie is not a California resident, the plaintiffs argued that it was responsible for Zeltiq’s activities in the state after it merged with Zeltiq’s parent company and assumed control over its CoolSculpting business. Judge Rogers found that the plaintiffs’ theory, however, was “incoherent and does not persuade that jurisdiction is proper” in the dispute.
Moreover, the judge found that although the plaintiffs placed “substantial emphasis” on the merger in an attempt to tie AbbVie to California, Zeltiq is actually a subsidiary of AbbVie and operates independently. Thus, not enough of a connection existed between AbbVie and Zeltiq’s business in California to allow the proposed class action to proceed, the dismissal order relays.
Judge Rogers gave the plaintiffs until May 6, 2022 to indicate how they wish to proceed in light of the dismissal order.
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A proposed class action alleges AbbVie’s purportedly fat-reducing CoolSculpting System can cause permanent deformities to a person’s body by damaging tissue in the targeted area.
The 82-page complaint claims AbbVie has known since at least 2011 that its non-surgical CoolSculpting device, touted as able to reduce stubborn fat bulges “in the areas that bother you most,” can cause patients to develop a condition called Paradoxical Adipose Hyperplasia, creating the opposite effect of the product’s advertised purpose. Per the case, use of the CoolSculpting device, sold by AbbVie unit Zeltiq Aesthetics, can create a deformity on an individual’s body much larger in size than the intended stubborn fatty area, and the condition does not resolve on its own given tissue affected by the product does not respond to weight loss.
“Thus, the only method of removing [Paradoxical Hyperplasia] is through invasive surgery,” the lawsuit, filed in California on May 28, reads. “The condition is solely attributed to the CoolSculpting device.”
According to the lawsuit, AbbVie has received thousands of reports of users developing Paradoxical Hyperplasia since the CoolSculpting device went on the market yet has creatively chosen the words it’s used to disclose the dangers to patients and providers. The company, the suit alleges, has created an environment wherein consumers have not been properly informed of the risks of undergoing the CoolSculpting procedure, in particular of developing Paradoxical Hyperplasia, due to what the case describes as the ambiguous and misleadingly written nature of the defendant’s disclosures. At the same time, businesses who’ve offered CoolSculpting have found themselves in an unfavorable scenario in that they, too, have not been advised by AbbVie of the alleged harm linked to the device, according to the complaint:
“Defendant withheld critical information about [Paradoxical Hyperplasia] from CoolSculpting providers, entangled itself in the providers’ CoolSculpting business, and gave assurance to providers that if a patient developed PH, Defendant would cover the claim with its ‘liposuction program.’ This created an atmosphere wherein providers did not understand the gravity of the adverse effect and were not motivated to disclose the risk thereof to their patients.”
CoolSculpting is a body contouring procedure that’s supposed to utilize a process called Cryolipolysis to freeze fat cells and program them to die over the course of several months, the lawsuit begins. The Cryolipoylsis process, per the case, was developed and patented in the early 2000s by Drs. Richard Rox and Dieter Manstein at Harvard University and Massachusetts General Hospital.
In 2005, the lawsuit says, AbbVie made a deal with Massachusetts General Hospital for an exclusive license to manufacture a medical device based on the patented Cryolipolysis process, and soon thereafter developed the CoolSculpting System to administer the procedure on patients looking to reduce stubborn fat without undergoing surgery.
The concept of Cryolipolysis is based on a theory that fat tissue is more vulnerable to cold temperatures than the skin, the suit continues. Therefore, if cold is applied to an unwanted fat bulge, the temperature is thought to kill the fat cells and leave the skin intact, the lawsuit states, noting that fat cells are not killed immediately but rather “programmed” to die over time. Those who undergo the procedure are expected to see “results” in the treated area in one to three months, according to the case.
Per the lawsuit, AbbVie’s CoolSculpting device is the only medical device in the U.S. with FDA clearance to offer body contouring services by way of Cryolipolysis. The device works by applying suction to a person’s body and cooling the treatment area for 30 to 60 minutes in cycles, the case relays. According to the suit, CoolSculpting is “relatively expensive,” with an average session costing between $2,000 and $4,000.
The lawsuit argues, however, that the benefits of CoolSculpting, i.e., the elimination of fat cells through cold temperatures, “makes sense in theory” but, in practice, is “nothing more than an illusion.” In reality, the case says, the CoolSculpting device can only attempt to kill fat cells by “traumatizing them” with cold temperatures “in the hopes of a later death.” As the suit tells it, two problems stand out with regard to the CoolSculpting device:
“The problem with the CoolSculpting device is twofold. First, the CoolSculpting device cannot ensure that any of the fat cells it targets will actually die. Second, even if some fat cells die, the effect is minimal and temporary.”
Even when the CoolSculpting device works and kills some targeted fat cells, the unwanted fat bulges “easily return” given the device does not eliminate all fat cells in the targeted area, the suit says. The void the device creates is quickly filled by the expansion of surviving fat cells, resulting in the opposite of the intended effect, according to the case.
“Therefore, although a CoolSculpting patient may initially see a reduction of fat in the treated area, the stubborn fat bulge will inevitably return if the patient does not adhere to a very strict diet,” the lawsuit reads.
In other cases, the suit states, patients have had their body’s healing process kick into gear in response to the “cryo-assault” of the CoolSculpting system, causing injured tissue to go into cellular adaption, the process by which cells act abnormally so as to acclimate to an adverse environment:
“Cellular adaptation can present itself in various ways including, hyperplasia – a process in which a cell multiplies, thereby increasing the size of the affected tissue, and hypertrophy – a process in which a cell enlarges caused by an increase in organelles, and structural proteins, also resulting in an increase in the size of the affected tissue.”
Paradoxical Hyperplasia is an example of the body’s response to injury and can cause a permanent increase in the size of the fat bulges CoolSculpting is intended to treat, the suit says, stressing that once PH develops, “the area affected … will never get smaller” without surgical intervention.
The lawsuit alleges AbbVie has since at least 2011 possessed knowledge that the CoolSculpting device can cause pathological tissue damage resulting in fibrosis of the treated area and disfigurement. Over the years, however, AbbVie has taken an active role in helping CoolSculpting providers diagnose PH and mitigate their liability exposure, including by offering patients money in exchange for a legal release, the lawsuit alleges.
Additionally alleged in the complaint is that AbbVie downplayed the seriousness of Paradoxical Hyperplasia to the FDA and misrepresented the nature of the condition to CoolSculpting providers. Moreover, the suit charges that AbbVie, amid intense marketing of the CoolSculpting device to the general public and aggressive pursuit of doctor’s offices, medical spas, and other cosmetic procedure providers in attempting to sell the product, “masterminded a system” whereby the company has injected itself into a provider’s practice so as to become inextricable from patients’ treatment with the device.
The lawsuit looks to represent all individuals nationwide who purchased a cycle or cycles of the CoolSculpting procedure, as well as a “subclass” of those in the United States who underwent the CoolSculpting procedure and suffered tissue damage in the form of Paradoxical Adipose Hyperplasia.
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