LOS ANGELES (Legal Newsline) – The defendant in a class action regarding a “cool sculpting” product supposed to reduce body fat is seeking dismissal of the suit.
Zeltiq Aesthetics Inc. filed its motion to dismiss first amended class action complaint on Aug. 21 arguing that the plaintiffs’ claims brought under federal consumer protection laws must fail because Zeltiq actually did receive clearance by the Food and Drug Administration for its CoolSculpting System.
Defendants refute the plaintiffs' claim that the phrase “FDA approved,” when in fact the device was only “FDA cleared,” is misbranding.
Carmen Otero and Abbey Lerman filed suit in April against Zeltiq Aesthetics Inc. alleging that the CoolSculpting system it markets to spas and businesses is advertised falsely as being approved by the Food and Drug Administration.
Plaintiffs argue that FDA approval, which requires rigorous testing and trials, is very different from FDA clearance. They allege that consumers are misled into thinking that FDA “clearance” in the same things as “FDA approved,” when it is not the same.
In its motion, Zeltiq argues that “Zeltiq had no duty to educate consumers on parameters of the 510(k) process or clarify that FDA Cleared is not the same as FDA Approved.”
Zeltiq also notes that “...their attempt to impose an additional, novel duty of disclosure on Zeltiq is contrary to California law, which rejects a broad obligation to disclose. Instead, the law imposes liability on manufacturers for omissions only where the undisclosed information relates to a known defect in a product that creates an unreasonable safety hazard,” the motion states.
The company promotes its product as “...an innovative way to contour your body by freezing unwanted fat away with no surgery or downtime” on its website.
Zeltiq is represented by Hueston Hennigan LLP law firm in Newport Beach, California. Plaintiffs are represented by Capstone Law APC in Los Angeles.