CoolSculpting Class Action Says Maker Misrepresents FDA Approval

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The maker of the CoolSculpting fat reduction system misrepresents the device as having earned FDA approval, according to two California women.

Plaintiffs Carmen Otero and Abbey Lerman claim defendant Zeltiq Aesthetics Inc. has been falsely advertising its CoolSculpting system in a way that misrepresents the device’s clearance by the U.S. Food and Drug Administration.

They say these misrepresentations allegedly lead consumers to think the CoolSculpting system has earned FDA premarket approval, a different and more rigorous certification.

According to Zeltiq’s promotional materials, the CoolSculpting system is a “non-surgical fat reduction treatment that uses controlled cooling to eliminate unwanted fat cells.”

Zeltiq markets the CoolSculpting system to businesses like spas and medical offices, who then provide the service directly to their customers. Treatments using the CoolSculpting system can cost between $2,000 to $4,000.

On its website and in marketing materials, Zeltiq promotes the CoolSculpting system as being “FDA-cleared” and “cleared by the FDA,” according to Otero and Lerman.

The plaintiffs argue representations like these are fraudulently designed to make consumers think the CoolSculpting system has earned FDA approval. Such approval would require the device to go through a rigorous testing process and would imply an endorsement by the FDA as to the device’s safety and effectiveness, they claim.

In fact, the plaintiffs say, these advertisements refer only to the FDA’s premarket notification clearance available under section 510(k) of the Medical Device Amendments to the Food, Drug, and Cosmetic Act.

Under the 510(k) process, the FDA may grant “premarket notification clearance” for medical devices that are “substantially equivalent” to devices already on the market as of May 28, 1976. The 510(k) process does not require the new device to undergo the testing required for “premarket approval.” Plaintiffs say that certification through the 510(k) process does not constitute “FDA approval.”

“[Premarket approval] requires rigorous trials and testing, while 510(k) merely entails a finding by FDA that Defendants’ medical device is substantially equivalent to a pre-existing device that was in commercial distribution before May 28, 1976,” the plaintiffs say.

In its representations about CoolSculpting, defendant Zeltiq exploits confusion between 510(k) clearance and premarket approval, according to this CoolSculpting class action lawsuit.

Such representations are specifically prohibited by FDA regulations, the plaintiffs say. The FDA says any representation that equates premarket notification with premarket approval is “misleading and constitute misbranding.” The plaintiffs point out that the FDA notified Zeltiq of that regulation in its initial premarket clearance letter of September 2010 and in all subsequent clearance letters.

Otero and Lerman seek to represent a plaintiff Class consisting of all persons in the U.S. who bought a CoolSculpting treatment within the four years preceding the filing of this action. They also propose two subclasses of Class Members who reside in California.

They are asking for a court order barring Zeltiq from any false or deceptive advertisement of the CoolSculpting system. They also seek an award of compensatory, statutory and exemplary damages, restitution and disgorgement of profits, and reimbursement of their court costs and attorneys’ fees.

The plaintiffs are represented by attorneys Lee A. Cirsch, Robert K. Friedl and Trisha K. Monesi of Capstone Law APC.

The CoolSculpting False Advertisement Class Action Lawsuit is Carmen Otero and Abbey Lerman v. Zeltiq Aesthetics Inc., Case No. BC659192, in the Superior Court for Los Angeles County, California.