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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.
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88 thoughts onCoolSculpting Class Action Says Maker Misrepresents FDA Approval
I had CoolSculpting done in 2018. Spent $5,000 for NO visible changes. Felt weak and Sick for a week after second treatment. Lost all of my money and would appreciate being added to the list!
I spent $4,500 and am bigger now around my waist. Please include me in lawsuit. David Todd Singleton
Again if this suit passes add me please I spent 6500 and and is bigger where they sucked fo coolsculpting. They false advertise because they do a thigh your not getting the entire thigh for paying g all that money you only get where the machine can fit for its size only and a abd is considered 3 areas it’s a money scheme
I have spent over 1k on this procedure with NO result whatsoever! Please add me to the Settlement. Thank you
I would like to be added to this class action lawsuit. I had this procedure done and have had horrible results. I now have to pay for liposuction to fix the damage. I haven’t been able to model for over a year now. :(
I would like to be added to this lawsuit.
Did you find out how to be involved? I’m struggling a lot with this atm— after trying to be positive through the whole thing I have hit a wall.
I had cool sculpting on all areas of my abdomen in February 2020, just for a more flat look. I now have an enlarged abdomen end it will not go away. Not only am out the money I spent but I’m seriously battling body image and depression because of it. I would love to get this product off the market!
I spent $5000 and got NO results. If there is a lawsuit for false advertising, I’m in!
I had coolsculpting done 2 years ago on my abdomen. Now I have an sort of oblong shaped pad of fat right on my belly where she put the paddles. It sticks out. Never had it before. It’s like it sucked all the fat to that one area! Would like to be part of any lawsuit.
I had cool sculpting done around May 2018. After couple months I noticed my abdomen getting bulgy and sticking out more. I have a noticeable dent didn’t have before. I feel so depressed. I spent almost $5,000 I feel I have a pillow stuck in my stomach. I need help ! I want them to fix it Thank you