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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 2 rounds of coolsculpting on the arms. No results, out 4k. Now the clinic is closed. Let me know if I can join the suit.
I spent over $3000 on cool sculpting and it did nothing promised. Total waste of my money. Count me in for any suits against them.
I had coolsculpting 3 years old and spent $600 for removal of chin fat. They said that it takes 6 weeks 3 years later NO CHANGE. I called after the procedure and they said it takes time. I would like to file a law suit
I had 27 applications of coolsculpting in June 2018. $14,700… I’ve never felt the same since. I had a 2nd degree burn and left with a scar. I filed a complaint with Zeltiq. After several phone calls with consumer complaint dept I was told that my surgeon did not follow proper protcol. My surgeon known to be one of the best in the San Fran Bay Area woud not retun my phone calls and offered no refund.
I would like to file a medical malpractice suit.
I also want to be added to this class action. I spent 5000.00 with absolutely no results. I get sick to my stomach every time I think about the money for nothing. I’m hard working and am still paying for no results. Told to wear a girdle, told to purchase pills to help curve my appetite, drink meal replacement shakes all to help achieve optimal results. Mind you I’m only 135 lbs. not over weight at all just the stubborn belly fat. This company is getting rich form woman that are feeling down on areas of their body that they just can’t achieve result they want. They are getting rich too.
I spent over 5000.00 with no results. I would like to be added to the lawsuit.
I had cool sculpting done in January of 2017, and I could kick myself for doing it. I spent $4,500, and all I got was months of being in pain every time I moved, and then numbness that lasted for a year. I was told that the fat cells would continue to decrease for several months, but that never happened. I was offered a second session for, of course, the same price. This is a total scam, and should not be offered as a valid treatment.
Dear Karin thanks for sharing your experience with the procedure. I had cool sculpting done on my belly with no results as well 1 year ago and 8 months after the procedure I started having debilitating nerve pain around my belly button. I am beginning to suspect that this is related to the procedure since doctors can’t find any explanation for the pain
Can you share with me a description of the type of pain you experienced and if it ever resolved. I have been in agonizing pain for 5 months now but my pain comes and goes. I can get an attack for 2 weeks continously then it disappears for several weeks only to return again. I am so frustrated and would appreciate that you share your experience with me.
I had CoolSculpting done almost 2 years ago. I did my entire abdomen up to my ribs and the area above my buttocks. I am now left with hard/lumpy blocks of fat on my flanks and abdomen- a totally different texture than what I walked in with. I have swollen up in the areas of “treatment” and also look permanently pregnant. Allergen denied my formal claim, citing “extreme weight gain” on my part. It’s definitely PAH. Worst of all, the pain was unbearable during and after the procedure. I was told it would be “mildly uncomfortable” and that I’d be back in the gym the next day, but in reality I was screaming in pain during the process, missed work, couldn’t exercise for weeks, and couldn’t bear to pull on a pair of jeans for 14 days. I still have chronic pain where the applicators were placed. I regret ever walking into Ideal Image in Buckhead, GA and listening to their greedy, fake rehearsed consultation. This is a fraud, medically dangerous, and has stripped me of my health and confidence. How do we all become a part of the class action lawsuits?
I had coolsculpting about a year ago and now have almost constant pain in my right flank/hip. Is there anything I can do?
I too would like to see conversant as well as payment for correct of surgery. It’s so sad that so many women on here at the same experience. Are there any women on here they had the same experience and were able to get thereI too would like to see conversant as well as payment for correct of surgery. It’s so sad that so many women on here at the same experience. Are there any women on here they had the same experience and were able to get Payment and reimbursement successfully? I would like to hear some success stories. Love to all