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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 cool sculpting done over a year ago and I believe I have PAH and now my self esteem has went from on a scale 1-10 to a 5. I can’t even suck in my bulge, it’s very noticeable, when before the procedure I could get away with it.?. Is there an exercise or other home remedy that I can do to get rid of this problem. I could barely afford the first. I THINKE THE COMPANY SHOULD BE HELD RELIABLE $ or reimburse me for laser light therapy. I want to be in the lawsuit.
I had the procedure 2014 because it was a non invasive procedure. It was extremely painful and the results were horrible no matter how much weigh I lose the area of the treatment is all fat and impossible to lose it unless I undergo plastic surgery.
I did it 1 year ago spent $3700.00 they tell you your a great candidate and the maybe how many treatments you need on certain areas. But truly the machine isnt big enough for certain areas and a tech does it not a doctor and where its placed etc., I had no results yet doctor said yes trust me no results and my abdomen it swollen ever since and some places hard., yet told me I gained weight . Actually I had been watching my weight but again swollen but it all they could say. I have a meshed intestine area and just feels as if the machine sucked it and hasn’t been right since. Pain in legs no sleep constance ache when did leg area as well. It’s just a money pit scheme.
How does one join this suit or is it automatic?
Agreed, I have the same question because I had it done a year ago and I have two large Paradoxical adipose hyperplasia On my abdomen and I’m seeking reimbursement and payment to get it fixed
PAH is extremely uncomfortable, embarrassing and painful. I was told by doctors office who performed the cool sculpting procedure on my abdomen that they had to do paperwork and would send to Allergan. Had to get quotes for liposuction to send with paperwork. I was paid the amount for surgery. I have just had to pay out of pocket for second liposuction procedure due to first not changing my deformed abdominal area. Not sure if second will work either. Very unhappy and would like to be added to class action suit. Would like to know if there is a suit with regards to the painful PAH that results in hard and difficult to remove fat. Please let me know.
Hello – I also developed PAH after coolsculpting last year – It looks horrible! I contacted them and they are willing to pay for lipo – however I really do not want to undergo lipo – I do not what to do – but feel horrible everytime I look at myself in the mirror.
Had three cycles and was promised results . I was told I was a great candidate. No results what so ever and it is all documented with pictures and measurements at the place I had it done . it is a total scam . it is painful and it is sold as being painless . what a waste of money and I contacted both the place I had it done and the company with no answer . after the first time I complained I was given a free cycle . but after no results again I called and was told pretty much oh well .
I’ve spent $6000 on Coolsculpting and am bloated and mishapened now. I’m depressed and horrified at how I look now. I don’t know where to turn and feel ashamed at how horrible my body looks now. It’s a crime. Total fraud.
I had cool sculpting in Mar 2016, by October 2016 i had corrective surgery, and again in Dec 2017. Here it is Jan 2019 and i need further corrective surgery for disfigurement. No one will take my case. They ruined my body. H E L P ME PLEASE
I am so sorry for your experience. I paid $2500 for just my arms. Was told needed 2 treatments. I began in August and ended in October. It’s February and have visible results showing that Coolsculpting works. I was under the impression that I would have 100% positive results.
OMG I HAVE THE SAME EXACT ISSUE
I had cool sculpting 3 1/2 years ago. It was extremely painful and now I have big fat pads on my back and belly where I was treated. I saw a plastic surgeon last week and he feels I need to seek legal help to pay to fix my body. It cost me $6000. I have cried many tears over this stupid choice. If I had known this was a possibility, I would NEVER have done it!
I had cool sculpting in Mar 2016, by October 216 i had corrective surgery, and again in Dec 2017. Here it is Jan 219 and i need further corrective surgery for disfigurement. No one will take my case. They ruined my body. H E L P ME PLEASE