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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 would be interested in filing a suit against Cool Sculpting if there is one. I had it done in 07/2016 and have had zero results after having such a hefty price tag for this procedure to be done. I measured myself before and after and a year and 2 months later there is no change. On top of that they mis-lead me about their financing and the payments.
looking for an attorney…had 3 series of cool sculpting and 9 months later I have been diagnosed by my provider a PA and a board certified plastic surgeon with PAH. Undergoing lipo and a mini tummy tuck to rid myself of the handfuls of spongy, sensitive fat on my braline, tummy and flanks. According to my provider they are told by the parent company and reps that they will reimburse patients for corrective surgery only if diagnosed with PAH.Well guess what I was..and they denied the claim saying its not consistent with PAH. they never contacted either of the physicians who performed a physical examination they just denied the claim based on 3 photos. I am seeking an attorney who will take them on. only 34 documented cases..make sure you have it documented!!!!!
Hi Ann!
Can you give us an update on whats been going on with cool sculpting?
on top of that they are going after small spa and doctors office filing law suit against them stating they are offering services not FDA approved like the services they offer!!!
I had cool sculpting done a little over a year ago. I’ve thought about contacting an attorney before, but didn’t want the hassle. First of all I had zero rusults in fact I got better bigger in my stomach ( treated area). And more importantly I think I have nerve damage. The procedure was WAY more painful then they ever warned me. I was told in an email that I would be comfortable during the procedure. I had pain during, after continually for days and I still have pain. Please contact me if you can help! Thanks!
you should seek an attorney . I had 3 cycles of cool sculpting, was diagnosed with PAH by my provider and a board certified plastic surgeon. Allergan who know owns coolsculpting denied the claim that it was PAH, they never contacted either of my providers who performed physical examinations. According to my provider the cool sculpting reps indicate that drug company will pay 100% of corrective surgery if you are diagnosed with PAH, I was but they medical review is saying it is not consistent with PAH. You should speak out about this as more people should be made aware of the side effects.
I went for a free consultation today and signed up for the belly and back treatment for this Friday. Perhaps I should cancel the appointment while I can? Estimated cost to me $5670.
Advice: Don’t do the Cool Sculpting!! I REGRET it TERRIBLY! I NEVER had upper fat between breasts & after Cool Sculpting NOW DO! It’s affected my confidence! I did it to IMPROVE my Body; NOT have Body DISFIGURED! Partner noticed it within days of getting done. HURT worse than anything in my life! I should have told staff to stop. It was Most excruciating PAIN EVER, & in area I had NO FAT in! I’m DAMAGED. Pennsylvania
I’ll join Legitimate Class Action Suit. Hope you SAVED yourself & Didn’t Do Cool Sculpting!!
Two sessions without results. I was devastated as the decision was not made quickly. I work out (High Intensity spin and weight classes) 5 days a week and was very much misled by not only the promise of the FDA approval but the advertising of targeting stubborn fat.
My abdomen IS larger now than before! Its so bad I wear a baggy shirt to work out in. So embarrassed I will not tell anyone I had it done.
Please contact me to discuss adding me to the class action suit.
Change your thought process about what you eat: Eat animal proteins, fats, reduce or ditch starches all together, and eat less frequently (practice daily fasting). Also, perform 1-2 HIIT session per week, with at least 24-48 hours in between each.
I spent $5000 with no changes to my body. Even the procedure administrator had to study the photos to try to prove a “difference” in my body. Her solution was to put the before and after photos side by side with the after photo zoomed out to make it appear my body had slimmed down. I also did this believing it was FDA approved. Please contact me regarding the class action lawsuit and seeking damages similar to what the California plaintiffs are seeking.
I had cool sculpting done now one year ago and initially I had so much pain that I was not told about. I was told there’s no down time and you can go back to work. Not true I felt bruised from the inside and it was excruciating. The pain was so great that when I had to do the flanks I backed out because I had months of pain that hurt on touch. Eventually the pain went away but the sides and MY BACK took all the fat that my stomach supposedly had frozen away. Its absolutely the worst thing that can happen to a body! Take away the belly pooch and replace it with a box back with fat rolls!! If I KNEW I would have NEVER EVER done the treatment. I had a waistline I had an hourglass with a pooch now I have a fat back and I’m so depressed I cry all the time. I cant wear any of my clothes – I never want to leave the house, I dont want anyone to hug me for fear that they’ll touch my once smooth back which is now …… deformed.
When I asked about the fat transferring the clinic just said if you gain weight, but what if you didnt gain weight?! BAD BAD all around BAD.
A few months ago I underwent the Cool Sculpting procedure. The worst decision that I have ever made. My abdomen is now larger than it was before I had the procedure. I had to be hospitalized with the worst pain that I have ever experienced in my life. I developed a really bad kidney infection. I regret the day i decided to have this procedure. Big waste of money. I am from Michigan and would love to be part of a Class Action Lawsuit… Thanx Brenda
The case is still moving through the courts and has not yet reached a settlement. Claim forms are usually not made available to consumers until after a court approved settlement is reached. We recommend you sign up for a free account at TopClassActions.com and follow the case. We will update the article with any major case developments or settlement news! Setting up a free account with Top Class Actions will allow you to receive instant updates on ANY article that you ‘Follow’ on our website. A link to creating an account may be found here: https://topclassactions.com/signup/. You can then ‘Follow’ the article above, and get notified immediately when we post updates!
You can also contact class counsel with any questions. Counsel is listed at the bottom of the article, and can be Googled for contact information.
I had one coolsculpting session about nine months ago and I am suffering from paradoxical adipose hyperplasia(PAH).
please contact me to discuss adding me to the class action suit.
I, too, was fooled into thinking Zeltiq’s CoolSculpting treatments were FDA approved, which is the primary reason I decided to undergo the fruitless $6,400 treatments that resulted in no fat loss and an abdomen that looks worse than it did before the treatments.
To that end, please contact me to discuss adding me to the class action suit and obtaining damages equal or similar to what the California plaintiffs are seeking.
Thank you.