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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’m going through a similar experience as everyone else. I had the cool sculpting done on my flanks. Now I’m been told by plastic surgeon, that I have paradoxical adipose hyperplasia. This is caused by cool sculpting, and usually occurs in men age 40 and older.
I did coolsculpting a few months back and they told me they would pay for Lipo if it didn’t work and of course it didn’t. Even they a gain a few pounds they made up an excuse. What if anything can I do?
The issue I have is with the advertisement on TV, the company states the treatment will remove the fat cells. The fat cells are affected by the product and eliminated by the bodies own function. Also, I researched fat cells and they have an incredible ability to decrease and increase in size. Meaning no matter how many are destroyed the ones left behind will enlarge if the food intake is larger than “needed” for one’s body. Perhaps this is the reason areas “grow” back mis-shappened? I just wonder if that information is given straight forward to the consumer before purchase of procedure? Thank You for letting me comment on this product! Haven’t used it and not planning to!
Paid almost $3000, same thing after few months my abdomen and love handles got bigger, I called them, they were very nice, they offered another cycle, I did, after a couple months not improvements but looked worst. Now my abdomen is double and I feel so bad, also I wasted money, any solution???
I also had the procedure done and the area got larger! I have emailed, called, and been emotionally and physically scarred by what I thought was an FDA approved procedure. I am now left with embarrassing and sometimes painful lumps that I try to hide under my clothes. Look into Paradoxical adipose hyperplasia. It happens more than we know and goes unreported. Something needs to be done.
I had it done i2 times on my stomach and 6 of my friends had it done in different areas we are all left with worse results then before we did it my stomach is permanently ruined not to mention the money we spent on this . Can someone contact me so we can be on this thread because we would like our money back for the fraud and lies we were told
Did anyone get help?
I HAD THIS DONE NOV. 2017 (ABDOMEN AREA) AS OTHERS HAVE REMARKED LOOK PREGNANT NOW .BELLY LARGER THAN BEFORE PICTURES. ALL OVER ABDOMEN BIGGER. THEY WILL DO MORE BUT WILL COST ME. DO NOT WHAT ANYMORE,MIGHT MAKE IT EVEN WORSE. HELP
I to was told this product was FDA approved. I paid $3k for treatment. I didn’t see any result. When I contacted the facility they said they could do more treatments. Of course it would cost me more money. What a FRAUD! I would like to join in on this class action.
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. 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!
I had this procedure on my abdomen and noticed no difference at all. Total waste of $1500
Me too!!! Abdomen and thighs. Made it worse.
I left a lenghthly reply a couple of weeks ago. Please let me know you received it
I had the stomach area done it was a double and my stomach was not black and blue it was black for a week the pain was unbearable I had other areas done it does not work I now seem to have a permanent bulge in my stomach I look permently pregnant. I had it don’t in NY at the same time my friend had it done in Florida and it failed ya both
I had abdoman done in nov 2017 stomach bulge very bad look pregnant, so sorry i did this and lost my money anything I can do to fix????
Hi, same for me it is PAH a consequence of fat freezing, the only solution is the liposuction, they told me that they will pay for that, I have to pay in advance, the day before the surgery they told me that if I will not wait 4-6 weeks they won’t pay me, they are a not reliable. They have to pay for the damage they did to all of us!