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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 too was scammed by this procedure I paid 4500.00. I too am bigger now.
I too had extremely horrible results
My abdomen continues to get bigger after treatment. I have lumps and am totally disfigured. I have lost weight my my measurements r. Bigger! I returned to spa & was told I now needed tummy tuck. Imagine. They wanted me to use them for another procedure. I asked for before and after photos and even they after looking at them admitted my dimensions were bigger. I contacted zeltiq and asked them for help but never got any satisfaction
It’s a disaster. I paid $3000 to be disfigured.
I was left botched, bruised lumpy stomach. Aka fat necrosis. They are no help! I’m still trying to fix this issue a year later. Do not do coolsculpting it is not worth it!
I was also scammed by this procedure, no results, I will be joining the lawsuit as,well.
I’d love to sue to get my money back! Not lost an inch…..actually gained some! How can I join this lawsuit?
I also got scammed into this procedure with absolutely NO results. Such a waste of hard earned money i’d like to get back.
Also a victim of this ‘scam’ so I’ll be signing up to follow the progress. I hope we can all get some money back.
I️ have Cool Sculpting done and it’s been 3 months on 11/5/2017. I️ had it done at Restivo Plastic Surgey in Napa CA. Please if anyone is thinking about doing this procedure, DON’T!!! it’s a scam. There is no results in fact it made me gain weight. The office had the nerve to call me to come in and get another cycle done and didn’t even hear how unsatisfied I️ was. And very disappointed. I️ told the doctor why would I️ give away more of my money? Now I’m stuck with a huge bill to pay off. Please take the advise from people who have had it done. Don’t make these people rich. We all want results and great result because that’s what should be given when we pay good money for any procedure.
I paid $4,000 for CoolSculpting in February I sit in the office for over 12 hours I had such high hopes and it was a scam I’ve known only not lost any weight I gained weight. I was never told that it may not work I was told that you may not lose pounds but you would lose sizes.
I’ve had coolsculpting done, with no results, feel I was mislead and would like more info on a class action.
I also would like to know if they are being looked at for possible spiffing of Dr’s and/or techs like the pharmaceutical industry was? I have a message from Coolsculpting saying it takes 4 to 6 applications and in my case the tech told me it would only take 1.
I had CoolSculpting done 7/2017 and had a lot of pain and numbness after along with intense itching on the inside for months after. I did not have any success and in fact am bigger in my stomach and love handle areas where I had the treatments as well as have gained 15 pounds since the treatments. Very misleading because I am pretty sure they said the fat wouldn’t “come back” where I had the treatments. Their financing is also a joke. You couldn’t sign up for auto pay and the minimum payment reduced each month when I was told I had to pay $190/month over 24 months so I wouldn’t have to pay interest or finance charges. I would be interested in pursuing a class action lawsuit against them!!! What a waste of over $4,000.
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same thing happened to me on the financing. No auto-pay – deceptive ways they ‘show’ you what you owe and put the minimum payments. I got hit with hundreds of dollars in finance charges
U R not a nice person. I’m & guessing u work for these SCAMMERS!
I lost 15 lbs the first month & I measured bigger in waist, abs, obliques, back & at bra line.
I AM LARGER THAN WHEN I STARTED & it cost me $8500!!!
I managed health spas for 8 years and this is not normal weight gain!