SoClean Class Action Lawsuit Filed Over Health Risks From CPAP Sanitizing Products

A class action lawsuit has been filed over potential SoClean health risks, alleging that popular devices used to clean and sanitize CPAP, BiPAP and mechanical ventilation machines release ozone gasses at dangerously high levels.

The complaint (PDF) was filed by Anthony Sakalarios on September 3 in the U.S. District Court for the Southern District of Mississippi, indicating false and misleading claims have been made about the SoClean 2 CPAP Sanitizing Machine, SoClean 2 Go CPAP Sanitizing machine and related products sold in recent years.

SoClean devices work by generating ozone to sterilize and deodorize CPAP breathing machines, which are used to treat sleep apnea. However, the SoClean lawsuit notes that to be effective at sanitizing the devices, the devices must emit levels of ozone that are higher than can be safely tolerated by humans or animals.

SOCLEAN LAWSUIT:

Did you experience health problems after using SoClean to sanitize your CPAP machine?

Sakalarios indicates he, and other similarly situated owners the SoClean machines, were misled by false advertising, which claimed the devices used “activated oxygen,” instead of telling consumers that it releases dangerous levels of ozone that exceed acceptable federal safety standards. In the company’s advertisements, it never mentions the use of ozone, and in some cases denies the devices are emitting ozone when asked directly, according to the complaint.

In fact, the advertisements claim the devices release no “harsh chemicals” at all, and Sakalarios’ lawsuit maintains that ozone released by SoClean machines is, in fact, considered a harsh chemical.

“The foregoing false claims deceive consumers into believing that the SoClean devices do not generate ozone, do not release ozone into the atmosphere, and are safe, healthy, and suitable for use in consumer’s bedrooms,” the lawsuit states. “SoClean’s falsehoods have allowed it to command a ninety-percent share of the market for CPAP sanitizing/sterilization devices.”

In late February, the FDA issued safety communication, indicating patients and healthcare professionals should not use what the agency considers illegally marketed ozone gas or ultraviolet (UV) light cleaning devices to disinfect or sanitize CPAP machines. The warning came following nearly a dozen reports of patients suffering respiratory complications.

Individuals reportedly experienced coughing, difficulty breathing, nasal irritation, headaches and asthma attacks after using these types of devices.

Just a few months later, in June, a massive Philips CPAP machine recall was issued, following the discovery that a polyester-based polyurethane (PE-PUR) sound abatement foam inside the machines may degrade and release toxic particles directly into the air pathways.

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Philips has suggested that use of SoClean and other similar cleaning devices involving ozone and UV light may exacerbate the foam’s degradation, which could worsen respiratory side effects for CPAP machine users.

The company now faces a mounting number of CPAP machine lawsuits and class action claims, indicating that users have been diagnosed with cancer, severe respiratory problems and other health complications.

Sakalarios’ lawsuit seeks class action certification for citizens of Mississippi who purchased SoClean devices to clean and sanitize their CPAP, BiPAP or mechanical ventilation breathing machines. He presents claims of breach of warranty, fraudulent misrepresentation, fraud by omission, negligent misrepresentation, unjust enrichment, failure to warn, and calls for the manufacturer to provide medical monitoring for the devices’ users.


266 Comments


KAREN
Is there a class action in CA? I bought mine this last year and am concerned and afraid to use it now!

Walt
I have been using the So-Clean for over 5 years. I would wake up every morning with severe nasal congestion that would take over 1-2 hours to go away.I would cough up mucus all day.These symptoms got much better after I stopped using the So-Clean. I am concerned about long-term effects from using this device.

Kasandra
Been using the so-clean machine for a little over a year. Started having trouble breathing and gasping for air when using my CPAP machine. Need to know if other states are going to be included in this class action lawsuit. I did get a new machine due to the re-call, but you can’t even hook it up the So-clean with the new machines. Has anyone been successful with at least getting their money back for a machine that is un-usable?

Alan
Cant trust anyone. Look at our own government after September 11. All officials said the air was safe around the area of the Towers. Yet people and responders later fell ill. Money and power rules and people are disposable it would appear.

Nicky
Looking for class action lawsuit against Soclean been having eye and respiratory problems didn’t know what could be causing this also used dream station cpap. Please help

Stacey
Please advise if there is a lawsuit in Pa. I have developed a chronic cough since using So Clean and can’t afford to just write the money it cost me off.

Wayne
Geez, I have a Philips on the recall list, and, I have a So Clean. Double-whammy. Maryland

Carole
My husband purchased and used the So Clean Machine until he was informed it can be hazardous to his health. How does he join a class-action lawsuit in Pennsylvania? Thank you.

Stephen
I have Socleam machine for several years. First Dreamstatin I used it on just quit working. It emits a strong unpleasant order. I obtained a second Dreamstation at my expense but just stopped using it after reading of cancer dangers.

Robert
Is there a class action suit in Pennsylvania? I’ve noticed on many occasions the strong odor of Ozone in my bedroom. Both my wife and I have our own SoClean 2 machines and put them both on in the morning. I also have problems breathing at night and can also smell ozone in my mask at night. Sometimes I feel I can not breath using my cpap machine. I will be seeing my pulmonologist about this condition.

Rebecca
I started wi a c pap n use if so clean for my device. Since then my numbers have increased an now have moved from c pap to by pap due to my air need n worsening w my lungs

Valerie
I just got for so clean machines for for my adult children in the month of April 2021 I called so clean to return The machines only one of my children use one he noticed that he was getting headaches and the smell is horrible in his house I told him not to use it anymore until I get a hold of so clean and they try their hardest assured me I don’t feel safe for anyone to use this product –I talked to Vicky F. She has a script to follow I’m sure I’m not blaming her I just blame the company for not sending me my labels to return these items I cannot use !!!!! They sure give a good sale pitch but if you really believe in your product and your product is safe you always give 100% moneyback guarantee not 30 days obviously they’re not backing up their product !!!!

David
I have been using a Soclean for two years now and recently I’ve been having breathing problems and shortness of breath. Been to several doctors but with no diagnosis.

Brenfa
My husband has parkinsons and has been using so ckean for his cpap machine. He has has developed a terrible time breathing at night. The breathing problems effect him more at night after getting into bed. Why weren’t physicians notified in order to give guidance to their patients. I would have disconnected both cpap and the so clean. I am making an appmt for my husband to find out why his bteathing has become so bad.

Jerry
My wife and myself have socleans. We believe they are the cause of lung problems we each have suffered.

Bonnie
Are there any Class Action Lawsuits against Soclean in any other state other Mississippi?

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