SoClean was recently served with a number of class action lawsuits accusing the company of falsely representing the safety and efficacy of its proprietary cleaning devices for continuous positive airway pressure (CPAP) machines. The lawsuit that we filed in the Southern District of Mississippi seeks to represent current and former Mississippi residents who have been affected.
We believe that SoClean has failed to properly inform customers of the potential dangers stemming from its devices’ use of ozone to clean CPAP machines.
If you or a loved one has used a SoClean device and noticed ANY symptoms of ozone exposure/inhalation such as irritation to the lungs which can result in pulmonary edema, adverse effects on the central nervous system, heart, and vision, and irritation of the mucous membranes, you may be entitled to compensation!
The FDA’s Maximum Acceptable Level of Ozone Rule stipulates that ozone gas-based devices are only allowed to generate up to 0.05 parts per million of ozone by volume of air circulating through the device.
As per the complaint, the ozone levels generated by SoClean’s devices are up to 560 times higher than the limit set by the U.S. Food and Drug Administration (FDA). The CPAP cleaning devices allegedly generate ozone for around 7 to 14 minutes per standard cleaning cycle.
If SoClean failed to properly label and market its CPAP cleaning devices, as alleged, it is in violation of the FDA’s ozone rules and regulations.
FDA regulations state that medical devices are prohibited from generating and releasing ozone gas into the atmosphere unless its maximum acceptable ozone concentration is properly indicated on its label.
SoClean is also accused of falsely purporting that its devices are properly “sealed” to prevent the “activated oxygen” from escaping.
Moreover, SoClean’s products are advertised as using “no water or chemicals” and “no harsh chemicals” to disinfect CPAP machines.
These claims are supposedly made despite knowing that ozone gas is a harsh chemical that can potentially cause or exacerbate existing respiratory problems.
Ozone (O3) gas has long been established as an unstable and toxic gas. It has a characteristic and pungent odor that is sometimes described as a “clean” scent. Ozone is sometimes also described to have a metallic, burning wire, or chlorine-like smell.
Although potentially toxic, using ozone for cleaning and disinfecting objects is also rooted in science. Gaseous ozone is a strong sanitation and fumigation agent, albeit only for specific commercial sanitation and in highly controlled conditions. It can kill harmful germs and bacteria, as well as prevent mold and yeast from proliferating on sanitized surfaces.
However, a large concentration of ozone is necessary to ensure optimal effectiveness.
The amount necessary to kill bacteria can also adversely affect our health. According to the FDA, “in tests conducted to study the bactericidal properties of ozone, test animals have died before the bacteria were completely destroyed.”
The potential health risks and effects of ozone range from mild to severe, depending on the level of exposure.
From 2017 to 2019, the FDA received at least 10 reports from CPAP machine users regarding worsening respiratory issues, including headaches and difficulty breathing. The reports were all submitted by CPAP machine users who used ozone gas-based devices to clean, sanitize, and disinfect their breathing devices or accessories.
The FDA has noted that cleaning devices that use ozone gas can potentially leak. This danger is especially high when used with tubing connections or filters and when the gas is in the containers used to store CPAP devices.
Leaks from the devices may cause the ozone levels within a room to reach unsafe levels, particularly if the room is small or not properly ventilated.
Moreover, the FDA also issued safety warnings about using ozone gas-cleaned CPAP machines. There may still be ozone gas remaining in the CPAP machines if they are used immediately after cleaning and without proper fresh air circulation.
These dangers are referred to in the SoClean CPAP lawsuit. SoClean’s misrepresentations are even more egregious as the cleaning devices are designed and marketed for use in close proximity to individuals that, in many cases, already struggle with breathing and respiratory problems.
For example, the products are commonly advertised, displayed, and otherwise encouraged for use in and around consumers’ bedside tables, bathroom counters, as well as other areas where exposures and pathways are possible.
SoClean is a private company that manufactures cleaning devices which they claim are suitable for use on CPAP machines and other breathing support equipment. CPAP machines are widely used by patients with obstructive sleep apnea and snoring problems.
The SoClean lawsuit in 2021 comes just a year after the company settled a separate lawsuit filed by an Australian distributor.
The latest complaint filed against SoClean accuses the company of falsely representing its SoClean 2 CPAP Sanitizing Machine, SoClean 2 Go CPAP Sanitizing Machine, and earlier cleaning devices (collectively “the SoClean devices”).
The company has allegedly been making misleading claims regarding the safety of its products for years.
According to the lawsuit, the company’s advertising claims that its cleaning devices work by using “activated oxygen” to sterilize, disinfect, and deodorize CPAP machines.
However, the devices allegedly generated and used ozone gas to clean CPAP machines. According to the SoClean CPAP lawsuit, the company’s marketing materials completely neglected to disclose this fact. Such declarations are long-standing requirements under federal law.
We believe that the company markets its CPAP cleaners as “safe” and “healthy” devices despite knowing they generate unsafe and toxic levels of ozone gas. The allegations in the lawsuit state that the amount of toxic ozone gas generated by the SoClean devices reach levels that are substantially beyond federal regulatory limits.
The false claims and misrepresentations that SoClean made in marketing its products have misled consumers for years. They have intentionally caused many to believe that the devices only used a benign form of oxygen to clean their CPAP machines, instead of the harsh and toxic gas that is actually used.
The SoClean lawsuit alleges that SoClean’s misrepresentations are done on purpose. In addition, it is possible that the misrepresentations have greatly contributed to SoClean’s business success. The company commands around 90% of the CPAP cleaning device market, potentially due in part to these supposed false advertisements.
If the company had properly labeled and marketed its products, these successes likely wouldn’t have happened. Due to the nature of SoClean’s products and its business, its customers already have pre-existing breathing problems and respiratory issues.
If people had known that the SoClean cleaning devices generate unsafe levels of toxic gas which may further exacerbate their health issues, they would be substantially less likely to risk purchasing the product.
Naturally, the effects of SoClean’s alleged misrepresentation of its products also extend towards its consumers. Unlike its positive effects for the company, though, customers largely experienced more health issues and setbacks.
The plaintiff has expressed their eagerness to form and represent a Mississippi Class group against SoClean. As such, any CPAP user who has bought and used a SoClean CPAP cleaning device is welcome to join the suit.
Get started with our free case review.