A proposed class action alleges SoClean, Inc. has violated a longstanding requirement under federal law by failing to disclose that its continuous positive airway pressure machine (CPAP) cleaning devices generate ozone.
According to the complaint, SoClean’s misrepresentations are “designed to mislead consumers”—including those who suffer from sleep apnea, a condition characterized by repeated disruptions to one’s sleep cycle due to collapses in the soft airway tissue—into believing the CPAP and bi-level positive airway pressure (BiPAP) cleaning devices use a benign form of oxygen rather than a harsh gas that is generally only suitable for highly controlled commercial sanitation.
Although ozone does possess virus-, bacteria- and odor-killing qualities, breathing the gas for even a short period of time can cause adverse health consequences, including shortness of breath, cough, dizziness, reduced lung function and a decreased ability to fight respiratory infections, the suit says. The case scathes that SoClean’s alleged misrepresentations are “especially reprehensible and dangerous” and made more egregious given the fact that the devices are designed and intended to be used by those who suffer from breathing problems.
“SoClean’s misrepresentations have allowed it to command ninety-percent of the relevant market,” the suit, filed in Mississippi on September 7, alleges, arguing that SoClean’s customers may have reconsidered their decision to buy the machine had they known it generates unsafe levels of toxic gas into their CPAP devices and bedrooms.
To be effective at killing bacteria and viruses, ozone must be present in a concentration “far greater than can be safely tolerated by people or animals,” the case emphasizes. According to the complaint, SoClean’s representation that the devices are safe and healthy is wholly false given they generate “toxic ozone gas at levels that substantially exceed federal regulations.”
“SoClean falsely represents that its devices use ‘no water or chemicals’ or ‘no harsh chemicals’ to clean CPAP machines, despite using ozone gas—a harsh chemical that causes respiratory problems in humans,” the lawsuit alleges.
Moreover, although SoClean purports that its CPAP cleaning devices use the same sanitizing process found in “hospital sanitizing,” hospitals cannot and do not use ozone sanitizers in spaces occupied by patients, the complaint continues. The lawsuit alleges SoClean has also falsely claimed that separately sold filters for its CPAP cleaning machines convert “activated oxygen” into “regular oxygen.” In truth, SoClean’s filters “have no measurable effect on the device’s ozone output,” according to the case.
The lawsuit lastly alleges that SoClean falsely purports that its CPAP cleaning devices are “sealed” such that the “activated oxygen,” i.e. ozone, cannot escape.
According to the case, SoClean’s devices are so unsafe that several of the largest CPAP machine manufacturers in the United States require buyers to acknowledge that they have been informed that they will void the warranty of their machine should they clean it with a SoClean device.
The lawsuit states that all medical devices must comply with the FDA’s Maximum Acceptable Level of Ozone Rule, which stipulates that the maximum acceptable concentration of ozone that may be generated is not to exceed 0.05 parts per million by volume of air circulating through a device. The suit stresses that the FDA has determined that ozone exposure can cause myriad undesirable physiological effects to the central nervous system, heart and vision.
Moreover, the FDA ozone rule makes it illegal for a medical device to generate ozone and release it into the atmosphere without indicating in its labeling the maximum acceptable concentration of ozone that may be generated.
According to the lawsuit, the levels of ozone generated by SoClean’s devices are as much as 560 times the FDA limit. The case alleges that a SoClean device actively generates ozone for roughly seven to 14 minutes during a standard cleaning cycle, which the company recommends CPAP and BiPAP machine users run at least once per day.
The lawsuit looks to represent all current and former Mississippi residents who bought or used a SoClean device to clean and sanitize their CPAP, BiPAP or mechanical ventilation machine.
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