Class Action Lawsuit Over SoClean Alleges Safety of CPAP Cleaning Devices Misrepresented

According to allegations raised in a recently filed class action lawsuit, SoClean’s use of ozone to sanitize CPAP devices has created a health risk which the company hid from consumers.

The company SoClean, Inc. manufactures devices which generate ozone to sterilize and deodorize CPAP breathing machines used to treat sleep apnea. However, a growing number of lawsuits are being filed by consumers who indicate SoClean must use ozone at levels higher than what can be safely tolerated by humans or animals in order to be effective sanitizing CPAP machines.

One such complaint (PDF) was filed by Eric Hill in the U.S. District Court for the Northern District of Oklahoma on October 22, seeking certification as a class action over SoClean falsely representing the presence of ozone as “activated oxygen,” and deceiving customers about potentially key safety issues.

“SoClean’s marketing materials fail to disclose that its devices emit ozone, which is a longstanding requirement of federal law,” Hill’s lawsuit states. “Instead, SoClean falsely represents that its devices use ‘activated oxygen’ to clean CPAP machines. SoClean markets the devices as ‘safe’ and ‘healthy,’ which is false given that they generate toxic ozone gas at levels that substantially exceed federal regulations.”

Hill’s lawsuit seeks to pursue damages on behalf of himself and similar consumers who bought SoClean to keep their CPAP machines clean, and thus protect their health, indicating that they were unaware SoClean may represent a health risk itself.

SoClean has faced intense scrutiny in the wake of a massive Philips DreamStation CPAP recall issued earlier this summer, due to problems with sound abatement foam used in millions of devices, which may break down and release toxic particles and debris directly into the machines’ air pathways and into consumers’ lungs.

There are now hundreds of Philips CPAP lawsuits and class action claims being filed against the makers of the sleep apnea machine, alleging that users were exposed to an increased of cancer, severe respiratory problems and other health complications after breathing chemicals and gases released as the foam breaks down.

At the time of the recall, Philips suggested that use of SoClean and other similar cleaning devices involving ozone and UV light may exacerbate the foam’s degradation.

In late February, the FDA issued safety communication about CPAP cleaning products like SoClean, months before the Philips recall, indicating users were experiencing respiratory complications after using certain ozone gas or ultraviolet (UV) light cleaning devices to disinfect or sanitize machines. However, some lawsuits now indicate that these complaints may have actually been side effects of Philips CPAP foam degrading.

On October 12, SoClean filed a lawsuit against Philips, claiming its products are being used as a scapegoat for respiratory problems linked to Philips use of toxic sound abatement foam, which it claims is the real cause of recalled Philips breathing machine users suffering respiratory problems. The lawsuit alleges Philips is trying to deflect blame to SoClean to cover up what it calls a “glaring design flaw” due to the use of the PE-PUR foam.