Philips has countersued SoClean and its private equity owner, DW Health Partners, for marketing SoClean’s ozone cleaners as compatible with Philips Respironics CPAPs and BiPAPs, despite knowing “all about the destructive properties of ozone for years,” according to the lawsuit filed on Jan 5 in the US District Court for the Western District of Pennsylvania.  

The filing, which alleges false advertising, trademark dilution, and deceptive trade practices, states that SoClean promoted and sold its products without the required US Food and Drug Administration (FDA) approval or clearance and that DW Health Partners knew or should have known that SoClean could be subject to an enforcement action at any time. 

The lawsuit comes after SoClean issued a voluntary recall of its ozone cleaners in November. The recall, intended “to help reduce potential health risks of exposure to ozone gas after the use of a SoClean device,” according to an FDA safety communication, informed users of a new manual with additional instructions for use and a hose and mask adapter provided by SoClean. 

“Since 2014, and up until its 2023 FDA recall, SoClean has recklessly and unlawfully promoted the fiction that its ozone cleaning devices are ‘compatible’ with the CPAPs and BiPAPs…designed and manufactured by Philips RS North America LLC (‘Philips RS’) when the reality is precisely the opposite. Contrary to SoClean’s repeated representations of compatibility, SoClean knew that its ozone cleaners had the potential to eat away at Philips Respironics’ PAPs from the inside,” the filing reads. 

Last August, Philips reported that its testing of recalled CPAPs and BiPAPs with PE-PUR foam found that devices whose users reported cleaning them with ozone were 17 times more likely to have significant visual foam degradation or volume reduction than those with no reported ozone use. 

Philips’ filing states that it has “suffered profound reputational harm and economic losses” and seeks damages for violations of unfair competition laws under the federal Lanham Act and Consumer Protection Act of New Hampshire, where SoClean is based. 

SoClean originally sued Philips for $200 million in 2021, alleging that Philips made false and misleading statements regarding ozone cleaners that negatively impacted SoClean’s business. 

Philips declined to comment beyond the filing.