SoClean, Inc. filed an amended lawsuit on October 10, 2022, against Philips for allegedly false statements the company made regarding SoClean’s contribution to the 2021 Philips CPAP and BiPAP machine recall. This amendment comes nearly a year after SoClean originally filed a lawsuit against the ventilator manufacturer Philips for spreading misleading information in an attempt to shift the blame onto SoClean for the massive CPAP and BiPAP recall. In the new complaint, SoClean offers more evidence that Philips deliberately used SoClean as a scapegoat by implying ozone cleaners were at fault.
SoClean Cleaners Contain Ozone Gas
Sleep apnea ventilator machines need cleaning and sanitization to ensure they are safe for patient use. This respiratory therapy equipment requires disinfection since it comes into contact with the mucus membrane. SoClean, Inc. distributes machines designed to easily clean sleep apnea machines like Philips CPAP and BiPAP ventilators. In order to effectively sterilize and deodorize the machines, SoClean uses ozone gas. Ozone gas is a potent germicide that eliminates bacteria and kills viruses.
Philips CPAP and BiPAP Recall Spurs SoClean Backlash
Complaints and lawsuits against SoClean for its sleep apnea machine cleaners emerged in the wake of the Philips CPAP and BiPAP recall in 2021. Philips recalled millions of its CPAP and BiPAP ventilators upon discovering that the PE-PUR sound abatement foam within the machines can degrade. Patients can inhale carcinogenic and toxic particles when the CPAP and BiPAP foam breaks down. Inhalation of these particles can result in severe injuries, such as various forms of cancer and organ damage.
Following the recall, Philips suggested that SoClean cleaning products may have exacerbated the foam degradation of Philips CPAP and BiPAP ventilators. In its recall notice, Philips informed patients that unapproved cleaning methods like ozone cleaners may account for the sound abatement foam degradation. Philips continued to propose a connection between SoClean ozone cleaning products and the ventilator recall.
Possibly encouraged by Philips’ comments and its reference to a 2020 FDA safety communication advising patients to avoid using illegally marketed ozone gas or ultraviolet light cleaning products to disinfect or sanitize CPAP devices, individuals began filing lawsuits against SoClean in 2021 and into 2022. These lawsuits against SoClean allege the company did not inform CPAP users about the high levels of ozone gas and deceived the public by marketing it as “activated oxygen.” In February 2022, the Judicial Panel on Multidistrict Litigation consolidated SoClean lawsuits before Judge Joy Flowers Conti in the Western District of Pennsylvania. Judge Canti also presides over the Philips CPAP recall MDL.
SoClean 2021 Lawsuit Against Philips
In October 2021, SoClean filed a lawsuit against Philips for deflecting attention and responsibility for the CPAP and BiPAP recall onto SoClean products. However, SoClean argued that “inexcusable design flaws” were at fault for the deteriorating sound abatement foam that released toxic particles into the air pathways. In its lawsuit, SoClean pointed to a glaring design defect in which the PE-PUR foam breaks down when exposed to heat and humidity. SoClean claimed Philips’ poor choice of foam was the culprit, not its cleaning devices. While the company admitted to using ozone gas, it asserted its cleaning products are necessary since Philips does not provide adequate cleaning instructions.
SoClean Amendments Shed New Light on Philips Recall
On October 10, 2022, SoClean submitted an amended complaint against Philips shortly before a status conference concerning lawsuits against SoClean for its CPAP cleaning device. SoClean expands its accusations by including new information uncovered since it filed the lawsuit against Philips in 2021. The company notes that Philips was aware of the foam degradation problems as early as 2015 but failed to alert the public. Additionally, the lawsuit condemns Philips for refusing to abide by the advice of its foam supplier in 2016. Its supplier recommended Philips switch to alternative foam materials that would not degrade in hot or humid conditions, but Philips refused to take any corrective action.
Also, SoClean cited an FDA hearing in May 2022, where the FDA told Philips the risks associated with CPAP devices were not caused by the “use of the devices related to the use of ozone cleaning agents.” The FDA informed Philips that no other entity is to blame for the hazards of the recalled ventilators other than Philips. To salvage Philips’ reputation and revenue, SoClean alleges that Philips repeatedly directed criticism toward SoClean cleaning devices through damning recall notices, interviews, cable news appearances, and videos on the company’s website.
The amended lawsuit accuses Philips of generating immense damage to SoClean’s brand through its false and misleading ozone cleaner statements. According to SoClean, Philips is responsible for SoClean’s plummeting sales and ruined reputation. Although the 2021 lawsuit sought $200 million from Philips, SoClean states Philips’ conduct has surpassed $200 million in total damages.