The Philips Respironics CPAP and BiPAP devices were recalled in June 2021 because the foam used for noise attenuation in respirators has degraded, causing a respiratory risk for consumers. A press release issued by Philips at the time of the recall stated: âFoam degradation can be exacerbated by the use of unapproved cleaning methods, such as ozone, and environments with high heat and high humidity can also contribute to the degradation of the foam.
The SoClean trial
In its lawsuit filed in Massachusetts District Court in October 2021, the ozone cleaner market leader claims Philip’s statement – blaming SoClean’s ozone cleaning machines for faulty design and poorly chosen noise-canceling foam in its recalls of BiPAP CPAPs and ventilators – was bogus and misleading. .
In a Press release (October 12), SoClean CEO Robert Wilkins said: âWe are disappointed that Philips has decided to point the finger at SoClean for its product recall and has chosen to make false and misleading claims about our productsâ¦ By this lawsuit, SoClean intends to defend itself. against dishonest attacks by Philips, restore its hard-earned reputation and correct the record of a consuming public that has been intentionally misled by Philips.
SoClean explains that the material chosen by Philips for noise reduction – polyester-based polyurethane foam – is “known to degrade in the presence of heat and moisture”, but many of the recalled products are used under severe conditions. hot and humid, often with the use of a heated humidifier. Additionally, the polyester-based polyurethane foam âgives off harmful chemicals right out of the box,â but the gaseous release of harmful chemicals was not related to ozone exposure. SoClean claims that the use of ozone cleaners would help to reduce the gassing of harmful chemicals by destroying them through chemical reactions.
How could Philips to choose polyester based polyurethane foam for noise reduction and not know that it might degrade with heat and humidity? And Philips cites âunapproved cleaning methods like ozone,â but why has it not been approved? Philips recorded 4.2 billion euros in third quarter sales quarterly report, one would therefore think that he had sufficient funds for research and development. (Interestingly, Philips’ Q1 2021 quarterly report included a warning: Philips had identified “possible risks” associated with the foam used by Philips for noise attenuation in some sleep and respiratory care devices.)
The dirty secret of the CPAP industry
And, given its billions of dollars in sales, you would also think that Philips wouldn’t need to be part of the CPAP industry’s âDirty Secretâ.
According to The SoClean trial, a “dirty secret” of the CPAP industry is that CPAP and BiPAP machines are often returned in just a few weeks to be refurbished and shipped to other customers without their knowledge. âThis could happen up to 5 to 10 times with ‘new’ CPAP equipment. In the absence of cleaning standards or regulations for refurbished equipment, no one knows what happens to these devices until they find a permanent home and what has been done, if any, to disinfect them between users.
Lawsuits filed against SoClean
At the beginning of September 2021, Anthony Sakalarios filed a complaint against SoClean, alleging that false and misleading claims were made about its disinfection machines and other popular devices used to clean and disinfect CPAP, BiPAP and mechanical ventilation machines. Sakalarios claims they release ozone gas at dangerously high levels.
Another class action lawsuit was filed in November by two law firms claiming that SoClean devices damage critical components of CPAP machines by generating ozone at levels above the FDA approved limit.
LEARN MORE LUNG CANCER CPAP LEGAL NEWS
The Kansas City Business Journal reported that SoClean is accused of damaging crucial components inside CPAP machines, rendering them unusable. Complainants claim that SoClean’s devices generate prohibited amounts of ozone, which remains in the mask, hose and CPAP tank after cleaning and damages critical components. Additionally, SoClean fraudulently claims that its devices do not use “harsh chemicals” to clean CPAP machines and that the devices can be used safely to clean machines. The lawsuits also accuse SoClean of breach of contract, unjust enrichment and breach of warranty.
The Ozone Case
SoClean devices work by generating ozone to sterilize and deodorize CPAP breathing machines, which are used to treat sleep apnea. However, lawsuits brought against SoClean State to effectively disinfect, SoClean devices must emit levels of ozone higher than those that can be safely tolerated by humans or animals. Numerous studies have shown that high levels of ozone are known to be highly caustic and corrosive, especially if water is present.
SoClean says this case is about a multinational corporation that distracts attention from inexcusable design flaws, misleads the public, creates confusion and causes hundreds of millions of dollars in damage in the process. Stay tuned for SoClean v. Philips …