The Philips Respironics CPAP and BiPAP machines were recalled in June 2021 because the foam used for sound abatement in the breathing devices degraded, thereby causing a breathing hazard for consumers. A news release by Philips at the time of recall said, “The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation.”
In its lawsuit filed in Massachusetts district court in October 2021, the market leader for ozone cleaners claims that Philip’s statement – blaming SoClean’s ozone cleaning machines for faulty design and badly chosen sound abatement foam in its CPAP BiPAP and ventilator recalls-- was false and misleading.
In a news release (October 12), SoClean CEO Robert Wilkins said “We are disappointed that Philips has decided to point the finger at SoClean for its product recall and has chosen to make false and misleading statements about our products…By this lawsuit, SoClean intends to defend itself against Philips’ dishonest attacks, restore its hard-earned reputation, and correct the record for a consuming public that has been intentionally misled by Philips.”
SoClean explains that Philips choice of material for sound abatement – polyester-based polyurethane foam –is "known to degrade in the presence of heat and humidity" but many of the recalled products are used in hot and humid conditions, often with the use of a heated humidifier. Also, the polyester-based polyurethane foam “off-gases harmful chemicals right out of the box”, but the off-gassing of harmful chemicals was unrelated to ozone exposure. SoClean claims that the use of ozone cleaners would help mitigate the off-gassing of harmful chemicals by destroying them through chemical reactions.
How could Philips choose polyester-based polyurethane foam for sound abatement and not know it could degrade with heat and humidity? And Philips cites “unapproved cleaning methods such as ozone”, but why wasn’t it approved? Philips recorded EUR 4.2 billion sales in its Q3 quarterly report, so you’d think it had enough funding 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 sound abatement in certain sleep and respiratory care devices.)
CPAP Industry’s Dirty Secret
And, given its billions of sales dollars, you’d also think Philips wouldn’t need to be part of the CPAP Industry’s “Dirty Secret”.
According to SoClean’s lawsuit, a "dirty secret" of the CPAP industry is that CPAP and BiPAP machines are often returned within a matter of weeks only to be refurbished and shipped out to other customers without their knowledge. “This could feasibly happen up to 5-10 times with ‘new’ CPAP equipment. In the absence of any cleaning standards or regulations for refurbished equipment, no one knows what happens to these devices before they find a permanent home and what, if anything, has been done to sanitize them in between users.”
Lawsuits Filed against SoClean
In early September 2021, Anthony Sakalarios filed a complaint against SoClean, alleging that false and misleading claims have been made about its sanitizing machines and other popular devices used to clean and sanitize CPAP, BiPAP and mechanical ventilation machines. Sakalarios claims they release ozone gases at dangerously high levels.
Another lawsuit seeking class action was filed in November by two law firms claiming that SoClean devices are damaging critical components in CPAP machines by generating ozone at levels higher than the FDA-approved limit.
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The Case Against Ozone
SoClean devices work by generating ozone to sterilize and deodorize CPAP breathing machines, which are used treat sleep apnea. However, lawsuits filed against SoClean state to effectively sanitize, SoClean devices must emit levels of ozone that are higher than can be safely tolerated by humans or animals. Multiple 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 deflecting attention away from inexcusable design flaws, misleading the public, creating confusion, and causing hundreds of millions of dollars of damage in the process. Stay tuned for SoClean v. Philips…