SoClean Inc. has filed a federal lawsuit in the United States District Court for the District of Massachusetts against Philips. According to the complaint, Philips has misled the public and engaged in acts of deliberate misdirection, placing blame on SoClean to divert attention away from obvious design flaws, including a poor choice of sound abatement foam, which led to its recent voluntary product recall of Philips’ CPAP machines, BiPAP machines, and ventilators. SoClean seeks damages from Philips in excess of $200 million.
SoClean alleges that Philips and its CEO and Chairman of the Board, Frans van Houten, made false and misleading statements regarding ozone cleaners that have had a negative impact on SoClean’s business. Among other things, the complaint states that Philips and its CEO wrongfully suggested to consumers, distributors, health care professionals, and the general public that SoClean and its ozone cleaners were somehow responsible for the product recall. SoClean is the market leader for ozone cleaners.
The true reason for the product recall, according to the complaint, was that Philips chose a material for sound abatement – polyester-based polyurethane foam – which is “known to degrade in the presence of heat and humidity” and “off-gases harmful chemicals right out of the box.” Many of the recalled products operate under hot and humid conditions, often with the use of a heated humidifier. Also, the off-gassing of harmful chemicals was unrelated to ozone exposure. If anything, the complaint asserts, the use of ozone cleaners would help mitigate the off-gassing of harmful chemicals by destroying them through chemical reactions.
People with untreated sleep apnea stop breathing repeatedly during the night, such that the brain and the rest of the body may not get enough oxygen. CPAP and BiPAP machines deliver sufficient air pressure to keep upper airway passages open thereby preventing sleep apnea.
According to the complaint, 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. The complaint asserts that this could 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.
“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,” said Robert Wilkins, CEO of SoClean. “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 is being represented by Proskauer Rose LLP.
They why does so clean not put their machine up for fda approval to clean the cpap equipment ? Yea not going to happens due to the damage of being exposed to ozone.
Soclean does not clean anything. It may disinfect my there is no cleaning. It’s like setting off a bugbomb in your house but not washing down everything after it is done. Not FDA approved. Ozone exposure potentially dangerous to patients.