Dutch health products company Royal Philips and its affiliates were hit with a proposed class action accusing them of selling millions of sleep apnea treatment devices that they knew put users at risk of inhaling foam particles containing dangerous chemicals, and then waiting too long to recall the products.

Plaintiff Michael Dansky said the company knew about the health risks of its continuous positive airway pressure, or CPAP, machines and other devices prior to revealing them to the public in a regulatory notice about five months ago. The now-worthless products were ultimately subject to an “unreasonably delayed” recall in June.

In June, Philips issued a recall of its CPAP, Bi-Level PAP and mechanical ventilator devices containing polyester-based polyurethane sound abatement foam, or PE-PUR foam, following its April announcement that it had determined there were risks that the foam on those devices may degrade or “off-gas” under certain circumstances.

The recall warned that “these issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.” The company advised consumers to discontinue usage of the devices and consult with their physicians regarding alternative ventilator options.

Royal Philips estimated that the recall applied to between 3 million and 4 million devices.

Prior to the recall, the company “received complaints regarding the presence of black debris/particles within the airpath circuit of its devices (extending from the device outlet, humidifier, tubing, and mask).” Users reported experiencing “headaches, upper airway irritation, cough, chest pressure and sinus infection”.

Dansky said he never would have purchased his Philips DreamStation CPAP device, which was among the models recalled because it contained a dangerous foam that could lead to ailments such as cancer and organ failure, had he known about the health risks.

He seeks to represent a class of purchasers and users of Philips’ CPAP devices, as well as its bi-level positive airway pressure devices and mechanical ventilators, which contain PE-PUR foam.

Dansky “has and will suffer economic loss to replace the devices” and is seeking damages based on alleged warranty breaches and purported consumer law violations in connection with the company’s sales and marketing of the CPAP and other devices.

Dansky also wants continuous medical monitoring damages for those who are at risk for asthma, headache, inflammation and irritation of the eye, skin and respiratory tract, along with adverse impacts on organs such as kidneys and liver and “toxic carcinogenic” effects.


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