Medical Equipment Supplier Files Lawsuit Seeking Refunds for Recalled Philips CPAP, BiPAP Devices

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A proposed class action against Koninklijke Philips N.V. and two North American subsidiaries seeks refunds for durable medical equipment suppliers who say they are unable to sell the company’s recalled BiPAP and CPAP machines in their inventory.

The 18-page case states that Philips became aware sometime before April 2021 that the sound-dampening PE-PUR foam used in certain models of its Bi-Level Positive Airway Pressure (BiPAP) and Continuous Positive Airway Pressure (CPAP) medical devices may degrade over time, causing the off-gassing of harmful chemicals and release of particles that could be inhaled or ingested by users.

Although Philips recalled the devices in June 2021 and announced a repair and replacement program for end users, no such relief or compensation has been offered to medical equipment resellers, the suit says.

The plaintiff, Glenside, Pennsylvania-based Baird Respiratory Therapy, claims it and other medical equipment suppliers are now stuck with unusable Philips BiPAP and CPAP devices that they cannot sell and for which they have not been compensated. The lawsuit looks to recover damages for durable medical equipment suppliers based on “Philips’ negligence, breach of express warranty, and fraud.”

Per the suit, Philips’ BiPAP and CPAP devices were designed to help treat sleep apnea, a condition that causes a person to experience breathing disturbances during sleep. A CPAP device, according to the suit, delivers a constant flow of air through a mask to keep a person’s airway from collapsing during inhalation, and a BiPAP device delivers inspiratory and expiratory pressurized air to assist a person with breathing in and breathing out, the suit relays. 

According to the case, Philips sells its BiPAP and CPAP devices to durable medical equipment suppliers such as the plaintiff, who then resell the devices at a markup to patients and receive partial or full reimbursement by the individuals’ insurance providers, with the patients themselves covering any difference.

The lawsuit claims that Philips first hinted at a problem with its CPAP and BiPAP devices in late April 2021, when the company disclosed in its first quarter report that “user reports” had led to a discovery that the sound abatement foam used in the machines posed a health risk. Philips recalled certain CPAP and BiPAP devices and mechanical ventilators over a month later on June 14, announcing that the machines presented “identified potential health risks” related to the PE-PUR foam they contained, the suit relays. Per the complaint, the manufacturer warned doctors that the off-gassing of volatile organic compounds and inhalation or ingestion of foam particles from the devices could cause “serious injury which can be life-threatening or cause permanent impairment.”

The recalled devices, according to Philips’ website, include:

• Philips E30 (Emergency Use Authorization)
• Philips DreamStation ASV
• Philips DreamStation ST, AVAPS
• Philips SystemOne ASV4
• Philips C Series S/T, AVAPS
• Philips OmniLab Advanced Plus
• Philips SystemOne 50 series, 60 series
• Philips DreamStation CPAP, Auto CPAP, BiPAP
• Philips DreamStation GO CPAP, APAP, Auto CPAP
• Philips Dorma 400, 500 CPAP, Auto CPAP

According to the suit, the plaintiff and likely all other durable medical equipment suppliers received an email from Philips after the recall in which the company “admitted that the Recalled Products are defective and unsafe” and instructed the suppliers not to resell them.

The lawsuit alleges Philips knew from user complaints about the problem with the PE-PUR foam “well in advance” of the recall yet continued to manufacture and sell the devices to medical equipment suppliers “for a significant period of time.”

“During this period, Philips unreasonably and unjustly profited from the sale of the Recalled Devices,” the complaint charges.

The suit notes that it was only after the manufacturer released its Philips Respironics DreamStation 2, a device that does not contain the PE-PUR foam, that Philips first disclosed a problem with the later-recalled devices.

Per the lawsuit, although Philips has announced a repair and replacement program for end users, medical equipment suppliers have not received any compensation or refunds for the recalled devices still in their inventory.

The case looks to represent all durable medical equipment suppliers in the U.S. and its territories who, from the beginning of any applicable statute of limitations period until June 4, 2021, purchased or leased for resale any of the recalled Philips products.

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