Philips CPAP Recall Lawsuit: Breathing Devices Linked to Cancer, Lung Damage

If you own one of the CPAP, BiPAP or mechanical ventilator devices subject to Philips’ June 2021 recall, attorneys working with ClassAction.org would like to speak with you.

They have filed a class action lawsuit alleging that Philips knew well before the recall about the health risks associated with the machines and is not likely to replace the lifesaving, necessary devices anytime soon. To help strengthen their case, the attorneys need to hear from additional users of the recalled machines.

Philips Recall: What Happened?

On June 14, 2021, Philips announced that it would be recalling three to four million continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and mechanical ventilator devices over risks associated with the products’ sound abatement foam. According to the recall notice, the polyester-based polyurethane (PE-PUR) foam may break down into particles and enter the devices’ air pathways where they could be inhaled or ingested by the user.

Lab analysis of the degraded foam has reportedly revealed the presence of several potentially harmful chemicals, including toluene diisocyanate and toluene diamine. The suit points out that the European Union considers toluene diisocyanate “highly toxic” and has concluded that toluene diamine is not safe for use, even as a hair dye.  

According to the recall, devices used in areas of high heat or high humidity may be more prone to foam degradation.

Philips also admitted that the foam material can “off-gas” certain chemicals that can lead to irritation and airway inflammation, which can be particularly concerning for patients with underlying lung disease and reduced cardiopulmonary reserve. According to the company, the potential risks associated with exposure to these chemicals include lung irritation, headaches, dizziness and even cancer.

In issuing the recall, Philips asked that CPAP and BiPAP patients discontinue their use of the machines and speak with their doctors about “the most appropriate options for continued treatment.” The company stressed that patients using life-sustaining mechanical ventilator devices should not alter or stop therapy before speaking to their physicians.

Which Devices Are Affected?

The following devices were part of Philips’ June 2021 recall.

The majority of the affected devices are in the first-generation DreamStation product family, according to Philips.

What Does the Lawsuit Say?  

The lawsuit accuses Philips of knowing well before the June recall of the health risks associated with the foam used to minimize noise in its sleep and respiratory devices.

In fact, the suit claims that users have complained about “black particles” in their devices “for several years before the recall.” Philips’ first announcement to the public, however, came only in April 2021 when the company disclosed in a quarterly reportthat testing and user reports led to the discovery that the foam posed certain risks.

The suit also alleges that patients would never have paid as much as they did for their sleep and breathing devices had they known the foam could lead to serious health problems.

Further, while the recall alerts patients and doctors to the foam issue, it does not offer a readily available fix for the millions of Americans who use the devices on a daily basis. According to the suit, Philips “has no concrete timeline for replacing any devices,” meaning that many patients will likely need to replace their devices at full price while they wait for a true resolution from Philips. 

What Side Effects Are Associated with the Recalled Devices?

How Could a Class Action Lawsuit Help?

A class action lawsuit could provide consumers with money back for the devices they had to purchase at their own expense following the recall. While Philips promises to replace the sound abatement foam, the lawsuit alleges the company “is not currently replacing the foam in the affected devices and may take a year or more to provide replacements.” Further, the design of the foam allegedly makes it difficult for consumers to replace on their own.

Many may be forced to buy Philips’ next-generation machine or one from a competitor to continue their therapy; however, there is a shortage of CPAP machines, which may make it difficult for some patients to obtain replacements. A class action lawsuit could help cover these costs, as well as force Philips to create a medical monitoring program for patients who used the devices and are concerned about future health risks.   

Philips CPAP Lawsuit Update, August 2024: $25M Medical Monitoring Settlement Approved by MDL Court

United States District Judge Joy Flowers Conti granted preliminary approval to a $25 million medical monitoring settlement for the Philips CPAP multidistrict litigation (MDL) on June 27, 2024.

Money from the $25 million medical monitoring deal, part of the $1.1 billion Philips CPAP settlement detailed below, will be used to fund independent medical research related to the injuries consumers allegedly suffered, or could suffer, from using the recalled ventilator machines, court documents state.

Settlement funds will also help create a research registry to which CPAP MDL class members can submit authorizations for the release and disclosure of medical information for review and evaluation purposes in connection with the aforementioned medical research. Lastly, the Philips CPAP medical monitoring settlement will fund the creation of a website meant to increase access to and understanding of the relevant medical information and long-term health effects of using any of the recalled devices.

Importantly, settlement documents point out that class members’ health is already being monitored by their doctors given the recalled devices are available only by prescription.

“The benefits are meaningful because they provide Settlement Class Members, along with their prescribing and treating physicians, with an opportunity to assess their risk of injury, or lack of risk of injury, in light of the most up-to-date and relevant science and guidance related to any medical conditions that may result from use of the Recalled Devices,” a brief in support of the agreement reads.

The Philips CPAP medical monitoring settlement covers all individuals in the U.S. and its territories who used one of the recalled breathing devices.

Counsel for the plaintiffs said in a statement that the Philips CPAP medical monitoring settlement provides “critical funding to conduct medical research on the injuries at issue in this litigation and ensures patients will gain access to important information about the long-term health effects of exposure to recalled Philips devices.”

Philips Respironics CPAP Settlement Update - $1.1 Billion Deal Ends CPAP Recall Injury MDL

Koninklijke Philips NV and Philips Respironics have agreed to pay $1.1 billion to plaintiffs who allege they suffered personal injuries and/or require medical monitoring as a result of the degradation of the foam in their CPAP breathing machines.

The Philips CPAP settlement reportedly breaks down into $1.075 billion for personal injury claims and $25 million for medical monitoring claims. The mega-deal comes on the heels of the court granting final approval to another Philips CPAP settlement worth at least $506.3 million. That deal, detailed below, addressed consumers’ economic losses stemming from the recalled Philips machines but did not cover personal injuries or the cost of medical monitoring for people who believe they may experience future health issues due to their use of the devices. 

Together, the $1.1 billion settlement and uncapped deal worth at least $506.3 million end the multidistrict litigation (MDL) formed in the wake of the recall of 10.8 million Philips CPAP, BiPAP and ventilator machines in June 2021.

Philips CPAP Update 2023: Recall Lawsuits Settled For At Least $479 Million

Philips has agreed to pay no less than $479 million to settle litigation over its recall of nearly 11 million CPAP, BiPAP and ventilator devices. 

The proposed settlement, if approved by the court, will resolve claims from individuals and healthcare entities nationwide who paid, in full or in part, for CPAP, BiPAP or ventilator machines equipped with potentially dangerous polyester polyurethane sound-insulating foam. The putative deal will provide extended warranties, cash payments, and reimbursements, among other forms of relief for economic harm stemming from the recalled breathing devices. 

Read ClassAction.org’s write-up of the settlement here. 

Has Philips Stopped Selling CPAP Machines? [2024 Update]

On January 29, 2024, Philips announced in an earnings report that it would stop selling sleep apnea machines and other respiratory care products in the United States pursuant to the terms of a consent decree between the company and the U.S. Food and Drug Administration. 

The company stated that while it will continue to service CPAP machines and respiratory care devices already with healthcare providers and patients, and continue to supply accessories, consumables and replacement parts, Philips will not sell new sleep apnea devices nationwide until it complies with certain improvement measures for its Respironics plants in the U.S. 

Per reports, this includes all Philips BiPAP, CPAP and ventilation machines—including the DreamStation 2. Some have anticipated that it could be years before the company resumes the sale of the affected devices. 

Details of the settlement, which is in the process of being finalized and has yet to be approved by a court, have not been released publicly. 

The announcement comes more than two years after Philips recalled millions of its breathing machines and admitted that the industrial foam with which the machines were equipped for noise reduction could degrade and potentially release toxic particles into the masks worn by patients. 

Last October, lawmakers called for a criminal investigation of Philips by the U.S. Department of Justice.

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