Class Action Filed After Philips Recalls CPAP, BiPAP, Ventilator Devices Over Potential Health Risks [UPDATE]

A proposed class action has been filed this week on the heels of a June 14 recall of certain Philips sleep and respiratory care devices after it was discovered that the “sound abatement” foam used in the products could pose a health risk to users.

The 31-page case claims defendants Koninklijke Philips N.V. (Royal Philips), Philips North America LLC, and Philips RS North America LLC knew well before the recall that some of their bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP) and mechanical ventilator devices contained PE-PUR sound abatement foam that could degrade and enter into the machines’ air pathways or off-gas chemicals. Despite having prior knowledge of the devices’ risks, however, Philips failed to alert consumers who purchased the products, which are designed to assist with a number of sleep, breathing and respiratory conditions, including sleep apnea, the suit says.

“Philips was aware, or should have been aware, of the toxic or dangerous health effects of the use of the Recalled Devices, but nowhere on the package labeling or on Philips’ websites or other marketing materials did Philips warn Plaintiff and members of the Class and State Subclasses that they were at risk of developing health problems as a result of the dangerous PE-PUR Foam used in the Recalled Devices,” the complaint, filed June 17 in Massachusetts federal court, states. “Instead, Philips concealed the dangerous health effects of the PE-PUR Foam used in the Recalled Devices and deceptively represented that these products were safe, healthy, and appropriate for use.”

According to the lawsuit, the health risks associated with using the Philips BiPAP, CPAP and ventilator devices—which range from skin and eye irritation to cancer—combined with the defendants’ concealment of these risks have rendered the products “completely worthless or, at the very least, . . . substantially diminished in value.” Per the case, consumers who purchased the devices have been left to replace them at great cost or continue using the products and face “health risks as grave as cancer.”

The Recall

The complaint centers on a June 14, 2021 recall of between three and four million Philips BiPAP, CPAP and mechanical ventilator devices “to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.”

Per the case, Philips determined that the foam “may degrade into particles” that could enter the devices’ air pathways and be ingested or inhaled by the user, or off-gas certain chemicals. According to Philips, the foam could cause skin, eye and respiratory tract irritation; an inflammatory response; headache; asthma; adverse effects to other organs, including the kidneys and liver; or “toxic and carcinogenic effects.” Some users reportedly complained to Philips that they had suffered headaches, upper airway irritation, cough, chest pressure and sinus infections after using the devices.

The recalled products include the following:

Philips has advised users of affected BiPAP and CPAP devices to stop using the machines and consult with their physicians to “determine the benefits of continuing therapy and potential risks.”

For those using life-sustaining mechanical ventilator devices, Philips has warned that users do not discontinue or alter their prescribed therapy without consulting a physician to determine the appropriate steps.

The company has stated that it is deploying a “permanent corrective action” to address the problems with the recalled products and has begun a registration process for those whose devices were affected.

More information can be found in Philips’ recall notice.

Lawsuit Claims Philips Knew of Health Risks Well Before Recall

According to the case, Philips was aware of the alleged side effects of its sleep and respiratory devices well before issuing the June recall. As part of the company’s Q1 2021 quarterly report filed on April 26, Philips disclosed for the first time that device users had reported experiencing adverse health effects after using the products, which led to the discovery of the problematic foam component.

The lawsuit argues that while Philips has not stated when it first started receiving user reports regarding the presence of “black debris/particles” within the respiratory devices’ airpath circuits, “it is unlikely that Defendants only recently learned of these issues” given how long the products have been on the market.

“Thus, as a result of user reports, Defendants were aware of the degradation of the PE-PUR sound abatement foam used in the Recalled Devices, yet continued to manufacture and sell the Recalled Devices with such awareness for a significant period of time,” the complaint alleges.

According to the suit, the defendants “unreasonably and unjustly profited” from the sale of the devices and put users at risk for known adverse health effects. The alleged side effects, the recall, and Philips’ advice to consumers have rendered the devices “worthless to patients with sleep and respiratory conditions,” the lawsuit alleges.

Who Is Covered by the Lawsuit?

The lawsuit looks to cover anyone in the U.S. who purchased one of the recalled Philips devices for household or business use (and not for resale) anytime from the beginning of the applicable statute of limitations period through June 14, 2021.

The case also proposes state-specific subclasses for Connecticut, Massachusetts and Pennsylvania residents who fit the above criteria.

It’s important to note that the class definitions have not been certified by a judge and could change as the lawsuit progresses.

 How Do I Join the Lawsuit?

Generally speaking, there’s nothing you need to do to join a proposed class action lawsuit. If the case moves forward and settles, those affected should receive notice of the settlement and then be able to claim whatever compensation the court deems appropriate.

In the meantime, one of the best things you can do is stay informed. Check back on this page for any notable updates or sign up for ClassAction.org’s free weekly newsletter to get class action news sent straight to your inbox.