On June 14, 2021, Philips Respironics issued a recall of millions of its sleep and respiratory care devices, including its Continuous Positive Airway Pressure (CPAP), BiLevel Positive Airway Pressure (BiLevel PAP) devices and mechanical ventilators due to serious health concerns related to the sound abatement foam used in these machines. Philips said the foam can degrade and release dangerous chemicals, that if inhaled can cause inflammation, irritation, headaches or even cancer. These devices treat sleep apnea, a relatively common condition that occurs when the upper airway becomes obstructed during sleep.  

The foam inside of the CPAP and BiPAP machines can decompose over time and leave tiny particles inside of the devices. In addition to particles, the degradation of the polyurethane foam can cause the emission of dangerous, carcinogenic gases that could lead to cancer.  According to its website, Philips states that high humidity and temperature as well as unapproved cleaning methods can exacerbate the degradation. Please click here for a complete list of the potential side effects from this foam degradation and a list of the devices covered by the recall. ‍

Recall updates 

After the June recall, the U.S. Food and Drug Administration (FDA) initially approved Philips’ plan to “repair and replace” the defective foam with a different silicone-based foam. However, during a manufacturing facility inspection, the FDA later found that the silicone-based foam used in a similar device marketed outside the United States had failed a safety test for the release of certain concerning chemicals. As a result, the FDA warned Philips that the replacement machines may also be defective.  

The FDA has not yet ordered a recall of the approximately 250,000 replacement devices Philips has sent out, but it’s concerned that the silicone-based foam used in the substitute devices could emit harmful gases just like the recalled devices. The FDA has asked Philips to hire an independent laboratory to run further tests on devices that use the silicone-based foam to identify any potential safety risks. The FDA is currently awaiting the results of that testing. Philips said it would continue to send out replacement machines in the interim. Philips Chief Executive Frans van Houten said in a statement that “We remain fully committed to supporting the community of patients who rely on the affected devices, and the physicians and customers who are dedicated to meeting patient needs.” 

The FDA recommends that patients continue to use devices containing the silicone-based foam, because it would be more harmful to stop treatment altogether. Without treatment, sleep apnea sufferers can go on to develop serious long-term conditions such as high blood pressure, stroke, diabetes, and heart problems. However, potential exposure to harmful gasses possibly resulting in respiratory and other problems has presented a dilemma to patients who rely on the CPAP and BiLevel PAP devices. ‍

Litigation updates  

In October of 2021, approximately 71 cases against Philips were consolidated for combined discovery in a process known as Multidistrict Litigation (MDL) in Pittsburgh federal court.This court was chosen because of its proximity to Philips’ Western Pennsylvania offices and manufacturing facilities. 

The parties in the MDL are currently fighting over issues related to the preservation of evidence for trial. Specifically, Philips has objected to a pretrial order barring any "tangible things" that could be evidence in the MDL over degrading, potentially harmful sound-dampening foam in the machines from being "destroyed" or "altered.”  

Philips filed an emergency request Friday asking the court overseeing the MDL to stay or modify the pretrial order, arguing that the company had to replace the foam at issue in the case under orders from the FDA. They argued that "Paragraph 13 imposes obligations on the parties that are in conflict with the FDA recall remediation. The preservation of evidence provision also arguably applies to absent class members, which could lead to users failing to submit their devices for replacement, and Respironics being unable to rework devices and provide replacements to users."  

Attorneys for plaintiffs countered: "Plaintiffs do not take issue with Philips repairing recalled machines and sending them to class members... But Philips proposes to destroy evidence unnecessarily... Philips should preserve all relevant evidence, including the PE-PUR foam that is at issue in this litigation, memory cards in the devices, and other component parts of machines that are removed in the retrofitting process, for possible inspection and testing at a later time. No person's legal rights should later be prejudiced because they returned their machine at Philips' request and Philips discarded relevant components." 

The court has taken the arguments under advisement and should make its decision soon.   

The VA issued these devices to Veterans 

Veterans given devices such as the DreamStation or SystemOne may be able to seek compensation through a CPAP lawsuit. The VA distributed approximately 300,000 of these devices for Veterans’ home use. Veterans may also have been exposed to these recalled devices in a VA hospital or clinic. Note that status as a veteran does not hinder one from pursuing legal actions against Philips and it would not affect a veteran’s benefits. 

We're here to help 

If you or someone you love has developed a chronic respiratory illness, such as asthma, or were diagnosed with cancer after your use of a Philips CPAP or BiPAP machine, you may be eligible to receive substantial compensation without ever going to court. Fill out our free case review today to find out if you could be eligible.  If you don't receive a recovery through a lawsuit or settlement, you don’t owe us anything. 

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