In June 2021, Philips Respironics issued a mass recall for its CPAP, BiPAP, and manual ventilator machines. These machines, used primarily to help treat sleep apnea or pauses in breathing during sleep, are often noisy and emit vibrations as they force air into the user’s respiratory systems. Sound abatement foam made from polyester-based polyurethane (PE-PUR), intended to dull the sound of the recalled sleep-disordered breathing assistive devices, can break down, especially when stored in high heat or humid environments causing people to swallow or inhale black particles of the foam or other non-visible chemicals. Additionally, using cleaning methods not approved by the manufacturer, including ozone or ultraviolet (UV) light cleaners, can worsen the foam’s damage.

Patients inhaling these toxic, broken-down PE-PUR foam particles can suffer injuries, including respiratory problems like asthma, upper airway irritation, cough, chest pressure, and sinus infections. Current lawsuits against Philips Respironics focus on the defective design of the company’s CPAP, BiPAP, and mechanical ventilator devices, leading to the foam’s breakdown and subsequent harm to users.

CPAP MDL Plaintiffs’ Counsel Leadership Announced in February 2022

January 2023 Update

Litigation is progressing slowly in MDL 3014, with the case currently in discovery. On December 12, 2022, the parties jointly stipulated to the Deposition Protocol, which limits most depositions to seven hours. This was approved in Pretrial Order #29.

On September 14, 2022, in Pretrial Order #25, Judge Conti granted a joint motion to approve a census registry form, which allows plaintiffs to file complaints on a short form directly with Philips Respironics. Completing this information has the effect of tolling the statute of limitations until a case can be filed or Philips withdraws the agreement. This replaces a private tolling agreement that had been approved on February 8, 2022.

The case against Philips has garnered the attention of the U.S. Justice Department. Philips is currently engaged in negotiations with the Justice Department regarding a consent decree the Justice Department proposed in 2022 with regards to the recall. 

In May 2022, the Food and Drug Administration’s Center for Devices and Radiological Health issued a “Notice of Opportunity for a Hearing” to Philips Respironics that the FDA had determined the Philips CPAP machines create an unreasonable risk of substantial harm to the public.

In the notice, the FDA specifically refuted Philips Respironics’ claim that the use of ozone cleaners may be the true cause of the foam breaking down, with the following statement:

“There is sufficient evidence for FDA to determine that there are reasonable grounds to believe that the risk associated with the devices was not caused by the failure of a person other than Philips to exercise due care in the installation, maintenance, repair, or use of the devices at issue. In particular, although the use of ozone cleaners by device users may have exacerbated degradation of the PE-PUR foam, evidence indicates that the unreasonable risk associated with the products was not caused by the use of ozone cleaning agents, nor did the use of ozone to clean the products constitute a failure to exercise due care.”

According to a December 2022 FDA update, the silicone material being used to replace the foam may move and block the air pathway, resulting in reduced air flow and the potential to activate the device alarm. The FDA also found residual foam in the replacement devices.

The devices affected include the first-generation DreamStation CPAP and BiPAP machines, with Philips’ DreamStation CPAP machines accounting for about 80 percent of the recalled sleep apnea devices, according to The other 20 percent are mechanical ventilators.

Personal injury lawyers opting to litigate CPAP cases could see many clients interested in recovering damages for serious injuries caused by Philips Respironics’ sleep apnea devices and the defects found with the sound abatement foam. Case Works offers case development and management tasks for lawyers with large caseloads, including those caseloads arising from CPAP litigation.

As of December 1, 2021, 127 CPAP lawsuits are pending against Philips in a multidistrict litigation (MDL) in the Western District of Pennsylvania. The lawsuits are in their initial stages and aren’t yet ready for trial.
After Philips voluntarily recalled its CPAP and other breathing assistive products, the U.S. Food and Drug Administration (FDA) implemented a Class I recall, the most urgent or serious out of the FDA’s three types of recalls. Essentially, a Class I recall means that using the product is likely to lead to serious adverse health consequences, including death.

By September, Philips had a plan to replace the PE-PUR foam with silicone-based foam. However, the silicone-based foam had not undergone testing for “volatile organic compounds” or VOCs. The FDA requested that Philips have the silicone-based foam independently tested.

While Philips began the testing process, the FDA continued its investigation of the manufacturer’s CPAP machines. The government agency determined that as early as 2015, Phillips was aware of the problem with the PE-PUR-containing foam decomposing and causing illness, yet continued to sell the devices until recalling them in June 2021, nearly six years after the discovery of potential or likely harm to consumers using its products.

What are the volatile organic compounds found in PE-PUR?

As the PE-PUR foam breaks down, it leads to the production of volatile organic compounds or VOCs. You cannot see these chemicals that infiltrate the products’ airflow and transfer to users. Additionally, patients and health care professionals might not always see or be aware of the tiny black particles or pieces of the sound abatement foam, signaling an issue with the sleep apnea devices.
Chemicals found by the Philips’ lab after testing the sound abatement foam include:
Diethylene glycol , which can cause eye irritation, skin irritation, and irritation of the mucous membranes if you swallow it
Toluene diisocyanate , which might cause eye problems, respiratory issues, skin irritation, and cancer, and can be fatal when inhaled
Dimethyl diazene , is a carcinogenic chemical that could be toxic. It can also cause colon cancer.
Toluene diamine , often found in hydraulic fluid, dyes, and explosives, could cause organ damage, infertility, cancer, genetic defects, and skin problems.
Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl) , most often used to make other chemicals, can cause damage to aquatic life and the environment.
The damage caused by these chemicals could be catastrophic, especially for individuals who have been using the CPAP machines since 2015, when Philips Respironics first learned about the breakdown of the sound abatement foam component and its dangers. The black particles from the deterioration of the toxic foam get into the device’s air pathway, meaning these particles can go directly into a patient’s lungs, causing severe health issues.

Recall Status for Philips Respironics CPAP Machines

Initially, Philips issued a voluntary recall of its sleep apnea machines, but the FDA followed up by issuing a mandatory recall once it learned about the extent of the problem. Currently, Philips has a program in place that replaces the PE-PUR foam with silicone foam. Patients and health care providers should register the affected medical devices online. The registration site will give the user more information about the recall and instructions on receiving the replacement foam. Users can also call (877) 907-7508 to register the problematic device.

Additionally, Philips recommends cleaning the machine as recommended and approved, avoiding ozone and UV light cleaners. Finally, the company reminds users to check the age of their CPAP machines and replace them if they’ve been using the medical device for more than five years.
CPAP and BiPAP machines help relieve sleep apnea disorders, which often cause less than adequate oxygen to reach the lungs. When people snore loudly, and their sleep is interrupted, it’s often a sign that an obstruction or other problem is restricting their breathing during sleep.

Due to the lack of airflow, the lungs and brain cannot get enough oxygen, causing pauses in breathing and interrupted sleep.
CPAP and BiPAP machines help relieve sleep apnea disorders, which often cause less than adequate oxygen to reach the lungs. When people snore loudly, and their sleep is interrupted, it’s often a sign that an obstruction or other problem is restricting their breathing during sleep.

Due to the lack of airflow, the lungs and brain cannot get enough oxygen, causing pauses in breathing and interrupted sleep.
A common complaint among CPAP users and those who sleep near them is the noise from the machine that often keeps people awake. Thus, the company uses sound abatement foam to decrease the sound and vibrations coming from the device. This foam and its degradation leading to exposure to harmful debris and toxins is the crux of current CPAP lawsuits.

The FDA estimates that the recall affects about 3.5 million CPAP, BiPAP, and ventilator machines. The product recall is for all devices manufactured before April 26, 2021, covering all serial numbers.

The recall includes:
CPAP and BiPAP Devices
Mechanical Ventilators
Philips asserted that reports of minor symptoms, such as upper airway irritation, headaches, chest pressure, cough, and sinus infections “may have been associated with the foam.” The company also claimed that it hadn’t received any reports of life-threatening injury or death due to the use of its CPAP machines.

However, testing found that continuous use of the machines containing the defective PE-PUR foam could cause serious injury or permanent impairment. The company issued a voluntary recall notice before the FDA’s recall to “preclude permanent impairment.”

Investigative Testing Found Health Risks

Investigative testing conducted by Philips found that the degradation of the foam resulted in the formation of at least five toxins. Depending on the longevity and extent of exposure, these toxins can cause minor and severe, as well as potentially deadly, injuries.

Additionally, the FDA determined that Philips knew of the problem with the CPAP machines since 2015 but didn’t take action until 2021, continuing to sell the defective medical devices throughout that time.

The FDA determined that exposure to the foam particles and chemicals released by the CPAP machines may cause dizziness, hypersensitivity, nausea, and vomiting.

Lastly, the agency found that ozone gas or UV light used to clean the sleep apnea devices can lead to additional health risks. Also, storing or using the CPAP, BiPAP, or mechanical ventilator machines in high heat or humid settings can further degrade the sound abatement foam, thereby increasing the risk of harm to patients.

Filing a CPAP Lawsuit

If someone uses a sleep apnea machine covered under the Philips CPAP recall, the user should retain a CPAP lawyer to represent them in the MDL to recover damages for any health issues suffered due to the degradation of the sound abatement foam.

Even if the patient believes their health complications are minor, symptoms like headache or nausea could lead to more severe health issues from breathing in the toxic foam through the device’s air pathway. CPAP users should ask their health care providers to check their lungs immediately if they are currently using or previously used an affected Philips Respironics sleep apnea machine.

Obtaining copies of patients’ medical records connected to evaluation and treatment from breathing in the black foam particles or toxins from an affected CPAP device can be burdensome for law firm staff. Due to the number of documents, especially if the patients used the recalled sleep apnea machines for several years, your legal team might spend hours, days, weeks, or months trying to request, obtain, organize, and analyze many patients’ medical records.

Patients can recover compensation for health complications stemming from defective CPAP machine use. Still, they’ll need to provide medical bills and other evidentiary records to their lawyer, who can properly investigate the case to determine if the harm suffered was due to toxic foam in the device’s air pathway. Case Works can help attorneys retrieve and manage the plethora of documents and other evidence uncovered during the investigation phase.

Injured CPAP users can recover the following compensatory damages:

Past and future medical expenses

Lost wages

Loss of earning capacity

Pain and suffering

Recovering Punitive Damages

If the court finds that Philips Respironics was grossly negligent in handling its investigation of its CPAP, BiPAP, and other mechanical ventilator devices, your client might recover punitive damages intended to punish the defendant and deter future wrongful actions. Philips continued to manufacture and sell its defective CPAP, BiPAP, and mechanical ventilator machines containing the potentially harmful sound abatement foam, even after testing revealed the risks, making it likely they acted intentionally and without regard for the public’s health or well-being. Their egregious actions increase the likelihood of the imposition of possible punitive damages, adding additional case management duties to each case.

Many states require plaintiffs to go through bifurcated trials to recover punitive damages, requiring another round of discovery to prove that the defendant was grossly negligent or willful in its behavior.
Case Works’ case management and development services can help attorneys better manage these complex cases, ensuring that their clients recover the maximum compensation they deserve. Contact Case Works today to discuss your law firm’s CPAP litigation needs.