Philips CPAP Recall Lawsuit & Resulting Claims

Philips CPAP Recall

Do you use a Philips CPAP, BiPAP, or ventilator? If so, you may have heard about a Philips CPAP recall lawsuit affecting these machines. Phillips has now admitted that their machines are safe and can cause cancer and other serious injuries; a fact which Phillips has know, but concealed for some time. The recall is limited to specific Philips machines. If you have a different device manufacturer, you are not affected by this recall. 

Many have already contacted our legal team to discuss filing a claim. If you are unsure if you are eligible, please don’t hesitate to reach out to us and lean on our experience with these cases.

Does The CPAP Recall Affect My Philips Device?

Philips has issued a voluntary recall for Phillips CPAP, BiPAP, and ventilators built at any time from 2009 until April 26, 2021. All of the devices, including all devices in Wes Virginia, identified in the recall contain polyester-based polyurethane (PE-PUR) sound abatement foam. This foam may degrade, and that possibility carries two potential health risks for users of these machines. 

The result of that degradation can release harmful gases and foam particles. 

If your device is part of the recall, you may have already been exposed to toxic and carcinogenic effects from the foam particles. So check your device against the recall list. You may need to take immediate action

Machines Recalled All recalled devices were manufactured prior to April 26, 2021, and all serial numbers of these devices are included:

  • SystemOne Q Series
  • DreamStation CPAP, Auto CPAP, BiPAP
  • DreamStation GO CPAP and APAP
  • Dorma 400/500 CPAP
  • REMStar SE Auto CPAP
  • DreamStation ASV
  • DreamStation SV/AVAPS
  • SystemOne ASV4
  • C Series ASV, S/T, AVAPS
  • OmniLab Advanced Plus In-Lab Titration Device
  • E30 Continuous Ventilator
  • Trilogy 100 Ventilator
  • Trilogy 200 Ventilator
  • Garbin Plus, Aeris, LifeVent Ventilator
  • A-Series BiPAP Hybrid A30 (not marketed in the U.S.)
  • A-Series BiPAP V30 Auto
  • A-Series BiPAP V30 (not marketed in the U.S.)

The Potential Health Risks

The first potential health risk from the degradation of the PE-PUR foam is due to the potential for the foam to off-gas as it breaks down. This can expose the user to chemical emissions that may have toxic and carcinogenic effects.

The second and potentially more serious effect of deteriorating foam is that it may break down into particles that enter the device’s breathing airpath, where they can become a hazard to the user.

While the intact foam is safe, its particles are much more dangerous. If the foam particles get into the airpath of the device, they may become ingested by the user. This possible introduction of foam particles into the body poses a serious health risk, as the particles are toxic and carcinogenic.

Full components of CPAP system on wooden table

The Potential Health Risks

The first potential health risk from the degradation of the PE-PUR foam is due to the potential for the foam to off-gas as it breaks down. This can expose the user to chemical emissions that may have toxic and carcinogenic effects.

The second and potentially more serious effect of deteriorating foam is that it may break down into particles that enter the device’s breathing airpath, where they can become a hazard to the user.

While the intact foam is safe, its particles are much more dangerous. If the foam particles get into the airpath of the device, they may become ingested by the user. This possible introduction of foam particles into the body poses a serious health risk, as the particles are toxic and carcinogenic.

Off-Gassing

As the PE-PUR foam begins to degrade, some users complained about skin irritation, eyes, nose, and respiratory tract. Others have reported hypersensitivity, nausea, headaches, and dizziness.  Philips says that as of mid-June of 2021, it hasn’t gotten any substantiated claims of health issues related to these gases. 

Debris in Airpath

Philips has gotten some reports of small black particles within the airpath of their CPAP, BiPAP, and ventilators.

The potential for PE-PUR foam particles to enter the airpath has similar risks of irritation of the eyes, skin, and respiratory tract. But, it may also lead to acute adverse reactions and even obstruction of a patient’s airway.

Some users may also experience adverse effects to other organs (like the liver) or headaches, asthma, and systemic inflammatory response to the exposure.

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Injured by complications related to Phillips CPAP recall?

Health Risks Associated With PE-PUR Foam Particles

Users exposed to these foam particles could experience any of the following health conditions:

  • Acute Respiratory Distress System (ARDS)
  • Bladder Cancer
  • Brain Cancer
  • Breast Cancer
  • Chemical Poisoning
  • Heart Attack
  • Heart Failure
  • Hematopoietic Cancer
  • Kidney Cancer
  • Kidney/Renal Damage
  • Kidney/Renal Disease
  • Leukemia
  • Liver Cancer
  • Liver Damage
  • Liver Disease
  • Lung Cancer
  • Lung Damage
  • Lung Disease
  • Lymphatic Cancer
  • Multiple Myeloma
  • Nasal Cancer
  • Non-Hodgkin Lymphoma
  • Papillary Carcinoma
  • Pleural Effusion
  • Prostate Cancer
  • Reactive Airway Disease (RAD)
  • Rectal Cancer
  • Respiratory Failure
  • Severe Ear Inflammation
  • Severe Nose Inflammation
  • Severe Throat Inflammation
  • Stomach Cancer
  • Testicular Cancer
  • Thyroid Cancer

Complicating Factors

For a user of a Philips CPAP, BiPAP, or ventilator, who are likely already suffering from chronic lung diseases or ailments, any health condition that risks further damage to their lungs or airway is a serious concern.

But, some users of these devices can’t stop using them without having first obtained a replacement. That isn’t always easy to do, as these devices are very costly and continue to be in short supply due to the increased demand for them to treat COVID19 patients. 

For instance, the Trilogy 100 is a life-sustaining mechanical ventilator, and discontinuing its use may have lethal consequences for some users. Due to the high cost of a new machine, the limits of their insurance coverage, and the high worldwide demand for these products, they may not have the luxury of simply getting a new one. 

The Trilogy 100 and other similar devices are part of the recall, so there is a risk in continuing to use them. Still, the benefits of using the device may outweigh the risks of exposure to potentially toxic and carcinogenic foam particles. This analysis of risk and reward is something each user should discuss with their personal physician. 

And, they may be entitled to take legal action if they have used these devices and suffered negative health consequences due to exposure to toxic foam particles.

Trilogy 100 cpap
Trilogy 100 by Phillips

What You Need to Do

The first thing to do is speak to your personal care provider. If your physician determines that it is inadvisable to discontinue your therapy, consider using an inline bacterial filter to minimize the risks of ingesting foam particles. 

You may also be able to purchase a similar device from another manufacturer. Sometimes, you may be able to offset that cost through your health insurance.

Other users who are not using a life-sustaining medical ventilator may be able to pause their therapy while waiting for a fix from Philips or obtain a device that is not affected by the recall. 

women wearing CPAP machine giving thumbs up

What Philips Says

Philips has plans to replace the current sound abatement foam on these devices. They claim that their fix will permanently address both the off-gassing and debris issues. But, it’s unclear what the timetable for these fixes may be.

Take Legal Action Today

Litigation in several different venues has followed the recall as an effort to seek redress for the millions of Philips customers negatively affected or even harmed by the exposure to their toxic and carcinogenic foam. One of their main contentions is that Philips was aware of the degradation of the foam well in advance of initiating their recall. 

If Philips continued to profit from the sale of these units even while they were aware of the degrading foam issue, they have likely caused harm to their clients in the interest of making more money.

The earlier your claim is presented, the better our attorneys will be able to position your claim for settlement discussions. To make sure your rights are protected, contact us about investigating your claim and potentially filing a lawsuit against Philips. 

Speak with one of our Phillips injury claim attorney today to investigate your rights and the best course of action today.

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CPAP, BiPAP, and Ventilators

It may be helpful to understand the differences between these three types of respiratory assist devices. People often use their names interchangeably, which can lead to confusion about what exact kind of machine you use.

What Is a CPAP Machine?

A CPAP machine provides continuous positive airway pressure (CPAP), keeping your airway open. Individuals who suffer from obstructive sleep apnea are often prescribed a CPAP machine for therapy. They wear a mask while they sleep to keep their airway wide open during rest.

What Is a BiPAP Machine?

BiPAP stands for bilevel positive airway pressure. Also known as BPAP or BiLevel PAP, these machines pump air pressure in the lungs and airway passage. They attenuate the pressure during expiration and ramp the pressure back up during inspiration.

In some applications, this sort of assisted breathing is life-sustaining. For sufferers of certain medical conditions like chronic obstructive pulmonary disease (COPD), BiPAP can help reduce their work of breathing.

What Is a Ventilator?

A ventilator is a machine that assists or controls a patient’s breathing. Often designed to deliver a specific concentration of oxygen in the breathing gas to a user, they are in many cases considered to be life-sustaining devices.

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Injured by complications related to Phillips CPAP recall?

Unapproved Cleaning Methods for CPAP Machines

Philips believes that by using unapproved cleaning methods, some users may be accelerating or contributing to the deterioration of the sound abatement foam. 

They remind users to avoid cleaning methods such as ozone, as they are likely to exacerbate the issue. One of the other possible contributing factors to the degradation of the PE-PUR foam may be exposed to high heat and high humidity environments. 

(Source: FDA.gov) Ozone is a gas that can be used to kill harmful bacteria. However, for ozone to be effective in killing harmful bacteria, it must be present at a concentration far greater than what is considered safe for humans. Although products claiming to clean, disinfect or sanitize CPAP devices that use ozone gas claim that they are designed to keep ozone gas inside the machine and its accessories, leaks can occur at tubing connections, filters, or through containers used to house CPAP accessories. When leaks occur, ozone gas in the room where the devices are used may temporarily rise to unsafe levels especially if the room is small or not well ventilated.

You may want to try and minimize the environmental heat and humidity in your home to try and help preserve the foam while you await a fix from Philips. Consider using an air conditioner to lower the temperature and humidity. You should also carefully and routinely inspect the airpath of your device, including the tubing, mask, and any other accessories. 

If you think you are having problems with your Philips device, report them to the Food and Drug Administration or contact us and we’ll assist you.

Complications After Using Phillips' CPAP Device?

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