Philips Respironics (Philips) is a major manufacturer of the CPAP and BiPAP machines that help people with central sleep apnea and obstructive sleep apnea. Philips also makes ventilators that have no doubt saved lives in hospitals and other healthcare settings. These machines use a special type of foam to reduce the sound and vibration coming from these devices. Unfortunately, the foam Philips chose years ago can degrade and injure users, which eventually led to a 2021 CPAP recall. Let’s take a look at a recent development concerning Philips and its ventilator, CPAP and BiPAP products.

A Brief Overview of How We Got Here

In June 2021, the U.S. Food and Drug Administration (FDA) issued a Safety Communication notifying the public that Philips had recalled certain BiPAP, CPAP and ventilator machines. There were concerns that the polyester-based polyurethane (PE-PUR) foam used in these devices could break down, allowing small bits of foam to enter a person’s body. The FDA also mentioned that the foam could off-gas and release harmful gasses into the machine’s airflow causing additional harm.

In response to the CPAP recall, the FDA asked Philips to do several things, including:

• Let the FDA inspect the Philips manufacturing facilities.
• Take additional steps to notify health professionals who use or prescribe the affected products.
• Have an independent laboratory conduct additional testing concerning the health risks presented by the PE-PUR foam.

Philips agreed to these requests and recently reported its findings from its independent laboratory testing to the FDA.

Philips Testing and the FDA’s Response

Throughout 2021, 2022 and 2023, Philips provided regular updates concerning the testing being done by its independent laboratories. This testing examined two types of PE-PUR foam used in the recalled devices and assessed the risk they presented when they broke down and off-gassed VOCs (volatile organic compounds) or introduced particulates (tiny bits of foam material) into the airflow.

Philips used five independent laboratories across the United States and Europe and the testing examined both new and used devices, as well as devices cleaned with ozone, which the FDA suspects might make the PE-PUR foam problem worse.

Also tested were “lab-aged” machines. These are machines that were exposed to temperatures (90 degrees Celsius) and relative humidity (95%) that are far higher than what’s typically found in people’s bedrooms. If you’re not familiar with the metric system, 90 degrees Celsius is more than 190 degrees Fahrenheit.

When testing Type A foam, the laboratories concluded that any particulate or VOC exposure was “unlikely to result in an appreciable harm to health in patients.” When testing Type B foam (which accounted for 5% of the recalled machines), the laboratories concluded that “no overall risk conclusion [were] available at this time.”

As you might expect, the FDA was not satisfied with these results and asked that Philips complete more testing. Philips has agreed to this and while the FDA awaits additional test data, the FDA stands by its original patient recommendations concerning the use of the recalled machines.

If you’re curious about the nitty-gritty details of this testing, you can review the results in Philips’ July 2023 report. Just be warned that the content is a bit dense, although reading this report would work as a great sleep aid if you’re having trouble falling asleep.

I’ll provide more updates as they arrive, including major news concerning the CPAP recall or the ongoing litigation. If you have any questions on what your legal options might be if you’ve used a recalled machine, don’t hesitate to reach out by calling me. My direct line in the office is (919) 830-5602.

Philips Respironics (Philips) is a leading manufacturer of CPAP and BiPAP machines to help individuals treat their sleep apnea. Philips also makes ventilators which are often used in the medical setting. Earlier this summer, they announced a recall of many of these devices due to the potential harm they could cause their users. Let’s take a quick look at the nature of this recall and the resulting litigation.

Why Is There a Recall?

A variety of ventilators, CPAP and BiPAP machines produced by Philips use polyester-based polyurethane (PE-PUR) foam. The purpose of this material is to reduce the sound and vibration from these devices. However, this foam may break down and injure the user. It’s suspected that high heat and humidity could make this problem worse.

What Are the Potential Injuries?

There are two potential types of injuries from the PE-PUR foam. First, the foam could fall apart into little bits that make their way into the air that the device pushes into the user’s lungs. Second, the foam could off-gas, or release harmful chemicals into the airflow from the device. Either of these events could result in the following injuries:

• Irritation to the eyes, skin and respiratory tract
• Sinus infection
• Cough
• Organ damage (such as to the kidneys and liver)
• Headache/dizziness
• Asthma
• Cancer
• Nausea
• Vomiting

What Machines Make Up the Recall?

Philips has reported that roughly 80% of the machines being recalled are used to help individuals with sleep apnea. These include the following ventilators, BiPAP and CPAP machines:

• E30
• DreamStation ASV
• DreamStation ST, AVAPS
• SystemOne ASV4
• C-Series ASV
• C-Series S/T and AVAPS
• OmniLab Advanced+
• SystemOne (Q-Series)
• DreamStation
• DreamStation Go
• Dorma 400 and 500
• REMstar SE Auto
• Trilogy 100 and 200
• Garbin Plus, Aeris, LifeVent
• A-Series BiPAP Hybrid A30 (not marketed in the United States)
• A-Series BiPAP V30 Auto
• A-Series BiPAP A30 and A40

Philips CEO stated that about three to four million machines are affected by the recall and it could take a year to fully repair or replace the affected machines.

What Should I Do If I’m Using One of These Machines?

You should stop using the machine and immediately talk to your healthcare provider. Depending on your medical issue and your ability to find an alternative treatment or device, it’s possible that your doctor could recommend you continue using the recalled device.

You should also consider registering your recalled device with Philips. This will allow you to get the most current information regarding the status of your machine’s recall and any relevant updates from Philips.

Could I Take Part in a Lawsuit Against Philips?

If you used one of the affected devices then yes, you may have a legal claim against Philips. What you could potentially recover and how you do it will largely depend on the nature and extent of your injuries.

If you only suffered financial injuries, your damages might be limited to your out-of-pocket costs and medical monitoring (future preventative care expenses you’ll have to pay to make sure your use of the Philips device didn’t make you sick).

But if you have physical injuries then your damage could be far higher, especially if they’ve been seriously hurt. For instance, if the PE-PUR foam gave you terminal cancer, your legal recovery will likely be far higher than if you suffered a minor headache for a few weeks.

As for how you might obtain your legal recovery, there are two likely scenarios. First, you take part in a class-action lawsuit. You’re more likely to join this type of lawsuit if you’re only suing due to limited financial injuries.

Second, there’s multi-district litigation or an MDL. This is where you file your own lawsuit, but due to similarities to so many other cases, your case gets consolidated. This merging of cases will only last for pre-trial matters, like discovery. Being part of an MDL is more likely if you’re seeking compensation for physical injuries.

Many affected users have already filed lawsuits against Philips. There’s at least one class-action lawsuit and dozens of individual cases. Philips has already asked for many of these cases to get consolidated into an MDL. The court is currently in the process of deciding this issue.

If you or someone close to you is affected by this recall, or you have additional questions, please call me at (919) 830-5602. If you’re not ready to talk to a lawyer, you can get more information about what’s going on from the FDA’s Safety Communication and Philip’s recall notification.