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.

What’s Wrong With the Foam?

These machines use polyester-based polyurethane (PE-PUR) foam that can break down into little bits and enter a user’s airway. The foam can also break down by off-gassing harmful chemicals that the user inhales. These can potentially cause health problems for users, such as:

• Cancer
• Dizziness/headaches
• Asthma
• Nausea
• Vomiting
• Cough
• Sinus infections
• Organ damage
• Irritation to the respiratory tract, skin and/or eyes

As you might expect, a lot of people who use these CPAP machines have filed lawsuits. There are so many cases that the courts have set up multi-district litigation, or MDL to handle many of them.

What’s Multi-District Litigation?

An MDL is a consolidation of many related lawsuits so the court can more efficiently handle the cases and encourage the parties to settle. MDL usually takes place in federal court, although a state may have its own version of MDL litigation where cases from various counties are consolidated.

MDLs are not the same as class-action lawsuits, though. Class-action litigation involves multiple plaintiffs in a single case. In contrast, an MDL consists of many individual cases that get their pre-trial matters (like discovery) handled by a single court.

MDLs are also sometimes more likely than class action lawsuits to settle, especially after several bellwether cases go to trial.

There are a variety of logistical and legal reasons why cases might end up in a class action lawsuit instead of an MDL or vice versa. The important thing to know concerning the Philips CPAP, ventilator and BiPAP recall litigation is that many (if not most) of the cases have been consolidated into an MDL.

The Philips CPAP, BiPAP and Ventilator MDL

The bulk of the CPAP, BiPAP and ventilator litigation against Philips is part of “MDL 3014 In Re: Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation” (MDL 3014). The Honorable Joy Flowers Conti from the U.S. District Court for the Western District of Pennsylvania is the presiding judge in this case.

The MDL is still in the very early stages, with plaintiffs still joining MDL 3014 and filing their complaints. The cases will progress with parties exchanging information through discovery and the court making decisions about discovery disputes.

Eventually, the court will schedule a few bellwether cases for trial. After the bellwether trials, the parties will see if a global settlement is possible. Depending on how these bellwether cases go, it could give the plaintiffs or defendants a major advantage during settlement talks.

If a global settlement isn’t possible, many of the cases could get sent back to their respective federal district courts where they were originally brought. The litigants can proceed with their lawsuits and settle or go to trial.

How Can I Find Out If Something Important Happens in MDL 3014?

There are three ways to learn about recent developments. First, you can use an online search engine such as Google to look for any news stories, blog posts or articles about the case.

This is the easiest and quickest approach, but the problem is that unless there’s a big development in the MDL, such as a global settlement, you’re not likely to find much.

Second, you can go to the MDL 3014 court website, which is free and readily available to anyone with an Internet connection. Here, you’ll find court orders from the case. A court order usually reflects something “official” the court does, such as transferring a case, deciding a motion or scheduling a bellwether trial.

The drawback of going to the MDL 3014 website is that it only contains a small fraction of what’s going on in the case. This means it’s sometimes hard to understand the meaning or importance of a particular order.

For example, let’s say you see an order that indicates a judge has granted a plaintiff’s motion for sanctions against the defendant for not providing the requested discovery. But you don’t see each side’s legal briefs or memos arguing their legal positions. You also won’t see any other related motions that the court has yet to rule on.

In a way, seeing a court order all by itself is like being told the current score of a football game, but you aren’t told what quarter it is.

The third option for keeping up with MDL 3014 (or any other federal case) is to review the federal dockets. Dockets consist of a list of pretty much everything that happens in a case, organized by date. The docket will reflect pleadings, motions, an attorney’s entrance of appearance or a jury’s verdict after the trial.

If you want to know all the relevant updates to a particular case or MDL, looking at the dockets is the best approach. That being said, it’s not always the easiest way to learn about recent developments. This is because it can be difficult to understand the various bits of legal and court-specific jargon and codes that appear.

Another problem is that they’re not easily accessible by the public. Yes, anyone with access to the Internet can access federal court dockets, but they need to make a free PACER (Public Access to Court Electronic Records) account.

What’s not always free is using PACER. Information you get from PACER can cost 10 cents per page, although there’s a cap of $3.00 when reviewing a particular document. This is handy when you want to look at a particular court document that’s 500 pages and only have to pay $3.00 instead of $50.00.

If your PACER fees are less than $30.00 for a calendar quarter (three months), the fees are waived. This $30.00 threshold gets reset every quarter, so as long as you’re only using PACER sparingly, you can use it all year and not have to pay anything. But the worst part about PACER is that it’s not the most user-friendly website.

If you want more information about the CPAP litigation, or are thinking about joining MDL 3014, feel free to reach out to me at (919) 830-5602.

There are as many as four million machines affected by the CPAP recall. The Philips CEO has stated that it may take a year or longer to fully repair or replace the affected machines. When he says repair he’s talking about replacing that problematic foam or replacing the entire machine for a brand new machine, so it’s going to take a while. And that’s one of the problems that a lot of the people that are calling my office are saying, and that is, that they use this machine to sleep and some of them are worried that they will have to use the recalled machine to sleep. So they’re in a tough position. Again, I’m not a doctor and I don’t give medical advice, but I would say if you can find a replacement machine quickly, set aside your recalled CPAP machine and don’t use it and beyond that, you just have to talk to your doctor about what’s going on and what you should do next.

Potential Injuries from the Recalled CPAP Machines

What are the potential injuries from the recalled CPAP machines? These injuries would include somewhat modest problems like irritation to the eyes or skin, a cough, headache or dizziness. These are not unimportant issues, they can be serious problems, and they run from the gamut from headaches and nausea to sinus infection. More serious injuries include organ damage, asthma and even cancers. The medical community is looking at this aggressively and quickly and trying to figure out all the many problems that can result from inhaling these particulate foam pieces from the CPAP machines or getting exposed to the off-gassing.

The FDA has classified the CPAP recall as Type 1, the most serious one they have, and they’re taking it very seriously. So there is a constellation of symptoms that could result from a breakdown in these CPAP and BiPAP and ventilator machines. Just be very aware of your health and any changes in your health and if you’re feeling a new and suspicious cough or an infection of the sinus, headaches, vomiting, nausea, anything like that, you need to take it and have a doctor to check you out.

CPAP Lawsuits

As you might imagine lawsuits have begun to be filed around the CPAP recall. Millions of these devices have been used for years by millions of patients. Now they’ve been recalled and and they have caused injuries. They suffered through no fault of their own. This litigation is very new and it’s emerging but a multi-district litigation (MDL) site was established in October 2021, in the US District Court for the Western District of Pennsylvania. The judge that is going to be overseeing the MDL for the CPAP device is Judge Conti. If you think you have a case, you can certainly call me ((919) 830-5602) and we can discuss further.

What Should You Do Next?

If you believe you may have a recalled CPAP machine and you have injuries that are flowing from this defective machine, you should not discard the machine. Don’t throw it away and don’t send it back to Philips. Hold on to it. I would encourage you to get a replacement machine if you need one to sleep with, but in any event, the existing machine that is subject to recall, you need to keep all of it and that includes the hoses, pieces and accessories. You want to keep it all because it may end up being evidence in your case.

The very next thing that I would do if I were in your position is to contact your doctor, schedule a visit and explain everything. Explain the kind of machine you have and that it has been recalled, that you are aware of at least two ways for the recalled machine to have caused injury and that you want to be checked out. The third thing I would do is to take inventory, take stock of what’s happened to you in the last few months, the last few years, whether there’s been a new onset of symptoms that you didn’t recognize but you just kind of wrote off because you know, you just thought it was the normal process of aging. I would also write down every detail you can think of that might help your case down the road, which includes when you started using the device, when you stopped using the device, how many nights a week you used it, how many hours per night. You can even note the pressure settings. If you know that how the device was cleaned, how you cleaned the device, and the products used to clean the device. Any time you keep kind of a journal of the basic facts of any case, it’s going to help out your attorney, it’s going to help out your case and it’s going to be useful for you down the road. These facts can be lost to memory and time if you don’t stay on top of it.

So that’s where we are at the moment in this defective product area. The MDL site has been created in Pennsylvania. Dozens of cases are already filed. There are going to be thousands of cases filed in the next year. If you are a user of the Philips CPAP, BiPAP or any ventilator machine that was subject to recall, and you also have symptoms, you need to be well aware of it and keep checking this site as I try to keep people up-to-date. Call me if you want to discuss your case further. But either way, good luck and good health

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.