It appears as if Philips’ legal problems concerning their CPAP and BiPAP machines in the United States may be coming to an end. Late last year, there was a tentative settlement concerning the plaintiffs’ economic loss claims. Then just recently, a court not only approved the economic loss settlement proposal, but Philips just agreed to pay $1.1 billion to settle the personal injury and medical monitoring claims. Let’s take a closer look at this CPAP settlement and what plaintiffs and future claimants can expect.

Economic Loss Settlement

In October 2023, the U.S. District Court for the Western District of Pennsylvania (District Court) issued an order preliminarily approving a settlement concerning the economic loss claims. These are claims that relate to the financial losses connected to the purchase of the affected machines. In April 2024, the District Court granted final approval of that settlement.

The official website handling the settlement claims process has been set up. It has eligibility information, how to submit a claim and the amount of money eligible claimants can receive. Generally speaking, if you’re eligible for an economic loss settlement payment, you could receive up to three payments.

First, there’s the Device Payment Award. This amount depends on the specific device you used. Award amounts range from $55.63 (for the DreamStation CPAP) to $1,552.25 (for the Trilogy 100/200, Garbin Plus or Aeris LifeVent).

Second, there’s the Device Return Award. This is a flat $100 payment for each recalled device that’s returned to Philips by August 9, 2024.

Third, there’s the Device Replacement Award. This is to reimburse you if you used your own money to buy a CPAP, BiPAP or ventilator device to replace an affected Philips machine. You must have purchased this replacement device on or after June 14, 2021 and before September 7, 2023.

The amount of this award depends on the price of the machine you purchased minus any financial payments you received to help pay for that machine (from an insurance company or third-party payer). The Device Replacement Award amount could also be reduced based on how many valid claims there are.

Personal Injury and Medical Monitoring $1.1 Billion CPAP Settlement

This is the big CPAP settlement that everyone is now talking about. The above-discussed economic loss settlement did not address legal claims relating to personal injuries and medical monitoring.

Medical monitoring claims are for current claimants and/or plaintiffs who aren’t aware of any health problems right now (that are related to the litigation), but believe health issues could develop in the future. As a result, the defendant agrees to pay for future medical tests and doctor visits to find any medical problems so they can be detected and treated as soon as possible.

Philips announced the $1.1 billion settlement on April 29, 2024, with the vast majority of those funds intended to pay for personal injuries. A small fraction, roughly $25 million, will go towards medical monitoring. This settlement came thanks to mediation and applies to the legal claims in the United States.

Because of how recent this settlement is, many details are still unclear. For example, we don’t know how much each victim will receive, as that amount will depend on how many people file a settlement claim and the extent of their injuries.

Additionally, it’s not clear what method will be used to calculate how much money each claimant receives. There will be a point system or formula that determines the settlement award based on factors like the severity of the personal injuries, how long the Philips BiPAP or CPAP device was used and the age of the claimant. The strength of the scientific link between personal injury and the use of the affected device might also be considered.

There are currently tens of thousands of people who are likely eligible for compensation under this settlement. Using very simple math, this means the average payout per person could potentially range anywhere from $10,000 to $100,000, although this is merely rough estimate and should not be considered the official range of settlement payouts.

Finally, we don’t know exactly when the settlement awards will be paid. That being said, we shouldn’t expect any checks to start going out until at least 2025. As I’ve said many times, the administration of settlements of this size move slowly.

If you believe you might be eligible for either settlement, it’s a good idea to talk to an attorney. You may not know which situation may apply to you until you have an initial consultation. After that, you can best decide what to do. I’m available to answer any questions you might have. You can call me at (919) 830-5602.

Note: This post is not legal advice.

I’ve written extensively about problems with some Philips CPAP and BiPAP machines, including alleged injuries, affected machines, recalls, and potential litigation. That litigation is ramping up, but a new concern has arisen over the FDA’s inadequate and delayed recall process.

Specifically, governmental safeguards designed to protect the public from faulty or dangerous medical devices may not be working properly. Using the Philips recall situation as a prime example, let’s examine what going on with the U.S. Food and Drug Administration (FDA) and why there might be room for improvement in how it handles potentially dangerous medical devices.

The FDA’s Role in Keeping Consumers and Patients Safe

The primary mission of the FDA is to regulate a large class of medical and consumer goods and products. Most of these include:

• Food (the regulation of certain foods is handled by another federal agency, the U.S. Department of Agriculture)
• Drugs (prescription and over-the-counter)
• Biologics (medical products that are biological, such as vaccines, gene therapy, and tissue products)
• Medical devices
• Devices that emit radiation
• Cosmetics
• Veterinary products
• Tobacco

The FDA’s primary goal in regulating these products is to make sure they’re safe and/or provide adequate warnings to the general public about their risks. This is especially true with medical devices and pharmaceutical drugs, which usually go through an extensive approval process that occurs before a device or medication gets sold to the general public.

Unfortunately, this approval process isn’t perfect. After a product hits the market, unexpected problems can arise. To deal with this, the FDA orders and/or oversees product recalls. The Philips BiPAP and CPAP machine recall has shed some light on how this recall process might not work as well as it should.

How the FDA Recall Process Should Work

The FDA requires certain entities (like medical device makers) to report problems with their devices to the FDA. Healthcare professionals and patients may also submit reports.

These reports go to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The FDA is then supposed to review each report and take appropriate action. Given how there could be thousands of medical devices in use, as well as the fact that a report may not be 100% complete (or truthful), the FDA won’t necessarily take immediate action if there’s just one negative report about a certain device.

But the FDA is supposed to analyze the data over time to identify any trends or patterns with a particular device or group of devices. One bad report may not mean anything. But several dozen bad reports when only a few hundred devices are in active use could be a sign of a problem. The FDA can then decide to order a recall themselves or suggest to the manufacturer that it should initiate a voluntary recall.

Why the FDA Recall Process May Be Broken

According to an investigative report by ProPublica, there are several problems with MAUDE in the recall process. First, mandatory reporters (like medical device companies) should submit reports in a timely fashion. This generally means filing a report within 30 days of a patient’s death or a device malfunction. However, these reports often get filed late.

How late? Well, ProPublica’s report found that Philips (and its related subsidiaries) filed at least 60,000 reports late since 2010. Many of these reports were late by several years. Of these 60,000 reports, at least 3,700 reports involved Philips breathing machines and ventilators.

Second, medical device makers often need to provide follow-up information to the FDA. During this follow up process, the FDA requires the companies to change the dates of when the companies first learned of the problem. This new date is usually later, meaning the records in MAUDE appear to show that the device company learned of the problem later than they actually did.

In addition to the ProPublica report, there was a 2011 report from the U.S. Government Accountability Office (GAO) that looked into how the FDA conducts its recalls. It found multiple problems within the recall oversight process, such as:

• The FDA often took more than a year to complete a recall (the FDA had a goal of completing them in 90 days).
• The FDA did not analyze the recall data to find systemic problems in the medical devices, such as common causes for problems leading to the recalls.
• The FDA did not always follow its own recall procedures, such as inspecting the manufacturing facility of a medical device maker.
• The FDA had inconsistent procedures that led to inconsistencies in recall effectiveness.
• The FDA did not have specific parameters in place to determine whether a medical device company properly completed its recall.

What’s Being Done About This Problem?

As of December 13, 2023, Senators Richard Durbin and Richard Blumenthal have sent a letter to the GAO asking them to update the 2011 report by investigating the FDA’s oversight of medical device recalls and identify ways the process could be improved.

Senator Blumenthal has also sent an October 10, 2023 letter to the FDA and U.S. Department of Justice (DOJ) asking them to “take immediate action” against Philips relating to allegations that it knew its ventilators and breathing devices were dangerous due to complaints it received, but withheld this information from the FDA. We’ll now have to wait and see how the FDA, DOJ and GAO respond to these letters.

If you’re using a Philips breathing machine that’s subject to a recall, please talk to your healthcare provider about whether you should continue using it. If you think you’ve been harmed by your machine, you might have some legal options. To discuss what these are, you can call me at (919) 830-5602 or contact my office.

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.

If you’ve used a Philips Respironics (Philips) CPAP or BiPAP machine to help with your sleep apnea, then there’s a good chance you’re aware that your Philips machine could be subject to a recall. I’ve written about this recall, as well as the health risks related to it and potential legal options if you’ve been harmed by your defective CPAP or BiPAP machine. In this blog post, I’ll look at one of the reasons why using one of these defective machines is so dangerous. I’ll focus on some of the studies that support the possibility that using one of these Philips machines could put you at greater risk for developing cancer.

How Do the Philips CPAP and BiPAP Machines Potentially Cause Cancer?

Many Philips CPAP and BiPAP machines (as well as Philips ventilators, but this blog post won’t focus on those) are made with polyester-based polyurethane (PE-PUR) foam. This foam is used to reduce the perceived sound and vibration coming from the CPAP and BiPAP machines. This is because many people who use these machines only use them when trying to sleep. So it’s important to make the machine as quiet as possible.

The problem is that the PE-PUR foam may break down and harm the user in two potential ways. The first way is when the foam physically falls apart so that the user inhales or ingests small bits of foam. The second way is when the foam releases harmful chemical gasses (off-gassing) which the user then breathes in. It’s this off-gassing that possesses the greatest risk for cancer.

What Kind of Chemicals Are the Recalled Machines Releasing?

There are many chemicals potentially off-gassed by the recalled BiPAP or CPAP machines. Some of these chemicals include:

• Dimethyldiazene (aka: azomethane)
• Phenol (aka: carbolic acid)
• Toluenediamine
• Toluene diisocyanate

Some of these can be classified as volatile organic compounds, or VOCs. Perhaps you’ve heard of these and how they should be avoided whenever possible. Various studies have examined these and related chemicals and the negative health effects they may have, including cancer.

“Cancer Incidence and Mortality in the Swedish Polyurethane Foam Manufacturing Industry” (British Journal of Medicine, 1993)

This study examined the effects of exposure to toluene diisocyanate and methylene diphenyldiisocyanate in the work setting. The researchers found that exposure to these chemicals resulted in a higher risk of rectal cancer and non-Hodgkin’s lymphoma.

“Infant Exposure to Emissions of Volatile Organic Compounds from Crib Mattresses” (Environmental Science and Technology, 2014)

This study compared crib mattresses made of polyurethane foam to crib mattresses made out of polyester foam. The authors of this study observed that both types of foam released VOCs, but that mattresses with polyurethane foam released a greater variety of VOCs.

“Carcinogenic Risk of Toluene Diisocyanate and 4,4’-Methylenedophenyl Diisocyanate: Epidemiological and Experimental Evidence” (Critical Reviews in Toxicology, 2001)

This article looked at the limited number of studies that examined the cancer-causing properties of Toluene Diisocyanate and 4,4’-Methylenedophenyl Diisocyanate. The goal was to see if these chemicals caused cancer through exposure in the work setting.

No definite conclusions were obtained, but the authors noted both chemicals likely damaged cellular DNA. Combined with the fact that these chemicals caused cancer in laboratory animals, the authors suspected that these chemicals could cause cancer in humans through exposure at work.

Do the Recalled Philips BiPAP and CPAP Machines Cause Cancer?

There’s evidence to suggest there is a link. But assuming there’s a link between the PE-PUR foam from faulty CPAP and BiPAP machines and cancer, the question remains of what amount of exposure to PE-PUR foam is sufficient to dramatically increase the risk of cancer. Additional studies are looking into this question. Still, it seems clear that prolonged exposure to PE-PUR foam can be harmful to your health.

You can expect that in any lawsuit alleging cancer, Philips will attempt to argue that the plaintiffs’ cancer was caused by something else, such as their lifestyle choices or what they did for a living.

Keep in mind that even if using a recalled Philips BiPAP, CPAP or ventilator did not give you cancer, it could have still harmed your health. So if you have any sustained symptoms that might be related to using your Philips machine, don’t hesitate to talk to your doctor. And if you want to learn about your possible legal options, feel free to give me a call (919.830.5602). Good luck.

Millions of people use the CPAP and BiPAP machines to alleviate symptoms of sleep apnea, so there’s a lot of people that should be interested in this topic. I’m going to move pretty quickly through this information, but I do want to start from the very beginning:

What is a CPAP and a BiPAP machine?

CPAP stands for continuous positive airway pressure. This machine is programmed to produce pressurized air at one steady air pressure level. The way this works is if you want to change the air pressure on any CPAP machine, you have to reset the device’s settings. CPAP machines are extremely common. There are millions of CPAP machines in use and they’re used to treat obstructive sleep apnea.

Obstructive sleep apnea disrupts your sleep patterns because the condition causes you to take pauses in your breathing. Sometimes this occurs because your air pathways briefly collapse, or there’s something that blocks them, but in any event those who suffer from sleep apnea often lose air as they’re sleeping at night, and it’s very disruptive to sleep and it can cause adverse health effects. That’s where the CPAP machine comes in because with this steady pressurized air, it keeps the air pathways open throughout the night, so you can get a decent night’s sleep.

The BiPAP or bi-level positive airflow pressure machine has two settings for air: one pressure for inhaling and a lower pressure for exhaling. This device is not used as commonly as the CPAP machine, but it’s for those who can’t tolerate the CPAP machine as well for a variety of health reasons. And this BiPAP machine is useful in treating central sleep apnea, which is slightly different from obstructive sleep apnea. Now, there is a third machine that is subject to recall in this related to the CPAP and BiPAP machines and that is the ventilator. We won’t talk much about that today, but ventilators may also be subject to this recall because they use the same materials inside the machine that Philips companies use with CPAP and BiPAP machines. So those are the three big machine devices that are subject to a recall for 2021.

The major players in this emerging large-scale litigation are the Philips Companies. That’s Philips North LLC, Philips Holding USA and Philips Respironics Company, and Royal Philips, a foreign company. These companies have produced millions of these machines over the last few decades, and very recently announced the recall. In April 2021 in the Philips quarterly report, Philips noted that there were some potential issues with these machines, the CPAP, BiPAP and ventilator machines, but no recall in April. There was just a indication that the company had recognized some problems occurring. In June 2021, the Philips company issued a formal recall for several of the machines they manufactured. Obviously the Companies worked really fast from April 26 to June 14, to get to the recall, but I think it’s important to note that this recall came very late in the game, and that is to say that early investigations indicate that adverse events were occurring with the CPAP and BiPAP machines well before April 2021, and that there is an issue of whether Philips should have issued a recall months or even years sooner than they did. But in any event Philips did issue the recall on June 14, 2021.

On July 22, 2021 the FDA classified the recall as Type 1. For those of you who may not know, Type 1 is the most serious type of recall and the language that the FDA uses in a Type 1 recall is that there’s a reasonable probability to cause serious injury or death. So it’s serious and not to be taken lightly. That’s where we are right now. The United States has millions of machines out there that are all subject recall.

Why the CPAP Recall?

The big question is why are these machines being recalled? Unfortunately these machines were manufactured with a material that we now understand can be very problematic and harmful to the human body. Philips utilized a polyester-based polyurethane foam, that was used to reduce the sound and the vibration that occurs when the CPAP machine is on and it’s generating air. This polyester-based polyurethane (or “PE-PUR”) foam is used in the Philips CPAP machines and BiPAP machines. Even the ventilator machines use this particular type of material. As it turns out that the PE-PUR foam is not resistant to water degradation. This is a condition called hydrolysis which can cause the foam to break down when exposed to water. The PE-PUR foam breaks down and degrades when exposed to water and there is naturally moisture in these machines because air is being passed through the hose and mouth-covering, which is exposed to breath, which has moisture in it. The studies found that the foam was breaking down and tiny particles and pieces, can break apart from the foam and a human being using the CPAP machines can inhale it or swallow it, ingest it. That is a very serious problem.

It’s important to point out that there is a different type of foam that is slightly more expensive but is highly resistant to hydrolysis and that is a polyether based polyurethane. Philips allegedly chose not to use this safer foam. This turned out to be a pretty significant mistake because the polyether-based likely would have not have caused any of these troubles, and there may not be a recall here, and I wouldn’t be writing and talking about it.

Two Ways the CPAP Machine Can Injury the Patient

The two main problems that have been recognized as a part of this PE-PUR foam breakdown. The first is foam degradation. Reports have shown in lab testing that the foam may degrade and produce particulates. These particulates can enter the person’s air pathway and it can be inhaled and that can cause all kinds of problems. I’ve heard of one case where an individual using a CPAP machine woke up after having found a small piece of the foam physically inside his mouth. I don’t think that’s common, but clearly the foam is degrading and that’s one of the significant problems with this PE-PUR foam.

The second problem that Philips and lab tests have shown is the concept of off-gassing. Lab testing has shown that chemicals can be admitted from this polyester based polyurethane foam and can be inhaled. These gases can be inhaled by the users of the machine. So those there are two issues that the medical community consumer, advocacy groups are looking at and certainly Philips as the emerging defendants in this unfortunate recall. So if you are a user of a CPAP machine or BiPAP machine, you are probably wondering which devices are subject to the recall. There is a long list, but some of the ones that are subject to recall would the E30, the Dream Station, the System One series of CPAP machines, the Dorma 400 and 500, the Remstar, the Trilogy 100 and the A-series BiPAP type machines.

In Part II next week we will take a look at the injuries that can occur and the emerging CPAP litigation.

Note: This information has been gathered from media reports and publicly available court filings. Philips has denied some of these allegations, and for plaintiffs to win their cases against Philips, these facts must be proven in court.

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.