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.

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.