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

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.