Over the past few years, there has been a growing number of lawsuits against Philips, a manufacturer of CPAP machines. CPAP machines are one of the most common treatments for sleep apnea, with millions of people using these products every day. However, some lawsuits are now alleging that a defect in some Philips CPAP machines has led to negative health consequences for many users.
At the heart of the issue is the recall issued by Philips for some of its CPAP, BiPAP, and ventilator products. Philips announced that a material used within these devices to reduce sound was starting to degrade, where it could then enter into the user while they wore the product. The plaintiffs in these lawsuits are alleging that not only did this degraded material cause health complications like respiratory issues and cancer, but that Philips knew about the issue long before issuing the recall.
Is there a CPAP lawsuit?
Yes, there are currently many lawsuits underway involving recalled CPAP devices. The people filing these lawsuits against Philips, the manufacturer of several CPAP machines, allege that the sound abatement foam used within the products may cause serious health complications, including respiratory problems and cancer. There are many individual lawsuits that are seeking compensation for the injuries they allegedly suffered as a result of the defective devices. There are also class-action lawsuits that are aiming to have Philips pay for the cost of replacing their CPAP devices.
Philips first issued a recall for some of its CPAP, BiPAP and ventilator products, which impacts millions of patients. In September 2021, Philips announced that it would repair or replace the recalled devices, but that it may take up to a year to complete the process. However, in November 2021, an FDA update on the CPAP recall found that the foam being used in replacement machines may also come with health risks.
It was around this time, in October 2021, that the Judicial Panel on Multidistrict Litigation (JPML) combined more than 100 federal CPAP lawsuits in one multidistrict litigation (MDL), which will take place in Pennsylvania. As of March 2023, there are now over 400 cases pending within the MDL, with more expected throughout the rest of the year.
In addition, in June 2022, unsealed court documents showed that Philips knew about the problem with their CPAP machines three years before they issued a recall. One engineer reported receiving complaints about disintegrating polyurethane entering into the user's airway. This new revelation has provided more evidence for plaintiffs seeking financial compensation from Philips.
The next step in the CPAP lawsuit process is completing several bellwether trials. Bellwether trials are select cases from the MDL which go to trial. After the completion of these trials, both the plaintiffs and the defendant can assess how the juries responded to the evidence and use this to determine how they can best proceed.
In January 2023, the plaintiffs submitted a plan that would allow the bellwether trials to start in 2024, while the defendants are pushing for trials starting in either 2025 or 2026. It's expected that soon the judge overseeing the MDL, U.S. District Judge Joy Flowers Conti in Pittsburgh, will decide on when the bellwether trials will begin.
Phillips CPAP recalled products
The lawsuits surrounding Philips CPAP machines are related to specific recalled products. If you or a loved one has used, or is using, one of the recalled products below, you should consider consulting your healthcare provider:
- A-Series BiPAP A30
- A-Series BiPAP A40 (ventilator)
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto (ventilator)
- C-Series ASV (ventilator)
- C-Series S/T and AVAPS
- DreamStation Go
- DreamStation ST, AVAPS
- Dorma 400
- Dorma 500
- Garbin Plus, Aeris, LifeVent (ventilator)
- OmniLab Advanced+
- REMstar SE Auto
- SystemOne ASV4
- SystemOne (Q-Series)
- Trilogy 100 (ventilator)
- Trilogy 200 (ventilator)
CPAP linked to cancer, other health effects
Over the past few years, there have been a significant number of reports that link the use of certain CPAP machines with negative health effects, such as respiratory problems or cancer. To understand how these recalled devices can cause problems, it's helpful to understand how CPAP machines work. In a CPAP machine, there are a few key parts. The first is a motor, which generates pressurized air. Next, there's a humidifier, which adds moisture to the airflow. Finally, there's a mask or nasal pillows, all connected by tubing.
The user places the mask or nasal pillows on their face, covering their airways, then turns on the machine. The motor then works to push pressurized air through the tubing and into the mask. This creates a continuous flow of air into the patient's airways. With each CPAP machine, the pressure level is set based on the individual patient and their specific needs. A doctor will typically determine this level after the patient completes a sleep study.
The issue with the recalled Philips CPAP machines is that tiny particles got mixed into this continuous airflow. Inside Philips CPAP machines, there is material that works to reduce the sound emitted from the device, making them quieter. This foam, called PE-PUR foam, started to degrade in certain CPAP machines, which released tiny particles and chemicals into the airstream. Once these particles and chemicals entered the air stream, they could be inhaled or swallowed by patients using the CPAP machine.
Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks
A report from the FDA details the risks associated with the recalled devices. According to the FDA, "The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users." The report goes on to say that some of the risks associated with exposure to PE-PUR foam may include asthma, headaches, and toxic or cancer-causing effects to vital organs, like the liver and kidneys.
Medical device manufacturers are also required to submit medical device reports (MDRs) when they suspect that one of their devices may have caused an injury or contributed to a death. Since April 2021, the FDA received more than 105,000 MDRs from Philips. This includes 385 reports of death. Of these cases, more than 6,000 came between Jan. 1, 2023 and March 31, 2023. All of these MDRs are reportedly associated with the breakdown of the PE-PUR foam.
The FDA will now conduct an in-depth review to learn more about why there is an increased number of reports. They caution that, while the MDRs can provide valuable information, there are limitations to this system. This reporting system cannot typically provide reasonable evidence about the prevalence or cause of an event, due to inaccuracies in the reports, a lack of verification, and under-reporting of events.
Cancer Risk Associated with Continuous Positive Airway Pressure: A National Study
In one study, the researchers aimed to evaluate the reports of cancer associated with CPAP devices to better understand how this would impact the field of sleep medicine. To do this, researchers looked at over 2,500 cases where patients reported injuries associated with using a CPAP device. Of these cases, the second most commonly documented problem was cancer, was more than 200 cases.
From there, the researchers looked at those cases that were reported to the FDA, with more than 95% of those 200 cases getting reported. Of those cases, 174 had descriptions of the CPAP sound abatement foam deteriorating and associated with the cancer diagnosis. Based on these results, the researchers concluded that while malignancy associated with CPAP devices has been reported, more research is needed to establish causation. However, they conclude by saying that since more than 95% of these cases were reported in 2021, otolaryngologists should be prepared to discuss the potential risks associated with using a CPAP machine.
Projected CPAP lawsuit settlement amounts
The settlement amount in a CPAP lawsuit depends on several factors. One factor is the extent of the damage caused by the CPAP machine. Those with more significant injuries or illnesses will likely receive a higher settlement. In addition, those who have strong evidence that the CPAP machine directly caused their problems, such as medical records, will be able to earn a higher settlement amount.
While settlement amounts can vary from case to case based on the individual circumstances, we can make some estimates on possible settlement ranges based on previous case history. If you or a loved one has received a cancer diagnosis and you believe it's the result of using a recalled CPAP device, you may be eligible for a settlement between $100,000 and $500,000. For others, who experienced other negative effects, your settlement will likely be lower. To learn more about potential settlement amounts, you should consult with a lawyer, who can review the specifics of your case and provide a more detailed assessment.
Do you qualify for a CPAP lawsuit?
If you think that you might be eligible for a CPAP lawsuit, there are a few eligibility requirements that you will likely need to meet. First, you or the person impacted by the recalled CPAP machine must be under 80 years of age. Second, you must have used one of the devices on the recalled list, not simply any CPAP device. You can likely find the make and model of your CPAP device on the device itself, or you can consult with your physician.
Finally, you must have experienced one of the negative effects associated with the recalled devices. Some of these symptoms include headaches, respiratory problems, and cancer. You'll also need to have this diagnosis from a doctor so that you can provide documentation as evidence. If you believe you meet these eligibility requirements, contact a lawyer. They can review the specifics of your case and help you determine if you should file a CPAP lawsuit.