Millions of Americans use CPAP (continuous positive airway pressure) devices, BiPAP (bilevel positive airway pressure) machines, and other ventilators. The most common use of the CPAP device is to treat obstructive sleep apnea. The continuous pressure from the machine pushes against obstructions, helping keep airways open and oxygen flowing. Other similar devices, like the BiPAP machine, provide similar relief.
How Serious is Sleep Apnea?
The importance of the CPAP or other device to a person’s health depends on the nature and extent of the condition being treated. For some, using a CPAP machine simply means a better night’s sleep, and helps eliminate effects like morning headaches and poor focus. But sleep apnea can be very serious–even life-threatening. This created a stressful and confusing situation for people reliant on the recalled devices.
It is generally not recommended to discontinue treatment without consulting a physician.
Recall of Philips CPAP Machines and Other Devices
Last summer, one major manufacturer of these devices recalled numerous models manufactured between 2009 and early 2021. An alert from the Food & Drug Administration (FDA) explained that a foam used in the machines to buffer sound and vibration might break down. The particles from this foam could then be swallowed or inhaled by the user.
The devices recalled include:
- DreamStation Go
- DreamStation ASV
- DreamStation ST and AVAPS
- SystemOne (Q Series)
- SystemOne ASV4
- Dorma 400
- Dorma 500
- A-Series BiPAP A30
- A-Series BiPAP A40
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto
- Trilogy 100
- Trilogy 200
- REMStar SE Auto
- OmniLab Advanced +
- C-Series ASV
- C-Series S/T and AVAPS
Exposure to these foam particles has been linked to a wide range of possible medical problems, including acute respiratory distress syndrome (ARDS) and other respiratory conditions, kidney damage, heart failure, pleural effusion, liver damage, and respiratory failure. The following is a partial list of types of cancer that may also be associated with exposure to the polyurethane foam particles:
- Stomach or rectal
- Prostate or testicular
- Multiple myeloma
The recall impacted millions of devices and left many consumers uncertain how to proceed. Philips announced a widespread repair and replacement program, but the process was moving slowly due to the large number of devices involved. Then, in November, new safety concerns cropped up. The FDA raised questions about the safety of the material being used to replace the foam and ordered the company to arrange for outside testing.
The agency did not advise those who had already received replacement devices or repair kits to stop using the machines–if you’re currently using one of the recalled Philips devices, a replacement device, or a repaired device, your own doctor is the best source of information about how to move forward.
CPAP and BiPAP Litigation
So many lawsuits have been filed against Philips since information about the possible defect emerged that all federal claims have been consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Western District of Pennsylvania. The consolidation of these cases will allow the court to address common issues, such as what materials the company has to turn over to plaintiffs and whether certain evidence is admissible, all at once. This saves time and resources and may help get the cases resolved more quickly.
As of mid-December, there were 137 cases pending in the MDL alone, with new filings continuing. Other cases are pending in various state courts around the country. Because information about the possible exposure and problems it may cause has only been publicly available for about six months, many people who have suffered medical conditions or developed cancers as a result of CPAP or BiPAP device use may not yet realize they were harmed by the device. And additional conditions may turn out to be connected to the exposure.
Philips May Have Known about the Risks for Years
Often, a product recall happens shortly after the discovery of a defect or other issue that makes it dangerous to users. But some plaintiffs are claiming that Philips was aware of the problem and failed to notify consumers and physicians of the risks, or even replace the foam substance in devices it continued to manufacture. Late in 2021, an FDA inspection report provided support for this claim. The FDA found that the company had received more than 200,000 reports regarding the foam, debris in the airway, contaminants, and other terms that should have put Philips on alert. The FDA also noted that risk assessments conducted in connection with certain devices significantly understated the number of relevant complaints and reached improper conclusions.
Did a Philips CPAP or BiPAP Device Make You Sick?
If the foam in your CPAP or BiPAP device broke down, you may have noticed black debris in the air tubes of the machine. You may also have experienced health issues you didn’t connect to the device, such as:
- Coughing and upper respiratory irritation
- Sinus infections
- Unexplained headaches
- Pressure in your chest
But it’s also possible that you didn’t experience any of those things or didn’t notice them. If you regularly used one of the recalled devices and have been diagnosed with one of the conditions or cancers listed above, you may have a claim against the manufacturer.
The time to file a CPAP/BiPAP lawsuit is limited, and may depend on specifics of your case, such as when you became aware of the injury. If you believe you may have a CPAP/BiPAP claim, it’s in your best interest to talk to an experienced Ohio product liability attorney as soon as possible.
At Plevin & Gallucci, we offer free consultations to help you protect your claims and make informed decisions about how to move forward. To schedule yours, just call 855-4PLEVIN or fill out the contact form on this page.