Articles Posted in CPAP BiPAP

FDA CPAP Recall
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

Untitled-design-20-300x169Philips 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.

For the past year or so, I’ve written extensively about the Philips Respironics (Philips) CPAP, BiPAP and ventilator FDA recalls. Hundreds of CPAP lawsuits have been filed against Philips. The primary problem comes from the foam material Philips uses to reduce the sound and vibration from these machines.

What’s Wrong With the Foam?

CPAP and BiPAP LitigationThese 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:

CPAP and cancerIf 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?

CPAP machine for people with sleep apnea.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.

Untitled-design-20-300x169There 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.

CPAP machine for people with sleep apnea.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.

CPAP Machine Recalls
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.

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