A number of popular CPAP, BiPAP, and ventilator machines were recalled in June 2021 over a problematic sound abatement foam that can cause a variety of injuries and illnesses. If you're thinking about filing an injury claim over health problems that might relate to your use of one of these defective devices—which are relied on by millions of sleep apnea patients nationwide—understanding your options starts with a clear picture of the recall and how these kinds of lawsuits work.
Sleep apnea is one of the most common sleeping disorders, and it's characterized by a stopping and starting of the patient's breathing while they are asleep. Untreated sleep apnea can lead to everything from interrupted sleep and fatigue to heart problems and other significant health impacts. Get more information on sleep apnea, including details on its three forms (obstructive, central, and complex) and the kinds of health problems that are linked to this condition (from WebMD).
CPAP is short for "continuous positive air pressure," which is used to treat and manage sleep apnea, and is delivered to a patient via a CPAP machine. These shoebox-size devices are a mainstay in many sleep apnea patients' lives, with calibrated air flow delivered through a hose and into a facemask, which is typically worn at all times during sleep. BiPAP, short for "bilevel positive airway pressure," differs from CPAP in that it delivers two kinds (or levels) of air pressure to the user of the device: inhale pressure and exhale pressure.
Here's a complete list of the recalled Philips Respironics CPAP and BiPAP machines (all serial numbers are part of the recall; in other words, the entire product line of any model listed below is included):
The following Philips Respironics ventilators have also been recalled (again, any serial number is part of the recall; the entire product line of any model listed below is included):
From a health risk perspective, it's worth noting that the U.S. Food and Drug Administration (FDA) labeled the Philips CPAP/BiPAP recall as a "Class I" recall, which is the agency's most urgent classification. Class I designation is reserved for product defects that pose a risk of serious health problems or death, and it means the FDA takes an active role in the recall process, including making sure that manufacturers like Philips Respironics take adequate steps to protect the public. Learn more about FDA classification of product and medical device recalls.
To figure out whether your Philips Respironics CPAP/BiPAP/ventilator device is part of the recall, the FDA recommends taking a number of steps, including making sure your device is registered (this will also help if your device might end up being part of the "repair and replace" program):
Keep your serial number and registration confirmation number handy, since Philips Respironics and other entities may ask for it in future communications.
The problem with the recalled Philips Respironics machines relates to the sound-abatement foam used to quiet their operation while the user (and anyone else nearby) sleeps. There are valid questions about when Philips Respironics first became aware of the problem with the sound abatement foam (more on this later), but throughout the latter part of 2021 the company and the FDA took a number of steps to try to rectify the situation after the initial June recall:
Health problems and illnesses linked to the recalled Philips Respironics devices relate to the problematic polyester-based polyurethane (PE-PUR) sound abatement foam used to reduce sound and vibration in these machines.
According to the FDA, the presence of this defective foam in the recalled devices can result in a range of health problems, including:
The most serious health risks associated with debris and chemicals released into the device's air pathway (due to the problematic foam) is that inhalation of particles and off-gassing might cause serious respiratory/lung illness like pulmonary fibrosis, and a number of forms of cancer. According to DrugWatch.com, lawsuits filed by CPAP/BiPAP plaintiffs and a number of health studies have linked the following forms of cancer to use of the recalled Philips Respironics devices:
It's important to note that deterioration of the sound abatement foam can be made worse if the CPAP/BiPAP/ventilator machine is stored or used in an environment with high temperature and/or high humidity.
As touched on above, debris from the polyester-based polyurethane (PE-PUR) sound abatement foam used in the recalled Philips Respironics devices can be inhaled or swallowed by the device user, and harmful chemicals can be released into the device's air pathway because of the foam's decomposition.
PE-PUR foam is manufactured using isocyanates, which according to the CDC "are a family of highly reactive, low molecular weight chemicals." When released into the air or onto/into the human body, isocyanates can cause inflammation and damage to the respiratory tract, as well as to the mucous membranes of the eyes, and the gastrointestinal system. So, as the foam begins to deteriorate, more of these irritants can be released directly into the CPAP patient's airway.
What about links between the problematic sound abatement foam and various forms of cancer? Isocyanates include compounds classified as potential human carcinogens, and which are known to cause cancer in animals, according to OSHA. But it's important to note that no definitive connection has been shown to exist between cancer and the PE-PUR foam used in the recalled Philips Respironics devices.
If you're currently using a Philips Respironics CPAP, BiPAP, or ventilator that's part of the widespread 2021 recall, your best first step is discussing your situation with your doctor or another qualified health care provider as soon as possible. The priority is setting the right treatment strategy considering your overall health picture. But don't stop using the device without first talking to a health care professional to figure out the right course of action. There are situations in which the health risks that come with stopping use of a recalled CPAP/BIPAP/ventilator, even briefly, outweigh any danger posed by the defective sound abatement foam that might be present in these devices.
If you're experiencing any of the symptoms detailed in the above section, even mild ones, be sure to let your health care professional know as part of the initial conversation. You can find more details on the Philips Respironics recall and instructions for customers on the company's Medical Device Recall Notification website.
As touched on above, since September 2021, Philips Respironics has had a "repair and replacement" program up and running. Initially, replacement devices featured a new silicone-based foam in place of the problematic polyester-based polyurethane foam, but a subsequent FDA investigation revealed that the new version of the foam used in the replacement machines might itself pose health risks, and the agency asked Philips Respironics to hire an independent lab to do additional tests. But the FDA stressed that patients should not stop using any new or repaired Philips Respironics device they had received as part of the program, despite questions about the safety new type of sound abatement foam. Check the FDA's Philips Respironics Recall page for the latest status of the repair and replacement program.
The most important thing to keep in mind here is that if you've got a CPAP machine that might be part of the recall, don't stop using the device on your own, don't wait for the product manufacturer to give you instructions, and don't wait for your supplier or provider to get you a new CPAP/BiPAP/ventilator device. The replacement process can take several months, and delays have been reported (this is on top of safety-related delays and concerns). Your best course of action is to talk to your doctor about the right path forward based on your current health situation.
It depends on how old the machine is. Shortly after the Philips Respironics recall was announced, Medicare issued a statement to beneficiaries, instructing them that if they wanted to have their recalled device repaired or replaced, they'll likely need to deal with the supplier who issued the device, if the equipment is less than five years old. In that situation, the supplier should fix the situation at no cost. For devices that are more than five years old, Medicare will help pay for replacement equipment. Get more details on how Medicare covers CPAP and similar devices (from Medicare.gov).
Most lawsuits over injury or illness linked to Philips Respironics devices rely on the injury law fault theory of "product liability," which can be used to hold consumer product and medical device manufacturers responsible for harm caused by an unreasonably dangerous product, or for the company's failure to adequately warn consumers of risks associated with the product's use.
In order to file a product liability lawsuit against Philips Respironics over your use of one of their CPAP/BiPAP/ventilator machines, you typically need to:
The fact that you've used one of the recalled Philips Respironics machines (even on a nightly basis, for years) isn't enough to file an illness-related lawsuit. There may be other non-injury kinds of claims you can file—especially if you've run into problems trying to get a replacement device or trying to have your health insurer pay for a new machine—including consumer fraud-based lawsuits. There are a number of consumer protection-oriented class actions you can join against Philips Respironics. But personal injury lawsuits alleging a link between the device and the specific plaintiff's injury or illness require measurable harm caused by one of the recalled machines.
Diagnosis of an injury or illness that can be traced to the problematic sound abatement foam used in the recalled CPAP/BiPAP machines goes straight to the nature and extent of your losses. It's crucial to see a doctor at the first sign of any health issue linked to your use of a recalled Philips Respironics device—to protect not only your legal rights, but also your health. And it all starts with an accurate diagnosis. From there, the damages picture starts to become clearer, and you and your lawyer can get a sense of how much your CPAP lawsuit might be worth. Get more details on the importance of medical diagnosis in a mass tort lawsuit.
Finally, it's important to keep in mind that even if you think you have a solid case, a lawyer might turn down the opportunity to represent you. That's especially true if a key element of your potential case against Philips Respironics is weak. Maybe your health issues can't be sufficiently linked to the problematic sound abatement foam, or perhaps you only used the recalled device for a brief time.
We've touched on issues of eligibility for filing a CPAP lawsuit, but even when you've been diagnosed with an injury or illness that's legitimately linkable to your use of a recalled Philips Respironics machines, whether you actually want to go ahead and file a lawsuit is a separate (and often fairly personal) question.
Some personal injury plaintiffs are motivated by a sense of justice—the simple notion of righting a wrong. In product liability cases in particular, claimants may even feel driven by anger at a large corporation's willingness to expose millions of consumers to a dangerous product. The decision to file a lawsuit can be also be motivated by more basic factors: the desire to be made whole again (to the extent possible) after a harmful act; that means making sure legitimate losses are fairly compensated. This brings us to another common question on the minds of potential Philips Respironics lawsuit plaintiffs.
A potential CPAP claimant will usually experience both "economic" and "noneconomic" (sometimes called "special" and "general") harm as a result of injury or illness linked to the recalled devices, and these are the kinds of losses (called "damages" in the language of the law) that can be compensated in a lawsuit. (Keep in mind that any damages or losses you claim need to be established.)
Economic damages in a CPAP lawsuit typically include:
Non-economic damages in a CPAP lawsuit typically include:
The value of a specific CPAP/BiPAP lawsuit isn't easy to estimate without a clear picture of the underlying facts. There are simply too many variables in play. But in general, how much you might receive through an out-of-court settlement or trial verdict in your favor depends on a few key factors:
Learn more about the criteria for settlement amounts in a product liability case.
It's safe to assume that if your CPAP lawsuit ends up making it all the way to trial, and a jury decides in your favor, any monetary award you receive will be significantly larger that what you might get through an out-of-court settlement. But juries are unpredictable, and Philips Respironics is sure to appeal any sizable jury award given to a plaintiff. The "sure thing" factor that's baked into a settlement is a big reason why plaintiffs (and their attorneys) typically prefer to settle out of court.
Deadlines for filing a CPAP lawsuit are set by a law called a "statute of limitations." In some states, the statute-of-limitations filing deadline that will apply to a product liability lawsuit is the same as the one that applies to most injury-related lawsuits (those stemming from car accidents and slip and fall injuries, for example). In other states, product liability lawsuits have their own separate statute of limitations deadline. In any event, you typically have two to three years to get a lawsuit filed against a product manufacturer like Philips Respironics (the deadline is longer in some states, shorter in a few). But when does the "clock" start ticking in a lawsuit over illness or injury caused by a recalled CPAP machine?.
If you're injured in a vehicle accident, there's little doubt about the timing or cause of your injuries. With product-related injuries, especially cases involving illness linked to inhalation of toxic chemicals over a period of years, it's not nearly as easy to pinpoint when the plaintiff (the person filing the lawsuit) was "injured" for purposes of the statute of limitations clock. Under the "discovery rule" in most states, the clock might start only when the plaintiff discovers (or should reasonably have discovered) that they were harmed by the product. In CPAP lawsuits, that date might coincide with a diagnosis of a health problem linked to the sound abatement foam, or the plaintiff's first experience of symptoms of such a health problem.
Regardless of when or how you first suspected that your Philips Respironics machine might be causing you health problems, talk to an attorney to understand the lawsuit deadlines that might apply to your specific situation.
As with a lot of lawsuits where consumers claim that a defective product caused them harm, two of the biggest questions in these CPAP cases are: How much did Philips Respironics know about the problems with the sound abatement foam used in their devices, and when did they first become aware of the issue?
The FDA's investigation into the affected CPAP/BiPAP/ventilator machines revealed that:
Since the recall didn't happen until 2021, there's plenty of evidence that the company spent years sitting on information that directly impacted the safety of its customers. Any significant delay in surfacing known health risks associated with a product would certainly seem to fuel the argument that the company failed to adequately warn consumers of the dangers of the (eventually) recalled machines. And this "failure to warn" argument is a key one for CPAP lawsuit plaintiffs, alongside claims that the machines were defectively designed and that Philips Respironics's action/inaction amounted to fraud.
While there's little room for Philips Respironics to dispute the clearly-established problems with the recalled CPAP/BiPAP/ventilator machines, that doesn't mean the company is willing to accept liability for any and all resulting health problems allegedly linked to the problematic foam.
Philips has already floated the argument that patients' use of certain ozone-based chemicals (counter to product instructions) is to blame for the deterioration of the sound abatement foam over time. That allegation prompted SoClean Inc., a supplier of ozone-based cleaning products, to file its own lawsuit against Philips , claiming that the company is "pointing the finger at SoClean's ozone cleaners to divert attention away from [its own] poor choice of materials and obvious design flaws," according to Reuters. It's likely not the last finger to be pointed by Philips as it tries to avoid legal responsibility for harm caused by its products. Bottom line: A recall is one thing; a lawsuit is something else entirely.
While we're on the subject, it's important to note that evidence of a recall isn't always admissible in a civil lawsuit. That means that even in a product liability case, the jury isn't always told that a recall of the product in question actually took place, so they're not always allowed to consider the recall as evidence of the manufacturer's liability for the plaintiff's claimed injury or illness. And even when evidence of a recall is allowed into a case, it's not definitive proof of the manufacturer's liability. Learn more about how a recall affects a product liability lawsuit.
While it's safe to say that thousands of CPAP/BiPAP/ventilator lawsuits have already been filed against Philips Respironics, the details of the company's potential liability are still taking shape, and many patients are still dealing with the repair/replacement process before they can figure out the best path forward (in terms of both their health and their legal options). This early in the game, none of the filed lawsuits have made it to the trial stage, so there are no verdicts to report, and there have been no large-scale settlements to note.
A class action is a large scale legal action in which the claims of a large number of individuals (these are the "class" members) are grouped together in a single case, usually against one defendant who has harmed the class members in the same way. But when the harm moves beyond economic, and into injury or illness territory, class actions are almost never a viable option. That's true with claims alleging illness linked to recalled Philips Respironics CPAP/BiPAP/ventilator machines too. While a number of class actions have been filed over the devices, those are limited to consumer protection-type claims (fraud, failure to warn, etc.). They don't involve allegations of personal injury (specific injury or illness suffered by a specific claimant).
Many lawsuits (both consumer protection-oriented and injury-based) over the recalled Philips Respironics devices have already been (and will continue to be) funneled into a process called multi-district litigation (MDL). That means the lawsuits are filed in (or moved into) a single federal district, before one judge, who shepherds the grouped cases through the pre-trial process, including decisions about evidence and information-gathering ("discovery") that will apply to every individual case. Both sides pick a few representative cases that will proceed to "bellwether trials," which are typically meant to give the parties a sense of the strengths and weaknesses of their respective positions, and spur settlement talks. But if no settlement occurs, each case can go back to its respective home court.
Hundreds of CPAP/BiPAP lawsuits have already been grouped together in the Philips MDL (officially titled In Re: Phillips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation, MDL 3014), which is being heard in the U.S. District Court for the Western District of Pennsylvania. Learn more about how multi-district litigation (MDL) works.
If you're thinking about taking legal action over injury or illness caused by use of a recalled Philips Respironics advice, your best first step is reaching out to a lawyer, who will evaluate your case and explain your options (including the pros and cons of joining the MDL).
If you're experiencing health problems that could be caused by your use of a recalled Philips Respironics medical device, having the right lawyer on your side is crucial to the success of any legal action you decide to take.
Filing an injury lawsuit against a big company like Philips Respironics isn't like going to small claims court over a fender bender. The issues at play are much more complex, there's a lot more at stake, and Philips Respironics has vast resources to defend itself. A successful CPAP lawsuit means showing that your diagnosed illness is linked to your use of one of the recalled devices. That kind of proof requires expert medical witnesses. And if your illness has affected your ability to make a living, you'll need additional experts to establish the precise financial impact that will have. Your CPAP lawyer will be able to assemble the right team of experts and advisers to put your best case together.
The short answer is that a lawyer's services will likely end up costing you anywhere from 25 to 40 percent of any compensation you receive.
As with almost any other kind of injury-related lawsuit, a lawyer will handle your case against Philips Respironics under a "contingency fee" agreement. The lawyer only gets paid their legal fees if your case is successful (that's the "contingency") , meaning you receive a settlement or court-ordered damages award. The lawyer's percentage is typically around 33 percent, but the percentage might vary on a "sliding scale."
For example, the lawyer might agree to receive 25 percent if the case settles before a certain point on the litigation timeline, or a 40 percent fee might be charged if the lawsuit enters the trial stage. If you don't receive any money from Philips Respironics one way or another, your lawyer doesn't get paid for their legal services.
But that's not always the end of the story when it comes to the financial side of things in a CPAP lawsuit. It's important to pay attention to the fine print of your attorney-client agreement, to understand key details like:
If you've read this far, the questions a lawyer is likely to ask you about your potential CPAP lawsuit probably won't come as much of a surprise. During the initial consultation, a lawyer will probably ask for details on:
You can use the tools on this page to connect with a CPAP lawsuit lawyer in your area. Answer three initial questions about your potential claim, and you'll be on your way to a free case evaluation.
Need a lawyer? Start here.