Our law firm is handling CPAP sleep apnea class action lawsuits for injuries from the recalled Philips CPAP machine.
In June, medical device company Philips issued a sweeping safety recall of its popular CPAP and BiPAP sleep apnea devices that millions of Americans use to sleep every night. The recalled devices contain a polyurethane sound abatement foam that can degrade and cause users to inhale foam particles that can cause respiratory damage and possibly cancer.
The Philips recall covered an estimated 3.5 million sleep apnea devices. There is now a new product liability mass tort with eventually thousands of plaintiffs consolidated into a Multi-District-Litigation (MDL) after a September 30, 2021, MDL panel hearing. So all CPAP lawsuits in federal court are consolidated in federal court in Pennsylvania.
In this post, we will take a closer look at the recall, the MDL class action, and what CPAP lawsuit settlement amounts might look like.
Latest CPAP Lawsuit Updates
Let’s start first with the latest CPAP lawsuit updates.
May 25, 2022: It has been a year since Philips first initiated the massive safety recall of over 15 million CPAP and BiPAP machines used for sleep apnea. During that time, regulators at the FDA have been deeply involved in – and concerned about – the CPAP recall investigation process and have kept the public well informed.
The FDA has published data on adverse health event reports it received between April 2021 and April 2020 in connection with recalled Philips CPAP devices. According to these reports, the FDA received over 21,000 reports of adverse health events connected to the CPAP machines.
Problems reported have included cancer, pneumonia, and respiratory problems. Depressingly, there have been 124 deaths related to CPAP that were reported. There is not conclusive evidence that all 124 deaths were solely due to the recalled CPAP machines. But, then again, adverse events are woefully underreported to the FDA. These reports to the FDA offer a glimpse into what we can expect to see in the developing CPAP recall lawsuits.
May 10, 2022: It is likely the CPAP defects will cause many deaths. Victims are just beginning to link the deaths of their loved ones with CPAP. One recently filed wrongful death CPAP lawsuit is a case in point. The plaintiff, Doug Shiffler of Oregon, lost his wife to cancer and filed a product liability lawsuit against both Philips and a Maryland company that manufactured the toxic sound abatement foam in the recalled CPAP machines (Wm. T. Burnett & Co). The CPAP lawsuit filed by Shiffler asserts that his wife used one of the recalled Philips DreamStation CPAP machines every night for about 20 months. She was diagnosed with advanced lung cancer. Joleen eventually died from her lung cancer and Doug filed a wrongful death lawsuit claiming that her lung cancer and death were caused by toxic particles in the foam of her DreamStation device.
May 6, 2022: The FDA is contemplating requiring Phillips to offer a full refund for people who want their money back for their defective CPAP. This seemingly logical decision is a bigger deal than you might think. It is a rare remedy that underscores how angry the FDA is with how Philips has botched the CPAP recall.
May 3, 2022: I have been writing about how Philips completely botched the CPAP recall and against all reason kept a product on the market it should have recalled. But I always wonder who out there is dismissing my diatribes as a CPAP lawyer who just wants to make money off CPAP lawsuits. So today’s update underscores that I’m not using hyperbole. The Wall Street Journal reports that the medical device company recently received a subpoena from the Department of Justice seeking information and documents related to the CPAP recall. The subpoena suggests the DOJ has launched a formal investigation which could lead to penalties and actions beyond the growing number of civil lawsuits.
April 16, 2022: There are now 274 active CPAP lawsuits in the MDL class action. This is a small fraction of the number of CPAP recall lawsuits. So where are these CPAP suits? Thousands of lawsuits will be registered with the MDL Court with a mechanism that allows victims to hold back filing a lawsuit but tolls the statute of limitations to preserve their claims.
The good news is these suits are now pushing forward. We have seen a surge of activity from the court of late. This is a good sign that the pretrial work should begin to flow.
March 23, 2022: The hits keep coming for Philips when it comes to their breathing machines. Philips is bungling everything. Nine months ago, the company had to recall 15 million CPAP and BiPAP breathing devices that were causing users to inhale small particles of cancer-causing foam during their sleep. Now Philips is announcing that they are recalling hundreds of ventilator machines used in hospitals across the country because defective adhesives can cause the machines to suddenly stop working. How does this relate to the CPAP recall lawsuit? It underscores that Philips is not a company that has its act together.
March 19, 2022: The FDA has now formally intervened in the Philips CPAP recall process. There is no question the FDA is frustrated with Philips. Earlier this month, the FDA sent Philips a letter advising the company that its efforts to notify consumers about the health risks posed by its recalled CPAP and BiPAP machines have been deficient. The FDA is now requiring Philips to “improve its communication about the recall and the serious risk posed by the foam used in the recalled products.” You do not typically see the FDA giving such a public lashing. The new notification efforts by Philips will take place under the close supervision of the FDA.
March 16, 2022: There are now 262 filed CPAP recall lawsuits in the MDL class action.
March 10, 2022: The next status conference on March 22, 2022, will be a different dynamic with the new CPAP lawyers Steering Committee in place. There were a lot of skeptics of the CPAP lawsuits’ viability in the early stages. But it is increasingly clear that many of these lawsuits will be viable.
January 29, 2022: The Philips CPAP MDL judge recently issued an order laying out options for evidence preservation of recalled CPAP and BiPAP devices. Plaintiffs can return their recalled device to Philips to have it repaired for free, in which case Philips will be required to take pictures and document the condition of the device as evidence. Plaintiffs can also elect to send their device to Philips and have it held in evidence preservation and not repaired.
January 22, 2022: After issuing a recall of around 15 million CPAP and BiPAP machines last year, Philips got the FDA’s preliminary blessing on a repair program that would have replaced the toxic PE-PUR foam in the recalled devices with an alternative silicone-based foam. Soon after this new repair program was announced, however, concerns arose as to whether the new silicone foam presented potential health risks. Earlier this week, the FDA ordered Philips to submit independent testing of the new silicone replacement foam.
January 19, 2022: There are now 221 CPAP lawsuits in the MDL class action lawsuit.
Recall of Philips CPAP and BiPAP Sleep Apnea Devices
Philips is one of the world’s leading manufacturers of night-time breathing assistance machines that are widely used for the treatment of sleep apnea. These include both Continuous Positive Airway Pressure (CPAP) devices and Bilevel Positive Airway Pressure (BiPAP). CPAP is a continuous airway stream that keeps those airways open to prevent sleep apnea and even snoring.
Last month, Philips publicly announced a nationwide safety recall of almost all of its existing CPAP and BiPAP devices. The recall was prompted by potential dangers related to a polyurethane foam called PE-PUR that all the Philips devices used for “sound abatement” to make them run quietly. Philips disclosed that this PE-PUR foam may degrade into small particles or “off-gas” into chemicals that get inhaled by machine users as they sleep.
According to the recall announcement from Philips, inhalation of the PE-PUR foam “can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.” Lab analysis of the degraded PE-PUR foam particles identified several very harmful chemicals including Toluene Diamine (“TDA”), which is a known human carcinogen.
Which Sleep Apnea Machines Were Recalled?
Philips is one of the largest manufacturers of sleep apnea devices. The safety recall applied to an estimated 3.5 million existing CPAP and BiPAP devices. Below is a list of recalled devices:
|LIST OF RECALLED PHILIPS SLEEP DEVICES|
|DreamStation ASV||DreamStation ST||AVAPS|
|SystemOne ASV4||C Series ASV||OmniLab Advanced Plus|
|SystemOne (Q Series)||DreamStation CPAP||DreamStation Auto CPAP|
|DreamStation BiPAP||DreamStation Go||Dorma 400|
|Dorma 500 CPAP||REMStar SE Auto CPAP||Trilogy 100 and 200|
How serious is the CPAP recall?
The recall of all Philips CPAP and BiPAP devices is considered very serious. The machines were recalled because they could be causing users to inhale chemicals that are known to be toxic and potentially cause cancer. The recalled devices pose a legitimate health hazard to users.
Lawsuits Following the Philips CPAP Recall
The CPAP and BiPAP safety quickly generated 18 CPAP lawsuits against Philips in federal courts across the country. The early lawsuits were not actual product liability tort claims or personal injuries. So far, all of these cases are what we would call “consumer class-actions.” The plaintiffs in these cases are NOT alleging that they suffered serious bodily injury or developed cancer from using one of the recalled CPAP devices. Instead, the plaintiffs are claiming that they were victims of consumer fraud because they wasted money on CPAP devices that are now basically worthless. These CPAP lawsuits spawned a petition with the Judicial Panel on Multidistrict Litigation (JPML) seeking to consolidate these cases into a new class-action MDL. This motion was granted
These types of “consumer fraud” class actions often follow in the wake of major product recalls. They often get confused with traditional product liability tort lawsuits, but they are much different. The individual plaintiffs in these consumer fraud cases are only seeking limited economic damages, basically reimbursement for time and money wasted on defective machines.
CPAP Recall Product Liability Lawsuits
Our CPAP lawyers expect the Philips CPAP recall will lead to thousands of plaintiffs in the MDL class action. These types of cases are more complex and need to be supported by expert medical and scientific evidence, so they take much longer to evolve compared to consumer fraud cases.
Right now, we do not have the benefit of any scientific studies establishing a concrete link between the inhalation of PE-PUR foam particles and any type of cancer or other physical injury or condition. Something along those lines may be forthcoming over the next few months and that would substantially bolster the viability of these cases.
What Are Expected CPAP Settlement Amounts?
I wrote out some projected settlement compensation payouts for CPAP recall victims. I don’t mind speculating about settlement amounts. But you have to understand that with so many different types of injuries, settlement compensation projections are difficult. That said, I will give you my current speculation as of May 2022.
I think the average settlement value of a CPAP cancer lawsuit that can make it to the jury – a big if – is between $100,000 and $500,000. I don’t see proving Philips is at fault as a huge obstacle. The key will be marshaling the science to link the defects in PE-PUR foam to cancer. How big of a hurdle will this be? We do not know yet.
I think the respiratory cases that are successful will be worth less than cancer cases. I’m predicting between $100,000 and $150,000 for serious respiratory injuries that can make it past any Daubert scientific challenges. Many CPAP recall lawsuits will have much higher settlement amounts. There will also be less serious injury CPAP lawsuits where the claims fall as low as $5,000 or $10,000 which will drag the average down.
Every CPAP lawyer seems to have a different opinion about the projected settlement amounts in the CPAP claims. Some attorneys believe it will be hard to prove respiratory claims, and easier to prove cancer cases. And I have heard the exact opposite, too. My settlement compensation amount predictions are fluid. But these are my thoughts as of today.
Projecting settlement amounts in mass torts is hard. I cannot think of a piece of litigation that is more difficult to project in 2022 than the ultimate settlement amounts in the CPAP recall lawsuits (and – importantly – how many of the cases will survive summary judgment). So please do not put a ton of stock in these settlement projections and check back and I will modify them as appropriate.
- Settlement and verdicts in cases involving a CPAP
Contact Us About Filing a CPAP Recall Lawsuit
If you believe you were physically injured as a result of using one of the recalled Philips sleep apnea devices, contact our CPAP recall lawyers today for a free case evaluation at 800-553-8082. You can also discuss your case with us online.