Phillips CPAP Litigation

This CPAP recalls lawsuit documents that were last updated with fresh material on Monday, April 10, 2023.

April 10, 2023
Phillips is still having difficulty using the Dreamstation BiPAP and CPAP devices. According to the FDA, Philips Respironics recalls some used DreamStation CPAP and BiPAP devices because they risk providing ineffective or inaccurate therapy. All those are machines that have likely undergone repairs since the recall. Since utilizing these devices has the potential to cause significant injury or even death, the FDA has categorized them into a Class I recall, the most severe recall category. According to Philips, they have not heard of any complaints of patient damage associated with this problem.

April 1, 2023
April 2023 this year, Phillips anticipates CPAP settlement amounts, just not that kind. In consumer class actions, personal injury, and wrongful death lawsuits, Philips is up against thousands of claimants. In the upcoming months, Phillps CEO Roy Jakobs was optimistic that the business would agree with individuals requesting compensation in consumer civil lawsuit cases. But, because this process is much more complex, a settlement with individuals seeking compensation for injuries is not anticipated until next year. However, he left the possibility of settling such claims in 2023 open. In addition, Philips has announced that it will finish the rework program for such recalled products this year and hopes to achieve a settlement with the FDA during the year’s initial half.

January 30, 2023
Today, Philips announced that it would be laying off over 6,000 employees to return to profitability in the future. The manufacturer of personal healthcare devices has been having trouble since it announced a massive recall of vast numbers of CPAP devices.

December 25, 2022
To maintain its position that it does not do as much harm as several medical experts feel it has, Philps keeps depending on “independent” studies.

December 21, 2022
In a consumer class action lawsuit, 110 people and ten businesses sued for financial compensation for everyone else who bought those recalled CPAP devices. Philips has filed a motion to dismiss the complaint. Philips contends in the motion that such named plaintiffs lack footing because Philips provided free repair or replacement of their recalled devices, making it impossible for them to demonstrate any harm. In reply, the plaintiffs assert that if they had been aware of the risk, they wouldn’t have ever bought the equipment in the first place.

December 5, 2022
The FDA issued a warning regarding new issues involving Philips ventilators which were a part of the extensive CPAP recall. Following the recall, the hazardous PE-PUR foam was replaced with a new, non-toxic silicone foam in the Philips 100/200 Trilogy ventilators. The FDA has warned that these replaceable silicone foam inserts may detach and obstruct the user’s airways, which could lead to additional safety issues. It is the most recent of Philips’ numerous mistakes over the previous two years.

December 1, 2022
According to the New York Times, Philips and the Justice Department are currently haggling over the specifics of a consent decree. Philips would be required to accept responsibility under the settlement decree for its negligence in handling the issue with said sound abatement foam, which resulted in the extensive CPAP recall last year. The ruling would also compel Philips to spell out precisely what efforts the company will take to prevent similar problems in the future. The cooperation decree reflects the severe concerns that surfaced when it was discovered during an FDA inquiry into the CPAP recall that Philips had been aware of problems with the foam in devices for years but had done nothing to address them.

November 20, 2022
The FDA will release the most recent information on Medical Device Reports regarding the recalled Philips BiPAP and CPAP devices in November 2022. The new report reveals that over 90,000 reports of adverse health incidents related to the recalled CPAP equipment have been documented. The direct attribution of 260 deaths to breathing in poisonous PE-PUR foam from CPAP devices is of more significant concern. Currently, 346 CPAP recall lawsuits are actively progressing in the MDL, with additional cases still pending due to a tolling arrangement made with Philips at the start of the litigation.

October 28, 2022
After learning that magnets inside the face masks of some Philips CPAP equipment were causing pacemakers and other surrounding medical devices to malfunction, Philips was compelled to announce another such CPAP-related recall last month. The CPAP face mask magnet recall was recently given a Class I classification by the FDA, the most severe recall category, suggesting a risk of serious injury or death. The FDA has already received 14 reports involving “severe harm.”

October 25, 2022
In response to yesterday’s report, Royal Philips NV declared employment cuts of 4,000. The company’s new CEO, Roy Jakobs, wants to turn Philips around.

October 24, 2022
Bankruptcy may be the most considerable risk to the plaintiffs in this case. The value of Philips is below $12 billion. Yet, Philips would’ve been worth over $12 billion if sold in bits. Why? Because the $12 billion accounts for the potential of litigation, which lowers the company’s value. 

October 21, 2022
Recently, SoClean Inc. filed an updated complaint in its case against Philips, alleging that the latter made false claims to attribute the widespread CPAP recall to the SoClean ozone machines utilized to clean CPAP equipment. Based on material gained through discovery in CPAP Recall MDL, many new factual accusations against Philips are included in the recently revised complaint. SoClean cites internal records showing, among other things, that Philips was aware of such a design problem with its foam seven years before the CPAP recall.

October 16, 2022
During the coming months, tens of thousands of people who contend that the recalled Philips CPAP machines caused them harm will likely file cases in a CPAP recall class action lawsuit. The MDL Court recently issued a ruling requiring every new plaintiff to utilize the judicial Short Form Complaint upon filing to streamline this significant surge of new case filings. In MDL class action litigation, brief complaint forms are typical, facilitating the filing of numerous claims simultaneously.

October 2, 2022
By October 2022, the Philips CPAP class action lawsuit, a new claim registry, has been created to replace the existing tolling agreements system. Potential CPAP plaintiffs can properly submit their product liability claims against Philips through the claim registry without launching a lawsuit.

Such claim registry systems are typical of mass tort MDLs. Also, the Zantac cancer litigation made use of one as well. Without initiating a lawsuit, claimants can use the registry to toll its statute of limitations upon their claim. Additionally, it provides more beneficial information to the parties and the MDL Court concerning the breadth and magnitude of the possible field of the plaintiff.

September 18, 2022
Another bad news for CPAP manufacturer Philips. According to a recent news statement from the Department of Justice, the beleaguered CPAP manufacturer recently agreed to pay the United States Government a $24 million settlement to resolve allegations that it was involved in an illegal kickback scheme.

The corporation allegedly paid unlawful kickbacks to medical equipment suppliers to encourage them to submit insurance claims regarding Philips CPAP or other breathing devices, according to charges in this whistleblower complaint against Philips. Because they take advantage of the federal Medicare and Medicaid programs, those kickback schemes are prohibited.

It confirms what CPAP attorneys and the FDA have suspected: Philips does not adhere to the same rules everyone else does.

September 1, 2022
Philips had to issue another significant recall of additional CPAP equipment this week, less than a year after releasing a big recall affecting millions of CPAP and BiPAP machines. This time, a plastic component of the machine was found to be incompatible and capable of leaking carcinogenic substances into the user’s lungs, leading to the recall.

August 21, 2022
This week, the FDA’s public update notice upon this Philips CPAP recalls highlights the continued suffering caused by these faulty CPAPs. The notice stated that the FDA received over 48,000 reports of adverse events between May 1, 2022, and July 31, 2022, including 44 deaths connected to the breakdown of the PE-PUR foam in recalled Philips CPAP machines.

The FDA has received reports of 168 deaths connected to Philips CPAP since April 2021. In the meantime, the Philips MDL was home to 323 active CPAP litigation as of August 15, 2022. That figure is quite deceptive. Instead of launching lawsuits, thousands more CPAP claimants have registered claims and settled in tolling agreements.

August 4, 2022
On September 1, the Philips CPAP lawsuit judge will hold a “science day.” A science day in the MDL procedure is meant to allow attorneys on both sides to present to the Court regarding challenging scientific matters in the case.

On August 18, the parties will present suggestions to the Court about managing the science day. A common occurrence in MDLs regarding product liability claims is science days.

July 7, 2022
The CPAP class action case does have a new Case Management Order that permits counsel for both sides to start the pretrial discovery process. The initial litigation discovery plan, which is the process required to set up a CPAP settlement, is laid forth by Judge Joy Flowers Conti. Now that the CPAP lawsuit has been filed finding the records proving that Philip’s errors were to blame for the harm, suffering, and deaths suffered by numerous victims, including their families, will begin.

July 1, 2022
Philips needs to engage a new P.R. agency. The company tested the sound abatement foam in its recalled CPAP devices earlier this week to address potential safety concerns, and updated results have been released as part of an effort to mitigate damage. The statement indicates that the initial analysis indicates that CPAP users were not exposed to dangerous levels of harmful VOC chemicals.

The announcement needs to be more accurate since the testing Philips claimed was only done on brand-new equipment. The old CPAP machines that constituted a safety risk had undergone extensive cleaning, which led to the breakdown and release of toxic chemicals from its sound abatement foam. Phillips should have considered the rationale behind each and every CPAP litigation that has been brought. Because used CPAP equipment wasn’t evaluated for VOC emissions, these findings are useless.

June 27, 2022
A tentative discovery plan that sets forth some primary deadlines for such a CPAP class action case was recently released by Judge Conti. By July 8, 2022, the judge requests collaborative ideas on plaintiff documentation and implementation methods. Plaintiffs are required to respond to written questions in this case. The judge also requests documented discovery plans and ideas for deposition protocols by August 15 (September 9).

June 21, 2022
The evidence against Philips keeps building. According to internal papers discovered inside the CPAP class action lawsuit, Philips was aware of the issue with the sound abatement foam of their CPAP equipment for at least three years before its company started a safety recall.

A mechanical engineer from Philips wrote to a supplier in April 2018 to complain that the sound foam, which contains hazardous chemicals, was shedding and exposing users to foam particles. The Philips engineer acknowledged that “this is not a nice situation for our users” in the email. What would a trustworthy business do with this knowledge? Philips took no action. This email will help prove that Philips carelessly disregarded a known risk with their CPAP machines from plaintiffs’ CPAP attorneys.

June 10, 2022
Philips is still having trouble. Almost 60,000 Philips V60 and V60 Plus ventilators were subject to a recall last week (breathing devices are primarily utilized in hospitals). According to the recall, the ventilators may shut down unexpectedly without sounding any alert or warning siren due to issues with their electrical power supply. This flaw has already been linked to numerous injuries, including at least one fatality.

June 9, 2022
According to the parties’ agreement, former Magistrate Judge Diane M. Welsh has been appointed as a Settlement Mediator by the Philips CPAP Recall MDL judge in Pretrial Order #16, published last week. Although an early settlement might be in Philips’s best interest, this does not necessarily mean the company is looking forward to a CPAP settlement. Parties to protracted legal disputes are required by Rule 16.1 of said Local Rules for the Western District of Pennsylvania to take part in Court-sponsored alternative resolution processes. The current selection of Judge Welsh as Settlement Mediator is merely an act of the parties’ participation in this ADR procedure. It is unlikely that any rapid movement will be made on a CPAP settlement due to the mediation.

June 2, 2022
In a company statement released last week, Philips acknowledged a “steep increase” in the complaints related to foam degradation. Over the past year, foam degradation has been mentioned in over 20,000 Medical Device Reports (MDRs). By arguing that ozone cleaners, which are not permitted cleaning chemicals, are the leading cause of PE-PUR foam degradation, Philips is teasing how it would defend CPAP claims. Additionally, it promotes a recent study published in the European Respiratory Journal, which finds no link between using Philips Respironics equipment for CPAP therapy and an increased risk of developing cancer. Remember that the study Philips is touting does not “enable decisive conclusions to be formed regarding the influence of P.R. devices on cancer risk,” as stated in the paper. 

May 25, 2022
Since it was initially disclosed last year, the FDA has been forced to play a significant role in the Philips CPAP machine recall. Recent data from the FDA show that during the previous year, the agency received more than 21,000 reports of severe health effects using Philips CPAP equipment (April 2021 to April 2022). Cancer, Pneumonia, respiratory problems, and various other illnesses have been among the health issues linked to the Philips DreamStation and some other recalled CPAP machines that have been reported to the FDA. Also, the toxic foam utilized by the defective CPAP machines has been linked to 124 fatalities, according to reports sent to the FDA. The 124 deaths exceed what even CPAP lawyers could have anticipated. It gives us a clear idea of the range of possible product liability claims that Philips will protect itself against in the CPAP class action litigation.

May 17, 2022
There have been 14 additional Philips CPAP recalled product liability cases filed since the beginning of May. It is anticipated that a significant surge in new CPAP product liability case filings will occur. Yet, only a few CPAP attorneys bring claims using the standard procedure. The administrative docket currently has an estimated 60,000 more CPAP recall lawsuits. At the following monthly status meeting in two days, we shall know more about the quantity of CPAP lawsuits that have been filed.

May 10, 2022
Many deaths will probably result from CPAP flaws. Recently, victims have begun to connect CPAP use to the deaths of their loved ones. A case in point is a recent wrongful death CPAP lawsuit. Doug Shiffler of Oregon, the plaintiff, lost his wife to cancer and brought a product liability claim against Philips and a Maryland business that created the hazardous sound-absorbing foam found in the recalled CPAP machines (Wm. T. Burnett & Co). According to Shiffler’s CPAP complaint, his wife used a recalled Philips DreamStation CPAP machine nightly for around 20 months. Her lung cancer was found to be advanced. Doug filed a wrongful death case when Joleen passed away from lung cancer, alleging that harmful particles inside the foam of his DreamStation device were to blame for Joleen’s lung disease and disappearance.

May 4, 2022
The FDA is considering compelling Philips to make an offer to refund the cost of the CPAP units that are the subject of the recall. This exceptional action would demonstrate just how angry the FDA is towards Phillips.

May 3, 2022
According to science, skin cancer is one injury this malfunctioning CPAP might cause, which CPAP lawyers may have first missed. A particularly compelling CPAP lawsuit would center on a claim for skin cancer in the area of the face in which the CPAP headgear or mask is used.

May 2, 2022
According to a recent Wall Street Journal report, the U.S. Department of Justice has subpoenaed Philips for information regarding the CPAP recall. The subpoena indicates that the DOJ is looking into the CPAP recall and that Philips’ situation might worsen.

The CPAP lawsuit is still in progress, and both parties’ lawyers are getting ready for a status meeting with the judge soon. CPAP lawsuits are still being brought administratively (as our attorneys explain below), and Judge Conti from Pennsylvania still receives them from their original districts.

March 24, 2022
Regarding breathing devices, Philips can’t consistently do anything right. Philips recalls numerous hospital ventilators since a faulty adhesive in the devices might lead them to abruptly cease working, less than a year after recalling 15 million BiPAP and CPAP devices due to exposing users to inhaling deadly carcinogens while they sleep.

March 22, 2022
The FDA informed Philips in a letter that the company’s attempts to inform clients about the health hazards connected with the recalled BiPAP and CPAP devices needed to have been revised. It was something our attorneys noted in the previous update.

In response, the FDA intervened and issued a “notice order,” forcing Philips to properly notify device users and medical professionals about the CPAP recall under the FDA’s supervision.

March 14, 2022
The FDA worries that Philip’s first-come, first-served replacement policy may endanger CPAP-dependent patients. Several individuals are phoning our CPAP attorneys to voice their concerns about not having a secure CPAP.

March 12, 2022
The FDA writes a medical device manufacturer one of the worst letters lawyers have ever seen. The FDA claims that Philips’ patient notification efforts and the CPAP recall must be more woefully inadequate. This terrible news might benefit plaintiffs in the CPAP recall lawsuit. Philips is undoubtedly more inclined to grant victims fair settlement sums as things get worse so they can put this legal dispute behind them.

March 5, 2022
By signing a tolling agreement with Philips, users using recalled Philips CPAP devices considering a CPAP lawsuit can now protect their legal rights. A Philips CPAP MDL judge granted a tolling deal this past week. A tolling agreement allows potential plaintiffs to keep their option to sue Philips open until the appropriate statute of limitations upon their claim has passed.

March 1, 2022
Politicians are paying attention to the tragic Philips CPAP recall. To guarantee Philips right the ship after this terrible recall and to stop products like the Philips CPAP from constantly entering the market, Senator Richard Blumenthal and Connecticut’s Attorney General William Tong are pleading with the FDA to take action.

February 25, 2022
Judge Joy Flowers Conti appointed 33 CPAP recall attorneys to top positions to manage this case. The CPAP lawsuits are moving forward thanks to this significant move.

What is the nature of the Phillips CPAP Litigation?

The Phillips CPAP litigation involves a legal dispute involving Philips Respironics, a leading manufacturer of continuous positive airway pressure (CPAP) and related sleep apnea machines. The nature of the litigation is primarily centered around allegations of product defects and potential health risks associated with specific models of Philips CPAP machines.

The litigation arose after Philips Respironics issued a voluntary recall in June 2021 for several of its CPAP machines and other sleep apnea machines due to concerns over potential health risks associated with the sound abatement foam used in these devices. The recall affected millions of devices globally, including popular models such as DreamStation CPAP machines.

The nature of the Phillips CPAP litigation involves various legal actions, including class action lawsuits filed by affected individuals and personal injury claims alleging harm caused by the alleged product defects. It claims damages related to the costs of replacing or repairing the affected devices. The litigation alleges that the defective foam used in the CPAP machines may deteriorate and release harmful particles or gases, potentially causing respiratory issues, lung injuries, and other health problems in users.

The litigation is ongoing, and the outcomes and resolutions may vary depending on each case’s jurisdiction and specific circumstances. Philips Respironics has taken steps to address the issue, including providing replacement and repair options for affected devices. Still, the litigation evolves as more information emerges and the legal process unfolds. It is essential for individuals who have been affected by the alleged product defects to seek legal advice and stay updated on the developments of the Phillips CPAP litigation.

About CPAP and BiPAP Machines

When a person has sleep apnea, their breathing can grow increasingly shallow or even stop entirely while asleep. It can result in various health issues, including hypertension, heart attacks, strokes, headaches, and fatigue.

The most common treatment method for sleep apnea is continuous positive airway pressure (CPAP) therapy. During CPAP therapy, a machine provides positive airflow through a mask placed over the mouth and nose.

It generates sufficient internal pressure to stop the person’s airway from closing during nighttime breathing. Two sleep apnea devices are Automatic Positive Airway Pressure (APAP) and Bilevel Positive Airway Pressure (BiPAP) machines.

Continuous positive air pressure treatment is also referred to as CPAP. The patient’s airway is kept open and helped to breathe, thanks to a positive air pressure tube. With CPAP, the patient wears a mask over their mouth and nose while they sleep. When there is a blockage, CPAP therapy pushes air into the airway and avoids respiratory depression.

A CPAP is a fantastic medical gadget when it is operating correctly. Even compared to surgery, CPAP is a more effective therapy for sleep apnea. CPAP is effective in treating the great majority of patients’ sleep apnea, as shown by the apnea/hypopnea index.

As a result, there has been a sharp increase in demand for CPAP equipment recently. It should come as no surprise that Covid-19 increased interest in CPAP devices. Philips generated $6 billion in income from the sale of CPAPs in 2020.

CPAPs typically function as intended. The main form of treatment for obstructive sleep apnea, this device frequently reverses the effects of sleep apnea.

Several lawsuits filed against Philips due to the CPAP safety recall allege that users of the defective devices experienced adverse health effects. A new “class action” has been established to consolidate the CPAP recall product liability claims. The MDL class action offers victims a relatively simple way to file a CPAP lawsuit.

How Serious Is the CPAP Recall?

The United States Food and Drug Administration gave the recalled products a Class I classification, which is considered the most serious and indicates that they may result in serious injury or death.

Suppose information shows a device may have led to a serious injury or death. In that case, manufacturers like Philips are required to prepare medical device reports for said FDA. Philips provided 30 reports between 2011 through April 2021. By November 2022, the FDA had received 90,000 reports regarding medical equipment and had recorded 260 fatalities, all related to the disintegration of foam and plastic. Moreover, the magnets in the mask can interfere with pacemakers and other medical devices (due to its severity, the FDA classed the recall as a Class 1 action). The reports came through Philips and from consumers, patients, and healthcare experts.

You must cease using your device immediately if it’s one of those being recalled. If you still need to register your equipment with Philips, it is on the recall list. It would be best if you did so to receive information on corrective action. You should register any other Philips products you own on the company’s website in case there are still updates regarding new products that are affected.

What CPAP machines are on recall?

Philips issued a voluntary recall for these sleep apnea devices from 2009 to April 26, 2021, and on June 14, 2021:

Recalled BiLevel PAPs and CPAPs:

• Dorma 400, 500 CPAP, Auto CPAP
• C Series S/T, AVAPS
• DreamStation ASV
• DreamStation GO CPAP, APAP, Auto CPAP
• DreamStation CPAP, BiPAP, Auto CPAP
• DreamStation ST, AVAPS
• E30
• REMstar SE Auto
• OmniLab Advanced Plus
• System One 50 series
• System One 60 series
• SystemOne (Q-Series)
• SystemOne ASV4

Recalled mechanical ventilator machines:

• A-Series BiPAP A30
• A-Series BiPAP A40
• A-Series BiPAP V30 Auto Ventilator
• A-Series BiPAP Hybrid A30
• Trilogy 100 Ventilator
• Trilogy 200 Ventilator
• LifeVent Ventilator, Garbin Plus, Aeris

Almost 15 million breathing devices are subject to this recall. The Respironics M-Series REMStar CPAPs should be noted as needing to be recalled.