Philips CPAP machines have been recalled because foam used in them can be inhaled by users and emit toxic gases. Users who inhale the foam or the gases emitted by the foam may develop numerous health effects, including numerous cancers.
Lawsuits allege that Philips knew about this problem well before they recalled the units, yet failed to warn users about the problem.
Call us today for a free consultation or text us from this page if you or a loved one became ill after using a Philips CPAP device. You may qualify for financial compensation. We won’t charge you a fee to handle your CPAP lawsuit until and unless we win your case.
2023 Philips CPAP Lawsuit Update & Latest News
July 13, 2024 Update
The judge overseeing the CPAP MDL, in October, will end up holding a hearing in order to decide on if a proposed settlement in a class action lawsuit is fair. The settlement would end up providing $25 million in order to cover former CPAP device users’ future medical monitoring after they were exposed to toxic foam inside the devices which has been linked with cancer as well as additional injuries.
In April, Philips announced it agreed to a $1.1 billion settlement resolving tens of thousands of injury claims.
July 2, 2024 Update
A recall has been issued for the Philips OmniLab Advanced+ (OLA+) Ventilator.
The recall involves Philips updating the instructions for use of the device because of a ventilator inoperative alarm failure which might lead to loss or interruption of therapy. The company will correct the issue by virtue of a software patch, or, alternately, will offer replacement devices until the affected devices are corrected.
The device may enter a ventilator inoperative state, leading to loss or interruption of therapy which may lead to death, respiratory failure, hypoventilation, respiratory acidosis, hybercarbia, low oxygen saturation, mild to severe hypoxemia, abnormal chest wall movement, tachycardia, dyspnea, decreased/increased respiratory rate, disorientation/confusion, or anxiety.
15 injuries and one death have been reported regarding the issue.
June 30, 2024 Update
A recall has been issued of numerous Philips BiPAP devices, including the BiPAP A40, BiPAP A30 and BiPAP V30.
The recall involves Philips updating the instructions for use of the devices, after reports have come in that some users experienced interruptions as well as loss of therapy.
The recall is due to the Ventilator Inoperative alarm failing, which can cause loss or interruption of therapy, possibly leading to death, respiratory failure, hypercarbia, hypoxemia or hypoventilation.
The devices, according to the recall, may intermittently reboot for 5-10 seconds or enter an inoperative state.
According to the recall, 952 injuries have been reported and 65 deaths have been reported.
June 3, 2024 Update
A motion has been filed by a plaintiff which objects to the Master Settlement Agreement which has been proposed. The lawyer for the plaintiff is arguing that the agreement is creating ethical conflicts for attorneys who represent affected clients, and that the agreement violates American Bar Association (ABA) rules.
Two paragraphs in the agreement are being objected to. One of the paragraphs restricts lawyers from taking on or soliciting new clients for claims against released parties. The plaintiff argues this violates an ABA rule prohibiting agreements which restrict attorneys’ rights to practice.
The other paragraph being objected to requires that lawyers recommend the settlement to every client, mandating withdrawal from representation of clients who do not choose to participate. The motion argues this leads to a conflict of interest which violates an ABA rule, and forces attorneys to abandon their clients contrary to their best judgment, violating an ABA rule.
The lawyer for the plaintiff is urging the court to remove these paragraphs or deny the entire agreement’s approval, claiming these provisions are not fair to clients and lawyers, and don’t meet standards of an adequate, reasonable and fair settlement.
In other news, 25 cases were added to the CPAP MDL in May, bringing the total number of cases pending to 792.
May 9, 2024 Update
The settlement agreement regarding CPAP came out yesterday morning.
Those eligible for participating in the settlement will include those who have used the recalled devices and are United States citizens who are represented by an attorney prior to April 29, 2024 or pro se victims who have already brought claims.
Those participating in the settlement will receive payments in 2025. Philips will end up depositing $1.05 billion into a settlement fund by the date of January 6, 2025.
Those who wish to opt out of the settlement may, but it will be difficult – plaintiffs who opt out will end up facing strict procedural requirements, including having to produce comprehensive info regarding their claims such as causation, device usage evidence and detailed medical records within 60 days of opting out, and having to produce expert reports which substantiate claims within 90 days.
May 6, 2024 Update
25 cases were added to the CPAP MDL in April, bringing the total number of pending cases to 787.
April 30, 2024 Update
An agreement has been reached in which Philips will pay $1.1 billion in order to settle injury lawsuits as well as claims for medical monitoring which stem from a 2021 recall of CPAP machines, mechanical ventilators and BiPAP machines containing defective foam used for sound abatement. The lawsuits claim that this foam breaks down, resulting in toxic particles being inhaled by users, and that this caused plaintiffs to become injured.
The settlement was announced by Philips in an earnings report regarding 2024’s first quarter. The settlement came following a mediation in which plaintiffs’ lawyers and Philips agreed to resolve claims alleging the machines caused numerous types of cancer, lung damage, respiratory injuries and additional injuries.
Funding for the settlement payouts will begin in 2025. $40 million of the settlement will come from insurers, with the rest coming from Philips’ revenues.
Additional details haven’t been released, such as average settlement amounts regarding specific injuries, or any info regarding claimants’ options to continue pursuing lawsuits in the future against Philips.
The agreement seemingly resolves most or all CPAP lawsuits in federal court. Philips has indicated it won’t admit liability or fault in any settlement agreement.
April 23, 2024 Update
The judge overseeing the Philips CPAP MDL issued a pretrial schedule calling for plaintiffs and defendants to come up with a plan for selection of bellwether personal injury claims by October 29, 2024. The claims will end up going through discovery which is case-specific in order to prepare for the initial trials over recalled devices, which are now not likely to start until at least the beginning of 2025.
The scheduling order also calls for discovery regarding general causation facts in personal injury claims to be completed by the start of July.
The court has indicated that after expert and case-specific discovery, Daubert hearings will take place in May 2025 or June 2025, in which the reliability of expert opinions and testimony will be evaluated, and in which it will be determined what experts will be allowed to testify during trial.
April 17, 2024 Update
After a fairness hearing was held the previous week, the judge overseeing the Philips CPAP MDL indicated an order an opinion will soon be issued, and they will determine if a class action settlement will be approved, a settlement to resolve claims of economic loss brought by CPAP machine owners.
This litigation is regarding a recall Philips issued in 2021 involving millions of CPAP, mechanical ventilator and BiPAP machines containing defective sound abatement foam, which was found to break down gradually, releasing gases and toxic particles which users may inhale.
If the settlement is approved, claimants will end up receiving $100 for every device returned to Philips, as well as $50 to $1,500 in financial compensation, based on what device they used.
Philips announced in September it would pay out at least $445 million to settle a class action lawsuit brought by users who bought, leased or rented the devices. However, this settlement doesn’t impact individuals’ ability to pursue personal injury lawsuits regarding conditions caused by the devices.
April 16, 2024 Update
A Kentucky man has filed a lawsuit alleging that he was diagnosed with bone cancer and breast cancer, and that he developed these diseases because he used a DreamStation CPAP machine.
The lawsuit claims Philips knew about risks which are associated with the machine’s polyurethane foam, which can allegedly degrade, releasing toxic particles which users can inhale, possibly causing serious health complications.
The plaintiff alleges he has suffered considerable emotional and physical distress because of this defect, such as invasive cancer treatments as well as their aftereffects.
April 12, 2024 Update
Philips has been banned by a federal judge from distributing and manufacturing BiPAP and CPAP machines from its United States facilities until it meets specific requirements from federal regulators which are a response to the company’s handling of its massive CPAP recall which began in 2021.
Philips will need to be able to prove to the FDA that its manufacturing facilities in California and Pennsylvania meet manufacturing standards which are accepted, as well as comply with a plan for remediation to replace or repair recalled devices using safe alternatives. Philips will also need to hire outside experts in order to inspect additional facilities which manufacture respiratory care sleep devices, correct deficiencies and independently evaluate testing which is done on potential materials to replace its recalled sound abatement foam.
The ban comes after the FDA, as well as prosecutors with the Department of Justice, filed a complaint on April 4 which alleged the company was manufacturing medical devices while under conditions that didn’t comply with the Food, Drug and Cosmetic Act, or Good Manufacturing Practices.
The DOJ and FDA also claimed the company didn’t give regulators written reports regarding device removals and corrections and didn’t properly have the FDA approve remediation plans.
April 9, 2024 Update
Philips warned about a risk of malfunction regarding some ventilators which may lead to a power loss. The Trilogy EV300, Trilogy Evo O2 and Trilogy Evo models may experience issues. These products may erroneously signal power failure or low battery alerts despite having an adequate amount of battery life. No deaths or injuries have been reported regarding this issue.
14 cases got added to the CPAP MDL in March, bringing the total number of cases to 762.
March 23, 2024 Update
Philips has filed a motion calling for SoClean, Inc. to be added to the CPAP MDL. SoClean markets devices which deodorize and sterilize CPAP machines using ozone gas.
Philips is facing hundreds of lawsuits alleging that users of its CPAP machines were injured because the sound abatement foam used inside the CPAP machines deteriorated, causing users to inhale toxic foam particles and offgassing. Philips is arguing that SoClean’s devices accelerated the foam’s breakdown inside the CPAP machines, contributing to users’ injuries.
March 17, 2024 Update
Philips has asked a judge to dismiss CPAP lawsuits which individuals are pursuing and which claim that exposure to toxic foam in CPAP machines injured plaintiffs, presenting the argument that federal law preempts the claims and that the claims shouldn’t proceed because pleadings by the plaintiffs have alleged deficiencies. The defendants claim the lawsuits weren’t filed properly and are preempted by not only federal law but various state laws as well.
March 8, 2024 Update
February saw the number of cases pending in the CPAP MDL decrease from 760 cases to 748 cases due to dismissals.
February 1, 2024 Update
The FDA has announced that at least 561 deaths have been linked with Philips’ recalled breathing devices since 2021. The FDA also announced that, since April 2021, they have received over 116,000 medical device reports regarding the recalled devices.
The FDA states that many injuries have been reported in the reports, including cancer, asthma, pneumonia, headache, infection, dyspnea, cough, nodules, chest pain and dizziness.
January 30, 2024 Update
Philips Respironics announced it is halting sales of its CPAP machines and its other breathing machines until it resolves issues which resulted in a CPAP recall over two years ago. The announcement came as part of a settlement with prosecutors and federal regulators.
The sales suspension is related to a consent decree involving the FDA. Philips is anticipating that it won’t sell mechanical ventilator, BiPAP and CPAP breathing machines again in the U.S. until 2025 or later.
The settlement does not impact ongoing lawsuits which Philips faces from users of its machines who claim the machines injured them.
January 22, 2024 Update
A new lawsuit has been filed in Illinois alleging that a man died from moderately differentiated invasive adenocarcinoma, a type of cancer, after he used a CPAP machine which was recalled by Philips. The man who died allegedly started using his CPAP machine in January 2012 for sleep apnea, then stopped using the machine after discovering that the product had been recalled by Philips.
January 15, 2024 Update
755 cases are now pending in the CPAP MDL.
December 13, 2023 Update
Senators Richard Blumenthal and Dick Durbin have sent a letter to the U.S. Government Accountability office, requesting the office update a report regarding FDA oversight of recalls. The senators noted that while Philips had received an adverse event report regarding defective foam in its CPAP, BiPAP and mechanical ventilator devices in 2010, they did not recall the devices until 2021. The senators stated that recalls must be done efficiently to prevent harm, urging the office to probe how the FDA oversees medical devices and medical device recalls.
December 1, 2023 Update
Several deadlines have been set in the CPAP MDL. Notable deadlines include a February 16, 2024 deadline for the settlement mediator to report to the court on the status of personal injury claim mediations, and a March or April 2025 deadline for a potential hearing date on Daubert/Rule 702 motions regarding general causation. Plaintiffs will thus be hoping for a 2024 settlement and, if a settlement isn’t reached, a 2025 trial.
The FDA has issued a safety communication warning patients as well as healthcare providers to carefully monitor any Philips DreamStation 2 CPAP machines for any signs that they may be overheating.
The agency has recently received reports regarding the Dreamstation 2 machines involving thermal issues like burns, smoke and fire, and noted that there has been a recent increase in thermal issue reports regarding the machines. The FDA stated that they’ve received over 270 problem reports regarding the machines, whereas they had only received less than 30 reports in the previous three years.
November 1, 2023 Update
Philips has recalled yet more ventilators. This time it’s the V60 Plus and V60 ventilators. The reason for the recall is that circuit board assemblies in the ventilators fail to meet required standards, according to the FDA.
Philips has proposed a $479 million settlement, which has been preliminarily approved by a federal judge, with CPAP machine owners who took part in class action lawsuits. The settlement proposal covers the costs of reimbursement to those who purchased, rented or leased defective CPAP devices. Depending upon the device owned, claimants will be able to expect between $55 and $1,552 per CPAP device, as well as $100 for each device returned. $34 million of the $479 million will go to health insurers and others since they paid users to replace CPAP machines. The settlement proposal does not cover the costs of injuries. If you’ve been injured by a defective Philips CPAP device, call us today for a free consultation – you may be eligible for financial compensation in a lawsuit.
On October 5, 2023, the FDA released an update regarding recalled Philips CPAP, BiPAP and ventilator machines. In July 2023, Philips released information and data regarding testing it did on the PE-PUR foam used in recalled devices. Philips came to the conclusion that exposure to particles of foam and volatile organic compounds from the devices isn’t likely to cause appreciable harm to patients. However, the FDA doesn’t believe the analysis and testing Philips shared with them is adequate to completely evaluate the devices’ risks, believing that more testing is needed. Philips agreed to do this additional testing. The FDA also published a new Philips CPAP resource section.
October 1, 2023 Update
According to a ProPublica report, Philips had received reports that the foam used for sound abatement in its CPAP devices was breaking down in 2010, causing users to inhale “black particles” consisting of toxic chemicals. According to the report, Philips waited 11 years to recall the devices, waited several years to recall the devices after its own scientists found the devices posed a health risk to their users, and hid over 3,700 problem reports from the FDA. According to the report, by 2015, numerous reports to Philips indicated the foam was problematic, yet Philips then decided to add the foam to more and more machines despite knowing of its risks. According to the report, Philips didn’t investigate the issue until 2019, nine years after becoming aware of the problem.
As of September 18, 2023, there are 716 cases in the Philips CPAP multidistrict litigation.
On September 7, Philips announced it agreed to an approximately $479 million settlement with plaintiffs who claimed economic damages regarding the CPAP recall. The settlement is regarding a multidistrict litigation. The final amount paid through the settlement will end up depending upon how many claims are filed.
September 1, 2023 Update
August 31 was the deadline for CPAP MDL plaintiffs to file any motions to remand their cases to state court. Only 3 such motions were files in the last two weeks of the month. This is a good sign that the plaintiffs in the CPAP MDL are confident that the judge in the MDL will deem their scientific evidence to be admissible. More motions to remand would have likely been filed if the plaintiffs had concerns or doubts about the admissibility of their scientific evidence.
A lawsuit was filed in August 2023 in Illinois alleging that the plaintiff developed kidney cancer because he used a Philips CPAP device. The lawsuit alleges the man needed to have his kidney as well as his adrenal gland removed because of this.
The CPAP MDL had 698 pending cases as of August 17, 2023.
Philips has released a report to healthcare providers and the public regarding testing they have done on their PE-PUR foam which was used in recalled CPAP machines. The company claims that their testing found that exposure to particulates of the foam as well as volatile organic compounds offgassed by the foam isn’t likely to cause patients appreciable harm. Lawyers have criticized the report as being “science for hire” since testing was done by a third party which was paid to do the testing.
August 1, 2023 Update
On July 10, Philips attorneys tried to trim or toss CPAP claims from the MDL, arguing that claims in the MDL are either:
- Covered by state laws regarding consumer protection
- Preempted via federal law
- Insufficiently detailed
- Not independent claims when in states not recognizing them
- Not allowed as an independent cause of action in the plaintiffs’ states
ABC 4 WTAE has reported that Philips customers who bought recalled CPAP machines are starting to receive replacement machines from Philips. The station reports that customers are receiving refurbished machines which are also on the recall list. The refurbished machines reportedly contain a new, silicone replacement foam which has been FDA approved.
July 1, 2023 Update
The FDA released an update regarding medical device reports relating to the recalled Philips devices. The FDA said it received over 6,000 medical device reports related to the recalled devices from January 1, 2023 to March 31, 2023, including 40 reports of deaths.
The number of lawsuits being filed has spiked because June 14, 2023 marked two years from the date of the initial CPAP recall. The statute of limitations in California for product liability cases is two years from the date a plaintiff knew or should have known their injuries were caused by a product.
May 1, 2023 Update
Philips announced it had set aside $630 million to resolve economic loss claims regarding its recalled CPAP devices.
April 1, 2023 Update
Philips recalled ventilators because dirt and dust path could reduce patients’ airflow.
Royal Philips CEO Roy Jakobs stated that Philips is close to settling CPAP class action lawsuits, and that the settlements may be finalized some time in 2023. Jakobs stated the company hopes they can settle personal injury lawsuits after that, perhaps in 2024.
March 1, 2023 Update
Philips recalled some Philips Dreamstations which had been reworked because, in the process of giving the devices their initial programming, some devices were assigned duplicate or incorrect serial numbers. This could lead to therapy failure or incorrect failure, which could lead to serious injury or death.
The FDA reported that almost 350 deaths have been linked with Philips’ recalled CPAP devices.
February 1, 2023 Update
Plaintiffs in the CPAP multidistrict litigation called for the first CPAP bellwether trial to take place in summer 2024. Defendants called for the first bellwether trial to take place in 2026.
January 1, 2023 Update
Philips recalled four BiPAP machines because the plastic in them may be contaminated with material which could cause volatile organic compounds to be released. The recalled models are: OmniLab Advanced+, A-Series BiPAP V30, A-Series BiPAP A40 and A-Series BiPAP A30.
December 1, 2022 Update
On November 17, 2022, Philips told the FDA that reworked Philips Respironics Trilogy ventilators involved in the June 2021 recall have two new possible issues:
- The new sound abatement foam might separate from its plastic backing, blocking the air inlet and lowering the air pressure
- Particulate matter has been found in some reworked ventilators’ air pathways
Then, on November 22, 2022, the FDA provided information about medical device reports they received between August 1 and October 31, 2022. The FDA reported that, during this time span, they received over 21,000 medical device reports involving foam breakdown in CPAP machines, BiPAP machines and ventilators, including 91 reports of deaths.
October 1, 2022 Update
Philips recalled over 17 million masks for BiPAP and CPAP units because of magnets in them which may cause serious injury or death by interfering with metallic objects in the body. Click here for more information.
