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What was the Philips DreamStation Recall Lawsuit?

Philips Respironics issued a massive recall for CPAP, Bi-PAP and ventilators sold between 2009 and April 2021, which contained a defective PE-PUR sound abatement, which may degrade and release black particles and chemicals directly into the sleep apnea machine air pathways and the lungs of users.

Former users pursued Philips CPAP lawsuits, seeking financial compensation and settlement benefits for health problems caused by the machines, including:

• Leukemia, Lymphoma or other Cancer Diagnosis
• Pulmonary Fibrosis, Sarcoidosis or other Lung Disease
• Chronic Asthma, Bronchitis or Pneumonia
• Liver Injury, Kidney Injury, Heart Attack, Stroke or Heart Failure
• Medical Treatment for Symptoms Like Headaches, Breathing Problems, Irritation, Nausea and Vomiting

Philips CPAP Settlement Updates

May 2024 Update: Philips Respironics has agreed to pay $1.1 billion to settle CPAP personal injury lawsuits and medical monitoring claims stemming from a massive recall issued in 2021, for CPAP, BiPAP and mechanical ventilators containing defective sound abatement foam. Royal Philips CEO Roy Jakobs announced the Philips CPAP injury settlement payouts will total $1.1 billion, with the funding beginning in 2025. Insurers will pay $40 million of that settlement amount, but the rest will come from the company’s revenues, Jakobs indicated.

April 2024 Update: Following a fairness hearing held earlier this month, the U.S. District Judge presiding over all Philips CPAP recall lawsuits indicates she will soon issue an opinion and order, determining whether to approve the Philips CPAP class action settlement that resolves economic loss claims brought by owners of the recalled machines.

January 2024 Update: Philips Respironics has reached a settlement agreement with the FDA and U.S. Department of Justice, agreeing to suspend sales of its CPAP, BiPAP, and mechanical ventilator devices in the U.S. until 2025. As part of the consent decree with the FDA, the manufacturer stated that it has also allocated $393 million for the required remediation efforts.

December 2023 Update: On December 7, the parties submitted a joint motion (PDF) asking Judge Conti to allow them to publish the details of the $445 million CPAP recall class action settlement for economic losses on the court’s website. According to the CPAP class action settlement agreement, users have until August 9, 2024 to enroll in the settlement agreement to receive $100 for each device they returned to Philips due to the recall, and another $50 to $1,500 in compensation, depending on the type of device the plaintiffs used.

The Philips CPAP class action settlement does not impact the thousands of ongoing personal injury claims being pursued over cancers, lung damage and other health problems caused by the machines toxic sound abatement foam.

November 2023 Update: A federal judge has granted the proposed Philips CPAP class action settlement preliminary approval, while negotiations continue in hopes of resolving the personal injury lawsuits sometime next year.

September 2023 Update: Parties filed a motion on September 7, 2023, asking the U.S, District Judge presiding over the Philips CPAP litigation to approve a $445 million Philips class action settlement agreement to resolve all economic loss claims. The proposed settlement would only resolve economic loss claims, and would not impact the thousands of Philips CPAP cancer and injury claims being pursued.

March 2023 Update: Royal Philips CEO Roy Jakobs indicated in an interview with Dutch newspaper Het Financieele Dagblad, that the company is close to a settlement agreement involving economic damage payouts for Philips CPAP class action lawsuits, which could be finalized in 2023, and hopes to reach a global Philips CPAP injury lawsuit settlement in 2024.

September 2022 Update: The U.S. Department of Justice issued a press release announcing the Philips Respironics whistleblower lawsuit settlement, which will require the manufacturer to pay $22.62 million to the federal government and another $2.13 million to various states for its involvement in an illegal kickback scheme to defraud the Medicare, Medicaid and other health programs.

May 2022 Update: Judge Conti has appointed a Philips CPAP recall settlement master early in the litigation, to oversee negotiation between the parties and attempts to resolve thousands of claims being pursued by users left with injuries.

Philips CPAP Lawsuit: MDL 3104 Updates and Status

April 15, 2024 Update: On April 9, U.S. District Judge Robert Colville, in the Western District of Pennsylvania, approved a consent decree between Philips and the U.S. Food and Drug Administration (FDA), banning the sale of Philips CPAP and BiPAP devices from manufacturing facilities in Pennsylvania and California, until the company can prove to the agency that those facilities meet accepted manufacturing standards and comply with a remediation plan to repair or replace its recalled devices with safe alternatives.

March 21, 2024 Update: On March 15, Philips and Plaintiffs’ co-lead counsel filed a joint motion calling for Judge Conti to enter a pretrial order setting forth the procedures for Philips to file a Master Third-Party Complaint against SoClean, Inc. and one of its investing partners, DW Management Services. If approved, Philips could directly involve SoClean as a defendant in numerous CPAP injury lawsuits in the MDL, potentially sharing the responsibility for the injuries due to the foam’s degradation.

March 14, 2024 Update: Philips Respironics filed a motion to dismiss this month, requesting a federal judge to dismiss injury lawsuits related to the CPAP recall. The company argues that the lawsuits, filed by individuals who allegedly developed cancer and other side effects from exposure to the toxic sound abatement foam in breathing devices, should be barred because they are preempted by federal law and the plaintiffs’ legal filings are allegedly inadequate.

March 11, 2024 Update: The U.S. JPML issued an updated docket report indicating there are currently 748 Philip CPAP lawsuits currently pending in the multidistrict litigation, with an estimated tens of thousands of additional claims registered under the tolling agreement.

February 29, 2024 Update: During a status conference with Judge Conti, the parties in the Philips CPAP lawsuits submitted a joint notice outlining key deadlines over the next 18 months, including discovery completion by April 2024, bellwether lawsuit proposals by August 2024, expert testimony challenges in early 2025, and pretrial hearings in March or April 2025.

February 1, 2024 Update: Two days after Philips officially announced it was halting sales of all its CPAP devices in the United States as part of an agreement with the federal government, the U.S. Food and Drug Administration (FDA) released an update on Philips CPAP medical device reports (MDRs), indicating recalled Philips CPAP machines and other breathing assistance devices have been linked to more than 116,000 MDRs and 561 deaths.

January 5, 2024 Update: Philips filed a counterclaim (PDF) against SoClean on January 5, 2024, asserting that SoClean was aware that their ozone-based cleaners could damage the PE-PUR sound abatement foam and other components within CPAP machines. The lawsuit states that the SoClean ozone cleaners use a “toxic gas” that can ear away at the sound abatement foam, and were falsely advertised as safe and compatible with Philips CPAP and BiPAP medical devices.

Why was there a Philips Respironics recall for DreamStation, CPAP, Bi-PAP and Ventilators?

Recalled Philips DreamStation, CPAP (Continuous Positive Airway Pressure), BiPAP (Bi-Level Positive Airway Pressure) and mechanical ventilator machines were sold with defective PE-PUR sound abatement foam, which was intended to reduce noise and vibrations from the devices. However, due to problems with the material and design of the breathing machines, this PE-PUR foam may break down and release toxic particles and chemicals directly into the machines air pathways.

The recalled Philips CPAP machines are used for the treatment of sleep apnea and some other breathing disorders, pushing air through the nostrils and into the back of the throat by increasing air pressure, which keeps the airways open and prevents both snoring and lapses in breathing during sleep. They can also be used to help infants breathe when they are born with lungs which are not fully developed.

BiPAP machines use two-level positive airway pressure, meaning they help both with inhaling and, unlike CPAP machines, assist in exhaling as well. They are often set to monitor the breathing of the subject and activate when the user stops breathing or when their breathing decreases below a set number of breaths per minute.

Philips ventilators may be used in an ICU, hospital, nursing home or in-home care setting among individuals who require mechanical assistance to breath, providing life-sustaining treatment.

What are the problems with Philips CPAP foam?

The Philips machine recall was issued after problems were discovered with the Philips PE-PUR sound abatement foam used inside the devices. The Philips CPAP foam problems may include:

• Foam degradation issues may cause black particles or debris to be inhaled or swallowed;
• Foam breakdown may release certain toxic chemicals into the machine air pathway

An estimated 80% of the recalled sleep apnea machines were CPAP and BiPAP devices sold primarily under the DreamStation label. The remaining 20% were mechanical ventilators often used in hospital settings.

In June 2023, the FDA indicated it has received more than 105,000 reports of Philips CPAP device problems, including 385 deaths associated with the sleep apnea machines.

In January 2024, just two days after Philips halted its CPAP device sales in the U.S. following a government agreement, the FDA updated on the rising medical device reports (MDRs) for Philips CPAP devices, with the latest update covering July to September 2023.

This period saw over 7,000 new MDRs, including 111 deaths, related to the malfunctioning PE-PUR foam in the recalled devices. These figures add to a total of over 116,000 MDRs and 561 deaths linked to the recalled Philips breathing devices since April 2021, noting that not all incidents occurred within the reported period.

Can my recalled Philips DreamStation be repaired?

Philips reported that it had received authorization from the FDA to “rework” recalled first-generation DreamStation CPAP devices in September 2021. This will involve removing and replacing the defective foam with a different material. However, it is estimated that repairing or replacing Philips CPAP machines will take up to a year to complete.

In November 2021, the FDA issued an update on the recall and raised concerns about the safety of repaired Philips DreamStation machines, indicating that the new silicone foam used as a replacement for the original polyester-based polyurethane foam may also release volatile organic compounds. In January 2022, the FDA warned that some customers had received the silicone foam in their repaired devices. The agency has ordered Philips to conduct an independent investigation into whether the silicone foam is safe.

Why was a SoClean lawsuit filed against Philips Respironics?

Several months after the DreamStation recall, the manufactures of SoClean filed a lawsuit against Philips over several statements that suggested SoClean and other ozone cleaning products may exacerbate the breakdown of the sound abatement foam in CPAP machines. The lawsuit by SoClean alleges their product is being used as a scapegoat for “inexcusable design flaws” in the Philips sleep apnea machines.

In addition to Philips Respironics CPAP lawsuits, there are now also a number of individuals pursuing a SoClean class action lawsuit, indicating that the SoClean 2 CPAP sanitizing machine releases dangerous levels of ozone, which were described as “activated oxygen” in marketing material.

According to allegations raised in the SoClean lawsuit against Philips, the CPAP sanitizing device is not responsible for the breakdown of the DreamStation sound abatement foam. Rather, SoClean maintains that an unreasonably dangerous and defective CPAP machine design is to blame, including:

• Use of a polyester-based polyester foam material known to break down and release toxic chemicals;
• Design decisions that placed the sound abatement foam directly in the sleep apnea machine’s air pathways, causing particles and gasses to immediately flow into the mouth and lungs of users;
• Delaying a Philips DreamStation recall for years after first learning that the foam was degrading and posing a direct health risk for users.

How long did Philips Respironics know the CPAP machines were dangerous?

An FDA inspection report (PDF) released in November 2021 suggested that Philips Respironics knew about the CPAP machine dangers for years before taking any action to recall the sleep apnea machines. A ProPublica report  published in September 2023 indicates the manufacturer knew, or should have known, about the problems with the sound abatement foam 11 years before the recall was announced.

Since 2008, the FDA identified at least 222,000 complaints involving keywords that suggested problems with foam deteriorating and releasing black particles or debris into the machine airways.

A number of internal emails with a raw foam supplier beginning in October 2015 confirmed that Philips Respironics was aware of the CPAP foam dangers, yet the company failed to investigate the problems, issue any warnings or recall the sleep apnea machines until 2021.

As late as March 2022, the FDA warned that Philips had failed to adequately notify owners of the recalled CPAP machines of the health risks linked to the sound abatement foam. Philips executives have also indicated that the Department of Justice has launched an investigation into the recalls.

Health Risks from Philips Respironics Breathing Machines

Since the recall, a growing number of CPAP health issues have been reported to the FDA by users who found black debris or particles in CPAP masks tubing and headgear, reporting symptoms of:

• Headache (often referred to as “CPAP Headaches”)
• Upper Airway Irritation
• Persistent Cough
• Irritation in the eyes, nose or respiratory tract
• Hypersensitivity
• Asthma
• Nausea and Vomiting

These toxic particles have also been found to contain several carcinogenic chemicals and gasses, raising concerns that side effects of the Philips CPAP machines may cause several cancers, including:

• Laryngeal cancer
• Oropharyngeal Cancer
• Nasopharyngeal Cancer
• Hypopharyngeal cancer
• Sinonasal Cancer (Nasal Cancer or Sinus Cancer)
• Thyroid Cancer
• Liver Cancer
• Kidney Cancer
• Lung Cancer
• Prostate Cancer
• Breast Cancer
• Acute Myeloid Leukemia (AML)
• Multiple Myeloma
• Non-Hodgkin’s Lymphoma (NHL)

Breathing the foam particles and chemicals may also cause various forms of long-term lung damage and respiratory injuries, including:

• Pulmonary fibrosis
• Interstitial Lung Disease (ILD)
• Sarcoidosis
• Pneumoconiosis
• Chronic/Severe Asthma
• Chronic Bronchitis
• Recurrent Pneumonia

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Philip CPAP Cancer and Injury Lawsuit Settlements

In April 2024, Philips Respironics agreed to a $1.1 billion CPAP settlement for certain cancers, injuries and medical monitoring claims linked to their recalled CPAP, BiPAP, and ventilator machines. This settlement resolves most, if not all, of the lawsuits filed over the following injuries experienced by recalled device users:

• Acute myeloid leukemia (AML)
• Acute respiratory distress syndrome
• Bronchiectasis
• Certain esophageal cancers
• Certain thyroid cancers
• Chronic bronchitis
• Chronic myeloid leukemia (CML)
• Hypopharynx cancer
• Larynx cancer
• Lung cancer
• Mucosa associated lymphoid tissue (MALT)
• Nasal cavity/sinus cancer
• Nasopharynx cancer
• New or worsening asthma
• New or worsening COPD
• Oral cavity cancers
• Other interstitial lung disease
• Obstructive or restrictive lung disease
• Oropharynx cancer
• Pneumonitis
• Pulmonary fibrosis
• Reactive airways dysfunction syndrome
• Salivary cancer
• Sarcoidosis

Philips CPAP Class Action Settlement Terms

A Philips CPAP lawsuit settlement for economic damages was reached by the parties on September 7, 2023. According to the motion filed with the U.S. District Judge presiding over the Philips CPAP litigation, Philips has agreed to pay a minimum of $445 million to individuals who bought, rented or leased one of the recalled CPAP or BiPAP devices, and another $34 million to health insurance companies and others who paid to reimburse users to replace the machines.

The parties involved in the Philips CPAP litigation filed a motion on September 7, 2023, seeking approval from the U.S. District Judge for a class action settlement agreement aimed at resolving all economic loss claims involving the recalled Philips CPAP, BiPap and ventilator machines.

Under the terms of the proposed settlement, Philips has agreed to a payment of $445 million to those who purchased, rented, or leased the recalled devices. An additional sum of $34 million is designated for reimbursement to health insurance companies and related entities that bore the costs of replacing the malfunctioning devices.

Class action participants are entitled to specific compensations. For every recalled device returned to Philips, the individual plaintiff will receive $100. Depending on the exact model of their device, they may receive an added compensation, ranging from $50 up to $1,500. Those whose devices were repaired or refurbished by Philips may also be eligible for extended warranty benefits.

According to the terms of the proposed settlement, Philips will be obligated to deposit 25% of the total settlement sum within two weeks following the court’s approval. If the court approves this settlement, it will resolve all economic grievances against Philips related to this matter.

However, it is important to note that this settlement only addresses the economic losses associated with the recalled devices. Thousands of personal injury claims are separately being pursued by individuals claiming the toxic sound abatement foam used in Philips CPAP, BiPap and ventilator machines caused them to develop cancer and other serious injuries. While the parties have reached a settlement for economic damage, lawyers are still actively investigating new Philips CPAP cancer and injury lawsuits.

Philips CPAP Device Payment Awards

The Philips CPAP class action lawsuit settlement has allocated a total of $309,082,312 for the Device Payment Awards. This compensation is set up to reimburse users for their recalled devices.

The compensation will be transferred to the “User Settlement Fund” in two phases: the first phase covers 25% of the total, and it’s due no later than 14 days after the “MDL Court Final Approval.” The second phase, which covers the remaining 75%, will be made by the “Effective Date,” when the agreement’s terms are officially in place.

The amount of compensation for the Device Awards are a fixed amount, and depend on the specific device.

• System One 50 Series ASV4 (Auto SV4): $469.14
• System One 50 Series Base: $69.14
• System One 50 Series BiPAP: $159.46
• System One 60 Series ASV4 (Auto SV4): $424.32
• System One 60 Series Base: $68.24
• System One 60 Series BiPAP: $152.70
• C-series S/T, AVAPS (C-series and C-series HT): $394.37
• DreamStation CPAP: $55.63
• DreamStation ASV: $379.50
• DreamStation ST, AVAPS: $329.05
• DreamStation BiPAP: $130.63
• DreamStation Go: $107.43
• E30: $453.83
• OmniLab Advanced Plus: $165.99
• Trilogy 100/200, Garbin Plus, Aeris LiveVent: $1,552.25
• V30 auto: $67.12

Philips CPAP Device Return Awards

Under the class action settlement, Philips will also establish a $136 million fund that will pay $100 compensation for each returned device. Additionally, Philips has set aside $10 million to reimburse those who replaced recalled devices between June 14, 2021, and September 7, 2023, with an extra $5 million available if necessary. The conditions for this reimbursement are as follows;

• You would have paid for the new device yourself.
• You bought the new device between June 14, 2021, and September 7, 2023
• At the time of your purchase, Philips had not already given you a repaired or fixed version of your recalled device.

Philips’ reimbursement is based on their “Comparable Replacement Devices List”, which pairs each recalled device with an equivalent replacement. If you chose a device not on their list, a “Settlement Administrator” will be appointed to determine its equivalence. If your chosen device is costlier than Philips’ recommended replacement, you may only be refunded the amount of the recommended device.

This brings us to the important part: understanding which devices Philips sees as equivalent replacements.

Philips Comparable Recalled Device List

Here’s a breakdown of the recalled device types and their comparable replacements:

• System One 50 Series ASV4 (Auto SV4): Comparable is ResMed Aircurve 10 ASV
• System One 50 Series Base: Comparable is ResMed Airsense 10, ResMed AirSense 11, React Health Luna II CPAP, React Health Luna G3 CPAP, Philips DreamStation 2
• System One 50 Series BiPAP: Comparable is ResMed Aircurve 10 S, ResMed AirCurve 10 VAuto, React Health Luna G3 BiLevel 25A
• System One 60 Series ASV4 (Auto SV4): Comparable is ResMed Aircurve 10 ASV
• System One 60 Series Base: Comparable is ResMed Airsense 10, ResMed AirSense 11, React Health Luna II CPAP, React Health Luna G3 CPAP, Philips DreamStation 2
• System One 60 Series BiPAP: Comparable is ResMed Aircurve 10 S, ResMed AirCurve 10 VAuto, React Health Luna G3 BiLevel 25A
• C-series S/T, AVAPS (C-series and C-series HT): Comparable is ResMed Aircurve 10 ST, ResMed Aircurve 10 ST-A, React Health Luna II CPAP, React Health Luna G3 BiLevel ST30VT
• DreamStation CPAP: Comparable is ResMed Airsense 10, ResMed AirSense 11, React Health Luna G3 CPAP, Philips DreamStation 2
• DreamStation ASV: Comparable is ResMed Aircurve 10 ASV
• DreamStation ST, AVAPS: Comparable is ResMed Aircurve 10 ST, ResMed Aircurve 10 ST-A, React Health Luna G3 BiLevel ST30VT
• DreamStation BiPAP: Comparable is ResMed Aircurve 10 S, ResMed AirCurve 10 VAuto, React Health Luna G3 BiLevel 25A
• DreamStation Go: Comparable is ResMed AirMini, Z1/Z2 Travel CPAP, Transcend Travel CPAP
• E30: ResMed Astral, Lowenstein LUISA
• OmniLab Advanced Plus: Comparable is ResMed S9 VPAP Tx Lab System
• Trilogy 100/200, Garbin Plus, Aeris LiveVent: Comparable is ResMed Astral 100, React VOCSN
• V30 auto: Comparable is ResMed Astral, ResMed S9 VPAP Tx Lab System

Philips CPAP Payer Awards

The Philips CPAP class action settlement has a specific portion dedicated to “Payer Awards.” This is meant for entities such as insurance companies who may have covered the costs of the devices for their customers. The amount each payer receives will be calculated based on their respective market share. This market share is determined by the number of individuals they insured in the U.S. and the total amount of direct premiums they collected for the years 2021 and 2022.

The settlement has a designated administrator who will use industry data and information from specific forms filled out by the payers to determine this market share percentage. Philips has committed to depositing $34,000,000 into a fund for these Payer Awards.

Philips CPAP Extended Warranties

Within the settlement agreement Philips is offering extended warranties on devices for those who received a “Remanufactured Device” as part of the recall. “Remanufactured” simply means that the device was either fixed or replaced by Philips after the initial recall. Below are the details of the Philips extended warranties;

• Two-Year Warranty for Entirely Different Devices: If you received a replacement device from Philips that has a different serial number than the one you originally had (which was recalled), you’ll get a two-year warranty covering any issues with materials or how it was made.
• Two-Year Warranty for Repaired Devices with the Same Serial Number: If Philips repaired your original device and returned it to you (meaning the serial number hasn’t changed), then you’ll get a two-year warranty. However, this warranty only covers the parts they fixed, not the entire device.

These two-year warranties will start from the date the remanufactured device was either shipped directly to you or when it was set up for you by a medical equipment provider.

Although the Philips CPAP class action settlement agreement has been reached by the parties, the proposed settlement must go through a mandatory procedural step called a “fairness hearing.” This hearing is held to evaluate the terms of the settlement, ensuring that they are fair, adequate, and in the best interest of all class members.

The court must give its approval at the fairness hearing for the settlement terms to be officially finalized and binding. It is expected that a fairness hearing will be held in the coming weeks.

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Philips CPAP Lawyers

Acknowledging the extensive impact and potential adverse effects of the recalled sleep apnea devices, AboutLawsuits has diligently followed the Philips CPAP recalls and litigation updates, and has facilitated connections between countless individuals and experienced lawyers, helping those impacted pursue compensation through a Philips CPAP lawsuit payout.

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