Product Liability Philips CPAP Lawsuit

Philips CPAP Lawsuit

Philips Respironics has issued a recall for some of its CPAP, BiPAP, and mechanical ventilator devices after potential health risks related to lung injury have been identified.

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Last updated: May 15, 2024

Firm News

May 9, 2024

Seeger Weiss Reaches $1.1 Billion Personal Injury and Medical Monitoring Settlement in Philips CPAPs, Bi-PAPs, and Ventilators Litigation

Seeger Weiss founder and court-appointed co-lead counsel Chris Seeger secured a nearly $1.1 billion settlement in the Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation. The agreement provides $1.075 billion to compensate patients who suffered injuries while using recalled Philips devices and also includes $25 million to cover the cost of medical monitoring […]

April 26, 2024

Seeger Weiss Secures Final Approval of Philips CPAP Economic Loss Class Action Settlement

On April 25, 2024, Judge Joy Flowers Conti of the Western District of Pennsylvania granted final approval to the economic loss class action settlement negotiated by Seeger Weiss partner Chris Seeger and his fellow co-lead plaintiffs’ counsel in the Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation. The uncapped settlement provides more than […]

December 15, 2023

Philips Economic Loss Settlement Claims Period Now Open; Millions Eligible for Compensation

The claims filing period for the Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator economic loss class action settlement is now officially open. Claimants including patients and medical providers who purchased, rented, or leased recalled devices, as well as payers who provided reimbursements for those payments are eligible to receive compensation during the claims filing […]

September 7, 2023

Seeger Weiss Announces Settlement with Philips to Resolve Economic Loss Claims for Recalled CPAPs, Bi-PAPs, And Ventilators

Today, Seeger Weiss founding partner Chris Seeger, who serves as co-lead counsel in the Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation, announced a settlement worth a minimum of $479M on behalf of device users who purchased or rented recalled devices and payers who reimbursed users for the cost of recalled devices. “This […]

February 16, 2022

Christopher Seeger appointed co-lead counsel in Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation

Senior United States District Court Judge Joy Flowers Conti has appointed Seeger Weiss LLP founder Christopher A. Seeger to serve as co-lead counsel in the Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation, pending in the Western District of Pennsylvania. Seeger is one of four attorneys, selected from a pool of 75 […]

Case Details

Case Name

In Re: Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation

Case Began

10/11/2021

Case Location

Western District of Pennsylvania

Case Type

Product Liability

Case Number

MDL 3014

Seeger Weiss’s role

Chris Seeger, Co-lead Counsel

Our Role

Seeger Weiss founding partner Chris Seeger was appointed as co-lead counsel by Senior U.S. District Court Judge Joy Flowers Conti in litigation related to the use of Philips CPAP sleep apnea machines and other Philips assisted breathing devices. Seeger Weiss was one of the first law firms to file a lawsuit against Philips regarding the disintegration or outgassing of the foam in these ventilator devices and has since filed more than a dozen cases while representing more than 2,500 people seeking to hold Philips accountable.

Case Updates

4/29/24

Plaintiffs reached a $1.1 billion personal injury and medical monitoring settlement with Philips in the Philips Recalled CPAP, Bi-Level Pap, and Mechanical Ventilator Products Litigation. The agreement provides $1.075 billion to compensate patients who suffered injuries while using recalled Philips devices and also includes $25 million to cover the cost of medical monitoring for potential long-term health risks.
4/25/24

Judge Joy Flowers Conti granted final approval to the economic loss class action settlement negotiated by co-lead plaintiffs counsel. The uncapped settlement provides more than $500 million to plaintiffs who purchased defective Philips CPAP, Bi-PAP, and ventilator devices. About 3 million class members have registered for benefits, and 1.6 million have returned their devices for payment.
4/9/24

In a consent decree reached with Philips, the U.S. Department of Justice required the company to overhaul its American manufacturing and to stop distributing devices until it meets the terms of a consent decree with the government.
3/22/24

According to a recent filing out of more than 5 million class members who received direct notice, more than 99.9% of eligible claimants participated in the settlement. The settlement provides substantial monetary benefits to eligible claimants. Under the agreement, Philips will pay at least $501.5 million into a user and payer settlement fund and up to $15 million in device replacement awards to eligible users. Philips is providing two-year extended warranties on all devices provided to patients as part of the recall. The more than 1.5 million users who registered for the recall or returned their devices to Philips will receive automatic device payments and device return awards without having to apply.
1/29/24

Philips announced a consent decree with the FDA and the Department of Justice regarding its recall of millions of defective CPAPs, Bi-PAPs, and ventilators. As part of the settlement, Philips agreed to cease selling its respiratory care devices in the US until it fulfills the terms of the decree.
1/24/24

As of January 24, 2024, 679 personal injury cases have been filed in the IN RE: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation.
1/17/24

The Government Accountability Office (GAO) initiated an investigation into the FDA’s oversight of Medical Device recalls based on a letter sent by U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Richard Blumenthal (D-CT). This investigation follows the reporting from the Pittsburgh Post-Gazette and ProPublica on the 2021 recall of Philips breathing machines and evidence the company received reports about issues with the sound-reducing foam for years prior to the recall.
12/11/23

Today, lead plaintiffs’ counsel in the Philips multidistrict litigation announced the opening of the claims filing period, which runs from December 11, 2023, through August 9, 2024. The uncapped settlement, which is prefunded with $479 million, fully resolves economic loss claims stemming from Philips’ recall of 10.8 million CPAP, BiPAP, and mechanical ventilator devices sold in the United States from 2008-2021. To check eligibility and obtain instructions on the necessary steps to receive a payment, please visit the official settlement website: https://www.respironicscpap-elsettlement.com/.
9/7/23

Seeger Weiss founding partner Chris Seeger, who serves as co-lead counsel in the Philips Recalled CPAP, Bi-PAP, and Mechanical Ventilator Litigation, announced an uncapped settlement worth a minimum of $479M to resolve economic loss claims of users and payers impacted by the recall. Seeger Weiss will continue to pursue personal injury and medical monitoring claims on behalf of its clients.
2/16/23

As of February 16, 2023, two class action complaints and more than 420 individual lawsuits alleging physical injury have been filed in In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation.
11/15/22

The New York Times reported the United States Department of Justice is negotiating a consent decree with Philips related to its conduct surrounding the recall.
8/22/22

Attorneys representing plaintiffs filed a class action complaint for medical monitoring and a master personal injury complaint. Plaintiffs are seeking to have Philips cover the cost of medical monitoring for patients who used the recalled devices. In addition, those with injuries allegedly caused by Philips’ recalled devices now have a set of common facts and claims for suing the company.
6/17/22

Attorneys representing plaintiffs filed a class action complaint for economic losses. The complaint alleges Philips knew of PE-PUR foam degradation issues with the recalled for years but continued to sell these devices and advertise them as safe while doing nothing to fix the problem. Plaintiffs allege the company failed to disclose the dangerous defect in its devices or remove them from the market until it initiated the recall in June 2021. The complaint seeks Plaintiffs to recover economic losses and punitive damages from Philips.
5/27/22

Email correspondence between Philips and a supplier about foam degradation was filed on the court docket. The documents show Philips knew about foam degradation issues with the recalled devices no later than 2015, but did not recall affected products until 2021.
5/2/22

The FDA issued a 518(b) notice, proposing a requirement for Philip to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices. In the notice, the FDA said there is sufficient evidence to determine “that the risk associated with the devices was not caused by the failure of a person other than Philips to exercise due care in the installation, maintenance, repair, or use of the devices at issue.”
3/10/22

The FDA issued a 518(a) notification order to Philips because of the company’s “failure to timely provide effective notice” of the recall. Philips was ordered to notify people of the “unreasonable risk of substantial harm to the public health” posed by the foam degradation within 45 days.
2/16/22

Senior U.S. District Court Judge Joy Flowers Conti appointed Seeger Weiss LLP founder Chris Seeger to serve as co-lead counsel in the Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation. Seeger is one of four attorneys, selected from a pool of 75 applicants, to lead the litigation. He has led some of the most complex, groundbreaking, and high-profile litigations in U.S. history, including National Prescription Opioid Litigation, 3M Combat Arms Earplug Products Liability Litigation, and National Football League Players’ Concussion Injury Litigation.
11/9/21

The FDA released an inspection report of Philips’ Murrysville, Pennsylvania manufacturing facility. The report concluded that Philips knew about the foam degradation issues since 2015, but failed to properly conduct a health hazard evaluation, a risk analysis, or a design review prior to the recall.
10/11/21

The Judicial Panel on Multidistrict Litigation (JPML) granted a motion to consolidate lawsuits against medical device manufacturer Philips over its CPAP, Bi-Level PAP and mechanical ventilator recall before Senior U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania. Centralization will help streamline the process of discovery and key legal motions before trials.
8/27/21

Seeger Weiss filed a class action lawsuit on behalf of Edward Haddix and other similarly situated assisted breathing machine users against Philips. The complaint alleged that Philips designed, manufactured, marketed, advertised, distributed, and sold dangerously defective apnea and breathing devices to consumers nationwide, despite knowing that the foam in these devices could disintegrate or outgas, resulting in serious injuries.
6/14/21

Philips issued a recall for its Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP), and mechanical ventilator devices over serious health risks caused by foam liners used in the design and manufacture of the recalled products. The company admitted that the foam may disintegrate or outgas, resulting in inhalation of toxic contaminants and chemicals, which may increase the chance of lung injury and may also increase the risk of cancer. The U.S. Food and Drug Administration Class I recall indicates the products have the potential to cause “serious adverse health consequences or death.”

FAQ

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Philips CPAP Lung Injury Lawsuit

Philips is facing hundreds of CPAP lawsuits for injuries or deaths due to degradation of the foam liner and outgassing of toxic chemicals in their breathing machines. In addition, the company may be responsible for the replacement of millions of devices which may place users at increased risk of injury or illness.

As of October 2023, over 700 Philips CPAP Lawsuits have been consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Western District of Pennsylvania. Bellwether trials are expected to begin in 2025. Other cases have been filed in both federal and state courts and more are expected to be filed in the near future.

In September 2023, Seeger Weiss partner Chris Seeger announced an uncapped settlement with Philips to resolve economic loss claims. The settlement provides a minimum of $479 million for people and payors who were financially harmed by the recall. Separately, Philips has also been ordered to pay $62 million to resolve allegations by the Securities and Exchange Commission (SEC).

Illnesses that have been reported include:

Respiratory:
- New Onset COPD
- New Onset Asthma
- Pulmonary fibrosis
- Sarcoidosis
- Pneumonitis
- ARDS
- RADS (Reactive Airway Disease)
- Bronchiectasis
- Bronchiolitis Obliterans
- Bronchitis
- Emphysema
Cancer:
- Lung Cancer
- Nasal Cancer
- Soft Palate Cancer
- Sinus Cancer
- Throat Cancer
- Tonsil Cancer

Philips CPAP Breathing Machines Recalled Over Potential Lung Injury

Millions of Philips Respironics breathing machines have been recalled due to a potential risk of lung injury. Phillips has issued a recall for Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices over concerns that the polyester-based polyurethane foam liners may disintegrate or outgas. This may potentially result in inhalation of contaminants and/or toxic chemicals, increasing the risk of cancer or serious respiratory illness.

The FDA has received over 98,000 adverse event reports relating to the use of the recalled Philips CPAP devices, including at least 346 deaths. Philips may be facing numerous Philips CPAP recall lawsuits filed by people who experienced injury or cancer after using a Philips sleep apnea CPAP, Bi-level PAP, or mechanical ventilator.

Philips CPAP Recall Upgraded to Class 1

Philips Respironics issued an April 2021 voluntary recall of some Philips Sleep Apnea Devices. The recall notification was amended as a safety notification in June 2021 and further in July 2021 to a Class 1 recall, indicating that the product may cause serious injury or death. In January 2022, the FDA announced that additional ventilators and ventilator repair kits were added to the recall list.

The recall involves millions of Philips sleep apnea and ventilator machines, most of which are of the DreamStation, first-generation production line and are within the 5-year service life. The recall has been issued for machines which contain a sound-abatement foam comprised of polyester-based polyurethane (PE-PUR) which may degrade to release particles and chemicals that may be inhaled.

Philips estimates that up to 4 million devices may be affected and has constrained the recall to the U.S. market. As of July 2023, two years after the recall, hundreds of thousands of patients had not received replacement devices as a result of a shortage. The company has stated that the shortage could last until the end of 2023.

Recalled Philips Devices Include:

CPAP and BiLevel PAP

Continuous Ventilator, Non-life Supporting

DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C Series ASV, S/T, AVAPS
OmniLab Advanced Plus In-Lab Titration Device

Non-continuous Ventilator

SystemOne Q series
DreamStation CPAP, Auto CPAP, BiPAP
DreamStation Go CPAP, APAP
Dorma 400, 500 CPAP
REMStar SE AutoCPAP

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

E30 (Under Emergency Use Authorization)

Mechanical Ventilators

Continuous Ventilator

Trilogy 100Ventilator
Trilogy 200Ventilator
Garbin Plus, Aeris, LifeVentVentilator

Continuous Ventilator, Minimum Ventilatory Support, Facility Use

A-Series BiPAP V30 AutoVentilator

Repair Kit

Trilogy Evo repair kit

Philips Recall Recommendations and Concerns

The FDA safety and recall notification for Philips breathing machines includes instructions on when to discontinue using the devices. People using non-life supporting devices such as CPAP are advised to discontinue using their machines and consult with their physician. Those using life-supporting ventilators should not stop using them but should immediately seek medical assistance.

In September 2021, Philips issued notification that it had received approval from the FDA to replace the troublesome foam lining or replace devices with new models. On November 12, 2021, however, the FDA issued another notification indicating that silicone foam used in replacement devices may also pose a safety risk. The Agency is requiring the company to submit independent testing of the replacement phone.

The FDA has also expressed concern that the problems may be more severe than has been recently represented by Philips. Some documents suggest that testing may have only been done on new devices, when many of the Philips CPAP devices in use are actually refurbished devices which may be subject to greater degradation.

Though the company has intended to replace recalled devices, many patients have had trouble obtaining replacements due to a shortage created by the recall and other issues including supply chain issues during COVID-19. Others have complained of trouble with a burning smell in the replacement devices.

Sound-reducing Foam Liner May Be to Blame

The June 2021 voluntary Philips Respironics CPAP and ventilator recall was issued due to a possibility of increased risk of airway contamination or inhalation of particles or chemicals. The recall was later upgrade to an FDA Class 1 recall, due to serious risk of injury or death. The effects on the user may include lung injury, chemical exposure, and an increase in cancer risk.

Risks of lung injury and cancer are related to polyester-based polyurethane (PE-PUR) foam which is a sound-abatement foam component of certain models of the devices. PE-PUR foam may degrade into particles, entering into the device air pathway, to be inhaled or ingested. In addition, the foam may also be prone to “off-gas” chemicals which may be toxic.

Devices which are more than three years old are more likely to have foam degradation. Philips has stated that degradation and outgassing may also be worsened by the use of unapproved cleaning methods including high heat, high humidity, and ozone cleaning environments.

Once company, SoClean, has disputed claims by Philips that ozone cleaning methods are to blame and has filed a lawsuit against Philips for false and misleading statements.

Philips Delayed Action on Degrading Foam in CPAP Devices

According to discovery documents for Philips CPAP Recall Lawsuits, internal communications show that the company may have known about the potential risks of the devices as early as 2015. In April 2018, three years before the first recall, a Philips engineering employee contacted the supplier of the foam used in the devices. Emails and customer reports show concerns over foam degradation and shedding, and the potential for inhalation of shed particles.

Philips has also been accused of making misleading statements about another device maker, SoClean over its ozone cleaning devices used on CPAP machines. SoClean filed a federal lawsuit against Philips in October 2021. The lawsuit claims that Philips misled the public by placing blame for foam degradation on SoClean’s ozone cleaning product to distract from flaws inherent in the Philips breathing machines. The complaint was amended in December 2021, to include information from FDA inspection of Philips manufacturing which showed that Philips had known about the foam degradation issues.

Exposure to Degradation of Philips Breathing Machines

The potential degradation of PE-PUR foam in Philips CPAP breathing devices and ventilators may lead to inhalation of degradation products, particles, and toxic chemicals. This may increase the chance of lung injury and may also increase the risk of cancer.

Symptoms of exposure may include: