Philips CPAP Recall Lawsuit Attorneys

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. People or loved ones of those who were injured due to a Philips Respironics Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) may be eligible for compensation through a Philips CPAP Recall Lawsuit.

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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

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.”

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

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 21,000 adverse event reports relating to the use of the recalled Philips CPAP devices, including at least 124 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.

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
Trilogy Evo Ventilator
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.

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 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:

Headache
Throat or mucous membrane irritation
Coughing
Lung inflammation
Chest pressure
Sinus infection
Nausea and vomiting
Carcinogenic effects

People who experience symptoms should seek medical assistance. Those who are using a life-supporting ventilator should not discontinue using the device but should seek immediate medical attention.

Philips CPAP Lung Injury Lawsuit

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

Hundreds of federal Philips CPAP Recall Lawsuits have been consolidated into multidistrict litigation (MDL) in the U.S. District Court for the Western District of Pennsylvania.

People who have suffered illnesses or injury after using a Philips CPAP, BiPAP or ventilator breathing device may be eligible for compensation.

Illnesses that have been reported include:

Respiratory:
- Lung damage
- New or worsening asthma
- Pneumonia
- Respiratory failure (such as Acute Respiratory Distress Syndrome (ARDS))
- Pleural effusion
- Reactive Airway Disease (RAD)
Cancer:
- Blood, Lymph Node, and Oral Cancers:
  - Acute Myeloid Leukemia (AML)
  - Blood Cancer
  - Bone Marrow Cancer
  - Esophageal Cancer
  - Hematopoietic Cancer
  - Laryngeal Cancer
  - Leukemia
  - Lymphoma
  - Multiple Myeloma
  - Nasal Cancer
  - Non-Hodgkin’s Lymphoma
  - Soft Palate Cancer
  - Sinus Cancer
  - Throat Cancer
  - Tonsil Cancer
- Thyroid Cancers:
  - Thyroid Cancer
  - Papillary Cancer
- Other Cancers:
  - Kidney Cancer
  - Liver Cancer
  - Lung Cancer
  - Bladder Cancer
Other:
- Severe ear, eye, nose, throat, sinus, oral cavity inflammation and injury including nodules, cysts, and tumors
- Sarcoidosis (particularly of the lungs and/or lymph nodes) that required treatment
- Kidney damage (acute kidney injury or chronic kidney disease)
- Liver damage (acute liver failure or chronic liver disease)

People who were injured after using a Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP) or mechanical ventilator device or who have used one of these devices may be eligible for compensation.

Sources

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.

Philips CPAP Recall Lawsuit Attorneys

Our Role

Case Updates

2/16/23

11/15/22

8/22/22

6/17/22

5/27/22

5/2/22

3/10/22

2/16/22

11/9/21

10/11/21

8/27/21

6/14/21

Our Role

Philips CPAP Breathing Machines Recalled Over Potential Lung Injury

Philips CPAP Recall Upgraded to Class 1

CPAP and BiLevel PAP

Mechanical Ventilators

Philips Recall Recommendations and Concerns

Sound-reducing Foam Liner May Be to Blame

Philips Delayed Action on Degrading Foam in CPAP Devices

Exposure to Degradation of Philips Breathing Machines

Philips CPAP Lung Injury Lawsuit

Sources