CPAP Injuries

Minneapolis CPAP Injury Attorneys

Defective CPAP Machine Lawsuits

On June 14, 2021, Philips announced the recall of millions of ventilators, BiPAP, and CPAP machines due to the degradation of its polyester-based polyurethane (PE-PUR) noise-canceling foam. The PE-PUR foam was found to disintegrate into particles that can enter the device’s air pathway and be inhaled and ingested by users. The foam may also release dangerous gas chemicals. Inhalation of the foam particles or gas chemicals is linked to serious injuries, including cancer.

Injuries linked to the defective CPAP machines include:

  • Esophageal cancer
  • Liver cancer or failure
  • Lung cancer
  • Kidney cancer or failure
  • Pulmonary fibrosis
  • Lymph node cancer
  • Nasal or paranasal cancer
  • Sinus cancer
  • Tonsil cancer
  • Respiratory system damage or failure
  • Heart attack and complications
  • And others

Do I Have a Philips CPAP Lawsuit?

GoldenbergLaw is currently hearing from and representing individuals who have used a recalled Philips CPAP, BiPAP, or ventilator device for at least 6 months and have been diagnosed with one of the injuries listed above. If you have received a recall letter for your Philips CPAP machine and experienced one of these injuries, you may be eligible for a Philips CPAP machine recall lawsuit. Our Minnesota attorneys have more than 35 years of experience helping victims of defective medical devices recover the compensation they deserve.

Contact us today for a free Philips CPAP lawsuit consultation.

Devices Impacted by Philips CPAP Recall

It is estimated that more than 15 million devices globally are impacted by the Philips recall with 80% of those devices being sleep apnea machines and 20% being mechanical ventilators. An unknown but assumedly high percentage of the devices were sold in the United States. The full list of affected devices by the CPAP Recall can be found below.

Recalled Philips CPAP & BiPAP Machines

The long and varied list of recalled Philips CPAP machinesincludes:

  • Continuous ventilator, minimum ventilatory support, and facility use devices:
  • Continuous ventilator and non-life supporting:
    • DreamStation ASV
    • DreamStation ST, AVAPS
    • SystemOne ASV4
    • C-Series ASV
    • C-Series S/T and AVAPS
    • OmniLab Advanced+
    • A-Series BiPAP A40
    • A-Series BiPAP A30
  • Continuous ventilator:
    • Trilogy 100
    • Trilogy 200
    • Garbin Plus, Aeris, LifeVent
  • Noncontinuous ventilator:
    • SystemOne (Q-Series)
    • DreamStation
    • DreamStation Go
    • Dorma 400
    • Dorma 500
    • REMstar SE Auto

How Do CPAP & BiPAP Machines Work?

Sleep apnea occurs when the upper airway is blocked during sleep, which reduces or stops airflow. Continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines are used to restore airflow by pumping air through a tube into a mask worn by a person suffering from sleep apnea. Sleep apnea is an extremely common condition, especially among older adults. The risk for sleep apnea increases with age, and it’s estimated that sleep apnea may affect between 38% to 68% of adults over 60.

What is PE-PUR?

The polyester-based polyurethane (PE-PUR) sound abatement foam is used to reduce the machine’s sound and vibration. However, Philips discovered and the FDA warned that the foam can degrade into particles that can enter the device’s air pathway and be ingested or inhaled by the user. The degraded foam may expose users to toxic chemicals. Exposure to the degraded particles or chemicals can be toxic and potentially cause cancer.

What are the Risks Associated with PE-PUR Exposure?

Health risks linked to exposure to degraded foam and related chemical emissions include:

  • Skin, eyes, and respiratory tract irritation
  • Inflammatory response
  • Headaches
  • Asthma
  • Kidney and liver damage
  • Certain cancers

Should I Keep My Recalled Device?

If you have been notified that your BiPAP or CPAP device has been recalled, you should stop using your device and consult your healthcare provider to discuss alternative treatment devices, as directed by the FDA. If you have been notified that your ventilator device has been recalled, you should consult your healthcare provider. If you have used your recalled Philips CPAP, BiPAP, or ventilator device for at least one year and been diagnosed with one of the cancers or injuries linked to the PE-PUR foam inhalation, you may have a claim against Philips. Therefore, you should keep your device to be preserved as evidence in your potential lawsuit.

FDA Investigation

In August 2021, the FDA announced that an investigation of the Philips recall concluded that Philips likely knew of the PE-PUR foam degradation problems as early as 2016. The FDA uncovered over 220,000 customer complaints, more than 100 relating to PE-PUR foam disintegration. The investigation documented at least 14 instances, assessments, and test reports internally produced by Philips between 2016 and 2021 that corroborated the issues with the faulty PE-PUR foam. Further, the FDA determined that Philips failed to conduct an adequate risk analysis or take proper corrective action once it learned of the risks of degradation.

On March 10, 2022, the FDA required Philips to notify all patients and any other relevant parties of the ventilator, CPAP, and BiPAP recall. The agency stated that this requirement was “necessary to eliminate the unreasonable risk of harm posed by the recalled products because the company's notification efforts to date have been inadequate.”

Call GoldenbergLaw Today

The Minneapolis CPAP recall attorneys at GoldenbergLaw are currently investigating cases where an individual has been diagnosed with cancer or injuries linked to the inhalation of foam from a recalled Philips CPAP device. The more people we hear from, the stronger each case becomes as more usable and related evidence is uncovered. Please do not hesitate to reach out and let us know what happened.

Contact us today at (800) 504-0281 for a free CPAP recall lawsuit consultation.

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