Written By : Michelle Llamas
Edited By : Sophia Clifton
This page features 14 Cited Research Articles

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Why Are People Filing CPAP Lawsuits?

People are filing lawsuits because damaged sound abatement foam from millions of recalled Philips CPAP, BiPAP and mechanical ventilator machines could cause serious injuries, including cancer and severe respiratory and inflammatory problems.

Phillips issued a recall for these devices on June 14, 2021, because polyester-based polyurethane (PE-PUR) sound abatement foam may break down in high-temperature and humid environments. Broken-down foam can release black particles and gases that may cause health problems if inhaled or swallowed.

Philips DreamStation CPAP

Most of the recalled sleep apnea devices come from Philips’ DreamStation CPAP machine line. CPAP devices make up 80% of all recalled devices, and 20% are ventilators, Philips spokesman Steve Klink told Reuters.

CPAP lawsuits claim Philips defectively designed these machines and put people at risk of serious health problems. Plaintiffs claim these devices are more dangerous than others available on the market. If you were injured as a result of using a recalled Philips device, you may file a lawsuit for compensation, including: lost wages and future income, pain and suffering, medical bills, future medical care and other damages.

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Side Effects Linked to Recalled CPAP Machines

According to Philips, CPAP side effects from foam particle and gas inhalation or ingestion range from mild symptoms such as headaches to serious side effects such as cancer. People may suffer from a range of inflammatory, toxic and carcinogenic effects.

As of December 31, 2022, the U.S. Food and Drug Administration reported it has received more than 98,000 medical device reports of side effects linked to devices recalled for PE-PUR foam issues. These reports include 346 deaths since April of 2021.

Potential symptoms of foam particle inhalation or ingestion include:
  • Airway irritation and inflammation
  • Asthma
  • Carcinogenic effects (various cancers)
  • Chest pressure
  • Cough
  • Headache
  • Inflammatory response
  • Damage to liver, kidney, lung or other organs
  • Respiratory and sinus infections
  • Skin, eye and respiratory tract irritation
  • Upper airway irritation

In September 2021, Philips announced it would repair or replace recalled machines because of the problematic foam. That process may take up to a year, according to the company. Some people may choose to ask their doctor for CPAP alternatives instead.

On June 28, 2022, Philips provided a research update regarding PE-PUR sound abatement foam testing. Preliminary results show chemical emissions from the foam aren’t expected to cause health problems, the company said. Philips also said machines cleaned with ozone cleaners were 14 times more likely to have foam degradation.

To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.

In January 2022, Philips added Trilogy Evo ventilators and repair kits to the recall list from 2021. In addition, it recalled about 1,660 BiPAP ventilators because of toxic plastic parts.

In October 2022, Philips also recalled more than 18 million magnetic CPAP and BiPAP masks because the magnets could interfere with certain metallic implants such as pacemakers, magnetic denture attachments, bone substitutes and more. The FDA classified the recall as a Class I recall, meaning using these masks could cause serious injury or death.

Why PE-PUR Foam May Cause Side Effects

PE-PUR foam may cause side effects because of the chemicals in the foam. Philips conducted lab tests and found at least five toxic chemicals present in foam particles and gases released from degraded foam. Chemical gases from foam are also called volatile organic compounds, or VOCs.

The company received reports of black particles in the airway circuit of recalled machines. But even if you cannot see particles, the foam may already be releasing harmful chemicals.

Harmful chemicals found during Philips’ lab tests include:
  • Diethylene glycol – a chemical that’s toxic if swallowed and may irritate eyes, mucous membranes and skin.
  • Dimethyl diazene – a potentially toxic, carcinogenic chemical that increases the risk of colon cancer.
  • Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl) – a chemical used to make other chemicals that could be harmful to the environment and aquatic life.
  • Toluene diamine – a chemical that has many health hazards, including: Organ damage, skin problems, cancer, infertility and genetic defects. It’s normally used in dyes, explosives and hydraulic fluid.
  • Toluene diisocyanate – a chemical that can be fatal if inhaled and may cause cancer, eye problems, skin irritation and respiratory problems.

Philips commented, “To date, Philips has received no reports of these types of safety issues alleged to be related to chemical emissions. But toxicological risk assessment indicates that VOCs [volatile organic compounds] levels exceed a safe exposure threshold.”

Who Can File a Philips CPAP Lawsuit?

Anyone under 80 years of age who used a recalled Philips CPAP or other device and suffered health problems, especially respiratory issues and cancers, may qualify for compensation. A number of cancers are associated with VOC exposure.

Injuries accepted in Philips CPAP lawsuits include:
  • Acute Respiratory Distress System (ARDS)
  • Bladder Cancer
  • Brain Cancer
  • Breast Cancer
  • Chemical Poisoning
  • Heart Attack
  • Heart Failure
  • Hematopoietic Cancer
  • Kidney Cancer
  • Kidney/Renal Damage
  • Kidney/Renal Disease
  • Leukemia
  • Liver Cancer
  • Liver Damage
  • Liver Disease
  • Lung Cancer
  • Lung Damage
  • Lung Disease
  • Lymphatic Cancer
  • Multiple Myeloma
  • Nasal Cancer
  • Non-Hodgkin Lymphoma
  • Papillary Carcinoma
  • Pleural Effusion
  • Prostate Cancer
  • Reactive Airway Disease (RAD)
  • Rectal Cancer
  • Respiratory Failure
  • Severe Ear Inflammation
  • Severe Nose Inflammation
  • Severe Throat Inflammation
  • Stomach Cancer
  • Testicular Cancer
  • Thyroid Cancer

There is a time limit called a statute of limitations that can range from two years to four, depending on the state. Make sure you talk to a lawyer right away to preserve your legal right to file.

Status of Philips CPAP Lawsuits

Philips CPAP lawsuits are in the initial stages and lawyers are still accepting cases. There have been no trials or settlement awards yet.

More than 110 cases have been given the green light to be consolidated into a multidistrict lawsuit, or MDL. A special federal panel of seven judges, the Judicial Panel on Multidistrict Litigation, ruled that these consumer class action claims will be handled in Pittsburgh with Senior U.S. District Judge Joy Flowers Conti presiding. The panel also decided to allow the MDL to include personal injury claims.

Please seek the advice of a qualified professional before making decisions about your health or finances.
Last Modified: February 15, 2023

14 Cited Research Articles

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  1. U.S. Food and Drug Administration. (2022, November 22). UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due#mdr
  2. U.S. Food and Drug Administration. (2022, October 19). Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices. retrieved from https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-masks-bipap-cpap-machines-due-safety-issue-magnets-may-affect
  3. U.S. Food and Drug Administration. (2022, August 16). Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due
  4. Park, A. (2022, June 29). Philips attributes foam breakdowns in recalled CPAP ventilators to ozone-based cleaners. Retrieved from https://www.fiercebiotech.com/medtech/philips-reports-foam-breakdown-only-4-recalled-ventilators-linked-formal-complaints
  5. Philips. (2022, June 28). Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program. Retrieved from https://www.philips.com/a-w/about/news/archive/standard/news/press/2022/20220628-philips-provides-update-on-philips-respironics-pe-pur-sound-abatement-foam-test-and-research-program.html
  6. Grzincic, Barbara. (2021, October 11). Judicial Panel Consolidates Philips CPAP, J&J Sunscreen Litigation. Retrieved from https://www.reuters.com/legal/litigation/judicial-panel-consolidates-philips-cpap-jj-sunscreen-litigation-2021-10-11/
  7. U.S. Food and Drug Administration. (2021, June 30). Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. Retrieved from https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks
  8. Philips. (2021, June 14). Sleep and Respiratory Care update: Clinical information for physicians. Retrieved from https://www.philips.com/c-dam/b2bhc/master/landing-pages/src/update/documents/philips-recall-clinical-information-for-physicians-and-providers.pdf
  9. Sterling, T. (2021, June 14). Philips recalls ventilators, sleep apnea machines due to health risks. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/philips-recalls-some-3-4-million-cpap-ventilator-machines-due-foam-part-2021-06-14/
  10. National Library of Medicine. (n.d.). DI(Hydroxyethyl)ether. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/8117
  11. National Library of Medicine. (n.d.). Toluene diisocyanate. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Toluene-diisocyanate
  12. National Library of Medicine. (n.d.). 2,4-Diaminotoluene. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/2_4-Diaminotoluene
  13. National Library of Medicine. (n.d.). Azoxymethane. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Azoxymethane
  14. Philips. (n.d.). Medical Device Recall Notification: Philips Respironics Sleep and Respiratory Care devices. Retrieved from https://www.usa.philips.com/healthcare/e/sleep/communications/src-update