Update on Philips CPAP, BiPAP and Ventilator Recall : Investigation Reveals Cancer-Causing & Toxic Chemicals Inhaled by Users

Philips RS North America, LLC (d/b/a “Respironics, Inc.”) manufactures devices that help people who suffer from breathing problems, like chronic sleep apnea, to breathe while they are sleeping. The CPAP and BiPAP machines both help move air in a person’s airway during sleep. Otherwise, people with chronic sleep apnea can suffer from episodes where they stop breathing for short periods of time, sometimes several times, during the night. This condition causes anything from fatigue and difficulty concentrating to severe health problems and even death. People who use these machines need them for safety and quality of life.

On June 14, 2021, Philips announced it was recalling many of its devices because they use dangerous PE-PUR foam that poses serious health risks to CPAP, BiPAP and mechanical ventilator users.

Problems with Philips CPAP, BiPAP and Mechanical Ventilator Machines

The defective machines all use a type of polyester polyurethane (“PE-PUR”) foam that make the machines quieter while they work. It turns out that this foam breaks down over time and releases toxic particles and gases directly into the user’s airways. These tiny pieces of toxic foam can be so small they may not be visible to the eye, but they can build up in the user’s lungs and airway.

According to the FDA’s recent investigation, Philips knew that there were complaints about this foam breaking down as far back as 2008. Philips did not investigate the problems, fix the problems, or tell its consumers that they were breathing hazardous chemicals.

The FDA recently reported that Philips received as many as 222,000 complaints about the foam from 2008-2017. Philips’ foam supplier warned about the foam’s problems starting in October 2015, but Philips did nothing. Philips later received at least fourteen warnings, assessments, and test reports that the degrading foam was releasing toxic “Volatile Organic Compounds” (“VOCs”) starting in April 2016.

Philips did not tell the public when it knew in 2020 –almost a year before the recall– that the compounds released by its PE-PUR foam were the type that cause cancer, are toxic and could lead to cell mutations in its users. A Philips report in 2020 said “risks from exposure to degraded PE-PUR foam are of concern and the severity of harm is crucial with respect to . . . patient populations . . ..” Another 2020 Philips report found that the degraded foam was a “significant biological risk to those patient populations who are exposed to degraded PE-PUR foam.”

Recalled Devices

  • A-Series BiPAP A30
  • A-Series BiPAP A40 (ventilator)
  • A-Series BiPAP Hybrid A30
  • A-Series BiPAP V30 Auto (ventilator)
  • C-Series ASV (ventilator)
  • C-Series S/T and AVAPS
  • DreamStation
  • DreamStation ASV
  • DreamStation Go
  • DreamStation ST, AVAPS
  • Dorma 400
  • Dorma 500
  • E30
  • Garbin Plus, Aeris, LifeVent (ventilator
  • OmniLab Advanced+
  • REMstar SE Auto
  • SystemOne ASV4
  • SystemOne (Q-Series)
  • Trilogy 100 (ventilator)
  • Trilogy 200 (ventilator)

Added January 2022:

  • Trilogy Evo ventilator
  • Repair kits for Trilogy Evo muffler assembly*

Injuries

The FDA and others have warned that exposure to this degraded PE-PUR foam can cause:

  • Irritation to the skin, eyes, nose and airways
  • Inflammation
  • Headache
  • Asthma
  • Injuries to organs such as kidneys or liver
  • Cancer in organs such as the kidneys or liver
  • Dizziness
  • Injury to the respiratory system
  • Other cancers, including of the respiratory system

Status of Litigation

In October 2021, the Judicial Panel on Multi-District Litigation (“MDL”) transferred all Philips CPAP, BiPAP and mechanical ventilator lawsuits to the United States District Court for the Western District of Pennsylvania, MDL No. 3014.

Manufacturers

Philips RS North America, LLC (d/b/a “Respironics, Inc.”), WM. T. Burnett Foam, LLC

If you or your loved one used a Philips Respironics device and developed lung injuries, respiratory injuries, or cancer, you may be able to participate in this case. Buchanan Law Firm, LLC is working with attorneys nationwide to bring justice to our clients in this case. You do not need to be located in New Mexico. Call 505-900-3559 if you have any questions. Time is limited to file claims.