Update: Philips CPAP Class-Action Lawsuit Filed in Massachusetts
A class-action lawsuit has been filed in Massachusetts alleging that Philips knew about the risks associated with the inhalation/ingestion of polyester-based polyurethane (PE-PUR) foam from its CPAP and BiPAP machines long before last month's recall.
The complaint further alleges that patients who used the recalled sleep apnea machines have complained to Philips about black particles in their machines for years, but the company did not warn the public about the hazards until late April and did not recall its machines until June 14.
What's the Problem?
The Philips ventilator machine and CPAP recall was initiated to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in the recalled Philips devices, according to the U.S. Food and Drug Administration (FDA) .
"Despite a low complaint rate (0.03% in 2020), Philips determined based on testing that there are possible risks to users related to this type of foam," FDA said. "The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. The foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone, and high heat and high humidity environments may also contribute to foam degradation."
CPAP devices are breathing machines that help treat sleep apnea symptoms, and they are prescribed to patients with obstructive sleep apnea to keep their airways open during sleep. A ventilator machine moves air in and out of a patient’s lungs, and it is used when a person is not able to breathe enough on their own.
Health Risks of Continuous Positive Airway Pressure Machines
Philips has received reports of possible patient impact due to foam degradation in recalled CPAP devices. The potential risks of particulate exposure include:
- Respiratory issues
- Toxic effects
- Cancer or other carcinogenic effects
Potential risks of chemical exposure due to off-gassing include:
- Toxic effects
- Carcinogenic effects
Instructions for Patients Using Recalled Philips BiLevel PAP and CPAP
Philips is advising patients to discontinue the use of their breathing machines and work with their doctor or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment.
Patients who need to continue using their device and have no alternative should consult their physician to determine if the benefit of continuing therapy with the recalled breathing machines outweighs the risks identified in the BiPAP and CPAP recall notification.
Instructions for Patients Using Recalled Life-Sustaining Mechanical Ventilator Devices
Patients who require life-sustaining mechanical ventilator devices should continue to use Philips breathing machines until they talk to their doctor about alternative treatment options.
In situations where alternatives are unavailable, the benefit of continued usage of the mechanical ventilator machines may outweigh the risks identified in the recall notification.
Risks of Using Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines
The FDA, on Feb. 27, 2020, issued a warning  about the risks associated with using ozone gas or ultraviolet (UV) light products that claim to clean, sanitize, or disinfect CPAP machines and accessories.
"The FDA has received reports from patients experiencing cough, difficulty breathing, nasal irritation, headaches, asthma attacks, and other breathing complaints when ozone gas-based products were used to clean, sanitize or disinfect CPAP devices and accessories," the agency said.
UV light may be used to disinfect surfaces in a setting where UV light does not escape to the surroundings. If products generating UV light do not shield the user from exposure, they pose a potential health hazard depending on the wavelength, intensity, and exposure time.
Repair and Replacement Program
Philips will replace the current sound abatement foam on affected devices with new material as quickly as possible, FDA said.
As part of the Repair and Replacement Program, the first-generation DreamStation CPAP and BiPAP product families will be modified with a different sound abatement foam and shipped upon receipt of the required regulatory clearances.
Philips’s next-generation CPAP platform, DreamStation 2, is not affected by this recall. To support the Repair and Replacement Program, Philips is increasing the production of its second-generation DreamStation CPAP and BiPAP devices, which are currently available for sale in the U.S.
This recall began on June 15, 2021.
Other CPAP Recalls
Fisher and Paykel CPAP Nasal Prong: May 23, 2014 - Fisher and Paykel issued an FDA Class I Recall for its Fisher & Paykel CPAP Infant Nasal Prong medical devices after the company received at least 24 reports of the prongs detaching from the nasal tubing during use. When this occurs, therapy is likely to be interrupted, leading to an increased risk of low blood oxygen (hypoxemia).
"The detached prongs may enter the baby’s mouth, causing choking and/or airway obstruction," FDA said. "Use of this device may cause life-threatening health complications, including death."
Other resources: Medical Devices Lawsuits
Get a Free Philips CPAP Machine Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in CPAP Machine Lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
If you or a loved one was injured by a recalled Philips CPAP machine or Philips mechanical ventilator device, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit, and our lawyers can help you receive fair compensation.