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Philips Recalls Sleep Apnea Machines Over Cancer Risk
Philips Respironics recalled several sleep apnea machines over concerns that people could be inhaling cancer-causing chemicals through a type of foam that’s embedded in the devices, according to an FDA safety communication.
The foam is used to reduce the sounds and vibrations emitted by the devices. According to the FDA, the foam may break down into small particles. These can then be inhaled and lead to short-term and long-term health issues.
Which Philips Devices Were Recalled?
- DreamStation ASV
- DreamStation ST
- SystemOne ASV4
- C Series ASV
- OmniLab Advanced Plus
- SystemOne (Q Series)
- DreamStation CPAP Machines
- DreamStation Auto BIPAP and CPAP machines
- DreamStation BiPAP Sleep Apnea Machines
- DreamStation Go
- Dorma 400
- Dorma 500
- CPAP REMStar SE Auto CPAP
- Trilogy 100 and 200
- Garbin Plus
- Aeris LifeVent
- A-Series BiPAP machine
- Philips Ventilator
Related: Philips Defibrillator Lawsuits
Side Effects / Injuries from Philips CPAP Machine
Philips Respironics has received reports of possible patient impact due to foam degradation in recalled CPAP machines. The potential health risks of particulate exposure in a defective medical device include:
- Chest pressure
- Respiratory issues
- Toxic effects
- Cancer (carcinogenic effects)
- Other health issues
Potential risks of chemical exposure due to medical device off-gassing include:
- Sinus infection
- High blood pressure
- Toxic effects
- Carcinogenic effects
Related Article: Can CPAP Cause Pneumonia? (Risk Factors)
Why is PE-PUR Foam Dangerous?
Intact PE-PUR foam might be relatively harmless, but if the foam breaks down it can release particles and chemical gases, according to Philips. If these particles or gases enter the body through the nose or mouth they can cause a variety of health issues.
“These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage,” the FDA said in its Safety Communication.
Even if there are no visible particles, the foam may already be breaking down and releasing harmful chemicals.
Philips’ lab analysis found degraded foam produced several potentially harmful chemicals, including:
- Toluene diamine - A chemical used to make polyurethane, dyes, hydraulic fluid and sensitizers for explosives. Health hazards include: Genetic defects, skin reactions, toxicity, cancer, damaged fertility and organ damage.
- Toluene diisocyanate - A chemical used to make foams and coatings. Health hazards include: Eye damage, skin irritation, may be fatal if inhaled, respiratory irritation and cancer.
- Diethylene glycol - A chemical used to make other chemicals that can irritate skin, eyes and mucous membranes and may be slightly toxic if swallowed.
- Dimethyl diazene - A chemical used to make other chemicals.
- Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl) - A chemical used to make other chemicals.
Obstructive sleep apnea (OSA) is a sleep disorder that affects your breathing. It occurs from complete or partial blockage of the airway during sleep.
If you have OSA, the soft tissue in the back of your throat relaxes while you sleep and blocks your airway. Your brain can jolt you awake each time that happens in order to restart your breathing.
OSA causes symptoms like:
- Gasping for breath during sleep
- Waking up many times during the night
Along with making you sleepy the next day, OSA can increase your risk of high blood pressure, heart attack, stroke, and depression.
The main treatment for OSA is a continuous positive airway pressure (CPAP) device. This device has a mask that you wear over your nose or your nose and mouth. The machine pushes air through your nose and mouth to keep your airway from collapsing while you sleep.
CPAP machines can improve sleep and mood, and lower blood pressure and other heart disease risks. Despite its effectiveness, more than one-third of people who try CPAP don’t stick with it.
Common reasons for discontinuing use of a CPAP machine is that the device is clunky, uncomfortable, or noisy. In some cases, it doesn’t help with OSA symptoms.
If you’re not happy with CPAP, here are a few other treatment options:
- Use a nasal decongestant, antihistamine, or saline wash to clear up nasal congestion before you go to bed
- Prop up your head on a pillow while you sleep
- Consult your doctor about surgery if you have a deviated septum or another structural problem with your nose
What Should I Do if I'm Using a Recalled Philips CPAP Machine?
Philips is advising patients to discontinue the use of their breathing devices and work with their doctor or medical device 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 Philips devices outweighs the risks identified in the BiPAP and CPAP recall notification.
What Should I Do if I'm Using a Recalled Mechanical Ventilator?
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
On Feb. 27, 2020, the FDA 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 machines 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.
How Much Settlement Compensation for CPAP Lawsuits?
The Philips CPAP litigation is still in its very early stages, so it is still uncertain as to how these Philips CPAP lawsuit claims will play out. Also, the injuries in these claims vary significantly. The most serious CPAP injuries are likely to be cancer, organ damage, and respiratory problems.
For Philips CPAP lawsuits, the average settlement compensation payouts for medical bills should be between $100,000 and $500,000, with the trial value being significantly higher if liability can be established.
Plaintiffs' lawyers are now seeking an MDL class action, asking the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federal court CPAP claims in federal court in Pennsylvania. Philips now concedes that an MDL class action is appropriate, but argues that the cases should be consolidated in Massachusetts.
Can I Sue Philips?
Potentially. If you used a recalled Philips CPAP machine and experienced organ damage or certain types of cancer listed below, you may be eligible to file a Philips CPAP recall lawsuit. Get a free case review today to see if Schmidt & Clark, LLP, can help with your potential case.
Injuries included in potential 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
- 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
What are Obstructive Sleep Apnea Lawsuits Alleging?
The recall of the DreamStation and other Philips CPAP devices has already prompted product liability lawyers to file class action lawsuits for people who used these devices and suffered adverse health consequences. More CPAP recall lawsuits are expected to follow because there is evidence that Philips was fully aware of the health risks and defects associated with the PE-PUR foam and failed to warn consumers.
Philips was aware of the problems with foam inhalation in its sleep apnea machines for years before it issued its recall in June 2021. Users of the recalled sleep apnea machines had been complaining for years about “black particles” in their lungs and similar issues.
Despite being aware of these issues for years, Philips did not make a public safety announcement until April 2021 and the recall didn’t come until June 2021. Even more troubling, Philips appears to have deliberately delayed the timing of its recall to coincide with the release of its “next-generation” sleep apnea products that supposedly do not have the foam inhalation problem.
Questions a CPAP Attorney May Ask
When you contact a lawyer about your potential Philips CPAP injury case, they may ask you questions about your experience with your CPAP machine. Make sure you gather medical records, medical bills, receipts and any other documents to answer questions with as much detail as possible.
Which Philips sleep apnea machine did you use?
This litigation involves breathing devices included in the Philips CPAP recall. Make sure you know the brand and model of your machine. If you aren’t sure if your breathing machine is a recalled Philips CPAP, BiPAP or ventilator, the attorney can help you figure it out.
Did you keep your recalled CPAP machine?
It’s important to keep your recalled Philips machine for evidence in a potential case. Your lawyer can help you keep the machine if your supplier is asking you to return it.
What serious injuries are you experiencing from your CPAP device?
Tell the lawyer about any serious Philips CPAP side effects your doctor diagnosed you with, especially serious breathing problems, organ damage or cancer. Have your medical records handy to answer questions.
Related Article: Cancer Risks of CPAP Machines
What symptoms did you experience?
Your lawyer will want to know if you experience any symptoms related to inhaling particles of toxic gas from sound abatement foam. This may include breathing problems, headaches, dizziness or other medical problems.
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.
"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 Respironics DreamStation Recall 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 a DreamStation Lawsuit. We are handling individual litigation nationwide and currently accepting new 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.