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What's the Problem With the Recalled Dorma CPAP Machines?
In June 2021, Philips recalled CPAP and BiPAP devices [1] because sound polyurethane foam (PE-PUR Foam) in the machines was degrading and causing users to inhale toxic particles. In September 2021, Philips announced an official “repair-and-replace” program for people with recalled CPAP devices. Part of this program involved replacing the problematic PE-PUR Foam with a new, silicone-based alternative foam.
"The polyester-based polyurethane (PE-PUR) polyurethane foam, which is used to reduce sound and vibration in these affected Philips CPAP and BIPAP sleep apnea machines, may break down and potentially enter the device’s air pathway," FDA said. "If this occurs, black debris from the sound abatement foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device."
FDA inspectors recently concluded their investigation into Philips and the CPAP machine recall that impacted millions of devices. The agency looked at internal emails, product testing, and operations reports at Philips to determine what led to the recall.
The inspection found hard evidence that Philips executives knew about the problems with the sound abatement foam “but did not immediately act.” Evidence included emails from 2015 sent by a Philips employee to the foam supplier and “at least 14 tests or assessments” dating back to 2016.
Dorma CPAP BIPAP Injuries / Side Effects
Philips CPAP machine users may experience the following side effects after using recalled sleep apnea machines:
- Headache
- Irritation
- Inflammation
- Chest pressure
- Respiratory issues
- Toxic effects
- Cancer (carcinogenic effects)
- Other health issues
Related Article: Philips CPAP Machine Recall Lawsuit Update
About Philips CPAP and BIPAP Machines
Continuous Positive Airway Pressure (CPAP) therapy is the standard form of treatment for apnea. In Philips CPAP therapy, a CPAP sleep machine delivers positive airflow through a mask over the nose and mouth.
This creates enough inward pressure to prevent the person’s airway from collapsing during breathing at night. Other types of machines include Bilevel Positive Airway Pressure (BiPAP) and Automatic Positive Airway Pressure (APAP) machines.
Philips CPAP machines are continuous positive air pressure treatments. The positive air pressure keeps the airway open and assists the patient with breathing.
CPAP machines include the use of a mask over the nose and mouth while the patient sleeps. CPAP treatment forces air into the airway when there is an obstruction and prevents respiratory depression.
Demand for CPAP machines has risen dramatically in recent years. Not surprisingly, Covid-19 sparked greater demand for CPAP machines. Philips Respironics brought in $6 billion in revenue in 2020 for CPAP sales.
Philips CPAP machines generally work as intended. This machine is the standard treatment option and can often reverse the consequences of the condition.
Related Article: Philips Defibrillator Recall
What is Sleep Apnea?
Sleep apnea is a serious sleep disorder that occurs when a person's breathing is interrupted during sleep. People with untreated sleep apnea stop breathing repeatedly during their sleep, sometimes hundreds of times throughout the course of the night.
If it’s not treated, the condition can cause a number of health problems, including hypertension (high blood pressure), stroke, cardiomyopathy (enlargement of the muscle tissue of the heart), heart failure, diabetes, and heart attacks. Untreated sleep apnea can also be responsible for job impairment, work-related accidents, and motor vehicle crashes, as well as underachievement in school in children and adolescents.
There are two types of sleep apnea:
1. Obstructive Sleep Apnea
Obstructive sleep apnea occurs as repetitive episodes of complete or partial upper airway blockage during sleep. During an apneic episode, the diaphragm and chest muscles work harder as the pressure increases to open the airway. Breathing usually resumes with a loud gasp or body jerk. These episodes can interfere with sound sleep, reduce the flow of oxygen to vital organs, and cause heart rhythm irregularities.
2. Central Sleep Apnea
In central sleep apnea, the airway is not blocked but the brain fails to signal the muscles to breathe due to instability in the respiratory control center. Central apnea is related to the function of the central nervous system.
Sleep Apnea Symptoms
The signs and symptoms of obstructive and central sleep apnea overlap, sometimes making it difficult to determine which type you have. The most common signs and symptoms of obstructive and central sleep apnea include:
- Loud snoring
- Episodes in which you stop breathing during sleep
- Gasping for air during sleep
- Awakening with a dry mouth
- Morning headache
- Difficulty staying asleep (insomnia)
- Excessive daytime sleepiness (hypersomnia)
- Difficulty paying attention while awake
- Irritability
Which CPAP and BIPAP Machines Were Recalled?
Recalled devices include:
- DreamStation ASV
- DreamStation ST
- AVAPS
- SystemOne ASV4
- C Series ASV
- OmniLab Advanced Plus
- SystemOne (Q Series)
- DreamStation CPAP Device
- DreamStation Auto BIPAP and CPAP machines
- DreamStation BiPAP Sleep Apnea Machines
- DreamStation Go Ventilator Machines
- Dorma 400
- Dorma 500
- CPAP REMStar SE Auto CPAP
- Trilogy 100 and 200
- Garbin Plus
- Aeris LifeVent
- A-Series BiPAP machine
- Philips Ventilator Devices
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 Respironics. 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,” 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 Respironics lab analysis found degraded foam produced several potentially harmful chemicals in ventilator machines, 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, which 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-dimethyl ethyl)-4-(1-methyl propyl) - A chemical used to make other chemicals.
Philips has Admitted to Many CPAP Lawsuit Allegations
In most mass tort cases, the hard part is proving that the product causes injury. This will not be a problem in the CPAP lawsuit. Philips Respironics was clearly aware of the problems with foam inhalation in its sleep apnea machines for a long time before it eventually issued its safety notice and recall in June 2021.
Philips Respironics further admits that “based on lab testing and evaluations, it may be possible that these potential health risks could result in a wide range of potential patient impact, from transient potential injuries, symptoms and complications, as well as possibly serious injury which can be life-threatening or cause permanent impairment, or require medical intervention to preclude permanent impairment.”
CPAP Repair and Replace Program
In September 2021, Philips announced an official “repair-and-replace” program for people with recalled Philips CPAP machines. Part of this program involved replacing the pe pur sound abatement foam with a new, silicone-based alternative foam.
Philips obtained preliminary FDA approval for this repair program based on testing results showing that the alternative silicone foam would be safe for use in the recalled devices. However, in November 2021, the agency suddenly withdrew its approval of the repair program after uncovering new evidence that the silicone replacement foam for the recalled CPAP machine may also present health and safety issues. Now the FDA is requiring Philips to halt the repair program and have replacement pe pur foam re-tested by an independent laboratory.
The continued investigation into the Philips CPAP recall has also uncovered new internal emails showing that the company was aware of the problem with PE-PUR foam degrading as early as 2015. This means that Philips ignored this potential safety hazard for 6 years before taking any action.
Has a CPAP Machine Recall Lawsuit Been Filed?
In October 2021, an MDL class action panel agreed with plaintiffs' lawyers that there should be a CPAP recall lawsuit over recalled CPAP sleep apnea machines and that it should be based in Pennsylvania.
The Panel transferred the 114 CPAP recall lawsuits pending in federal court to a single judge in Pennsylvania. So if you file a Philips CPAP lawsuit in California, Texas, New York, or any other state, the CPAP recall lawsuit will get transferred to this court.
Most plaintiffs' attorneys hoped the CPAP lawsuit would be in Eastern Pennsylvania (Philadelphia) and not Western Pennsylvania (Pittsburgh). The MDL Panel chose Western Pennsylvania as the location for the CPAP recall lawsuit.
U.S. District Judge Joy Flowers Conti in Pittsburgh will preside over both CPAP consumer class action lawsuits and personal injury claims. Judge Conti is an experienced jurist who has sat on the federal bench for nearly 20 years.
Our CPAP lawyers expect tens of thousands of CPAP lawsuits will soon flood this court. As of now, 110 CPAP lawsuits across the U.S. will be transferred to the MDL class action.
Do You Qualify to File a Claim?
Our lawyers are currently seeking new CPAP machine cases from individuals who used one of the recalled Philips sleep machines and suffered adverse health consequences. Specifically, we are seeking individuals who meet the following basic qualifying criteria for filing a Philips CPAP lawsuit.
You used one of the recalled CPAP, BiPAP, or other Philips sleep apnea machines every night for at least 6 months or longer. After using the recalled CPAP machine for at least 6 months, you suffered any of the following adverse health conditions:
- Pulmonary fibrosis or any other injury involving your respiratory system or diagnosis with a respiratory condition.
- Damage to your liver or kidney.
- Diagnosis with lung cancer, kidney cancer, liver cancer, or any other type of cancer.
Related Articles:
- Can CPAP Machines Cause Cancer?
- CPAP Linked to Pneumonia
- Philips Microstream Co2 Filter Lines Recall Lawsuit
See all related medical device lawsuits our attorneys covered so far.
What is the Deadline to File a CPAP Recall Lawsuit?
Philips CPAP lawsuits must be filed before the statute of limitations (“SOL”) for the claim expires. The applicable SOL deadline varies by state and can be anywhere from 1 to 6 years.
The statute of limitations for a CPAP or BiPAP device lawsuit may start on June 14, 2021, when Philips announced the CPAP recall. The statute of limitations varies by state. So if your state has a 2-year SOL, your deadline for filing a lawsuit will be June 14, 2023.
The rules governing deadlines to sue to have scores of exceptions that may shorten or extend your obligation to file a CPAP lawsuit or provide notice of your intention to do so. So you want to talk to a CPAP lawyer to verify the deadline to file a lawsuit for your claim.
How Much Compensation Could I Be Awarded?
Lawyers are still very early in the stages of the CPAP sleep apnea machine recall litigation. So speculation about settlement amounts in the Philips CPAP recalls lawsuits is premature.
Injuries vary wildly in these cases. The most serious CPAP injuries are likely to be cancer, organ damage, and respiratory problems.
For CPAP cancer lawsuits, the average settlement compensation payouts should at least be between $100,000 and $500,000, with the trial value being significantly higher if liability can be established.
Get a Free Dorma CPAP Recall Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in CPAP lawsuits. We are handling individual litigation nationwide and currently accepting new sleep apnea machine cases in all 50 states.
If you or a loved one was injured by a recalled CPAP machine, you should contact our law firm immediately. You may be entitled to a settlement by filing a Philips CPAP lawsuit, and our lawyers can help you receive fair compensation.
