Obstructive sleep apnea (OSA) can cause you to stop and start breathing while you sleep. The condition can manifest as snoring, dry mouth, sore throat, sluggishness during the day, and morning headaches. An estimated 22 million Americans suffer from obstructive sleep apnea, with nearly four out of five people in this group going undiagnosed.
Treatment for OSA comes from continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), and ventilators. These devices rely on foam to suppress sound and vibration so you can sleep while receiving your OSA treatment.
Despite the apparent benefits of CPAP and similar devices, Philips, the manufacturer, finds itself as a defendant in numerous lawsuits alleging product liability and violations of consumer protection laws. The United States District Court for the Western District of Pennsylvania oversees these cases as part of a United States Judicial Commission for Multidistrict Litigation. Here, a federal judge is controlling the preliminary proceedings in the Philips CPAC lawsuits.
Claims for these suits focus on the foam dampening sound and vibration. Below we discuss the properties of this foam and the potential injuries that may occur to users of Philips CPAP, BIPAP and Ventilation devices.
Why is the foam in Philips CPAP devices toxic?
Noise suppressing foam can cause potentially serious or fatal illnesses in Philips CPAP users. Polyester-based polyurethane (PE-PUR) forms the essential basis of the foam. With the breakdown or degradation of PE-PUR, small particles and gases that sleep apnea patients ingest or inhale while using CPAP. The chemicals in these gases and other materials include isocyanates. Below, we will discuss the potential adverse effects of degraded PE-PUR.
Bacteria and fungi are catalysts for the degradation of polyester-based polyurethane. Often, these microorganisms take up residence in constantly used CPAP masks and breathing tubes that are poorly cleaned or maintained. To kill bacteria, some users may turn to ozone-based cleaners. This simply replaces one decomposition agent of PE-PUR (microorganisms) with another (ozone). Humidity and high temperatures are also responsible for the release of gases and particles from PE-PUR.
What are the potential injuries from exposure?
Increased risk of cancer
Researchers have linked isocyanates to cancer in animals. Based on this, organizations that study cancer and toxins have used terms such as “possibly carcinogenic to humans” and “reasonably suspected to be a human carcinogen” to refer to toluene diisocyanate (TDI). This chemical is found in polyurethane foam. Compounds found in this form of isocyanates can potentially cause cancer in humans.
The US Food and Drug Administration (FDA) has taken cancer risk seriously enough to designate the Philips CPAP recall as a “Class 1” recall. According to the FDA, products subject to a Class I recall have a “reasonable probability that use of or exposure to an infringing product will result in serious adverse health consequences or death.”
Foam breakdown puts CPAP device users at risk of cancer in many parts of the body, including the lungs, brain, stomach, thyroid, breasts and kidneys. Other forms of potential cancer include leukemia (cancer of blood cells in general), non-Hodgkin’s lymphoma, and multiple myeloma. Many of these types of cancer impair your body’s ability to fight infection. Myeloma can damage the bone marrow and eliminate or neutralize red blood cells.
The chemicals inhaled or ingested by the foam can cause your liver and kidneys to fail. Liver failure leads to reduced blood clotting and increased bleeding, even minor cuts and scrapes. You may have high blood pressure due to fluid buildup in your brain and more frequent infections.
Toxins can also build up in the blood and around the brain due to liver failure. Complications include impaired judgment, decreased memory, confusion, and other loss of cognitive function.
Philips CPAP users may suffer from kidney failure. Your kidneys remove acid, waste, and excess fluid from your body. Loss of proper kidney function can lead to heart disease, kidney stones, weak bones, low red blood cell count, and elevated potassium with potential for heart failure.
In addition to cancer, the lungs face an increased risk of infections, irritations and other illnesses from CPAP foam. Breathing problems result from irritation and disease in the lungs and airways that make up the respiratory system.
Isocyanates can trigger asthma attacks, some severe enough to be fatal. Wheezing, coughing, and inflamed airways characterize this condition. Studies and literature often cite asthma as the most common side effect of prolonged exposure to isocyanates, especially in the workplace.
What are the warning signs of exposure?
Symptoms of exposure to degraded foam may themselves constitute bodily harm. Victims may experience headaches, nausea, vomiting, coughing, chest tightness, difficulty breathing, and hypersensitivities (or allergic reactions). Symptoms mimicking a cold or flu, such as a sore throat, dry throat, or stuffy nose, may signal exposure to CPAP foam chemicals.
These discomforts represent pain and suffering. When you go to a doctor or hospital for them, you incur medical expenses.
How to prove exposure to toxins from PE-PUR foam?
If you develop the symptoms listed above, tell your doctor or hospital if you have recently used a Philips CPAP machine that uses PE-PUR foam. In particular, note if you were using any of the following recalled models:
- E30 (emergency use authorization)
- DreamStation VAS
- DreamStation ST, AVAPS
- One ASV4 System
- C-Series ASV, S/T, AVAPS
- OmniLab Advanced Plus Laboratory Titration Device
- SystemOne (Q-series)
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP
- Dorma 400, 500 CPAP
- REMStar SE Automatic CPAP
- Trilogy 100 Respirator
- Trilogy 200 Respirator
- Garbin Plus, Aeris, LifeVent Ventilator
- BiPAP V30 A Series Automatic Ventilator
Philips manufactured the recalled models between 2009 and April 26, 2021.
Also, look for black particles in the tubes or water chamber of these machines. The presence of the thin material may be evidence that the polyester-based polyurethane has degraded.
What compensation can you get for your injuries?
Injuries sustained from defective products or unsafe conditions result in considerable medical treatment and expense. For example, people with end-stage kidney disease face an average of $14,399 per month in medical bills. That’s about 33 times more than the expenses for those without end-stage kidney disease. For patients who rely on private insurers, outpatient dialysis costs an average of $10,149 per month.
The financial burden of cancer adds to the emotional and mental stress of cancer. On average, a cancer treatment costs around $150,000. Chemotherapy, drugs that treat cancer and preserve immunity, and complicated surgeries contribute to these costs. Cancer treatment and visits to doctors and hospitals can take years.
Complications from exposure to toxins in the form of PE-PUP can affect your income and ability to work. Adults with asthma miss 14.2 million accumulated workdays each year. Chemotherapy, dialysis, surgeries, and constant doctor visits all mean wasted time and money. People with advanced stages of cancer or organic disease may eventually become disabled.
The physical and emotional trauma of faulty CPAP devices also has non-economic costs. Pain and suffering, cancer and other serious illnesses cause stress, anxiety and depression. Spouses may lose the affection and companionship of those exposed to toxins from Philips CPAP devices.
For more information, please visit our dedicated Philips Respironics CPAP recall main page.