If you or a loved one has used a Philips CPAP or BiPAP device and suffered from medical complications, you may be entitled to compensation. Unfortunately, the lawsuits claim that many individuals who relied on these sleep apnea machines have faced challenging health complications, and that certain devices have endangered patient health. In fact, Philips has recalled several models.
Philips CPAP and BiPAP Devices
These devices provide a steady flow of oxygen to users as they sleep. These help to open airways and aid breathing. Not surprisingly, these devices are widely used to help those who suffer from sleep apnea. “A continuous positive airway pressure (CPAP) machine is the most commonly prescribed device for treating sleep apnea disorders.”
A CPAP machine uses a compressor or motor to generate a steady stream of pressurized air. The air moves through a filter into a flexible tube, allowing purified air to flow into the mask that covers the user’s nose and/or mouth.
Consequently, users experience uninterrupted sleep. Since the device’s air is pressurized, it pushes against any blockages, allowing airways to stay open and lungs to fill with oxygen.
Breathing Machine Types
CPAP devices are one of three machines prescribed to keep patients breathing normally as they sleep. APAP and BiPAP devices are also prescribed. Find out how each device works and differs from one another below
- CPAP – This breathing device generates pressurized air, at one constant air pressure level. This air pressure setting can only be changed by resetting the device.
- APAP – This automatic positive airflow pressure machine monitors nighttime breathing. Adjusting air pressure automatically as users change position throughout the night, this device also compensates for medications that may impact breathing.
- BiPAP – This bi-level positive airflow pressure device is equipped with two pressure settings. The first uses pressure for inhalation, while the second uses lower pressure for exhalation. BiPAP devices are often equipped with a backup respiratory rate, which helps central sleep apnea patients ensure breathing. This device works better for those who don’t tolerate CPAP machines well, or those with higher levels of carbon dioxide in the blood.
Foam Inhalation May Result in Serious Injury or Death
Based on the lawsuit claims and other available information, polyester-based polyurethane (PE-PUR) sound abatement foam was used to manufacture Philips CPAP and BiPAP devices. This foam, later identified as a potential danger to device users, led to the recall of certain devices.
According to the U.S. Food & Drug Administration (FDA), the foam, “which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.”
On November 12, 2021, the FDA issued a recall update after inspecting a Philips facility “to determine what may have caused or contributed to the foam issues and to assess adherence to the agency’s quality system regulations.”
The inspection prompted the FDA to request independent laboratory tests on the replacement foam used at the facility. Philips’ replacement foam, which was silicone-based, was found to potentially contain volatile organic compounds (VOCs).
Additionally, it was uncovered that Philips was aware, no later than 2015, that there was a degradation issue with the PE-PUR foam that was later recalled, that posed a danger to users. Internal company testing also showed Philips opted to continue use of PE-PUR foam, over safer alternatives, despite the identification of toxins and potential carcinogenicity of PE-PUR foam degradation products.
The lawsuit alleges the manufacturer, Philips Respironics, used PE-PUR foam to improve the quality of its breathing devices, which minimized sounds and vibrations. Yet, this foam is known to cause serious side effects and medical complications when it comes into contact with airways or digestive tracts.
Inhalation or swallowing of the particles can occur if the foam breaks down; foam particles can also release toxic chemicals that users might breathe in or ingest. Subsequent inhalation or swallowing of PE-PUR foam particles may seriously injure users — these may be life-threatening and permanent, requiring medical intervention to prevent irreversible damage.
Patient Complaints and Harmful Side Effects
The lawsuit claims Philips is aware of the harmful side effects caused by inhalation of PE-PUR foam. Patients have complained to the company directly, citing; black particles in their breathing device’s air pathway, headaches, irritation in the upper airway, chest pressure, coughing, and sinus infections. Patient complaints have been consistent with inhalation of foam particles.
Numerous side effects and complications may arise if users inhale or swallow PE-PUR foam particles. These include:
- Headache
- Dizziness
- COPD
- Irritation of the eyes, nose, respiratory tract, or skin
- Asthma
- Inflammatory responses
- Hypersensitivity
- Nausea and vomiting
- Toxic and carcinogenic effects to internal organs, including the kidneys and liver
Potential Life-Threatening Complications
The lawsuits claim that PE-PUR foam can cause long-term, permanent, and life-threatening complications – including cancer. If you have been diagnosed with any of these conditions, and have used a Philips CPAP or BiPAP device, your illness may have resulted from use of these devices.
- Acute Respiratory Distress Syndrome (ARDS)
- Certain types of cancer
- Reactive Airway Disease
- Respiratory failure
- Recurrent pneumonia
- Pleural effusion
- Lung/Pulmonary disease
- Severe ear, nose, and throat inflammation
- Liver damage
- Kidney/Renal damage
- Chemical poisoning
If you or a loved one have experienced serious medical complications or injury after using a recalled Philips medical device, you may be entitled to compensation. We are working in conjunction with co-counsel Weitz and Luxenberg on CPAP cases.
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