Philips CPAP and BiPAP Device Lawyers

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.

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.