CPAP & BiPAP Device Foam Degradation Products Liability Litigation

Philips Respironics, a leading manufacturer of sleep apnea and respiratory therapy devices, issued a massive recall in June 2021 affecting an estimated 10–15 million CPAP, BiPAP, and mechanical ventilator devices sold in the United States. The recall was triggered by findings that the PE-PUR sound-abatement foam inside the devices could degrade over time — especially when exposed to heat, humidity, and certain cleaning methods like ozone cleaners — releasing black particulate matter and volatile organic compounds (VOCs), including potentially carcinogenic chemicals such as diethylene glycol and various aldehydes, directly into the breathing pathway of sleeping users. Many patients, unaware of the danger, had used these devices for years.

Multidistrict litigation was consolidated before the Western District of Pennsylvania, encompassing thousands of personal injury claims alleging cancers (including lung, kidney, and thyroid cancers), respiratory illness, and other serious health conditions linked to foam particle inhalation. In 2024, Philips reached a landmark settlement of approximately $1.1 billion to resolve personal injury claims and a separate $479 million settlement for medical monitoring of device users who had not yet developed diagnosed injuries. The settlement was a major development but drew some criticism from plaintiff advocates who argued the per-claimant payouts were insufficient given the severity of the alleged harm. Claims deadlines for various settlement components continue into 2025.