CPAP / Philips Respironics Recall Litigation

In June 2021, Philips Respironics — a subsidiary of the Dutch multinational Koninklijke Philips N.V. — issued one of the largest medical device recalls in history, affecting approximately 5.5 million CPAP, BiPAP, and mechanical ventilator devices in the United States (10-15 million worldwide). The recall shook the sleep medicine industry and left millions of patients with obstructive sleep apnea scrambling for alternatives.

The recall centered on polyester-based polyurethane (PE-PUR) sound abatement foam used in the devices to reduce noise and vibration. Philips disclosed that the foam could degrade into black particulate matter and release volatile organic compounds (VOCs) — including suspected carcinogens — directly into the device's air pathway. Because CPAP machines deliver pressurized air through a mask worn over the nose or mouth during sleep, users may have been inhaling toxic foam particles and chemical off-gases for years during nightly use, often for 6-8 hours per night.

Internal Philips documents obtained during litigation suggest the company received complaints about black particles in device tubing and masks as early as 2015 — six years before the recall. Plaintiffs allege Philips was aware of the foam degradation problem but delayed the recall for years while continuing to sell millions of devices.

The FDA classified the recall as Class I — its most serious classification — indicating 'a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.' The agency received over 100,000 medical device reports related to the recalled devices.

The PE-PUR foam used in recalled Philips devices can degrade through multiple mechanisms, including exposure to heat, humidity, ozone, and certain cleaning agents (particularly ozone-based cleaners that Philips warned against but users widely employed).

Laboratory testing commissioned by the FDA and independent researchers identified multiple potentially harmful chemicals released by degrading foam:

• Formaldehyde — a known human carcinogen (IARC Group 1) • Toluene diamine (TDA) — a suspected carcinogen • Diethylene glycol — a toxic compound that can cause kidney and liver damage • Dimethyl diazene — a suspected carcinogen

The FDA's own testing found that degraded foam particles ranged in size from visible fragments to respirable particles small enough to reach the deep lung (alveolar region). The prolonged, nightly exposure pattern — with pressurized air forcing particles and gases directly into airways for 6-8 hours — represents a unique and concerning exposure route with no parallel in other product liability cases.

Eligible individuals may include anyone who used a recalled Philips Respironics CPAP, BiPAP, or ventilator device manufactured before April 26, 2021, and subsequently developed cancer (particularly lung, kidney, liver, or bladder cancer), respiratory conditions (pneumonia, asthma exacerbation, respiratory failure), or other health issues. The recall covers multiple product lines including the DreamStation, DreamStation 2, SystemOne, and certain ventilator models.

This eligibility information is general and informational only. Consult a licensed attorney.

The MDL (No. 3014) is in the Western District of Pennsylvania before Judge Joy Flowers Conti. Philips has reached two major settlements:

• $1.1 billion for personal injury claims (cancer and respiratory illness) • $479 million for economic loss claims (device owners who were not injured but whose devices were recalled)

However, personal injury litigation continues for claims not covered by the existing settlement or for claimants who opted out. Bellwether trial preparation continues for remaining claims. Discovery has produced significant internal Philips documents showing early awareness of foam degradation issues.

Philips has also faced regulatory action: a $1.1 billion consent decree with the DOJ/FTC in 2024 related to the recall itself.

Philips has acknowledged the foam degradation issue and implemented the recall. The company has argued that its testing and analysis show the health risks from degraded foam exposure are lower than initially feared, citing its own health risk assessment that concluded 'the potential patient health risks are not at a level that would result in appreciable harm to health' for most device configurations.

Critics — including plaintiff attorneys and the FDA — have challenged Philips' health risk assessment, noting that the company's testing may not have fully replicated real-world conditions of prolonged nightly exposure over years.

Philips has committed approximately $1.6 billion to settling recall-related claims and has incurred billions more in device replacement costs, regulatory penalties, and lost revenue.

Philips has committed approximately $1.6 billion to resolve recall-related claims:

• $1.1 billion for personal injury claims (tiered based on injury severity and device usage duration) • $479 million for economic loss claims

Philips also agreed to a $1.1 billion consent decree with the U.S. government related to the recall process.

Individual settlement amounts within the personal injury fund vary based on the diagnosed condition, duration of device use, and supporting medical documentation.

Past settlement amounts are not a guarantee of future results.