CPAP Machine Lawsuit (Philips Respironics)

What Is the CPAP Machine Lawsuit About?

The CPAP machine lawsuit involves claims against Philips Respironics and its parent company Koninklijke Philips N.V. arising from a massive recall of approximately 3 to 4 million CPAP, BiPAP, and mechanical ventilator devices. The recall, announced on June 14, 2021, was triggered by the discovery that a polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices could degrade and release potentially toxic particles and gases that users inhaled during sleep therapy.

The federal lawsuits are consolidated in MDL 3014 in the Western District of Pennsylvania. The FDA classified this as a Class I recall — the most serious category — indicating that the devices posed a risk of serious injury or death. In April 2024, Philips agreed to a $1.1 billion settlement to resolve personal injury claims.

Plaintiffs allege that Philips knew about the foam degradation issue for years before the recall and failed to act. The PE-PUR foam was used for sound dampening in the devices, but it broke down over time — particularly when exposed to heat, humidity, or ozone-based cleaning products — releasing black particles and harmful chemical off-gasses directly into the airway of users. For another medical device lawsuit, see our Bard PowerPort lawsuit page.

Recalled Devices and Models

The recall covers a wide range of Philips Respironics devices manufactured before April 26, 2021. It is important to note that the DreamStation 2, released after the recall, does not contain the problematic PE-PUR foam and is not part of the recall.

If you are unsure whether your device is part of the recall, check the model and serial number on the Philips recall website or contact an attorney who can help verify your device status.

Health Risks from PE-PUR Foam Degradation

When the PE-PUR sound abatement foam degrades, users may be exposed to two types of hazards: (1) inhaling or ingesting small black foam particles, and (2) breathing in volatile organic compounds (VOCs) and other chemical off-gasses released by the degrading foam. The risk of degradation increases with device age, heat, humidity, and use of ozone-based cleaning products.

Reported health effects from exposure to degraded PE-PUR foam include:

• Cancer: Including lung cancer, nasal cancer, throat cancer, and liver cancer, linked to inhalation of carcinogenic chemicals released by the degrading foam.
• Respiratory issues: Coughing, difficulty breathing, wheezing, chest tightness, new or worsening asthma, and upper airway irritation.
• Headaches and dizziness: Persistent headaches, lightheadedness, and sinus pressure, particularly upon waking after device use.
• Organ damage: Kidney and liver damage from systemic exposure to toxic compounds, including diethylene glycol and toluene diisocyanate.
• Nausea and skin irritation: Gastrointestinal symptoms and skin reactions from foam particle exposure.

Who Qualifies for the CPAP Lawsuit?

Eligibility for the CPAP lawsuit depends on several factors related to your device use and any health effects you experienced. The following criteria are generally used to evaluate potential claims:

Lawsuit Timeline

The CPAP lawsuit has progressed rapidly since the recall announcement, culminating in a $1.1 billion settlement in 2024. Here are the key dates:

Settlement Amounts

In April 2024, Philips agreed to a $1.1 billion settlement to resolve personal injury claims related to the recalled CPAP devices. This settlement is separate from the economic loss class action settlement that addressed device replacement costs. Individual payouts from the personal injury settlement are based on a tier system that considers the type and severity of the claimant's health effects.

It is important to note that these are estimated ranges based on publicly available information about the settlement structure. Your actual compensation will depend on the specifics of your claim, including your diagnosis, the duration of device use, medical documentation, and other factors. For a general explanation of how mass tort settlement amounts work, see our mass tort settlement amounts guide.

How to File a CPAP Lawsuit Claim

If you used a recalled Philips CPAP, BiPAP, or ventilator and experienced health problems, here is the process for filing a claim:

For more on the general mass tort filing process, read our guide on how to join a mass tort lawsuit. You can also learn about how mass tort attorneys get paid through contingency fees.

Named Defendants

The CPAP lawsuit names the following defendants:

• Philips Respironics, Inc. — The Philips subsidiary that designed, manufactured, and sold the recalled CPAP, BiPAP, and ventilator devices. Headquartered in Murrysville, Pennsylvania.
• Koninklijke Philips N.V. — The Dutch parent company of Philips Respironics. Plaintiffs allege the parent company had oversight responsibilities and knowledge of the foam degradation issue.

Plaintiffs allege that Philips received complaints about black particles and foam degradation as early as 2015 but did not issue the recall until June 2021. Internal documents obtained during discovery suggest the company was aware of the potential risks for years before acting. For another case involving a medical device manufacturer's alleged concealment of product risks, see our hernia mesh lawsuit page.

Medical and Scientific Evidence

The scientific basis for the CPAP lawsuit rests on both the known toxicity of the chemicals released by degrading PE-PUR foam and the reported health outcomes of device users:

• Philips testing results: Philips's own testing confirmed that the PE-PUR foam could degrade and release harmful compounds. The company identified formaldehyde, toluene diisocyanate (TDI), and diethylene glycol among the chemical off-gasses.
• FDA analysis: The FDA's independent testing found elevated levels of certain volatile organic compounds (VOCs) in recalled devices. The agency received over 100,000 medical device reports related to the recall.
• Known carcinogenic compounds: Formaldehyde is classified as a Group 1 carcinogen by the International Agency for Research on Cancer (IARC). Toluene diisocyanate is a known respiratory sensitizer and suspected carcinogen.
• Adverse event reports: Thousands of CPAP users reported new health problems, including cancers, respiratory conditions, and organ damage, to the FDA's MedWatch adverse event reporting system.