CPAP Recall Lawsuit Lawyer – Georgia

In June 2021, Philips Respironics, one of the world’s largest manufacturers of sleep apnea and respiratory therapy devices, issued a massive recall affecting an estimated 15 million devices worldwide, including approximately 5.5 million CPAP, BiPAP, and mechanical ventilator machines in the United States. The recall was triggered by a defect in the polyester-based polyurethane (PE-PUR) sound abatement foam used inside these devices. Philips acknowledged that the foam could degrade and break down, releasing toxic particulate matter and chemical gases directly into the device’s airway — the very air that millions of sleep apnea patients breathed in every night for hours while they slept.

The recalled devices exposed users to potential carcinogens and toxic chemicals including formaldehyde, toluene diisocyanate, diethylene glycol, and phenol, among others. Patients who used these devices have reported a range of serious health problems, including cancer (lung, kidney, liver, bladder), respiratory illness, headaches, organ damage, and other conditions.

At Wetherington Law Firm, our Georgia mass tort attorneys are representing patients across the state who have been harmed by recalled Philips CPAP machines. These patients trusted a medical device prescribed by their doctors to help them breathe and sleep safely. Instead, they were exposed to toxic chemicals night after night. We are committed to holding Philips Respironics accountable.

The Philips CPAP Recall: What Happened

Understanding CPAP Devices

Continuous Positive Airway Pressure (CPAP) machines are medical devices prescribed for patients with obstructive sleep apnea (OSA), a condition in which the airway repeatedly collapses during sleep, causing breathing interruptions. CPAP machines deliver a continuous stream of pressurized air through a mask worn during sleep, keeping the airway open and preventing apnea events. Millions of Americans rely on CPAP machines every night to breathe safely during sleep.

BiPAP (Bilevel Positive Airway Pressure) machines are similar but deliver two different pressure levels for inhalation and exhalation. Mechanical ventilators are life-sustaining devices used in hospitals and home care settings for patients who cannot breathe adequately on their own.

The PE-PUR Foam Defect

Philips Respironics used a polyester-based polyurethane (PE-PUR) foam inside its CPAP, BiPAP, and ventilator devices as a sound-dampening component. The foam was designed to reduce the noise generated by the device’s motor and air pressure system. However, Philips discovered — and users experienced — that this foam degrades over time.

When the PE-PUR foam degrades, it can:

• Release black particles and debris into the device’s air pathway. These particles are then inhaled by the user or potentially ingested (swallowed) during sleep.
• Off-gas toxic volatile organic compounds (VOCs) that enter the air stream and are inhaled by the user. These chemicals include formaldehyde, toluene diisocyanate, diethylene glycol, dimethyl diazene, and phenol, among others.

Several factors accelerate foam degradation:

• Heat and humidity: CPAP machines that include heated humidifiers create warm, moist conditions that accelerate foam breakdown
• Use of ozone-based cleaning products: Products like SoClean, which use ozone gas to sanitize CPAP equipment, have been identified as accelerating PE-PUR foam degradation
• Normal aging: Even without accelerating factors, the foam degrades over time with normal use

The Recall Timeline

• April 2021: Philips first discloses the foam degradation issue in its Q1 2021 earnings report, initially characterizing it as a potential risk.
• June 14, 2021: Philips issues a formal recall notification to the FDA, classifying it as a Class I recall — the most serious type, reserved for situations where there is a reasonable probability that the device will cause serious adverse health consequences or death.
• June 2021 onward: The FDA issues multiple safety communications warning patients about the recall and advising them to consult with their physicians before discontinuing use (because of the health risks of untreated sleep apnea).
• 2021-2023: Philips conducts testing on the degraded foam and its chemical emissions. Initial test results are disputed, with the FDA expressing concerns about the adequacy and methodology of Philips’ testing.
• 2023: The FDA conducts its own independent testing and issues findings that contradict some of Philips’ conclusions, identifying additional chemicals of concern.
• January 2024: Philips enters into a consent decree with the U.S. Department of Justice and the FDA, agreeing to significant remedial actions including quality system improvements and ongoing FDA oversight.
• 2024-2025: The litigation continues to grow. Medical monitoring and individual injury claims proceed through the courts.

Recalled Devices

The recall affects numerous Philips Respironics devices manufactured before April 26, 2021, including:

• CPAP machines: DreamStation, DreamStation Go, System One (Q-Series), System One 50 Series
• BiPAP machines: DreamStation BiPAP, A-Series BiPAP, C-Series, OmniLab Advanced+
• Ventilators: Trilogy 100, Trilogy 200, Garbin Plus, LifeVent, A-Series ventilators
• Other respiratory devices: SystemOne ASV, DreamStation ASV, various Dorma series devices

Health Risks: Toxic Chemicals in Recalled CPAP Machines

The chemicals released by degrading PE-PUR foam include several known or suspected carcinogens and toxic substances:

Formaldehyde

Formaldehyde is classified by the International Agency for Research on Cancer (IARC) as a Group 1 carcinogen (carcinogenic to humans). It is associated with nasopharyngeal cancer, sinonasal cancer, and leukemia. Chronic inhalation exposure can also cause respiratory irritation, asthma exacerbation, and pulmonary fibrosis.

Toluene Diisocyanate (TDI)

TDI is a chemical used in the production of polyurethane foams. It is a potent respiratory sensitizer that can cause occupational asthma, chronic obstructive pulmonary disease (COPD), hypersensitivity pneumonitis, and respiratory irritation. IARC classifies TDI as a Group 2B possible carcinogen.

Diethylene Glycol (DEG)

DEG is a toxic chemical that has been responsible for mass poisoning incidents when inadvertently included in pharmaceutical products. It is toxic to the kidneys, liver, and nervous system. Chronic exposure can cause renal failure, hepatic damage, and neurological dysfunction.

Phenol

Phenol is a corrosive chemical that can cause tissue damage on contact and systemic toxicity when absorbed. Chronic exposure through inhalation is associated with liver and kidney damage.

Dimethyl Diazene

Also known as azomethane, this chemical is classified as a probable carcinogen. It has been linked to tumors of the lungs, kidneys, and liver in animal studies.

Particulate Matter

Beyond chemical off-gassing, the physical degradation of PE-PUR foam releases black particles and debris into the air pathway. These particles can be inhaled into the lungs or ingested. Inhaling particulate matter can cause respiratory inflammation, lung tissue damage, and exacerbation of existing respiratory conditions. Ingestion of foam particles can cause gastrointestinal irritation and potential organ exposure to the chemicals within the foam.

Health Conditions Linked to Recalled CPAP Devices

Patients who used recalled Philips CPAP machines have reported a wide range of health problems. While research into the specific health effects of PE-PUR foam exposure is ongoing, the following conditions have been reported and are being investigated in the litigation:

Cancers

• Lung cancer: Chronic inhalation of carcinogenic chemicals and particulate matter directly into the airways represents a direct exposure pathway to the lungs.
• Kidney cancer: Several chemicals in the PE-PUR foam, including diethylene glycol and dimethyl diazene, are nephrotoxic and potentially carcinogenic to the kidneys.
• Liver cancer: The liver metabolizes inhaled and ingested chemicals, making it vulnerable to toxic and carcinogenic effects.
• Bladder cancer: Chemical metabolites excreted through the urinary system can cause bladder carcinogenesis.
• Nasal and sinus cancer: Formaldehyde inhalation is specifically associated with nasopharyngeal and sinonasal cancers.
• Leukemia and lymphoma: Formaldehyde exposure has been linked to hematologic malignancies.

Respiratory Conditions

• New-onset asthma or asthma exacerbation
• Chronic obstructive pulmonary disease (COPD)
• Chemical pneumonitis (lung inflammation from chemical exposure)
• Pulmonary fibrosis (scarring of lung tissue)
• Chronic sinusitis and upper airway inflammation
• Recurrent respiratory infections

Other Conditions

• Persistent headaches
• Chest tightness and pressure
• Skin irritation (from mask contact with foam particles)
• Nausea and gastrointestinal problems
• Kidney and liver damage
• Neurological symptoms (dizziness, cognitive impairment)

Current Status of the CPAP Recall Litigation

Federal MDL Proceedings

CPAP recall lawsuits have been consolidated into a multidistrict litigation proceeding: In Re: Philips Recalled CPAP, Bi-Level PAP, and Mechanical Ventilator Products Liability Litigation, MDL No. 3014, pending in the United States District Court for the Western District of Pennsylvania before Judge Joy Flowers Conti.

As of early 2025, key developments include:

• Thousands of cases filed: The MDL has grown to include thousands of individual personal injury and medical monitoring claims.
• Economic loss settlement: In 2023, Philips reached a proposed economic loss class action settlement to resolve claims from users who sought compensation for the diminished value of their recalled devices (as opposed to personal injury claims). This settlement, if finalized, would compensate device owners for the cost or value of their recalled machines but would not resolve personal injury claims for cancer and other health conditions.
• Personal injury claims ongoing: Individual personal injury claims — for cancer, respiratory disease, and other health conditions caused by foam exposure — are proceeding separately from the economic loss settlement. These are the higher-value claims.
• Bellwether case selection: The court has been working on the bellwether process, selecting representative cases for early trial to help establish case values and promote settlement.
• Expert discovery: Both sides have retained medical, toxicological, and engineering experts. Daubert challenges to expert testimony are expected to be a significant battleground.
• Consent decree: The January 2024 consent decree between Philips, the DOJ, and the FDA includes admissions and remedial actions that may be relevant to the litigation.

What to Expect Going Forward

The CPAP personal injury litigation is expected to continue for several years. Bellwether trials, if they occur, will provide the first jury assessments of case value and causation. Global settlement discussions for personal injury claims are likely to intensify as bellwether results come in. Our firm monitors all MDL developments and provides regular updates to our clients.

Eligibility: Who Can File a CPAP Recall Lawsuit?

Basic Eligibility Criteria

1. Device use: You must have used a recalled Philips Respironics CPAP, BiPAP, or mechanical ventilator. The recall covers devices manufactured before April 26, 2021.
2. Duration of use: The strength of your claim generally correlates with how long you used the recalled device. Users who relied on their device nightly for months or years have the most significant cumulative exposure.
3. Qualifying injury: You must have been diagnosed with a qualifying condition, including:
   • Cancer (lung, kidney, liver, bladder, nasal/sinus, leukemia, lymphoma, or other cancers)
   • Serious respiratory conditions (new-onset asthma, COPD, pneumonitis, pulmonary fibrosis)
   • Kidney or liver damage
   • Other serious conditions linked to chemical or particulate exposure

Medical Monitoring Claims

Even if you have not yet been diagnosed with a specific illness, you may have a claim for medical monitoring — the cost of ongoing medical surveillance and screening to detect diseases that may develop in the future as a result of your exposure to the degraded foam and toxic chemicals. Medical monitoring claims recognize that exposed individuals face an increased risk of developing serious conditions and should not bear the financial burden of necessary screening.

Documentation to Gather

• Device information: Model name/number, serial number, and purchase date of your recalled Philips device. Check the device itself or your original purchase records.
• Medical records: Records showing your sleep apnea diagnosis, CPAP prescription, and any subsequent health conditions
• Usage history: How long you used the device, how many hours per night, and whether you used a heated humidifier or ozone-based cleaning product
• Diagnostic records: Records of any cancer diagnosis, respiratory diagnosis, or other health conditions that developed during or after device use
• Recall correspondence: Any letters, emails, or notices you received from Philips regarding the recall

Georgia-Specific Legal Considerations

Georgia Statute of Limitations

Georgia’s personal injury statute of limitations is two years under O.C.G.A. § 9-3-33. For CPAP recall claims, the critical question is when the statute begins to run. Possible accrual dates include the date of cancer or illness diagnosis, the date you learned the illness was connected to the CPAP device, or the date of the recall announcement (June 2021).

Given that the recall was announced in June 2021, some filing deadlines may have already passed depending on the circumstances. However, for claims where the injury (cancer diagnosis, for example) occurred more recently, the statute may still be open. Additionally, the discovery rule may extend the filing deadline in cases where the connection between the device and the illness was not immediately apparent. Contact our office immediately if you believe you have a CPAP recall claim, as delay can be fatal to your legal rights.

Georgia Product Liability Law

Under O.C.G.A. § 51-1-11, Georgia provides several theories of liability applicable to CPAP recall cases:

• Design defect: The decision to use PE-PUR foam in a device that delivers air directly to a patient’s airways was an inherently dangerous design choice
• Manufacturing defect: The foam was defective in its composition or manufacturing, causing it to degrade and release toxic substances
• Failure to warn: Philips knew or should have known about the foam degradation risk long before the 2021 recall and failed to warn patients and physicians
• Negligence: Philips failed to exercise reasonable care in the design, testing, and post-market surveillance of its devices

Georgia Punitive Damages

Under O.C.G.A. § 51-12-5.1, punitive damages may be available if Philips is found to have acted with willful misconduct or conscious disregard for the safety of its users. Evidence that Philips knew about foam degradation issues before the recall and delayed action could support a punitive damages claim. Georgia generally caps punitive damages at $250,000, but exceptions exist for cases involving product liability where the defendant acted with specific intent to cause harm.

Sleep Apnea in Georgia

Sleep apnea affects approximately 22 million Americans, and Georgia’s population includes hundreds of thousands of CPAP users. The prevalence of obesity — a major risk factor for sleep apnea — is particularly high in Georgia and the Southeast. Many Georgia CPAP users relied on Philips DreamStation devices, one of the most popular and widely prescribed CPAP machines before the recall.

Georgia CPAP users who are affected by the recall receive care through a wide range of providers, including pulmonologists and sleep medicine specialists throughout the Atlanta metro area and the state, sleep laboratories at Emory, Grady, Piedmont, and WellStar health systems, VA medical facilities for veteran CPAP users, and community health centers serving rural Georgia populations.

Types of Compensation in CPAP Recall Lawsuits

If your CPAP recall claim is successful, you may be entitled to compensation for:

• Medical expenses: All costs of treating conditions caused by the recalled device, including cancer treatment (surgery, chemotherapy, radiation, immunotherapy), respiratory treatment, and ongoing medical monitoring
• Lost wages and earning capacity: Income lost due to illness, treatment, and recovery
• Pain and suffering: Physical pain and emotional distress caused by your illness
• Loss of quality of life: Impact on your daily activities, hobbies, relationships, and overall enjoyment of life
• Loss of consortium: Impact on your spousal relationship
• Medical monitoring: Costs of ongoing screening and surveillance for conditions that may develop in the future
• Wrongful death: If a family member died from a condition caused by a recalled CPAP device, surviving family members may recover funeral costs, loss of support, and loss of companionship
• Punitive damages: If Philips is found to have acted with willful disregard for patient safety

Why Choose Wetherington Law Firm for Your CPAP Case

• Product liability expertise: Our attorneys handle complex defective product cases and understand the technical, regulatory, and scientific issues involved.
• Individual attention: We evaluate each client’s device use history, exposure duration, and medical condition individually.
• Georgia-based: We meet with clients locally and provide personal service that national firms handling tens of thousands of CPAP cases cannot match.
• No upfront costs: Contingency fee basis — you pay nothing unless we recover compensation for you.
• Bilingual services: We serve clients in English and Spanish.

Frequently Asked Questions About the CPAP Recall Lawsuit

Which Philips CPAP machines are recalled?

The recall affects most Philips Respironics CPAP, BiPAP, and ventilator devices manufactured before April 26, 2021, that contain PE-PUR foam. This includes the popular DreamStation and DreamStation 2 (first generation), System One, and numerous other models. The DreamStation 2, released after the recall, uses a different foam material and is not included in the recall. If you are unsure whether your device is affected, check the serial number on the Philips recall website or contact our office.

I used my recalled CPAP for years but feel fine. Should I be concerned?

Many of the health conditions associated with PE-PUR foam exposure, particularly cancer, have long latency periods — meaning they may not manifest for years or even decades after exposure. If you used a recalled device for an extended period, we recommend discussing your exposure history with your physician and requesting appropriate screening. You may also have a medical monitoring claim even without a current diagnosis.

I received a replacement device from Philips. Does that affect my lawsuit?

Receiving a replacement device from Philips resolves the economic loss portion of your claim (the value of the defective device) but does not resolve any personal injury claim for health conditions caused by your use of the recalled device. If you developed cancer, respiratory illness, or other conditions from using the recalled device, you still have the right to pursue a personal injury claim regardless of whether you received a replacement.

I used an ozone cleaner (like SoClean) with my CPAP. Does that affect my case?

The use of ozone-based CPAP cleaners may have accelerated the degradation of the PE-PUR foam, potentially increasing your exposure to toxic chemicals and particles. This does not disqualify your claim. In fact, Philips was aware that many users employed ozone cleaners and arguably should have warned users that ozone could accelerate foam degradation or should have designed foam that could withstand common cleaning methods.

How long will the CPAP recall lawsuit take?

The CPAP recall litigation is complex and involves thousands of claimants. The economic loss class settlement is being finalized separately from personal injury claims. Personal injury bellwether trials and any global personal injury settlement will likely take several additional years. We provide regular updates to all clients about the progress of the litigation.

I stopped using my CPAP after the recall and my sleep apnea is untreated. Can I include that in my claim?

Yes. The recall placed millions of sleep apnea patients in an impossible position: continue using a device that exposes them to toxic chemicals, or stop using the device and suffer the serious health consequences of untreated sleep apnea (including cardiovascular disease, stroke, and motor vehicle accidents from daytime sleepiness). The disruption to your sleep apnea treatment and any resulting health consequences can be part of your damages claim.

Does it matter how many hours per night I used my CPAP?

Yes, your nightly usage duration is relevant to your total cumulative exposure. Most sleep medicine guidelines recommend using CPAP for at least 4-6 hours per night, and many compliant users wear their devices for 7-8 hours. Greater nightly usage means greater cumulative exposure to degraded foam particles and chemical off-gassing. Your CPAP machine may have a built-in compliance tracker that records your nightly usage data, which can be valuable evidence.

My family member died from cancer after using a recalled Philips CPAP. Can I file a claim?

Yes. If your family member used a recalled Philips CPAP device and died from cancer or another condition potentially caused by the device, you may have a wrongful death claim. Under Georgia law (O.C.G.A. § 51-4-1 through 51-4-5), the surviving spouse, or if none, the children, may bring a wrongful death action. The deceased person’s estate may also have a survival claim for damages the deceased suffered before death.

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