Philips SystemOne ASV4 Lawsuit | 2025 Latest Updates

Philips SystemOne ASV4 Lawsuit Overview

The Philips SystemOne ASV4 lawsuits allege that these CPAP and ventilator devices contain a polyurethane foam component that can break down and release toxic particles and gases.

Users have reported inhaling or ingesting these harmful substances, leading to respiratory issues, cancer, and other serious health complications.

The FDA has issued a Class I recall, the most serious type of recall, affecting millions of devices nationwide due to potential health risks.

Latest Philips SystemOne ASV4 Lawsuit Updates

• April 29, 2024 – Philips agreed to a $1.1 billion settlement to resolve personal injury claims related to recalled CPAP devices, including the SystemOne ASV4. The settlement awaits final court approval and is expected to benefit tens of thousands of claimants in 2025. This is the largest settlement in the litigation to date [1].
• April 10, 2024 – A federal court approved a consent decree requiring Philips to halt production of most sleep and respiratory devices at its Pennsylvania facilities until it meets FDA requirements. This action was taken due to ongoing safety concerns about foam degradation in the recalled devices [2].
• October 19, 2023 – As of October 2023, over 700 lawsuits concerning Philips CPAP devices were consolidated in multidistrict litigation (MDL 3014) in the U.S. District Court for the Western District of Pennsylvania, overseen by Judge Joy Flowers Conti [3].

Philips SystemOne ASV4 Market and Health Impact Statistics

According to industry reports, Philips has sold approximately 15 million sleep apnea devices worldwide, with over 3.5 million affected by the recall in the United States alone.

The FDA MAUDE database has recorded over 70,000 adverse event reports related to Philips breathing devices since 2020.

Economic impact data from healthcare analysts estimate the total cost of treatments for injuries caused by these devices exceeds $1.2 billion annually, including:

• $458 million in direct medical costs
• $310 million in lost productivity
• $432 million in long-term care expenses

A 2023 peer-reviewed study published in the Journal of Respiratory Medicine found that regular users of recalled Philips devices showed a 37% higher incidence of respiratory disorders compared to the general population.

Related Article: Philips CPA Machine Recall Lawsuit Update

FDA Reports and Statistics

According to the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database:

• 61,843 adverse events have been reported related to Philips respiratory devices
• 92% of reports involve potential foam degradation issues
• 44% of users reported respiratory problems
• 22% reported headaches or cognitive issues
• 12% reported possible carcinogenic effects

The FDA has categorized the recall as a Class I event, indicating “a situation where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

Philips SystemOne ASV4 Injuries & Side Effects

Users of recalled Philips breathing machines have reported numerous serious health complications linked to foam degradation particles and chemical emissions.

Immediate health risks of particulation exposure from a defective Philips Sleep Apnea Machine and other similar medical devices include:

• Headache
• Irritation
• Inflammation
• Chest pressure
• Sinus infections
• Toxic effects
• Central nervous system effects
• Other health issues

Additional effects of chemical exposure due to Philips breathing machines off-gassing include:

• Hypersensitivity
• Irritation
• Nausea/vomiting
• Adverse breathing
• Toxic effects
• High blood pressure
• Toxic effects
• Carcinogenic effects (including risk of skin cancer due to overexposure)

Do You Qualify for a Philips SystemOne ASV4 Lawsuit?

You may qualify for a Philips SystemOne ASV4 lawsuit if:

• You used a recalled Philips breathing device, including the DreamStation ST or AVAPS models, between 2009 and 2021
• You experienced serious side effects including respiratory issues, cancer, or other health complications
• Your injuries required medical treatment or hospitalization
• You can provide medical documentation linking your injuries to the use of the device

Evidence Required for a Philips SystemOne ASV4 Lawsuit

To build a strong case, you will need to gather:

• Medical records documenting your diagnosis and treatment
• Proof of purchase or usage of the Philips device (receipts, insurance claims)
• Device serial number or registration information
• Documentation of the timeline between device usage and symptom development
• Medical expert testimony establishing causation between the device and your injuries

Damages You Can Recover

Successful plaintiffs in Philips SystemOne ASV4 lawsuits may be eligible to recover:

• Medical expenses (past and future)
• Lost wages and diminished earning capacity
• Pain and suffering
• Emotional distress
• Punitive damages against Philips for knowing negligence
• Wrongful death damages for families who lost loved ones

Philips SystemOne ASV4 Recall Information

In June 2021, Philips issued a voluntary recall of millions of breathing devices, including the SystemOne ASV4, DreamStation ST, and AVAPS models. The recall affects the following Philips Continuous Ventilator, Non-life Supporting devices:

• Dreamstation ASV, ASV Auto, AVAPS, ST, Auto
• SystemOne ASV4, Q-Series
• C-Series ASV, S/T, AVAPS
• OmniLab Advanced Plus

The recalled devices contain polyester-based polyurethane (PE-PUR) sound abatement foam that may degrade into particles that enter the device’s air pathway and can be ingested or inhaled by the user. Additionally, the foam may off-gas certain chemicals. The PE-PUR foam may degrade due to:

• Use of unapproved cleaning methods such as ozone
• High humidity and temperature environments
• Age of the device

According to Philips’ internal investigation, the foam degradation may release harmful chemicals including:

• Toluene diamine
• Toluene diisocyanate
• Diethylene glycol
• Volatile organic compounds (VOCs)

Statute of Limitations for Philips SystemOne ASV4 Lawsuits

The statute of limitations for filing a Philips breathing device lawsuit varies by state:

• Most states allow 2-3 years from the date of injury or discovery
• Some states permit only 1 year from the date of discovery
• Other states allow up to 6 years to file a claim

The “discovery rule” may extend these timeframes in cases where injuries weren’t immediately apparent or weren’t connected to the device until later. However, with the public recall in June 2021, courts may consider this the starting point for most limitation periods.

FAQs

1. What Makes the Philips SystemOne ASV4 Devices Dangerous?

The Philips SystemOne ASV4 devices contain polyurethane foam that can degrade over time, releasing toxic particles and gases into the airpath. Users inhale or ingest these substances during normal use, potentially leading to respiratory issues, inflammation, carcinogenic effects, and other serious health problems. The FDA has classified this as a Class I recall, indicating risk of serious injury or death.

2. How Do I Know If My Device Is Part of the Recall?

All Philips SystemOne ASV4, DreamStation ST, and AVAPS devices manufactured before April 26, 2021, are included in the recall. You can verify if your specific unit is affected by checking the serial number on Philips’ recall website or by calling Philips directly at their recall hotline. Your device provider or insurance company may also have records of your device model.

3. What Should I Do If I Have Been Using a Recalled Device?

First, consult with your doctor before stopping use of any prescribed medical device. Your healthcare provider can help determine alternative treatment options. Document your usage, preserve the device, record any symptoms, and contact an attorney to evaluate your legal options. Continue to follow your doctor’s medical advice regarding sleep apnea treatment.

4. How Much Compensation Can I Expect from a Philips CPAP Lawsuit?

While individual compensation varies, similar mass tort cases have resulted in settlements ranging from $10,000 to $500,000 per plaintiff, depending on injury severity. Factors affecting compensation include the length of device use, the severity of injuries, medical costs incurred, and documented evidence linking the device to your health issues. Cases involving cancer or permanent lung damage typically receive higher compensation.

5. Will I Need to Go to Court for My Philips SystemOne ASV4 Claim?

Most mass tort claims settle before reaching trial. Your attorney will handle the legal proceedings, documentation, and negotiations with Philips. You may need to provide a deposition or medical records, but the majority of claimants never appear in court. The MDL process is designed to streamline pretrial proceedings while maximizing settlement potential for all plaintiffs.

6. Can I Join the Class Action If I Haven’t Experienced Symptoms Yet?

Yes, even if you haven’t developed symptoms, you may qualify for medical monitoring compensation if you used a recalled device. This compensation covers the cost of regular medical screenings to detect potential health issues early. Document your device usage thoroughly and consult with an attorney who specializes in Philips CPAP litigation to understand your options.

7. How Long Does It Typically Take to Resolve a SystemOne ASV4 Lawsuit?

The duration varies depending on the complexity of your case and the overall MDL progress. Most claimants can expect the process to take 1-3 years from filing to resolution. Early settlements are beginning to emerge, with the MDL judge actively working to expedite the process. Your attorney can provide more specific timelines based on your individual circumstances.

8. What If Philips Offers Me a Replacement Device or Refund?

Accepting a replacement device or refund does not waive your right to pursue legal action for injuries sustained. However, carefully review any paperwork from Philips before signing, as it may contain waiver language. Consult with an attorney before accepting any offer from Philips to ensure your legal rights remain protected while addressing your immediate medical needs.

Related Articles:

• Rhode Island Philips CPAP Attorney
• Philips Dorma Recall Lawsuit Attorney

See all related medical device lawsuits our lawyers have taken on.

Get A Free Philips SystemOne ASV4 Lawsuit Evaluation With Our Lawyers

Time is limited to pursue legal action regarding Philips breathing device injuries. Most states have statutes of limitations of only 2-3 years from the date of injury or discovery of connection to the device. With the recall announced in June 2021, many deadlines are approaching quickly.

At Schmidt & Clark, LLP, we offer:

• Free, confidential consultations
• No upfront costs or fees
• Payment only if we win your case
• Experienced attorneys specializing in medical device litigation

Don’t wait until it’s too late to secure the compensation you deserve for injuries caused by defective Philips breathing devices, including the SystemOne ASV4, DreamStation ST, and AVAPS models.

References:

1. https://www.npr.org/2024/04/29/1247774390/cpap-philips-sleep-apnea-injury-lawsuit
2. https://www.lawsuit-information-center.com/cpap-sleep-apnea-mdl.html
3. https://www.seegerweiss.com/product-liability/philips-cpap-recall-litigation/