Philips AVAPS Lawsuit | 2025 Latest Updates

AVAPS Lawsuit Overview

The AVAPS lawsuits center around serious health risks posed by Philips Respironics AVAPS devices due to defective polyester-based polyurethane (PE-PUR) sound abatement foam. The primary allegations against Philips include that the company knew about foam degradation problems years before issuing a recall, yet continued manufacturing devices with the defective component. As of May 2022, the FDA had received over 21,000 medical device reports linked to the foam problem from April 2021 to April 2022, including at least 124 patient deaths from Philips CPAP and BiPAP machines. The FDA designated this as a Class I Recall in June 2021, indicating a high risk of serious injury or death.

Latest AVAPS Lawsuit Updates

May 2022 – FDA received over 21,000 medical device reports linked to the foam abatement problem from April 2021 to April 2022, with at least 124 patient deaths reported from Philips CPAP and BiPAP machines [1].

June 2021 – Philips initiated a Class I recall of CPAP, BiPAP machines, and ventilator machines including AVAPS devices due to potential health risks from degrading PE-PUR foam that can be inhaled or emit carcinogenic chemicals [2].

April 2021 – Philips anticipated the recall by setting aside 250 million euros after identifying a quality issue in a component that is used in certain sleep and respiratory care products [3].

2018 – Court documents revealed that Vincent Testa, a mechanical engineer at Philips, contacted foam suppliers about degradation issues, stating: “Recently we’ve received a few complaints from our customers that the foam is disintegrating. The material sheds and is pulled into certain Koninklijke Philips Respironics ventilators’ air path. As you can imagine, this is not a good situation for our users [4].”

2016 – Foam manufacturer representatives warned against using polyester foam in warm, high-humidity environments like CPAP machines, with expert Lee Lawler stating: “I would not be surprised if ester foam, continuously exposed to 40°C (104°F) at high humidity in recalled CPAP machines, would exhibit signs of hydrolysis in as short a time as a year.”

FDA Reports and Statistics

The FDA has documented extensive adverse events related to Philips AVAPS and related devices. Over 21,000 medical device reports were filed between April 2021 and April 2022 specifically related to the PE-PUR foam degradation issue. The reports include at least 124 patient deaths directly linked to Philips CPAP and BiPAP machines. The recall affects millions of devices worldwide, with Philips devices being widely used for sleep apnea and respiratory therapy. The FDA classified this as a Class I recall, the most serious type of recall indicating reasonable probability that use of the product will cause serious adverse health consequences or death.

AVAPS Injuries & Side Effects

Users of recalled AVAPS devices have reported a wide range of serious health complications due to foam particle inhalation and chemical exposure from off-gassing.

Potential health risks of particulate exposure from defective AVAPS devices include:

• Respiratory Issues: Breathing problems, chest pressure, and lung irritation from inhaled foam particles
• Cancer Risk: Carcinogenic effects from exposure to degraded foam chemicals
• Inflammation: Irritation and inflammatory responses in airways and respiratory system
• Toxic Effects: Systemic toxicity from chemical exposure and particle inhalation

Potential risks of chemical exposure due to off-gassing include:

• Neurological Symptoms: Headache, nausea, and vomiting from chemical exposure
• Cardiovascular Issues: High blood pressure and related complications
• Hypersensitivity: Allergic reactions and increased sensitivity to environmental factors
• Infections: Sinus infections and related complications

What is an AVAPS Machine?

Average volume-assured pressure support (AVAPS) is a relatively newer modality of non-invasive ventilation that integrates the characteristics of both volume and pressure-controlled non-invasive ventilation. AVAPS is designed specifically for taking over the control of and adapting automatically to each patient’s changing therapy needs. It is a noninvasive home ventilator that provides the patient with the accurate pressure volume required to maintain adequate treatment.

AVAPS vs BiPAP

Although both AVAPS and BiPAP are reliable in the treatment of acute hypercapnic respiratory failure, AVAPS is associated with a speedy improvement of the patient clinically. The patients have also experienced greater comfort and satisfaction comparatively, and therefore, improved treatment compliance.

Do You Qualify for an AVAPS Lawsuit?

You may qualify for an AVAPS lawsuit if:

• You used a Philips AVAPS device between 2009 and 2021.
• You experienced serious side effects including respiratory issues, cancer, cardiovascular problems, or neurological symptoms.
• The injuries required medical treatment or hospitalization.
• You can provide medical documentation linking your injuries to AVAPS device use.

Evidence Required for an AVAPS Lawsuit

To build a strong AVAPS lawsuit case, you will need comprehensive documentation including medical records showing your injuries and treatment, proof of AVAPS device ownership or use with serial numbers and purchase receipts, and medical expert testimony linking your health problems to the defective foam in the device. Documentation should include all medical treatments, hospitalizations, and ongoing care related to your injuries.

Damages You Can Recover

Victims of defective AVAPS devices may be entitled to compensation for medical expenses including past and future treatment costs, lost wages and reduced earning capacity, pain and suffering from physical and emotional trauma, and punitive damages designed to punish Philips for its conduct and deter similar behavior in the future.

AVAPS Recall Information

The June 2021 recall affects multiple AVAPS models and related devices manufactured between 2009 and April 2021. Recalled continuous ventilator, non-life supporting devices include DreamStation ASV, DreamStation ST AVAPS Bilevel Positive Airway Pressure, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, and OmniLab Advanced+. The recall was designated as Class I by the FDA, indicating the highest level of risk. Devices manufactured as recently as April 22, 2021, were still using the defective polyester foam.

Statute of Limitations for AVAPS Lawsuits

Time is limited to pursue legal action for AVAPS-related injuries. The statute of limitations varies by state but typically ranges from 1-3 years from the date you discovered or should have discovered your injury was related to the AVAPS device. Given that the recall was announced in June 2021, time may be running out for some potential claimants. It’s crucial to consult with an experienced attorney immediately to preserve your legal rights.

FAQs

1. Is there any compensation for owners of the recalled Philips AVAPS machines?

Philips is offering replacements or refunds for affected devices, and injured users may also be entitled to legal compensation through lawsuits for medical expenses, lost wages, and pain and suffering.

2. Can I still use my Philips AVAPS machine if it hasn’t shown any issues?

It is recommended to stop using recalled devices immediately to ensure safety, even if no issues have been observed, as health risks may not be immediately apparent.

3. How long will it take to receive a replacement or refund for the recalled device?

The timeframe for receiving a replacement or refund varies, and you should contact Philips customer service for specific processing and shipping details.

4. What should I do if I’m using a recalled Philips AVAPS device?

Speak with your physician immediately to determine the best options for continued treatment and discuss potential health risks from your device use.

5. How do I know if my AVAPS device is part of the recall?

Check your device model against the recalled list including DreamStation ASV, DreamStation ST AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, and OmniLab Advanced+.

6. What is the difference between AVAPS and BiPAP machines?

AVAPS (Average Volume-Assured Pressure Support) integrates characteristics of both volume and pressure-controlled ventilation, while BiPAP provides two levels of pressure during breathing cycles.

7. Are there any long-term health effects from using recalled AVAPS devices?

Potential long-term effects include cancer risk from carcinogenic chemical exposure and chronic respiratory problems from inhaled foam particles.

8. How much compensation can I receive from an AVAPS lawsuit?

Compensation varies based on the severity of injuries, medical expenses, lost wages, and other factors, with settlements potentially ranging from thousands to hundreds of thousands of dollars.

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References:

1. https://www.fiercebiotech.com/medtech/philips-flagged-ventilator-foam-issues-years-beginning-recall-court-docs-show
2. https://www.fda.gov/medical-devices/respiratory-devices/recalled-philips-ventilators-bipap-machines-and-cpap-machines
3. https://www.philips.com/a-w/about/news/archive/corpcomms/news/press/2021/philips-first-quarter-results-2021.html
4. https://www.bloomberg.com/news/articles/2022-06-09/philips-knew-of-cpap-foam-decay-years-before-recall-emails-show?embedded-checkout=true