Published by 
Dorma CPAP Recall Lawsuit Overview
September 2021 - Philips announced an official "repair-and-replace" program for people with recalled CPAP devices. Part of this program involved replacing the problematic PE-PUR Foam with a new, silicone-based alternative foam.
June 2021 - Philips recalled CPAP and BiPAP devices because sound polyurethane foam (PE-PUR Foam) in the machines was degrading and causing users to inhale toxic particles [1].
FDA Reports and Statistics
FDA inspectors concluded their investigation into Philips and the CPAP machine recall that impacted millions of devices. The agency examined internal emails, product testing, and operations reports to determine what led to the recall.
The inspection uncovered hard evidence that Philips executives were aware of the problems with the sound abatement foam "but did not immediately act." Evidence included emails from 2015 sent by a Philips employee to the foam supplier and "at least 14 tests or assessments" dating back to 2016.
Dorma CPAP Injuries & Side Effects
Users of recalled Philips CPAP machines may experience several serious side effects due to the degrading PE-PUR foam.
- Headache: Persistent headaches, particularly upon waking
- Irritation: Irritation of the airways, throat, and lungs
- Inflammation: Inflammatory responses in respiratory tissues
- Chest pressure: Discomfort and pressure in the chest area
- Respiratory issues: Difficulty breathing and other pulmonary problems
- Toxic effects: Exposure to harmful chemicals released by degrading foam
- Cancer (carcinogenic effects): Potential development of cancer from toxic exposure
- Other health issues: Various adverse health effects from foam particle inhalation
Related Article: Philips CPAP Machine Recall Lawsuit Update
Do You Qualify for a Dorma CPAP Recall Lawsuit?
You may qualify for a Dorma CPAP lawsuit if:
- You used one of the recalled CPAP, BiPAP, or other Philips sleep apnea machines every night for at least 6 months or longer.
- You experienced serious side effects including pulmonary fibrosis or other respiratory system injuries, liver or kidney damage, or diagnosis with lung cancer, kidney cancer, liver cancer, or any other type of cancer.
- The injuries required medical treatment or hospitalization.
- You can provide medical documentation linking your injuries to the Dorma CPAP device.
Evidence Required for a Dorma CPAP Recall Lawsuit
To successfully pursue a Dorma CPAP lawsuit, you will need to provide:
- Proof of purchase or use of a recalled Dorma CPAP machine
- Medical records documenting your injuries
- Documentation showing you used the device as directed
- Evidence linking your health issues to the defective CPAP machine
Damages You Can Recover
Compensation in Dorma CPAP lawsuits may include:
- Medical expenses for treatment of related injuries
- Lost wages due to inability to work
- Pain and suffering associated with your injuries
- Punitive damages against the manufacturer
Which CPAP and BIPAP Machines Were Recalled?
Recalled devices include:
- DreamStation ASV
- DreamStation ST
- AVAPS
- SystemOne ASV4
- C Series ASV
- OmniLab Advanced Plus
- SystemOne (Q Series)
- DreamStation CPAP Device
- DreamStation Auto BIPAP and CPAP machines
- DreamStation BiPAP Sleep Apnea Machines
- DreamStation Go Ventilator Machines
- Dorma 400
- Dorma 500
- CPAP REMStar SE Auto CPAP
- Trilogy 100 and 200
- Garbin Plus
- Aeris LifeVent
- A-Series BiPAP machine
- Philips Ventilator Devices
Why is PE-PUR Foam Dangerous?
Intact PE-PUR foam might be relatively harmless, but if the foam breaks down it can release particles and chemical gases, according to Philips Respironics. If these particles or gases enter the body through the nose or mouth they can cause a variety of health issues.
"These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage," FDA said in its Safety Communication.
Even if there are no visible particles, the foam may already be breaking down and releasing harmful chemicals.
Philips Respironics lab analysis found degraded foam produced several potentially harmful chemicals in ventilator machines, including:
- Toluene diamine - A chemical used to make polyurethane, dyes, hydraulic fluid, and sensitizers for explosives. Health hazards include Genetic defects, skin reactions, toxicity, cancer, damaged fertility, and organ damage.
- Toluene diisocyanate - A chemical used to make foams and coatings. Health hazards include Eye damage, skin irritation, which may be fatal if inhaled, respiratory irritation, and cancer.
- Diethylene glycol - A chemical used to make other chemicals that can irritate skin, eyes, and mucous membranes and may be slightly toxic if swallowed.
- Dimethyl diazene - A chemical used to make other chemicals.
- Phenol, 2,6-bis (1,1-dimethyl ethyl)-4-(1-methyl propyl) - A chemical used to make other chemicals.
Philips has Admitted to Many CPAP Lawsuit Allegations
In most mass tort cases, the hard part is proving that the product causes injury. This will not be a problem in the CPAP lawsuit. Philips Respironics was clearly aware of the problems with foam inhalation in its sleep apnea machines for a long time before it eventually issued its safety notice and recall in June 2021.
Philips Respironics further admits that "based on lab testing and evaluations, it may be possible that these potential health risks could result in a wide range of potential patient impact, from transient potential injuries, symptoms and complications, as well as possibly serious injury which can be life-threatening or cause permanent impairment, or require medical intervention to preclude permanent impairment."
CPAP Repair and Replace Program
In September 2021, Philips announced an official "repair-and-replace" program for people with recalled Philips CPAP machines. Part of this program involved replacing the PE-PUR sound abatement foam with a new, silicone-based alternative foam.
Philips obtained preliminary FDA approval for this repair program based on testing results showing that the alternative silicone foam would be safe for use in the recalled devices. However, in November 2021, the agency suddenly withdrew its approval of the repair program after uncovering new evidence that the silicone replacement foam for the recalled CPAP machine may also present health and safety issues. Now the FDA is requiring Philips to halt the repair program and have replacement PE-PUR foam re-tested by an independent laboratory.
The continued investigation into the Philips CPAP recall has also uncovered new internal emails showing that the company was aware of the problem with PE-PUR foam degrading as early as 2015. This means that Philips ignored this potential safety hazard for 6 years before taking any action.
Has a CPAP Machine Recall Lawsuit Been Filed?
In October 2021, an MDL class action panel agreed with plaintiffs' lawyers that there should be a CPAP recall lawsuit over recalled CPAP sleep apnea machines and that it should be based in Pennsylvania.
The Panel transferred the 114 CPAP recall lawsuits pending in federal court to a single judge in Pennsylvania. So if you file a Philips CPAP lawsuit in California, Texas, New York, or any other state, the CPAP recall lawsuit will get transferred to this court.
Most plaintiffs' attorneys hoped the CPAP lawsuit would be in Eastern Pennsylvania (Philadelphia) and not Western Pennsylvania (Pittsburgh). The MDL Panel chose Western Pennsylvania as the location for the CPAP recall lawsuit.
U.S. District Judge Joy Flowers Conti in Pittsburgh will preside over both CPAP consumer class action lawsuits and personal injury claims. Judge Conti is an experienced jurist who has sat on the federal bench for nearly 20 years.
Statute of Limitations for Dorma CPAP Lawsuits
Philips CPAP lawsuits must be filed before the statute of limitations ("SOL") for the claim expires. The applicable SOL deadline varies by state and can be anywhere from 1 to 6 years.
The statute of limitations for a CPAP or BiPAP device lawsuit may start on June 14, 2021, when Philips announced the CPAP recall. The statute of limitations varies by state. So if your state has a 2-year SOL, your deadline for filing a lawsuit will be June 14, 2023.
The rules governing deadlines to sue to have scores of exceptions that may shorten or extend your obligation to file a CPAP lawsuit or provide notice of your intention to do so. So you want to talk to a CPAP lawyer to verify the deadline to file a lawsuit for your claim.
Related Articles:
- Can CPAP Machines Cause Cancer?
- CPAP Linked to Pneumonia
- Philips Microstream Co2 Filter Lines Recall Lawsuit
See all related medical device lawsuits our attorneys covered so far.
FAQs
1. Who is eligible to file a claim in the Dorma recall lawsuit?
Individuals who used one of the recalled Dorma CPAP devices for at least 6 months and subsequently developed respiratory issues, organ damage, or cancer may be eligible to file a claim. Medical documentation linking your injuries to the device use is required.
2. How can I check if my Dorma product is part of the recall?
To verify if your Dorma product is part of the recall, check the product's model number against the list of recalled devices. The recall includes Dorma 400 and Dorma 500 models, along with other Philips Respironics devices that contain the PE-PUR foam.
3. What compensation can be sought through the Dorma CPAP lawsuit?
Compensation may include medical expenses, lost wages, pain and suffering, and punitive damages. For CPAP cancer lawsuits, the average settlement compensation payouts are expected to be between $100,000 and $500,000, with trial values potentially being significantly higher.
4. What is the problem with the recalled Dorma CPAP machines?
The recalled Dorma CPAP machines contain polyester-based polyurethane (PE-PUR) foam that can degrade over time, releasing potentially harmful particles and chemicals into the device's air pathway that may be inhaled or swallowed by users.
5. How long has Philips known about the CPAP machine issues?
FDA investigations revealed that Philips knew about the problems with the PE-PUR foam as early as 2015, with evidence including emails from that year and at least 14 tests or assessments dating back to 2016, yet the company did not issue a recall until June 2021.
6. What should I do if I'm currently using a recalled CPAP machine?
If you're using a recalled CPAP machine, consult with your healthcare provider immediately to discuss alternative treatment options. Do not stop using your device without medical guidance, as untreated sleep apnea poses serious health risks.
7. How much could my CPAP lawsuit be worth?
While each case is unique, for CPAP cancer lawsuits, the average settlement compensation payouts are expected to be between $100,000 and $500,000. Cases with severe injuries that go to trial could potentially result in significantly higher compensation if liability is established.
Get a Free Dorma CPAP Recall Lawsuit Evaluation With Our Lawyers
Time is limited to pursue legal action regarding Dorma CPAP devices. Most states have statutes of limitations ranging from 1-6 years from the date of the recall (June 14, 2021) or from when you discovered your injuries.
Our services include:
- Free, confidential consultations to evaluate your case.
- No upfront costs or fees for our legal representation.
- Payment only if we win your case and secure compensation for you.
References