Millions of Americans have been diagnosed with sleep apnea and have used a Continuous Positive Airway Pressure (CPAP) device. According to the American Medical Association, approximately 30 million Americans have sleep apnea. Unfortunately, on June 14,2021, Philips Respironics, one of the major manufacturers of CPAP devices, recalled millions of its CPAP and Bilevel Positive Airway Pressure (BiPAP) machines, which are used to treat sleep apnea, and ventilators, which treat respiratory failure. As part of the recall, Philips disclosed that they have identified serious risks associated with their devices due to the cancer-causing chemical emissions they produce. As a result, CPAP users have begun to file Philips CPAP recall lawsuits.
UPDATE: In a major development, on April 9, 2024, a federal district court finalized a consent decree against Philips Respironics (Philips). The U.S. Department of Justice has issued a court order instructing Philips to overhaul its manufacturing and quality control systems. They are also required to hire independent contractors to vet the changes. Philips must also continue to replace, repair or provide refunds to all U.S. customers who received the defective devices. This is a major step in resolving one of history’s largest recalls of a medical device, which has been ongoing for almost three years. For more information, you can also visit the U.S. Food & Drug Administration page regarding the recalled devices.
UPDATE: On January 24, 2024 Philips announced that it will not sell new continuous positive airway pressure or bilevel positive airway pressure sleep therapy devices in the U.S. until it meets certain terms of a consent decree with the Department of Justice.
The consent decree must be finalized and submitted to a U.S. court for approval. Philips will continue to service existing sleep and respiratory care devices and supply replacement parts and repair kits. This follows Philips 2021 massive recall of more than 15 million sleep apnea devices and ventilators due to the breakdown of soundproofing foam. Philips attempts to address the FDA’s concerns through independent testing were inadequate: “The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.” In connection with the Consent Decree, Philips has discontinued many of its popular products, including the DreamStation Go and Trilogy 100/200/202.
If you or a loved one has been diagnosed with cancer or organ failure due to the recalled Philips devices, you may be entitled to compensation.
Philips Respironics recalled millions of its CPAP, BiPAP, and mechanical ventilator devices due to the health risks associated with the breakdown of noise reduction foam used in the machines. The polyester-based polyurethane foam (PE-PUR) reduces the sound and vibration of the devices. In testing, Philips found that as the foam degrades, it releases toxic chemicals and particles.
Lab tests indicated emissions of the following harmful chemicals: toluene diamine, toluene diisocyanate, diethylene glycol, and dimethyl diazine.
Black foam pieces—which you may not be able to perceive—and volatile organic compounds (VOCs) can enter the air tubes. According to the FDA, when inhaled or ingested, these foam fragments and toxic chemicals can result in serious injury, permanent health impairment, and even death.
Three types of breathing aid devices have been recalled:
Recalled CPAP and BiPAP devices include the following models:
Impacted ventilators include the following models:
The recalls on each model listed above apply to all serial numbers.
Certain Trilogy Evo ventilators with specific serial numbers were also recalled between April 15, 2021 and May 24, 2021. Users can find the serial number on the bottom of the ventilator. Philips published images and information on their website to help you determine whether your device has been recalled.
In January 2023, the FDA classified the recall as a Class I recall: the most severe recall classification due to potentially serious health hazards and even death.
Inhaling or ingesting the foam pieces can lead to eye, skin, nose, and airway irritation in addition to inflammation, headache, and asthma. The toxins can also cause cancer in organs such as the kidneys or liver.
Breathing in the chemicals emitted as the foam breaks down can also result in irritation as well as headache, dizziness, nausea and vomiting, and allergic or immune system reactions. Inhaling these toxic chemicals also has cancer-causing effects.
Since April 2021, the number of medical device reports (MDRs) documenting malfunctions and device-related health risks has dramatically increased for Philips CPAP, BiPAP, and ventilator devices. From 2011-2021, only 30 MDRs related to PE-PUR foam breakdown were submitted to the FDA with no reports of injury or death. This data greatly contrasts the 105,000 MDRs filed since April 2021, 385 of which document user deaths from suspected foam degradation.
As part of Philips’ repair and replacement program, impacted users received reworked Trilogy 100, Trilogy 200, and Garbin Plus ventilators that replaced the PE-PUR foam with silicone-based foam. However, the devices contained residual PE-PUR foam, and the silicone foam material presented additional risks. The adhesive used to secure the silicone foam to its plastic backing can fail, leading users to experience life-threatening breathing issues such as asphyxia, hypoventilation, and hypoxemia.
These outcomes demonstrate the severity of the devices’ malfunction and underscore the importance of Philips CPAP recall lawsuits.
The breakdown of foam insulation from CPAP, BIPAP or ventilator machines may result in inhalation of foam particles and toxic chemicals potentially leading to a wide variety of health conditions, including:
These conditions can cause serious injuries, and even permanent damage resulting in lifelong health impacts. In some cases, conditions triggered by defective Philips devices may be fatal. If you have used a Philips device and experienced one of these health conditions, you may be entitled to compensation.
If you use a recalled Philips device, the FDA recommends that you continue using the device and contact your doctor. In some cases, stopping the use of the machine may pose a greater risk. You should discuss your situation with your healthcare provider before making any changes to your respiratory therapy. Your doctor may recommend transitioning to alternative devices based on clinical assessment.
While you are likely concerned about the integrity of your device, you should not use ozone or UV light cleaners, add a filter to your CPAP or BiPAP machine, or attempt to remove the foam from your device.
After speaking with your healthcare provider, register your device with Philips to initiate the process for device replacement. Regularly monitor your device for trigger alarms until you receive your new machine. If you have been diagnosed with a serious injury, we recommend that you contact our office to discuss device preservation prior to returning the device to Philips.
You can also report adverse events related to the use of your Philips device through the MedWatch Voluntary Reporting Form.
For the most recent information related to this and other recalls, visit the FDA’s Medical Device Recall Page.
A 2021 FDA investigation found that Philips knew about and ignored the problems related to the PE-PUR foam degradation years before the voluntary recall was initiated. If you or a loved one has been diagnosed with cancer or another serious health condition while using a recalled Philips CPAP, BiPAP, or ventilator machine, you may be entitled to compensation.
If you have a claim, you may be eligible to recover compensation for healthcare expenses, lost wages or benefits, childcare costs, and pain and suffering. Our experienced team at Lipsitz, Ponterio & Comerford, LLC, can help determine your eligibility for a Philips CPAP recall lawsuit.
There are strict time limits to file a claim in New York State. The statute of limitations for a personal injury action based on a defective medical device generally requires that an action be commenced within three years of the date of discovery. The statute of limitations often depends on the particular facts of your case and can be a complicated analysis. If you used a recalled CPAP device, such as the DreamStation, and experienced a health-related issue, please call us to discuss your potential claim.
Lipsitz, Ponterio & Comerford, LLC is now accepting CPAP litigation cases. As your trusted attorneys, we will fight to seek compensation for your injury or illness so that you don’t have to fight alone. We will handle everything your case requires, from gathering evidence to building a strong legal strategy. With decades of experience and a proven track record of success, we skillfully navigate the complexities of personal injury cases, ensuring you receive the best possible outcome from your Philips CPAP recall lawsuit.
If you were diagnosed with cancer or organ failure after using a Philip device, please contact our attorneys for a free consultation to review the specifics of your case and determine your eligibility for a CPAP lawsuit. Our compassionate attorneys are here to support you and hold Philips Respironics accountable for their defective breathing assistance products.
Contact our firm today to learn more about filing a lawsuit against Philips for their defective CPAP devices.
We hope that you will never be diagnosed with mesothelioma, lung cancer, or suffer a catastrophic injury, but if you are, contact us at Lipsitz, Ponterio & Comerford so we can begin the fight.
Call Today: 866-238-1452 or fill out the online form.
Your state’s law may limit your time to file a legal claim. For a free and confidential case evaluation, please complete this form.