Update: Philips CPAP Lawsuit & Recall
As you have already heard by now, Philips Respironics recalled CPAP & BiPAP machines after the FDA put them under Class I recall. This is a very serious recall type because it means the continued use of these devices can cause injuries and death. If you have been affected, we encourage you to speak to the defective medical device attorneys at Cohen & Jaffe regarding the Philips CPAP lawsuit. You may qualify for compensation.
Device Descriptions and Use
The non-continuous and continuous ventilators provide non-invasive and invasive support for patients who need treatment for sleep problems and those with respiratory issues. The ventilator type used depends on the patient’s therapeutic needs. BiPAPs, CPAPs, and other ventilators find use in hospitals, homes, and other healthcare settings. The devices in question are those used to help patients with their breathing difficulties. They include:
- CPAP (Continuous Positive Airway Pressure) machine keeps the patient’s airway open, so he can receive a continuous stream of air. CPAP is useful if you are suffering from obstructive sleep apnea. It will help keep your airways open as you sleep.
- BiPAP, BPAP, or BiLevel PAP, a two-level positive airway pressure machine that pumps air into the patient’s lungs. This machine has high pressure when the patient breathes in and low pressure when the patient breathes out.
- Continuous ventilator. This machine mechanically assists or controls patient breathing. It delivers the right amount of oxygen to the patient.
Why the Philips CPAP Lawsuit & Recall
Philips Respironics recalled both non-continuous and continuous ventilators because they contain PE-PUR (polyester-based polyurethane) sound mitigation foam. This substance reduces vibrations and the associated sounds in these devices. This substance is prone to break down, and its particles can enter the air pathway of the device and end up in the patient’s body. Exposure to chemicals and debris from PE-PUR can cause adverse effects on patients, including toxic cancer-causing effects, harmful effects to body organs like liver and kidneys, nausea/vomiting, hypersensitivity, asthma, headache, inflammation, and irritation in the respiratory tract, eyes, and skin. So far, users of these devices have reported over 100 injuries and 1200 complaints.
Who is at Risk
People who are likely to get affected by these ventilators include:
- Sleep and DME (Durable Medical Equipment) laboratories
- Health care workers
- Anyone using these devices
What You Should Do
Philips Respironics notified their customers via an urgent device recall to:
- Work with their DME provider and qualified physician to determine the best treatment option available. If there are no alternatives and you want to continue using this device, let a physician help you determine whether the benefits you’ll get outweigh the risk under the Class I recall.
- Philips Respironics is willing to replace the polyester-based polyurethane foam with silicone foam to correct the problem in the field.
- Whether you are a patient or customer, stop using ozone-related products for cleaning and make sure you follow the correct cleaning products and methods approved by the manufacturer. However, this will not protect you against the chemicals and particles resulting from the degradation of PE-PUR.
- Make sure you register your device on the company’s recall website. You’ll get current information on the website on how your case can be resolved permanently. The website will also help you locate the device’s serial number and guide you through the registration process. CPAP and BiPAP patients and customers can review their devices’ ages because these devices need to be replaced after every five years.
Recommendations for Caregivers and Those Using these Ventilators at Home
The FDA recommends that:
- You do not change or stop using the ventilator until your healthcare provider is notified. You can’t stop using the ventilator until an alternative life-sustaining therapy is made available. This will be the case if disruption of your ventilation can cause more harm than the continued use of the device. In the meantime, your health care provider will be working to get another device or have the PE-PUR replaced.
- Discuss with your physician whether you can use an inline bacterial filter, a component that helps filter small particles from PE-PUR. Even though the FDA is still evaluating the effectiveness of this filter to mitigate foam risks, it can act as a short-term measure to ensure the patient continues with the ventilation. The filter is not 100% safe because it affects the ventilator’s performance and may not provide maximum protection against chemicals and particles from PE-PUR.
- Register your device at Philip’s recall website and report the problems with the device through the MedWatch Voluntary Reporting Form (by FDA).
Recommendations for Health Care Facilities and Providers
Health care facilities and health care providers should follow the same recommendation above. They should also review the above recommendations with their affected patients. Finally, they have to service all the affected devices, and either replace the PE-PUR or look for alternative ventilators. If any of their devices show signs of degradation, they should report via the MedWatch Voluntary Reporting Form.
Actions by the FDA
The FDA posted answers to Frequently Asked Questions (FAQs) about the recall way back in July 2021. In the same month, they identified and classified the device problems under Class I recall. The FDA has taken steps to ensure Philips Respironics evaluates the problems with their devices, adheres to the recall, and takes steps to mitigate the problem by taking appropriate corrective actions. The FDA is still scrutinizing the MDRs (Medical device reports) that relate to these ventilators for the period 2009 to 2021. This will help the agency come up with further remedial measures concerning these ventilators.
Right now, the agency has no evidence that any other ventilators, BiPAP machines, or CPAP machines from Philips Respironics or other companies are affected. The FDA will continue monitoring the demand and supply of the affected devices to address any potential shortages. The agency promises to continue sharing more information and updates with the public as they become available.
Get Legal Help Today
The FDA tries to advocate for the nation as a whole, but you need to ensure you have an advocate looking out specifically for your interests. If you believe your family was affected by a a defective medical device, medical product error like this one, please contact a knowledgeable injury lawyer to protect your rights. Our team at The Law Office of Cohen & Jaffe LLP is available today to provide a free case evaluation to see if you qualify for compensation from a Philips CPAP lawsuit. Call today or contact us online!
For a free legal consultation, call 516-358-6900