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Philips Respironics is recalling more ventilators due to continuing issues with its polyurethane (PE-PUR) sound abatement foam, according to the U.S. Food and Drug Administration (FDA).
The FDA announced the expanded recall on January 26, identifying it as a Class I recall. This is “the most serious type of recall. Use of these devices may cause serious injuries or death.” (1)
According to the FDA, “The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.” (2)
Philips Kept Using Foam It Knew Was Defective
It is almost beyond belief that even while Philips was preparing its recall last year, Philips was still using the defective foam in other devices, and didn’t announce the recall of those devices until the FDA discovered it six months later. That is not just an oversight, it is, at best, sheer incompetence by Philips and/or its contractor,” emphasizes Ellen Relkin, partner and chair of Weitz & Luxenberg’s Drug and Medical Device Litigation practice group.
Initial Philips Recall Expanded
This recall follows an earlier recall in the summer of 2021 for some of the same devices — the Trilogy 100 and 200 ventilators. Philips had already issued a recall for many ventilators, CPAP, and BiPAP units due to serious health risks, including their flagship DreamStation products. (3)
The additional Trilogy products were recalled by Phillips and announced on the FDA website in December 2021. These include certain models of the Trilogy Evo ventilator (4) and specific repair kits for the Trilogy Evo muffler assembly. The items were manufactured and distributed between April 15 and May 24, 2021. (5)
FDA Indicates Wrong Foam Used
The FDA indicates, “A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material, in the muffler assembly of the affected Trilogy Evo ventilators. The issue was identified during lab testing.” (6)
The announcement from the FDA also states, “As noted during a recent FDA inspection, an incorrect and non-specified polyester polyurethane, raw foam product, not intended for use in Trilogy Evo ventilators, was used to manufacture certain Trilogy Evo ventilators with specific serial numbers. The foam was determined to be PE-PUR foam, the same foam used in Philips Respironics devices previously recalled in June 2021.” (7)
Ms. Relkin states that, “Consumers should be grateful that in recent months, the FDA has been vigilant to inspect and act to protect the public health of users of Philips’ breathing devices.”
Health Risks Are Life-Threatening
As an FDA Class 1 recall, these ventilators can potentially cause life-threatening injuries and even result in death.
Overall categories of health risks from the deteriorating foam include: (8)
- Asthma and other respiratory and lung problems.
- Irritation (skin, eye, and respiratory tract).
- Inflammatory response.
- Headache.
- Adverse effects to other organs (e.g., kidneys and liver).
- Toxic and carcinogenic affects.
Although the ventilators are less than a year old, there is a potential greater concern of volatile organic compounds (VOCs) with the defective PE-PUR foam.
The U.S. Environmental Protection Agency (EPA) explains, “Volatile organic compounds (VOCs) are emitted as gases from certain solids or liquids. VOCs include a variety of chemicals, some of which may have short- and long-term adverse health effects.” (9)
Attorney Brendan McDonough points out, “There is obviously more continuous exposure for clients in those early months of high VOC release with a ventilator. This risk is ongoing 24/7.” In addition to being a W&L medical device attorney, Mr. McDonough is also a medical engineer. His training gives him an added edge in understanding all the mechanics behind defective medical devices.
Why Are Ventilators Used?
Mechanical ventilators are used to help people breathe. Ventilators push air in your lungs to help you breathe better, or in some case, at all.
“The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of pediatric through adult patients weighing at least 2.5 kg who require mechanical ventilation,” according to the FDA. “It may be used for both invasive and non-invasive ventilation.” (10)
What To Do If You Have a Defective Ventilator
If you have one of the defective ventilators or related items, there are several things you should do.
Call your doctor immediately. The FDA recall notice indicates Urgent Medical Device Recall notifications were sent out by Philips Respironics in December 2021 and January 2022 suggesting certain actions. (11)
Reach Out to Our Law Firm for Help
If you think you have been injured, reach out to our law firm, Weitz & Luxenberg. We have received thousands of calls since July of 2021 from people who were injured after using one of these defective Philips PAP, CPAP or ventilator devices.
If you have suffered from any injuries, consider hiring our team to represent you in any possible future settlement — and in court if necessary.
Getting Justice for Our Clients
When you have to go up against a big multinational company, you need a law firm and attorneys who already have that type of experience. The attorneys on our defective medical device team have done so multiple times. W&L’s defective drug and device team has won more than $12 billion in verdicts and settlements for our clients.
Ms. Relkin is the court-appointed lead counsel in a multibillion dollar settlement for clients with the recalled DePuy ASR hip implant. She is also on the team for a $1+ billion settlement, due to Stryker Rejuvenate and ABGII modular hip implants defects. She is current Co-Lead Counsel in the JUUL Multi-District litigation involving another product that is injurious to the lungs. She was appointed by the MDL Judge in this Phillips Recalled CPAP and Mechanical Ventilator Products Liability Litigation to negotiate the Interim Preservation Order to ensure that the Phillips Dream Station I devices were properly preserved by Phillips as evidence in the case.
Our team of attorneys has helped thousands of clients over the three decades W&L has been getting justice for people hurt by large manufacturers. Call us to discuss your legal options. It’s free.
