Philips Breathing Devices Foam Problems May Cause Cancers, Lung Diseases, Kidney and Liver Failures, Other Medical Conditions
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The Law Offices of Thomas J. Lamb represents people who have been harmed by unsafe medical products, including cases that involve the June 2021 Philips breathing devices recall.
June 2021 Recall of Philips Bi-Level PAP and CPAP Devices, Mechanical Ventilators
There was a June 2021 Philips products recall for certain Philips Bi-Level PAP devices, Philips CPAP machines, and Philips Mechanical Ventilators due to possible toxic exposures from the polyester-based polyurethane (PE-PUR) sound abatement foam component in those Philips products. This Philips breathing devices defect is found in many of its Bi-Level PAP devices and CPAP machines as well as Mechanical Ventilators that were manufactured between July 2009 and April 2021. Regarding patient health issues, the harmful foam problem in defective Philips devices might cause cancers, lung diseases, organ failures, and other medical conditions in patients who used these recalled Philips products in the past.
From the June 2021 Philips recall notification, we get this important information for patients:
Philips determined based on testing that there are possible risks to users related to [the polyester-based polyurethane (PE-PUR) sound abatement foam component]. The risks include that the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals. [emphasis added]
In this document, “Medical Device Recall Notification — Philips Respironics Sleep and Respiratory Care devices“, Philips Respironics provides some product identification information about the various Philips Bi-Level PAP devices (also known as BiLevel PAP, BiPAP, or BPAP), Philips CPAP machines, and Philips Mechanical Ventilators covered by this June 2021 Philips products recall — as well as what Philips products are not covered by this June 2021 Philips recall, and why.
On June 30, 2021, the FDA issued this document to alert and inform patients, “Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication“, which lists the Philips breathing devices manufactured between July 2009 and April 26, 2021 that are covered by the June 2021 Philips products recall. For more information from this June 2021 FDA document about the Philips breathing devices recall, see our report: “FDA Safety Alert about Philips Recall of Ventilators, BiPAP, and CPAP Machines“.
Products Liability Lawsuits Against Philips for Personal Injury and Wrongful Death
Our law firm is investigating lawsuits against Philips for patients who have been diagnosed with cancer, lung disease, and kidney or liver failure, as well as other medical conditions, following their use of these recalled Philips products:
- Philips Bi-Level Positive Airway Pressure (Bi-Level PAP) Devices
- Philips Continuous Positive Airway Pressure (CPAP) Machines
- Philips Mechanical Ventilators
We encourage you to submit a Philips Breathing Devices Case Evaluation – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible Philips breathing devices lawsuit. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
We are here to help patients and their families who have been injured in connection with this Philips breathing devices recall situation. We have successfully handled personal injury and wrongful death cases for people throughout the country.
Our firm does not put its clients into large class actions lawsuits. Rather, an individual lawsuit is filed for each case. There are no costs associated with having us review your possible Philips breathing devices case.
Be assured that the information you provide to our law firm is treated as strictly confidential. Submitting a Philips Breathing Devices Case Evaluation does not obligate you to hire our law firm.
Lastly, we want you to know that you will get a reply directly from attorney Tom Lamb no later than the next business day.
Most Recent Article on This Topic
Philips Faces Lawsuit from SoClean Inc. Over Its Statements About Use of Ozone Cleaners in CPAP and BiPAP Machines
According to this October 13, 2021, Boston Globe article, “N.H. cleaning products frim files suit against Philips“, SoClean Inc., a cleaning products company that provides ozone cleaners for CPAP and BiPAP machines, has filed a lawsuit against medical device maker Philips:
SoClean Inc. on Tuesday filed a lawsuit in US District Court in Boston demanding $200 million in damages, saying Philips wrongly implicated its products for the problems that prompted Philips in June to issue the massive recall of devices commonly known as CPAP and BiPAP machines.
“Philips’s false and misleading statements” regarding SoClean products “have had a devastating impact on SoClean,” the lawsuit says. “SoClean’s sales have plummeted, its brand reputation has been tarnished, and the company has lost an enormous amount of goodwill.”
The lawsuit comes following Philips’s recall of nearly 2 million machines after the discovery that a foam sound abatement component on the machines was thought to have the potential to break down over time, leading to the inhalation of foam particles.
Since the recall, Philips’ CEO and chairman Frans van Houten has recommended its people discontinue the use of ozone-related cleaning products with Philips CPAP and BiPAP machines:
In a Q&A published on its website after the recall, Philips wrote that it recommends that patients “halt use of ozone-related cleaning products,” the complaint says.
Philips also told consumers “the foam degradation may be exacerbated by the use of unapproved cleaning methods, such as ozone,” the complaint says.
And in an earnings call in July, van Houten said of ozone cleaners, “It’s a very aggressive cleaning method that should not be used on medical devices at all,” the complaint says.
SoClean’s lawsuit filed against Philips rejects the notion its products may be to blame for the breakdown of the foam component in the Philips breathing machines and places the blame solely on Philips:
The SoClean complaint says the real reason that foam is breaking down in some CPAP machines is a faulty design by Philips. “Simply put, the safety concerns that led to the recall arose because of Philips’s poor choice of foam,” the complaint says.
The complaint also says the cleaning instructions provided by Philips “are wholly inadequate to disinfect the entire machine. A superficial cleaning with soap and warm water is not sufficient.”
Philips is also currently facing lawsuits on behalf of the users of its machines, stating Philips failed to disclose the defect in a timely manner. Numerous class-action lawsuits have been filed based on consumer fraud allegations, while some individual lawsuits for people have been filed for their personal injury claims. To date, Philips has reported receiving a “limited number” of reports of adverse events related to its machines.
Philips has acknowledged the potential impact that inhalation of the foam sound abatement component may have on patients:
After an investigation, the company has said, it determined that patients exposed to the degradation of the foam risk serious consequences, including “asthma, adverse effects on other organs (e.g., kidney and liver) and toxic carcinogenic effects.”
Philips has said it first discovered the breakdown of the foam and its risks to patients through its own quality management system.
Philips has pledged to repair or replace the affected CPAP machines. In a statement released Wednesday, a company spokesman said completion of that task may take a year or more.
Philips has implemented a patient awareness initiative and is working closely with providers to contact CPAP users, as Philips does not have the complete contact information to communicate directly with CPAP users.
If you or someone you know used one of the recalled Philips Bi-Level PAP, Philips CPAP, or Philips Mechanical Ventilator devices and, in turn, developed cancer or experienced organ failure, we are providing free case evaluations for possible lawsuits against Philips. You can use our online Philips Breathing Devices Case Evaluation Form or, if you prefer, call us on our toll-free number, 800-426-9535.[Read article in full at original source][/expand]
Our earlier articles about this Philips breathing devices recall situation:
- Philips Brand Breathing Devices Part of June 2021 Product Recall
- Products Recall: Philips Bi-Level PAP, CPAP, and Mechanical Ventilator Devices Using PE-PUR Sound Abatement Foam
- FDA Safety Alert about Philips Recall of CPAP Machines, BiPAP Devices, and Ventilators
- Philips CPAP Machines Recall: FDA Warning Issued in July 2021