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FDA Orders Philips to Improve Communications About CPAP Recall & Health Risks

Riddle Brantley LLP   |  April 25, 2022   |  

Philips Warned By FDA to Step Up CPAP Health Risk Warnings

The FDA has ordered Philips to improve its communications related to its CPAP recall and potential health risks.In June 2021, Philips issued a recall of many of their CPAP and ventilator devices due to findings that the devices may pose a risk to consumers’ health, including putting them at higher risk for cancer and breathing problems. However, the FDA has now made clear that it does not believe Philips has been proactive enough in warning consumers about the machines’ risks and is ordering them to more directly notify patients and the public of the current recall.

The Director of the FDA’s Center of Devices and Radiological Health stated, “The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process.”

In the notification order they’ve now received, Philips is being instructed to directly notify all device users, suppliers, distributors, retailers, and healthcare providers of the recall and health risks associated with the products. They are also providing recommendations about how Philips should communicate with the public regarding the recall, including recommending monthly updates to registered device users.

“We are concerned Philips is not taking seriously the health risks potentially linked to its CPAP machines, and we are determined to hold the company accountable for any potential negligence or wrongdoing.”

Gene Riddle, CPAP lawsuit attorney, Riddle & Brantley

Millions Potentially at Risk

It is estimated that around three to four million people were using these devices worldwide before the recall, and the FDA has made it clear that many of these users could still be at risk due to insufficient efforts from Philips to get them to discontinue using their machines.

If you’ve used a recalled Philips CPAP machine, Bi-Level PAP machine, or mechanical ventilator and were later diagnosed with a qualifying cancer or breathing problem, please call 1-800-525-7111 or complete the quick form below. You may qualify for a CPAP lawsuit and be entitled to compensation and we would love to help however we can.

Why is Philips Recalling CPAP Machines and Other Devices?

Many CPAP and ventilator machines manufactured by Philips contain polyester-based polyurethane sound abatement foam (known as PE-PUR). When PE-PUR is exposed to moisture, it can break down and release small pieces of particulate and off-gas toxic chemicals. These chemicals can pose serious health risks, potentially including breathing problems and cancers.

Due to the design of many of these machines, the PE-PUR component is regularly exposed to moisture, which can cause degradation of the component inside the machine and lead to users inhaling the gasses and particulate.

Recalled Philips CPAP devices include:

  • All CPAP and BiLevel PAP devices manufactured before April 26th, 2021
  • E30 model continuous ventilator
  • Dreamstation ASV, Dreamstation ST/AVAPS, Dreamstation GO systems
  • All mechanical ventilators manufactured before April 26th, 2021

CPAP Lawsuits Pending Against Philips

Lawsuits have been mounting against Philips as consumers not only bring cases against them for adverse health effects associated with using the machines but also seek reimbursement for the costs associated with purchasing an entirely new replacement machine.

In July of 2021, three class-action lawsuits were filed by plaintiffs in Pennsylvania and Massachusetts seeking reimbursement from Philips for costs associated with replacing their defective Philips devices and other expenses such as missed work due to not having a functioning machine. As of writing, there are currently 262 suits pending in the class action.

On July 7th, a plaintiff in Pennsylvania filed a motion requesting his case be combined into a multi-district litigation (MDL) with all other similar cases.

As the lawsuits move forward, many more users continue to face difficult choices as one investigative journalism team found that out of five million recalled devices, Philips has only been able to send out repair kits to one and a half million patients. This leaves the rest of the users to face going without the machine they depend on or putting themselves at risk for respiratory complications by continuing to use their device.

If you are someone who is currently using one of these recalled devices, you should consult with your physician immediately to discuss alternatives. If possible, you should discontinue using the device immediately and utilize alternative treatment methods.

Do You Have a Claim?

If you’ve used a recalled Philips CPAP machine or other device and were later diagnosed with lung cancer, kidney cancer, liver cancer, another qualifying type of cancer or breathing problems like severe asthma or recurring pneumonia, you may have a claim for compensation in a CPAP lawsuit. Call 1-800-525-7111 today and let’s see how we can help.

Call 1-800-525-7111 and let’s review your claim. You may be entitled to compensation and Justice Counts.