Philips CPAP Lawsuits: Problems With Device Replacement Leave Recall Issues Unresolved

Many people still do not have devices they need to treat sleep apnea after Philips Respironics recalled millions of devices in June of 2021. Philips says that supply chain delays will force patients to wait for replacement devices until 2023. Additionally, the U.S. Food & Drug Administration (FDA) notes that certain reworked ventilators that were updated to address the original product defects have new potential defects of their own. 

Five million Philips sleep apnea devices, including CPAP, BiPAP, and other mechanical ventilator devices, were recalled by the manufacturer. Now, hundreds of plaintiffs have filed lawsuits to hold Philips accountable. Thousands more are expected to join the existing suits. 

Why Did Philips Issue a Recall for Sleep Apnea Machines?

In June of 2021, Philips issued a product recall for its CPAP, BiPAP, and mechanical ventilators due to a defect in the devices’ polyester-based polyurethane (PE-PUR) sound abatement foam. The foam could degrade over time, causing patients to inhale foam particles along with other dangerous chemicals. This could lead to serious respiratory irritation and other conditions, including cancer. 

The company faced scrutiny from the FDA for failing to properly track these defects in these machines and alert patients to the known risks involved with their use. Internal company documents show that Philips was aware of these defects long before issuing the recall. 

What Did Philips Do to Address the Problem?

After Philips issued its product recall in June of 2021, the company said that it would repair defective products that contained PE-PUR sound abatement foam. (FDA) The company would place this foam with a silicone foam designed for the same purpose. This initially allowed people with devices included in the recall to have their devices repaired. The company later created a device replacement program. 

Initially, many patients did not receive notification about the recall, however. Additionally, patients faced many issues with getting their devices replaced. The FDA has issued several warning letters to the FDA throughout the recall process about the company’s failure to appropriately organize a replacement process and test replacement devices. 

To date, Philips says that it has produced 3,950,000 replacement devices and repair kits and shipped 2,000,000 of those replacement devices. However, that number falls short of the five million devices affected by the recall. 

Plaintiffs Are Filing Lawsuits for Damages Against Philips

People are now filing lawsuits for injuries and losses they faced due to recalled Philips sleep apnea devices. Patients are filing injury lawsuits and wrongful death lawsuits on behalf of loved ones who passed away from cancer related to these defective devices. If you or a family member faced injuries and damages because of a Philips sleep apnea machine, you could join the existing lawsuits and seek compensation. Victims could seek compensation for their necessary medical treatment, lost earnings due to their injuries, and wrongful death damages, among other losses. Fill out a contact form to connect with a mass torts lawyer in your network to learn more.