Nearly 350 Deaths Linked to Recalled Philips CPAP Sleep Apnea Machines, FDA Warns

The breakdown of sound abatement foam in recalled Philips CPAP sleep apnea machines has been linked to nearly 350 deaths, and almost 100,000 reports involving health complications among former users, according to a new report by federal regulators.

A Philips CPAP recall was issued in 2021, impacting millions of machines sold since 2009, following widespread reports of small black particles being found in the tubing and face masks, which was released by a polyester-based polyurethane (PE-PUR) foam intended to reduce noise and vibrations while the sleep apnea machines were used at night.

As a result of the potential CPAP foam health risks, federal health officials immediately warned all consumers to stop using the recalled machines, unless needed for life-sustaining therapy, and reports immediately began to surface of former users developing various cancers, lymphoma, lung damage and other injuries linked to the toxic chemicals and gasses released as the sound abatement foam breaks down.

Thousands of Philips CPAP lawsuits have been filed throughout the federal court system, and it is widely expected that the litigation may become one of the active largest mass torts in the U.S. within a few years.

On February 9, the U.S. Food and Drug Administration issued an update about the current number of medical device reports received by the agency linked to PE-PUR foam degradation in recalled Philips CPAP devices.

Since April 2021, the FDA indicates it has received more than 98,000 medical device reports following exposure to the recalled sleep apnea machines, as well as recalled ventilators and BiPAP machines also affected by the recall. That number includes 346 reports of death linked to the foam particles.

“The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients,” according to the FDA update. “A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.”

The update comes after Philips announced in December that it had done its own assessment of some recalled DreamStation CPAP machines, claiming the company found the health risks from PE-PUR foam are low. However, Philips acknowledged at the time that the FDA might “reach different conclusions” about the data.

February 2023 Philips CPAP Recall Lawsuit Update

Given common questions of fact and law raised in product liability lawsuits filed throughout the federal court system against Philips, a multidistrict litigation (MDL) has been established before U.S. District Judge Joy Flowers Conti, in the Western District of Pennsylvania, who is presiding over coordinated discovery and pretrial proceedings to establish which specific injuries are caused by exposure to the foam, and the average Philips CPAP settlement amounts each individual plaintiff should receive.

On February 6, Judge Conti issued a pretrial order (PDF) which schedules monthly status conferences throughout the year on the following dates:

• April 20, 2023
• May 24, 2023
• June 15, 2023
• July 20, 2023
• August 17, 2023
• September 21, 2023
• October 19, 2023
• November 16, 2023
• December 14, 2023

As part of the coordinated management of the litigation, it is expected that Judge Conti will establish a “bellwether” process, where the parties will identify small groups of representative claims to prepare for early trial dates, which are designed to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the proceedings. However, if Philips CPAP machine settlements are not reached in the MDL, each claim may later be remanded to different U.S. District Courts nationwide for separate trial dates in the future.