More Than 561 Deaths Linked to Recalled Philips CPAP Devices: FDA

Recalled Philips CPAP, BiPAP and other breathing assistance devices have been linked to at least 561 deaths since 2021, as well as nearly 120,000 reports of involving other serious health problems that stemmed from exposure to toxic sound abatement foam particles released by the machines, according to federal regulators.

Just two days after Philips officially announced it was halting sales of all its CPAP devices in the United States as part of an agreement with the federal government, the U.S. Food and Drug Administration (FDA) released an update on Philips CPAP medical device reports, which continue to climb.

A massive Philips CPAP DreamStation recall was first announced in July 2021, impacting millions of CPAP, BiPAP and mechanical ventilators sold since 2009, which contained a defective polyester-based polyurethane (PE-PUR) foam that was intended to cut down on noise as the machines were used.

The manufacturer acknowledged at the time of the recall that the CPAP foam was known to degrade and breakdown, releasing small black particles, chemicals and toxic gasses directly into the machine’s air pathways.

Due to the serious health issues from breathing the Philips CPAP foam, consumers were told to immediately stop using their machines unless needed for life supporting treatment. Consumers expected Philips to repair or replace the devices, but the FDA has repeatedly castigated the company for failing to properly handle the CPAP recall, moving too slowly, or having to recall repaired machines due to further problems.

More than two years after the recall, there are now thousands of Philips CPAP lawsuits being pursued by former users, each involving allegations that the company placed a desire for profits before the health and safety of consumers, who have now been left with various types of cancer, lung damage and respiratory injuries.

The January 31 update by the FDA looks at medical device reports (MDRs) submitted between July 1, 2023, to September 30, 2023, adding them to the total number of reports filed since April 2021. All of the reports are associated with the breakdown, or suspected breakdown, of PE-PUR foam in recalled Philips devices.

During that time period, the FDA indicates it received more than 7,000 Philips breathing device MDRs, including reports of 111 deaths. However, those numbers do not mean those incidents happened within that timeframe. Some reports are filed months or even years after the incidents occurred.

To date, the FDA indicates recalled Philips CPAP machines and other breathing assistance devices have been linked to more than 116,000 MDRs and 561 deaths.

“A wide range of injuries has been reported in these MDRs, including cancer, pneumonia, asthma, infection, headache, cough, dyspnea, dizziness, nodules, and chest pain,” The FDA update states. “The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients.”

Philips CPAP Sales Suspended

On January 29, Philips filed a report with the U.S. Securities and Exchange Commission (SEC), announcing that it will halt sales of all CPAP and other breathing assistance devices in the U.S. The manufacturer indicated the decision was part of a consent decree with the FDA and Justice Department.

As part of the plan, Philips says it is not likely to sell breathing assistance devices in the U.S. again until at least 2025.

The consent decree has not yet been finalized and filed in court, according to FDA officials. The Philips Respironics CPAP settlement also has no impact on ongoing lawsuits the company faces from consumers diagnosed with cancers, lung damage and other injuries after using the recalled devices.

February 2024 Philips CPAP Lawsuit Update

According to a docket report (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on February 1, there are currently about 760 Philips CPAP lawsuits filed in the federal court system. However, tens of thousands of additional claims have been registered on a tolling agreement.

Given similar questions of fact and law raised in personal injury lawsuits and Philips CPAP class action lawsuits filed since the recall, the litigation has been centralized before U.S. District Judge Joy Flowers Conti, in the Western District of Pennsylvania, for coordinated discovery and pretrial proceedings.

In September 2023, a $445 million Philips CPAP recall settlement was announced by the manufacturer, which provided reimbursements for individuals who bought, rented or leased one of the impacted devices, and another $34 million to health insurance companies and others who paid to reimburse users to replace the machines. However, that still left all of the individual injury claims unresolved.

As part of the coordinated management of litigation, Judge Conti has indicated the Court will establish Philips CPAP lawsuit bellwether process, where small groups of representative claims involving different injuries will be prepared for early trial dates if settlements can not be reached to resolve large numbers of claims.

While the outcome of these early verdicts will not have any binding impact on other plaintiffs, the average Philips CPAP lawsuit payout amounts awarded by juries are likely to have a big influence on how much the manufacturer will pay to settle claims, to avoid each claim being remanded to different U.S. District Courts nationwide for separate trial dates in the future. However, a settlement agreement reached before then may make such trials unnecessary.