Philips Respironics CPAP Settlement Reached With FDA, DOJ Results in Halt of U.S. Sales

Settlement sets aside about $393 million to meet the requirements of a Philips CPAP recall consent decree with the FDA, after millions of sleep apnea machines were sold with toxic sound abatement foam

As part of a settlement with federal regulators and prosecutors, Philips Respironics has announced it will halt sales of CPAP and other breathing machines until issues are resolved that resulted in a massive CPAP recall more than two years ago.

The suspension of sales was announced by Philips in a report to the Securities and Exchange Commission (SEC) on January 29, indicating that it was part of a consent decree with the U.S. Food and Drug Administration (FDA). As part of the plan, Philips anticipates it will not sell CPAP, BiPAP and mechanical ventilator breathing machines in the United States 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.

Philips DreamStation CPAP Recall

The 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.

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.

According to the SEC filing, the consent decree will be submitted to a U.S. court for approval once finalized, and will “provide a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and to restore the business.”

Philips indicates it will continue to service CPAP and other breathing devices already with consumers, and will supply the accessories, consumables and replacement parts for those devices.

However, Philips indicates it will not sell new CPAP or BiPAP sleep therapy devices or other respiratory assistance products in the U.S. until it meets the consent decree’s requirements, which may not occur until 2025. The sales suspension will only apply to the U.S. market, the company indicates.

“Patient safety and quality remain Philips’ highest priority across the company. Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused,” Roy Jakobs, CEO of Royal Philips, said in the SEC filing. “We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”

The company indicates it has set aside more than $393 million to meet consent decree remediation requirements.

Lawsuits Claim Philips Delayed Toxic Foam Recall

In addition to regulatory issues that resulted in this consent decree, a mounting number of Philips CPAP lawsuits being pursued throughout the U.S. Court system also allege that the manufacturer delayed issuing a recall or warning consumers about health risks linked to the toxic foam until after it had finished developing the DreamStation 2 CPAP machines, and had them available to sell to individuals who rely on sleep apnea machines.

In a recent investigation into the extensive history of consumer complaints to the manufacturer, the FDA revealed that Philips sat on more than 220,000 consumer complaints prior to the recall, including adverse events that contained keywords like contaminant, particles, foam, debris, and other clear signs there was a recurring problem with the sound abatement foam.

According to a recently published investigation by ProPublica, Philips concealed problems with the CPAP machines for years, even after the company’s own scientists confirmed there was a serious health risk for users.

As a result of the findings, Senator Richard Blumenthal, of Connecticut sent a letter to the FDA’s Administrator Robert Califf, and Attorney General Merrick Garland at the Department of Justice (DOJ) calling for “immediate action”, suggesting that criminal charges should be brought against Philips, if the findings are substantiated.

February 2024 Philips CPAP Lawsuit Update

According to a recent docket report (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML), there are currently about 755 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.