Lawsuits Between Philips and SoClean Over CPAP Machine Problems To Be Trial Ready by July 2025

Both companies have accused each other of being responsible for problems with Philips CPAP machines, which have been linked to injuries and deaths.

The U.S. District Judge presiding over all lawsuits between Philips and SoClean, Inc., involving claims that the ozone-based cleaning device caused problems with millions of CPAP machines recalled in recent years, has advised the parties that no delays or extensions will be permitted in a case management schedule, which calls for the first lawsuits to be ready for trial beginning within the next year.

SoClean, Inc. has manufactured and sold various devices that it claims will sterilize and deodorize CPAP machines, which are used to treat obstructive sleep apnea and help individuals breathe while sleeping. However, to be effective at cleaning the CPAP machines, SoClean devices use high levels of ozone gas, which has been linked to health risks for consumers, as well as concerns that it may damage the CPAP machines themselves.

Questions about the safety of SoClean products began to emerge in the aftermath of a massive Philips CPAP recall announced in June 2021, which impacted millions of DreamStation, CPAP, BiPAP and mechanical ventilators sold with a polyester-based polyurethane (PE-PUR) sound abatement foam that was found to degrade and release toxic chemical and particles directly into the machine’s air pathways.

Shortly after the recall, Philips made statements suggesting that SoClean and other CPAP cleaning devices may be responsible for accelerating the breakdown of the foam. However, SoClean has defended the safety of their products, filing lawsuits against Philips alleging that the problems were actually the result of faulty designs, which placed the CPAP foam directly in the machine’s air pathways.

The U.S. Food and Drug Administration (FDA) did issue a SoClean recall in November 2023, after determining that more than 7,400 complaints had been linked to the ozone cleaning devices, including adverse event reports involving mildew smells, excessive ozone emissions, coughing and other health problems. The action required the manufacturer to publish a new User Manual, as well as provide a hose and mask adapter to prevent ozone-related illnesses.

Although Philips announced in April that it has agreed to pay $1.1 billion to settle CPAP injury lawsuits brought by tens of thousands of individuals who experienced health problems from their machines, litigation continues to move forward in lawsuits between Philips and SoClean over the role the ozone cleaners played in degrading the foam inside of Philips machines.

Dueling Philips and SoClean Lawsuits Remain Unresolved

U.S. District Court Judge Joy Flowers Conti, who has been presiding over the centralized pretrial proceedings of all federal Philips CPAP recall lawsuits over the last few years, has overseen the resolution of most of the litigation in recent months. However, the lawsuits between SoClean and Phillips remain unresolved, including each company’s claims and counterclaims over liability for the CPAP machine problems.

At a status conference in July 2024, Judge Conti called for the parties to have the first case ready for trial by July 2025. But in a motion (PDF) filed on August 14, the parties asked for her to update important deadlines that both parties would have to meet in order to select the first case, and ensure it is trial-ready by that date.

The motion outlines a slew of disagreements between the parties on a wide-ranging number of key issues, such as how the first case to go to trial should be selected. Complicating matters even more, there are four different “tracks”, or categories of claims involved, depending on who is suing whom, and for what type of damages.

“The parties agree on this trial date but disagree on which claims should be tried first or whether now is the time for the Court to decide that question,” Phillips’ attorneys wrote. “Philips believes the sequencing of trials should be determined later in proceedings, after the tracks have advanced further, and after the parties have briefed which track should be tried first.”

Following a status conference held with attorneys for Philips and SoClean on August 22, Judge Conti issued a docket entry urging the parties to return to mediation and work with special masters to resolve the ongoing disputes. However, the Court emphasized that delays or extensions in the case management schedule will not be permitted.

Philips CPAP Recall Lawsuit Settlements

While continuing to battle with SoClean over the role of its device in causing problems experienced by users of recalled machines, Philips has moved swiftly to settle liability it faced in CPAP injury lawsuits pursued by former users diagnosed with various forms of cancer, respiratory injuries and other problems.

In September 2023, the company announced it would pay at least $445 million in a CPAP recall economic loss class action settlement 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.

A second, larger deal announced in April provides another $1.1 billion to resolve most of the remaining personal injury complaints filed by former users, as well as a medical monitoring class action lawsuit. Insurers will pay $40 million of that settlement amount, but the rest will come from Philips’ revenues.

Philips and SoClean lawyers are expected to meet again with Judge Conti for a status conference on September 19, 2024, with additional conferences set for October 10, 2024, November 13, 2024 and December 19, 2024.