FDA Warns of New Problems with Recalled Philips Respironics Trilogy Ventilators

It is the latest stumble in the company’s efforts to remediate and replace recalled Philips CPAP devices and ventilators

Federal regulators are warning about new problems with Philips Respironics Trilogy Ventilators, following reports of issues with new silicone sound abatement foam used in the machines, as well as on-going health risks associated with residue from toxic polyester-based polyurethane (PE-PUR) foam it replaced.

On November 17, the U.S. Food and Drug Administration (FDA) issued an update on last year’s massive Philips CPAP, Bi-Pap and Ventilator recall, which involved problems with the PE-PUR foam used in millions of sleep apnea and breathing assistance machines.

Although the foam had been used for years, it is now known that the PE-PUR foam breaks down and releases black particles directly in the machine’s air pathways, exposing users to a number of toxic chemicals and gases.

As a result of the health risks, the FDA has urged owners of millions of Philips DreamStation, CPAP, BiPAP and mechanical ventilators to stop using their device, unless it is needed life-saving treatment. A rapidly growing number of former users exposed to the machines are now coming forward and filing lawsuits alleging that the Philips CPAP caused cancer, lung damage and other life-changing side effects.

In this latest update, the FDA announced that Philips has informed the agency of new problems with Philips Trilogy 100/200 ventilators, which had already gone through the process of having the old, recalled sound abatement foam removed and replaced with a new silicone foam.

The first issue involves new reports received by Philips that suggests the new foam is separating from its plastic backing, which could lead to it blocking the air pathways of the device, lowering the amount of air getting to the patient. If this happens, and the air pressure is significantly affected, this could lead to a Low Inspiratory Pressure alarm sounding, but Philips does not seem to guarantee the alarm will sound.

The second issue involves reports that trace amounts of particulate matter have been found in some of the air pathways of the remediated ventilators. Preliminary third-party lab testing has revealed that some of the particles are remnants of the old, toxic PE-PUR foam, which was supposed to have been cleaned out.

On November 7, Philips Respironics issued a ventilator recall update on its website, informing customers that it had temporarily paused the Trilogy 100/200 remediation plan due to a number of complaints, but did not tell its customers what the complaints entailed.

Philips CPAP Recall Remediation Failures

In September 2021, Philips announced a CPAP machine repair and replacement program, but the pace of repairs has been extremely slow and there have been some concerns about the safety of the alternative foam material the manufacturer is using, which may also release harmful chemicals directly into the machine’s air pathways.

The FDA has criticized Philips handling of the recall, indicating that the company has not done enough to warn consumers about the health risks associated with continuing to use recalled CPAP machines.

In August 2022, the FDA indicated that it had already received more 69,000 adverse event reports involving health problems caused by the recalled Philips CPAP machines, including 168 deaths. However, over the coming years, the number of long-term problems diagnosed among prior users is expected to continue to increase dramatically.

November 2022 Philips Respironics Recall Lawsuit Update

According to a docket report (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on November 15, 2022, there are currently at least 346 Philips recall lawsuits filed in the federal court system. However, thousands of additional claims involving cancer and lung damage among former users of the breathing machines have been registered on a tolling agreement.

Given common questions of fact and law raised in the Philips Respironics CPAP lawsuits brought throughout the federal court system, the federal claims are all consolidated before U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania, who is presiding over coordinated discovery and pretrial proceedings.

Over the remainder of 2022 and 2023, the parties are expected to establish a “bellwether” process where a small group of representative claims involving different types of breathing machines will be prepared for early trial dates to help gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout the litigation. However, Judge Conti has already appointed a Philips CPAP recall settlement master to work with the parties and determine whether an early agreement can be reached to resolve claims.