Repaired Philips Trilogy Ventilators Recalled Again Due to Problems With Replacement Sound Abatement Foam

Federal regulators are again warning consumers about a risk of problems with repaired Philips Respironics Trilogy Ventilators, which were supposedly fixed after a massive Philips CPAP, BiPAP and Ventilator recall last year, but may still pose serious health risks due to residue from the toxic polyester-based polyurethane (PE-PUR) foam that should have been replaced.

The U.S. Food and Drug Administration (FDA) issued a safety communication on December 22, indicating PE-PUR foam residue has been observed in reworked Trilogy 100 and 200 ventilators that were repaired and returned to customers. In addition, the agency warns the adhesive for the replacement silicone sound abatement foam may fail, leading to the ventilators becoming blocked, which could be life threatening for patients receiving ventilator care.

Philips Breathing Machine Recalls

Millions of recalled Philips breathing machines sold since 2009 were pulled from the market last year, following widespread reports of small black particles being found in the tubing and face masks, which was released by PE-PUR foam intended to reduce noise and vibrations while the sleep apnea machines were used at night.

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 potential CPAP foam health risks, federal health officials indicated that all consumers should immediately stop using the recalled machines, unless needed for life-sustaining therapy, since a number of toxic chemicals and gases may be released directly into the machine’s air pathways.

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 more 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.

According to the FDA, the adhesive problems do not affect reconditioned Philips CPAP and BiPAP devices, because they do not use adhesive to keep the foam in place.

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 aventilator 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. On November 17, the FDA issued an almost identical Trilogy Ventilator warning after the problems were first observed.

The FDA indicates Philips distributed 13,811 reworked Trilogy 100 and 200 ventilators in the U.S., and another 7,544 in other countries.

Philips CPAP Recall Repair Problems

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.

January 2023 Philips CPAP Lawsuit Update

More than 352 lawsuits against Philips have been filed in the federal court system, according to a docket report (PDF) issued in December 2022, with thousands of additional CPAP injury claims registered on a census established by the court to toll the statute of limitations.

Throughout 2023, Philips CPAP lawsuits are expected to mount, both involving injuries diagnosed long before the recall, as well as new injuries that continue to be diagnosed months after users breathed the toxic particles released as the sound abatement foam degraded inside their machines.

To help manage the growing litigation, a federal MDL (multidistrict litigation) was established late last year before U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania, who is presiding over coordinated discovery and pretrial proceedings.

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.