Recalled Philips CPAP Machines Linked to Nearly 400 Deaths By FDA Medical Device Reports

The FDA reports 40 deaths have been linked to sound abatement foam in recalled Philips CPAP machines this year alone.

The U.S. Food and Drug Administration (FDA) issued an update this week on the widespread Philips CPAP health problems experienced by former users, indicating that the agency is now aware of more than 105,000 medical device reports involving problems caused by exposure to toxic sound abatement foam inside the sleep apnea machines, including 385 deaths.

The agency has been posting regular updates for consumers and the medical community since a massive Philips CPAP recall was issued in 2021, impacting millions of machines sold since 2009, following widespread reports of small black particles being found in the tubing and face masks, which was released by a polyester-based polyurethane (PE-PUR) foam intended to reduce noise and vibrations while the sleep apnea machines were used at night.

In a safety communication posted on June 2, 2023, the FDA outlined additional information about medical device reports involving the recalled Philips CPAP machines that were received between January 1, 2023 and March 31, 2023, indicating that the rate of new problems submitted to the agency has slowed as the two year anniversary of the Philips CPAP recall approaches, with about 6,000 new MDRs received during the quarter, as well as 40 new deaths.

While the rate of new FDA complaints has begun to drop, the rate of new Philips CPAP Lawsuits filed is spiking, as many former users expect that the manufacturer may argue that the statute of limitations began running at the time the recall was announced, creasting a potential deadline later this month for injuries suffered in certain states.

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Millions of recalled Philips DreamStation, CPAP, BiPAP and ventilator machines may release toxic foam particles and chemicals into the air pathway.

Immediately following the recall, federal health officials warned consumers to stop using the recalled machines, unless they were needed for life-sustaining therapy, given the serious health risks from the degrading sound abatement foam inside the machines. During the subsequent months, reports immediately began to surface involving former users developing various cancers, lymphoma, lung damage and other injuries linked to the toxic chemicals and gasses released as the sound abatement foam breaks down.

During the the first 18 months after the recall, more than 90,000 MDRs were submitted to the manufacturer or federal health officials. However, during the last two quarters the number has begun to trail off, with 8,000 submitted between November 1, 2022 and December 31, 2022, and another 6,000 submitted over the first three months of this year.

The latest numbers comes after the FDA's last update warned consumers waiting for the replacement of their Philips devices that the company appeared to be releasing deceiving information about the number of new units produced.

After Philips claimed it had shipped 2,460,000 replacement devices and repair kits, the FDA shot that number down in April 2023, saying the number included units shipped internally to their repair facilities, and not just those returned to customers.

The FDA has been extremely critical of Philips’ handling of the recall, at first warning that the company's Philips CPAP recall notifications had been inadequate, and that the company's CPAP repair program has been slow to get much-needed breathing assistance machines back to the consumers who need them.

The agency urged consumers to contact Philips to get an update on the status of their replacement device.

There are currently more than 300 lawsuits against Philips already filed in the federal court system, with thousands of additional CPAP injury claims registered on a census established by the court to toll the statute of limitations.

Throughout 2023, the number of claims is expected to rapidly grow, 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.

Given common questions of fact and law raised in Philips CPAP lawsuits filed throughout the federal court system, all cases have been centralized before Senior U.S. District Judge Joy Flowers Conti in the Western District of Pennsylvania for coordinated discovery and pretrial proceedings, as part of a multidistrict litigation (MDL).

As part of the coordinated management of the litigation, Judge Conti has directed the parties to establish a bellwether process, where small groups of representative claims will be prepared for early trial dates if Philips CPAP 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.

03/17/23

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