Philips Shipping Far Fewer Replacements for Recalled CPAP Machines Than It Claims: FDA

While Philips Respironics claims it has shipped nearly 2.5 million replacement CPAP machines and repair kits since issuing a massive recall nearly two years ago, federal regulators indicate that number is deceiving.

The U.S. Food and Drug Administration (FDA) issued an updated safety communication about the recalled CPAP machines on April 13, warning that consumers waiting for Philips CPAP, BiPAP and ventilators may still have long wait times before getting replacement or repaired devices.

The Philips CPAP recall was first announced in June 2021, impacting millions of machines sold since 2009, which contain a defective polyester-based polyurethane (PE-PUR) foam. While the foam was intended to reduce noise and vibrations while the sleep apnea machines were used at night, it has been found to breakdown and release small black particles and chemicals directly into the machine’s air pathways and users’ lungs.

As a result of the potential CPAP foam health risks, federal health officials immediately warned all consumers to stop using the recalled machines nearly two years ago, unless needed for life-sustaining therapy. In the months after the recall, reports began to surface of 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.

Thousands of Philips CPAP lawsuits are now being pursued by former users, and it is widely expected that the litigation may become one of the active largest mass torts in the U.S. within a few years.

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.

In this latest update, the FDA indicates the company claims it has shipped 2,460,000 new replacement devices and repair kits. However, the FDA warns that number is deceptive to consumers still waiting on their replacement devices.

“The 2,460,000 number includes manufactured repair kits that Philips shipped internally to their repair facilities, which are not replacement or remediated devices that have been shipped to consumers,” the FDA update states. “We are concerned this may impact the estimated wait time for consumers still awaiting a replacement device.”

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

Philips CPAP Recall Repair Problems

Philips initially announced the CPAP machine repair and replacement program in September 2021, but the pace of repairs has been extremely slow, along with 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.

As of February 2023, the FDA indicated it was aware of nearly 100,00 medical device reports involving problems with Philips CPAP, BiPAP and ventilator devices, including reports of nearly 350 deaths.

In addition to the slow pace of repaired and replacement CPAP devices, there have also been concerns over the safety and quality of the refurbished machines.

Earlier this month, the FDA announced a recall of more than 1,000 supposedly repaired DreamStation CPAP and BiPAP devices which could fail to provide proper breathing assistance due to a serial number mix up which could lead to prescription errors.

In February, the agency also announced a repaired Trilogy and Garmin ventilators recall, due to risks that the new foam lining could come loose and block breathing assistance to the user. The FDA also warned that the devices contained remnants of old, toxic foam which could pose a health risk to consumers.

April 2023 Philips CPAP Lawsuit Settlement Update

While the size and scope of the federal litigation over the recall continues to expand, the manufacturer announced last month that it hopes to start making Philips CPAP settlement payouts for some claims this year, to resolve economic damage claims. However, settlements for individual injury cases will take substantially longer.

Given common questions of fact and law raised lawsuits filed throughout the federal court system, the Philips CPAP litigation has 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).

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.

Negotiating Philips CPAP settlements for the injury claims will be more complex than the economic loss class action lawsuits, given the wide variety of different types of cancer and lung damage individual plaintiffs have alleged may be caused by the sleep apnea machines, including:

• Leukemia, Lymphoma or other Cancers
• Pulmonary Fibrosis, Sarcoidosis or other Lung Diseases
• Chronic Asthma, Bronchitis or Pneumonia
• Liver Injury, Kidney Injury, Heart Attack, Stroke or Heart Failure

As part of the coordinated management of the litigation, Judge Conti has also 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.