The United States Food and Drug Administration (FDA) has linked the deaths of 561 people to the use of Philips brand sleep apnea machines, specifically CPAP and BiPAP device models that were recalled in 2021. The machines are commonly used to treat people with sleep apnea, a disorder that affects nearly one billion people worldwide.
Since April 2021, the FDA has received more than 116,000 reports of medical incidents related to foam degradation in Philips CPAP machines and BiPAP sleep therapy devices, including reports of deaths. The polyester-based polyurethane foam used in the devices can break down, releasing small pieces of foam or invisible chemicals that users can inhale or ingest, potentially causing serious medical incidents.
In response to the issues, Philips announced the decision to recall approximately 5.5 million devices globally for repair or replacement. The company is currently facing court cases brought by patients who claim to have suffered health deterioration due to the use of these devices. Additionally, Philips is under the scrutiny of the United States Department of Justice, which has begun an investigation into the handling of the recall.
As a result of the controversy, Philips has announced that it will not sell new devices to treat sleep apnea in the United States in the coming years. The company has also agreed to compensate users of 20 different respiratory devices and ventilators sold in the United States between 2008 and 2021 with at least $479 million, in response to a class action lawsuit over the recalled devices.
Affected users may be entitled to compensation claims, including a “Device Payment” for each device purchased, rented, or leased, a “Device Return Rebate” of $100 for each device returned, and/or a “Device Replacement Award” for money spent on purchasing a comparable machine to replace a retired device.