In a troubling development, the Food and Drug Administration (FDA) has revealed a concerning connection between recalled Philips devices meant to treat obstructive sleep apnea and other respiratory issues, and a reported 561 deaths. The FDA disclosed on Wednesday that since April 2021, it has received over 116,000 medical device reports regarding the breakdown of foam in Philips CPAP (continuous positive airway pressure) machines and BiPAP sleep therapy devices.
Philips, a Dutch medical device manufacturer, initiated a massive recall of these breathing machines after reports emerged that they were releasing gas and foam particles into users’ airways. The polyester-based polyurethane foam used in these devices, designed to reduce sound and vibration, has been found to break down, potentially leading to black foam particles or invisible chemicals being inhaled or swallowed by the device user.
The FDA issued a statement expressing concerns about these issues, emphasizing the potential for serious injury and the need for medical intervention to prevent permanent harm. The grim revelation comes shortly after Philips announced it would cease selling the machines in the U.S., in a settlement with the FDA and the Justice Department, estimated to cost around $400 million.
As part of the tentative agreement, subject to approval by a U.S. court, Philips will continue servicing existing apnea machines while refraining from selling new ones until specific conditions are met. This decision follows an initial recall in June 2021, where attempts to repair over 5 million devices proved unsuccessful, leading to a subsequent recall of the repaired ones.
In late 2023, Philips agreed to a compensation payout of at least $479 million for users of 20 different breathing devices and ventilators sold in the U.S. between 2008 and 2021. A proposed class-action settlement in September allowed users to file claims for financial losses related to the purchase, lease, or rent of the recalled machines.
Eligible users can now make claims for various awards, including a Device Payment Award, Device Return Award, and Device Replacement Award. The settlement administrator has set up an interactive website to assist users in determining their eligibility and providing instructions for the claims process.
The deadline for claim submissions is August 9, 2024, and the settlement explicitly excludes personal injury or medical monitoring relief claims, according to the U.S. District Court for the Western District of Pennsylvania.
While approximately 30 million people in the United States suffer from sleep apnea, Philips maintains that its investigation into complaints and allegations of malfunction or serious injury has found no conclusive data linking the devices to the reported deaths.