Over 500 Deaths Linked to Recalled Philips Breathing Devices, FDA Reports

The U.S. Food and Drug Administration (FDA) has announced that it has received reports of 561 deaths associated with Philips respiratory devices designed for the treatment of obstructive sleep apnea and other respiratory disorders.

Since April 2021, the FDA has been alerted to over 116,000 incidents where the sound abatement foam in Philips CPAP (continuous positive airway pressure) and BiPAP sleep therapy devices has degraded. This degradation includes instances where users have inhaled or ingested black foam particles or potentially harmful chemicals.

Philips, a Dutch medical technology company, initiated a recall of millions of these devices after discovering that the polyester-based polyurethane foam used for noise and vibration reduction could disintegrate. This issue has the potential to cause serious harm or necessitate medical intervention to prevent lasting damage.

This disclosure follows Philips' recent announcement to discontinue the sale of these devices in the United States as part of a preliminary agreement with the FDA and the Justice Department. This settlement is expected to incur costs of approximately $400 million for Philips, as detailed in a recent regulatory filing. Philips had previously attempted to address the issue by repairing over 5 million recalled devices. However, the repaired devices were also subsequently recalled. In late 2023, Philips agreed to compensate users of 20 different respiratory devices and ventilators sold in the U.S. between 2008 and 2021, with the total compensation amounting to at least $479 million.

This settlement enables affected users to claim financial losses related to the purchase, lease, or rental of the recalled devices. Eligible individuals can file claims for a Device Payment Award for each recalled device they purchased, leased, or rented; a Device Return Award of $100 for each device returned by August 9, 2024; and a Device Replacement Award for expenses incurred to purchase a comparable device as a replacement. To verify eligibility and understand the necessary steps to receive compensation, the settlement administrator has launched an interactive website.

Users can also check their device's serial number to determine their entitlement to a Device Payment Award. For those who have acquired a comparable replacement device, a device replacement claim form must be completed. The claim submission deadline is August 9, 2024. It's important to note that this settlement does not cover claims for personal injuries or medical monitoring relief. Approximately 30 million Americans suffer from sleep apnea, a condition characterized by the obstruction of airways during sleep, as per data from the American Medical Association.

Philips has conducted investigations into all complaints and allegations of device malfunction and related serious injuries or deaths. The company has stated that there is no conclusive data linking the devices to the reported fatalities.