Philips Sleep Apnea Devices Linked to 561 Deaths Amid Major Recall

In a significant health and safety alert, the Food and Drug Administration (FDA) has reported a worrisome number of deaths tied to Philips sleep apnea machines. A recall has been vigorously underway after both Philips Continuous Positive Airway Pressure (CPAP) machines and BiPAP sleep therapy devices have been linked to 561 fatalities. The FDA highlighted these startling figures amidst more than 116,000 medical device complaints since April 2021.

These reports largely stem from the breakdown of a sound abatement foam used in the machines, which could degrade and enter the air path of the device, thereby presenting potential dangers including toxic and carcinogenic effects to users. This situation has necessitated the Dutch multinational, Philips, to recall millions of these devices globally.

Amidst spiraling concerns, Philips has agreed to put a full stop to selling these devices in the United States, pursuant to a settlement with the FDA and the Department of Justice that according to their regulatory filing is projected to cost the company in the vicinity of $400 million. This settlement also articulates mandates for Philips to support devices currently in use while discontinuing the sale of new units until they meet certain corrective measures agreed upon with the regulatory authorities.

Philips initially stepped on to manage the crisis with a recall in June 2021, making attempts to fix the problems with the devices. However, even the repaired units ended up being recalled again, pointing to the severity and complexity of the issue.

In a recent settlement, Philips agreed to shell out at least $479 million in compensation to affected users in the United States for 20 different breathing devices and ventilators available in the market between 2008 and 2021. This proposed class-action settlement, reached in September of the preceding year, now opens a window for claimants to recover financial losses incurred from the purchase, lease, or rental of these now-recalled machines.

Eligible Philips device users can pursue a variety of compensation options including a Device Payment Award, a Device Return Award of $100 for each returned device by August 2024, and/or a Device Replacement Award for those who had to acquire a comparable alternative to one of the recalled devices between June 14, 2021 and September 7, 2023.

Filing a claim is a structured process, and individuals are encouraged to utilize an interactive website set up by the settlement administrator for eligibility determination. The site provides users with the ability to check the status of their device based on the serial number, as well as instructions on how to proceed with receiving payment. Moreover, a toll-free number and additional website links are available to facilitate the claims process, with the final date for submissions pegged at August 9, 2024.

The settlement does not affect any ongoing or future claims related to personal injuries or demands for medical monitoring compensation, a point underscored by the U.S. District Court for the Western District of Pennsylvania.

Sleep apnea, as detailed by 2022 data from the American Medical Association, affects approximately 30 million individuals, marking the recall's significant impact due to the disorder's prevalence. It is a condition where respiration is intermittently halted during sleep owing to blocked airways.

As part of their commitment to user safety, Philips has asserted that it has diligently examined all complaints along with allegations of device malfunctions leading to severe injury or death, but maintains that it has found no conclusive evidence directly linking their devices to the reported fatalities.