The Food and Drug Administration (FDA) has reported 561 deaths associated with the recalled Philips devices used for treating obstructive sleep apnea and other breathing disorders. Since April 2021, the FDA 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. This includes 561 reports of deaths, as stated by the agency on Wednesday.
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Philips, the Dutch medical device manufacturer, has recalled millions of these breathing machines following reports of gas and foam particles being blown into the airways of users. This somber count of deaths comes shortly after Philips announced that it would cease selling the machines in the United States. The company settled with the FDA and the Justice Department, which is expected to cost approximately $400 million, as disclosed in a regulatory filing, as reported by Yahoo! News.
The tentative agreement, subject to approval by a U.S. court, stipulates that Philips must continue servicing the apnea machines currently in use while refraining from selling new ones until specific conditions are met. Despite attempting to address the issue through a recall announced in June 2021 and subsequent repairs, the fixed devices were also recalled.
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In late 2023, Philips agreed to pay a minimum of $479 million to compensate users of 20 breathing devices and ventilators sold in the U.S. between 2008 and 2021. In September, a proposed class-action settlement was reached, allowing claims for financial losses related to the recalled machines’ purchase, lease, or rent. Users can now file claims for financial losses. They may be eligible for a Device Payment Award for each recalled device, a Device Return Award of $100 for each returned device by August 9, 2024, or a Device Replacement Award for the cost of purchasing a comparable machine to replace a recalled device between June 14, 2021, and September 7, 2023.
The settlement administrator has set up an interactive website to determine eligibility and receive payment instructions. Users can check their recalled device’s serial number to determine the entitled device payment award. Those who return a recalled Philips machine by the August deadline are eligible for both the return and payment awards without needing to submit a claim form. Prepaid shipping labels are available at no cost. Individuals who purchased their own replacement CPAP or ventilator to replace a recalled device will need to complete a device replacement claim form.
The deadline for claim submissions is August 9, 2024. According to the U.S. District Court for the Western District of Pennsylvania, the settlement does not affect or release any claims for personal injuries or medical monitoring relief. Sleep apnea affects approximately 30 million people, causing the airways to become blocked during rest and interrupting breathing, according to the American Medical Association’s 2022 data. Philips has investigated all complaints, allegations of malfunction, and reports of serious injury or death. The company stated that it had found no conclusive data linking these devices to the reported deaths.
Very informative article. Thank you.