Philips Respironics has reached an agreement to settle claims for $479 million related to its CPAP machines, which were found to release foam particles into users’ respiratory systems. This settlement pertains to the Philips Respironics OmniLab Advanced+ among other models recalled in 2021, as reported by Andrea Ellen Reed for The New York Times.
This agreement, part of ongoing class-action litigation, provides for monetary compensation for consumers and suppliers who provided replacements. The lawyers for the plaintiffs have stated that there is no cap on the monetary claims, allowing for additional claims.
The proposed settlement, awaiting judicial approval, does not concede to claims involving personal injury or healthcare costs arising from the use of these machines. Philips has not acknowledged any misconduct or liability in this deal.
The issue traces back to the recall of around five million Philips breathing machines in the U.S., designed to assist individuals with sleep apnea and similar conditions. Allegations have linked the foam used in the devices, intended for noise and vibration reduction, to serious health issues, including respiratory diseases, lung cancer, and deaths.
The FDA CPAP Recall Started in June 2021
The FDA’s recall in June 2021 included Philips BiPAP and ventilators produced since 2009, citing the foam’s deterioration could severely harm users. Initially, Philips warned medical professionals of the risk of toxic carcinogens from the foam. However, later updates indicated less severe concerns.
The plaintiffs’ lawyers have expressed confidence in their case against Philips, intending to hold the company responsible for the alleged physical harm caused to patients who used the devices for sleep apnea treatments.
Many individuals with sleep apnea, a condition known for causing interrupted breathing and associated health risks, have been impacted by these recalls. This has placed a strain on healthcare providers and patients, forcing them to choose between potential risks or discontinuing treatment, with limited alternatives available.
CPAP Case Settlement Terms
Under the terms announced, affected consumers could receive $50 to $1,500, plus $100 for returning the devices to Philips, which claims to have replaced approximately 2.5 million units.
Philips asserts that patient safety is paramount and assures confidence in the use of their Respironics devices.
The FDA, along with some specialists, have criticized Philips for delaying communication about the defects, which surfaced in company records as early as 2015, with over 105,000 injuries and 385 deaths potentially linked to the issue reported to the FDA.
Additionally, the U.S. Department of Justice has been in discussions with Philips regarding a consent decree to address recall-related problems, as revealed in a July earnings report. Philips has been cooperative under a subpoena from April 2022, providing ongoing information about the recall events.