The settlement only covers the reimbursement costs of users and vendors who financed the devices. Claims made for the costs of personal injuries and medical expenses are not included in the settlement and remain ongoing, according to the filings.
The company has recalled 10.8 million of its sleep apnea devices and replaced 2.5 million in recent years, including ventilators and BiPAP and CPAP models. The oldest of the 16 models it has recalled date back to 2009.
In 2021, Philips put out a memo alerting customers and physicians that the foam used in its sleep apnea machines “may degrade into particles which may enter the device’s air pathway and be ingested or inhaled,” which could lead to “headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic effects.”
“We have structured this settlement to quickly deliver value to eligible patients in the U.S. and provide an additional measure of confidence in the safety and quality of Philips Respironics products,” Philips told The Washington Post in a statement.
In a 2021 recall statement, Philips said that it had not received any reports of death caused by the foam in its machines. But since April 2021, the Food and Drug Administration said it has received more than 105,000 complaints, including 385 reports of death, associated with the breakdown of the foam.
Sleep apnea devices are a multibillion-dollar market, and Philips is among its largest players.