Philips Respironics, the maker of CPAP sleep apnoea machines, will pay $479m to settle some claims that its devices spewed carcinogenic foam and gas into the mouths of its customers – although it has not admitted liability as part of the settlement.
The Washington Post reports the company will pay those who bought, leased or rented its recalled machines an amount of $55 to $1,552 per device, depending on the model, as well as an additional $100 for every device returned, according to court filings.
The settlement covers only 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 10.8m of its sleep apnoea devices and replaced 2.5m 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 apnoea 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 US and provide an additional measure of confidence in the safety and quality of Philips Respironics products,” the company 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 US Food and Drug Administration (FDA) said it has received more than 105 000 complaints, including 385 reports of death, associated with the breakdown of the foam.
Sleep apnoea devices are a multibillion-dollar market, and Philips is among its largest players.
See more from MedicalBrief archives:
Massive Philips recall highlights flaws in medical device surveillance
Philips recalls 5.5m sleep apnea machines and ventilators in US
Global ventilator safety alert from Philips after one patient dies, four injured
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