CPAP sleep apnea machine maker Philips Respironics agreed to pay at least $479 million in a settlement over alleged health risks from toxic sound reducing foam, lawyers for the plaintiff announced Thursday.
The settlement will go toward users who bought or rented the recalled devices and those who incurred out-of-pocket costs or had to reimburse users for those costs, the lawyers said.
“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,” said a spokesperson for Philips Respironics in an email to CNN. As part of the agreement, Philips did not admit to any wrongdoing.
In 2021, Philips recalled about 10.8 million devices, saying the silicone-based foam they used to reduce sound and vibration can break down and can be breathed in by the user.
“While there have been limited reports of headache, upper airway irritation, cough, chest pressure and sinus infection,” Philips said in 2021, “it may be possible that these potential health risks could result in a wide range of potential patient impact, from transient potential injuries, symptoms and complications, as well as possibly serious injury which can be life-threatening or cause permanent impairment.”
The FDA received reports alleging at least 385 deaths associated with the broken down foam since April 2021. Forty of those reports took place in the first three months of 2023.
Philips Respironics said in a statement that since 2021, it has completed risk assessments for about 95% of devices covered by the recall, and those results show potential exposure to the foam particles or emissions “is unlikely to result in appreciable harm to health.”
Lawyers said the $479 million amount will increase as more devices are returned.
Philips will pay awards to users for each recalled device, which range from $55.63 to $1,552.25. They’ll also receive a device return award of $100 for each recalled device given back to the company to cover the cost of a new machine.
Philips set aside 575 million euros, or about $615 million, in the first quarter of 2023 to cover the estimated costs, the company said.
This is just one segment of claims facing the company. Claims made for personal injury and medical monitoring costs are not included in the settlement, though the lawyers said in the statement they will continue to pursue those claims.
The agreement is subject to approval by Judge Joy Flowers Conti in the United States District Court for the Western District of Pennsylvania.
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