Senior District Judge Joy Flowers Conti, of the U.S. District Court for the Western District of Pennsylvania, has granted preliminary approval for a settlement of at least $479 million by Philips for economic damage claims over alleged health risks caused by toxic sound-reducing foam in its 10.8 million recalled respiratory devices.

In June 2021, the company recalled 5.5 million bilevel positive airway pressure and continuous positive airway pressure machines after discovering that the polyester-based polyurethane sound abatement foam within could break down and release particles that could enter a device’s air pathway and become toxic, possibly causing cancer. This number has since risen to the current figure.

Philips has agreed to pay users who paid out of pocket to buy or rent recalled devices and payers who reimbursed them. The money will go toward a fund for covering payments of claimants. How much each will receive depends on the type of device, but payments will range from $55.63 to $1,552.25.

Those who returned recalled devices will receive an additional $100 award, and the company will compensate certain individuals who acquired replacements post-recall, including with extended warranties for replacements. The multidistrict litigation was filed in 2021 and currently includes more than 300 civil actions.

“This settlement is an important first step toward holding Philips accountable for their negligence and disregard for consumer safety. We will continue to pursue justice on behalf of those injured by Philips’ defective products and seek the creation of a comprehensive medical monitoring program for all those exposed to toxic foam,” said the plaintiffs’ co-lead counsel in a statement.

In an emailed statement to CNN, Philips said the settlement would “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.”

Since April 2021, the FDA has received 105,000 reports of problems, including 385 deaths, potentially linked to the devices, but these may be underestimated, it says. Limited reports of headache, upper airway irritation, cough, chest pressure, and sinus infection have come out and could possibly lead to life-threatening injuries or permanent impairment, says Philips.

The company took out a €575 million ($615.48 million) provision earlier this year to finance the estimated costs for economic claims but still faces ongoing lawsuits concerning personal injury and medical monitoring. It has moved to dismiss these claims.

The U.S. Justice Department is also investigating after finding 2018 emails that allege the company was aware of the foam issues long before the recall. Philips is currently negotiating a consent decree or settlement with the FDA and plans to complete the Respironics recall and test program in 2023.

It says that since 2021, it has completed risk assessments on about 95% of devices that have shown potential exposure to foam particles and emissions are “unlikely to result in appreciable harm to health.” In a July conference call, CEO Roy Jakobs said that the company has produced about 99% of replacement devices and repair kits, and provided the “vast majority” to patients and providers.

Claimants are not expected to see their compensation until the first quarter of 2024 at the earliest. Lawyers say the $479 million will increase as more devices are returned.

Philips admits to no wrongdoing, and the settlement does not include or constitute any admission of liability or fault by any of its parties.

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