CPAC maker Philips Respironics will pay $479 million in a partial settlement to address issues related to its malfunctioning breathing machines.
The devices in question had caused concerns by releasing gases and foam particles into users’ airways.
It led to extensive recalls and subsequent lawsuits.
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Lawyers representing the plaintiffs in the lawsuit announced this settlement on Thursday, September 7.
This agreement exclusively pertains to monetary reimbursements for device users and vendors who may have financed replacements for consumers.
Notably, the economic claims are uncapped, allowing other device users to seek compensation.
However, this tentative settlement, subject to federal court approval, does not address other significant claims within the plaintiffs’ cases.
Those are personal injuries or the expenses associated with medical care due to these breathing machines.
Philips has not admitted wrongdoing or liability as part of this proposed deal.
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The company has been grappling with a protracted setback.
It began with recalls of approximately five million breathing machines designed for individuals with sleep apnea and related conditions in the US.
Lawsuits have contended that the foam disintegration and gas emissions from these devices were linked to health problems.
It includes respiratory ailments, lung cancer, and even fatalities.
The foam was originally used in the machines to reduce noise and vibrations.
In June 2021, the Food and Drug Administration (FDA) issued a recall for Philips devices, including BiPAP machines and ventilators produced since 2009.
Foam deteriations could cause “serious injury”
The agency cited concerns about foam deterioration that could lead to “serious injury” among users.
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Initially, Philips informed doctors that the foam breakdown posed risks of “toxic carcinogenic effects.”
However, subsequent updates from the company lowered the level of concern significantly.
The plaintiffs’ lawyers expressed their confidence in these claims and their commitment to holding Philips accountable for the physical harm caused to patients.
Millions suffer from sleep apnea, characterized by interrupted breathing, carrying risks such as strokes, heart attacks, and potentially cognitive decline due to reduced oxygen supply.
The recent recalls left doctors and device users in a quandary: whether to continue using potentially hazardous machines or forego treatment altogether.
Rival companies struggled to meet the demand for replacements, leaving numerous consumers with limited options.
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Under the terms of the agreement, affected consumers will receive compensation ranging from approximately $50 to $1,500.
They will get $100 for each device returned to Philips.
The company said it had replaced and delivered nearly 2.5 million devices to US consumers and suppliers.
The FDA and experts have criticized Philips for not promptly notifying consumers of potential device flaws.
Agency and court records show concerns over the company emerged as early as 2015.
The FDA has received over 105,000 reports of injuries and 385 reports of potentially related deaths related to foam degradation in Philips machines.