Dutch medical device-maker Philips will pay $1.1bn to settle hundreds of personal injury lawsuits in the US over its defective sleep apnoea machines, which have been subject to one of the biggest medical device recalls in the industry’s history, having dragged on for nearly three years.
The company did not admit any fault and said this week that it had reached the agreement to resolve any uncertainty over the cases. The payout also includes medical monitoring claims from patients who used the company's devices and could be exposed to future risks, reports Medpage Today.
Philips has recalled more than 5m of its continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines since 2021 because their internal sound-dampening foam can break down over time, leading users to inhale tiny particles and fumes while they sleep.
Efforts to repair or replace the machines have been plagued by delays that have frustrated regulators and patients not just in the US but in other countries, too.
Earlier this month the company reached a settlement with the US Government that requires an overhaul of how it manufactures its sleep apnoea devices. The agreement also requires the company to replace or reimburse patients for recalled machines.
Most of the recalled devices are CPAP machines, which force air through a mask to keep mouth and nasal passageways open during sleep.
The US Food & Drug Administration’s website warns patients that the risks of ingesting the polyester-based polyurethane foam could include headache, asthma, allergic reactions and more serious problems.
An FDA inspection of Philips’ Pennsylvania offices in 2021 uncovered information suggesting the company was warned about the problem with its foam six years before the recall.
Last April, the FDA announced another recall related to the manufacturer’s CPAP and BiPAP devices, saying that some reworked machines may not deliver the correct therapy.
And in November, the agency issued a new warning that the DreamStation 2 machines can overheat, and in rare cases, cause fires.
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