WASHINGTON — Medical device maker Philips said Monday it will pay $1.1 billion to settle hundreds of personal injury lawsuits in the U.S. over its defective sleep apnea machines, which have been the subject of a massive global recall.
The Dutch manufacturer did not admit any fault and said it had reached an agreement to resolve any uncertainty surrounding the cases. The payout also includes medical monitoring claims from patients who used the company’s devices and could be exposed to future risks.
Philips has recalled more than 5 million ventilators since 2021 because the internal foam can break down over time, causing users to inhale small particles and fumes while they sleep. Efforts to repair or replace the machines have been plagued by delays that have frustrated regulators and patients in the U.S. and other countries.
Monday’s announcement is another step toward resolving one of the largest medical device recalls in the industry’s history, which has dragged on for nearly three years.
Philips shares rose more than 35% on the news to a one-year high.
Earlier this month, the company reached a settlement with the U.S. government that requires an overhaul of how it produces sleep apnea devices. The agreement also requires the company to replace or reimburse patients for recalled machines.
Most of the recalled devices are Continuous Positive Airway Pressure (CPAP) machines. They force air through a mask to keep the mouth and nasal passages open during sleep.
Company CEO Roy Jakobs said in a statement that the recent settlements “are important milestones and provide further clarity on the path forward for Philips.”
The FDA’s website warns patients that the risks of taking the sound-deadening foam can include headaches, asthma, allergic reactions and more serious problems.
An FDA inspection of Philips offices in Pennsylvania in the fall of 2021 revealed a flurry of red flags, including emails suggesting the company had been warned about the foam problem six years before the recall.
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