Royal Philips NV said new tests on its recalled sleep apnea products showed the vast majority of the devices are unlikely to cause considerable health damage to patients.
Tests show being exposed to degraded foam in 95% of the breathing apparatuses is “unlikely to result in an appreciable harm to health in patients,” the Netherlands-based health company said Tuesday. Philips initiated its first recall of potentially faulty sleep apnea products in June 2021, with the US Food & Drug Administration also labeling those as a Class 1 issue, or the most serious type.
The company has set aside around €1 billion ($1.1 billion) for the recall of around 5.5 million devices globally and booked additional provisions of €575 million as part of a planned settlement in the US to compensate patients.
Philips is a defendant in several class-action lawsuits and individual personal injury claims in the US. Consumers have accused the company of violating the US Federal Food, Drug and Cosmetic Act, which requires that medical devices be safe and effective. They claim the breathing machines were defectively designed by using foam that could degrade if exposed to moisture.
Today’s results may form part of Philips’s defense in looming court cases over health claims. The FDA is still considering the data provided by the company and he health authority may reach different conclusions.
In sleep apnea, breathing stops and starts, which can cause fatigue and longer-term health problems. Philips products designed to improve sleep patterns include its DreamStation CPAP machines and Trilogy ventilators.
