Philips Agrees to Stop Selling CPAP Machines as Part of Settlement Deal

Dutch medical device company, Philips Respironics has agreed to stop selling its CPAP and BiPAP sleep apnea breathing machines as part of an agreement with the U.S. Food and Drug Administration (FDA). The breathing machines have been linked to at least 561 deaths and were the subject of a 2021 recall.

As part of a settlement agreement with government regulators, Philips has agreed to pay about $479 million in compensation to people who purchased or leased the machines and will stop selling the devices in the U.S. until issues are resolved with the FDA. The agreement must still be signed by a judge but is expected to resolve complaints for financial losses.

Still to be resolved are hundreds of device injury lawsuits which claim injury or death. At least 561 deaths have been attributed to use of the Philips CPAP and BiPAP breathing devices. Philips currently faces over six hundred personal injury lawsuits which have been consolidated in federal court in Pennsylvania. The company may also face legal action in other countries including Canada, Australia, Israel, Chile, and the European Union.

Philips Sleep Apnea Machines Recalled

In 2021, the FDA announced a voluntary recall of multiple models of sleep apnea and ventilator devices manufactured by Philips. The recalls have since been expanded to include additional models.

The recall was issued after the company admitted that sound abatement foam inside of the devices could degrade and break apart during use. Degradation of the foam may result in release of toxic and carcinogenic fumes and particles which could be breathed in by users, resulting in injury or even death. At least 561 deaths worldwide have been attributed to the devices.

Recently exposed communications with the FDA show a reluctance of Philips to address safety concerns which may have expanded into 2022, after the recall. About 675 personal injury lawsuits have been filed against Philips Respironics for injuries and death which may have been caused by the devices. The recent settlement will only address financial losses by users of the devices but does not resolve injury or death claims.