Billion dollar settlement reached in US with medical device manufacturer over sleep ventilator machines

Dutch company Phillips will pay the money to people in the US who sued the company and alleged that they had been injured due to faults with the devices, which include CPAP, ventilators and BiPAP machines.

The devices, which are used to help people with sleep apnoea keep breathing while they sleep, were part of a mass recall in 2021 of some 15 million machines worldwide.

This recall was triggered by a problem with the polyurethane foam used to limit noise and vibration. The material can potentially disintegrate, leading to people breathing in pieces of the foam or chemicals released by it breaking down.

Users reported a wide range of injuries to the US Food and Drug Administration (FDA) including asthma, infection, pneumonia and cancer. More than 116,000 medical reports were made to the FDA regarding the devices, with 561 reports of death alleged to be associated with the breakdown of the foam since April 2021.

The devices recalled were sold in the US between 2008 and 2021, with Phillips saying that it had addressed 99% of the actionable sleep therapy device registrations to date. The devices recalled are listed on the company’s website.  

Leigh Day product safety partner Tina Patel said: 

“It is concerning to see such a large number of issues reported with these sleep apnoea devices. People with ongoing health concerns should not be put at risk by the devices they rely on for vital support. While we are pleased to see a settlement reached in the US, concerns remain for users across the world who may have experienced issues linked to these devices.”