Philips reaches major settlements related to respiratory devices recall

Philips is still working through a recall of more than 15 million respiratory devices and laying out the next steps it will take through multiple settlements. The company recently struck agreements that spell out how it will correct problems and what restitution patients will get if they were affected by the recall.

Philips began the recall of ventilators and continuous positive airway pressure and bilevel positive airway pressure machines in 2021, when it disclosed risks of soundproofing foam breaking down in the devices and being inhaled by patients. According to the Food and Drug Administration, the risks include irritation, asthma, headaches and toxic or cancer-causing effects. 

On April 29, Philips said it agreed to settle personal injury and medical monitoring claims in the U.S. for $1.1 billion. The settlement has not yet been finalized or filed in court.

A judge recently finalized a separate settlement that would pay out economic loss claims to users who bought or rented one of the affected devices.

The company also reached a consent decree of permanent injunction with the Department of Justice that would bar Philips from selling certain sleep or respiratory devices in the U.S. The consent decree would require the firm to repair or replace recalled devices, or issue refunds, in a plan agreed to by the FDA. 

Here is a collection of MedTech Dive’s coverage of the latest developments related to the recall: