The Dutch medtech giant is set to face European class-action lawsuit over potential health risks from foam used in sleep therapy devices.
The class action seeks compensation for over 1.2 million users of certain medical devices manufactured by the Dutch healthcare multinational, with compensation of at least €70,000 per claimant sought for emotional distress and other damages, according to the lawyer spearheading the claim.
The collective action, promoted by the international pool of lawyers Global Justice Network and the Italian consumer association ADUSBEF, was filed in Milan on June 27, said Stefano Bortone, partner of Ambrosio&Commodo. Milan is where Philips’ head office for product quality is located. The court is yet to indicate the initial trial date, according to Bortone, who is president of Global Justice Network (GJN).
The products in question are sleep therapy devices and mechanical ventilators marketed by Philips for over a decade. These devices help patients with sleep apnea or major respiratory issues breathe through the night. To reduce noise from the electrical engine, Philips included a sound abatement foam in the devices.
In June 2021, Philips issued a field safety notice for some respirators after discovering potential health risks related to polyester-based polyurethane (PE-PUR), the main component of the sound abatement foam.
When deteriorating, this foam degrades into a sticky powder. “People have been inhaling this powder made of a toxic substance which is carcinogenic and can lead to potentially lethal illnesses,” said Bortone on July 4.
Philips subsequently recalled these devices globally and agreed in September 2023 on a $1.1 billion settlement to resolve a similar class action litigation in the US for people who claimed being injured by the use of the respirators – but admitting no fault or liability for the injuries.
The new collective action aims to properly compensate European users for emotional distress and physical damages. “We want to be sure that everyone who has the right can participate in the action,” said Bortone.
The class action was filed under the 2020 EU directive on representative actions, which allows European citizens to file collective actions for a class of consumers.
Philips has not been formally served with the lawsuit, a company spokesperson told Euronews, declining to comment further on the suit.
The company spokesman said that together with five independent, certified testing laboratories and third-party experts, Philips had carried out extensive testing o the devices since June 2021.
Based on these results, it concluded that use of the sleep therapy devices would not result in appreciable harm to patients’ health. “Further testing related to the sleep therapy and ventilator devices remains ongoing,” the spokesperson added.