Dutch company Philips has been ordered in Italy to replace faulty sleep apnea breathing devices by 30 April, according to a court ruling reported on Friday to French news agency AFP.
In a decision dated 30 March, the Milan court ordered Philips and Respironics Deutschland to speed up the recall and replacement operations, which should already have been completed by 31 December.
The court thus vindicated the two associations, Associazione Apnoici Italiani and Adusbef, that had filed a complaint on behalf of some 100.000 users of defective devices in Italy, 70,000 of whom are still waiting for a replacement.
Philips faces penalty of €20,000 per day if it fails to comply
If the replacements are not made by 30 April, the Dutch multinational will incur a penalty of €20,000 for each day's delay in complying with the court's decision.
“We have shown that Philips was fully aware of the problem at least since 2014, but waited until after 2021 to intervene. This is totally irresponsible behaviour,” one of the plaintiffs’ lawyers, Stefano Bertone, was quoted by the daily Il Corriere della Sera as saying.
Philips said in a statement that it was considering “next steps,” including appealing the ruling.
Major worldwide recall
The group assured that it was working “very hard to get a resolution as quickly as possible for patients,” while conceding that it was a ”complex undertaking” because of the number of devices to be replaced and the effort required to contact each user.
Troubled Philips announced in late January that it would cut another 6,000 jobs worldwide due to a recall of sleep apnea breathing devices that plunged the group into the red in 2022. Philips had had to recall 5.5 million of the first generation DreamStation devices worldwide. The US drug and health care agency, FDA, had issued a warning, saying that using the device could lead to serious injury.
The company is also facing investigations and legal challenges in the US after it was forced to recall breathing devices for people with sleep problems in June 2021. Users risked inhaling or swallowing pieces of toxic soundproofing foam that could cause irritation and headaches. At the time, the group also cited a “potential” risk of long-term cancers.
Breathing machines found to be safe, says Philips
Philips recently assured users that extensive testing had shown that the devices were “within safe limits” and advised them to consult their healthcare professionals to decide on a course of action.
The company stressed on Friday that the results of tests carried out to better understand the health risks indicated that “the prevalence of visible foam degradation [was] low” in its first-generation 'DreamStation' devices.
A spokesman for the group said more than 1,000 sleep apnea devices were to be recalled, mainly in the United States, and in France.
In the meantime, half of the defective devices have already been taken back.
