Philips has suspended sales of its sleep apnea devices and ventilators in the US following an agreement with the US Food and Drug Administration (FDA) over faulty medical equipment that has been linked to over 105,000 injuries and 385 reported deaths.
The suspension comes as part of a consent decree settlement, with Philips setting aside $393 million in the fourth quarter to address the agreement's financial implications. The company cautioned that additional costs are expected this year, compounding its challenges.
"Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologise for the distress and concern caused. We are fully committed to complying with the consent decree," said CEO Roy Jakobs.
The setback indicates a prolonged hiatus for Philips in the US market, with Jefferies analysts noting that it will "likely take years" to resume sales of sleep apnea products.
The company initiated a recall over two years ago, affecting around 5.5 million devices due to concerns related to disintegrating noise-dampening foam.
Despite allocating approximately 1 billion euros for the issue and reaching a $479 million settlement in September, Philips faces potential class-action lawsuits and thousands of individual legal claims. The US Department of Justice is also investigating the matter.
The consent decree deal, currently in the finalisation stage, is pending court approval in the US. Philips said that it will continue serving existing customers of its Respironics division with accessories and replacement parts but will refrain from selling new products in the US until specific conditions are met, anticipating an additional impact of around 100 basis points of costs this year.
Bloomberg Intelligence analyst Holly Froum suggests that Philips may face a substantial financial burden, estimating potential settlements between $2 billion and $4.5 billion for personal injury claims tied to the devices. The compensation claims to each customer would range from about $50 to $1,500, in addition to $100 for each device returned to Philips.
Jakobs, who assumed the role in October 2022 amid the recall, indicated last year that the consequences of the consent decree could linger for another seven years. Exor NV, the largest shareholder in Philips, expressed confidence in November that safety issues are resolvable.
(With inputs from Bloomberg)
(Edited by : Amrita)
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