The manufacturer of a popular CPAP machine has reached a settlement regarding recalled devices that could impact millions of users.
In June 2021, Royal Philips issued a voluntary recall of select ventilators, CPAP and Bi-Level PAP machines over concerns that the foam used to dampen the sound created by the units could degrade and become toxic or possibly cancerous.
According to Philips’ recall notice, the devices were sold between 2008 and 2021 in the U.S. under the Philips Respironics brand. The company said roughly 15 million machines worldwide were affected by the recall.
The U.S. Food and Drug Administration classified it as a Class I recall, the most serious type, which entails “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
In April, the FDA announced a consent decree had been reached with the device manufacturer. Under the settlement, Philips Respironics agreed to pay damages totaling $1.1 billion to users of the recalled machines. The company said those payments are expected to begin in 2025.
“The remediation of the sleep therapy devices for patients is almost complete,” Roy Jakobs, CEO of parent company Royal Philips, said in a statement. “We do regret the concern that patients may have experienced.”
According to the settlement, the funds will go to “users of the now-recalled CPAP and other respiratory devices who suffer from significant physical injuries.” The company said that already, around 58,000 people have filed claims or registered for the settlement.
From the billion-dollar settlement, $25 million is to be earmarked for medical monitoring and funding research on treating injuries related to the recall.
“Patient safety and quality is our No. 1 priority. We know what we must do to meet the consent decree requirements. Philips Respironics has been working with the FDA and is already making significant changes in its organization, quality management systems and operations,” Steve C de Baca, chief patient safety and quality officer with Philips, said in a statement. “This includes strengthening the quality management processes and deepening the competencies of the relevant teams. We are fully committed to meeting the terms of the consent decree and continuing to serve the millions of patients who rely on our products and services every day.”
The $1.1 billion personal injury settlement came one week after the company announced it had settled a class-action lawsuit over economic damages incurred as a result of the recalled CPAP machines.
The settlement – which is worth a minimum of $613.3 million and includes $94.4 million in attorneys’ fees – offers reimbursement to users (including insurance companies) for recalled machines they had bought or leased.
Under the settlement agreement, users are entitled to a $100 award if they return their recalled device by the claim deadline of Aug. 9. Philips’ recall page offers ways to check serial numbers and register products.
Users are eligible for a payment for each recalled device they purchased, leased or rented. Additionally, any user who paid out-of-pocket to replace a recalled machine may be entitled to a device-replacement award.
For now, U.S. sales of Philips’ DreamStation and other respiratory devices are on hold. The company said it plans to resume selling the machines once it has satisfied the terms of the consent decree. Philips added that it will continue to service units and provide replacement parts for devices that are still in use. LL
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