The agreement with the FDA and Justice Department, which requires approval from a U.S. court, specifies that the company will keep servicing the machines already in use while halting new sales until certain conditions are met.
The final amount of the settlement hasn’t been determined and will depend in part on the number of claims ultimately filed. But the company recorded a provision of about $392 million and told investors it expects further costs to cover remediation and other punitive charges in 2024, according to the SEC filing.
The sales halt covers the company’s widely used CPAP (continuous positive airway pressure) machines, used to treat sleep apnea and other breathing disorders, as well as BiPAP sleep therapy devices.
Executives said the company values safety and quality above all else and apologized for the harm caused to patients.
“Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused,” Philips chief executive Roy Jakobs said in a statement. “We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”
The company recalled certain ventilators starting in June 2021 over concerns related to the polyester-based foam that is used to reduce sound and vibration in the machines. “If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device,” according to the FDA.
The company conducted additional testing, which it said in July showed that the levels of particulate matter released into users’ airways were “within the applicable safety limits and are unlikely to result in appreciable harm to health of patients.” In a response dated Oct. 5, however, the FDA countered that it didn’t “believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices.”
The FDA said it “remain[ed] unsatisfied with the status of this recall” as of October, according to a statement attributed to Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
The settlement reached with the FDA also resolves product liability claims brought against the company.
