Health technology company Royal Philips agreed to resolve personal injury litigation and medical-monitoring class action suits related to the recall of Respironics sleep therapy devices in the United States in 2021, according to a press release outlining the company's 2024 first quarter results.
"The remediation of the sleep therapy devices for patients is almost complete, and the test results to date show the use of these devices is not expected to result in appreciable harm to health," said Roy Jakobs, CEO of Royal Philips, in the press release dated April 29, 2024.
Philips Respironics agreed to pay $1.1 billion to address claims filed in US courts and potential claims submitted through the census registry; the company has not admitted any fault or liability or that the company's devices caused any injuries, according to the press release.
In 2021, Philips Respironics recalled certain of its sleep therapy ventilators, including continuous positive airway pressure (CPAP) machines and bilevel positive airway pressure (BiPAP) machines, because of concerns over potential breakdown of the foam used in the devices and subsequent release of potentially harmful chemicals, according to a press release from the US Food and Drug Administration (FDA).
The FDA stated that Philips' resolution of legal action also involves a consent decree with provisions not only for a recall remediation plan to ensure relief for patients affected by the device recall but also restrictions on the production and sale of new sleep therapy devices.
According to a progress update from Philips Respironics, remediation of sleep therapy devices is nearly complete, and the company has received feedback from the FDA on testing and analysis for sleep therapy devices.