A U.S. federal court has officially ordered Philips to restrict the production and sale of its CPAP and BiPAP ventilators for sleep apnea. The move is the culmination of a years-long international recall and repair effort, and a milestone that the company says provides a roadmap to rebuilding its business.
Philips had previously come to an agreement on the terms of the consent decree this past January, which had been proposed by the FDA and the Department of Justice after a year-and-a-half of discussions.
Now with a stamp from the western Pennsylvania district court, the decree includes an injunction against the company’s Respironics division, based outside Pittsburgh, and requires it to implement a recall remediation plan aimed at providing relief to affected patients—including offering new or repaired hardware or the option for a partial refund.
Philips’ ventilator recall efforts began in June 2021, after it was discovered that pieces of the polyurethane foam lining the inside of the machines—used to dampen the sound and vibration of their motors—could break down over time and float into the airways of sleeping users, potentially causing a series of health problems. Philips Respironics voluntarily stopped selling its CPAP and BiPAP devices in the U.S. at the time.
The recall ultimately grew to include about 5.5 million CPAP and BiPAP machines in use worldwide. In February, the FDA said it had tallied more than 116,000 complaints, including reports of 561 deaths.
“Throughout this recall, we have provided patients with important health information by issuing numerous safety communications and have taken actions rarely used by the agency to help protect those impacted by this recall,” the FDA’s device center director, Jeff Shuren, said in an agency statement. “This also marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.”
Philips previously settled a portion of a class-action lawsuit last fall, limited to economic claims—such as refunds for people who had paid out-of-pocket to replace their sleep apnea machine. The company had set aside about $615 million in April 2023 to cover those and other costs, and later took a separate provision of more than $380 million for additional remediation work and inventory write-downs. Hundreds of personal injury and wrongful death claims, plus requests to cover medical monitoring, are still working their way through the courts.
“Strengthening patient safety and quality remains Philips’ highest priority and the increased scrutiny will help us to improve even more,” said Philips CEO Roy Jakobs. “With the agreement on a consent decree for Philips Respironics in place, we now have a clear path forward to gradually restore the business, serving patients around the world.”
The consent decree’s deliverables include finishing Philips’ repair and remediation efforts, which the company said are 99% completed and demonstrating compliance with the FDA’s medical device quality regulations and good manufacturing practices.
“Philips Respironics has been working with the FDA, and is already making significant changes in its organization, quality management systems and operations,” said Philips’ chief patient safety and quality officer, Steve C de Baca. “This includes strengthening the quality management processes and deepening the competencies of the relevant teams.”
The order also requires that Philips fund a new independent evaluation of the safety testing and biocompatibility of the silicone-based sound insulation foam that the company is using in its replacements and repairs—including whether previous testing can determine that the foam does not degrade during the machine’s service life.
“The testing expert will submit findings of this evaluation to the FDA for review,” the agency said. “The company will be required to submit a plan to the FDA to address any gaps in testing, analysis or other information that may be identified by the expert.” Philips said the silicone foam has “been subject to extensive testing in accordance with the applicable industry testing standards, and Philips Respironics has not identified any safety issues.”
The order also restricts product exports until Philips Respironics can show that it has offered remediation to all registered U.S. patients and that it has enough devices in stock to address U.S. demand for the next year.
Philips said it plans to resume selling new CPAP or BiPAP sleep devices, or other respiratory care devices, in the U.S. after all of the requirements are met.