by
Gus Iversen, Editor in Chief | April 10, 2024
The U.S. District Court for the Western District of Pennsylvania has mandated a consent decree of permanent injunction against Philips Respironics, its subsidiaries, and top executives, including Roy Jakobs, CEO of Royal Philips. This legal action stems from the June 2021 recall of certain ventilators, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) machines, affecting approximately 15 million devices globally.
The
previously disclosed decree restricts the production and distribution of new sleep therapy machines at Philips Respironics facilities in the U.S., with limited exceptions, until compliance with regulatory requirements is verified.
It also necessitates Philips Respironics to implement a Recall Remediation Plan, collaboratively formulated with the FDA, to facilitate relief for affected patients through device replacement, rework, or partial refunds. This plan outlines specific remediation options and timelines, marking a first for a device company under such a decree to offer a remediation payment option.
Concern arose over the use of polyester-based polyurethane (PE-PUR) foam in these devices, intended to minimize sound and vibration, which was found to potentially degrade and pose health risks to users. Following Philips' recall, the FDA issued an alert highlighting the serious potential for injury requiring medical intervention due to inhalation or ingestion of degraded foam particles or related chemicals.
In a statement, Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health, emphasized the decree's role in ensuring patient relief and hailed it as a culmination of the FDA's protective efforts during the recall. The allegations leading to the decree included violations of the Federal Food, Drug, and Cosmetic Act related to manufacturing standards and failure to report device corrections or removals to the FDA, as evidenced by inspections of Philips Respironics facilities.
The decree includes specific provisions to prioritize the remediation of U.S. patients before any export for commercial distribution and mandates testing requirements for the new silicone-based foam used in remediated devices. Moreover, it requires Philips Respironics to retain an independent expert to evaluate compliance with federal regulations at their other Sleep and Respiratory Care facilities, ensuring broader regulatory adherence.
“Strengthening patient safety and quality remains Philips’ highest priority and the increased scrutiny will help us to improve even more," said Roy Jakobs, CEO at Philips, in a statement. "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.”
