The U.S. District Court for the Western District of Pennsylvania “entered a consent decree of permanent injunction against [Philips Respironics]” restricting the “production and sale of new [CPAP] machines, [BiPAP] machines, and other devices at several Philips Respironics facilities in the United States until certain requirements are met.” The decree also necessitates implementation of a so-called Recall Remediation Plan “to help ensure relief is provided to patients impacted by Philips Respironics’ June 2021 recall of certain ventilators, CPAP and BiPAP machines, by way of receiving a new or reworked/remediated device or, for certain devices, providing the option for a partial refund.”
In June 2021, Philips Respironics recalled certain ventilators, CPAP and BiPAP machines because of health risks stemming from the possible breakdown of polyester-based polyurethane (PE-PUR) foam used in the devices. If the foam does break down, “black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device,” which could “potentially result in serious injury and may require medical intervention to prevent permanent injury.”
The complaint was filed by the Department of Justice on behalf of the FDA, and it alleges that the devices were introduced into interstate commerce despite the fact that they were “not manufactured in accordance with current good manufacturing practice requirements,” among other things. Plus, additional violations of “current good manufacturing practices” were observed as recently as 2023 at Philips Respironics factories and facilities.
The consent decree “restricts the defendants from manufacturing and distributing devices at or from the Philips Respironics facilities” that were found to not be adhering to good manufacturing practices “until the defendants have completed the repair/rework, replacement, and refund activities set forth in the Recall Remediation Plan, and are in compliance with requirements applicable to current good manufacturing practice, reporting corrections and removals and medical device reporting.”
The FDA’s website has the news release.
