A federal court ordered Philips RS North America LLC (Philips Respironics) to stop manufacturing most sleep and respiratory devices at three Pennsylvania facilities, and to stop distributing such devices from those facilities, until the company takes specific measures designed to increase the safety of its devices and ensure compliance with the Federal Food, Drug, and Cosmetic Act (FDCA). In a complaint filed April 4, in federal court in the Western District of Pennsylvania, the United States alleged that Philips Respironics, a subsidiary of Philips Holding USA Inc., violated the FDCA by manufacturing and distributing adulterated and misbranded medical devices. Specifically, the complaint alleged that Philips Respironics manufactured continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines, and mechanical ventilators at facilities in Murrysville and New Kensington, Pennsylvania, and remediated certain ventilators at a facility in Mt. Pleasant, Pennsylvania, under conditions and using practices that failed to comply with the FDCA and with Good Manufacturing Practice regulations designed to assure the safety and effectiveness of the devices.
The complaint also alleged that Philips Respironics failed to submit to FDA written reports of manufacturer-initiated corrections or removals for its devices, and further failed to validate and approve the process the company used to perform remediation work on certain recalled ventilators according to established procedures. The complaint further alleged that these violations were similar to violations observed during previous inspections that resulted in two FDA Warning Letters to Philips Respironics (for its Murrysville facility), a Warning Letter to its subsidiary Respironics California LLC (for another facility in Carlsbad, California) and a civil lawsuit and consent decree with another subsidiary of Philips Holding USA Inc., Philips North America LLC.
According to the complaint, millions of CPAP machines, BiPAP machines, and mechanical ventilators manufactured at the Murrysville and New Kensington facilities were recalled in June 2021 due to potential health risks. The recalled devices contained polyester-based polyurethane (PE-PUR) foam, which was used for sound abatement. According to the recall notices issued at that time, the PE-PUR sound abatement foam “may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user,” and “the PE-PUR foam may off-gas certain chemicals.” The FDA classified the recalls as Class I, the most serious type of recall. Philips Respironics’ efforts to remediate the PE-PUR foam in those recalled devices are ongoing, and some of the remediated devices have themselves been the subject of additional recalls.
