A federal court today 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.
Defendants Philips Respironics, its parent company Philips Holding USA Inc., and subsidiary Respironics California (collectively Philips), along with Philips executives Thomas Fallon, Daniel Leonard, and Jeff DiLullo, as well as executives Roy Jakobs and Steven B. C de Baca from Philips’s Dutch parent company, all agreed to resolve the complaint through a consent decree of permanent injunction. Under the consent decree, entered today by U.S. District Judge Robert J. Colville, the defendants are barred (subject to certain limited exceptions, such as for “medically necessary” devices) from manufacturing and distributing devices at or from the three Pennsylvania facilities — or resuming such activities at the other facility in Carlsbad, California — unless and until Philips meets certain conditions. Those conditions include retaining an outside expert to inspect the defendants’ facilities, methods and controls to determine whether they conform to Good Manufacturing Practice regulations; completing activities described in an FDA-approved recall remediation plan and receiving written notification from FDA that the defendants appear to be in compliance with the FDCA and the decree.
“Medical device manufacturers have a responsibility to comply with requirements designed to ensure the safety and effectiveness of their products,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “Today’s action reflects our commitment to vigorously enforce federal law and prevent manufacturers from marketing adulterated and misbranded devices to vulnerable patients who need them.”
“Today’s consent decree requires Philips Respironics to meet a series of stringent thresholds before restarting production and establishes safeguards against future violations of the Food, Drug and Cosmetic Act,” said U.S. Attorney Eric G. Olshan for the Western District of Pennsylvania. “This office, the FDA and our partner agencies are committed to holding manufacturers accountable when they violate the law and put the public at risk.”
“The finalization of this decree is a significant milestone,” said Director Jeff Shuren, M.D., J.D., of the FDA’s Center for Devices and Radiological Health. “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. Today’s action is a culmination of those efforts and includes novel provisions aimed at helping ensure that patients receive the relief they have long deserved. This also marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.”
The consent decree also requires the defendants to retain outside experts to inspect their other Sleep and Respiratory Care facilities to evaluate whether those facilities are operating in compliance with the FDCA, to correct any identified deficiencies, and to evaluate the testing that the defendants have performed and are performing on foam being used to replace the sound abatement foam in the recalled devices. The consent decree also allows FDA to subject other facilities owned by the corporate defendants to certain provisions of the injunction if a future inspection shows that those facilities are not operated in conformity with the FDCA and applicable regulations.
Trial Attorneys Natalie N. Sanders and Ryan E. Norman of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Adam B. Fischer for the Western District of Pennsylvania handled this matter, with the assistance of Senior Counsel Paige H. Taylor of the FDA’s Office of the Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Western District of Pennsylvania, visit www.justice.gov/usao-wdpa.
The claims resolved by the consent decree announced today are allegations only. There has been no determination of liability.
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