AMARILLO, TX – On April 9, 2024, the United States District Court for the Western District of Pennsylvania ordered Philips RS North America LLC (Philips) to stop manufacturing most of the sleep and respiratory devices at three of their Pennsylvania facilities and to stop distributing those devices from their facilities until Philips takes specific measures to ensure an increase in the safety of its devices and to ensure compliance with the Federal Food, Drug and Cosmetic Act (Act).
On April 4, The Department of Justice (DOJ) and the United States Food and Drug Administration (“FDA”) filed a Complaint for Permanent Injunction (“Complaint”) on behalf of the United States (“US”) in which it alleged that the FDA inspected Philips’ Murrysville, Pennsylvania, where their investigator discovered numerous violations of the Act.
The Complaint alleged that after Philips discovered that the foam used to soundproof devices could break down and be inhaled by the user, causing health risks, and initiated a recall, the FDA initiated an inspection. According to the complaint, the FDA inspector documented a failure by Philips in submitting written reports to the FDA of corrections or removals of their devices initiated earlier in the year.
The Complaint also alleges that Philips failed to submit to the FDA written reports of manufacturer-initiated corrections or removals for its devices and failed to validate and approve the process the company used to perform remediation work on the recalled ventilators. The violations determined by the FDA were allegedly the same ones that previous inspections had identified and warned Philips about in two FDA Warning Letters issued to the Murrysville facility.
Allegedly, an additional inspection of Philips’ Mount Pleasant facility in 2023 showed that there were further violations of manufacturing requirements. Philips conducted remediation work on two recalled ventilators at the Mount Pleasant facility by removing the abatement foam and replacing it with silicone foam after the recall. Philips began receiving complaints in July 2022 that the reworked ventilators contained residual foam degradation particulates of the sound abatement foam.
The investigator allegedly documented that Philips failed to ensure that they were compliant with established procedures with a high degree of assurance in repairing recalled devices. The processes that were used by Philips allegedly were not verifiable by subsequent tests and inspections.
Philips entered into a Consent Decree of Permanent Injunction (“Decree”) with the US. This Decree comes after a long discussion between the DOJ and Philips that began in July 2022 regarding the recall of CPAP and BiPAP sleep therapy devices and other respiratory care devices Philips began in June 2021. The Decree resolves the claims in the Complaint.
The Decree focuses on the operations of Philips’ US facilities. The Decree provides a roadmap of actions and deliverables for Philips to meet regulatory requirements required by the Act. Under the Decree, Philips must demonstrate continued compliance with the FDA’s current Good Manufacturing Practice requirements for medical devices. Once certain requirements are met, Philips will be permitted to resume selling new CPAP and BiPAP sleep devices and other respiratory care devices in the US.
The Decree also requires Philips to retain outside experts to inspect their Sleep and Respiratory Care facilities to evaluate their facilities and ensure they are operating in compliance with the Act. After at least five years and notice from the FDA that Philips is in compliance with the requirements of the Decree, Philips may petition the Court to be relieved of the requirements in the Decree. The Decree being finalized is a cumulation of the efforts by the FDA and DOJ to protect those patients impacted by the recall.
Cara C. Bachenheimer, JD, is an attorney with the Health Care Group at Brown & Fortunato, a law firm with a national health care practice based in Texas, where she heads up the firm’s Government Affairs Practice. Bachenheimer’s practice focuses on federal lobbying activities with Congress, the Administration, and federal regulatory agencies, such as CMS, FDA, IRS, and FAA. She can be reached at (806) 345-6321 or [email protected].
Jacque K. Steelman, JD, is a member of the Health Care Group at Brown & Fortunato, PC, a law firm with a national health care practice based in Texas. She represents pharmacies, infusion companies, HME companies, manufacturers, and other health care providers throughout the United States. Steelman can be reached at (972) 684-5789 or [email protected].