They are prohibited (with limited exceptions for "medically necessary" devices) from manufacturing and distributing devices at or from the three Pennsylvania facilities, as well as resuming such activities at the Carlsbad, California facility, unless Philips fulfills specific conditions.
The U.S. District Court for the Western District of Pennsylvania has issued a permanent injunction against Philips RS North America LLC, Respironics California LLC, and Philips Holding USA Inc., as well as Roy Jakobs, CEO of Royal Philips, and other individuals listed in the decree. This decree limits the production and sale of CPAP machines, BiPAP machines, and other devices at various Philips Respironics facilities in the U.S. until specific conditions are fulfilled.
CPAP and BiPAP machines are tools utilized in the treatment of obstructive sleep apnea. To aid patients impacted by the recall of certain ventilators, CPAP (see our previous post), and BiPAP machines in June 2021, a Recall Remediation Plan is being enforced. This plan, agreed upon by the FDA and Philips Respironics, aims to provide relief to affected patients by offering either a new or remediated device, or in certain instances, a partial refund.
“The finalization of this decree is a significant milestone. 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,” said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. “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.”
In June 2021, Philips Respironics took the responsible step of recalling specific ventilators, CPAP, and BiPAP machines due to potential health risks. This recall affected a staggering 15 million devices worldwide. The reason behind the recall was the breakdown of the polyester-based polyurethane (PE-PUR) foam used in these devices to minimize sound and vibration. When this foam breaks down, it can release black pieces or invisible chemicals that could be inhaled or swallowed by the user. Recognizing the seriousness of the situation, the FDA promptly issued an alert to inform device users about the potential dangers associated with the breakdown of the PE-PUR foam. They emphasized that these issues could lead to severe injuries and might even require medical intervention to prevent permanent harm.
The complaint claimed that Philips Respironics did not report manufacturer-initiated corrections or removals to the FDA for its devices. It was also alleged that the company failed to validate and approve the process used for remediation work on certain recalled ventilators. These violations were said to be similar to those observed during previous inspections, resulting in FDA Warning Letters, a civil lawsuit, and a consent decree with various subsidiaries of Philips Holding USA Inc.
The complaint alleged that in June 2021, millions of CPAP machines, BiPAP machines, and mechanical ventilators produced at the Murrysville and New Kensington facilities were recalled because of possible health hazards.
“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.”
Defendants Philips Respironics, its parent company Philips Holding USA Inc., and subsidiary Respironics California (collectively referred to as 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, have all agreed to settle the complaint by entering into a permanent injunction consent decree. This consent decree, approved today by U.S. District Judge Robert J. Colville, imposes certain restrictions on the defendants.
They are prohibited (with limited exceptions for "medically necessary" devices) from manufacturing and distributing devices at or from the three Pennsylvania facilities, as well as resuming such activities at the Carlsbad, California facility, unless Philips fulfills specific conditions. These conditions include hiring an independent testing expert within 10 days to assess the company's testing procedures for the new silicone-based foam.
The expert will evaluate Philips' testing plan, including completed, ongoing, and planned tests to ensure the foam's integrity and safety. The findings will be submitted to the FDA for review, and the company must address any deficiencies identified by the expert in a comprehensive plan. Additionally, they must complete the tasks outlined in an FDA-approved recall remediation plan and receive written confirmation from the FDA that they are in compliance with the FDCA and the consent decree.
“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.”
Earlier this year, the FDA revealed that 561 deaths were linked to the recalled Philips devices. CBS reported that more than 750 individuals have filed personal injury lawsuits against the company regarding these devices. These cases have been consolidated in a federal court in Pennsylvania.
(CBS)Similar lawsuits are also pending in Canada, Australia, Israel, and Chile, as stated by the company. The Dutch manufacturer recently announced that they have reached a preliminary agreement with the FDA and the Department of Justice. However, the deal has not yet been confirmed by U.S. regulators as it still needs to be reviewed by a federal judge.
On the FDA's website, patients are warned about the potential risks of ingesting the sound-dampening foam, which include headaches, asthma, allergic reactions, and more serious complications. Patients affected by the recent Philips Respironics recall are still a major focus for the FDA as they work diligently to safeguard the well-being of those using these devices. The FDA urges anyone with a recalled device to register it if they haven't already, and for those who have registered, to verify that their contact details are current.
In addition, the agency is actively monitoring the supply chain for this product area and is confident that there is enough stock available. Furthermore, alternative manufacturers are fully capable of meeting the demand for CPAP and BiPAP machines, ensuring that patients' needs are met.
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