Note: The information provided may be updated as further details become available.
Latest News: Consent Decree Finalized Against Philips Respironics
A consent decree has been finalized and issued by the U.S. District Court for the Western District of Pennsylvania against Philips Respironics (and other associated business entities), which limits the production and sale of new CPAP, BiPAP, and related devices until the company meets specific requirements. This follows the 2021 recall of 15 million devices due to potential health risks from degrading sound-abatement foam.
The decree also mandates a Recall Remediation Plan to provide affected patients with replacement devices, reworks, or partial refunds. Philips must also comply with good manufacturing practices and reporting standards before resuming full operations. Read more here.
Latest News: Philips reaches resolution of US economic loss litigation
On Sept. 7, 2023, Royal Philips and certain of its U.S. subsidiaries, including Philips Respironics, reached an agreement to resolve all economic loss claims in the U.S. Multidistrict Litigation (MDL) related to Philips Respironics’ voluntary recall of certain sleep and respiratory care devices. This settlement, submitted to the U.S. District Court for the Western District of Pennsylvania, does not include or constitute any admission of liability, wrongdoing, or fault by any of the Philips parties.
The agreement, which is subject to approval by the court, will provide predefined cash awards to all eligible participants in the U.S. depending on the type of device, extended warranties on all replacement devices, and an additional cash award if they return the recalled device to Philips Respironics. The settlement will further compensate certain individuals who acquired replacement devices post-recall.
The final cost of the settlement may vary based on, among other things, how many patients participate in the settlement and what the court awards for the professional fees relating to the resolutions. Philips Respironics has recorded a provision for an amount of EUR 575 million in the first quarter of 2023 to cover for the estimated costs of the final settlement.
Subject to final court approval, payments to class members under the settlement are not expected to begin until the first quarter of 2024 at the earliest.
The agreement does not settle any personal injury or medical monitoring claims in the MDL, which the Philips parties have moved to dismiss.
- Patients, hospitals, and sleep labs in the U.S. eligible for benefits under the agreement do not need to take any action at this time in order to participate in the settlement.
- The settlement must be approved by the U.S. District Court for the Western District of Pennsylvania, and additional information will be provided in the future.
- All related inquiries by patients, hospitals and sleep labs in the U.S. should be directed to the third-party Settlement Administrator, Angeion Group. More information will be available at RespironicsCPAP-ELSettlement.com.
Philips Respironics Field Action for Specific Sleep Therapy and Ventilator Devices
Philips Respironics continued to make progress with the repair and replacement program and the comprehensive test and research program for the CPAP, BiPAP and mechanical ventilator devices affected by the June 2021 field safety notice. To date, approximately four million replacement devices and repair kits have been produced. Philips Respironics aims to complete around 90 percent of the production and shipments to customers in 2022.As previously communicated, following the FDA’s inspection of certain of Philips Respironics’ facilities in the US in 2021 and the subsequent inspectional observations, the US Department of Justice, acting on behalf of the FDA, began discussions with Philips in July 2022 regarding the terms of a proposed consent decree to resolve the identified issues.Due to revisions to the financial forecast of Philips Respironics driven by current assumptions regarding the estimated impact of the proposed consent decree and changes to the pre-tax discount rate, Philips is recording a EUR 1.3 billion non-cash charge in the third quarter for the impairment of goodwill of this business.As disclosed, Philips Respironics is subject to an investigation by the US Department of Justice, is a defendant in several class-action lawsuits and individual personal injury claims, and is in ongoing discussions with the FDA regarding the proposed consent decree. Given the uncertain nature and timing of the relevant events, and of their potential financial and operational impact and associated obligations, if any, the company has not made any provisions in the accounts for these matters. Learn more.
Philips Respiratory Device Recall Notification
A variety of devices are involved in the recall; these include the first generation DreamStation devices though not the DreamStation 2 devices. Please refer to the complete list.
General Questions, Repair and Replacement
Philips is creating a registration process that will allow patients to look up their device serial number and begin a claim if the unit is affected.
Read the Philips press release for more information.
Patient Advice
For patients using life-sustaining mechanical ventilator devices, we would recommend that patients do not stop or alter prescribed therapy until after talking to your physician. Appropriate therapeutic decisions need to balance risks of continuing therapy versus temporarily discontinuing the device while awaiting a reasonable alternative. For patients on Bi-level PAP and CPAP devices who have severe breathing difficulties, or were very sleepy during the daytime before treatment, have significant pulmonary, cardiovascular or neurologic comorbidity, or who work in safety-critical positions (e.g. professional drivers, pilots, heavy equipment operators), we would recommend that they not stop their prescribed therapy until first discussing with their physician. For other patients, Philips recommends the device should be discontinued and the physician/DME provider be contacted to determine the most appropriate option for continued treatment. If your physician determines that you should continue using this device, consider use of in-line bacterial filter. Consult your Instructions for Use for guidance on installation.
Recommendations from the Philips Website
Recommendations are based upon current information and may require further updates.
Patients, physicians and DME suppliers can call Philips at 877-907-7508 for additional support.
