Respironics field action

On June 14, 2021, Royal Philips’ subsidiary, Philips Respironics, initiated a voluntary recall notification* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the U.S. and several other markets is under way. Philips Respironics has also been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain Volatile Organic Compounds (VOCs).

Repair and Replacement, Testing and Program Management
Repair and Replacement, Testing and Program Management
The Respironics recall remains highest priority

2022

~90% production and 80% shipment of recall units

Encouraging test results for DS1 platform (within safety norms)

483 remediation in progress

2023

Finalize recall and testing

Manage litigation, DoJ investigation

483 remediation and clarity on proposed Consent Decree

2023-2025

Manage impact of proposed Consent Decree

Manage litigation, DoJ investigation

Gradually restore position

Taking the learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips

Extensive patient, clinician and regulator engagement

Driving patient engagement and registrations with dedicated registration system and infrastructure

Continued patient outreach through mailing, call center, websites and direct contact with interest groups

Comprehensive DME outreach

Met the requirements in FDA's 518(a) order and continue to report progress

Ongoing engagement with regulators to optimize the recall efforts

Sharing progress on testing program to ensure patients and physicians fully informed

~90% production and 80% shipment of recall units in 2022

The task at hand

Around 5.5M devices expected to be repaired or replaced

Equivalent to over 5x previous annual production volume

>1 thousand new product configurations released globally

Partnering with DME’s for patient delivery

Progress to date

Quadrupled production capacity compared to pre-recall

>1,000 people cross functional team engaged

Dependency on supply of materials and global logistics capacity

~90% production and 80% shipment of recall units in 2022

Testing

Philips Respironics is conducting a comprehensive test and research program to better assess and scope potential patient health risks:

Encouraging test results for DreamStation1 devices

VOC testing

Emissions within ISO limits (devices not exposed to ozone)

Visual inspection and assessment of the foam in used devices

Low prevalence of significant visible foam degradation

Even when significant visible particulates are formed, likely to accumulate inside the device

Particulate Matter testing

Foam degradation does not contribute to appreciable elevated levels of respirable particles; within ISO limits

Bioassay evaluation, chemical characterization and toxicological risk assessment

Exposure to particulates is unlikely to result in an appreciable harm to health in patients, even based on a worst-case assumption that the patient is exposed to 100% of the foam

Thorough consideration and mitigation of testing limitations that are inherent to any test standard and/or scientific research; very conservative assumptions taken

DreamStation1 represents ~68% of the total # of devices registered as part of the Respironics recall

Test & research program - next steps

Finalize toxicological risk assessment of the VOC emissions resulting from ozone-induced foam degradation in DreamStation1 devices ❱ Expected in Q2 2023

Complete testing for SystemOne (~26% of registered devices) and DreamStation Go (~1%), which contain the exact same foam as the DreamStation1 devices ❱ Expected in Q2 2023

Complete VOC and PM testing, as well as chemical evaluation and toxicological assessments for Trilogy 100/200 (~3%) and OmniLab (~2%), where a different PE-PUR foam is used ❱ Expected in Q3 2023

Ongoing engagement with FDA and other competent authorities

Please click here for the latest testing results and updates

Summary of third-party epidemiological studies

There were thirteen identified epidemiological studies, all of which found no consistent statistical association between use of PAP devices - including Philips Respironics’- and the risk of cancer in patients with obstructive sleep apnea (OSA) - click here for more details

Two of the studies [1] [2] showed no statistical difference in cancer risk between users of Philips Respironics PAP devices and users of other brands of PAP devices

Eleven studies provided limited additional insights, but their results also suggested no excess risk of cancer associated with use of PAP devices

The 2022 study by Palm and others reported more frequent prescription of respiratory relief medication among patients with both OSA and obstructive lung disease, but no statistical difference in hospitalization, i.e. health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foam PAP - click here for more details

[1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. 1484–1488; Tetyana Kendzerska, Richard S. Leung, Mark I. Boulos, Daniel I. McIsaac, Brian J. Murray, Gregory L. Bryson, Robert Talarico, Atul Malhotra, Andrea S. Gershon, Constance Mackenzie, and Marcus Povitz.

[2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (https://doi.org/10.1183/13993003.00551-2022), Grégoire Justeau, Chloé Gervès-Pinquié, Marie Jouvenot, Thierry Pigeanne, Sandrine Launois, Laurene Leclair-Visonneau, Philippe Masson, Acya Bizieux-Thaminy, Sébastien Bailly, Nicole Meslier, Abdelkebir Sabil, Jean-Louis Racineux, Wojciech Trzepizur, and Frédéric Gagnadoux.
Regulatory and legal update
Regulatory and legal update
Regulatory and legal update - FDA/DOJ

Philips Respironics continues to engage with the US Food and Drug Administration (FDA) on the steps it has taken in response to the FDA’s Form 483 observations

Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issues on a forward-going basis

In addition, on April 8, 2022, Philips Respironics and certain of Philips’ subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall. The relevant subsidiaries are cooperating with the agency. The criminal and civil investigation is being conducted by the DOJ’s Consumer Protection Branch and Civil Fraud Section and the US Attorney’s Office for the Eastern District of Pennsylvania

Regulatory and legal update - Civil litigation

Collective and individual civil complaints have been filed in various jurisdictions globally, including but not limited to the United States, Australia, Canada, Israel and Chile. The complaints variously allege economic loss, personal injury and, in some cases, the need for medical monitoring related to devices subject to the Philips Respironics recall

In the United States, as of January 2023, putative economic loss and medical monitoring class actions and approximately 320 personal injury lawsuits have been consolidated into a multidistrict litigation (MDL) in Pennsylvania and are currently pending

In September 2022, the MDL court established a voluntary, court-approved census registry, and associated tolling, for potential claimants who have not filed claims, but may file claims in the future, relating to the recalled devices. As of January 27, 2023, approximately 20,000 individuals had joined the census registry. The company anticipates that the number of individuals on the census registry will increase in 2023

In September 2022, the Court requested that plaintiffs resubmit consolidated or master complaints for their economic loss, medical monitoring and personal injury claims. Since then, the various Philips defendants have filed motions to dismiss each of these complaints on numerous grounds.

Formal discovery has started, and it is expected to continue throughout 2023 and beyond

SoClean, a manufacturer of ozone-based CPAP cleaning devices, filed an amended complaint against Philips and certain of its U.S. affiliates, including Philips Respironics, in October 2022 for alleged unfair competition, tortious interference with business relationships, defamation and commercial disparagement. Philips believes SoClean’s claims have no basis in fact or law and is seeking dismissal of the case in its entirety, including on the basis that the FDA has stated that CPAP ozone cleaners, like SoClean’s products, “are not legally marketed for this use.”

In the Eastern District of New York, a securities class action suit was filed against the company in August 2021, alleging Philips’ statements in connection with the recall triggered a fall in stock price. Plaintiffs filed a Second Amended Complaint in November 2022. Philips will be moving to dismiss the Second Amended Complaint

Given the uncertain nature of the relevant events, and of their potential impact and associated obligations, if any, the company has not provided for these matters

Medical Device Reporting

Process

Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues

These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers

The FDA acknowledges that “the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event” and that the “cause of an event cannot typically be determined from this reporting system alone.”

Background

Following Philips’ public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation.

This led to approximately 99,000 MDRs filed by Philips Respironics to the FDA from April 2021 through December 31, 2022.

The vast majority (93% as of December 2022) of the MDRs filed since April 2021 are alleged technical malfunctions that do not involve serious injury.

Frequently Asked Questions and key materials

Respironics field action - FAQ - January 30, 2023 (203.0KB)

Summary of a systematic literature review of PAP device use and cancer risk - July 25, 2022 (182.0KB)

Third party epidemiological studies - FAQ related to the Swedish Study by Palm et al. - July 8, 2022 (201.0KB)

More information

For more information on the recall notification for customers, users and physicians, please click here.

News

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Disclaimers

* This is a recall notification for the US only, and a field safety notice for the rest of the world

Respironics field action

The Respironics recall remains highest priority

2022

2023

2023-2025

Taking the learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips

Extensive patient, clinician and regulator engagement

~90% production and 80% shipment of recall units in 2022

Testing

Philips Respironics is conducting a comprehensive test and research program to better assess and scope potential patient health risks:

Encouraging test results for DreamStation1 devices

Test & research program - next steps

Summary of third-party epidemiological studies

Regulatory and legal update - FDA/DOJ

Regulatory and legal update - Civil litigation

Medical Device Reporting

Frequently Asked Questions and key materials

More information

News

You may also find the following articles interesting

Philips Respironics provides update on filed MDRs in connection with the voluntary recall notification/field safety notice* for specific CPAP, BiPAP and mechanical ventilator devices

Philips provides update on completed set of test results for first-generation DreamStation sleep therapy devices

Philips Respironics provides update on filed MDRs in connection with the voluntary recall notification/field safety notice* for specific CPAP, BiPAP and mechanical ventilator devices

Philips Respironics update related to Trilogy 100/200 repairs

Summary of a systematic literature review of Positive Airway Pressure device use and cancer risk

Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program

Philips Respironics provides update on filed MDRs in connection with the voluntary recall notification/field safety notice* for specific CPAP, BiPAP and mechanical ventilator devices

Philips Respironics issues voluntary recall notification/field safety notice* for the V60 ventilator product family

Philips Respironics provides update for the US on ongoing CPAP, BiPAP and Mechanical Ventilator field action

Philips provides update on the test and research program in connection with the CPAP, BiPAP and Mechanical Ventilator recall notification*

Philips provides update on earlier announced voluntary CPAP, BiPAP and Mechanical Ventilator recall notification

Philips starts repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification

Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices

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