Contingencies
Legal proceedings
The company and certain of its group companies and former group companies are involved as a party in legal proceedings, regulatory and other governmental proceedings, including discussions on potential remedial actions, relating to such matters as competition issues, intellectual property, commercial transactions, product liability, participations and environmental pollution.
While it is not feasible to predict or determine the ultimate outcome of all pending or threatened legal proceedings, regulatory and governmental proceedings, Philips is of the opinion that the cases described below may have, or have had in the recent past, a significant impact on its consolidated financial position, results of operations and cash flows.
Significant developments regarding legal proceedings that have occurred since the publication of the Annual Report 2023 are described below. For more information on these matters including the company’s assessment of each matter, reference is made to the Annual Report 2023.
Public investigations
In February 2023, the company received a statement of objections from the French Competition Authority (FCA) initiating a formal investigation to verify whether the company and certain other manufacturers of small domestic appliances breached antitrust rules in France in the period 2009-2014 through the alleged exchange of commercially sensitive information. The company denies any allegations in this regard and is defending itself against possible enforcement actions. Philips presented its defense to the FCA during the oral hearings in the first half of 2024 and is now awaiting the final decision of the FCA. It is the company’s assessment that it is possible but not probable that this matter could lead to an outflow of economic resources. The company is not able to reliably estimate the financial impact, if any, and no provision has been recognized as of June 30, 2024.
Respironics recall
On June 14, 2021, Philips’ subsidiary Philips RS North America LLC (Philips Respironics) issued a voluntary recall notification in the United States and field safety notice outside the United States for specific Philips Respironics CPAP, Bi-Level PAP, and mechanical ventilator devices (the “Respironics Recall”).
Consent decree and DoJ investigation
In the first half of 2024, Philips Respironics reached an agreement with the US Department of Justice (DoJ), acting on behalf of the US Food and Drug Administration (FDA), regarding the terms of a consent decree to resolve the identified issues in relation to the Respironics Recall. The consent decree was entered by the court in April 2024.
In April 2022, the DOJ issued a subpoena to Philips Respironics in relation to the events leading up to the Respironics Recall. Philips Respironics has continued to respond to the information requests in the subpoena. The company is not able to reliably estimate the financial impact, if any.
Product liability claims
Following the Respironics Recall, a number of civil complaints have been filed in several jurisdictions against Philips Respironics and certain of its affiliates (including the company) generally alleging economic loss, personal injury and/or the potential for personal injury allegedly caused by devices subject to the recall.
In 2023, Philips Respironics entered into a settlement agreement to resolve the US economic loss class action for which a EUR 575 million provision was recognized in the first quarter of 2023. On April 25, 2024, the settlement agreement received final approval from the US District Court for the Western District of Pennsylvania. The settlement agreement has now become final and non-appealable.
In the first half of 2024, Philips Respironics entered into settlement agreements to resolve the personal injury litigation and medical monitoring class action in the US. Under the settlement agreements, Philips Respironics has agreed to pay a total of USD 1,075 million to resolve the personal injury claims and USD 25 million to resolve the medical monitoring class action.
Under the personal injury settlement agreement, Philips Respironics has the right to terminate this settlement agreement if less than 95% of eligible claimants with qualifying injuries participate in the settlement. The deadline for personal injury claimants to register for the settlement is December 10, 2024. For any individuals who still wish to pursue litigation, they will be the subject of case management orders that set strict terms and deadlines, including for expert reports. Non-compliance by such individuals may result in dismissal of their claims. The personal injury settlement agreement is not subject to court approval.
The medical monitoring settlement received preliminary approval from the District Court for the Western District of Pennsylvania on June 27, 2024, with a final approval hearing scheduled for October 30, 2024. The effectiveness of the medical monitoring settlement is subject to court approval.
In connection with the settlements, Philips and Philips Respironics do not admit any fault or liability, or that any injuries were caused by Respironics’ devices.
On July 4, 2024, a group of lawyers announced they filed a product liability lawsuit in Italy on behalf of users of Respironics devices in Europe, allegedly claiming personal injury related damages. Philips has not yet been served with the complaint and is therefore not yet able to assess the merits of the alleged claim.
In the first half of 2024, the company also reached an agreement with its product liability insurance carriers regarding their contribution to the Respironics recall-related product liability exposure. Q2 2024 includes EUR 538 million insurance income related to this agreement, of which EUR 150 million had been received as of June 30, 2024.
Securities claims
In August 2021, a securities class action was filed against the company in the US District Court for the Eastern District of New York alleging disclosure deficiencies in relation to the Respironics Recall. The court held a hearing on the company’s motion to dismiss in April 2024 and the court is now expected to decide on the motion to dismiss.
Following earlier requests for information from the US Securities and Exchange Commission (SEC), in March 2024, the company received a subpoena from the SEC relating to the Respironics Recall and compliance with relevant securities laws. The investigation is not an indication that the SEC or its staff have determined that any violations of law have occurred. The company is fully cooperating with the investigation.