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COMMITMENTS AND CONTINGENCIES | 6 Months Ended
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Jun. 30, 2026
Commitments and Contingencies Disclosure [Abstract] |
COMMITMENTS AND CONTINGENCIES | 12. COMMITMENTS AND CONTINGENCIES On September 28, 2021, Aortic Innovations LLC, a non-practicing entity (“Aortic”), filed a lawsuit against Edwards Lifesciences Corporation and certain of its subsidiaries (“Edwards”) in the United States District Court for the District of Delaware (the “Delaware District Court”) alleging that Edwards’ SAPIEN 3 Ultra product infringes certain of its patents. Edwards obtained a judgment of non-infringement, which Aortic appealed. The Federal Circuit affirmed the Delaware District Court’s claim construction in favor of the Company, and Aortic’s remaining claims were remanded to the Delaware District Court, which granted summary judgment in favor of Edwards. Aortic has filed a notice of appeal. The Company cannot predict the outcome of any appeal or the potential impact on its financial statements. The Company will continue to vigorously defend itself with respect to any appeal or additional litigation related to this matter. On January 14, 2026, Cardiovalve, Ltd. and MTH IP, L.P. filed a lawsuit against Edwards Lifesciences Corporation and one of its subsidiaries in the Delaware District Court alleging that the Company’s PASCAL products infringe their patent. The complaint seeks damages and a permanent injunction. The trial is currently scheduled to begin on November 13, 2028. The Company cannot predict the outcome of the litigation or the potential impact on its financial statements. The Company intends to vigorously defend itself in this litigation. On February 16, 2026, Valtech Shareholder Representative LLC (“VT Shareholders”) filed a complaint against the Company in the Delaware Court of Chancery (the “Delaware Chancery Court”) alleging breach of contract and seeking accelerated milestone payments set forth in a merger agreement in which the Company acquired transcatheter structural heart repair technology from Valtech Cardio Ltd. The complaint alleges the Company failed to exercise commercially reasonable efforts in the development and commercialization of such technology causing certain milestone payments to not come due. This suit is the second suit brought by VT Shareholders. The first, filed in 2023, was dismissed by the Delaware Chancery Court on procedural grounds in July 2024. The Company cannot predict the outcome of the litigation or the potential impact on its financial statements. The Company is vigorously defending itself in this litigation. On October 14, 2024, a purported stockholder of Edwards filed a putative securities class action (the “Securities Class Action”) complaint against the Company and certain of its executive officers in the United States District Court for the Central District of California (the “California District Court”), captioned Patel v. Edwards Lifesciences Corporation, et al., No. 24-cv-02221. The complaint alleges violations of various securities laws based on alleged false or misleading statements regarding the Company’s business prospects. The complaint seeks damages, interest, costs and other fees. On September 17, 2025, the Court held a hearing on the Company’s Motion to Dismiss, and on September 19, 2025, the Court granted in part and denied in part the motion. The parties have reached a proposed settlement which was preliminarily approved by the Court on August 3, 2026, for an amount that is not material to the financial statements. The expense was recorded within Certain Litigation Expenses on the condensed consolidated statements of operations for the six months ended June 30, 2026. On December 31, 2024, Plaintiff Manh Ho filed a shareholder derivative action in the California District Court, captioned Ho v. Zovighian, et al., Case No. 8:24-cv-02822, purportedly on behalf of Edwards against certain of its officers and directors for alleged violations of federal securities laws, breaches of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets (the “Ho Action”). On January 17, 2025, Plaintiff Barbara Sheridan filed a different shareholder derivative action in the California District Court, Sheridan v. Zovighian, et al., Case No. 8:25-cv-00097, purportedly on behalf of Edwards against certain of its officers and directors for similar alleged violations (the “Sheridan Action”). Both the Ho Action and the Sheridan Action are based on the same facts as the Securities Class Action. On April 10, 2025, the California District Court consolidated the Ho Action and the Sheridan Action and on June 17, 2025 issued an order staying the consolidated derivative action until the Securities Class Action is resolved. On May 11, 2026, Plaintiff Kenneth Webb filed a shareholder derivative action in Delaware Chancery Court, captioned Webb v. Valeriani, et al., Case No. 2026-0591, purportedly on behalf of Edwards against certain of its officers and directors for alleged breaches of fiduciary duties and unjust enrichment based on the same facts as the Securities Class Action. The Company cannot predict the outcome of the litigation or the potential impact on its financial statements. The Company intends to vigorously defend itself against the lawsuits. The Company is or may be a party to, or may otherwise be responsible for, other pending or threatened lawsuits including those related to products and services currently or formerly manufactured or performed, as applicable, by the Company, workplace and employment matters, matters involving real estate, the Company's operations or health care regulations, contingent consideration, commercial matters, or governmental investigations (the “Lawsuits”). The Lawsuits raise difficult and complex factual and legal issues and are subject to many uncertainties, including, but not limited to, the facts and circumstances of each particular case or claim, the jurisdiction in which each suit is brought, and differences in applicable law. Management does not believe that any loss relating to the Lawsuits would have a material adverse effect on the Company's overall financial condition, results of operations or cash flows. However, the resolution of one or more of the Lawsuits in any reporting period could have a material adverse impact on the Company's financial results for that period. As of June 30, 2026 and December 31, 2025, the Company has accrued an aggregate estimated liability of $56.9 million and $146.2 million, respectively, related to its outstanding legal proceedings within Accrued and Other Liabilities. The Company is not able to estimate the amount or range of any loss for legal contingencies related to outstanding legal proceedings for which there is no accrual or additional loss for matters for which an accrual has been taken. The Company is subject to various environmental laws and regulations both within and outside of the United States. The Company's operations, like those of other medical device companies, involve the use of substances regulated under environmental laws, primarily in manufacturing and sterilization processes. While it is difficult to quantify the potential impact of continuing compliance with environmental protection laws, management believes that such compliance will not have a material impact on the Company's financial results. The Company's threshold for disclosing material environmental legal proceedings involving a governmental authority where potential monetary sanctions are involved is $1 million.

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