Edwards Lifesciences CorpEW
Edwards Lifesciences Corp Commitments Disclosure
20. COMMITMENTS AND CONTINGENCIES
Legal Proceedings
On September 28, 2021, Aortic Innovations LLC, a non-practicing entity (“Plaintiff”), filed a lawsuit against Edwards Lifesciences Corporation and certain of its subsidiaries (“Edwards”) in the United States District Court for the District of Delaware alleging that Edwards’ SAPIEN 3 Ultra product infringes certain of its patents. Edwards obtained a judgment of non-infringement, which Plaintiff appealed, and argument was held before the U.S. Court of Appeals for the Federal Circuit on June 2, 2025. On October 27, 2025, the Federal Circuit affirmed the district court’s claim construction in favor of the Company. Plaintiff’s remaining claims were reassigned to Judge Noreika (Case No. 23-cv-00158) on June 18, 2025 and are proceeding with a trial scheduled to begin on March 23, 2026. 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 January 14, 2026, Cardiovalve, Ltd. and MTH IP, L.P. filed a lawsuit against Edwards Lifesciences Corporation and one of its subsidiaries in the United States District Court for the District of Delaware alleging that the Company’s PASCAL products infringe their patent. The complaint seeks damages and a permanent injunction. 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.
The European Commission (the “Commission”) was investigating certain business practices of Edwards, including its unilateral pro-innovation (anti-copycat) policy (“UPIP”) and patent enforcement practices. The Company has been cooperating with the Commission and believes its business practices support healthy competition. On February 15, 2026, in connection with Edwards’ removal of the UPIP from its website, the Commission announced the closure of its preliminary investigation into these practices without a finding of any wrongdoing on Edwards’ part.
On February 16, 2026, Valtech Shareholder Representative LLC (“VT Shareholders”) filed a complaint against the Company in the Delaware Court of Chancery alleging breach of contract and seeking accelerated milestone payments set forth in the 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 Court of Chancery on procedural grounds in July of 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 March 22, 2024, Fortis Advisors (“Fortis”), LLC, the designated representative of the former stockholders of Harpoon Medical, Inc. filed suit against the Company in the Delaware Court of Chancery, alleging breach of the Agreement and Plan of Merger, dated December 8, 2015, by and between Harpoon Medical, Inc. and Edwards (the “Agreement”). Fortis sought acceleration and payment of all contingent milestone payments in the Agreement. Trial was scheduled for December 2025. In the third quarter of 2025, the Company entered settlement negotiations with Fortis and recognized an estimated provision for the settlement offer. On December 1, 2025, the Company and Fortis entered into a confidential settlement agreement to resolve all claims related to the Agreement. As a result of the settlement, the Court, on December 16, 2025, dismissed all of Fortis’ claims in this case with prejudice. The settlement amount was recorded within Intellectual Property Agreement and Certain Litigation Expenses on the consolidated statements of operations.
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, 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 our 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 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 December 31, 2024, Plaintiff Manh Ho filed a shareholder derivative action in the United States District Court for the Central District of California, 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 United States District Court for the Central District of California, 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 Court consolidated the Ho Action and the Sheridan Action. The Court issued an order on June 17, 2025 staying the consolidated derivative action until the Securities Class Action is resolved. 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 December 31, 2025 and 2024, the Company has accrued an aggregate estimated liability of $146.2 million and $10.5 million, respectively, related to its outstanding legal proceedings and settlements within Accrued and Other Liabilities on the consolidated balance sheets. For further information, see Note 9. 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.
Historical Timeline
| Fiscal Year | Filed | |
|---|---|---|
| 2025 | Feb 25, 2026 | Showing above |
| 2024 | Feb 28, 2025 | |
| 2023 | Feb 12, 2024 | |
| 2022 | Feb 13, 2023 | |
| 2021 | Feb 14, 2022 | |
About Commitments Disclosures
Commitments and contingencies disclosures catalog a company's off-balance-sheet obligations and legal exposures — purchase commitments, guarantee arrangements, pending litigation, and regulatory proceedings. These items represent potential future cash outflows that may not appear as liabilities on the balance sheet until they become probable and estimable.
Key signals: litigation reserves and disclosed loss ranges quantify management's estimate of legal exposure, but unquantified "reasonably possible" losses often represent the larger risk. Watch for changes in language around pending cases — shifts from "remote" to "reasonably possible" or increases in estimated loss ranges signal deteriorating outcomes. Unconditional purchase obligations and take-or-pay contracts create fixed cost structures that reduce operational flexibility. Guarantee arrangements for subsidiaries or joint ventures can create cascading obligations. Compare the total commitment schedule against projected free cash flow to assess whether the company can meet its obligations without additional financing.