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Federal District Court Grants Preliminary Injunction Blocking Pre-Commercial Heart Valve Acquisition
02/03/2026On January 23, 2026, the U.S. District Court for the District of Columbia unsealed its order granting a preliminary injunction blocking a life sciences company’s proposed $945 million acquisition of a heart valve company, prompting defendant to abandon the deal. Fed. Trade Comm’n v. Edwards Lifesciences Corp., No. 1:25‑cv‑02569 (D.D.C. Jan. 23, 2026).
The Federal Trade Commission sued to block defendant’s acquisition of the heart valve company, asserting that the deal would substantially lessen competition in the U.S. for the research, development, and future commercialization of transcatheter aortic valve replacement devices to treat aortic regurgitation—a condition that occurs when the aortic valve does not close properly, allowing blood to leak backward into the heart, possibly enlarging the heart and leading to heart-failure. The FTC further alleged the deal would harm innovation by eliminating head‑to‑head rivalry between the only two products in U.S. clinical trials for that use.
In its order, the court agreed with the FTC’s product and geographic market definitions. Specifically, the FTC alleged a product market limited to transcatheter aortic valve replacement devices and a geographic market limited to the U.S. Defendant argued for a broader product market including surgical and transapical alternatives and a geographic market covering developers abroad as well. The court opted for the FTC’s more limited product definition and rejected defendant’s proposed geographic market, stating that patients and physicians cannot “practically turn” to those overseas options.
The court held that, although no device has yet received U.S. commercial approval, competition is crucial at the development stage and eliminating head‑to‑head rivalry would likely reduce incentives to innovate and slow the pace of progress. Anchoring its analysis in the 2023 Merger Guidelines and appellate authority recognizing Clayton Act Section 7’s reach to research‑and‑development markets, the court emphasized the clinical reality: open‑heart surgery is currently the only approved option for aortic regurgitation, which heightens the need to preserve pre‑commercial rivalry for alternative treatments. The court declined to rest its decision on a structural presumption in this pre‑commercial context, as requested by the FTC; instead, it relied on direct evidence of active, head‑to‑head rivalry and a credible risk that common ownership would reduce design improvements, delay timelines, and weaken future price competition at launch. Against that backdrop, the court underscored that defendant’s July 2024 purchase of another company, followed by the current target, would consolidate under one owner the only two U.S. clinical‑stage devices.
The court found defendant’s claim that the deal would accelerate access and save lives unpersuasive. The court explained that these asserted benefits were not verified, not merger‑specific, and not shown to be achievable only through this transaction, relying instead on speculative promises of post‑merger conduct. The court was also unconvinced that the target needed the buyer’s resources to reach approval and compete. While acknowledging the resource gap, the court pointed to the heart valve company’s proximity to FDA approval, its demonstrated progress as an independent developer, and the availability of alternative financing as evidence that it could remain an effective independent competitor.
This case underscores courts’ increasing willingness to protect pre-commercial rivalry and innovation and block mergers that risk harming innovation competition.
