On July 13, 2026, the Federal Trade Commission (FTC) announced that it had secured a combined $12 million civil penalty settlement with Edwards Lifesciences Corporation and Genesis MedTech Group Limited to resolve allegations that the parties violated the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the HSR Act) in connection with Edwards’ acquisition of JC Medical, a Genesis subsidiary. This settlement represents the largest combined penalty ever imposed for failure to make an HSR filing and sends a clear message to dealmakers: the FTC will aggressively pursue parties that structure transactions to avoid premerger notification requirements.

The Edwards/JC Medical Transaction

JC Medical was developing transcatheter aortic valve replacement devices for treating aortic regurgitation (“TAVR-AR devices”) and was in clinical trials at the time of the acquisition. In July 2024, Edwards acquired JC Medical from Genesis without filing the required HSR notification. Critically, just one day after closing the JC Medical deal, Edwards attempted to acquire JenaValve Technology, Inc.—the only other U.S. company with a TAVR-AR device in clinical trials—for $945 million. Had both deals succeeded, Edwards would have controlled the only two companies developing this technology in the United States.

The FTC subsequently sued to block the JenaValve acquisition as anticompetitive, and in January 2026, the U.S. District Court for the District of Columbia granted a preliminary injunction following a six-day evidentiary hearing.

The Alleged HSR Avoidance Scheme

According to the FTC’s complaint, Edwards was concerned that HSR review of the JC Medical acquisition would delay closing—particularly given its concurrent negotiations to acquire JenaValve. Also according to the complaint, to avoid triggering a mandatory HSR filing, Edwards and Genesis allegedly structured the JC Medical deal at $115 million (plus milestone payments), which fell just below the then-applicable $119.5 million size-of-transaction threshold.

However, Edwards simultaneously agreed to make a $25 million investment in Genesis in connection with the JC Medical transaction. The FTC alleged that the combined value of the JC Medical acquisition and the contemporaneous Genesis investment exceeded the $119.5 million threshold, thereby triggering HSR reporting obligations that the parties failed to satisfy.

Settlement Terms

Under the proposed final judgment, Edwards (including former Genesis subsidiary JC Medical) will pay $10 million, and Genesis will pay $2 million. Additionally, Edwards must provide advance written notice to the FTC before acquiring any ownership interest in firms that commercially sell, are conducting clinical trials on, or hold an FDA Investigational Device Exemption for TAVR-AR devices in the United States. Edwards must also implement and maintain a comprehensive antitrust compliance program. The settlement does not constitute an admission of wrongdoing.

Miles & Stockbridge’s corporate lawyers will continue to monitor this matter as it goes through the courts and are available to answer questions about how the ruling affects pending or planned transactions.

Practical Takeaways for M&A Practitioners

The case underscores the FTC’s willingness to invoke 16 C.F.R. § 801.90, the HSR anti-avoidance rule. That regulation provides that any transaction “entered into or employed for the purpose of avoiding the obligation to comply with the requirements of the act shall be disregarded, and the obligation to comply shall be determined by applying the act and these rules to the substance of the transaction.” (emphasis added). In other words, when parties structure a deal to circumvent HSR thresholds, the FTC will look through the form of the arrangement to the economic reality of the transaction. The key takeaways from this settlement:

• Do not structure around HSR thresholds. The FTC will aggregate related transactions and side agreements when assessing whether the size-of-transaction threshold has been met. Splitting consideration across multiple agreements will not insulate parties from filing obligations.
• Section 801.90 has teeth. This enforcement action demonstrates that the anti-avoidance rule is not a dead letter. The FTC will apply a “substance over form” analysis to transactions that appear designed to fall below reporting thresholds.
• Penalties are escalating. A $12 million combined penalty, the largest in HSR enforcement history, signals that the FTC views avoidance schemes as serious violations warranting significant financial consequences.
• Timing and sequencing matter. The proximity of these transactions heightened FTC scrutiny. Dealmakers pursuing multiple acquisitions in the same space should carefully assess whether transactions may be aggregated for HSR purposes.
• Consult antitrust counsel early. When transaction values approach HSR thresholds, particularly where related agreements or investments are contemplated, parties should seek antitrust counsel’s guidance before finalizing deal structures.

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