Summary of the enforcement action

The United States, on behalf of the FTC, filed a complaint and proposed final judgment in the U.S. District Court for the District of Columbia alleging that Edwards and Genesis violated the HSR Act by closing Edwards’ acquisition of JC Medical without making the required filing or observing the waiting period. The proposed judgment requires $12 million in combined civil penalties: $10 million from Edwards (including former Genesis subsidiary JC Medical) and $2 million from Genesis.

Underlying facts: The JC Medical and JenaValve transactions

According to the complaint, JC Medical and JenaValve Technology, Inc. were the only U.S. companies then conducting clinical trials for transcatheter aortic valve replacement devices used to treat aortic regurgitation (TAVR-AR devices). Edwards was negotiating to acquire both companies in close succession.

The JC Medical acquisition

The complaint alleges that Edwards was concerned HSR review of the JC Medical acquisition would delay closing, particularly because it was also negotiating to acquire JenaValve. Edwards and Genesis allegedly set the JC Medical purchase price at $115 million plus contingent milestones, just below the then-applicable $119.5 million HSR threshold, while Edwards simultaneously agreed to make a separate $25 million investment in Genesis connected to the same transaction.

The FTC alleges that the acquisition price and $25 million investment were, in substance, one integrated transaction exceeding the HSR threshold and therefore reportable. Edwards closed the JC Medical acquisition in July 2024 without making an HSR filing.

The JenaValve acquisition

One day after closing the JC Medical deal, Edwards moved to acquire JenaValve, JC Medical’s only competitor in U.S. TAVR-AR clinical trials, for $945 million. The FTC challenged that transaction in August 2025, alleging it would reduce innovation, diminish product quality, and potentially increase prices. On January 9, 2026, after a six-day trial, the district court preliminarily enjoined the acquisition; Edwards then abandoned the transaction, and the FTC’s related administrative proceeding was dismissed on January 28, 2026.

Terms of the proposed final judgment

The proposed final judgment imposes the $12 million penalty and forward-looking obligations on Edwards:

• Prior notice requirement. Edwards must provide advance written notice to the FTC before acquiring, directly or indirectly, any ownership interest in any firm that sells a TAVR-AR device in the United States, is conducting U.S. TAVR-AR clinical trials, or has received an FDA Investigational Device Exemption for such trials.
• Antitrust compliance program. Edwards must design, maintain, and operate an antitrust compliance program reasonably designed to ensure compliance with the final judgment and antitrust laws.

Once entered, the judgment will have the force of law. The prior-notice obligation creates a targeted reporting regime for the TAVR-AR device market and illustrates the type of bespoke remedy the FTC may seek when it believes a party has attempted to evade the HSR process.

Practical implications and considerations

The settlement sends a clear enforcement signal for companies pursuing M&A, particularly in concentrated or nascent health care and medical device markets:

• Aggregate consideration matters. The FTC treated a below-threshold acquisition price and a contemporaneous, related investment as a single transaction. Parties should not assume they can avoid HSR obligations by splitting consideration across a purchase price, investment, side agreement, or other payment stream tied to the same deal.
• Deal timing, intent, and communications matter. The complaint emphasizes Edwards’ alleged concern that HSR review would delay closing while it pursued a competing target, underscoring that the FTC will review contemporaneous deal activity and internal communications suggesting an intent to avoid antitrust review.
• Penalties are severe and can accrue quickly. The $12 million settlement is the largest HSR non-filing penalty on record. Civil penalties are adjusted annually for inflation; as of the FTC’s February 2025 notice, the maximum was $53,088 per day of violation.
• Bespoke remedies may follow. The prior-notice and compliance program requirements show that the FTC may seek durable obligations beyond civil penalties, including product-market-specific reporting obligations.
• Health care and medical device deals remain a priority. The settlement, alongside the JenaValve challenge, reflects continued FTC focus on innovation competition in markets with few clinical-stage participants.

What this means for you: Recommendations for corporate counsel and deal teams

Clients engaged in, or contemplating, M&A should:

• Aggregate related consideration when assessing HSR thresholds. Evaluate whether concurrent or related investments, side payments, licensing arrangements, or other consideration should be aggregated with the primary purchase price, and document any independent business rationale for ancillary payments.
• Involve antitrust counsel early. Build HSR analysis into deal pricing and structure before signing, and require counsel sign-off before signing or closing.
• Use caution with concurrent or sequential transactions. Deals involving competitors or related firms in narrow markets may draw heightened scrutiny of timing, sequencing, and internal communications.
• Avoid documenting HSR-avoidance rationale internally. Communications suggesting that terms were selected to fall below HSR thresholds or avoid regulatory delay can create litigation and enforcement risk.
• Refresh HSR compliance protocols. Active acquirers should maintain documented HSR threshold analyses for each transaction and related side arrangement, clear escalation paths to antitrust counsel, and periodic training for corporate development teams.
• Anticipate remedies beyond penalties. Companies under FTC investigation for HSR violations should be prepared for prior-notice obligations and mandatory compliance programs, particularly where the agency perceives an intent to evade review.

We will continue to monitor developments. Please contact your antitrust and competition counsel to discuss how this enforcement action may affect pending or contemplated transactions, deal structuring, or HSR compliance programs.

Client Alert 2026-149