FTC Secures $12 Million in Penalties for Alleged HSR Violation

On July 13, 2026, the FTC announced that it had entered into settlement with Edwards and Genesis, resolving allegations that the two companies violated the HSR Act by failing to report Edwards's proposed acquisition of JC Medical. Under the terms of a proposed final judgment, Edwards will pay a $10 million civil penalty, while Genesis will pay a $2 million civil penalty.

According to the complaint, filed in the U.S. District Court for the District of Columbia, Edwards sought to acquire JC Medical, which was in clinical trials to bring to market a transcatheter aortic valve replacement ("TAVR-AR") device, designed to treat a heart condition known as aortic regurgitation, from Genesis. At the same time, Edwards was seeking to acquire JC Medical's only TAVR-AR competitor, JenaValve Technology, Inc. ("JenaValve"), which also had a TAVR-AR device in clinical trials in the United States.

The government alleges that Edwards sought to keep the JC Medical purchase price below the HSR threshold then in existence ($119.5 million), to avoid antitrust scrutiny that could delay the transaction. But, according to the government, Genesis placed a higher valuation on the JC Medical business and refused to accept a lower offer. So, Edwards instead allegedly agreed to pay $115 million in cash up front, plus future contingency payments valued at approximately $1.8 million, and to make a contemporaneous $25 million investment in Genesis itself. According to the complaint:

On April 27, 2024, JC Medical sent two term sheets to Edwards: one for JC Medical and one for the Genesis investment. The transmittal email made clear that both were part of a single transaction and stated that the Genesis investment would be concurrent with the closing of the JC Medical acquisition. Documents and testimony show that Edwards and Genesis considered the Genesis investment part of the deal but did not count it for HSR purposes. Edwards told JenaValve that there was no HSR review for the JC Medical acquisition because it was "below the threshold! Intentional[.]"

The government contends that a "sufficient part of the $25 million Genesis investment is attributable to additional compensation for JC Medical such that, when added to the $115 million direct payment, the total price paid for the acquisition of JC Medical was above the HSR filing threshold of $119.5 million." Invoking HSR Rule 801.90, 16 CFR § 801.90, which states that "[a]ny transaction(s) or other device(s) entered into or employed for the purpose of avoiding the obligation to comply with the requirements of the [HSR Act] shall be disregarded, and the obligation to comply shall be determined by applying the [HSR Act] and these rules to the substance of the transaction," the government concluded that the parties had failed to file on a reportable transaction.

In announcing the settlement, FTC Chairman Andrew Ferguson stated: "Companies that try to sneak deals through without lawful FTC review should take notice. The FTC will be vigilant in enforcing the requirements of the Hart-Scott-Rodino Act, and we will not hesitate to seek penalties for its violation."

In January 2026, the U.S. District Court for the District of Columbia granted the FTC's application for a preliminary injunction blocking Edwards's proposed acquisition of JenaValve. The parties subsequently abandoned that deal.

The $12 million penalty is the highest fine ever imposed for an HSR violation. It is also noteworthy that fines were imposed on both the buyer Edwards ($10 million) and the seller Genesis ($2 million).

The enforcement action serves as a continuing reminder that the FTC is willing to look past the paper structure of a transaction to get to the underlying substance in assessing HSR reportability. Moreover, while HSR risk is most often borne by the buyer, the agency will seek penalties against the seller in instances in which it concludes that the seller is also culpable for a violation of the HSR Act.