Antitrust Law Daily Wrap Up, ACQUISITIONS & MERGERS NEWS: Medical tech companies agree to pay $12 million to settle HSR violation, (Jul 14, 2026)
Organizations Mentioned:Edwards Lifesciences | Edwards Lifesciences Corp. | JC Medical, Inc. Genesis MedTech Group Limited | Jenavalve Technology, Inc.
By Jody Coultas, J.D.
The FTC alleged that Edwards Lifesciences failed to comply with the notification and waiting period requirements of the Hart-Scott-Rodino Antitrust Improvements Act.
The FTC announced that Edwards Lifesciences Corp. and JC Medical, Inc. will pay $12 million in total penalties to settle charges that the companies failed to comply with the notification and waiting period requirements of the Hart-Scott-Rodino Act (HSR). The combined $12 million penalty is the largest ever for failing to make an HSR filing (U.S. v. Edwards Lifesciences Corp., No. 1:26-cv-02450 (D.D.C. Jul. 13, 2026)).
On July 22, 2024, Edwards Lifesciences acquired JC Medical from Genesis MedTech Group Limited for $115 million and future milestone payments with an ostensible value of approximately $1.8 million. Also, Edwards acquired non-voting shares in Genesis for $25 million. According to the FTC, Edwards was keen to avoid a delay and an investigation by the FTC into its acquisition of JC Medical. Because the transaction would have exceeded the then-HSR reporting threshold of $119.5 million, the companies agreed to view the $115 million payment for JC Medical and the $25 million investment in Genesis as separate payments. By viewing the payments as independent, Edwards acquired JC Medical without complying with the notification and waiting period requirements of the HSR Act.
By not filing as required by the HSR, Edwards and Genesis immediately closed the transaction and did not publicly announce the deal at that time. The day after closing the JC Medical acquisition, Edwards entered into an agreement to purchase JC Medical’s only competitor, JenaValve Technology, Inc., thereby owning the only two companies in the U.S. with transcatheter aortic valve replacement for aortic regurgitation (TAVR-AR) devices in clinical trials.
The HSR Act, which requires parties to submit an HSR form to the federal antitrust agencies and observe a waiting period before completing a transaction. The waiting period provides the antitrust agencies with time to evaluate the transaction for potential competitive harm. Under the HSR Rule 16 C.F.R. 801.90, (a) if parties structure a transaction “for the purpose of avoiding” the HSR Act’s requirements, then determining whether an HSR notification should have been filed is based on an analysis of the “substance of the transaction,” as opposed to the form of the avoidance scheme; and (b) carrying out this notification analysis requires determining the full value of the consideration paid for the voting securities being acquired, no matter what form that consideration takes.
The FTC alleged that, in substance, the transactions between Edwards and Genesis met the thresholds for mandatory reporting under HSR, as the combination amounted to more than $119.5 million.
Proposed order. Edwards LifeSciences and JC Medical will pay a $10 million penalty to settle the charges. Genesis will pay a $2 million penalty. On top of the monetary penalties, the proposed final judgment also specifies, among other terms, that Edwards will not, without providing advance written notification to the FTC, acquire, directly or indirectly, through subsidiaries or otherwise, any ownership interest, in whole or in part, in any firm that: (1) Commercially sells a TAVR-AR device in the United States; (2) Is engaged in clinical trials in the United States for a TAVR-AR device; or (3) Has received an Investigational Device Exemption from the U.S. Food and Drug Administration to conduct clinical trials on a TAVR-AR device in the United States.
Edwards also will be required to design, maintain and operate an antitrust compliance program to ensure compliance with the final judgment and the antitrust laws.
JenaValve acquisition. The FTC sued to block Edwards’ acquisition of JenaValve alleging that the deal was anticompetitive and, in January 2026, the U.S. District Court for the District of Columbia granted the FTC’s request for a preliminary injunction after a six-day hearing.
Attorneys: Jennifer Lee, U.S. Attorney's Office, for the U.S.
Companies: Edwards Lifesciences Corp.; JC Medical, Inc. Genesis MedTech Group Limited
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