FTC Secures Proposed Record $12 Million Penalty Against Edwards Lifesciences for Alleged HSR Filing Violation

The Federal Trade Commission said Monday it has secured a proposed record $12 million civil penalty against Edwards Lifesciences Corp. and Genesis MedTech Group Limited over allegations that they failed to make a required premerger filing for a 2024 medical-device deal.

Under a proposed final judgment filed July 13 in the U.S. District Court for the District of Columbia, Edwards would pay $10 million and Genesis would pay $2 million. The settlement, which the Justice Department filed on the FTC’s behalf, would also impose added restrictions on Edwards, including advance notice to the FTC before certain future acquisitions involving TAVR-AR devices and a requirement to maintain an antitrust compliance program overseen by a designated compliance officer.

The government’s complaint alleges that Edwards acquired JC Medical from Genesis on July 22, 2024, for $115 million plus contingent milestone payments, while also committing to a contemporaneous $25 million investment in Genesis. The Hart-Scott-Rodino Act requires companies in certain larger deals to notify federal antitrust agencies before closing and wait for review. According to the complaint, the parties structured the transaction so the JC Medical purchase price would appear to remain below the then-applicable $119.5 million reporting threshold, even though the FTC says the deal exceeded that level when the related Genesis investment is included. The complaint also points to Edwards’ Aug. 9, 2024, purchase of $25 million in nonvoting Genesis shares as part of what the agency describes as an intentional effort to avoid antitrust review.

The filing says the deal drew heightened concern because one day after closing the JC Medical acquisition, Edwards moved to acquire JenaValve Technology Inc. At that time, JC Medical and JenaValve were the only two companies in the United States conducting clinical trials for TAVR-AR devices, according to the FTC. TAVR-AR is a transcatheter aortic valve replacement device used to treat aortic regurgitation. The FTC later sued to block the JenaValve deal, and the same federal court granted the agency a preliminary injunction on Jan. 9, 2026, after a six-day hearing.

FTC Chairman Andrew N. Ferguson said in a statement: “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.” The agency said the $12 million combined penalty is the largest ever obtained for an alleged failure to make a required HSR filing, topping the previous public record of $11 million in the 2016 ValueAct matter. The FTC said the commission voted 2-0 to accept the settlement and refer the matter to the Justice Department.

Beyond the monetary penalties, the proposed judgment would require Edwards to give the FTC advance written notice before acquiring any U.S. company that commercially sells a TAVR-AR device in the United States, is engaged in U.S. clinical trials for such a device, or has a Food and Drug Administration investigational device exemption for those trials.

The settlement is still subject to court approval. The proposed judgment says it does not constitute an admission or finding of wrongdoing or liability, and the defendants deny wrongdoing.