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FTC Fines Edwards Lifesciences $12 Million Over Antitrust Evasion

A $12 million penalty marks the largest fine ever issued for violating pre-merger filing requirements under the Hart-Scott-Rodino Act. Federal regulators allege that Edwards Lifesciences and Genesis MedTech deliberately structured a recent acquisition to bypass antitrust scrutiny and avoid mandatory waiting periods that could have stalled their market strategy.

FTC Fines Edwards Lifesciences $12 Million Over Antitrust Evasion

The dispute centers on Edwards Lifesciences’ July 2024 purchase of JC Medical, a developer of aortic-valve replacement technology. According to the Federal Trade Commission, the companies engineered the transaction value to slip just beneath the statutory reporting threshold, effectively circumventing the oversight process. This move allowed the deal to close without the legally required review period.

Regulators claim the urgency was driven by a concurrent move to acquire JenaValve Technology, JC Medical’s only direct competitor. The FTC alleges that Edwards sought to avoid a simultaneous antitrust investigation that would have likely delayed the JC Medical acquisition. Under the proposed settlement, Edwards and JC Medical will pay $10 million, while Genesis MedTech contributes $2 million.

Beyond the financial penalty, the order imposes strict new compliance mandates on Edwards. The company must provide the FTC with advance notice regarding any future acquisitions involving transcatheter valve devices for aortic regurgitation. Edwards has also been directed to establish a formal antitrust compliance program. While the company maintains it acted within the law, it agreed to the settlement to resolve the matter without an admission of wrongdoing.

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