Substantial Penalties Under the FCA Without Real Damages Violates Eighth Amendment
Client Alert | 1 min read | 02.23.12
Using reasoning that could prove useful to other FCA defendants, the court in U.S. ex rel. Bunk v. Birkart Globistics GmbH & Co. (E.D. Va. Feb. 14, 2012), after the jury found over 9,000 false claims based on invoices submitted, refused to award statutory penalties of between $50.2 and $100.4 million. The court held that, when the qui tam relator failed to show that the government suffered any damage, imposing penalties of this magnitude would have violated the Eighth Amendment’s Excessive Fines Clause and, because it lacked discretion under the FCA to fashion a civil penalty that would be within Constitutional limits, no penalties could be imposed.
Insights
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On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026.
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