Reverse False Claim Requires "Established" Obligation to Pay
Client Alert | less than 1 min read | 12.15.16
On December 13, 2016, the Fifth Circuit, reversing the district court, held in U.S. ex rel. Simoneaux v. E.I. DuPont De Nemours & Co that the 2009 amendments to the FCA did not abrogate its prior precedent holding that reverse false claims liability did not extend to potential or contingent obligations to pay unassessed government fines or penalties. Agreeing with both the defendant and, notably, the United States, the court concluded that, while the 2009 amendments clarified that the amount of the obligation need not be “fixed,” the duty to pay had to be “established” before liability could attach.
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Client Alert | 6 min read | 09.03.26
FDA Seeks Input for Regulating GenAI-Powered Medical Devices
The U.S. Food & Drug Administration (FDA) is seeking feedback on a regulatory framework that could be used to evaluate generative artificial intelligence (GenAI)-enabled medical devices. Such devices could create new types of risks because their outputs can vary and evolve, unlike more traditional software-enabled devices. An August 18, 2026, discussion paper (“Considerations for the regulation of GenAI-enabled medical devices”) discusses potential regulatory considerations for GenAI-enabled medical devices.
Client Alert | less than 1 min read | 09.03.26
SBA Proposal to Overhaul Size Standards Would Transform Federal Government Contracting
Client Alert | 5 min read | 09.02.26
DOJ’s Civil Rights Fraud Initiative Claims Another DEI-Related FCA Settlement
Client Alert | 4 min read | 09.02.26
