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 | 9 min read | 10.21.26
The life sciences sector is uniquely vulnerable to the inherent risks of AI-generated evidence in drug development and discovery. This client alert focuses on five core challenges: hallucinations, skewed predictions from unrepresentative training data, the opacity of AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. To address these risks, companies should use experimental validation and human oversight as the common legal and regulatory safety net. This entails among other measures auditing AI outputs, characterizing training data, and structural oversight. Companies also should prepare for evolving frameworks and guidance from the U.S. Food and Drug Administration (FDA) and the European Union (EU) that address use of AI in drug discovery and development .
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