Eighth Circuit Applies Escobar's Materiality Standard
Client Alert | 1 min read | 10.24.16
In U.S. ex rel. Miller v. Weston Educ. Inc. (Oct. 19, 2016), the Eighth Circuit became the first appellate court to apply the materiality standard recently articulated by the Supreme Court in Escobar (discussion of Escobar available here), holding that defendant’s promise to keep accurate grade and attendance records was material in inducing the government to enter into an agreement under the Higher Education Act. The court rejected defendant’s argument that no individual false record caused payment by the government, reasoning instead that the false promise to keep accurate records was material based on the express regulatory conditions of participation, their reasonable importance to payment, and evidence that the government had terminated other institutions that falsified similar records.
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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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