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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Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage.
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