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Contractor's Report to OIG Insufficient to Trigger Public Disclosure Bar

Client Alert | less than 1 min read | 03.27.14

In U.S. ex rel Saunders v. Unisys Corp. (E.D. Va.), the court found that the relator's FCA claim was not precluded by the public disclosure bar despite the defendant providing its internal investigation report to OIG because (1) the report failed to reveal allegations or transactions creating an inference of fraud (its conclusion that the alleged fraudulent billing practices were "unacceptable" was not enough) and (2) it was made available only to the DOD IG and the government agency overseeing the contract and not the general public.


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Client Alert | 9 min read | 10.21.26

Artificial Intelligence in Life Sciences: Reliability of AI-Generated Evidence in Drug Discovery and Development

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 .  ...