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Federal Circuit Drops Bombshells on CDA Statute of Limitations and CAS "Materiality" Test

Client Alert | less than 1 min read | 12.11.14

In Sikorsky Aircraft Corp. v. U.S., the Federal Circuit upended the prevailing case law on the CDA statute of limitations by holding that the six-year SOL for filing CDA claims is "not jurisdictional" and "need not be addressed before deciding the merits." In denying the merits of the government's $80 million CAS 418 claim, the Federal Circuit also held that the cost of Sikorsky's management and supervision was "not a material amount of the total pool costs" because managers/supervisors comprised only 7 to 14 percent of the pertinent workforce, clarifying that materiality requires "a significant amount."


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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 .  ...