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D.C. Circuit Creates Split over the Reach of the First-to-File Bar

Client Alert | 1 min read | 04.18.14

In U.S. ex rel. Shea v. Verizon Co., the D.C. Circuit held that (1) two complaints may be "related" even if they involve different agencies or contracts, (2) the bar applies even when the same relator filed the earlier action, and (3) it continues to operate even after the earlier-filed action is resolved. The third holding (which drew a dissent) conflicts with dicta from two other circuits and the Fourth Circuit's 2013 opinion in U.S. ex rel. Carter v. Halliburton Co., petition for cert. filed (discussed here), holding that the first-to-file bar only applies while the earlier action is still pending.

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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 .  ...