Seal Violation Does Not Mandate Dismissal, Supreme Court Says
Client Alert | 1 min read | 12.07.16
On December 6, 2016, the Supreme Court in State Farm and Casualty Co. v. U.S. ex rel. Rigsby rejected the argument that a violation of the FCA’s seal requirement — here, disclosure of the allegations of the sealed complaint to the news media by relator’s counsel — mandates dismissal of a relator’s complaint, holding instead that such a determination is better left to the discretion of the district court. The Court reasoned that the FCA is silent as to the remedy for violating the seal provision, whereas it expressly mandates dismissal elsewhere, and that a rule mandating dismissal could harm the government’s interests —which the seal requirement was meant to protect — by depriving the government of assistance from relators on which it relies to prosecute FCA claims.
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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 .
Client Alert | 2 min read | 10.21.26
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Private Investigations Act Series: Temporal, material and territorial scope
Client Alert | 7 min read | 10.21.26
