Supreme Court Denies Cert. in Rule 9(b) Pleading Requirements Case
Client Alert | 1 min read | 04.03.14
The Supreme Court has followed the government's recommendation (discussed in a previous bullet point and blog post) not to hear an appeal challenging the dismissal of relator's complaint in U.S. ex rel. Nathan v. Takeda Pharmaceuticals, 707 F.3d 451 (4th Cir. 2013), for failure to allege specific false claims instead of a false scheme – an issue over which the government admits there is "at least some continuing uncertainty." The Court has invited the government's views on granting cert. in another prominent FCA case, KBR, Inc. v. U.S. ex rel. Carter (addressing the scope of the FCA's first-to-file bar and the Wartime Suspension of Limitations Act) (discussed here), but the Solicitor General has not yet weighed in.
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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 .
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Private Investigations Act Series: Temporal, material and territorial scope
Client Alert | 7 min read | 10.21.26
