Solicitor General Weighs in (Sort of) on Rule 9(b)
Client Alert | 1 min read | 02.27.14
In October 2013, the Supreme Court invited the Solicitor General to express the government's views on a pending petition for certiorari in U.S. ex rel. Nathan v. Takeda Pharmaceuticals, whose central issue concerns the requisite level of particularity required by Rule 9(b) in FCA cases. The Solicitor General has now asked the Supreme Court to deny the relator's petition, calling the case "not a suitable vehicle" for resolving the particularity question (because the lower court reached the correct result on other grounds), while expressing the government's view that "a qui tam complaint satisfies Rule 9(b) if it contains detailed allegations supporting a plausible inference that false claims were submitted to the government, even if the complaint does not identify specific requests for payment"(emphasis added).
Insights
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
