Fourth Circuit Interprets Corporate Knowledge And Materiality Under FCA
Client Alert | 1 min read | 01.08.04
In United States ex rel. Harrison v. Westinghouse Savannah River Co. (Dec. 19, 2003), the Fourth Circuit upheld a civil penalty of $195,000 ($7500 times 26 invoices) because the false cert "negatively affected the integrity of the bidding process," although zero actual damages were proven. The court held that (a) the False Claims Act's "knowledge" element was satisfied when one employee of the corporate defendant had knowledge of the facts making the corporation's certification false, even though there was no evidence that the same employee knew that the cert was required or even that it had been submitted; and (b) the false cert (that no organizational conflict of interest (OCI) existed in connection with a subcontract award) was "material" because it would have "had a natural tendency to influence" the government's decision to fund the subcontract "if it had known the full details" at the time of award, even though the government in fact concluded that no OCI existed when it subsequently learned of the issue and continued to pay for the subcontract work thereafter.
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
Client Alert | 3 min read | 10.21.26
Private Investigations Act Series: Temporal, material and territorial scope
Client Alert | 7 min read | 10.21.26
