Fourth Circuit Weighs in on Public Disclosure Bar and Retroactivity
Client Alert | 1 min read | 12.13.13
The Fourth Circuit in U.S. ex rel. Radcliffe v. Purdue Pharma.(Dec. 12, 2013) became the first court of appeals to address whether the FCA's public disclosure bar is still jurisdictional after its 2010 amendment by the Affordable Care Act (a topic about which Crowell & Moring attorneys wrote articles in March and September) and held that it is not, reasoning that the word jurisdiction was excised from the statute and that the government was newly empowered to veto application of the bar. This decision came in the context of a broader analysis in which the court clarified that the date of the allegedly fraudulent conduct, not the date that the complaint was filed, governs potential retroactive effect.
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 | 3 min read | 10.21.26
Private Investigations Act Series: Temporal, material and territorial scope
Client Alert | 7 min read | 10.21.26
Client Alert | 4 min read | 10.20.26
California Follows New York’s Lead in Requiring AI “Synthetic Performer” Disclosures in Advertising
