Defective Pricing & the False Claims Act
Client Alert | 1 min read | 05.21.19
The enactments of the False Claim Act (FCA) and the Truth in Negotiations Act (TINA) were separated by nearly 100 years, yet the two statutes have become kissing cousins, with many defective pricing cases turning into fraud actions. In Defective Pricing & the False Claims Act, published in the April 2019 issue of Thomson Reuters’s Briefing Papers, Crowell & Moring attorneys discuss: (1) the historical factors and practical warning signs linking defective pricing and FCA actions; (2) the burdens and elements of proof in TINA and FCA litigations and how certain elements may overlap and even bolster defenses to both defective pricing and fraud actions; and (3) the procedural elements of TINA and FCA actions—such as stays of proceedings, evidentiary standards, and statutes of limitation—and where these factors may determine the outcomes in both defective pricing and fraud proceedings.
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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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