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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 | 7 min read | 09.14.26

AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development

Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage. ...