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FOIA Release Is FCA 'Public Disclosure'

Client Alert | less than 1 min read | 11.30.09

In U.S. ex rel. Ondis v. City of Woonsocket (1st Cir. Nov.18, 2009), the First Circuit concluded that, under the False Claims Act's public disclosure bar, courts lack subject-matter jurisdiction over qui tam actions when the relator's allegations are based upon information released through Freedom of Information Act requests, finding that FOIA releases of "substantially similar" information which include the essential elements of the alleged fraud qualify as public disclosures. The court noted that it was joining the majority view, adopted by every circuit to consider the issue except the Fourth, taking into account the recent shift by the Seventh Circuit to the majority.

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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. ...

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