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Substantial Penalties Under the FCA Without Real Damages Violates Eighth Amendment

Client Alert | less than 1 min read | 02.23.12

Using reasoning that could prove useful to other FCA defendants, the court in U.S. ex rel. Bunk v. Birkart Globistics GmbH & Co. (E.D. Va. Feb. 14, 2012),  after the jury found over 9,000 false claims based on invoices submitted, refused to award statutory penalties of between $50.2 and $100.4 million.  The court held that, when the qui tam relator failed to show that the government suffered any damage, imposing penalties of this magnitude would have violated the Eighth Amendment’s Excessive Fines Clause and, because it lacked discretion under the FCA to  fashion a civil penalty that would be within Constitutional limits, no penalties could be imposed.

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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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