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Profit Seeking Is Not Fraudulent

Client Alert | less than 1 min read | 10.12.12

In United States ex rel. Williams v. Renal Care Group, Inc., the Sixth Circuit found the defendants did not knowingly submit false claims to Medicare when they followed industry practices and sought guidance -- both from outside legal counsel and the government -- on how to follow ambiguous federal regulations, even though the contractors sought to maximize government payments. The court dismissed the idea that contractors "ought to be punished solely for seeking to maximize profits" and rejected the government's argument that the companies had "recklessly" misinterpreted the regulations to do so.


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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. ...