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Supreme Court Hears Argument on Implied Certification Theory

Client Alert | 1 min read | 04.20.16

On April 19, 2016, the Supreme Court heard oral argument in U.S. v. Universal Health Servs., Inc., which concerns (1) whether the implied certification theory of legal falsity under the FCA is ever viable; and (2) if it is, whether a contractor’s reimbursement claim can be legally false under that theory if the contractor fails to comply with a statute, regulation, or contractual provision that is not an explicit condition of payment. In a post on the Whistleblower Watch Blog, C&M attorneys share first impressions from yesterday’s argument and examine the significance of the case for government contractors who could face potential FCA exposure for failure to comply with myriad contract provisions or regulations.

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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. ...