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Defendant’s Reasonable Interpretation of Ambiguous Regulation Negates FCA Liability

Client Alert | less than 1 min read | 12.01.15

The D.C. Circuit overturned a jury verdict against MWI Corp., represented by C&M, in a long-running civil FCA suit in which the government asserted claims for approximately $225 million in trebled damages (plus additional civil penalties), alleging that false claims and statements were submitted to the Export-Import Bank in connection with eight loans to Nigeria for the purchase of MWI's water pumps. The court held that there was no evidence that the government "had officially warned MWI away from its otherwise facially reasonable interpretation of [an] undefined and ambiguous [regulatory] term" and ruled that, in such a situation, the FCA's knowledge/scienter element cannot be established.


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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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