Reverse False Claim Requires "Established" Obligation to Pay
Client Alert | less than 1 min read | 12.15.16
On December 13, 2016, the Fifth Circuit, reversing the district court, held in U.S. ex rel. Simoneaux v. E.I. DuPont De Nemours & Co that the 2009 amendments to the FCA did not abrogate its prior precedent holding that reverse false claims liability did not extend to potential or contingent obligations to pay unassessed government fines or penalties. Agreeing with both the defendant and, notably, the United States, the court concluded that, while the 2009 amendments clarified that the amount of the obligation need not be “fixed,” the duty to pay had to be “established” before liability could attach.
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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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