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Unanimous Supreme Court Holds that Implied Certification Can be Basis for FCA Liability

Client Alert | 1 min read | 06.16.16

On June 16, 2016, the Supreme Court handed down Universal Health Services v. United States ex rel. Escobar, holding unanimously that the “implied certification” theory can be a basis for False Claims Act (FCA) liability when a defendant submitting a claim makes specific representations about the goods or services provided, and fails to disclose noncompliance with material statutory, regulatory, or contractual requirements, thereby making those representations misleading. Although the Court rejected the First Circuit’s broad materiality standard (that any legal noncompliance is material so long as the defendant knows that the government would be entitled to refuse payment were it aware of the violation), it made clear that the underlying statutory, regulatory, or contractual requirement need not be an explicit condition of payment to trigger liability under the implied certification theory; rather, the test is whether the representation would likely influence government payment, a determination that may be made using both objective and subjective standards.

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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. ...