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Enough Is Enough! Supreme Court Puts an End to 18-Year FCA Litigation

Client Alert | less than 1 min read | 01.17.17

More than 18 years since the original qui tam complaint was filed, one of the longest-running FCA cases in history, U.S. ex rel. Purcell v. MWI Corp., came to an end in favor of defendant MWI, represented by C&M, when the Supreme Court on January 9, 2017, denied the relator’s petition for certiorari. The Supreme Court’s order caps MWI’s success on appeal, with the D.C. Circuit overturning a jury verdict against MWI on the grounds that the FCA’s scienter/knowledge element cannot be established when a defendant reasonably interprets an ambiguous regulation.

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Client Alert | 9 min read | 10.21.26

Artificial Intelligence in Life Sciences: Reliability of AI-Generated Evidence in Drug Discovery and Development

The life sciences sector is uniquely vulnerable to the inherent risks of AI-generated evidence in drug development and discovery. This client alert focuses on five core challenges: hallucinations, skewed predictions from unrepresentative training data, the opacity of AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. To address these risks, companies should use experimental validation and human oversight as the common legal and regulatory safety net. This entails among other measures auditing AI outputs, characterizing training data, and structural oversight. Companies also should prepare for evolving frameworks and guidance from the U.S. Food and Drug Administration (FDA) and the European Union (EU) that address use of AI in drug discovery and development .  ...