Expert Advice -- Caveat Emptor
Client Alert | 1 min read | 01.15.04
On the heels of a district court rejecting a company's reliance on expert advice in a recent False Claims Act case involving independent research and development charges (U.S. v. Newport News Shipbuilding, Inc., 276 F. Supp. 2d 539 (E.D. Va. 2003)), the Department of Justice has filed a complaint against a major accounting firm alleging that advice provided by that firm to a number of its healthcare clients caused the clients to submit "false claims" in the form of inflated bills for Medicare patients (U.S. v. Ernst & Young, LLP (E.D. Pa., filed Jan. 5, 2004)). Read in conjunction, these cases suggest that reliance on advice from outside accounting experts and other consultants as a defense to FCA charges may not be a safe harbor, particularly in circumstances where there is reason to believe that the expert advice will be perceived as "aggressive" by the government.
Insights
Client Alert | 9 min read | 10.21.26
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 .
Client Alert | 2 min read | 10.21.26
Client Alert | 3 min read | 10.21.26
Private Investigations Act Series: Temporal, material and territorial scope
Client Alert | 7 min read | 10.21.26
