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 | 4 min read | 01.07.26
On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026.
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CMMC for AI? Defense Policy Law Imposes AI Security Framework and Requirements on Contractors
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New Year, Same CIPA Uncertainty – When Will the Appellate Courts Enter the Chat?
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