Defendant’s Reasonable Interpretation of Ambiguous Regulation Negates FCA Liability
Client Alert | 1 min read | 12.01.15
The D.C. Circuit overturned a jury verdict against MWI Corp., represented by C&M, in a long-running civil FCA suit in which the government asserted claims for approximately $225 million in trebled damages (plus additional civil penalties), alleging that false claims and statements were submitted to the Export-Import Bank in connection with eight loans to Nigeria for the purchase of MWI's water pumps. The court held that there was no evidence that the government "had officially warned MWI away from its otherwise facially reasonable interpretation of [an] undefined and ambiguous [regulatory] term" and ruled that, in such a situation, the FCA's knowledge/scienter element cannot be established.
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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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