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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.


Insights

Client Alert | 2 min read | 09.18.25

FDA Announces Intention to Initiate an Aggressive Enforcement Campaign Against Misleading Pharmaceutical Advertising

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (HHS) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising. This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”...