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Earlier Complaint Fails 9(b), But Bars FCA Suit

Client Alert | 1 min read | 11.08.11

Addressing a question of first impression for it, the D.C. Circuit in U.S. ex rel Batiste v. SLM Corp. held that the FCA’s “first-to-file” rule deprives the district courts of subject matter jurisdiction when a complaint filed earlier alleges “the same material elements of a fraudulent scheme,” even if the earlier complaint did not meet the heightened standard of Rule 9(b).  In so holding, the D.C. Circuit disagreed with the Sixth Circuit in Walburn v. Lockheed Martin Corp., noting that nothing in the FCA incorporates Rule 9(b)’s particularity requirement into the first-to-file rule and that the earlier complaint was sufficient to allow the government to investigate the fraudulent scheme.

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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.”...