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Supreme Court Denies Cert. in Rule 9(b) Pleading Requirements Case

Client Alert | 1 min read | 04.03.14

The Supreme Court has followed the government's recommendation (discussed in a previous bullet point and blog post) not to hear an appeal challenging the dismissal of relator's complaint in U.S. ex rel. Nathan v. Takeda Pharmaceuticals, 707 F.3d 451 (4th Cir. 2013), for failure to allege specific false claims instead of a false scheme – an issue over which the government admits there is "at least some continuing uncertainty." The Court has invited the government's views on granting cert. in another prominent FCA case, KBR, Inc. v. U.S. ex rel. Carter (addressing the scope of the FCA's first-to-file bar and the Wartime Suspension of Limitations Act) (discussed here), but the Solicitor General has not yet weighed in.


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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.”...