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Solicitor General Weighs in (Sort of) on Rule 9(b)

Client Alert | 1 min read | 02.27.14

In October 2013, the Supreme Court invited the Solicitor General to express the government's views on a pending petition for certiorari in U.S. ex rel. Nathan v. Takeda Pharmaceuticals, whose central issue concerns the requisite level of particularity required by Rule 9(b) in FCA cases. The Solicitor General has now asked the Supreme Court to deny the relator's petition, calling the case "not a suitable vehicle" for resolving the particularity question (because the lower court reached the correct result on other grounds), while expressing the government's view that "a qui tam complaint satisfies Rule 9(b) if it contains detailed allegations supporting a plausible inference that false claims were submitted to the government, even if the complaint does not identify specific requests for payment"(emphasis added).


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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.”...