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Sixth Circuit Recognizes Exception to Heightened Standard for Pleading False Claim

Client Alert | less than 1 min read | 10.12.16

In U.S. ex rel. Prather v. Brookdale Senior Living Communities Inc. (Sept. 30, 2016), the Sixth Circuit held that a relator pled the “presentment” element even though the relator did not allege information regarding the submission of a specific request for payment. The court reasoned that, in the majority of cases, plaintiffs would need to plead representative false claims but that a relator could survive a motion to dismiss by pleading specific facts based on personal, billing-related knowledge that support a strong inference that specific false claims were submitted for payment.

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Client Alert | 2 min read | 05.09.25

FDA Seeks Stakeholder Consultation on Prescription Drug User Fee Reauthorization

On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization....