Ninth Circuit Opens Door to FCA Liability for Alleged 340B Overcharges

A recent decision from the U.S. Court of Appeals for the Ninth Circuit significantly reshapes the intersection of the False Claims Act (FCA) and the 340B Drug Pricing Program (340B Program). In United States ex rel. Adventist Health System of West v. AbbVie, No. 24-2180 (9th Cir. Mar. 17, 2026), the court reversed the dismissal of a qui tam action alleging that pharmaceutical companies inflated drug prices in violation of the 340B statutory ceiling, holding that such claims may proceed under the FCA notwithstanding the absence of a private right of action under the 340B statute. The decision marks a notable departure from a district court ruling—and from prior assumptions about the scope of the Supreme Court’s decision Astra USA, Inc. v. Santa Clara County, 563 U.S. 110 (2011)—and opens the door to increased FCA exposure tied to 340B Program pricing practices.

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Fourth Circuit Highlights Tougher Path to Dismissal of FCA Cases Post-SuperValu

A divided panel of the Fourth Circuit reversed the dismissal of a qui tam FCA suit alleging that the defendant pharmaceutical company underpaid Medicaid rebates by misreporting “best price” under the Medicaid Drug Rebate Statute. The decision marks the Fourth Circuit’s first application of the subjective scienter standard articulated by the Supreme Court in United States ex rel. Schutte v. SuperValu Inc., and underscores the difficulty defendants may face in securing dismissal at the pleading stage on the scienter element.

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Fifth Circuit Panel Produces Three Opinions Wrestling with Application of First to File Bar

On March 9, 2026, a divided panel of the Fifth Circuit revived a long-running qui tam suit against Lockheed Martin and reversed a district court’s dismissal of the relator’s complaint on first-to-file grounds. United States of America ex rel. Ferguson v. Lockheed Martin Corp., No. 24-10713 (5th Cir. 2026) (“Ferguson”). Under the False Claims Act’s first-to-file bar “no person other than the Government may intervene or bring a related action based on the facts underlying” a pending, first-filed action. 31 U.S.C. § 3730(b)(5).

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Strictly Enforcing Rule 9(b), Second Circuit Affirms Dismissal of FCA Claim Based on Allegedly Defective Medical Devices

The Second Circuit affirmed dismissal of an FCA qui tam based on allegedly faulty medical devices, an area marked for particular FCA scrutiny by the DOJ-HHS FCA Working Group, as discussed here.  The Second Circuit held the relator failed to plead either a claim or materiality with the requisite specificity and affirmed the dismissal pursuant to Rule 9(b).  Wood v. Siemens Med. Sols. USA, Inc., No. 25-864, 2026 WL 504530 (2d Cir. Feb. 24, 2026).

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Court Grants Motion to Dismiss FCA Claim for Failure Adequately to Plead Scienter

Recently a court took the rare step of granting a motion to dismiss a qui tam suit because the relator’s vague and conclusory scienter allegations failed to satisfy Rules 8 and 9(b).  U.S. ex rel. Dietz v. Philips Respironics, No. 2:21-CV-00272 (W.D. Pa. Feb. 23, 2026).

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TX AG’s Office Continues Aggressive Enforcement Against Healthcare Entities Operating in Texas

In just the last week, the Texas Attorney General’s Office (“TX AG’s Office”) filed three actions against healthcare providers and entities, continuing an increasingly robust and aggressive enforcement regime that dates back to at least the beginning of 2025.

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DAAG Brenna Jenny Warns Heightened FCA Enforcement Is “The New Normal,” Addresses Enforcement Priorities and Policies

During her keynote speech at the Federal Bar Association’s Qui Tam Conference, Brenna Jenny,  Deputy Assistant Attorney General for the Commercial Litigation Branch, stated that robust FCA enforcement is “the new normal.” Key statistics, including those we discussed here, back her up: she revealed that DOJ has issued more than 1,000 Civil Investigative Demands (“CIDs”) in each of the last four years, noted that qui tam actions increased by 33% last year, and that 480 qui tam actions have already been filed so far in fiscal year 2026.  She attributed this dramatic increase at least in part to enhanced data mining being conducted by DOJ and whistleblowers.  Describing the FCA as a “flexible tool,” Jenny left no doubt that FCA enforcement will remain high even as she acknowledged that it is not “an all-purpose anti-fraud statute.”

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DAAG Jenny Reinforces Commitment to FCA Enforcement Premised on Discrimination

At the Federal Bar Association’s Qui Tam Conference, Brenna Jenny, the Deputy Assistant Attorney General of DOJ’s Commercial Litigation Branch, offered the most detailed description yet of the Trump Administration’s effort to employ the FCA to combat practices that violate federal antidiscrimination laws, as we have previously reported here, here, and here.  Jenny noted that while promoting diversity is not itself unlawful, it is also “not a protective talisman.” She stated that she believed some companies had “lost their way” in the pursuit of DEI and engaged in unlawful discrimination by pressuring their employees to make hiring and promotion decisions based on race or sex.

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