Health Law Daily Wrap Up, FALSE CLAIMS ACT—3d Cir.: Third Circuit affirms dismissal of whistleblower’s False Claims Act suit against drugmakers, (Apr 14, 2025)

By Elena Eyber, J.D.

The Third Circuit ruled that a whistleblower failed to plead sufficient facts showing pharmaceutical companies misled the FDA about antibiotic side effects.

The Court of Appeals for the Third Circuit affirmed the dismissal of a qui tam lawsuit filed by a whistleblower under the False Claims Act (FCA) against Bayer, Johnson & Johnson, and other pharmaceutical companies. The whistleblower alleged that the companies fraudulently induced the FDA to approve two fluoroquinolone-class antibiotics by concealing or misrepresenting the drugs' neurological and psychiatric side effects. The whistleblower argued this led to improper reimbursements by federal healthcare programs. The Third Circuit upheld the district court’s ruling that the whistleblower failed to state a viable claim under the FCA, concluding that he did not sufficiently plead falsity or materiality (U.S. ex rel. Bennett v. Bayer Corporation, No. 24-1807 (3d Cir. Apr. 10, 2025)).

The case revolved around ciprofloxacin and levofloxacin, antibiotics developed in the 1980s and 1990s. The whistleblower contended that the companies knowingly withheld or downplayed adverse side effects during and after the FDA’s drug approval process. The whistleblower claimed the companies either omitted crucial clinical data or presented it in a disaggregated form to obscure the incidence of a condition he termed “fluoroquinolone-associated disability” (FQAD). However, the Third Circuit found that these allegations lacked the specificity required under the heightened pleading standards of Rule 9(b), noting that the whistleblower relied too heavily on speculation and failed to show what was knowingly omitted or misrepresented.

Further, the Third Circuit found the whistleblower’s argument about disaggregated data unpersuasive, as he failed to demonstrate that aggregating the data would have materially altered the FDA’s actions. The opinion noted that the FDA already had access to various forms of side-effect data and that the agency did not accept “FQAD” as a recognized medical diagnosis. Because the whistleblower did not plausibly allege that the companies’ conduct materially influenced the FDA’s decisions or that any misrepresentation was knowingly made, his FCA claims were insufficient. Consequently, the Third Circuit affirmed the district court’s dismissal of the complaint.

The case is No. 24-1807.

Judge: Chung, C.

Attorneys: Andrew Grosso (Andrew Grosso & Associates) for Charles Bennett. Allon Kedem (Arnold & Porter Kaye Scholer LLP) for Bayer Corp. Kendall T. Burchard (Covington & Burling LLP) for Johnson & Johnson.

Companies: Bayer Corp.; Johnson & Johnson; Merck & Co., Inc.

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