In U.S. ex rel. Bennett v. Bayer Corporation, No. 24-1807 (3d Cir. Apr. 10, 2025) the Third Circuit ruled that a whistleblower failed to plead sufficient facts showing pharmaceutical companies misled the FDA about antibiotic side effects and affirmed the dismissal of a whistleblower lawsuit 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, thus leading to improper reimbursements by federal healthcare programs.
The complaint revolved around ciprofloxacin and levofloxacin, antibiotics developed in the 1980s and 1990s and contended that the companies knowingly withheld or downplayed adverse side effects during and after the FDA’s drug approval process by omitting crucial clinical data or presenting it in a disaggregated form to obscure the incidence of a condition 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.