Federal Government Already Suing — States Now Add Firepower
The U.S. Department of Agriculture initiated its own FCA action on Nov. 13, alleging Abbott misrepresented compliance with USDA rules governing WIC products. Abbott’s certifications, the complaint asserts, were material to state contract awards.
The states’ filing aligns their claims with the federal suit, forming a united front over what they describe as years of unsafe practices and misinformation.
Violations Trace Back to 2019 — With Fires Still Burning in 2022
Cronobacter Findings, Filthy Equipment, and a “Time Code Removal” Scheme
The lawsuit ties Abbott’s troubles to 2019, when FDA investigators detected Cronobacter sakazakii, a deadly bacterium, at the Sturgis facility.
In 2021, inspectors again reported serious violations: unsanitary facilities, unwashed hands among formula handlers, and failures to maintain a safe production environment.
Early 2022 FDA findings were even more damning — Cronobacter was discovered in multiple locations, including on tools inserted directly into formula containers. Combined with whistleblower allegations and reports of infant deaths, regulators urged a massive recall.
According to the states, Abbott not only knew about “systemic violations” but employed a ‘time code removal’ scheme to avoid discarding contaminated product. They accuse the company of withholding documents from FDA investigators.
One senior Abbott leader allegedly summed up the company’s approach in a March 2022 message:
“Just don’t want to give more [to FDA] than what we committed.”
