Seven states — California, Michigan, New York, Maryland, Massachusetts, Connecticut, and Tennessee — have moved to intervene in a sweeping False Claims Act lawsuit against Abbott Laboratories, alleging the company knowingly endangered infants while misrepresenting safety compliance tied to federally funded nutrition programs.

Their 176-page intervention, filed Monday in Michigan federal court, escalates the legal battle stemming from the 2022 infant formula crisis that left shelves empty and families scrambling for safe alternatives.

States Say Abbott Knew Its Sturgis Plant Was Unsafe

Allegations of Endemic Contamination and Regulatory Evasion

The states argue that Abbott—once the nation’s largest producer of powdered formula—knew its Sturgis, Michigan, facility was riddled with regulatory violations and failed to remedy “horribly dangerous conditions,” despite manufacturing products for vulnerable infants enrolled in Medicaid and the Women, Infants, and Children (WIC) program.

“Abbott put millions of vulnerable infants and children at risk,” the states said, accusing the company of concealing violations and falsely certifying compliance to continue winning federally supported formula contracts.

Millions of babies rely on specialized formulas covered by Medicaid, the suit notes—making Abbott’s alleged misconduct not only a public health hazard but a direct blow to taxpayer-funded programs.

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.”

Outdated Equipment and Invalidated Safety Protocols

A Broken Clean-In-Place System

States say Abbott leaned on unvalidated dry-out procedures—a critical step in sanitation—through late 2022. Equipment at the Sturgis plant was “old and always in need of repair,” undermining safe production.

Before 2022, Abbott allegedly tested its environment only after surfaces had been cleaned, effectively defeating the purpose of microbial monitoring. Once FDA conducted its own tests, employees noted a sharp rise in contamination indicators.

The FDA also found Abbott failed to follow its own complaint procedures, often closing cases without identifying root causes of infant illnesses.

No Comment From Abbott

Neither Abbott nor the attorneys for the states immediately responded to requests for comment Tuesday.
Counsel for Abbott has not yet been disclosed.