DOJ declined criminal charges some prosecutors argued were warranted
Abbott Laboratories has agreed to pay $385 million to settle Justice Department civil allegations that the company knowingly sold infant formula produced in conditions that put products at “unacceptable risk of microorganism contamination,” the department said Monday.
The agreement resolves a federal investigation into Abbott’s Sturgis, Michigan plant, where inspectors in early 2022 found traces of Cronobacter bacteria — a potentially deadly pathogen — on equipment near infant formula containers. Cronobacter infections sickened four babies who drank Abbott formula produced at the plant, two of whom died, according to the department. Abbott has maintained that no unopened, distributed Abbott infant formula tested positive for the bacteria that sickened the babies and that there was no proof the infants became ill because of its formula.
In a Monday statement, the Justice Department said Abbott knowingly sold the government formula and other products manufactured in an environment that put them at risk of contamination, rendering them less safe. Acting Deputy Attorney General Trent McCotter said the settlement “makes clear the safety of our children is not negotiable.”
Abbott did not admit liability or fault. In its own statement, the company said, “We make infant formula with the same care we would for our own families and are deeply committed to earning and maintaining caregivers’ trust.”
The outcome closes a multiyear federal investigation that divided career prosecutors from senior department leadership. Some prosecutors believed the evidence supported a misdemeanor charge against Abbott under the federal Food, Drug and Cosmetic Act — a statute that has been used to pursue other businesses for selling contaminated foods — the Wall Street Journal previously reported. Prosecutors also weighed a separate count for allegedly misleading the government and had considered charging at least one individual.
Senior Justice Department officials ultimately concluded criminal charges would have been heavy-handed and opted instead for the civil settlement, which claws back money Abbott earned from selling formula through federally funded nutrition programs.
The settlement includes more than $36 million to resolve claims made by state government programs.
The resolution illustrates how the Justice Department under President Trump has moved away from strict approaches to corporate enforcement and raised the bar for punishing companies, according to the Journal’s reporting. The outcome is the more lenient of the possibilities under consideration.
Inspectors who visited the Sturgis plant in early 2022 documented a long list of problems, the Justice Department said. They found roof leaks that caused standing water in multiple locations, and employees who worked directly with baby formula but did not adequately wash their hands. Inspectors also found Cronobacter bacteria in multiple spots inside the plant and noted that the company had detected the bacteria repeatedly in prior years. The department said Abbott used temporary but inadequate fixes to address the problems.