Justice Department leaders’ shutdown of a long-running criminal case against Abbott Laboratories over contaminated baby formula has fueled a broader pullback on corporate prosecutions protecting consumer health, said people familiar with the situation.
DOJ Criminal Division head Tysen Duva and his top aides have directed prosecutors to close other food and drug industry probes after the deputy attorney general’s office, then led by Todd Blanche, overruled Duva’s effort to charge the company and its executives, ending the criminal investigation earlier this year, several individuals said.
Division supervisors also imposed a heightened evidentiary standard for other corporate investigations brought by an office with a history of targeting big pharmaceutical companies, they said, speaking anonymously about internal deliberations.
A senior DOJ official, in a statement, said the Criminal Division “remains fully committed to aggressive enforcement of federal health and safety laws” and will keep bringing charges when warranted.
The criminal fraud section’s health and safety unit, which pursued the Abbott case, has other investigations open, but they’re stalling under the higher evidence threshold, as leaders seek to avoid a repeat of the DAG office’s prior rejection, the people familiar said.
The retreat followed Duva’s unsuccessful push of a felony theory alleging Abbott executives conspired to defraud the US, along with a separate Food, Drug, and Cosmetic Act charge against the company, multiple people said. The case stemmed from a 2022 bacteria outbreak at the pharmaceutical company’s Michigan powder formula plant that’s been accused of contributing to infant deaths and illnesses.
The DAG’s office ordered the criminal probe closed, determining a civil deal under the False Claims Act, which allows for treble damages, was a more appropriate resolution, the people said.
Kirkland & Ellis partner Mark Filip, a former federal judge and George W. Bush administration deputy attorney general, had urged DOJ officials not to prosecute Abbott, cautioning, among other factors, that a criminal indictment may force the multinational to cancel plans of building a roughly $1 billion plant in Ohio estimated to create hundreds of jobs, they added.
“The Department did not give any weight” to Abbott’s potential Ohio facility when deciding to close the criminal case, a senior DOJ official said. “The Department and Abbott have reached an agreement in principle that includes a significant monetary payment. Once finalized, this resolution will send an unmistakable message: companies that violate consumer health and safety standards—particularly standards designed to protect babies—will face serious consequences.”
Senior DOJ officials’ decision to decline prosecuting Abbott was first reported by the Wall Street Journal.
In a statement to Bloomberg Law, Abbott maintained its products are safe and cited a previous defense against allegations the company faced.
Rigid control from DOJ’s second-in-command over litigating divisions has also thwarted or delayed white collar cases in prior administrations, including under Biden-era No. 2 Lisa Monaco, said former officials.
But the Trump administration’s cost-cutting reorganization of DOJ in 2025 helped enable what individuals described as a wider scale-back in consumer health enforcement.
The realignment included dissolving the Civil Division’s consumer-focused office that launched the Abbott probe and merging its criminal prosecutors into the Criminal Division fraud section’s newly formed health and safety unit late last year.
The move restricted those prosecutors from their previous latitude to pursue both civil remedies and criminal indictments, and required them to report to Criminal Division managers who’d previously expressed skepticism about their work — viewing the consumer team’s prosecutions as overly aggressive or based on looser pre-charging standards, DOJ veterans said.
But Duva, a veteran line prosecutor from Florida, reported back favorably on the Abbott case when he was briefed on it while awaiting Senate confirmation as criminal leader, the individuals said.
As the consumer unit lawyers transitioned into the Criminal Division in November, supervisors reviewing their cases prioritized Abbott as ripe to advance and were particularly keen on the investigation’s ability to hold individuals accountable, the people said. They directed the lawyers to draft a prosecution memo over Thanksgiving weekend laying out their evidence, they said.
But what was then seen as a promising sign that the team’s traditional casework on healthcare misbranding and unsanitary food production would align with a new office structure has since soured.
The unit’s series of other corporate cases against well known brands remain underway, including targeting companies and individuals for mislabeling alkyl nitrates — or “poppers” — by fraudulently selling them as cleaning products.
But by shutting down the Abbott investigation and other health and safety probes, DOJ officials have revived worries among former federal consumer-protection attorneys about the office’s future and the administration’s commitment to its work.
The health and safety unit’s chief, Kate Payerle, recently signaled to corporate defense lawyers that their clients should expect her team to remain active. Speaking on a conference panel June 28, Payerle said her unit would target cases such as food plant disease outbreaks, according to law firm Arnold & Porter’s recap of the event.
Hours after her remarks, the Wall Street Journal broke the news that the Abbott baby formula probe was terminated.