Contaminated formula: DOJ opens criminal probe into Abbott after infant deaths

Abbott's manufacturing plant in Sturgis, Michigan on May 13, 2022.
Enlarge / Abbott’s manufacturing plant in Sturgis, Michigan on May 13, 2022.

The Justice Department’s consumer protection arm has opened a criminal investigation into the conduct of Abbott Laboratories, one of the nation’s largest formula makers, at the center of a contamination scandal and persistent national shortage.

The existence of the investigation was first reported by the Wall Street Journal. Although the DOJ does not comment on the matter, an Abbott spokesperson said the department has informed them of the investigation and the company is “cooperating fully.”

Last year, federal regulators found numerous violations and “extremely unsanitary” conditions at Abbott’s plant in Sturgis, Michigan, the nation’s largest formulas plant. Regulators previously received reports that at least four babies who drank formula made at this facility fell ill with dangerous infections from the bacteria. Cronobacter sakazakii, which had also been detected in the factory. Two of the infants died.

The Food and Drug Administration had also received a whistleblower complaint alleging security breaches, falsification of records and cover-ups at the facility. But it took several months for that complaint to reach senior FDA officials, during which time one child died and others fell ill. The FDA’s clumsy handling of the complaint drew backlash from lawmakers and sparked an external review of the agency.

Meanwhile, Abbott denied that his formula was to blame for infant illnesses and deaths. The company argued that the strains of C. sakazakii found at its Sturgis facility did not genetically match a strain found in an open container of infant formula from one of the sick infants’ homes, which matched the strain infecting that infant, or a strain found sickening a other infants. (There is no genetic data on the strains infecting the other two infants.) FDA food safety experts rejected Abbot’s argumentnoting that several strains of C. sakazakii were found in the plant and the facility’s sampling could easily have missed other strains. They also noted that a lack of bacteria showing up in the company’s end-product testing is inconclusive; testing small amounts of formula batches that total hundreds of thousands of pounds will almost always miss low level contamination.

“Refusal or incapacity”

The FDA investigation led to the closure of the Sturgis plant last February, which exacerbated a nationwide formula shortage. Parents found themselves staring at bare store shelves as they desperately searched for food for their children, some of whom needed specialized formulas. Federal authorities rushed to increase supply, waiving regulations and tariffs, and bringing in the formula from overseas. Although the shortage has eased somewhat, supply has yet to recover. Reckitt Benckiser, the maker of Enfamil, announced in December that it expects the shortage stretch until spring.

To safely return the Sturgis plant to service, Abbott entered into a legal agreement, called decree of consentwith the FDA last May, which set out the strict steps Abbott would have to follow to reopen the facility safely.

In an accompanying complaintthe Department of Justice exposed a series of violations and failures found at Sturgis facilities, including the fact that the company’s own testing revealed continued contamination of C. sakazakii in the facility and that the FDA had issued previous warnings.

“The continuing deficiencies in manufacturing conditions and practices at Defendants’ facilities demonstrate that Defendants have been unwilling or unable to implement lasting corrective measures to ensure the safety and quality of food manufactured for infants, a consumer group particularly vulnerable to foodborne pathogens,” the department wrote. .

The Wall Street Journal notes that the department has successfully sued other food companies and their executives for bringing tainted food to market. In 2020, for example, an ice cream company Blue Bell paid $19 million and pleaded guilty to shipping tainted ice cream tied to a Listeria epidemic that killed three. In 2015, the former owner of Peanut Corp. of America, Stewart Parnell, was guilty on numerous charges related to a Salmonella epidemic that killed nine people and sickened more than 700 others. He was sentenced to 28 years in prison.

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