Tainted formula: DOJ opens criminal investigation into Abbott after child death

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

The Justice Department’s consumer protection division has opened a criminal investigation into the conduct of Abbott Laboratories, one of the country’s largest formula manufacturers, which has been at the center of a contamination scandal and an ongoing nationwide shortage.

The existence of the study was first reported by The Wall Street Journal. While the DOJ is not commenting on it, an Abbott spokesperson said the department has notified them of the investigation and that the company is “fully cooperating.”

Federal regulators last year found numerous violations and “extremely unsanitary” conditions at Abbott’s Sturgis, Michigan, plant, the country’s largest formula plant. Regulators previously received reports that at least four babies drinking formula made at that facility fell ill with dangerous infections from the bacteria Cronobacter sakazakii, which was also found in the plant. Two of the babies died.

The Food and Drug Administration had also received a whistleblower complaint alleging security violations, data falsifications and cover-ups at the facility. But it took several months for that complaint to reach top FDA officials, during which time one baby died and others got sick. The FDA’s clumsy handling of the complaint drew backlash from lawmakers and led to an external review by the agency.

Meanwhile, Abbott denied that his formula was responsible for the babies’ illness and death. The company argued that the tensions of C. sakazakii found in the Sturgis facility was genetically dissimilar to a strain found in an opened formula container from one of the sick babies’ homes, which matched the strain that infected that baby, or a strain that infected another made baby sick. (There is no genetic data on the strains that infect the other two babies.) FDA food safety experts rejected Abbot’s argument, noting that multiple strains of C. sakazakii were found in the plant and that sampling from the facility could easily have missed other strains. They also noted that a lack of bacteria in the company’s final product tests is inconclusive; testing small amounts of formula batches totaling hundreds of thousands of pounds will almost always miss a low level of contamination.

“Unwilling or unable”

The FDA’s investigation led to the closure of the Sturgis facility last February, exacerbating a nationwide formula shortage. Parents were faced with empty shelves in stores as they desperately searched for food for their children, some of whom required special formulas. Federal officials scrambled to boost supply, waive regulations and tariffs, and fly in formulas from abroad. Although the shortage has decreased somewhat, the supply has not yet recovered. Reckitt Benckiser, the maker of Enfamil, reported in December that it expects the shortage to continue into the spring.

To get the Sturgis plant back up and running safely, Abbott entered into a legal agreement, called a consent decree, with the FDA last May, outlining strict steps Abbott would need to take to safely reopen the facility.

In an accompanying complaint, the Justice Department chronicled a series of violations and failures found at the Sturgis facility, including that the company’s own testing showed a persistent contamination of C. sakazakii in the facility and that the FDA had issued previous warnings.

Persistent deficiencies in manufacturing conditions and practices at Defendants’ facilities demonstrate that Defendants were unwilling or unable to take sustained corrective action to ensure the safety and quality of food produced for infants, a consumer group particularly vulnerable to foodborne pathogens,” the department wrote. .

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

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