The Justice Department has launched a criminal investigation into operations at the Abbott Nutrition plant in Sturgis, Michigan where 40 percent of the nation’s baby formula is manufactured. Following reports of infant illnesses and fatalities last year, FDA inspectors deployed to the plant found multiple food safety violations and the presence of Cronobacter sakazakii, a pathogen that is deadly to newborns and immune-compromised infants. The agency’s findings prompted a months-long closure of the plant which exacerbated a nationwide baby formula shortage.
The DOJ declined requests for comment from major news organizations. But company officials confirmed first to the Wall Street Journal, that DOJ’s consumer protection branch was investigating.
What is Cronobacter?
Cronobacter bacteria live on dry foods. Infections don’t cause illness in adults, but for newborns, they can be deadly. And the main vehicle of transmission is powdered infant formula which, unlike liquid formula, is not sterile. A tiny portion of one scoop may contain the only Cronobacter in a can of formula, but it’s enough to cause severe illness or death in the infant who consumes it.
There is a long history of Cronobacter illnesses from powdered infant formula. But it is difficult to know how many babies are actually affected each year because only one state in the nation –Minnesota, requires these illnesses to be reported.
Among infants, Cronobacter can cause sepsis, meningitis, and necrotizing enterocolitis NEC. Symptoms of sepsis and meningitis include blotchy skin, a pinprick rash, high fever, shivering, fatigue, rapid breathing/difficulty breathing, unusual grunting sounds, refusal to feed, stiff jerky movements, or a very floppy body, irritability, diarrhea, cold hands, and feet.
Infant Illnesses and Deaths
On February 17, 2022, the U.S. Food and Drug Administration (FDA) announced a joint investigation with the Centers for Disease Control and Prevention (CDC), of illnesses among four infants who consumed products made at Abbott’s Sturgis plant. The illnesses, reported from three states, MN (1), OH (1), and TX (2), occurred from September 16, 2021, to January 5, 2021.
Three of the infants had developed Cronobacter sakazakii infections and one of them contracted a Salmonella Newport infection. Prior to their illnesses, the infants had consumed Similac Sensitive, Similac Pro-total Comfort, or Similac Advance powdered infant formula. . All four babies were hospitalized and Cronobacter may have contributed to the death of one of the infants, the FDA said at the time.
One month later, the CDC announced that the agencies were investigating additional reports of Cronobacter illnesses among infants who consumed the recalled formula and that an additional fatality had been added to the outbreak. The CDC used whole genome sequencing (WGS) to compare the genetic “fingerprint” of the Cronobacter strain isolated from the sick babies to the Cronobacter the FDA found at Abbott Nutrition’s facility in Sturgis
In early March, Ohio health officials confirmed that both Cronobacter fatalities had occurred in that state. Weeks later, the Salmonella illness was excluded from the investigation due to lack of information.
On March 25, 2022, the CDC announced that it had completed the WGS on Cronobacter isolates from “the two available patient samples.” Results showed that these two isolates did not share the same genetic fingerprint, nor did they closely resemble the fingerprints of any of the multiple Cronobacter strains cultured from the environmental swabs taken from Abbott’s Sturgis plant.
On June 22, 2022, the FDA revealed that it had received one additional report of an infant who died after consuming powdered infant formulas produced by Abbott. The agency said the death occurred in January 2022 and that it was notified on June 10, 2022.
Food Safety Lawyers with Experience
If your baby developed a Cronobacter infection and you would like a free consultation with an experienced Food Safety lawyer, please contact us. You can reach us by calling 1-888-377-8900, sending a text to 612-261-0856, or by completing the form below. There is no obligation and we don’t get paid unless we win.