NORTH CHICAGO, IL — Abbott Laboratories faces a growing number of lawsuits over its recalled baby formula following reports linking it to potentially fatal bacterial infections.
As of Friday, at least eight complaints had been filed in federal court in Chicago on behalf of parents who bought Abbott’s powdered infant formula products, branded as Similac, Alimentum and EleCare. The lawsuits seek state and federal class action status for the parents.
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have launched investigations into whether formula produced at an Abbott Nutrition facility in Sturgis, Michigan, is connected to infections with the bacteria Cronobacter sakazakii, which can cause sepsis, meningitis and bowel damage and is especially dangerous for young children.
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Four babies have been hospitalized with the bacteria, and at least two have died after consuming the formula and falling ill. Federal regulators have not confirmed the deaths to be “solely attributable” to the infection. Another infant was hospitalized with a case of Salmonella Newport.
Abbott first announced a voluntary recall on Feb. 17. In a statement, company representatives said testing at its Sturgis plant showed evidence of Cronobacter in “non-product contact areas.” No bacteria was found in formula that had been distributed, according to the company.
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“We’re taking this action so parents know they can trust us to meet our high standards, as well as theirs,” said Joe Manning, Abbott’s executive vice president for nutritional products, in a statement. “We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals.”
Abbott expanded its recall Monday to include Similac PM 60/50, following news of the second infant death.
“This case is under investigation, and at this time the cause of the infant’s Cronobacter sakazakii infection has not been determined. We want to extend our heartfelt sympathies to the family,” company officials said in a statement.
The proposed class action suits against Abbott filed in Chicago this week were brought on behalf of parents in Arkansas, California, Florida, Maryland, New York, Ohio and Texas.
At least two parents allege that their children — babies born in September 2016 in Columbus, Ohio, and October 2019 in Corpus Christi, Texas, became ill with necrotizing enterocolitis, or NEC, a potentially deadly intestinal disease. According to the complaint brought on his behalf, premature babies who are fed cow’s milk-based formula like the products produced by Abbott have significantly higher rates of the condition.
“The companies who manufacture these products often intentionally mislabel and misrepresent the contents of the products both to the public at-large and to the health care community, passing off these deadly products as something similar or even superior to human breast milk,” the complaint said.
Parents in the other half-dozen cases filed this week in Illinois did not say that their children got sick. Instead, they allege that they would not have bought the formula if they had known about the danger and that they were uncompensated for the resulting damage.
“Despite the recall, Abbott is not crediting or replacing affected Recalled Products, which many parents and caretakers rely on daily to feed and care for their children,” the complaints allege. “Since Abbott is now telling consumers it is not safe for their infants to consume these products, but many consumers rely on them to feed their children, Abbott leaves many consumers with no safe option but to pay full price for a newer version.”
According to statistics cited in a complaint, sales of Similac Advance made up 21 percent of all the powdered baby formula sold globally in 2016, and two other Abbott Nutrition products were also among the top 10.
Earlier: 2nd Baby Dies: Recall Expanded For Similac, Other Baby Formula
According to the CDC, Minnesota is the only state where Cronobacter sakazakii infections must be reported. It was public health officials in the state that first traced the pathogen to the Sturgis, Michigan, plant.
Health officials in Minnesota first notified the FDA and CDC in September 2021 that a baby who got sick with Cronobacter had consumed Abbott’s powdered formula produced at the plant, Politico reported. The FDA inspected the facility on Jan. 31 and discovered records indicating that workers there had previously found the bacteria in formula and destroyed product as a result.
“As this is a product used as the sole source of nutrition for many of our nation’s newborns and infants, the FDA is deeply concerned about these reports of bacterial infections,” Frank Yiannas, FDA deputy commissioner for food policy and response, said in a statement announcing the recall last month. “We want to reassure the public that we’re working diligently with our partners to investigate complaints related to these products, which we recognize include infant formula produced at this facility, while we work to resolve this safety concern as quickly as possible.”
On Friday, two Democratic U.S. senators released a letter they sent to Abbott CEO Robert Ford asking for assurances that the North Chicago-based company is providing necessary information to parents and caregivers, The 19th reported. Sens. Patty Murray, of Washington, and Bob Casey, of Pennsylvania, requested “all internal documents and communications” connected to the contamination of the Michigan facility and complaints about the formula.
Containers of recalled Similac, Alimentum or EleCare products have lot numbers starting with the numbers 22 to 37. The recalled batch of Similac PM 60/40 has a lot code of 27032K80 for cans and 27032K800 for cases. Consumers can find more information about how to locate lot numbers and online product checker on a website Abbott created for the recall.
