Parents who bought recalled infant formulas made by Abbott Laboratories are filing proposed class-action lawsuits against Abbott, as the U.S. Food and Drug Administration investigates reports of three babies who became sick and two who died after consuming the formulas.
At least half a dozen of those lawsuits have been filed in the U.S. District Court for the Northern District of Illinois, with filings on Feb. 25 and March 1. Many of the lawsuits allege that north suburban-based Abbott failed to warn consumers about the risks of feeding the formula to their babies before they purchased it and that Abbott didn’t promptly replace the recalled formulas.
The FDA announced Feb. 17 it was investigating complaints of Cronobacter sakazakii and Salmonella Newport infections among four babies who reportedly consumed powdered infant formula made at an Abbott facility in Sturgis, Michigan. All four babies were hospitalized, and Cronobacter may have contributed to one baby’s death, according to the FDA.
The FDA said it found several instances of Cronobacter sakazakii in environmental samples, and a review of the firm’s internal records also “indicated environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.”
Abbott announced the same day it was voluntarily recalling Similac, Alimentum and EleCare powder formulas made at that Sturgis facility.
On Feb. 28, Abbott expanded its recall to include one lot of Similac PM 60/40 made in the facility after the death of a baby who consumed the formula and tested positive for Cronobacter sakazakii. That case, like the others, is still under investigation.
Cronobacter bacteria can cause life-threatening infections or meningitis, with symptoms potentially including poor feeding, irritability, temperature changes, jaundice, grunting breaths and abnormal movements, according to the FDA. It can also cause bowel damage and can spread to other parts of the body.
Salmonella bacteria can cause diarrhea, fever and abdominal cramps, with severe cases potentially leading to lethargy, rash, blood in the urine or stool and, in some cases, death.
Abbott spokesman Scott Stoffel said in a statement: “We are very sympathetic to families in these situations. We value the trust parents and caregivers place in us, and ensuring the safety and quality of our products is our top priority.”
He said all of Abbott’s infant formulas are tested for Cronobacter sakazakii, Salmonella and other pathogens and must test negative “before any product is released.” He said no distributed product from the company’s Sturgis facility has tested positive for Cronobacter sakazakii or salmonella.
One of the Illinois lawsuits was filed by a South Carolina mother who said her baby had diarrhea for two weeks after drinking Alimentum formula. The other five Illinois lawsuits were filed by consumers in Maryland, Arkansas, Texas, Florida, Louisiana, Delaware, Pennsylvania and Indiana who bought the formulas and then were unable to use them because of the recall. Those plaintiffs said they wouldn’t have bought the formulas if they’d known about the risks, and they are seeking damages.
“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,” several of the lawsuits 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.”
A Florida father also filed a lawsuit seeking class-action status Feb. 18 in the U.S. District Court for the Southern District of Florida. That father said he purchased Alimentum for his daughter in late January, and she developed diarrhea, abdominal pain, diaper rash with blisters and blood, dehydration and sleeplessness.
The FDA is advising consumers not to use Similac, Alimentum or EleCare powder infant formulas if the first two digits of the lot code on the container are 22 through 37; and the code on the container contains K8, SH or Z2; and the expiration date is April 1 or later. Also part of the recall is Similac PM 60/40 with lot code 27032K80 for a can, or 27032K800 for a case.
Consumers can also go to Abbott’s website to check if they have formula that is part of the recall.
Parents who’ve used the products and are concerned about their children’s health should contact their doctors, according to the FDA.
