The parents of a Kentucky baby who after drinking bacteria-tainted infant formula are the latest to sue Abbott Nutrition, the manufacturer at the heart of a 2022 crisis that left millions of Americans scrambling to feed their children.
Willow Jade Dellaquila, of Carrollton, Kentucky, was 13 days old when she died on Nov. 5, 2023. She was infected with Cronobacter sakazakii, a dangerous germ traced to a can of Similac Total Comfort powdered formula used in the baby's bottles, records show.
"They told me she had a stroke on her right side of the brain," Cheyenne Ping, Willow's 25-year-old mother, said in an interview. "It's really heartbreaking. No one should have to go through this."
Ping and the baby's 26-year-old father, Christian Dellaquila, can move forward with a lawsuit against Abbott, an Illinois judge ruled Wednesday.
The couple had previously sought to join a lawsuit with two other families who say their children suffered devastating brain damage caused by Cronobacter linked to a different type of Abbott powdered formula, Similac Neosure. Mira White, a Missouri baby, was sickened with Cronobacter in March 2023 at age 6 weeks. Ryker Brown, an Illinois toddler, was infected with the bacteria in July 2021, at age 4 weeks. Both survived.
But the judge on Wednesday asked that the three cases be filed separately, leaving open the question of whether they would be consolidated later.
The original lawsuit in December targeted Abbott, whose Sturgis, Michigan, plant was shuttered for months in 2022 after similar reports of infant illnesses and deaths. FDA inspectors found what agency chief Robert Califf, MD, called "shocking" conditions, including Cronobacter, which and that rocked U.S. formula supplies for more than a year.
Willow consumed formula made at the Sturgis plant and sold at a local Walmart store more than a year after Abbott was placed under by the FDA, the Associated Press has learned. The formula Ryker and Mira consumed was made at the company's plant in Casa Grande, Arizona, which was the target of a separate whistleblower complaint about dangerous conditions, according to federal records.
Documents obtained by the Associated Press show that an April 2023 FDA inspection at the Arizona site found lapses in contamination-prevention protocols, multiple detections of Cronobacter at the plant, and nearly two dozen complaints of confirmed Cronobacter, Salmonella, or other infections in infants who had been fed formula made at the plant. Abbott officials said no link was found between the illnesses and the company's formula, the records show.
The lawsuits accuse Abbott of negligence, fraud, and failing to warn parents of potential dangers of powdered formula and demand at least $450,000 per family.
Abbott officials say there is no proven link between the product and any infections, including the cases outlined in the lawsuit. Every can of Similac says that the product is not sterile and should not be fed to premature infants or infants who might have immune problems, unless directed and supervised by a doctor.
"No sealed, distributed product from our facilities have tested positive for Cronobacter sakazakii and we don't believe these claims have merit," Abbott officials said in an email Wednesday.
In a court filing, Abbott officials argued that there was no common connection between the cases, which occurred at different times, in different states, and involved two different types of formula.
"The fact that each infant experienced a Cronobacter infection (months or years apart) is of no moment," the company said.
The illnesses underscore the difficulty for regulators and health officials to keep tabs on bacteria that are everywhere -- but also notoriously difficult to detect and track.
Cronobacter bacteria are common in nature, including in water and soil, and are found in home kitchens, including sinks, counters, and even the scoops used to measure formula powder. But they can also be found in large factories, where they lurk on equipment and in the environment.
The bacteria's ubiquity can make it hard to determine exactly when it got into the formula cans.
Evidence of Cronobacter was found in open cans of Abbott formula in the homes of Willow and Mira and confirmed to be the cause of their infections, documents show. But the same strains of the bacteria were not detected in sealed cans of formula or at the Abbott factories, federal officials said. It's not clear how Ryker became infected.
That doesn't prove that the products were free of contamination, said Barbara Kowalcyk, PhD, director of the Center for Food Safety and Nutrition Security at George Washington University. Cronobacter cells tend to clump within dry foods like formula and are not distributed evenly, making detection unreliable, if not impossible.
"If you get negative test results, it doesn't tell you as much as a positive test result does," said Kowalcyk. "If you get a positive, you've got a big problem. If you get a negative, you don't know what's going on."
That stymies efforts to detect and stop Cronobacter infections, which are particularly dangerous to newborns and babies born prematurely. Such infants are vulnerable to illnesses caused by the germ because their immune systems aren't developed enough to fight it off. In those babies, the bacteria can move from the gut to the bloodstream and from there to the brain, where they can have devastating effects.
The CDC typically receives two to four reports per year of infections caused by Cronobacter, though officials believe that's an undercount. In 2023, four infections were reported to the agency, records show. They included reports of invasive illness in Mira and Willow and in an unidentified baby in Maryland who was infected with Cronobacter and developed meningitis in December after consuming Similac Advance powdered formula made by Abbott.
The CDC began illnesses from the germ this year. So far, one confirmed case of Cronobacter infection in an infant has been reported, officials said, though they provided no details. Powdered infant formula is the most common cause of Cronobacter infections in babies, the agency said.
The 2022 Abbott crisis led Congress and federal investigators to sharply criticize the FDA's oversight of infant formula. In a scathing audit issued in June, federal investigators found that the agency took 15 months to respond to a whistleblower complaint about the Sturgis plant and lacked basic safeguards to prevent dangerous and deadly infections.
The FDA says it has revamped oversight by creating a new human foods program and overhauled the way officials respond to reports of contamination, illnesses, and deaths tied to infant formula. The audit "represents a snapshot in time, and the FDA continues to make progress," the agency said in a statement.
Jim Jones, head of the program, said inspection issues, consumer complaints, and whistleblower reports will now be routed to a single office.
"It will make it easier for us to be quicker at identifying a signal," he said in a recent interview.
But for Willow's family, such changes come too late. Ping, who received the formula through her state's Supplemental Nutrition Program for Women, Infants, and Children program for low-income families, said she had no idea that powdered formula could contain bacteria that might harm her baby.
She said her family agreed to file a lawsuit to help hold Abbott accountable and raise awareness about the dangers of powdered formula.
"Parents need to know that powdered formula is not sterile," Ping said. "It just needs to be out there. It needs to be known."