Riley San Miguel said her son, Kru, was just a month old when he started crying all the time, not wanting to eat. When he had a fever, he was rushed to an intensive care unit. His spinal fluid was infected with bacteria and was spreading to his brain. Doctors believed it probably came from his infant formula.
“At first, the doctors were worried that Kru would not go,” she said. San Miguel, 23, lives in Sonora, Texas. The baby underwent the first of several operations on the brain to control the increase in seizures and swelling, and when he could no longer breathe on his own, he was ventilated for 21 days. Eventually, most of the right side of his brain had to be removed.
Her son was known to have been exposed to Cronobacter sakazakii, a deadly bacterium that is often associated with babies consuming formula powder and can cause severe brain damage, developmental disabilities and death. Health they analyzed two open cans of Mrs. San Miguel’s house formula; one gave negative and the other did not have enough product to try.
Kru fell ill in August 2019, more than two years before similar infections in four babies, two of them fatal, triggered a voluntary withdrawal at an Abbott Nutrition plant in Sturgis, Michigan, which manufactured formula consumed by the latter. sick babies.
The withdrawal helped pave the way for a national shortage of infant formulas that has caused parents to struggle to feed their children; the Biden administration has responded by working with Abbott to restart production and fly with additional supplies from Europe.
As with Kru’s disease, no link was established between infections in the four recent sick babies and production at any Abbott Nutrition plant. But while most of the attention has been focused on addressing the severe supply shortfall, regulators are facing deeper safety issues that persist in the manufacture of powdered infant formulas.
There is no complete mechanism for detecting or investigating Cronobacter infections, and only one state, Minnesota, requires doctors and labs to report cases to authorities. Manufacturers must test themselves on a relatively small sample of their production, with less than 1 percent of the total production of the Abbott plant required to be tested. The combination of blind spots makes it difficult to track infections to their source and could leave families at risk for future closures and child deaths.
The Sturgis plant has been in trouble since 2010, when parts of the beetle in the formula caused another withdrawal. In recent years, according to inspection reports, federal inspectors have found stagnant water in manufacturing areas, a fan laden with dust and debris placed near a formula drying area and sanitary areas. that they were not cordoned off.
In October, a complaint from a complainant of a former Sturgis quality assurance worker reached the Food and Drug Administration. He stated that in 2019, the plant did not destroy an entire batch of formulas where problematic microorganisms had been found because “senior management was under significant pressure to meet their‘ numbers ’”; and that the company was “disinfecting” the files before providing them to FDA auditors, without revealing details about the microorganisms it found.
Abbott said no Cronobacter samples from the four sick babies match the findings at the Sturgis plant. An open formula container consumed by one of the babies had tested positive for two strains of Cronobacter, the company said, but those strains also did not match any found on the plant, and one matched a sample found in a bottle of water that had been used to mix the formula.
“The formula of this plant did not cause these childhood diseases,” the company said.
Abbott has said the former employee who filed the complainant’s complaint was fired for violating his food safety policies and has made “evolving, new and growing” claims since then. The company said it hoped to address all of the FDA’s concerns when it reopens the Sturgis plant in the next two weeks. A consent decree the company signed with the government offers a number of new safeguards, including hiring a qualified expert to monitor plant improvements and notifying the FDA if it finds any contamination. Cronobacter and salmonella samples found should be stored for three years.
Read more about baby formula shortages
“We are confident that we can continue to produce safe, high-quality infant formulas in all of our facilities, as we have been doing for millions of babies around the world for decades,” Abbott said.
The lack of public evidence and reports makes it difficult to know how many people are infected with Cronobacter. One study estimated about 18 cases a year in American babies, according to Dr. Julia Haston, an official at the Federal Centers for Disease Control and Prevention. The results are usually severe, he said, and up to 40 percent of babies with bacterial meningitis, a common complication, die from the infection.
Cronobacter is common in dirt and water. This means that it is not uncommon to find it in homes, let alone in food processing plants. But there are only a few ways in which it is likely to enter a baby’s body, the researchers say.
“It’s not falling off the ceiling,” said Dr. Janine Jason, an infectious disease specialist who worked at the CDC for 23 years. “Where we know it grows well is the powdered formula. It’s one of the few organisms that can survive on powdered milk or food.”
A CDC study said the powdered formula “has been identified as the transmission vehicle in almost every Cronobacter infection for which a source was found.”
The relatively low rate of testing makes it difficult to provide a positive link between disease and pollution in a given plant. The fact that there was no genetic match between the bacteria found in a sick baby and the bacteria found in a plant could be because the contamination occurred in the home, in an untested batch, or in a portion of a sample not found. analyzed.
“It’s like reaching for a big Lego box, pulling out a few, and saying that this shows that there are no blue Legos in the box,” said Samuel Geisler, a lawyer representing families in a lawsuit against Abbott.
The Abbott factory is located on the outskirts of Sturgis and dominates the rest of the city, with its huge white structure visible long before the city limits.
The plant employs hundreds of people, and many more in the city of 11,000 people are closely connected to the plant. For some, it was their first safe job; for others, he was the lifelong employer of a father or close friend.
“We are very proud that the products made in Sturgis can be found all over the world and we are very happy to know that they will be producing infant formula again soon,” said the city’s mayor, Jeff Mullins.
The plant has had a history of regulatory issues with the FDA. The 2010 withdrawal on beetle pollution came when an FDA inspection pointed to the company’s three-year battle with warehouse and flour beetles.
Before and after this withdrawal, the FDA was pressuring the industry to test its products for Cronobacter, stimulated by a group of cases in a neonatal intensive care unit in Tennessee that was linked to the contaminated powder formula of a another company.
In 1996, the FDA began what would be an 18-year effort to institute tougher industry standards. When Cronobacter testing requirements were added in 2003, an industry group representing Abbott and other companies withdrew.
He argued that while it made sense to test the bacterium in the formula for premature babies, it was not necessary to do so in the formula marketed for healthy babies because they were not at risk. Abbott said the trade group’s position was not in line with its own practices, which included voluntary testing of Cronobacter.
The FDA maintained and in 2014 began requiring infant formula makers to take 30 samples, each weighing about two nickels, from each batch of formula and test them for Cronobacter.
But the regulations did not define the size of the site. Some factories have lots of about £ 30,000. For Abbott, the lots could reach £ 300,000, said Scott Donnelly, a former food safety executive who has testified as a witness for a plaintiff suing Abbott over problems with the formula.
“The FDA virtually let the industry, Abbott, define a lot ‘to minimize testing,” he said in an interview.
The FDA, armed with the new supervisory authority, soon found problems at the Sturgis plant. While Abbott’s internal policy was to try more product than necessary, it hadn’t, the F.DA. show report. The company discovered Cronobacter in finished production batches that were finally destroyed in 2019 and the following year, FDA records show. Finally, the Justice Department cited pollution as a justification for going to federal court this month to force reforms.
A September 2019 FDA inspection noted that Abbott had received a complaint from a practicing nurse about five babies who had consumed Similac Sensitive formula and were vomiting with projectiles for reasons that were unclear. A baby with confirmed Cronobacter was having seizures after consuming three types of Similac, according to the report.
The son of Mrs. San Miguel, Kru, was one of the babies who became ill that year after receiving food from Similac, although at the time his illness was not reported to the authorities.
The company had discovered Cronobacter that year in its Similac Alimentum product for sensitive babies, according to records, weeks before Kru fell ill drinking the same type of formula.
The 2019 FDA inspection report showed that Abbott found no link between any of Cronobacter’s complaints and his …