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Abbott Laboratories Investigated by FDA who is Investigated by Lawmakers

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The FDA is under fire for taking months to inspect the Abbott baby formula plant after reports of infant illnesses.

Sturgis, MIThe FDA began to investigate the Abbott baby formula plant on February 17th, almost two weeks after Stephen’s son died, allegedly from exposure to Cronobacter sakazakii – a bacteria found at Abbott Laboratories Inc.'s facility in Sturgis, Michigan.

“My son passed away on February 4th 2022 and was four days shy of being two months old,” said Stephen (not his real name pending a lawsuit), his voice wavering. After a few deep breaths, he went on. “He was premature and right away was given Abbott's Similac formula in the NICU. After a week he was putting on weight so we took him home with some formula to supplement my wife’s breastfeeding.” The baby seemed to be doing well. The pediatrician advised the parents to breastfeed as much as possible and to give the Baby Similac Neosure -- as much as he can take. But a follow-up visit the next week was cause for concern.

“Our pediatrician said he should be gaining more weight—he suspected a stomach sensitivity and if that’s the case we would have to switch his formula,” said Stephen. “One week later we were back in the doctor’s office and he gave us a new formula to try: Similac Alimentum. He also told us not to breastfeed and if he didn’t gain more weight they would need to take a biopsy.”

After just two days on the Allementum formula, Stephen said the baby was very fussy; he had a lot of gas and wasn’t sleeping very well. And he seemed to be pooping more than he was eating. “On February 2nd my mother visited. Right away she thought the baby’s stomach was bloated, like he had to poop,” Stephen said. “Next day he seemed to be congested. After a morning feeding the baby and my wife took a nap together. No more than 15 minutes later she woke to find our baby unconscious with vomit on his face. We immediately called 911 but it was too late.”

The FDA’s investigation started after several infants became ill following exposure to Cronobacter sakazakii and a fourth baby became sick due to a salmonella infection. The FDA said that two babies died – all of them were fed Abbott's Similac PM 60/40 formula. By the end of February, the agency confirmed that the Cronobacter infection “may have been a contributing cause of death.”

FDA Under Investigation

On May 19, 2022 Law360 reported that the FDA's commissioner, Dr. Robert Califf was  questioned by lawmakers about the agency's handling of the Abbott plant investigation for bacterial contamination linked to a national shortage.

Lawmakers said that it was "unconscionable" that it took the FDA months to inspect the Abbott plant. The agency received a whistleblower report in October about “egregiously unsanitary” conditions that included bacteria inhabiting key production equipment. "That is a dereliction of duty, in my view," said U.S. Rep. Rosa DeLauro, D-Conn.

Califf told lawmakers during a virtual subcommittee hearing that, although he had read the whistleblower report, he declined to answer details about the agency's response, citing an ongoing investigation.

"It's not acceptable to say you just can't comment on it," Rep. Mark Pocan, D-Wisc., said. "This is a problem I've seen over and over with the FDA in my 10 years here. You guys aren't good at communicating."

Just one day after the FDA announced its investigation, a proposed class action lawsuit was filed against Abbot by purchasers of its infant formula. They accuse the company of allowing tainted formula to make it to the market. Plaintiff Luis Alfredo Suarez claims that his daughter ingested allegedly tainted baby formula, and developed symptoms of gastrointestinal distress. Suarez purchased Alimentum baby formula on Jan. 30 that had a lot number and expiration date that matched what the FDA identified in its release as the tainted lots, and his daughter suffered gastrointestinal distress for several weeks.

Steven looked up the Alimentum code that his baby consumed and sure enough, it is part of the recall. “I think the bacteria in Abbot’s formula killed our baby. As soon as we get the autopsy results, which could take three or four months, I am filing a complaint,” he said.

An Abbott spokesman told Law360 that the company extends its "heartfelt sympathies" to the families.


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