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Similac (dairy formula for children)

Product
Developers: Abbott Laboratories
Branches: Food industry

Content

2024

Abbott baby food causes necrosis. Company fined $0.5 billion

On July 26, 2024, a jury in St. Louis (Missouri, USA) issued a verdict according to which Abbott Laboratories baby food provokes necrosis. The company will have to pay a fine of almost $0.5 billion.

We are talking about a special mixture for premature babies. According to the case file, the use of this nutrition provoked a serious illness in a girl from Illinois. She was diagnosed with necrotizing enterocolitis, an ailment that is characterized by necrosis of the mucous membrane or even deeper layers of the intestines. The disease can be caused by infectious agents against the background of damage to the intestinal mucosa or its functional immaturity.

Abbott fined $0.5bn for baby food causing necrosis

In her lawsuit, according to Reuters, Illinois resident Margot Gill said Abbott Laboratories did not warn of the potential threat her baby food could pose to premature babies. Daughter Gill developed necrotizing enterocolitis in 2021 after being fed Abbott Laboratories formula in the intensive care unit. The child survived, but due to the disease received irreversible neurological damage. In this regard, the girl needs long-term care.

In accordance with the jury order, Abbott Laboratories will pay compensation in the amount of $95 million. In addition, the company was fined $400 million. Abbott Laboratories says it strongly disagrees with the verdict and will try to challenge it. Specialized formulas, like the one in the lawsuit, are among the only available options for feeding premature babies, the company said. Abbott Laboratories' defence says daughter Gill's illness was triggered by a birth injury that deprived the baby's brain of oxygen.[1]

Abbott formula dairy kills babies in hospitals

In early July 2024, it was revealed that Abbott would stand trial over the company's formula formula for premature babies used in neonatal intensive care units causing a severe bowel disease known as necrotising enterocolitis (NEC). NEC leads to the death of intestinal tissues, primarily in newborns, with a mortality rate of 15% to 40%.

The company was sued by Illinois resident Margot Gill, who claims her premature baby developed NEC after being fed Abbott dairy formula. Although the child survived, he faces chronic health problems. In response, Abbott said that the baby "suffered a traumatic brain injury in utero and during childbirth, well before the start of feeding Abbott formula," and that "no one is to blame" for his health problems.

Abbott to face trial

However, so far USA about 1,000 similar lawsuits have been filed against Abbott and Enfamil Reckitt maker Benckiser Group Plc in federal and state courts. More than 500 cases are pending in Illinois federal court, others are pending in Illinois, Missouri and state courts. Pennsylvania According to the lawsuits, the company did not warn customers that babies fed on dairy formula from these producers were at a higher risk of NEC than breast-fed babies receiving donor milk or formula derived from breast milk. The first lawsuit against Reckitt ended in March with a fine of 60 million. dollars Reckitt appealed the verdict, however, arguing that the plaintiff's version was based on unsubstantiated expert testimony.

Abbott's attorneys and representatives Margot Gill will deliver opening statements before a jury in St. Louis, Missouri. The trial is expected to last most of the month.[2]

2023: Removal from sale of infant formula following the death of a child

On October 30, 2023, Abbott announced it was discontinuing sales of all probiotic-based infant formula. The reason was the warnings of the regulatory authorities after the death of the child due to the product.

The decision to halt sales of the Similac Tri-Blend was made on October 26, 2023, when Food and Drug Administration (FDA - Food and Drug Administration)\ The U.S. Food and Drug Administration issued a warning that said the products contained living organisms (yeast and bacteria) that could be dangerous to infants.

Abbott announced it will stop selling all probiotic-based infant formula

The FDA also sent a warning letter to Abbott, indicating that Bifidobacterium infantitis and Streptococcus thermophilus bacteria were found in Similac Tri-Blend. According to the FDA, B. Infantitis is unsafe to add to food, and S. Thermophilus is a new and not fully studied bacterium, information about which is not enough to consider it safe and add to food, especially for babies.

A month earlier, the Office issued a letter to medical organizations warning of the infant's death after consuming a probiotic formula due to the formation of sepsis. It's all about Abbott promoting their product as curative, capable of reducing infant mortality, which reduces the risk of sepsis and necrotising enterocolitis.

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The FDA is concerned that these products are unsafe for premature infants and are sold illegally, as curative and able to reduce the risk of necrotising enterocolitis. Infants who receive a probiotic product have a risk of potentially having a fatal disease or infection due to bacteria or yeast in the product, the letter says.[3]
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2022

State of emergency declared in New York due to lack of infant formula

On May 22, 2022 New York , Mayor Eric Adams signed a decree imposing a state of emergency in the city due to a shortage of infant formula after the closure Abbott of the Nutrition plant. A nationwide shortage of infant formula is forcing parents and families to look for supplies, while store shelves are emptying and communities are resorting to levies to redistribute available supplies.

The deficit is estimated at 50% of the needs of the American market. The problem arose after the closure of the production line of Abbott Nutrition, one of the largest suppliers of infant formula in the United States, pathogenic bacteria were found in them.

State of emergency declared in New York due to lack of infant formula

The decree will be valid for 30 days, the law was passed on May 22, 2022, due to the fact that almost half of all retail stores in the three states USA faced a shortage of milk mixtures, according to to data the mayor's office. This is stated in a statement on the website of the city of New York.

New York City Mayor Eric Adams said New York will now send teams from the U.S. Department of Consumer Protection and workers to stores across the city to check dairy prices. Adams added that the emergency order is only the first quick action, and that his staff is developing a strategy for how the city can do more to protect the city's parents.

In mid-May 2022, the president Joe Biden invoked the Defense Production Act to prioritize the delivery of milk formula ingredients to manufacturers. Biden also launched Operation Flying Formula, in which the first batches of dairy formula from abroad were delivered on May 21-22, 2022. On May 25, White House spokeswoman Karin Jean-Pierre announced that US military transport aircraft had begun an emergency import United States Europe into newborn milk formula.[4]

Recall of mixtures due to bacterial infections in children

On February 18, 2022, Abbott Laboratories said it was recalling three types of infant formula following consumer complaints of bacterial contamination that could cause severe illness in infants.

The U.S. Food and Drug Administration (FDA) is investigating complaints about four cases of infant disease in Minnesota, Ohio and Texas related to exposure to the cronobacteria and salmonella. All four babies were hospitalized, one died. Bacteria in the Cronobacter family are believed to have contributed to this death, the authority said.

Abbott recalls popular dairy formula due to bacterial infections in children

The recall includes separate batches of Similac, Alimentum and EleCare blends that were produced at Abbott's facility in Sturgis, Michigan. The recall comes after the FDA received four consumer complaints about bacterial infections related to these mixtures.

Three complaints involved Cronobacter sakazakii, a bacterium that can cause severe, life-threatening infections or inflammation of membranes that protect the brain and spine. Cronobacter infection can also cause intestinal damage and spread through blood to other parts of the body, according to the FDA.

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We appreciate parents' trust in us regarding high-quality and safe food and will do everything necessary to maintain that trust and resolve this situation, "said Vicky Assardo, senior director of communications at Abbott Nutrition.
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The recall affects certain batches of Similac, Alimentum and EleCare with an expiration date of April 1, 2022 and beyond. The recall does not apply to Abbott products made at other facilities, the company said. In its statement, the company did not specify how many units of products affected the recall.

Abbott said that when checking the Sturgis facility, she "found signs of Cronobacter sakazakii at the plant in areas not in contact with products," but found no signs of Salmonella Newport, the bacterium mentioned in the fourth consumer complaint.

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None of the products distributed tested positive for these bacteria, Abbott said.
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The FDA said it inspected the site at a plant where environmental samples tested positive for Cronobacter. Inspectors also identified potential production problems, and an analysis of internal records showed the company had destroyed products in the past due to bacterial contamination, the agency said.[5]

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