ByHeart Formula Lawsuit Filed Over Infant Botulism Diagnosis

Infant botulism outbreak linked to recalled ByHeart formula has reportedly sickened nearly 40 children nationwide, all of whom required hospitalization.

The parents of a Texas infant say they had to watch as their newborn nearly died of infant botulism after being fed ByHeart formula, which was later found to be contaminated, causing multiple illnesses nationwide.

Anit Joseph and Luke Pooley, the parents of a child identified only as K.P., filed the complaint (PDF) in the U.S. District Court for the Southern District of Texas on December 1, naming ByHeart Inc. as the defendant. They accuse the company of selling contaminated food that put their child’s life at risk.

ByHeart Infant Formula Recall

On November 8, the U.S. Food and Drug Administration (FDA) announced a ByHeart Whole Nutrition Infant Formula recall after federal and state health regulators linked the product to at least 15 infant botulism illnesses in 12 states. While the first recall only affected two batches of the formula, an expanded recall was announced three days later, impacting all batches of ByHeart Whole Nutrition Infant Formula Cans and Anywhere Packs on shelves nationwide.

According to the U.S. Centers for Disease Control and Prevention, as of December 3 the ByHeart infant botulism outbreak has sickened at least 39 infants in 18 states. The cases were reported between August 9 and November 19, and all infants involved were hospitalized.

K.P.’s parents indicate their baby, born on July 11, was one of those sickened by the recalled ByHeart infant formula. According to the family, they began feeding K.P. ByHeart infant formula on September 30.

The four-month-old began showing symptoms of illness on November 6, just two days before the recall. Ten days after his first symptoms, K.P.’s parents took the infant to the hospital, after the child became fussy, lost his appetite, was sleeping through the day, and appeared constipated. His cry was weak, the boy would not take a bottle, and he began to seem “floppy.”

By then, medical professionals were aware of the ByHeart recall, identified that K.P. was fed the recalled formula, and diagnosed the child with infant botulism. He was hospitalized in Texas Children’s Hospital for emergency care.

In the lawsuit, his mother referred to the incident as a parent’s worst nightmare.

“The nurses had to put a bunch of wires on him to monitor him, and we were told he couldn’t eat in case he needed to be intubated as he could aspirate. That night the only thing he was able to drink was small packets of sugar water – it was so horrible seeing him be so hungry and sick.”

– Anit Joseph

The day after arriving at the hospital, K.P.’s symptoms worsened before he regained enough strength to be released on November 25. However, his parents say the infant is “still weak and recovering.”

They present claims of strict products liability, breach of warranty, negligence, and negligence per se.

ByHeart Infant Botulism Lawsuits

The new complaint is one of several ByHeart formula recall lawsuits filed in recent months, involving both individual injuries and at least one class action. Each complaint claims that the manufacturer should have detected and prevented the contamination before the food went into circulation.

The claims placing fault on the manufacturer appear to be backed up by reports from FDA inspectors, who found significant problems at the company’s Reading, Pennsylvania facility in the summer of 2022, when they discovered cronobacter sakazakii in the processing area of the plant. Several weeks later, the same contaminants were found in a can of finished formula, yet the report indicates the company determined that the laboratory made a mistake.

At the time, the investigators discovered mold in sources of clean water, dead insect corpses in food production areas and roof leaks. These factors led to a ByHeart cronobacter recall in December 2022.

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