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A 3-month-old baby is in the hospital in Minnesota after being fed formula linked to a 

. The family filed a lawsuit Wednesday against the company that makes ByHeart Whole Nutrition infant formula.

The Plymouth family started using ByHeart formula in early November. They chose the brand because its advertising claimed a more holistic, nutritious and high-quality baby formula. But weeks after feeding it to their infant daughter, she's still in the hospital, with her family by her side.

The family’s attorney, Ryan Osterholm with OFT Food Safety Injury Law, said the whole case is alarming. 

“There's very, very few outbreaks that raise my level of concern like this,” Osterholm said. “This is obviously a contaminated product. It's very dangerous. We're talking about kids.”

The Centers for Disease Control and Prevention and the Food and Drug Administration report two cases of infant botulism in Minnesota linked to ByHeart's product. Nationwide, about 30 cases of infant hospitalizations in 15 states 

have been reported since the start of November

Shortly after feeding it to their child, the parents noticed she was unable to eat, lethargic, weak and constipated — all common symptoms of botulism. 

According to the lawsuit filing, the baby girl required a feeding tube in the pediatric intensive care unit and suffered from muscle weakness and paralysis. She’ll require therapy to help her regain the ability to feed, swallow and regain muscle strength.

ByHeart released a statement to consumers

 confirming their own investigation, which found the bacteria that causes botulism in their product. The company has recalled all products and urges parents and caregivers to stop using ByHeart formula immediately.

“It is notoriously difficult to test for this in products, and the fact that they were able to culture this out of what sounds like numerous different products really goes to the heart of this,” Osterholm said. “That we believe that this was a widespread contamination event, and that the risk to using this formula is very, very high.”

 by the Minnesota Department of Agriculture found that this product was still on the shelves in at least four stores in the state. Authorities urge parents and caregivers to dispose of any ByHeart products they may have.

Infants affected ranged in age from 16 days to 6 months. Though no deaths have been reported in this case, botulism is a rare but serious illness caused by a toxin that attacks the body’s nerves. It causes difficulty breathing, muscle paralysis and even death. Infant botulism often starts with constipation but is usually first noticed as difficulty feeding, a weak and altered cry and lack of head control.

“Obviously, it's quite alarming,” Osterholm said. “Any time you're dealing with an infant formula in children, it's a very scary thing, and I think when the dust settles, this is going to represent one of the largest infant botulism outbreaks that we've ever seen.”

The attorney said the family is asking for compensation due to negligence from ByHeart and for their distress and medical expenses.

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Kyra Miles

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According to the lawsuit filing, the baby girl required a feeding tube in the pediatric intensive care unit and suffered from muscle weakness and paralysis. She’ll require therapy to help her regain the ability to feed, swallow and regain muscle strength.


Minnesota baby in hospital due to nationwide baby formula botulism outbreak

Close-up of a container of ByHeart baby formula.

Minnesota baby in hospital due to nationwide baby formula botulism outbreak

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