Minnesota parents sue formula maker over infant’s botulism

A Plymouth mother and father are suing baby formula maker ByHeart, alleging the New York-based manufacturer of a now-recalled product is responsible for a rare case of botulism that has hospitalized their 3-month-old daughter.

Colin and Jennifer Flowers said in their lawsuit, filed in U.S. District Court on Wednesday, that their second child suffered “alarming neurological symptoms” after consuming the formula and that they rushed the infant to an emergency room Nov. 11. She received an emergency antitoxin medication the next day, but continued to be lethargic and withdrawn. She remained hospitalized Friday.

“I am absolutely frustrated and angry,” her mother said in a phone interview from her daughter’s hospital room. “I have definitely felt helpless. I can’t soothe my child in the same way I was able to before.”

Botulism is a rare disease caused by a toxin released from bacteria that attacks the body’s nerves and can cause breathing problems or paralysis. A surge of cases starting in August prompted public health investigations, which over time found 31 sickened infants had consumed ByHeart formula. Two of the cases were discovered in Minnesota, where the formula was widely available online and at major retail outlets.

The Flowers’ lawsuit said their daughter suffered “worsening muscle tone, which included facial paralysis, muscle weakness, difficulty breathing, and other marked symptoms.” Her pupils weren’t reacting to light, prompting her doctors to order multiple tests and ultimately call for an antitoxin drug called BabyBIG to be flown from California.

The drug stopped the toxin from spreading, but didn’t reverse the immediate damage, her mother said. Doctors expect the infant to recover, slowly, but she still needs a feeding tube to receive adequate nutrition, the mother added.

“We want answers,” she said, “and we want to protect other children.”

“We are investigating every facet of our process — from ingredient-sourcing to our manufacturing process and facilities, packaging, transportation, everything,” the company stated Wednesday. “We do not yet know the root cause, but we are committed to finding the answers.”

The Flowers had fed more common store-bought formulas to their first child, but were attracted to ByHeart’s products, which were marketed as clean, better and easy to digest. Their child had showed healthy development in her third month of life — smiling, discovering her hands, and monitoring her older sister with intense curiosity.

Problems emerged about a week after she started consuming ByHeart formula, her mother said. The company initially issued a recall of two lots of its formula, but questioned whether it was actually at fault.

The Flowers checked the lot numbers on their cans, and they weren’t listed in the initial recall, so they continued to feed the formula to their daughter. She had also started childcare the day before symptoms emerged, so they thought it could just be her adjusting to her new routine.

The nationwide recall of all ByHeart products came on the same day when the Flowers took their daughter to the hospital. The parents received a call from their local retailer and an email from the manufacturer.

The recall notice urges parents to stop using ByHeart formula but to keep unused cans for 30 days for possible use in the public health investigation if their children develop symptoms. Retailers have been ordered to remove the formula from shelves.

Minneapolis attorneys Ryan Osterholm and Brendan Flaherty filed the lawsuit. While ByHeart attracted customers with its “whole nutrition” marketing, the lawsuit claims that it had earlier evidence of problems.

After a separate formula recall in 2022, the company blamed a third-party lab, but public health investigators said that was implausible and pointed to manufacturing problems at a plant in Pennsylvania, the suit stated.