Families of two babies sickened by infantile botulism sue ByHeart over recalled formula

The parents of at least two babies sickened in an infantile botulism outbreak are suing the makers of the ByHeart baby formula at the heart of a nationwide recall.

Stephen and Yurany Dexter, of Flagstaff, Arizona, said their 4-month-old daughter, Rose, had to be flown by air ambulance to a children’s hospital two hours from home and treated for several weeks this summer.

Michael and Hanna Everett, of Richmond, Kentucky, said their daughter, Piper, also 4 months, was rushed to a hospital Nov. 8 with worsening symptoms of the rare and potentially deadly disease.

The lawsuits, filed in federal courts in two states, allege that the ByHeart formula the babies consumed was defective and that the company was negligent in selling it. They seek financial payment for medical bills, emotional distress and other harm.

Both families said they bought the organic formula to provide what they viewed as a natural, healthier alternative to traditional baby formulas, and that they were shocked and angered by the suffering their children endured.

“I wouldn’t guess that a product designed for a helpless, developing human in the United States could cause something this severe,” said Stephen Dexter, 44.

“She’s so little and you’re just helplessly watching this,” said Hanna Everett, 28. “It was awful.”

Outbreak began in August

Rose Dexter and Piper Everett are among at least 15 infants in a dozen states who have been sickened in the outbreak that began in August, according to federal and state health officials. No deaths have been reported.

Both received the sole treatment available for botulism in children less than a year old: an IV medication called BabyBIG, made from the blood plasma of people immunized against the neurotoxins that cause the illness.

Investigations into more potential botulism cases are pending after ByHeart, the New York-based formula manufacturer, recalled all of its formula nationwide on Tuesday. At least 84 U.S. babies have been treated for infantile botulism since August, including those in the outbreak, California officials said.

The company sells about 200,000 cans of formula per month. It can take up to 30 days for signs of infantile botulism infection to appear, medical experts said.

California officials confirmed that a sample from an open can of ByHeart formula fed to an infant who fell ill contained the type of bacteria that can lead to illness.

The lawsuits filed Wednesday could be the first of many legal actions against ByHeart, said Bill Marler, a Seattle food safety lawyer who represents Dexter.

“This company potentially faces an existential crisis,” he said.

ByHeart officials didn’t respond to questions about the new lawsuits but said they would “address any legal claims in due course.”

“We remain focused on ensuring that families using ByHeart products are aware of the recall and have factual information about steps they should take,” the company said in a statement.

Parents fretted as babies grew sicker

In Rose Dexter’s case, she received ByHeart formula within days of her birth in July after breast milk was insufficient, her father said. Stephen Dexter said he went to Whole Foods to find a “natural option.”

“I’m a little concerned with things that are in food that may cause problems,” he said. “We do our best to buy something that says it’s organic.”

But Rose, who was healthy at birth, didn’t thrive on the formula. She had trouble feeding and was fussy and fretful as she got sicker. On Aug. 31, when she was 8 weeks old, her parents couldn’t wake her.

Rose was flown by air ambulance to Phoenix Children’s Hospital, where she stayed for nearly two weeks.

Hanna Everett said she used ByHeart to supplement breastfeeding starting when Piper was 6 weeks old.

“It’s supposed to be similar to breast milk,” she said.

Last weekend, Piper started showing signs of illness. Everett said she became more worried when a friend told her ByHeart had recalled two lots of its Whole Nutrition Infant Formula. When a family member checked the empty cans, they matched the recalled lots.

“I was like, ’Oh my god, we need to go to the ER,” Everett recalled.

At Kentucky Children’s Hospital, Piper’s condition worsened rapidly. Her pupils stopped dilating correctly and she lost her gag reflex. Her head and arms became limp and floppy.

Doctors immediately ordered doses of the BabyBIG medication, which had to be shipped from California, Everett said. In the meantime, Piper had to have a feeding tube and IV lines inserted.

In both cases, the babies improved after receiving treatment. Rose went home in September and she no longer requires a feeding tube. Piper went home this week.

They appear to be doing well on different formulas, the families said.

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