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The makers of a popular baby formula, ByHeart, are facing legal action as two families have filed lawsuits in connection with a widespread recall linked to an outbreak of infantile botulism. The parents of the affected infants, who experienced serious health repercussions, are seeking justice and compensation for the ordeal they have endured.
Stephen and Yurany Dexter from Flagstaff, Arizona, recount the harrowing experience of their 4-month-old daughter, Rose, who required emergency air transport to a distant children’s hospital. Rose spent several weeks receiving intensive medical care this past summer after being diagnosed with the rare and dangerous condition.
Similarly, Michael and Hanna Everett from Richmond, Kentucky, describe the distressing situation when their daughter, Piper, also 4 months old, was urgently hospitalized on November 8th as her symptoms rapidly worsened. The fear and anxiety these families faced highlight the gravity of the situation.
The legal complaints, lodged in federal courts across two states, argue that the ByHeart formula consumed by the infants was defective and that the company was negligent in its distribution. The families are pursuing financial compensation for medical expenses, emotional trauma, and other damages incurred during this difficult period.
Both the Dexter and Everett families chose the organic ByHeart formula, believing it to be a natural and healthier option for their babies. The revelation that the product caused such severe health issues has left them feeling both shocked and outraged. “I never imagined that a product meant for vulnerable, developing children in the United States could lead to something so severe,” stated Stephen Dexter, clearly expressing the deep concern and disappointment shared by both families.
“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 23 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.
RELATED: Preliminary tests find germ that causes botulism in ByHeart baby formula
“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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