Two families have filed federal lawsuits against ByHeart after their infant daughters contracted botulism from the company’s recalled baby formula, ByHeart Whole Nutrition.
The legal actions follow a nationwide outbreak that has sickened at least 15 babies across 12 states since August. The New York-based manufacturer recalled its entire product line on Tuesday.
Stephen and Yurany Dexter of Flagstaff, Arizona, said their daughter Rose required emergency airlifting to Phoenix Children’s Hospital when she was just 8 weeks old. Michael and Hanna Everett of Richmond, Kentucky, watched their daughter Piper’s condition deteriorate rapidly last week.
Both families purchased the organic formula, believing it offered a healthier alternative to traditional products.
“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, per the Associated Press.
The lawsuits allege that ByHeart sold a defective formula and seek compensation for medical expenses and emotional distress.
Seattle food safety attorney Bill Marler, representing the Dexters, warned: “This company potentially faces an existential crisis.”
ByHeart officials said they would “address any legal claims in due course” while focusing on informing families about the recall.
The company sells approximately 200,000 cans monthly nationwide.
Rose Dexter began receiving ByHeart formula days after birth in July when breastfeeding proved insufficient. Her father specifically sought “natural” options at Whole Foods, concerned about the presence of food additives.
The infant struggled to feed and became increasingly fussy. On August 31, her parents could not wake her, triggering the emergency airlift.
Hanna Everett started supplementing breastfeeding with ByHeart when Piper was 6 weeks old.
“It’s supposed to be similar to breast milk,” she said, AP reported.
When Piper showed signs of illness last weekend, a friend alerted Everett to the recall.
After checking empty cans that matched recalled lot numbers, Everett panicked: “I was like, ‘Oh my god, we need to go to the ER.'”
At Kentucky Children’s Hospital, Piper’s pupils failed to dilate correctly. She lost her gag reflex, and her head and arms became limp.
“She’s so little and you’re just helplessly watching this,” said Hanna Everett, 28. “It was awful.”
Both infants received BabyBIG, the only treatment for botulism available for babies under one year. The medication, derived from immunized blood plasma, must be shipped from California.
California health officials confirmed the presence of botulism-causing bacteria in an open ByHeart can. At least 84 U.S. babies have received botulism treatment since August, including outbreak victims.
Medical experts warned that symptoms can take up to 30 days to appear. The delayed onset could mean more cases emerge despite Tuesday’s recall.
Rose Dexter returned home in September after nearly two weeks in the hospital. Piper was discharged this week following her admission on November 8.
Both families report their daughters are thriving on different formulas. The infants no longer require feeding tubes or IV support.
ByHeart stated it remains “focused on ensuring that families using ByHeart products are aware of the recall and have factual information about steps they should take,” according to AP. The company has not responded to specific questions about the lawsuits.