Parents Sue ByHeart After Babies Get Botulism From Formula

ByHeart baby formula is at the center of a nationwide recall after an infant botulism outbreak sent 23 babies to the hospital across 13 states. Now at least two families are suing the company.

No deaths reported yet, but all 23 infants were hospitalized, according to the FDA. The agency is investigating alongside the CDC.

ByHeart voluntarily recalled two batches of its Whole Nutrition Infant Formula on November 8. Three days later, the company expanded the recall to include every single batch of formula cans and Anywhere Packs nationwide.

Two families—Stephen and Yurany Dexter from Flagstaff, Arizona, and Michael and Hanna Everett from Richmond, Kentucky—filed federal complaints alleging ByHeart is directly responsible for their babies contracting the rare and potentially deadly disease.

What Happened to These Babies

The Dexters' daughter was born healthy on July 5. They started supplementing breast milk with ByHeart formula on July 8.

By August 21, their baby started showing stomach discomfort and gas. Her feeding steadily decreased. "She appeared hungry but would refuse to eat as soon as the bottle touched her lips. Eventually, she stopped eating altogether," according to the lawsuit.

Initially diagnosed with thrush, the infant's symptoms worsened until August 31 when her parents couldn't wake her. She was airlifted to Phoenix Children's Hospital on September 2.

Treatment included IV fluids, a feeding tube, antitoxin, plus occupational, physical, and speech therapy. She was discharged September 13 with a feeding tube and can't be left alone while awake.

The Everetts' 4-month-old daughter was "happy, healthy" until consuming ByHeart formula in early November. She became lethargic and constipated. Within days, she developed neurological symptoms including inability to take a bottle.

She was admitted to the hospital November 9, diagnosed with infant botulism, and received antitoxin treatment. Kentucky Department of Public Health investigated and discovered the child received one of the initially recalled batches.

"It was just absolutely terrifying," Hanna Everett told CBS News. "We just kind of felt like we failed as a parent in some ways."

Both families are seeking payment for medical costs, jury trials, and other damages.

The Company's Response

ByHeart co-owners Mia Funt and Ron Belldegrun posted a letter November 11 after learning about the outbreak Friday evening.

"We immediately began conducting our own extensive testing on all ByHeart batches. Additionally, we are providing the FDA complete and unrestricted access to all of our facilities and products for their investigation," the letter states.

At this moment, the most important thing for you to know is that all ByHeart product must be discarded," they wrote. "We are so sorry, and are committed to doing anything we can to support you.

The company added that neither they, the FDA, nor CDC have found Clostridium botulinum spores or toxins in any unopened can of ByHeart formula. That's the bacteria that produces the toxin causing botulism.

The Numbers

As of Friday, November 14, 23 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart formula have been reported from 13 states: Arizona, California, Kentucky, Illinois, Minnesota, Michigan, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

For 22 cases with illness onset information, symptoms began between August 9 and November 11. The 22 infants with age and sex data range from 16 to 200 days old. Ten are female.

All 23 were hospitalized. No deaths so far.

FDA Investigation Status

The FDA is conducting onsite inspections and collecting samples to determine contamination point, according to their November 14 update.

"My hopes right now is that they're able to catch it before their children get too sick, before they have to be on ventilators," Hanna Everett told CBS News.

Stephen Dexter said he never would've guessed "that a product designed for a helpless, developing human in the United States could cause something this severe."

Symptoms to Watch For

Parents seeing these symptoms in infants should seek immediate medical care, according to the CDC:

• Poor feeding

• Loss of head control

• Difficulty swallowing

• Decreased facial expression

Botulism symptoms can take multiple weeks to develop. Parents who recently fed infants the recalled formula should stay vigilant.

What Parents Should Do

ByHeart says consumers who purchased any ByHeart Whole Nutrition Infant Formula cans or Anywhere Packs should immediately stop using them and throw them away.

"If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately," the company stated in its November 11 recall.

To report illness or adverse events, parents can call an FDA consumer complaint coordinator, complete an electronic Voluntary MedWatch form online, or complete a paper form and mail it to the FDA.

Parents with questions can contact ByHeart experts at hello@byheart.com or call 1-833-429-4327. The company says they're available 24/7.

For more information, visit byheart.com.

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