Parents of 2 Babies Sickened by Infant Botulism Sue Formula Maker ByHeart

Two families whose babies were hospitalized with infant botulism have filed lawsuits against ByHeart, the baby formula company that issued a nationwide recall after its products were linked to an outbreak.

ByHeart expanded its recall on Nov. 11 to cover all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack, after 15 infants across 12 states were reported to have suspected or confirmed botulism after consuming its formula. All the infants have been hospitalized. No deaths have been reported to date.

Infant botulism occurs when babies eat food or beverages that have spores from a bacterium called Clostridium botulinum.

The company faces two lawsuits, including one filed by Michael and Hanna Everett in Kentucky, who say their four-month-old daughter became sick with infant botulism after consuming ByHeart’s formula.

In their lawsuit, the Everetts say that their daughter developed constipation and “disturbing neurological symptoms,” including an inability to take a bottle. The infant was hospitalized on Nov. 9 and received anti-toxin treatment, which is a scarce medication.

The second lawsuit was brought by Stephen and Yurany Dexter in Arizona, whose infant daughter, also aged four months, was airlifted to a children’s hospital on Sept. 2 and hospitalized for over a week.

Their daughter experienced stomach discomfort and gas on Aug. 21 after consuming ByHeart’s formula, and her feeding gradually declined until she stopped eating altogether, according to the lawsuit.

The Dexters stated that during her stay at the children’s hospital, their daughter was unable to “suck, swallow, smile, hold her head up, move her limbs normally, or cry with normal strength.” She was discharged on Sept. 13 with a feeding tube.

The couple said their child has not fully regained strength and normal digestive function, and she continues to have constipation and gas.

“Plaintiffs do not yet know whether there will be long-term effects, and that uncertainty remains with Plaintiffs every day,” their lawyers said in the complaint.

Both lawsuits alleged that ByHeart was negligent in manufacturing, distribution, storage, and sale of its products, which they described as “defective and unreasonably dangerous” for consumer use.

The parents are seeking compensatory damages from the company for medical and hospital expenses, emotional distress, and other losses.

The Epoch Times reached out to ByHeart for comment, but did not receive a response by publication time.

The company issued an apology to consumers on Nov. 13 and said it would make available a 24/7 support hotline after receiving numerous calls from parents.

ByHeart said it would provide refunds to consumers who purchased its infant formula on or after Oct. 1.

“We started this company to give parents confidence in what they feed their babies. So knowing that the past few days have caused confusion and fear for many of you has been heartbreaking, and we are so sorry,” the company said. “Our team is doing everything we can to support you in real time.”

The states with at least one case are Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington state, according to the U.S. Centers for Disease Control and Prevention.

“Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and lack of head control,” the CDC states.

Testing conducted by the California Department of Public Health detected bacteria that produce botulinum toxin, the agency said on the same day the recall was announced.

The sample was taken from an open can of ByHeart formula that was fed to an infant who fell ill. Officials injected mice with the cultured bacterium and then waited up to four days to see if they got sick.

“These mice got sick really quickly,” Dr. Erica Pan, health officer for the California Department of Public Health, said at the time.

ByHeart stated on Nov. 11 that no unopened products have tested positive for Clostridium botulinum spores or toxin, adding that an investigation has been launched “to get the answers parents expect and deserve.”

Zachary Stieber contributed to this report.