Last week, the baby nutrition company ByHeart recalled all of its infant formula over concerns that it may be contaminated with Clostridium botulinum, the bacterium that causes infant botulism.
Now the company is facing increasing legal drama and backlash from customers for potentially exposing babies to the dangerous illness.
According to a November 14 update from the Food and Drug Administration (FDA), a total of 23 infants in 13 states who were exposed to the formula have developed suspected or confirmed infant botulism. All of the infants have been hospitalized, and no deaths have been reported to date.
ByHeart had voluntarily recalled two batches of its infant formula on November 8. Just three days later, it expanded that recall to encompass all of its products, including any unexpired lots of formula cans and single-serve “anywhere pack” sticks.
Per the FDA, most babies with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest.
Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion. Parents are advised to stop using any ByHeart infant formula products immediately.
As new botulism cases potentially related to ByHeart’s products continue to emerge, the company—which positions itself as dedicated to making the “best formula in the world”—is facing backlash both through multiple lawsuits and a social media firestorm led by its own customers.
Legal backlash against ByHeart ramps up
As of this writing, at least five different lawsuits have been filed against ByHeart related to the infant botulism outbreak, according to federal court records.
All of the plaintiffs are identified in the complaints as buyers of ByHeart’s products. Three of the complaints are proposed class actions. In at least two cases, the plaintiffs have infant children whom they believe contracted infant botulism through the contaminated formula, the court filings show.
According to a November 12 legal complaint, plaintiffs Stephen and Yurany Dexter of Flagstaff, Arizona, decided to introduce formula three days after the birth of their child (referred to as E.D.) to supplement breast milk.
“Looking at the available choices, they chose the ByHeart brand because of the healthy-looking labeling, top shelf placement, and higher price,” the filing reads.
But over a month later, the child began to exhibit symptoms of infant botulism, it says, resulting in multiple hospital stays and hundreds of thousands in medical expenses.
In a second complaint filed on that same day, plaintiffs Michael and Hanna Everett of Richmond, Kentucky, detail a similar experience with their child, referred to as “P.E.”
“This case arises from a parent’s worst nightmare: infant formula laced with dangerous Bacteria,” the suit reads.
It goes on to explain that the Everetts purchased ByHeart’s products due to its promises to be a “healthier alternative to traditional formula,” only for their four-month-old daughter to contract infant botulism.
“Soon after consuming the formula, she developed constipation and alarming neurological symptoms,” it reads. “Plaintiffs brought their first-born daughter to the emergency department where doctors diagnosed P.E. with infant botulism. Public health investigators later confirmed that she was part of a multistate outbreak caused by ByHeart formula.”
Reached for comment by Fast Company, ByHeart emailed a statement from cofounder and president Mia Funt.
“Our number one priority is infant health,” Funt says. “We express our deepest sympathy to the families currently impacted by the cases of infant botulism. We are working with the FDA and independent experts to implement the recall quickly while the factual investigation continues. We are committed to getting answers—including partnering with the FDA and independent experts—and will share updates as soon as we can.”
Throughout the new lawsuits against ByHeart, a recurring theme is the idea that parents chose the company’s products due to its positioning as a healthy, science-backed alternative to traditional formula.
And under an Instagram post from ByHeart apologizing for the recalls, hundreds of commenters have echoed those sentiments, expressing their disappointment in the brand.
“I’m a sitting duck waiting around to see if my baby is okay because she consumed contaminated formula from you,” one commenter wrote, added that “we trusted you with nourishing our baby and you failed us.”
Another added, “From the bottom of my heart I hope your company goes bankrupt and that no retailer will ever carry your products again.”
New York-based ByHeart was founded in 2016 and most recently raised $72 million in a Series C round from undisclosed investors, according to PitchBook, for a post-valuation of $908 million.
In the wake of the recalls, ByHeart has updated its website to spotlight information about the situation, including a link to its customer support line (866-201-9069).
Fast Company reached out to the FDA for the latest details. The agency says it is continuing to investigate the outbreak along with the Centers for Disease Control and Prevention (CDC) and state-level public health officials.
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