Infant Botulism Lawsuit Filed Over Recalled ByHeart Formula

Parents say infant daughter began to suffer constipation and lethargy, followed by disturbing neurological symptoms.

A Kentucky couple has filed a lawsuit against the makers of ByHeart infant formula, saying their four-month-old daughter was part of a multistate infant botulism outbreak that led to a recall of the contaminated products.

In a complaint (PDF) brought in the U.S. District Court for the Eastern District of Kentucky on November 12, parents Hannah and Michael Everett say ByHeart Inc. is liable for injuries to their child, and for them having to face “a parent’s worst nightmare.”

The lawsuit comes just four days after the U.S. Food and Drug Administration (FDA) announcement of a ByHeart Whole Nutrition Infant Formula recall, where regulators traced more than a dozen infant botulism cases back to the company’s products. At the time, two batches of infant formula were affected.

However, the FDA announced a ByHeart infant formula recall expansion on November 11, now pulling all batches of ByHeart Whole Nutrition Infant Formula Cans and Anywhere Pack nationwide. The latest U.S. Centers for Disease Control and Prevention (CDC) update on the outbreak indicates a total of 15 infants in 12 states have been sickened and hospitalized.

According to the Everetts’ lawsuit, their infant daughter, P.E., became lethargic and developed constipation, before beginning to exhibit “disturbing neurological symptoms,” including being unable to drink from her bottle.

P.E.’s parents then took her to the hospital, where she was diagnosed with infant botulism and had to undergo anti-toxin treatment. An investigation by the Kentucky Department of Public Health determined that the Everetts had received and fed P.E. infant formula from one of the recalled batches.

The Everetts accuse ByHeart of continuing to downplay its connection to the outbreak. They note that in the recall expansion, ByHeart officials emphasized that FDA and CDC investigators did not detect Clostridium botulinum spores or toxin in the company’s products. However, the lawsuit points out that ByHeart failed to disclose that California Department of Public Health officials did detect the bacteria in the leftovers of a can that had been fed to an infant.

“The company’s announcement does not mention the leftover product testing, and its announcement serves only to undermine the actual evidence, and, of course, protect its carefully cultivated brand image.”

– Hannah Everett et al v. ByHeart Inc. et al

The couple presents claims of strict product liability, negligence and breach of warranty. They seek both compensatory and punitive damages.

Infant Botulism Risks

Although infant botulism is rare, it can lead to serious and potentially life-threatening side effects.

The illness develops when Clostridium botulinum spores, which are naturally found in soil, dust and certain vegetables, are swallowed and begin to grow inside an infant’s intestines, where they release dangerous neurotoxins.

While botulinum contamination is rare in dairy products or baby formula, federal health officials warn that affected infants may show signs such as:

• Difficulty sucking and swallowing
• Weak or altered cry
• Respiratory difficulty and arrest
• Constipation
• Poor feeding
• Droopy eyelids
• Sluggish pupils
• Low muscle tone and weakness

Parents are urged to seek immediate medical attention if a baby shows any of these symptoms. The FDA also advises reporting any related illnesses or adverse reactions to its MedWatch Adverse Event reporting program.

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