ByHeart, a baby nutrition company, is facing lawsuits from families in Arizona and Kentucky after their infants contracted botulism linked to the company's recalled formula. The lawsuits come amid a nationwide recall of ByHeart Whole Nutrition Infant Formula due to contamination concerns with Clostridium botulinum, a bacterium that can cause severe illness in infants.
The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating the outbreak, which has affected at least 23 infants across 13 states. The FDA has advised against using the recalled formula and is conducting onsite inspections and sample collections to determine the source of contamination. According to FDA reports, all 23 affected infants have been hospitalized, though no deaths have been reported.
In Arizona, Stephen and Yurany Dexter's daughter, Rose, was hospitalized after consuming ByHeart formula. Stephen Dexter expressed disbelief, stating, "I wouldn’t guess that a product designed for a helpless, developing human in the United States could cause something this severe." In Kentucky, Michael and Hanna Everett's daughter, Piper, also fell ill after consuming the formula. The families are seeking damages for medical expenses and emotional distress, alleging that ByHeart sold a defective product and was negligent in its production processes.
ByHeart has stated that it is cooperating with the FDA and has provided "complete and unrestricted access" to its facilities, including its plant in Berks County. The company has not responded directly to the lawsuits but has emphasized its commitment to ensuring families are aware of the recall and necessary precautions.
The lawsuits could be the first of many legal actions against ByHeart, as investigations into additional cases continue. The company, which sells about 200,000 cans of formula monthly, is facing significant scrutiny over its manufacturing practices and quality control measures.