ByHeart Infant Formula Crisis Deepens: Four Families Sue Over Botulism Outbreak
At least four families have filed lawsuits against ByHeart, the infant formula maker at the center of a botulism outbreak, alleging that contaminated products caused their babies to fall ill with the deadly disease. The company has confirmed that laboratory tests detected Clostridium botulinum spores in its formula, which could lead to botulism if ingested.
According to the Food and Drug Administration (FDA), 31 infants have been affected by the botulism outbreak, resulting in hospitalization across 15 states. However, no deaths have been reported so far. The families who sued ByHeart claim that they had chosen the formula because it contained organic whole milk and minimal additives, believing it to be a healthier option for their babies.
Hanna Everett, whose 2-month-old daughter Piper was affected by the botulism outbreak, described harrowing days in the hospital with her baby. Piper's condition improved after she received treatment, but Everett is still wracked with guilt over what she perceives as ByHeart's delay in addressing the contamination issue.
Experts argue that ByHeart should have taken comprehensive action more quickly to identify the root cause of the contamination and notify consumers. The company has faced scrutiny from federal investigators and a separate class-action lawsuit filed last week. A Washington state couple, Madison Wescott and her daughter, also sued ByHeart, alleging their child suffered chronic constipation, difficulty feeding, and extreme fatigue while taking the formula.
The botulism outbreak highlights concerns about infant formula safety. While formula makers are not required to regularly test for Clostridium botulinum, they must follow sanitary control practices to prevent contamination. The FDA has issued a warning letter to ByHeart regarding significant violations at its manufacturing facility in Pennsylvania, which was involved in the 2022 Abbott Nutrition recall.
The crisis has also raised questions about the safety of whole milk-based infant formulas like ByHeart's. Dr. Abigail Snyder, an associate professor of microbial food safety at Cornell University, stated that a warning letter like ByHeart received is "pretty unusual," but acknowledged increased regulatory activity around infant formula after the Abbott recall.
At least four families have filed lawsuits against ByHeart, the infant formula maker at the center of a botulism outbreak, alleging that contaminated products caused their babies to fall ill with the deadly disease. The company has confirmed that laboratory tests detected Clostridium botulinum spores in its formula, which could lead to botulism if ingested.
According to the Food and Drug Administration (FDA), 31 infants have been affected by the botulism outbreak, resulting in hospitalization across 15 states. However, no deaths have been reported so far. The families who sued ByHeart claim that they had chosen the formula because it contained organic whole milk and minimal additives, believing it to be a healthier option for their babies.
Hanna Everett, whose 2-month-old daughter Piper was affected by the botulism outbreak, described harrowing days in the hospital with her baby. Piper's condition improved after she received treatment, but Everett is still wracked with guilt over what she perceives as ByHeart's delay in addressing the contamination issue.
Experts argue that ByHeart should have taken comprehensive action more quickly to identify the root cause of the contamination and notify consumers. The company has faced scrutiny from federal investigators and a separate class-action lawsuit filed last week. A Washington state couple, Madison Wescott and her daughter, also sued ByHeart, alleging their child suffered chronic constipation, difficulty feeding, and extreme fatigue while taking the formula.
The botulism outbreak highlights concerns about infant formula safety. While formula makers are not required to regularly test for Clostridium botulinum, they must follow sanitary control practices to prevent contamination. The FDA has issued a warning letter to ByHeart regarding significant violations at its manufacturing facility in Pennsylvania, which was involved in the 2022 Abbott Nutrition recall.
The crisis has also raised questions about the safety of whole milk-based infant formulas like ByHeart's. Dr. Abigail Snyder, an associate professor of microbial food safety at Cornell University, stated that a warning letter like ByHeart received is "pretty unusual," but acknowledged increased regulatory activity around infant formula after the Abbott recall.