ByHeart Class Action Lawsuit Filed Over Infant Formula Botulism Outbreak

Complaint alleges ByHeart set up a refund system that prevents most families from receiving reimbursement for recalled products.

The manufacturer of ByHeart infant formula is facing growing backlash and litigation after a contaminated batch of its infant formula were recalled earlier this month, in connection with a nationwide botulism outbreak.

Monica Valenzuela filed a complaint (PDF) in the U.S. District Court for the Eastern District of New York on November 13, seeking class action status to pursue claims for families that purchased the infant formula, indicating that the manufacturer, ByHeart Inc., failed to keep its infant formula free of contamination and did not take adequate steps to protect families once the problem came to light.

The ByHeart Whole Nutrition Infant Formula recall was issued by the U.S. Food and Drug Administration (FDA) on November 8, after regulators traced at least 15 infant botulism cases in 12 states back to the company’s products. At that time, only two batches of infant formula were affected.

However, the FDA later announced a ByHeart infant formula recall expansion three days later, pulling all batches of ByHeart Whole Nutrition Infant Formula Cans and Anywhere Packs from shelves nationwide.

Valenzuela’s class action complaint is at least the third claim filed to date, with two other individual ByHeart recall lawsuits brought in recent days. A resident of Brooklyn, New York, Valenzuela indicates she bought ByHeart Anywhere Packs and Whole Nutrition Formula products in September and October, which were affected by the recall.

While Valenzuela’s complaint does not involve injuries to her own children, she is seeking class action status for parents who bought products that she says are “worthless” due to their contamination, noting that no parent would buy infant formula that might be tainted with Clostridium botulinum, and claiming that ByHeart Inc. did not allow parents to make that decision.

“As detailed at length in this Complaint, Defendant orchestrated deceptive marketing and labeling practices. Defendant’s customers were uniformly impacted by and exposed to this misconduct.”

– Monica Valenzuela v. ByHeart Inc.

The lawsuit says ByHeart’s refund policy is unreasonable because it requires parents to still have the recalled formula, which many had already thrown away due to safety concerns. Valenzuela argues this policy was intended to limit the number of families eligible for refunds.

She is seeking class action status for all persons nationwide who purchased the products, as well as presenting claims of violations of the New York General Business Law, negligence and unjust enrichment.

ByHeart has issued a press release in response to the recall, apologizing to affected consumers, and arguing that no Clostridium botulinum spores or toxin have been detected in any unopened cans of the recalled formula.

ByHeart Production Facility Inspections

However, FDA investigators’ reports have been highly critical of the state of the company’s production facilities, according to a recent New York Times report, adding credence to the complaints of Valenzuela and other parents.

Inspectors found significant problems at the company’s Reading, Pennsylvania facility in the summer of 2022, when they discovered cronobacter sakazakii in the processing area of the plant. Several weeks later, the same contaminants were found in a can of finished formula, yet the report indicates the company determined that the laboratory made a mistake.

Inspectors investigating the facility also found mold in sources of clean water, thousands of dead insect corpses in the food production area, and several incidents where the roof leaked. The problems were classified by FDA inspectors as the highest level of concern, leading to a ByHeart cronobacter recall in December 2022.

That facility was not responsible for the products affected by the latest recall, the report noted, yet inspectors now are turning their attention to those facilities, which are located in Portland, Oregon and Allerton, Iowa.

Infant Formula Bacteria Contamination

A similar cronobacter infant formula recall was announced by Abbott Laboratories for certain lots of its Similac products in February 2022, leading to nationwide infant formula shortages and hundreds of infant formula recall lawsuits brought against Abbott Laboratories.

Following the Abbott formula recall, the FDA faced sharp criticism for failing to prevent the widespread distribution of contaminated formula, as reports suggested that the manufacturer and regulators were aware of cronobacter infections for months before the recall was issued for Similac, Alimentum and EleCare.

In the wake of that recall, the FDA outlined new strategies to prevent Cronobacter contamination of infant formula.

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