OFT Files Federal Lawsuit Against ByHeart for Infant Botulism Outbreak

Posted by: OFT Food Safety & Injury Lawyers

OFT Law PLLC has filed a Complaint and Demand for Jury Trial against ByHeart, Inc. (“ByHeart”) in the United States District Court for the Eastern District of Kentucky, Case No. 25-cv-00422. The lawsuit is on behalf of Hanna and Michael Everett, individually and as the parents of their four-month-old daughter, P.E., who developed infant botulism after consuming ByHeart’s infant formula, which has been linked to a multistate outbreak of Infant Botulism.

The Incident: Infant Botulism

Plaintiffs Hanna and Michael Everett, residents of Richmond, Kentucky, purchased ByHeart’s infant formula because it was marketed as a superior, “clinically proven,” and healthier alternative to traditional formulas.

After consuming the formula, their daughter P.E. became lethargic and developed constipation, followed by disturbing neurological symptoms, including an inability to take a bottle. P.E. was admitted to the hospital and diagnosed with infant botulism. This serious illness is caused by the bacterium Clostridium botulinum. The Kentucky Department of Public Health launched an investigation and discovered the formula P.E. consumed was from one of the initially-recalled batches.

Mrs. Everett appeared on ABC’s Good Morning America to discuss their ordeal:

The Allegations Against ByHeart

The Complaint alleges that ByHeart, Inc. manufactured and sold a defective and unreasonably dangerous product that was contaminated with the deadly bacteria Clostridium botulinum. The formula’s contamination and the resulting injuries form the basis of the following claims:

• Strict Products Liability: Alleging the infant formula was defective and unreasonably dangerous because it contained Clostridium botulinum and was not safe as an ordinary consumer would expect it to be.
• Negligence: Stating that ByHeart failed to use due care in designing and manufacturing the formula to avoid contamination, and placed an unsafe, contaminated product into the stream of commerce.
• Breach of Express Warranty: Claiming the formula did not conform to the company’s aggressive marketing promises of being “safer, cleaner, and more innovative” because it contained Clostridium botulinum
• Breach of Implied Warranty of Merchantability: Asserting the formula was not merchantable and fit for its ordinary purpose (consumption by infants) because it contained Clostridium botulinum.

The lawsuit also seeks punitive damages due to the Defendant’s allegedly extreme and dangerous conduct, including having actual notice of manufacturing issues resulting in pathogenic contamination in 2022, but choosing to blame others and protect its brand rather than fully evaluating its production processes. The Plaintiffs state that this conduct demonstrated an outrageous conscious disregard for the physical safety of consumers.

The Everetts bring this case to hold ByHeart, Inc. responsible for producing contaminated infant formula that has likely sickened at least fifteen infants in twelve states, according to the Centers for Disease Control.

Need to consult with an experienced food safety lawyer?

OFT Law PLLC’s food safety attorneys are dedicated to representing clients affected by foodborne illnesses and serious product safety issues nationwide. We handle cases involving pathogens like Listeria, Salmonella, E. coli, and others.

If your child has recently become ill with Infant Botulism, please contact us using the form on our Outbreak Post or:

• Call Us: 888-828-7087
• Email Us: advice@oftlaw.com
• Free Consultation: We offer 100% free consultations and there are no fees unless you recover compensation.