ByHeart need to step up and pay families medical expenses and lost wages in Botulism Outbreak

Last night I spoke to a family whose child suffered infant botulism after consuming ByHeart formula. The child was hospitalized for weeks, including time in ICU and on a feeding tube, and received live-saving BabyBIG botulism anti-toxin. Medical expenses and lost wages are in well into six figures. They also learned that some of the medical expenses would not be covered because of both a deductible and the insurer denying coverage as apparently “experimental.” This is the reality of medical care in the United States today.

Bill Marler, food safety advocate and foodborne illness attorney since 1993, whose Seattle area law firm, Marler Clark’s work was recently profiled in the Netflix documentary “Poisoned,” The Dirty Truth about your Food, is calling on ByHeart to pay the medical bills and lost wages of the families of victims of the Botulism outbreak in the United States that has so far sickened 39.

The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.

As of December 3, 2025, a total of 39 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from Arizona 3, California 5, Idaho 1, Illinois 2, Kentucky 1, Massachusetts 2, Maine 1, Michigan 1, Minnesota 2, North Carolina 2, New Jersey 1, Oregon 4, Pennsylvania 1, Rhode Island 1, Texas 8, Virginia 1, Washington 2, Wisconsin 1. 

Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from August 9 to November 19, 2025. All 39 infants were hospitalized. No deaths have been reported to date. For 38 infants with age and 39 with sex information available, they range in age from 16 to 264 days and 15 (38%) are female.

“Unfortunately, those infants sickened will likely rise in the coming weeks,”  Marler said. “In fact, the CDC is presently investigating ByHeart’s link to earlier infant botulism cases in 2025 and 2024,” added Marler. “The cost of treating victims of Botulism infections can run in the tens of thousands of dollars, or in a severe case, even in the hundreds of thousands of dollars. These families need ByHeart to do more than promise to cooperate in the investigation into this outbreak. They need to know that ByHeart intends to fulfill their corporate responsibility by looking out for their customers.”

Marler noted that over the last two decades in other outbreak-situations, companies such as Chi-Chi’s, Dole, Jack in the Box, Conagra, Odwalla and Sheetz advanced medical costs for outbreak victims whose illnesses were traced to their food products.

William “Bill” Marler has been a food safety lawyer and advocate since the 1993 Jack-in-the-Box E. coli Outbreak which was chronicled in the book, “Poisoned” and in the recent Emmy Award winning Netflix documentary by the same name. Bill work has been profiled in the New Yorker, “A Bug in the System;” the Seattle Times, “30 years after the deadly E. coli outbreak, A Seattle attorney still fights for food safety;” the Washington Post, “He helped make burgers safer, Now he is fighting food poisoning again;” and several others. 

Dozens of times a year Bill speaks to industry and government throughout the United States, Canada, Europe, Africa, China and Australia on why it is important to prevent foodborne illnesses.  He is also a frequent commentator on food litigation and food safety on Marler Blog. Bill is also the publisher of Food Safety News.

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.