The ByHeart Botulism Outbreak is a Moral Disaster

Jonel Aleccia Reports: A Portland, Oregon, boy is struggling to recover from infant botulism after drinking contaminated ByHeart baby formula donated through a program that aims to help poor and homeless families.

Ashaan Carter, now 10 months old, was hospitalized twice and remains on a feeding tube after contracting the dangerous infection that has sickened more than 50 babies across the U.S.

His mother, Angel Carter, said she received a can of ByHeart formula from a case worker with the Oregon Department of Human Services in early November, days before a nationwide recall of the product.

Carter, who receives state food and housing assistance, said she had been exclusively breastfeeding her son, but her milk supply was waning. The case worker told the 27-year-old that the ByHeart formula “was closest to breast milk” and could help, she said.

“I accepted it thinking, ‘OK, I’m hoping my baby can get on a bottle,’” Carter said. “It’s been all downhill since then.”

State officials wouldn’t comment on Carter’s case, but they acknowledged that the agency received ByHeart formula from PDX Diaper Bank. That was one of nearly two dozen nonprofit groups nationwide who are part of ByHeart’s “OpenHearted Initiative” that donated formula to “families in need,” according to the company’s website.

Since June 2022, nearly 24,000 cans of formula have been distributed to groups that aid homeless and other vulnerable families, the company said. All the company’s products have been recalled since production began in March 2022 because of potential contamination. 

Soon after consuming the ByHeart formula, Ashaan developed severe constipation and muscle weakness, becoming so limp that he couldn’t move his head, Carter said.

After a trip to an emergency room, he was sent to Randall Children’s Hospital in Portland. Doctors, there diagnosed him with presumed infant botulism tied to the ByHeart formula, according to Dr. Sylvia Peterson-Perry, a family medicine doctor who delivered Ashaan and cares for him and his mother.

He was treated with BabyBIG, an IV medication that provides antibodies to the infection to stop the progress of the disease.

Ashaan was hospitalized for nearly two weeks in November and discharged without a feeding tube. His health rapidly declined, including dramatic weight loss, and he was hospitalized again in December. He got so sick that his mother was afraid he would die.

“He was just withering away,” Carter said. 

The Oregon caseworker texted Carter after the recall, she said, warning her to stop using the formula.

But it was too late for Ashaan, who had to have the feeding tube down his throat replaced because his muscles remain weak, his doctor said. It’s not clear how long it will remain. He is having to relearn how to crawl and to talk.

“It’s devastating, especially for our vulnerable families who are trusting this product to nourish their child and trusting our social services to provide safe food for their babies,” Peterson-Perry said. 

ByHeart had partnered with Baby2Baby, a Los Angeles-based nonprofit that includes high-profile celebrities among its supporters. The news outlet Healthbeat was first to report that recalled formula went to groups serving at-risk families.

PDX Diaper Bank received about 400 cans of donated ByHeart formula through Baby2Baby and distributed more than 300 of them before they were recalled, Rachel Alston, the group’s executive director, said in an email. 

“All of our partners confirmed that they took immediate action to inform families, and we offered support where we could along the way,” she said in an email.

Baby2Baby officials did not respond to email requests for comment. ByHeart officials said the company worked with Baby2Baby and other groups that received formula to ensure that the products were pulled and families were notified.

No new cases of infant botulism tied to the outbreak have been reported since Dec. 17, according to the U.S. Centers for Disease Control and Prevention. The U.S. Food and Drug Administration has conducted inspections at ByHeart plants but has released no information about the source of the outbreak. Production remains shut down. 

Seattle food safety lawyer Bill Marler said Carter is one of more than 30 families he represents whose babies were sickened by ByHeart products. At least 18 lawsuits have been filed against ByHeart and stores that sold the contaminated formula. This week, Marler asked a federal panel to consolidate the cases in a U.S. district court in New York.

In summary, consolidation is appropriate because all related actions arise from the same nationwide outbreak of infant botulism caused by contaminated infant formula manufactured and distributed by Defendant ByHeart, Inc. (“ByHeart”)^[2]. The outbreak sickened and hospitalized at least 51 infants across 19 states, giving rise to multiple civil actions asserting overlapping factual allegations, common questions of law, and substantially identical claims for relief. In addition to the personal injury actions, several Economic Loss Class Actions have also been filed. 

Absent centralization, the parties and courts will be forced to litigate the same issues repeatedly in courts across the country—conducting duplicative discovery, presenting repetitive expert testimony, and risking inconsistent pretrial rulings on core issues such as causation, liability, and damages. Centralization will eliminate these inefficiencies and promote the just and efficient conduct of this litigation. 

Centralization is particularly critical given the limited insurance coverage available to satisfy claims. ByHeart reportedly maintains only $10 million in liability insurance, subject to “burning limits”^[3] that are being rapidly depleted by defense costs. This is especially true in multi-State and District cases where defense counsel need to retain local counsel, only adding to additional attorney’s fees and costs. Allowing parallel litigation to proceed independently across numerous jurisdictions threatens to exhaust all available coverage, to the detriment of injured infants and their families. 

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^[2] See CDC report – https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/investigation.html and FDA report – https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025

^[3]  “Burning limits” refers to a type of liability insurance policy under which the costs of legal defense (e.g., attorney fees, court costs, and expert witness expenses) are deducted from the total policy limits. Such policies are also commonly referred to as eroding limits, wasting policies, or defense-within-limits (“DWL”) coverage. Given the scope of this litigation and ByHeart’s retention of multiple national law firms (including Munger, Tolles & Olson and DLA Piper), the available insurance coverage is expected to be rapidly depleted in the coming months.

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

Source: https://www.marlerblog.com/case-news/the-byheart-botulism-outbreak-is-a-moral-disaster/