The first civil action filed against the SoyNut Butter Co. in relation to an ongoing E. coli outbreak seeks compensation for a 25-day hospital stay and what will likely be life-long health consequences for an 8-year-old boy.

I.M. Healthy logoThe boy is one of 12 victims in five states confirmed with the outbreak strain of E. coli O157:H7, which was not among the isolates on file in the PulseNet data base before this outbreak, according to the Centers for Disease Control and Prevention. Of the nine victims interviewed so far, all nine reported eating I.M. Healthy brand soy nut butter before becoming sick.

SoyNut Butter recalled some 15-ounce jars of its I.M. Healthy brand soy nut butter on Friday and expanded the recall Saturday to include additional sizes and date codes. However, the CDC, several state health departments and the Food and Drug Administration are warning consumers not to eat any I.M. Healthy brand products containing any SoyNut Butter.

Officials with the SoyNut Butter Co. have not responded to requests for comment.

Saying “the legal and health risk is gone” and promoting its products as “an institutional answer to the peanut allergy issue,” the SoyNut Butter website specifically targets marketing efforts toward foodservice operations that serve two populations most at risk of developing serious complications from E. coli infection — child care centers, schools and nursing homes serving young children and elderly people.

The SoyNut Butter Co. points out its peanut-free soy products meet federal requirements for the school lunch program: “For any school/institution formulating a federally credited/reimbursable menu, I.M. Healthy Original Creamy SoyNut Butter is treated exactly as peanut butter with no requirement of a CN (Child Nutrition) label. 1.12oz serving meets the 1MA(Meat Alternative) requirement and satisfies the ‘Buy American’ federal stipulation.”

What the company’s website does not include are statistics on soy allergies in the United States. The Asthma and Allergy Foundation of America reports that soy allergy is a common allergy among children.

“Approximately 0.4 percent of American children have a soy allergy. Children with a soy allergy must avoid soy in all forms,” according to the foundation’s website.

About 0.8 percent of children younger than 18 are allergic to peanuts, according to the National Institute of Allergy and Infectious Diseases, which is part of the U.S. Department of Health and Human Services.

I.M. Healthy SoyNut Butter labelsThe litigation
Filed Monday in federal court in Illinois by California residents Mosby and Erin Simmons in regard to their son, the first case against SoyNut Butter contends the Glenview, IL, company is guilty of negligence and breach of warranty and subject to strict product liability laws.

The Simmons boy, who regularly ate I.M. Healthy brand SoyNut Butter products in his home, became ill on Jan. 25. His symptoms worsened and he was admitted to a hospital on Jan. 30 and transferred to Lucille Packard Stanford Children’s Hospital in Palo Alto on Feb. 2, where his E. coli infection was diagnosed, according to the civil lawsuit.

“(He) was treated with dialysis and blood transfusions for life-threatening hemolytic uremic syndrome (HUS),” according to the complaint, which also states that at least 5 percent of children who develop HUS have long-term kidney damage. Five percent also suffer severe brain damage.

After 25 nights of hospitalization, the boy was released on Feb. 23 to go home to continue his recovery, according to the case filed by Gary Newland and Erin Walgrave of Newland & Newland LLP in Arlington Heights, IL, and Bill Marler of Marler Clark LLP in Seattle.

The recall and outbreak
Of the 12 people confirmed by the CDC as outbreak victims as of March 2, 11 are younger than 18 years of age. Victims are in five states on both coasts: Arizona, California, Maryland, New Jersey and Oregon.

Test results are pending on at lest one more child who is in intensive care and on dialysis in a Seattle hospital. As with all nine of the confirmed victims on whom information is available, the Seattle patient ate I.M. Healthy SoyNut Butter before becoming sick.

Five of the confirmed victims ate SoyNut Butter products in their homes before becoming ill. Four children in Arizona who are confirmed as part of the outbreak ate the products at child care centers. Illness onset dates range from Jan. 6 through Feb. 15.

On March 3, SoyNut Butter Co. recalled a limited number of 15-ounce jars of its I.M. Healthy Original Creamy SoyNut Butter.

“The recall was initiated after ill people or their family members answered questions about the foods they ate and other exposures in the week before they became ill, according to the recall notice.

“Consumers who have purchased I.M. Healthy SoyNut Butter are urged not to consume the product and return it to the place of purchase for a full refund. Consumers with questions may contact the company at 800-288-1012.”

recalled I.M. Healthy SoyNut ButterOn March 4 the company expanded the recall to include other sizes and date codes of its I.M. Healthy Original Creamy SoyNut Butter. The CDC and state health departments are warning against eating all I.M. Healthy brand products with soy nut butter, specifically including granola.

The expanded recall includes:

  • 15-ounce plastic jars of I.M. Healthy Original Creamy SoyNut Butter with the Best By dates July 05, 2018, August 30, 2018, and August 31, 2018;
  • Individual portion cups of I.M. Healthy Original Creamy SoyNut Butter with the Best By date as August 08, 2018; and
  • 4-pound plastic tubs of I.M. Healthy Original Creamy SoyNut Butter with Best By dates of November 16, 2018, and July 25, 2018.

Advice for consumers nationwide
Anyone who has eaten I.M. Healthy brand SoyNut Butter products or anything containing the products and developed symptoms of E. coli infection should immediately seek medical attention and tell their doctors about the possible exposure to the bacteria.

“The symptoms of STEC infections vary but often include severe stomach cramps, diarrhea — often bloody — and vomiting,” according to the CDC.

“Most people get better within 5–7 days, but some infections are severe or even life-threatening. Hemolytic uremic syndrome (HUS), a type of kidney failure, is a potentially life-threatening complication of E. coli O157 infection. Very young children and the elderly are more likely to develop severe illness and HUS than others, but even healthy older children and young adults can become seriously ill.”

The CDC advises people to watch for diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.

Public health officials are concerned that consumers and kitchens in schools, childcare centers and nursing homes may have the I.M. Healthy “SoyNut Butter” and other products containing it on hand and are urging people to check for the products and discard any unused portions.

Editor’s note: Bill Marler is publisher of Food Safety News.

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