Nine children have contracted hemolytic uremic syndrome (a type of kidney failure, often referred to as HUS) in an E. coli O157:H7 outbreak linked to I.M. Healthy SoyNut Butter.
“We need to find out why over 30 percent of the children sickened in this outbreak developed HUS,” said Brendan Flaherty, an attorney at our law firm who filed a lawsuit on behalf of one of the 9 children. “In most E. coli outbreaks, about 5 to 15 percent develop this complication.”
Brendan and attorney Ryan Osterholm are looking at how conditions at Dixie Dew Products Inc. (Dixie Dew) may have contributed to the high incidence of hemolytic uremic syndrome. Dixie Dew manufactured the product and sold it for I.M. Healthy branding to The SoyNut Butter Company.
Attorneys Brendan Flaherty and Ryan Osterholm, two of our top lawyers, filed a lawsuit on behalf of little M.R. who has permanent kidney damage after eating an I.M. Healthy SoyNut Butter product at a daycare facility. Brendan and Ryan have won millions for children sickened by contaminated food, including $7.55 million for a little girl with E. coli-HUS from another outbreak who lost 50% of her kidney function and is predicted to require dialysis and kidney transplantation in her early twenties.
To contact Brendan and Ryan for a free consultation regarding a lawsuit for compensation, submit the form below or call our law firm at 1-888-377-8900. Our law firm has a national practice.
Submitting the form on this page does not create an attorney-client relationship. To hire Brendan Flaherty and Ryan Osterholm and have an attorney-client relationship, you will need to sign a retainer form.
FDA Inspection of Dixie Dew Finds Multiple Sanitation Violations
As stated above, Dixie Dew made the SoyNut butter that was used for the I.M. Health products that most likely caused this outbreak. Prompted by the outbreak, the FDA inspected the Dixie Dew facility in Kentucky from March 3 to 15, 2017. FDA inspectors outlined unsanitary conditions at the Dixie Dew facility on a Form FDA 483, some of which are listed below (exact language from the form in quotation marks and our notes in brackets):
- “Your firm does not conduct a kill step for SoyNut Butter product remaining in your firm’s mixing kettle leftover from a production run.” [The kill step is heat at a temperature that would kill E. coli and other bacteria.]
- The accuracy of the thermometer used during production has not be verified, according to the Plant Manager interviewed by the FDA. [This means the company has not tested the accuracy of the thermometer, which would be used to make sure the product reached a high enough temperature to kill bacteria.]
- “During production of I.M. Healthy SoyNut Butter Creamy cups, Lot 065171 on 3/6/2017, a clear liquid substance was observed dripping intermittently from a hole in a ceiling tile . . . and splashing on food manufacturing equipment below.” [This would be one possible source of contamination.]
- “The floors, walls and ceilings in the Soy Butter Processing and Packaging Rooms are heavily coated with apparent old SoyNut Butter build-up from previous production runs. Additionally, standing water and brown and black apparent filth was observed on the Processing Room floor.”
- Wooden pallets on the floor of the Soy Butter Processing Room were sitting in water and were covered in apparent black mold and filth from 3/3/2017 – 3/9/2017.
- “Various hand tools used to maintain production equipment in the Soy Butter Processing Room were stored on the floor and on employee walking platforms.
- Some of the sinks at the facility did not have hot water.
- “You and your Plant Manager stated you have not disassembled any SoyNut Butter processing equipment and all associated piping for cleaning and sanitization since December of 2015.”
- “Per your Plant Manager, your firm does not routinely wash and sanitize smaller pipes, pipe fittings, gaskets, seals and the rubber (plug) when broken down following a production run of SoyNut Butter. These are all contact surfaces.”
E. coli and Hemolytic Uremic Syndrome Outbreak Linked to I.M. Healthy SoyNut Butter
There are now 29 confirmed E. coli cases in 12 states:
Arizona (4), California (5), Florida (1), Illinois (1), Massachusetts (1), Maryland (1), Missouri (1), New Jersey (1), Oregon (9), Virginia (2), Washington (2), and Wisconsin (1).
Illnesses started on dates ranging from January 4, 2017, to March 13, 2017. Ill people range in age from 1 to 57 years, with a median age of 8. Twenty-four (83%) of the 29 ill people are younger than 18 years. Among ill people, 59% are male. Twelve of the people who are part of this outbreak have been hospitalized, nine of whom are children who developed hemolytic uremic syndrome. Thankfully, none of these little ones have died.
Interviews with People Sickened and Parents
Twenty-one (75%) of the 28 people reached for interview reported either eating I.M. Healthy brand SoyNut Butter at home (15 people) in the week before they became ill, attending a facility that served I.M. Healthy brand SoyNut Butter (2 people), or attending childcare centers that served I.M. Healthy brand SoyNut Butter and I.M. Healthy brand granola coated with SoyNut Butter (4 people).
Laboratory Test Results Linking Product to Illnesses are “Smoking Gun” Evidence
Laboratory testing identified Shiga-toxin producing E. coli (often referred to as STEC) O157:H7 in opened containers of I.M. Healthy brand SoyNut Butter collected from the homes of ill people in California, Oregon, and Washington. In addition, officials in California isolated E. coli O157:H7 in unopened containers of I.M. Healthy brand SoyNut Butter collected from retail locations.
The E. coli O157:H7 isolates were further tested using pulsed-field gel electrophoresis (PFGE) , which found that the E. coli O157:H7 in all of these containers of SoyNut Butter had the same DNA fingerprints as the isolates from ill people. With this, a microbiological connection was made between the illnesses and the product. This is evidence that can be used in a lawsuit for compensation.
I.M. Healthy SoyNut Butter and Granola Recall
On March 7, 2017, The SoyNut Butter Company recalled all varieties of I.M. Healthy SoyNut Butters and all varieties of I.M. Healthy Granola products. This recall has been expanded to include Dixie Diner’s Club brand Carb Not Beanit Butter and Lifestyle Yogurt Peanut Crunch Bars. You should not eat these products.