8. According to the Center for Disease Control (CDC), 109 people from Ohio (24) (although Wood County reports a total of 23), Michigan (67), Pennsylvania (2), Indiana (11), Kentucky (2), Pennsylvania (4), and New York (1) have been infected with the same strain of E. coli O157:H7, with illness onset dates ranging from July 26 through August 17, 2022. At least 52 individuals have been hospitalized, and at least 13 have developed hemolytic uremic syndrome, a potentially lethal complication of E. coli O157:H7. 

9. In its October 4, 2022 outbreak summary, CDC stated as follows with regard to the above-described outbreak: State and local public health officials interviewed people about the foods they ate in the week before they got sick. Among 82 people with detailed food history, 68 (83%) reported eating at a Wendy’s restaurant in the week before their illness started. The Wendy’s restaurants where sick people ate were in Indiana, Kentucky, Michigan, New Jersey, Ohio, and Pennsylvania. People reported eating a variety of menu items, including burgers and sandwiches. Of 68 people with detailed information about what they ate at Wendy’s, 46 (68%) reported eating romaine lettuce served on burgers and sandwiches.

10. Based on this and other epidemiologic evidence, including the lack of any plausible alternate source for the outbreak, CDC concluded that the outbreak that sickened 109 people in 7 states was caused by contaminated food from Wendy’s restaurants. 

11. The CDC did not make a specific finding as to the ingredient, or food item, in the affected Wendy’s restaurants in the 7 states that was the original source of the outbreak. However, epidemiologic data from the outbreak investigation, including the relatively short exposure period and sharp peak in onset dates, as well as the commonality of leafy greens exposures (specifically romaine lettuce) amongst outbreak cases signaled that contaminated romaine lettuce was, in fact, the original source of contamination.

12. In fact, in recognition of these and other factors, on August 19, 2022, Wendy’s took the precaution of removing romaine lettuce from its products in the Midwest region.

13. On information and belief, Defendant Pacific International was the sole supplier of romaine lettuce products to the Defendant Wendy’s and BG Main’s restaurant located at 1094 S. Main Street, Bowling Green, OH 42402. Further, on information and belief, Defendant Pacific International was the sole supplier of romaine lettuce products to other Wendy’s restaurant locations implicated in the subject outbreak.

14. According to the Wood County Department of Health, twenty-three people in the Wood County, Bowling Green, Ohio area were recently infected by E. coli O157:H7, prompting the health department to begin an investigation. From 2016 to 2020, the county only saw twenty-seven cases in total. Those individuals who have fallen ill range from ages 13 to 68 years old. 

15. Individuals who contract the illness can experience different levels of sickness and gastrointestinal symptoms. Out of the twenty-three people who have contracted E. coli O157:H7 in Wood County, seven were or are currently in the hospital. The Wood County Health Department has sent lab samples to the Ohio Department of Health to learn whether the illnesses are connected. Results, and more information, are expected early next week.

Historical outbreaks associated with contaminated leafy greens

16. E. coli outbreaks associated with lettuce, specifically the “pre-washed” and “ready-to-eat” varieties, are by no means a new phenomenon. In fact, the frequency with which this country’s fresh produce consuming public has been hit by outbreaks of pathogenic bacteria is astonishing. Here are just a sample of E. coli outbreaks based on information gathered by the Center for Science in the Public Interest, Kansas State University, Barf Blog and the Centers for Disease Control and Prevention:

July 1995Lettuce (leafy green; red; romaine)E. coli O157:H7741:MT
Sept. 1995Lettuce (romaine)E. coli O157:H7201:ID
Sept. 1995Lettuce (iceberg)E. coli O157:H7301:ME
Oct. 1995Lettuce (iceberg; unconfirmed)E. coli O157:H7111:OH
May-June 1996Lettuce (mesclun; red leaf)E. coli O157:H7613:CT, IL, NY
May 1998SaladE. coli O157:H721:CA
Feb.-Mar. 1999Lettuce (iceberg)E. coli O157:H7721:NE
Oct. 1999SaladE. coli O157:H7923:OR, PA, OH
Oct. 2000LettuceE. coli O157:H761:IN
Nov. 2001LettuceE. coli O157:H7201:TX
July-Aug. 2002Lettuce (romaine)E. coli O157:H7292:WA, ID
Nov. 2002LettuceE. coli O157:H7131:Il
Dec. 2002LettuceE. coli O157:H731:MN
Oct. 2003-May 2004Lettuce (mixed salad)E. coli O157:H7571:CA
Apr. 2004SpinachE. coli O157:H7161:CA
Nov. 2004LettuceE. coli O157:H761:NJ
Sept. 2005Lettuce (romaine)E. coli O157:H7323:MN, WI, OR
Sept. 2006Spinach (baby)E. coli O157:H7 and other serotypes205Multistate and Canada
Nov./Dec. 2006LettuceE. coli O157:H7714:NY, NJ, PA, DE
Nov./Dec. 2006LettuceE. coli O157:H781 3:IA, MN, WI
July 2007LettuceE. coli O157:H7261:AL
May 2008RomaineE. coli O157:H791:WA
Oct. 2008LettuceE. coli O157:H759Multistate and Canada
Nov. 2008LettuceE. coli O157:H7130Canada
Sept. 2009Lettuce: Romaine or IcebergE. coli O157:H729Multistate
Sept. 2009LettuceE. coli O157:H710Multistate
April 2010RomaineE. coli O145335:MI, NY, OH, PA, TN
Oct. 2011RomaineE. coli O157:H760Multistate
April 2012RomaineE. coli O157:H7281:CACanada
June 2012RomaineE. coli O157:H752Multistate
Sept. 2012RomaineE. coli O157:H791:PA
Oct. 2012Spinach and Spring Mix BlendE. coli O157:H733Multistate
Apr. 2013Leafy GreensE. coli O157:H714Multistate
Aug. 2013Leafy GreensE. coli O157:H7151:PA
Oct. 2013Ready-To-Eat SaladsE. coli O157:H733Multistate
Apr. 2014RomaineE. coli O12641:MN
Apr. 2015Leafy GreensE. coli O14573:MD, SC, VA
June 2016Mesclun MixE. coli O157:H7113:IL, MI, WI
Nov. 2017Leafy GreensE. coli O157:H767Multistate and Canada
Mar. 2018RomaineE. coli O157:H7219Multistate and Canada
Oct. 2018RomaineE. coli O157:H762Multistate and Canada
Nov. 2019 RomaineE. coli O157:H7167Multistate
Dec. 2020Leafy GreensE. coli O157:H740Multistate
Jan. 2021Baby SpinachE. coli O157:H715Multistate
Mar. 2022Packaged SaladE. coli O157:H710Multistate

E. coli O157:H7 Infection and Hemolytic Uremic Syndrome

17. Escherichia coli are the name of a common family of bacteria, most members of which do not cause human disease. E. coli O157:H7 is a specific member of this family that can cause bloody diarrhea (hemorrhagic colitis) in humans. In the years since E. coli O157:H7 was first identified as a cause of diarrhea, this bacterium has established a reputation as a significant public health hazard.

18. E. coli O157:H7 lives in the intestines of cattle and other ruminants. E. coli O157:H7 is also notable among pathogenic bacteria for its extremely low infectious dose—that is, the number of bacteria necessary to induce infection in a person. While for most pathogenic bacteria, it takes literally millions of bacterial colonies to cause illness, it is now known that fewer than 50 E. coli O157:H7 bacteria can cause illness in a child. The practical import is that even a microscopic amount of exposure can trigger a devastating infection.   

19. The most severe cases of E. coli O157:H7 infection occur in young children and in the elderly, presumably because the immune systems in those age populations are the most vulnerable. After a susceptible individual ingests E. coli O157:H7, the bacteria attach to the inside surface of the large intestine and initiate an inflammatory reaction in the intestine. Which ultimately results in the painful, bloody diarrhea and abdominal cramps characteristic of the intestinal illness. 

20. The mean incubation period (time from ingestion to the onset of symptoms) of E. coli O157:H7 is estimated to be two to four days (range from 1-21 days). Typically, a patient with an acute E. coli O157:H7 infection presents with abdominal cramps, bloody diarrhea, and vomiting. The duration of diarrhea in children with E. coliO157:H7 infections is significantly longer than that of adults.

21. E. coli O157:H7 can produce a wide spectrum of diseases from mild, non-bloody diarrhea to severe, bloody diarrhea accompanied by excruciating abdominal pain to life-threatening complications. In most infected individuals, the intestinal illness lasts about a week and resolves without any long-term effects. Antibiotics do not appear to aid in combating these infections, and recent medical studies suggest that antibiotics are contraindicated for their risk of provoking more serious complications. Apart from good supportive care, which should include close attention to hydration and nutrition, there is no specific therapy.  

21. About 10% of individuals with E. coli O157:H7 infections (mostly young children) go on to develop hemolytic uremic syndrome (HUS), a severe, potentially life-threatening complication. The essence of the syndrome is described by its three central features: the destruction of red blood cells, destruction of platelets (those blood cells responsible for clotting), and acute renal failure due to the formation of micro-thrombi that occlude microscopic blood vessels that make up the filtering units within the kidneys.  

22. There is no known therapy to halt the progression of HUS. The active stage of the disease usually lasts one to two weeks, during which a variety of complications are possible. HUS is a frightening illness that, even in the best American medical facilities, has a mortality rate of about 5%. The majority of HUS patients require transfusion of blood products and develop complications common to the critically ill.