The 2022 Food Safety Summit opened on Tuesday, May 10, with a "Mock Civil Trial 2.0" workshop led by Shawn Stevens, national food industry attorney and Founder of Food Industry Counsel LLC, and Joel Chappelle, food industry attorney at Food Industry Counsel LLC. The mock civil jury trial centered on a fictional, large-scale foodborne illness outbreak, with testimony from a mother who lost her child to an infection caused by Listeria monocytogenes, as well as testimony and cross-examination from the food company CEO, Vice President of Food Safety, and Vice President of Quality Assurance. Gary Ades, Ph.D., President of G&L Consulting Group and Chair of the Food Safety Summit Educational Advisory Board, served as judge for the trial.
"I hope this experience changes your life," said Mr. Stevens, "To understand what it feels like to be a food company accused of causing a foodborne illness, or what it feels like to lose your child to a Listeria infection."
In the case, a fictional 11-year-old girl, "Stella Davies," died on January 3, 2021 of a Listeria infection that was allegedly caused by egg salad produced by Harding Foods Inc. Stella was undergoing chemotherapy for cancer at the time of her infection and had a weakened immune system. Other cases of listeriosis were reported in six patients from January 4, 2020 through Stella's case on December 24, 2020. Three weeks after Stella's death on January 21, 2021, the U.S. Food and Drug Administration (FDA) conducted a routine inspection of Harding Foods' egg salad facility and found L. monocytogenes that matched the strain found in the six patients, which prompted a recall of the Harding egg salad on February 4, 2021.
The trial opened with Mr. Chappelle presenting evidence from the plaintiff. He explained the pathology of listeriosis infections in healthy people and in people with compromised immune function, such as Stella Davies. L. monocytogenes can have an incubation period of up to 70 days, making it difficult to pinpoint the food source that originally caused a listeriosis infection or foodborne illness outbreak. After Harding Foods recalled its egg salad, no additional listeriosis infections were reported. Mr. Chappelle also explained to the jury how whole genome sequencing (WGS) was used to compare the isolates from the listeriosis patients and the isolates from the Harding Foods facility to identify a match.
Mr. Stevens then took the stage to defend Harding Foods. He asserted that the facts show less than a ten percent chance that the company's egg salad caused Stella Davies' illness. He also noted that neither FDA, the U.S. Centers for Disease Control and Prevention (CDC), nor any state or local regulators concluded that the 2020 listeriosis outbreak was caused by Harding Foods. Mr. Stevens noted that the defense's expert epidemiologist had testified that, "In a case where four of six patients cannot recall eating egg salad, then egg salad cannot be the source [of the foodborne illness]."
Witness Testimony and Cross-Examination
The plaintiff's counsel then presented the witnesses, which included Stella Davies' mother, Claire Davies. In a video testimony, Ms. Davies said that she purchased the egg salad with her shopper card on December 12 at her grocery store deli. Ms. Davies made her daughter two egg salad sandwiches that day for lunch. The mother recalled how Stella fell ill on Christmas Eve and grew progressively worse until she and her husband brought their daughter to the emergency room on December 28. At the hospital, Stella's speech became slurred and her heartbeat became erratic, and she was airlifted to Chicago Children's Hospital. Stella's condition stabilized for a few days after she was hospitalized in Chicago, where she was also discovered to be positive for L. monocytogenes. On the night of January 2, Stella's heart membrane became inflamed and she became septic, and died early the next morning.
During his cross-examination, Mr. Stevens asked Ms. Davies about the positive L. monocytogenes samples discovered at the Harding Foods facility. He verified that no one from FDA, CDC, or any state or local health department had informed her that the L. monocytogenes that sickened her daughter had come from the Harding Foods facility. He also verified that Ms. Davies understood that L. monocytogenes has an incubation period of up to 70 days, and that she had also purchased ready-to-eat salads with her shopper cards on the same day as she purchased the egg salad. Ready-to-eat salads have also been proven to harbor L. monocytogenes.
Mark Yoder, CEO of Harding Foods, next testified on video that spending on quality assurance (QA) had been cut by around 15 percent at Harding Foods in 2020, the year of the listeriosis outbreak. L. monocytogenes positives also increased by around 50 percent year over year between 2019 and 2020, but QA spending was not increased. Instead, Mr. Yoder was focused on readying the company for sale, according to Mr. Chappelle. In his cross-examination, Mr. Stevens stressed that Harding Foods spent over $2 million on food safety in 2020 alone, and conducted 1,024 tests for L. monocytogenes during that year. Mr. Stevens also verified that no one from FDA, CDC, or any state or local health departments had informed Mr. Yoder that Harding's products had caused the 2020 listeriosis outbreak.
Dr. Alan Melnick, an expert epidemiologist for the plaintiff, next testified about the epidemiological methods (including WGS) used to identify listeriosis infections. With two of the six patients in the listeriosis outbreak being confirmed as having eaten Harding Foods products, and three of the other patients having shopped at stores where Harding products were sold, Dr. Melnick said he believed Harding Foods to be the most likely source of the foodborne illness outbreak, which was linked by WGS to the L. monocytogenes samples found in the Harding facility. "The game is over—that’s why FDA made them [Harding Foods] do a recall," Dr. Melnick said. The listeriosis outbreak ended after the egg salad was recalled, leading Dr. Melnick to become more convinced that the sole source of the L. monocytogenes was the Harding facility. "Based on my review of the records and my experience as an epidemiologist, I believe the source of the illness that killed Stella Davies was the egg salad that her mother purchased on December 12, 2021," Dr. Melnick said.
In his cross-examination, Mr. Stevens noted that Dr. Melnick previously stated that it can be very difficult to remember what a person has eaten in recent days, let alone weeks ago, and that only two of the six case patients reported a confirmed purchase of the Harding egg salad. Mr. Stevens verified that the complete history of the patients' food consumption could not be known. The attorney also verified that the strain of L. monocytogenes was never found in a container of Harding egg salad, but rather a non-food-contact zone in the Harding facility. Mr. Stevens suggested that the pathogen could have come from a supplier and could have been spread to other manufacturers' food facilities, which Dr. Melnick agreed was possible.
Tom Reynolds, Executive Vice President of Harding Foods, was next examined by Mr. Stevens in a video deposition. He noted that his job is to improve efficiency and reduce waste by streamlining costs. He also said that the company always places food safety first and would never do anything to compromise the safety of its products. In his cross-examination, Mr. Chappelle pointed out that Mr. Reynolds received hefty bonuses from achieving cost reductions as part of his job, and that Mr. Reynolds stood to gain a bonus by cutting spending on QA.
Vice President of QA, Jackie Hofstetter, was next examined by Mr. Stevens. She verified that around 20 swab samples were being tested each week for L. monocytogenes—a large volume—and that the company was spending millions per year in 2019 and 2020 on food safety and quality assurance. Ms. Hofstetter also stated that neither FDA nor CDC told her that Harding Foods was the source of the 2020 listeriosis outbreak. She also verified that the positive L. monocytogenes samples collected by FDA in 2021 from the Harding Foods plant were all Zone 2 non-food-contact surfaces. In his cross-examination, Mr. Chappelle noted that Zone 2 surfaces are immediately adjacent to Zone 1 food contact surfaces. Ms. Hofstetter verified that the two positive samples that matched the L. monocytogenes that killed Stella Davies were swabbed from a Zone 2 surface that was adjacent to the Zone 1 food contact surface used to produce egg salad in the Harding facility. In 2019, the Harding facility had 23 Listeria positives; in 2020, 36 positives were identified, but QA spending was cut by 15 percent in 2020. Ms. Hofstetter said she shared her concerns about Listeria with the CEO, but that her concerns were not addressed.
The last witness in the trial was Dr. Curt Hagen, an expert epidemiologist for the defense. Dr. Hagen stated that there was not enough evidence to reach a conclusion as to the source of the listeriosis outbreak, as only two of the six patients reported having consumed egg salad. "The source is inconclusive at best," he said. Dr. Hagen also disagreed with the conclusion offered by the WGS analysis, saying that WGS is only one epidemiological tool to analyze a foodborne illness outbreak. He also pointed to Harding Foods' continued spending on food safety and its frequent swabbing as evidence of the company's commitment to food safety. He estimated the likelihood of the Harding egg salad having caused Stella Davies' illness as zero to ten percent. In his cross-examination, Mr. Chappelle broke down the science behind WGS and dispelled the likelihood of WGS as being inadequate or inaccurate in identifying a link between the isolates gathered from the listeriosis patients and the isolates discovered in the Harding Foods facility. Dr. Hagen confirmed that the specific L. monocytogenes strain had not been found in any other facility, or in any other listeriosis case since the egg salad recall.
Mr. Chappelle stood up and asked the jury not to be misled about the number of cases associated with the Harding egg salad. He noted that one of the six individuals provided no response at all, according to the CDC line list, while two of the six were confirmed to have purchased the egg salad. Another two of the six did not specifically recall if they had consumed egg salad, but did shop at stores selling Harding products. Only one out of six denied having consumed egg salad. Mr. Chappelle also pointed to Ms. Hofstetter's unaddressed concerns about Listeria in the Harding facility as evidence of fault on the part of the company. He concluded his arguments by asking the jury to find Harding Foods responsible for the listeriosis outbreak and to award the estate of Stella Davies $10 million for the death of their daughter.
Mr. Stevens noted, "It is the plaintiff's burden to show, by a preponderance of evidence, that it is more likely than not that egg salad caused Stella Davies' illness." He also pointed out that the expert for the CDC, Dr. Hagen, said that there was a zero to ten percent probability that egg salad from Harding Foods caused Stella's illness. Mr. Stevens also reminded the jury that neither the FDA, CDC, nor any state or local health department concluded that the egg salad caused the listeriosis outbreak, and that L. monocytogenes was never found in any samples of egg salad from Harding. "We're inserting speculation and words into a case exposure history that do not exist," Mr. Stevens argued. "The plaintiff has failed to satisfy its burden of proof in this case."
The jury was then given ten minutes to deliberate among the individual tables spread throughout the room and decide a single verdict for each table. After Gary Ades, Ph.D., the acting judge, tallied the verdicts, 14 jury groups decided the company was not guilty, ten jury groups said the company was guilty, and eight jury groups were divided. With considerable disagreement among the collective jury groups, a decisive outcome for the mock trial could not be reached.
To round out the workshop, Mr. Stevens led a brief, post-trial discussion about the evidence in the trial, the state of FDA pathogen testing in the industry, and how food company and food safety executives can better handle communication in the face of such incidents.The 2022 Food Safety Summit is taking place in person at the Donald E. Stephens Convention Center in Rosemont, Illinois from May 9–12. Stay tuned for more conference coverage!