Hell yes!

Restaurants tend not to see themselves as a “manufacturer” of the food they serve – especially, when one of the ingredients – like lettuce the received from a supplier, is contaminated with a pathogen – like E. coli.

But, the law treats the restaurant that makes an E. coli-tainted salad the same as a manufacturer of a car that has a defective part that causes the car to explode on the highway.  The definition of a “manufacturer” is broad:

Why does it matter?  As a manufacturer, the restaurant is “strictly liable” to the customer due to the defective (E. coli tainted) product (the salad).  Once the customer proves the salad was defective and caused harm, the case is essentially over.

That is just what a New Jersey court ruled last week – the restaurant that made a take out chicken Caesar salad is a manufacturer and therefore strictly liable to the customer for any injuries caused by the consumption of the product – the chicken Caesar salad that contained E. coli-tainted romaine lettuce.

Here is the full order:

Stranagahn Order for Partial SJ is granted

We just filed this motion to amend to add in JIMMY JOHN’s, LLC, an Illinois Limited Liability Company, INSPIRE BRANDS, INC., a Delaware corporation:

This matter arises out of an outbreak of Shiga toxin-producing E. coli (STEC) O103 that occurred in the early months of 2020. After thorough investigation and laboratory testing, the Utah Department of Health and Centers for Disease Control and Prevention (CDC) linked this outbreak to clover sprouts used by D&L to manufacture its sandwiches.

After purchasing and consuming a Billy Club Sandwich from D&L’s restaurant on February 21, 2020, Plaintiff Travis Knorr began to develop symptoms consistent with a STEC O103 infection and within the typical STEC incubation period on February 26, 2020. He was later diagnosed with STEC O103:H2 via stool sample testing, and the Utah Department of Health further conclusively determined, using whole genome sequencing (WGS), that he was a confirmed case in the 2020 STEC O103 outbreak linked to clover sprouts from Jimmy John’s (CDC cluster code 2002IAEXW-1).

Plaintiffs filed this lawsuit on March 31, 2020, alleging that the sandwich Travis Knorr consumed from D&L’s restaurant was the source of bacteria that caused his illness. The discovery process, as well as plaintiff’s investigation of Proposed Defendants’ history of foodborne illness outbreaks, has revealed that the Proposed Defendants have been linked to numerous other sprouts-related outbreaks.[1] Jimmy John’s Franchise, LLC was linked to three outbreaks between 2008 and late 2010, the last of which led to 140 illnesses.[2] Following the November 2010 outbreak, then owner John Liautaud stated in January of 2011 that the chain would replace alfalfa sprouts with clover sprouts as they were allegedly easier to clean.[3]

Less than one year later, Jimmy John’s was again implicated in a sprouts-related outbreak prompting a February 2012 announcement that Jimmy John’s Franchise, LLC would be removing all raw clover sprouts from their menus.[4] However, three months later, at a meeting with the FDA, Jimmy John’s Franchise, LLC changed its position and stated that it would serve only clover sprouts sourced from specific suppliers.[5]

Since that meeting, the FDA has documented three additional sprouts-related outbreaks implicating Jimmy John’s establishments where traceback investigations show Jimmy John’s has used suppliers that were not on its approved supplier list in 2012.[6] In his report, Ben Chapman, PhD notes that in over 20 years as a food safety professional, he has never encountered a situation “where a firm said they would do something in an official meeting with FDA, and then eventually decided to do something else.”[7]

In 2016, Roark Capital, a private equity firm that would go on to form Inspire Brands, Inc., purchased a majority share of Jimmy John’s, LLC. In late 2017 and early 2018, an outbreak of Salmonella Montevideo that sickened 10 people was linked to sprouts served at Jimmy John’s restaurants in Illinois and Wisconsin. As a precautionary measure, during the last week of December, Jimmy John’s, LLC, though an email to all franchisees, initiated a temporary ban on the sale of sprouts. Following this outbreak, sprouts, which had been a mandatory menu item at all Jimmy John’s franchise locations, became optional.

In September 2019, Inspire Brands announced that in addition to the majority stake purchased by Roark Capital in 2016, it would be purchasing the remainder interest in Jimmy John’s, LLC. In late 2019, an outbreak of E. coli O103 in Iowa was linked to clover sprouts served at Jimmy John’s restaurants.[8] On or around December 19, 2019, Jimmy John’s, LLC was informed that sandwiches sold at its restaurants were the suspected source of the outbreak, and on December 23, 2019, Inspire Brands was contacted by the Iowa Department of Inspections and Appeals to inform them of the sprouts-related outbreak.[9] Neither Inspire Brands nor Jimmy John’s, LLC, informed Jimmy John’s franchisees out of the state of Iowa of the 2019 outbreak, specifically, they did not inform D&L of the outbreak.[10] D&L owner Daniel Star stated that, had D&L been informed, it is likely sprouts would have been removed from the menu at the location at which Plaintiff Travis Knorr purchased the sandwich that caused his injuries.[11]

In response to the 2019 outbreak of E. coli O103, the FDA sent Jimmy John’s, LLC a warning letter on February 21, 2020, five days before Travis Knorr began exhibiting symptoms as part of the Jimmy John’s linked 2020 E. coli 0103 outbreak.[12] In that letter, the FDA detailed evidence from five outbreaks that the FDA said, demonstrated that Jimmy John’s, LLC, through its franchised restaurants, “engaged in a pattern of receiving and offering for sale adulterated fresh produce, specifically clover sprouts and cucumbers.”[13] The letter went on to state that “[t]aken together, these outbreaks, which spanned over the past seven years and impacted no fewer than seventeen states demonstrate the corporate-wide supplier control mechanisms you have in place for receiving fresh produce are inadequate.”[14] In response to this letter, Inspire Brands, Inc., the owner of Jimmy John’s, LLC, replied to the FDA that sprouts had been permanently removed from the menu at all Jimmy John’s locations. The 2019 outbreak would later be genetically linked to the 2020 10-state outbreak of E. coli O103 which sickened Plaintiff Travis Knorr.[15]

In his expert report, Benjamin Chapman, PhD, noted that, in his opinion, Jimmy John’s decision to ignore evidence of the dangers of selling sprouts; failure to provide adequate resources to food handlers, specifically to control cross-contamination from sprouts; and failure to practice good risk communication towards customers “demonstrates a poor food safety culture.”[16]

In spite of significant available data on the dangers posed by sprout sales for consumption,[17] Proposed Defendants’ experience with several sprouts–related outbreaks, and Proposed Defendants’ acknowledgement of the dangers of serving sprouts during the 2012 meeting with the FDA,[18] Jimmy John’s restaurants continued to offer and sell raw sprouts leading to several outbreaks of life-threatening foodborne illness, including the 2020 outbreak that injured Plaintiff Travis Knorr.

Here is the Amended Complaint:

Plaintiffs TRAVIS and AIMEE KNORR (hereinafter “Plaintiffs”) complain against Defendants DWIGHT & LINFORD ENTERPRISES, LLC, d/b/a JIMMY JOHN’S (hereinafter “D&L”), JIMMY JOHN’S, LLC, (hereinafter JJ) and INSPIRE BRANDS, INC. (hereinafter “Inspire”) (“JJ” and “Inspire” collectively hereinafter “Jimmy John’s Corporate”) (all defendants collectively hereinafter “Defendants” or “Jimmy John’s”), as follows:

PARTIES

  1. Travis and Aimee Knorr are residents of the State of Utah.
  2. Dwight & Linford Enterprises, LLC, d/b/a, Jimmy John’s is a limited liability company, organized and existing under the laws of the State of Utah, with its corporate headquarters and principal place of business located at 81 West 3300 South, Suite B, Salt Lake City, Utah 84115. At all times relevant to this complaint, Jimmy John’s owned and operated the Jimmy John’s restaurant located at 13893 Bangerter Parkway, Draper, Utah 84020.
  3. Jimmy John’s, LLC is a limited liability company, organized and existing under the laws of the State of Illinois, with its corporate headquarters and principal place of business located at 2212 Fox Drive, Champaign, Illinois 61820. Upon information and belief, at all times relevant to this complaint, Jimmy John’s, LLC operated or franchised all of the more than 2,000 Jimmy John’s restaurants nationwide, including Utah. Jimmy John’s, LLC is a wholly owned subsidiary of Inspire Brands, Inc.
  4. Inspire Brands, Inc. is a corporation organized and existing under the laws of the State of Delaware, with its corporate headquarters located at 3 Glenlake Parkway NE, Atlanta, Georgia, 30328. Inspire Brands, Inc. also maintains a “Support Center” at 2212 Fox Drive, Champaign, Illinois 61820, where the Jimmy John’s, LLC corporate headquarters are located. Upon information and belief, Inspire Brands, Inc. purchased Jimmy John’s, LLC on October 18, 2019, and, at all times relevant to this matter, operated in conjunction with Jimmy John’s, LLC, and previous owner Jimmy John Liautaud as a brand advisor, to act as the franchisor or operator of all Jimmy John’s restaurants nationwide. Inspire Brands, Inc. owns a portfolio of more than 3,500 restaurants in 46 states including Utah.

JURISDICTION AND VENUE

  1. The Third Judicial District Court in and for Salt Lake County, State of Utah, has jurisdiction of the claims asserted below, pursuant to the provision of §78A-5-102, Utah Code Ann. (1953 as amended). Both out of state defendants do business within and avail themselves of the laws of the state of Utah, and maintain minimum contacts such that the Court’s assertion of jurisdiction over them would not violate traditional notions of fair play and substantial justice.
  2. Venue is properly laid before the Third Judicial District Court in and for Salt Lake County, State of Utah, pursuant to the provisions of §78B-3-307, Utah Code Ann. (1953 as amended), in that the causes of action alleged below arose within Salt Lake County, State of Utah.
  3. Pursuant to Rule 26(c)(3), of the New Utah Rules of Civil Procedure, the amount in controversy exceeds $300,000.00, qualifying this claim for a Tier 3 standard discovery.

GENERAL ALLEGATIONS

A HISTORY OF JIMMY JOHN’S AND SPROUTS-RELATED OUTBREAKS

  1. Jimmy John’s Restaurant Alfalfa Sprouts and Iceberg Lettuce coli Outbreak 2008. 28 Sickened – Several University of Colorado students from one sorority became ill with symptoms of bloody diarrhea and cramping. Additional illnesses were reported. E. coliO157:NM(H-) was determined to be the cause. Consumption of alfalfa sprouts at the Jimmy John’s Restaurants in Boulder County and Adams County were risk factors for illness. In addition, the environmental investigation identified Boulder Jimmy John’s food handlers who were infected with E. coli and who had worked while ill. The health department investigation found a number of critical food-handling violations, including inadequate handwashing. The fourteen isolates from confirmed cases were a genetic match to one another.
  2. CW Sprouts, Inc., SunSprout Sprouts, “restaurant chain (Chain A),” a.k.a. Jimmy John’s Salmonella Outbreak 2009. 256 Sickened – In February 2009, Nebraska Department of Health and Human Services officials identified six isolates of Salmonella Although this is a common strain of Salmonella, during 2008, only three cases had been detected in Nebraska, and only four subtypes of this outbreak strain had been identified in 2008 in the entire USA. As additional reports were made, a case control study was conducted; alfalfa sprout consumption was found to be significantly related to illness. The initial tracebacks of the sprouts indicated that, although the sprouts had been distributed by various companies, the sprouts from the first cases originated from the same sprouting facility in Omaha, NE. Forty-two of the illnesses beginning on March 15 were attributed to sprout growing facilities in other states; these facilities had obtained seeds from the same seed producer, Caudill Seed Company of Kentucky. The implicated seeds had been sold in many states. On April 26, the FDA and CDC recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts. In May, the FDA alerted sprout growers and retailers that a seed supplier, Caudill Seed Company of Kentucky, was withdrawing all alfalfa seeds with a specific three-digit prefix. Many of the illnesses occurred at restaurant chain (Chain A),” according to the CDC, which generally does not identify specific business.
  3. Multistate Salmonella Outbreak, Tiny Greens Organic Farm, Jimmy John’s Restaurants Alfalfa Sprouts 2010 and Subsequent Removal of Alfalfa Sprouts. 140 Sickened – On December 17, the Illinois Department of Health announced that an investigation was underway into an outbreak of Salmonella, serotype I4,[5],12:i:-. Many of the Illinois patients had eaten alfalfa sprouts at various Jimmy John’s restaurants in the Illinois counties of Adams, Champaign, Cook, DuPage, Kankakee, Macon, McHenry, McLean, Peoria, and Will. The sprouts were suspected to be the cause of the illnesses. On December 21 of that year, Jimmy John Liautaud, the owner of the franchised restaurant chain, requested that all franchisees remove all sprouts from the menu as a “precautionary” measure. On December 23, 2010, the CDC revealed that outbreak cases had been detected in other states, and that the outbreak was linked with eating alfalfa sprouts from a nationwide sandwich chain. On December 26, preliminary results of the investigation indicated a link to eating Tiny Greens’ Alfalfa Sprouts at Jimmy John’s restaurants. The FDA subsequently advised consumers and restaurants to avoid Tiny Greens Brand Alfalfa Sprouts and Spicy Sprouts produced by Tiny Greens Organic Farm of Urbana, Illinois. The Spicy Sprouts contained alfalfa, radish, and clover sprouts. On January 14, 2011, it was revealed that the FDA had isolated Salmonella serotype I4,[5],12:i:- from a water runoff sample collected from Tiny Greens Organic Farm; the Salmonella isolated was indistinguishable from the outbreak strain. The several FDA inspections of the sprout-growing facility revealed factors that likely led to contamination of the sprouts. Following this outbreak, then owner of Jimmy John’s, LLC, John Liautaud, stated in January that all Jimmy John’s restaurants would replace alfalfa sprouts with clover sprouts because clover sprouts were allegedly easier to clean.
  4. Sprouters Northwest, Jimmy John’s Restaurants Clover Salmonella Sprouts Outbreak 2010. 7 Sickened – Sprouters Northwest of Kent, WA, issued a product recall after the company’s clover sprouts had been implicated in an outbreak of Salmonella Newport in Oregon and Washington. At least some of the cases had consumed clover sprouts while at a Jimmy John’s restaurant. Concurrent with this outbreak, a separate outbreak of Salmonella,serotype I4,[5],12:i:- involving alfalfa sprouts served at Jimmy John’s restaurants was under investigation. The recall of Sprouters Northwest products included clover, clover and onion, spicy sprouts, and deli sprouts. The Sprouters Northwest products had been sold to grocery stores and wholesale operations in Washington, Oregon, Idaho, Alaska, British Columbia, Saskatchewan, and Alberta. The FDA inspection found serious sanitary violations.
  5. Multistate coli O26 Outbreak Jimmy John’s Restaurants Sprouts 2012. 29 Sickened – As of April 5, 2012, the CDC reported that 23 of 27 people interviewed reported eating sprouts at one of six Jimmy John’s restaurants in the seven days preceding their illness. Through a traceback investigation, the FDA identified a single lot of seed grown and distributed through multiple sprouting firms that supplied the six Jimmy John’s restaurants that were implicated in the outbreak. In response to the outbreak, Jimmy John, LLC announced in February 2012 that all Jimmy John’s restaurants would remove all raw clover sprouts from their menus permanently. In May 2012, however, at a meeting with the FDA concerning the several outbreaks related to sprouts, Jimmy John’s changed their position and stated that its restaurants would only serve clover sprouts sourced from specific suppliers.
  6. Multistate coli O121 Outbreak Jimmy John’s Restaurants Sprouts 2014. 19 Sickened – A CDC report from August of 2014 stated that 19 people in Idaho, Montana, Michigan, Utah, California, and Washington were infected with E. coli O121. 13 of 16 people interviewed reported having eaten raw clover sprouts prior to falling ill. The FDA’s traceback investigation revealed seven points of service as the locations of these sprout exposures, five of which were identified as Jimmy John’s restaurants. All the sprouts served at those seven locations were sourced from the same grower.
  7. Multi-state Salmonella Montevideo Outbreak Jimmy John’s Restaurant Sprouts 2018. 10 Sickened – The CDC reported that, as of February 28, 2018, eight of the ten people confirmed as part of this outbreak reported eating meals at Jimmy John’s restaurants in Illinois and Wisconsin, and all eight reported eating raw sprouts as part of their meals. One of the other individuals reported purchasing sprouts from a grocery store in Minnesota. All the Salmonella Montevideo infections were found to be closely related by whole genome sequencing. According to the FDA, evidence, including invoices collected by local and state agencies, supported a finding that sprouts were the vehicle for this outbreak. On January 19, 2018, Jimmy John’s, LLC emailed its franchisees mandating that all restaurants discontinue the sale of sprouts during the ongoing investigation into this outbreak. See Attachment 1. In a public statement, Jimmy John’s Management stated that the ban on service of sprouts was a precautionary measure instituted while investigating seven food safety complaints in Illinois and Wisconsin during the last week of December 2017.
  8. Iowa 2019 Jimmy John’s Restaurant Sprouts coli O103 Outbreak – Genetically Related to 2020 Utah Outbreak. 22 Sickened – The Iowa Department of Public Health reported that, as of January 7, 2020, 100 percent of the individuals interviewed had reported eating at one or more of 15 Jimmy John’s restaurants. The Iowa Department of Inspections and Appeals determined that several of those restaurants had received clover sprouts during the period of interest. Samples of sprouts and sprout irrigation water collected from the firm that supplied those sprouts yielded a strain of E. coli O103 that was highly related to the outbreak strain by whole genome sequencing and genetic subtyping. Additionally, this outbreak was a whole genome match to the 2020 Jimmy John’s outbreak described below. On or about December 19, 2019, Jimmy John’s, LLC was informed that sandwiches sold at its restaurants were the suspected source of the illnesses in this outbreak, and on December 23, 2019, Inspire Brands was contacted by the Iowa Department of Inspections and Appeals to inform them of the sprouts related outbreak.

THE 2020 JIMMY JOHN’S E. COLI OUTBREAK

  1. The Centers for Disease Control and Prevention (CDC), public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) are investigating a multi-state outbreak of coli O103 infections linked to clover sprouts.
  2. As of April 22, 2020, 51 people infected with the outbreak strain of coli O103 have been reported from ten states: Florida (1); Idaho (1); Illinois (7); Iowa (3); Missouri (1); New York (1); Texas (1); Utah (34); Virginia (1); and Wyoming (1).
  3. Illnesses started on dates ranging from January 6, 2020, to March 15, 2020. Ill people range in age from 1 to 79 years, with a median age of 29. Fifty-five percent of ill people were female. Three people were hospitalized. No deaths were reported.
  4. Epidemiologic, traceback, and laboratory evidence indicate that clover sprouts are the source of this outbreak. State and local public health officials are continuing to interview ill people to determine what they ate and other exposures they had in the week before their illness started. Eighteen (56%) of 32 people interviewed reported eating sprouts. Seventeen (63%) of 27 people interviewed reported eating sprouts at a Jimmy John’s restaurant.
  5. Jimmy John’s, LLC and Inspire Brands, Inc. did not report that all of their restaurants had stopped serving clover sprouts until February 24, 2020.
  6. The FDA identified the outbreak strain of coli O103 in samples of Chicago Indoor Garden products that contain sprouts. On March 16, 2020, Chicago Indoor Garden recalled all products containing red clover sprouts.
  7. FDA’s traceback investigation has shown that a common seed lot was used to grow the sprouts recalled by Chicago Indoor Garden and the sprouts that were served at Jimmy John’s locations where people sickened in the current outbreak reported eating. Chicago Indoor Garden sourced seed from the same supplier, International Specialty Supply, also known as International Sprout Holding, Inc., that supplied Reynolds Industries, Inc., the sprouts supplier for the D&L Jimmy John’s restaurants. The same seed lot was also used to grow sprouts linked to an outbreak of the same strain of coli O103 infections in 2019. As of April 22, 2020, this outbreak appears to be over.

JIMMY JOHN’S CORPORATE’S FAILURES THAT CAUSED THE OUTBREAK, AND ITS WILLFUL AND CONSCIOUS DISREGARD OF KNOWN RISKS TO CONSUMER HEALTH

  1. Between 2008 and January 2020, Jimmy John’s restaurants were directly linked to nine foodborne illness outbreaks caused by contaminated sprouts, including the outbreak responsible for Plaintiff’s injuries.
  2. Four times, in response to those outbreaks, Jimmy John’s Corporate has halted the sale of sprouts in all Jimmy John’s owned and franchised restaurants nationwide.
  3. In February 2012, Jimmy John’s, LLC (formerly Jimmy John’s Franchise, LLC) stated that all restaurants nationwide would no longer offer sprouts, however, three months later, Jimmy John’s, LLC backtracked at a meeting with the FDA and stated that its restaurants would serve only clover sprouts from specific approved suppliers.
  4. Since that 2012 meeting, the FDA has documented three sprouts related outbreaks linked to Jimmy John’s restaurants where traceback investigations have shown that restaurants used suppliers not on the approved list given to the FDA in 2012.
  5. The 2014 outbreak that sickened 19 people across six states was traced back to one grower that served all five implicated Jimmy John’s locations.
  6. During the 2018 outbreak of Salmonella Montevideo, ten people in Illinois and Wisconsin were sickened, and Jimmy John’s Corporate temporarily halted the sale of sprouts in all owned and franchised restaurants nationwide as a precautionary measure.
  7. Prior to the 2018 outbreak, clover sprouts were a mandatory menu option for all Jimmy John’s restaurant locations. Following the outbreak, Jimmy John’s, LLC wrote franchisee locations indicating that clover sprouts would be reinstituted as an optional menu item, and that all Jimmy John’s, LLC owned restaurants would offer clover sprouts.
  8. Jimmy John’s Corporate retains control over all other menu items and offered extras, as well as the décor and signage in all owned and franchised restaurants.
  9. All Jimmy John’s Corporate owned and franchised locations that offered sprouts after the 2018 outbreak were required to display a sign in store warning of the dangers of sprouts consumption and a pop-up warning online as follows:
  10. Jimmy John’s restaurants do not serve any items that would include under-cooked meat, poultry, shellfish, or eggs.
  11. On or about December 19, 2019, Jimmy John’s, LLC was notified of the sprouts outbreak linked to Jimmy John’s restaurants in Iowa.
  12. On December 23, 2019, Inspire Brands was contacted by the Iowa Department of Inspections and Appeals to inform them of the sprouts related outbreak.
  13. On February 21, 2020, in response to the 2019 outbreak, to which the 2020 outbreak has been linked by whole genome sequence matching, the FDA issued a warning letter to Jimmy John’s, LLC with evidence that demonstrates Jimmy John’s, LLC engaged in a pattern of receiving and offering for sale adulterated fresh produce, specifically clover sprouts and cucumbers. See Attachment 2.
  14. Inspire Brands’, rather than Jimmy John’s, LLC, responded to that letter and stated that sprouts had been removed from the menu at all Jimmy John’s restaurants indefinitely. See Attachment 3.
  15. Jimmy John’s Corporate did not report that all of their restaurants had stopped serving sprouts until February 24, 2020.
  16. Jimmy John’s Corporate failed to notify their franchisees of the 2019 Iowa outbreak linked to sprouts despite having specific knowledge of the outbreak in December 2019.
  17. In a deposition of D&L owner Daniel Clark, Mr. Clark stated that, had he known of the 2019 outbreak, or the information contained in the February 21, 2020, letter from the FDA, sprouts would not have been offered at the Jimmy John’s locations owned by D&L in February 2020.
  18. Jimmy John’s Corporate failed to notify franchisees of Jimmy John’s Corporate’s long history of sprouts related outbreaks.
  19. Jimmy John’s Corporate failed to inform franchisees of the many dangers of serving clover sprouts.
  20. Jimmy John’s Corporate failed to inform franchisees of the specific danger of cross contamination from sprouts despite retaining control over the interior design of franchise restaurants, including the location of containers of sprouts within the production line for sandwiches.
  21. In spite of informing the FDA in 2012 that Jimmy John’s locations would only serve clover sprouts from approved vendors, Jimmy John’s Corporate failed to ensure that franchise restaurant locations served sprouts from only approved vendors.
  22. Contrary to significant available data on the dangers posed by serving sprouts, and with knowledge of the several sprouts related outbreaks directly linked to Jimmy John’s restaurants, Jimmy John’s Corporate failed to protect Travis Knorr and other customers at its owned and franchised locations by continuing to make sprouts an available menu item in February 2020, and by failing to sufficiently educate and warn its franchisees of these dangers.

TRAVIS KNORR’S E. COLI ILLNESS

  1. The plaintiffs, by and through this reference, hereby incorporate paragraphs nos. 1 through 23, above, as if fully set forth herein.
  2. Travis and Aimee Knorr reside in Saratoga Springs, Utah.
  3. On February 21, 2020, Travis ordered and paid for a Billy Club sandwich (“the Sandwich”) from the Jimmy John’s located at 13893 Bangerter Parkway in Draper, Utah. The Sandwich was delivered to his workplace, where he subsequently consumed the Sandwich upon its arrival.
  4. On February 26, 2020, Travis began experiencing the onset of coli symptoms, including abdominal cramping and diarrhea. His symptoms eventually grew in severity to the point that he had to leave work early on February 27.
  5. Travis visited his family physician on March 2, 2020, because his symptoms continued unabated. His doctor started him on an antibiotic for a possible difficile infection and also sent him home with a stool kit to be returned for further analysis. Travis returned the stool sample to his physician the next day.
  6. On March 6, 2020, Travis’s physician notified him that his stool sample tested positive for coli.
  7. After learning of his diagnosis, Travis went to Mountain Point Medical Center emergency room. Scans and bloodwork revealed he was suffering from acute kidney failure, and he was admitted on March 8, 2020, for treatment and additional testing and observation.
  8. Travis’s kidney function steadily improved into March 10, when he was finally discharged from the hospital. That same day, the Utah County Health department contacted Travis about his coli exposure and illness.
  9. Unfortunately, Travis began experiencing a relapse of diarrhea and abdominal cramping on March 14, 2020, prompting him to eventually return to his family physician on March 17, 2020. His doctor performed additional kidney function blood tests and collected another stool sample.
  10. Travis also attended an appointment with his gastroenterologist on March 20, who proscribed medication for his stomach cramping.
  11. On March 21, Travis learned that he now suffered from a diff infection. He was prescribed antibiotics, and his doctor also informed him that his E. coli infection had subsided.
  12. Travis continued to recover through the end of March, and, on March 24, 2020, he was again contacted by the Utah County Health Department, who informed him that the coli strain that had sickened him was identified as E. coli O103:H2 and given the cluster codes 202002STEC002 by the Utah County Health Department and 2002IAEXW-1 by CDC.

Motion to add Defendants Exhibits 1-6

______________________

[1] See Plaintiffs’ Proposed Third Amended Complaint Paragraphs 8 – 15, Exhibit 1.

[2] Expert report of Benjamin Chapman, PhD, Exhibit 2 at 5.

[3] Id.

[4] Id.

[5] Id., at 6.

[6] Warning Letter to Jimmy John’s Franchise, LLC, Exhibit 3 at 3.

[7] Exhibit 2, at 6.

[8] See Iowa DPH Report – Outbreak of E. coli O103 Associated with Clover Sprouts Sold at Jimmy John’s, Exhibit 4.

[9] Id. at 8.

[10] See Deposition of Daniel Clark, Exhibit 5 at 39, 40.

[11] Id.

[12] See Exhibit 3.

[13] Exhibit 3, at 1.

[14] Id., at 3.

[15] See Inspire Brands, Inc. Response to FDA Letter, Exhibit 6.

[16] Exhibit 2, at 1.

[17] See Sprout-associated–outbreaks-4-5-21.xls attached to Exhibit 2.

[18] See Exhibit 3.

FDA Issues Improvement Plan Focused on Modernizing Foodborne Illness Outbreak Responses 

The following is attributed to Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response,and Stic Harris, D.V.M. director of the FDA’s Coordinated Outbreak Response and Evaluation Network

The U.S. Food and Drug Administration has a longstanding commitment to strengthening food safety and better protecting consumers, as part of its public health agenda. Today, we are taking an important step to build on this commitment with the release of the Foodborne Outbreak Response Improvement Plan. This plan is designed to help the FDA and our partners enhance the speed, effectiveness, coordination and communication of foodborne outbreak investigations. We are confident that the actions outlined in this plan will in turn translate into activities focused on enhancing the prevention of outbreaks.

As part of our work implementing the FDA Food Safety Modernization Act (FSMA)and our New Era of Smarter Food Safety initiative, we have collaborated with experts in both the public and private sectors for input on additional ways to strengthen the agency’s outbreak response. Input from the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) and the Centers for Disease Control and Prevention (CDC), state health officials, industry and consumer foodborne outbreak experts, along with the input of FDA leadership and staff, was key to the development of our new improvement plan.

The agency also contracted with the University of Minnesota’s School of Public Health to assess the FDA’s capacity to support, join, or lead multistate outbreak investigations and to provide recommendations in an independent report, which we are also making public today. This report played an important role in the development of our new plan.

The Foodborne Outbreak Response Improvement Planfocuses on four specific priority areas in which improvements will have the most impact on outbreaks associated with human food.

  • Tech-enabled product traceback –Engaging smarter ways to digitize and routinely receive information needed to streamline the traceback process, which are the steps we use to pinpoint the source of contaminated foods during investigations. These tactics include obtaining more complete voluntarily provided consumer purchase data to better specify critical traceback information, facilitating and expediting how the FDA receives data, and employing more advanced analytical methods and computational approaches. We will work to harmonize our efforts with our federal, state, local and territorial counterparts, as well with industry and others involved in traceback investigations.
  • Root-cause investigations (RCIs) –Systematizing, expediting and sharing FDA RCIs. The plan focuses on adapting and strengthening protocols and procedures for conducting timely RCIs of foodborne illness outbreaks, standardizing criteria for producing FDA RCI reports, and expediting the release of investigation findings to industry and the public.
  • Strengthen analysis and dissemination of outbreak data –Working with the CDC, the USDA’s FSIS and other partners to identify reoccurring, emerging and persistent strains of pathogens. Specifically, we will facilitate improvements to sharing of data with the CDC as well as other regulatory partners to further increase transparency of outbreak investigations, increase public confidence in results, and facilitate improved collaboration on investigation activities.
  • Operational improvements –Building on performance measures across the FDA’s foods program to better evaluate the timeliness and effectiveness of outbreak and regulatory investigation activities. The FDA is committed to using performance and outcome measures to assess progress of this improvement plan by updating stakeholders, posting updates on FDA.gov and through a public webinar in early 2022 to discuss how regulatory partners, industry and others can work together to achieve these goals.

We know that the 21st century has brought new challenges in identifying, investigating and controlling outbreaks of foodborne disease, but it has also brought new tools to meet those challenges. We also recognize that today’s U.S.food system is large and decentralized, with a broad array of widely distributed products, which we must adapt to in order to help ensure the safety of these products.That is why we are taking steps through this improvement plan to evolve our outbreak investigations to meet modern-day needs using the most modern-day tools available. Our investigations must be faster, more streamlined and more effective to identify, pinpoint and remove contaminated food from the market and identify root-cause factors in the food system to prevent similar outbreaks in the future.

Our improvement plan sets out a clear pathway to achieving these important goals. We will continue to do everything we can to protect consumers from unsafe food. Adding the Outbreak Response Improvement Plan to our arsenal, which includes FSMA and the New Era of Smarter Food Safety, will ultimately prevent illnesses and save lives; and that is what this work is all about for us.

Additional Resources: 

Since early February 2020, I have continued to do talk on “why it is a bad idea to poison your customers,” but all have been by Zoom or some other video platform.  Today I had the honor to hang with one of my food safety heroes – Craig Wilson – from Costco.  I have known Craig from nearly 30 years.  His commitment to food safety is second to none.

“HACCP: A systematic approach to the identification, evaluation, and control of food safety hazards.”  – So says the FDA.

Although today’s announcement (FDA Proposes Changes to Food Safety Modernization Act Rule to Enhance Safety of Agricultural Water Used on Produce) is a bit to fully digest in one sitting, I am intrigued by FDA’s focus on pre-harvest risk assessment of water risk as opposed to water testing for pathogens generally.  The FDA’s requirement of an annual water risk assessments by farms to “determine whether corrective or mitigation measures are reasonably necessary to reduce the potential for contamination,” arguably creates “HACCP for produce.”  That produce HACCP requires that produce growers take stock in what pathogen risks surround them on nearby lands, like cattle operations and/or wild animal populations that may impact water quality, and take measures to protect the produce consumer from possible infection from a deadly pathogen.

With respect to risky adjacent land operations, it is unclear at this point what a grower can do to mitigate those risks short of relocation or treatment and testing of water, however, this rule seems to remove certain water testing requirements.  One method of confirming if HACCP is working can be science-based  testing to help understand if mitigation measures are in fact working.

So, in my view the jury is still out on 1) will eliminating water testing and increasing assessments make for a safer product? and, 2) should there not be a recognition that produce is essentially a “ready-to-eat” product grown outside with the risks inherent by what is directly around it or what may blow or flow to it, and therefore a broader environmental approach will be required to assure produce safety?

I look forward to the comments and remaining engaged in the process.

Here is the FDA’s press release with links:

Today, the U.S. Food and Drug Administration issued a proposed rule that aims to enhance the safety of produce. It proposes to require farms to conduct comprehensive assessments that would help them identify and mitigate hazards in water used to grow produce. This is the latest step in the agency’s implementation of the FDA Food Safety Modernization Act (FSMA), and it proposes to replace some of the existing requirements for agricultural water in the Produce Safety Rule (PSR).

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms. As a federal government agency charged with protecting public health, the FDA is committed to implementing effective modern, science-based measures designed to prevent these outbreaks from occurring in the future,” said Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. “The proposed rule is the latest action taken by the FDA to continue working towards implementation of key provisions of FSMA. If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives. This proposed rule is a monumental step towards further improving the safety of the fruits and vegetables Americans serve their families every day, and the FDA looks forward to engaging with stakeholders on the proposed changes.”

The proposed rule, if finalized, would change certain pre-harvest agricultural water requirements for produce and farms subject to the PSR, other than sprouts operations. Key provisions in the proposed rule include:

  • A requirement for farms to manage their agricultural water quality based on the results of a comprehensive systems assessment (“agricultural water assessment”) that is adaptable to the wide variety of water sources and uses and future scientific advancements.
  • An annual assessment by farms of their pre-harvest agricultural water to identify any conditions likely to introduce hazards into, or onto, covered produce or food contact surfaces. Based on these assessments, farms would then determine whether corrective or mitigation measures are reasonably necessary to reduce the potential for contamination. The assessment would include an evaluation of the farm’s water system, agricultural water use practices, crop characteristics, environmental conditions and other relevant factors, such as the results of any testing conducted to inform the assessment.
  • A requirement that farms implement expedited mitigation measures for hazards related to certain activities associated with adjacent and nearby lands, to protect the quality of the water used on produce. This is being included following several recent outbreak investigations on produce that revealed potential routes of contamination including activities and conditions, such as animal grazing and the presence of livestock and wildlife on land adjacent to, or near, produce farms or their water sources.
  •  The removal of certain testing requirements for pre-harvest agricultural water and replacing them with the agricultural water assessments identified above. The proposed revisions are intended to address stakeholder concerns about complexity and practical implementation challenges while protecting public health.

The FDA intends to continue working closely with stakeholders and our state and tribal partners to provide necessary training, technical assistance, education and outreach. The agency will hold two virtual public meetings to discuss the proposal and hear feedback, and more details will be announced in a forthcoming Federal Register notice. In addition, the agency is also developing an online tool to assist growers in understanding agricultural water assessments.

Recognizing that the current agricultural water compliance dates for covered produce other than sprouts under the PSR are set to begin in January 2022, the agency intends to exercise enforcement discretion for those agricultural water requirements while pursuing another proposed rule to extend the compliance dates for all of the agricultural water requirements in the PSR for such covered produce. More information on the proposed compliance date extension will be announced in a forthcoming Federal Register notice.

Today’s proposal is one of the critical remaining pieces of working towards FSMA implementation. The FDA has taken many important steps to achieve the food safety goals envisioned by Congress when FSMA was established in 2011, such as implementing seven foundational rules. The FDA also has developed multiple action plans to address specific food safety issues and has further built on the foundation under FSMA through the New Era of Smarter Food Safety initiative.

Related Information

Volume 28, Number 1—January 2022
Dispatch
Salmonella Serotypes Associated with Illnesses after Thanksgiving Holiday, United States, 1998–2018

Here is the CDC’s conclusion:

Salmonella Reading was the serotype most strongly associated with illness during the Thanksgiving holiday. Given the dramatic increase in turkey consumption around Thanksgiving, one might expect that serotypes we identified are primarily associated with turkey consumption, and indeed, Reading caused a multistate outbreak with a raw turkey source during 2017–2019, and a new clone of this serotype has emerged since 2014 in commercial turkey production. Other serotypes significantly associated with Thanksgiving in our study (i.e., Hadar, Schwarzengrund, and Heidelberg) have also been associated with turkey.

Other significantly associated serotypes are not among those most commonly identified in turkey (e.g., Heidelberg and 4,[5],12:i- are more commonly identified in chicken; Derby, Brandenburg, and 4,[5],12:i- in swine and pork; and 4,[5],12:i- in cattle). However, all these serotypes have been found in turkeys and in retail samples of turkey or have been associated with outbreaks attributed to turkey. Some of the serotypes significantly increased after Thanksgiving, such as, Baildon and Ohio, were rare, causing <200 illnesses annually, and were not reported among food animals, retail products, or outbreaks during 2015‒2020. Although our study may have identified serotypes associated with other foods eaten during the Thanksgiving holiday, particular attention probably should be paid to evidence of these serotypes emerging in turkey production.

So, again, why is Salmonella NOT an adulterant?

Goodness, it has been a crazy few years.  When the pandemic hit, Marler Clark went all in to help food banks, food service workers and first responders.  As the pandemic has continued (please 40% of our friends and neighbors, please get vaccinated), we have looked to other places to help.  Here is were we are focused this season and we would ask others to consider the same.

I can’t make it, but my daughter in D.C. will.  Please consider supporting – https://www.farmworkerjustice.org/2021-awards-dc/

No child should sleep outside.  Please consider supporting – https://secure.e2rm.com/p2p/event/368075

Some, I am sure are a bit tired of my ranting about the FSIS doing its job and deeming Salmonella that causes human illness an adulterant in meat.

Fact, after E. coli O157:H7 was deemed an adulterant in ground beef in 1994, it took about a decade for E. coli illness cases to drop.  During that time, we saw the same drop in clients seeking our help.  Go figure, the FSIS and the beef industry heeded my call.  It is time to do the same with Salmonella.

Here is a link to a PowerPoint from a presentation I gave a few days ago – https://www.slideshare.net/marlerclark/2021-british-columbia-food-safety-speech

It was in an Op-ed in the Denver Post on August 4, 2002, entitled, “Four steps to safer food.”  Here it is in full:

This summer, scores of Americans, most of them small children or senior citizens, have already or will become deathly ill after eating ground beef boldly labeled “USDA approved.”

The now infamous ConAgra case started with a few sick kids in Colorado and quickly spread coast-to-coast, eventually triggering the recall of 18 million pounds of ground beef tainted with E. coli.

Now we know that this recall came weeks late, after most of that meat had been consumed by innocent consumers from Washington State to New Jersey. Because they trusted government’s food inspections, several kids suffered kidney failure and spent days or weeks hooked up to kidney dialysis machines. For some, the long-term prognosis is grim, with the risk of further kidney failure, dialysis, transplants or worse. I know this because I am a trial lawyer who has built a practice on food pathogens. Many of those kids’ parents have hired me to help them get compensation for hundreds of thousands in medical costs. Which may prompt some readers to consider me a blood-sucking ambulance chaser who exploits other people’s personal tragedies.

If that’s the case, here’s my plea:

Put me out of business. Please.

For this trial lawyer, E. coli has been a successful practice – and a heart-breaking one. I’m tired of visiting with horribly sick kids who did not have to be sick in the first place. I’m outraged with a food industry that allows E. coli and other poisons to reach consumers, and a federal regulatory system that does nothing about it.

Stop making kids sick – and I’ll happily move on. Here’s how:

Actually inspect and sample food. At present, the U.S. Department of Agriculture employs thousands of inspectors across the nation to inspect hundreds of plants that produce millions of pounds of beef at processing plants and retail outlets. The General Accounting Office has warned that the USDA’s food samplings are so scattered and infrequent that there is little chance of detecting microscopic E. coli or any other pathogen.

So hire more inspectors and give them real authority to sample meat and stop its distribution as soon as a pathogen is detected. Implement a sampling system that provides a reasonable chance of preventing another outbreak.

Doing so might add a nickel a pound – maybe less – to the price of hamburger. But it will also cut into my business. And isn’t that the idea?

Consider mandatory recall authority. This authority was required in Sen. Tom Harkin’s Safer Meat, Poultry and Foods Act of 2002. Under the present system of voluntary recalls, no company has actually refused to recall contaminated product. But in its recent report, the GAO did document several instances where companies delayed complying with recall requests. Delays mean tainted product has more time to reach consumers.

Require the meat industry to document where specific lots of food are sold. That way, it can be recalled quickly if a pathogen is detected. In most E. coli outbreaks, there is no recall because retailers don’t know where the meat came from and processors rarely step forward. ConAgra deserves credit for owning up to its responsibility to track down as much of the tainted meat as possible and for covering the medical costs of its victims.

But ConAgra is the exception. Timely online records would allow meat to be efficiently tracked down and recalled as soon as inspectors get a positive test result. Those plastic club cards issued by grocery chains could enable stores to contact specific individuals who have bought suspect ground beef. Merge the two federal agencies responsible for food safety. Right now USDA’s Food Safety Inspection Service and the inspection arm of the Food and Drug Administration share this mission. The system is bifurcated, which leads to turf wars and split responsibilities. We need one independent agency that deals with food-borne pathogens.

None of this will stop E. coli entirely. This invisible poison has been around a long time and is bound to pop up again. But these steps will enable us to detect it far more quickly, to alert stores and families, and to keep our most vulnerable citizens – kids and seniors – out of harm’s way. And, with a little luck, it will force one more damn trial lawyer to find another line of work.

Here is me testifying before Congress in 2008.

Essentially, USDA/FSIS is treating Salmonella as an adulterant in this situation.

I mean, it is not a bad idea to protect school kids, but why the differences?

While you all were sleeping off your “turkey coma,” I was thinking about why Salmonella is not an adulterant by reading, Michael Ollinger, John Bovay, Casiano Benicio, and Joanne Guthrie. Economic Incentives to Supply Safe Chicken to the National School Lunch Program, ERR-202, U.S. Department of Agriculture, Economic Research Service, November 2015.

Here are the highlights:

The U.S. Department of Agriculture’s (USDA) National School Lunch Program (NSLP) provides subsidized and free meals to over 31 million qualified students across the United States each school day (USDA, FNS, 2013). Chicken is a major component of the meals served to students. Some of that chicken is purchased through typical commercial channels, but schools can also obtain it via the Poultry Products Purchase Program, which is administered by USDA’s Agricultural Marketing Service (AMS). The NSLP used about $9 million worth of raw and $240 million worth of processed chicken products in the 2009-10 school year (USDA, FNS, 2012). Most of the processed chicken used in the NSLP was purchased by AMS as raw product and then further processed by State agencies prior to distribution to schools. Like all chicken sold in interstate commerce, the chicken purchased by AMS for the NSLP must meet Federal food safety standards, including tolerances for Salmonella spp. established by the USDA’s Food Safety and Inspection Service (FSIS).

Proper cooking and handling of raw chicken can reduce the risk of foodborne illness by killing Salmonella and other pathogens. Nevertheless, Salmonella remains the second-most common
cause of foodborne illness in the United States, causing an estimated 1 million illnesses, 19,000 hospitalizations, and 380 deaths each year (Scallan et al., 2011). Schools generally use processed (precooked) products such as chicken nuggets, fajita strips, etc., in school meals (Hecht et al., 2008). Processing kills harmful pathogens if it involves cooking the meat to more than 165° Fahrenheit (Burr et al., 2005). Some school systems, however, contend that processing removes some control over the nutritional content of school meals, and purchase the raw commodity (Stanley and Conner, 2013).

Both raw and processed chicken products have been recalled in recent years for food safety reasons. Between 2009 and 2012, there were six recalls of processed chicken due to Salmonella contamination, amounting to nearly 8 million pounds. Processed chicken products have also been recalled due to contamination with Listeria monocytogenes, allergens, and other reasons. Additionally, Foster Farms recently recalled over 1 million pounds of raw chicken products due to excessive Salmonella. However, to our knowledge, there have been no product recalls of raw or processed chicken products purchased by AMS for the NSLP.

Previous research (Ollinger et al., 2014) showed that, from 2006 to 2012, ground beef sold to the NSLP performed better on Salmonella spp. tests than ground beef sold to the commercial market. AMS imposes a zero-tolerance standard for Salmonella spp. in ground beef, a higher standard than that required by FSIS for ground beef sold in general commerce. This may have incentivized suppliers of ground beef to the NSLP to be more diligent when fulfilling an AMS contract, but it also likely raised costs, since suppliers may have taken extra precautions to meet FSIS standards.

AMS does not impose stricter Salmonella tolerances for raw chicken sold to AMS for the NSLP relative to the FSIS standard. AMS selects the lowest cost bidder among all AMS-registered suppliers, as long as that bidder meets FSIS standards. The combined effect gives establishments an incentive to invest in food safety up to the point that the establishment just meets the FSIS standard. However, food recalls and other announcements about the safety of food products can affect demand and profit, leading to declines in the stock prices of implicated suppliers (Thomsen and McKenzie, 2001), and in some cases, bankruptcy (Andrews, 2012; Tavernise, 2013). A food safety recall from a school could be particularly costly because the NSLP is a highly visible program and subject to particular scrutiny, potentially resulting in a greater reputation loss than that which would occur in the commercial market for a similar event. Moreover, it may be easier to trace the AMS-purchased chicken served in schools to their suppliers than chicken sold in commercial markets, making a product recall more likely.

Traceability is the ability to identify the supply chain of a product. It enhances food safety because, if a food is linked to a foodborne illness outbreak or other public health threat, then the source can be identified and the producer can be managed by regulators and may be targeted by liability lawsuits. Traceability also helps pinpoint the location of products so they can be removed from the marketplace.

There are fewer AMS suppliers than suppliers in the broader commercial market since not all chicken plants are eligible to bid on AMS contracts. This smaller number of AMS suppliers facili- tates traceability because there are fewer possible sources, and public health officials can inspect shipping records to determine the suppliers most likely responsible for shipping food associated with outbreaks of foodborne illness. Traceability becomes more complicated if the school system buys identical products in the commercial market, since there are more suppliers.

This report investigates the food safety performance of suppliers of raw chicken purchased by
AMS for the NSLP. In particular, we examine whether concerns about reputation for food safety encourage AMS suppliers to outperform commercial-only suppliers on tests for Salmonella spp.
The results could have implications for the AMS purchase specifications and the FSIS food safety program and may help policymakers and private managers better understand the conditions under which stricter standards may be warranted, and those under which private incentives are sufficient to maintain food safety.

Some more recent papers with some interesting tidbits:

Ollinger, Michael, John Bovay. 2018. Pass or Fail: Economic Incentives to Reduce Salmonella Contamination in Ground Beef Sold to the National School Lunch Program. American Journal of Agricultural Economics.100:414–433, doi.org/10.1093/ajae/aax088

“… the incentives generated by the zero-tolerance standard for Salmonella are highly effective: ground beef supplied to the NSLP is 21–22 percentage points more likely to meet a zero-tolerance standard for Salmonella than ground beef tested as part of typical meat-plant inspections.”

Ollinger, Michael, Matthew Houser. 2020. Ground beef recalls and subsequent food safety performance. Food Policy.  97:101971, doi.org/10.1016/j.foodpol.2020.101971.

“The results show that plants have high Salmonella levels before and during the year of the recall and have much lower levels afterward.”

Ollinger, M. and Bovay, J. (2020), Producer Response to Public Disclosure of Food-Safety Information. Amer. J. Agr. Econ., 102: 186-201. doi.org/10.1093/ajae/aaz031

“We find that (1) announcements in 2003 and 2004 were associated with improved performance by the poorest-performing chicken-slaughter plants; (2) the introduction of an easily-understood measure of food-safety quality and the threat of disclosure of the identities of poorly performing plants in 2006 were associated with improved performance by all chicken-slaughter plants; and (3) implementation of a public disclosure program in 2008 was associated with improvements among better-performing chicken-slaughter plants.”

So, why zero-tolerance for Salmonella in ground beef at schools but not at the kids’ homes?