Search romaine lettuce

How is this acceptable?

I have spent today reviewing this most interesting study and took the liberty of editing it down for reading “consumption.” https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciz1182/5669965

This outbreak was the largest multistate STEC O157 outbreak in several decades, eclipsing in magnitude a 2006 outbreak linked to fresh spinach. As there are an estimated 26 unreported illnesses for every STEC O157 case reported to PulseNet, the true size of this outbreak was likely much larger than the 240 illnesses reported through PulseNet, suggesting that thousands of people were actually sickened in this outbreak.

240 case-patients (not 210) from 37 states; 104 were hospitalized, 28 developed hemolytic uremic syndrome, and five died. Of 179 people who were interviewed, 152 reported consuming romaine lettuce in the week before illness onset. Twenty sub-clusters were identified.

Product traceback from sub-cluster restaurants identified numerous romaine lettuce distributors and growers; all lettuce originated from the Yuma growing region.

Water samples collected from an irrigation canal in the region yielded the outbreak strain of E. coli O157.

One case-patient was co-infected with E. coli O157 and E. coli O61, and two case-patients were infected with only E. coli O61. Case-patients were 1–93 years (median 26 years), and 66% (158/239) were female. All outbreak isolates were related genetically by WGS (0–40 SNP differences). Two distinct sub-clades that included the majority of outbreak isolates, which had isolates with 0–19 SNP differences.

In April 2018, the New Jersey Department of Health and the Pennsylvania Department of Health notified the Centers for Disease Control and Prevention of two E. coli infection clusters. Before becoming ill, people in both clusters reported eating salads at a national restaurant chain. Pulsed- field gel electrophoresis showed that the E. coli O157 isolated from ill people in both states had the same, rare PFGE pattern combination.

Product traceback efforts by local health jurisdictions, state health departments, and FDA could not identify a single product lot, processor, or farm as the source of the entire outbreak. In total, 36 fields on 23 farms were identified during the traceback investigation. Only the Alaska correctional facility sub-cluster could be traced to a single farm. All of the romaine lettuce identified was traced to farms in the Yuma growing region. FDA, CDC and state partners conducted an EA in the growing region, which consisted of farms in Imperial County, CA and Yuma County, AZ.

In June 2018, E. coli O157 with PFGE patterns indistinguishable from clinical outbreak isolates and closely related genetically to clinical isolates in both main clades were detected in irrigation water from the Yuma growing region. The outbreak strains were detected in three separate water samples from sites along a 3.5-mile section of the Wellton irrigation canal that runs adjacent to romaine lettuce farms identified during traceback and next to a concentrated animal feeding operation (CAFO) with approximately 105,000 cattle. No E. coli O61 was identified from the environmental assessment or water samples collected. No romaine lettuce was available for sampling during this outbreak since harvesting had ended in this region by the time the environmental assessment began.

In addition to this outbreak being unusually large, case-patient clinical course was unusually severe. The proportion of case-patients developing HUS (12.7%) was twice as high as previous outbreaks of STEC O157 (6.3%). There were five deaths in this outbreak (2.2%), which is almost four times higher than expected (0.6%). This could be explained by the strain’s stx2a toxin subtype, which produces more virulent toxins than other types. Outbreaks with stx2 toxin are more likely to result in increased rates of HUS.

The ultimate source of E. coli O157 for this outbreak is unknown, but reasonable hypotheses exist that explain how romaine lettuce could have become contaminated. The E. coli O157 outbreak strain was detected at multiple points in a Yuma growing region irrigation canal, and the contaminated canal water may have subsequently contacted romaine lettuce in several ways, including direct application to the crop through aerial or land-based spray chemicals diluted with canal water.

However, how and when E. coli O157 was introduced into the irrigation canal is unknown, as well as why the majority of illnesses were associated with romaine when other types of lettuce were grown in the same area during the time of interest. A CAFO was located adjacent to the irrigation canal where the outbreak strain was found, but no obvious route for contamination from the facility was identified. Environmental contamination could have been caused by the adjacent CAFO, as cattle are a well-documented reservoir for pathogenic E. coli O157.

References

  1. Rangel JM, Sparling PH, Crowe C, Griffin PM, Swerdlow DL. Epidemiology of Escherichia coli O157:H7 outbreaks, United States, 1982-2002. Emerging Infectious Diseases, 2005; 11(4): 603-9.
  2. Dewey-Mattia D, Manikonda K, Hall AJ, Wise ME, Crowe SJ. Surveillance for Foodborne Disease Outbreaks – United States, 2009-2015. Morbidity and Mortality Weekly Report Surveillance Summaries, 2018; 67(10): 1-11.
  3. Sharapov UM, Wendel AM, Davis JP, et al. Multistate Outbreak of Escherichia coli O157:H7 Infections Associated with Consumption of Fresh Spinach: United States, 2006. Journal of Food Protection, 2016; (12): 2024.
  4. Food Bill Aims to Improve Safety. FDA Consumer Health Information 2010.
  5. Scallan E, Hoekstra RM, Angulo FJ, et al. Foodborne illness acquired in the United States– 
major pathogens. Emerging Infectious Diseases, 2011; 17(1): 7-15.
  6. Heiman KE, Mody RK, Johnson SD, Griffin PM, Gould LH. Escherichia coli O157 Outbreaks in the United States, 2003-2012. Emerging Infectious Diseases, 2015; 21(8): 1293-301.
  7. National Shiga toxin-producing Escherichia coli (STEC) Surveillance Overview. Atlanta, Georgia: CDC, 2012.
  8. General information: Escherichia coli. Available at: https://www.cdc.gov/ecoli/general/index.html.
  9. PulseNet home page. Available at: https://www.cdc.gov/pulsenet/.
  10. Katz L.S., Griswold T., Williams-Newkirk A.J., et al. . A Comparative Analysis of the Lyve-SET 
Phylogenomics Pipeline for Genomic Epidemiology of Foodborne Pathogens. Frontiers in 
Microbiology, 2017; 8:375.
  11. Foodborne Diseases Active Surveillance Network (FoodNet): population survey. Available at: https://www.cdc.gov/foodnet/surveys/population.html.
  12. Environmental Assessment; Yuma 2018 E. coli O157:H7 Outbreak Associated with Romaine Lettuce. US Food and Drug Administration, October 24, 2018.
  13. National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS). Available at: https://www.cdc.gov/narms/antibiotics-tested.html.
  14. National Antimicrobial Resistance Monitoring System for Enteric Bacteria (NARMS): Human Isolates Surviellance Report for 2015 (Final Report). Atlanta, Georgia: CDC, 2018.
  15. National Outbreak Reporting System (NORS) Dashboard. Available at: https://wwwn.cdc.gov/norsdashboard/.
  16. Gould LH, Demma L, Jones TF, et al. Hemolytic Uremic Syndrome and Death in Persons with Escherichia coli O157:H7 Infection, Foodborne Diseases Active Surveillance Network Sites, 2000– 2006. Clinical Infectious Diseases, 2009; 49(10): 1480-5.
  17. Food Safety Modernization Act (FSMA) Final Rule on Produce Safety. Available at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm.
  18. Beauvais W, Gart EV, Bean M, et al. The prevalence of Escherichia coli O157:H7 fecal shedding in feedlot pens is affected by the water-to-cattle ratio: A randomized controlled trial. PloS One, 2018; 13(2): e0192149-e.
  19. Karmali MA. Factors in the emergence of serious human infections associated with highly pathogenic strains of shiga toxin-producing Escherichia coli. International Journal of Medical Microbiology, 2018; 308(8): 1067-72.
  20. Wilson D, Dolan G, Aird H, et al. Farm-to-fork investigation of an outbreak of Shiga toxin- producing Escherichia coli O157. Microbial Genomics, 2018; 4(3): e000160.

Since the previous update on November 26, an additional 35 ill people have been reported. As of December 2, 2019, a total of 102 people infected with the outbreak strain of E. coli O157:H7 have been reported from 23 states. AZ (3), CA (4), CO (6), FL (1), IA (1), ID (3), IL (1), MD (4), MI (1), MN (3), MT (1), NE (1), NJ (7), NC (1), NM (2), OH (12), OR (1), PA (8), SD (1), TX (4), VA (4), WA (2), WI (31).

Illnesses started on dates ranging from September 24, 2019, to November 18, 2019. Ill people range in age from less than 1 to 89 years, with a median age of 25. Sixty-five percent of ill people are female. Of 98 ill people with information available, 58 hospitalizations have been reported, including 10 people who developed hemolytic uremic syndrome (HUS), a type of kidney failure. No deaths have been reported.

Epidemiologic, laboratory, and traceback evidence indicate that romaine lettuce from the Salinas, California, growing region is the likely source of this outbreak.

FDA and states continue to trace the source of the romaine lettuce eaten by ill people. Preliminary information indicates that some of the ill people ate lettuce grown in Salinas, California. No common grower, supplier, distributor, or brand of romaine lettuce has been identified.

CDC continues to advise that consumers not eat and retailers not sell any romaine lettuce grown in Salinas, California. The investigation is ongoing to determine the source of contamination and if additional products are linked to illness.

This outbreak is caused by the same strain of E. coli O157:H7 that caused outbreaks linked to leafy greens in 2017 and to romaine lettuce in 2018.

We need to take a hard look at the safety of romaine and what we can do to make is safe.

At this time, there is no outbreak of E. coli occurring in Canada. There is one Canadian illness related to the U.S. outbreak that has been identified in the province of Manitoba. This individual became ill in mid-October.

A bit of recent problems with romaine:

 2019

23 people sickened and 11 hospitalized. The FDA, CDC, along with state and local partners, investigated the illnesses associated with the outbreak. A total of 23 people infected with the outbreak strain of E. coli O157:H7 were reported from 12 states: Arizona, California, Florida, Georgia, Illinois, Maryland, North Carolina, Nevada, New York, Oregon, Pennsylvania  and South Carolina. Eleven people were hospitalized, and no deaths were reported. Illnesses started on dates ranging from July 12, 2019 to Sept. 8, 2019. No illnesses were reported after CDC began investigating the outbreak on Sept. 17, 2019.

2018

218 people sickened, 96 hospitalized, 27 with HUS and 5 deaths. 210 people infected with the outbreak strain were reported from 36 states. 96 people were hospitalized, including 27 people who developed a type of kidney failure called hemolytic uremic syndrome. 5 deaths were reported from Arkansas, California, Minnesota, and New York. In total, there were eight Canadian cases of E. coli O157 that were genetically similar to the U.S. outbreak linked to romaine lettuce coming from the Yuma growing region in the U.S. The eight Canadian illnesses were reported in five provinces: British Columbia, Alberta, Saskatchewan, Ontario, and Quebec. Individuals became sick between March and April 2018. One of the Canadian cases was hospitalized, and no deaths were reported in Canada. Individuals who became ill were between 11 and 76 years of age. The majority of cases (75%) were female.

91 people sickened, 35 hospitalized, 4 with HUS. Sixty-two people infected with the outbreak strain of Shiga toxin-producing E. coli O157:H7 were reported from 16 states and the District of Columbia. Illnesses started on dates ranging from October 7, 2018, to December 4, 2018. Twenty-five people were hospitalized, including two people who developed hemolytic uremic syndrome, a type of kidney failure. No deaths were reported. In Canada, there were a total of 29 confirmed cases of E. coli illness investigated in Ontario, Quebec, New Brunswick, and British Columbia. The illnesses in British Columbia were related to travel to Quebec, Ontario and the United States. Individuals became sick between mid-October and mid-November 2018. Ten individuals were hospitalized, and two individuals suffered from hemolytic-uremic syndrome (HUS), which is a severe complication that can result from an E. coli infection. No deaths were reported. Individuals who became ill were between 2 and 93 years of age. The majority of cases (52%) were female.

2017

76 people sickened, 9 people hospitalized, 2 with HUS and 2 deaths. Twenty-five people infected with the outbreak strain of E. coli O157:H7 were reported from 15 states. Illnesses started on dates ranging from November 5, 2017 to December 12, 2017. Nine people were hospitalized, including two people who developed hemolytic uremic syndrome, a type of kidney failure. One death was reported from California. In total, there were 42 cases of E. coli O157:H7 illness reported in five eastern provinces: Ontario, Quebec, New Brunswick, Nova Scotia, and Newfoundland and Labrador. Individuals became sick in November and early December 2017. Seventeen individuals were hospitalized. One individual died. Individuals who became ill were between the ages of 3 and 85 years of age. The majority of cases (74%) were female.

Additional Resources

Since the previous update on November 22, an additional 27 ill people have been reported. As of November 25, 2019, a total of 67 people infected with the outbreak strain of E. coli O157:H7 have been reported from 19 states.

Illnesses started on dates ranging from September 24, 2019, to November 14, 2019. Ill people range in age from 3 to 89 years, with a median age of 25. Sixty-seven percent of ill people are female. Of 50 ill people with information available, 39 hospitalizations have been reported, including six people who developed hemolytic uremic syndrome (HUS), a type of kidney failure. No deaths have been reported.

Epidemiologic, laboratory, and traceback evidence indicate that romaine lettuce from the Salinas, California, growing region is the likely source of this outbreak.

FDA and states continue to trace the source of the romaine lettuce eaten by ill people. Preliminary information indicates that some of the ill people ate lettuce grown in Salinas, California. No common grower, supplier, distributor, or brand of romaine lettuce has been identified.

CDC continues to advise that consumers not eat and retailers not sell any romaine lettuce grown in Salinas, California. The investigation is ongoing to determine the source of contamination and if additional products are linked to illness.

This outbreak is caused by the same strain of E. coli O157:H7 that caused outbreaks linked to leafy greens in 2017 and to romaine lettuce in 2018.

“When in doubt, throw it out,” says William (Bill) Marler, managing partner at the Food Safety Law Firm, Marler Clark.

“It is past time for the leafy green industry to take the safety of greens, especially romaine lettuce, seriously.  The FDA must require, and the industry must implement, better environmental controls and more rigorous testing of products.  There have been too many outbreaks leaving hundreds of consumers with life-long complications,” said Bill Marler.

“Over the last decades, and recently, I have represented the families of people who have died as a result of consuming a product deemed ‘healthy.’  I have also represented dozens of children who face a lifetime of complications – including kidney failure – due to eating leafy greens.  This has to stop,” added Marler.

What to know about the E. coli outbreak:

The FDA, CDC, state and Canadian health authorities are presently investigating an outbreak of illnesses caused by E. coli O157:H7 tainted romaine lettuce in the United States and Canada. Thus far at least 41 people have been sickened in the United States and Canada.  This is in addition to 23 people sickened by E. coli O157:H7 tainted romaine lettuce in September.  Both outbreaks involve romaine lettuce grown in Salinas California.

Epidemiologic, laboratory, and traceback evidence indicates that romaine lettuce from the Salinas, California growing region is a likely source of this outbreak.

Consumers should not eat romaine lettuce harvested from Salinas, California.

Additionally, consumers should not eat products identified in the recall announced by the USDA on November 21, 2019 related to Missa Bay, LLC, products and Ready Pac Bistro Chicken Raised Without Antibiotics Caesar Salad.

Restaurants and retailers should not serve or sell romaine harvested from Salinas, California.  If you do not know the source of your romaine lettuce, and if you cannot obtain that information from your supplier, you should not serve, nor sell it.

Romaine lettuce may be voluntarily labeled with a harvest region. If this voluntary label indicates that the romaine lettuce was grown in “Salinas” (whether alone or with the name of another location) do not eat it. Throw it away or return it to the place of purchase.  If romaine lettuce does not have information about harvest region or does not indicate that it has been grown indoors (i.e., hydroponically- and greenhouse-grown), throw it away or return it to the place of purchase. Consumers ordering salad containing romaine at a restaurant or at a salad bar should ask the staff whether the romaine came from Salinas.  If it did, or they do not know, do not eat it.

What to know about the E. coli:

Shiga toxin–producing E. coli (STEC) cause approximately 100,000 illnesses, 3,000 hospitalizations, and 90 deaths annually in the United States. Most reported STEC infections in the United States are caused by E. coli O157:H7, with an estimated 73,000 cases occurring each year.

What to know about the E. coli complications:

Hemolytic Uremic Syndrome, or HUS, occurs in around 10 percent of hospitalized  E. coli O157:H7 infections. HUS occurs when Shiga toxins get into the bloodstream and cause the part of the kidney that filters toxins out of the blood to break down, causing kidney injury and sometimes kidney failure. Some HUS patients also suffer damage to the pancreas and central nervous system impairment.

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 is just a sample of E. coli outbreaks based on information gathered by the Center for Science in the Public Interest, Kansas State University, and the Centers for Disease Control and Prevention (CDC ) – NOTE: It is very likely that there or dozens of other outbreaks that the CDC and FDA did not make public:

Date Vehicle Etiology Confirmed
Cases		 States/Provinces
July 1995 Lettuce (leafy green; red; romaine) E. coli O157:H7 74 1:MT
Sept. 1995 Lettuce (romaine) E. coli O157:H7 20 1:ID
Sept. 1995 Lettuce (iceberg) E. coli O157:H7 30 1:ME
Oct. 1995 Lettuce (iceberg; unconfirmed) E. coli O157:H7 11 1:OH
May-June 1996 Lettuce (mesclun; red leaf) E. coli O157:H7 61 3:CT, IL, NY
May 1998 Salad E. coli O157:H7 2 1:CA
Feb.-Mar. 1999 Lettuce (iceberg) E. coli O157:H7 72 1:NE
Oct. 1999 Salad E. coli O157:H7 92 3:OR, PA, OH
Oct. 2000 Lettuce E. coli O157:H7 6 1:IN
Nov. 2001 Lettuce E. coli O157:H7 20 1:TX
July-Aug. 2002 Lettuce (romaine) E. coli O157:H7 29 2:WA, ID
Nov. 2002 Lettuce E. coli O157:H7 13 1:Il
Dec. 2002 Lettuce E. coli O157:H7 3 1:MN
Oct. 2003-May 2004 Lettuce (mixed salad) E. coli O157:H7 57 1:CA
Apr. 2004 Spinach E. coli O157:H7 16 1:CA
Nov. 2004 Lettuce E. coli O157:H7 6 1:NJ
Sept. 2005 Lettuce (romaine) E. coli O157:H7 32 3:MN, WI, OR
Sept. 2006 Spinach (baby) E. coli O157:H7 and other serotypes 205 Multistate and Canada
Nov./Dec. 2006 Lettuce E. coli O157:H7 71 4:NY, NJ, PA, DE
Nov./Dec. 2006 Lettuce E. coli O157:H7 81 3:IA, MN, WI
July 2007 Lettuce E. coli O157:H7 26 1:AL
May 2008 Romaine E. coli O157:H7 9 1:WA
Oct. 2008 Lettuce E. coli O157:H7 59 Multistate and Canada
Nov. 2008 Lettuce E. coli O157:H7 130 Canada
Sept. 2009 Lettuce: Romaine or Iceberg E. coli O157:H7 29 Multistate
Sept. 2009 Lettuce E. coli O157:H7 10 Multistate
April 2010 Romaine E. coli O145 33 5:MI, NY, OH, PA, TN
Oct. 2011 Romaine E. coli O157:H7 60 Multistate
April 2012 Romaine E. coli O157:H7 28

1:CA

Canada
June 2012 Romaine E. coli O157:H7 52 Multistate
Sept. 2012 Romaine E. coli O157:H7 9 1:PA
Oct. 2012 Spinach and Spring Mix Blend E. coli O157:H7 33 Multistate
Apr. 2013 Leafy Greens E. coli O157:H7 14 Multistate
Aug. 2013 Leafy Greens E. coli O157:H7 15 1:PA
Oct. 2013 Ready-To-Eat Salads E. coli O157:H7 33 Multistate
Apr. 2014 Romaine E. coli O126 4 1:MN
Apr. 2015 Leafy Greens E. coli O145 7 3:MD, SC, VA
June 2016 Mesclun Mix E. coli O157:H7 11 3:IL, MI, WI
Nov. 2017 Leafy Greens E. coli O157:H7 67 Multistate and Canada
Mar. 2018 Romaine E. coli O157:H7 219 Multistate and Canada
Nov. 2018 Romaine E. coli O157:H7 91 Multistate and Canada
Sept. 2019 Romaine E. coli O157:H7 23 Multistate
Nov. 2018 Romaine E. coli O157:H7 41 Multistate and Canada

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of E. coli outbreaks and hemolytic uremic syndrome (HUS). The E. coli lawyers of Marler Clark have represented thousands of victims of E. coli and other foodborne illness infections and have recovered over $650 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our E. coli lawyers have litigated E. coli and HUS cases stemming from outbreaks traced to ground beef, raw milk, lettuce, spinach, sprouts, and other food products.  The law firm has brought E. coli lawsuits against such companies as Jack in the Box, Dole, ConAgra, Cargill, and Jimmy John’s.  We have proudly represented such victims as Brianne Kiner, Stephanie Smith and Linda Rivera.

To contact Bill Marler, email: bmarler@marlerclark.com or call: 1-206-794-5043.

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert due to illnesses caused by E. coli O157:H7 associated with romaine lettuce from the Salinas, California, growing region. FSIS warns against consuming any wraps, sandwiches, prepackaged salad, salad kits, or other product containing romaine lettuce harvested from the Salinas, California, growing region. Additionally, consumers should not eat any salad products identified in a Missa Bay, LLC, recall announced by FSIS on November 21, 2019.

On November 22, 2019, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA)advised consumers, retailers, and restaurants not eat or sell any romaine lettuce harvested from the Salinas, California, growing region. Most romaine lettuce products at retail are labeled with a harvest location showing where they were grown. CDC and the FDA are advising that if this voluntary label indicates that the romaine lettuce was grown in “Salinas” (whether alone or with the name of another location) do not eat it. If the romaine does not have information about harvest region or does not indicate that it has been grown indoors (i.e. hydroponically- and greenhouse-grown), throw it away or return it to the place of purchase.

FSIS-regulated establishments are advised not to serve, ship, or sell products that contain romaine lettuce from the Salinas, California, growing region. This advice includes all types of romaine lettuce from the Salinas, California, growing region, such as whole heads of romaine, hearts of romaine, and packages of precut lettuce and salad mixes that contain romaine, including baby romaine, spring mix, and Caesar salad. If you do not know the source of your romaine lettuce, and if you cannot obtain that information from your supplier, you should not serve, ship, or sell the product.

Anyone concerned about an illness should contact a healthcare provider. E. coli O157:H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 2–8 days (3–4 days, on average) after exposure the organism. While most people recover within a week, some develop a type of kidney failure called hemolytic uremic syndrome (HUS). This condition can occur among persons of any age but is most common in children under 5-years old and older adults. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of E. coli outbreaks and hemolytic uremic syndrome (HUS). The E. coli lawyers of Marler Clark have represented thousands of victims of E. coli and other foodborne illness infections and have recovered over $650 million for clients. Marler Clark is the only law firm in the nation with a practice focused exclusively on foodborne illness litigation.  Our E. coli lawyers have litigated E. coli and HUS cases stemming from outbreaks traced to ground beef, raw milk, lettuce, spinach, sprouts, and other food products.  The law firm has brought E. coli lawsuits against such companies as Jack in the Box, Dole, ConAgra, Cargill, and Jimmy John’s.  We have proudly represented such victims as Brianne Kiner, Stephanie Smith and Linda Rivera.

If you or a family member became ill with an E. coli infection or HUS after consuming food and you’re interested in pursuing a legal claim, contact the Marler Clark E. coli attorneys for a free case evaluation.

We have a romaine E. coli case in Idaho of a young man who suffered a severe case of hemolytic uremic syndrome (HUS), was hospitalized for a month and incurred nearly $250,000 in medical expenses and lost wages.  He has a risk of future kidney complications (including a transplant), but not likely to meet the legal standard of more likely than not – greater than 50%.  He did suffer seizures because of the HUS, but it is well maintained on medications, and it is hopeful, over time, that he may well be weaned off the medications and be able to drive again.  Under Idaho law he will be able to recover wage loss and medical expenses (economic damages) and a capped amount for nonmonetary losses (pain and suffering) – Well, unless a court and a jury determines that it is “reckless misconduct” to grow, process and sell romaine lettuce.

Sometimes bad facts make good law – recall the lawsuit against the auditor in the Jensen Farms Listeria cantaloupe case?

Idaho Code § 6-1603 established in 2003 a cap of $250,000.00 for noneconomic damages, damages that are subjective, nonmonetary losses including, but not limited to, pain, suffering, inconvenience, mental anguish, disability or disfigurement incurred by the injured party; emotional distress; loss of society and companionship; loss of consortium; or destruction or impairment of the parent-child relationship. Idaho Code § 6-1603(1) also provides for an annual adjustment tied to the increase or decrease of the annual wage; for 2018, the effective cap was established at $357,210.62.

The full text of the statute reads as follows:

6-1603.  LIMITATION ON NONECONOMIC DAMAGES. (1) In no action seeking damages for personal injury, including death, shall a judgment for noneconomic damages be entered for a claimant exceeding the maximum amount of two hundred fifty thousand dollars ($250,000); provided, however, that beginning on July 1, 2004, and each July 1 thereafter, the cap on noneconomic damages established in this section shall increase or decrease in accordance with the percentage amount of increase or decrease by which the Idaho industrial commission adjusts the average annual wage as computed pursuant to section 72-409(2), Idaho Code.

(2)  The limitation contained in this section applies to the sum of: (a) noneconomic damages sustained by a claimant who incurred personal injury or who is asserting a wrongful death; (b) noneconomic damages sustained by a claimant, regardless of the number of persons responsible for the damages or the number of actions filed.

(3)  If a case is tried to a jury, the jury shall not be informed of the limitation contained in subsection (1) of this section.

(4)  The limitation of awards of noneconomic damages shall not apply to:

(a)  Causes of action arising out of willful or reckless misconduct.

(b)  Causes of action arising out of an act or acts which the trier of fact finds beyond a reasonable doubt would constitute a felony under state or federal law.

Setting aside the fairness of capping noneconomic damages at $357,210.62 for a case as serious as this one, the real issue is whether the cap applies at all under section (4)(a) above?  In 2018 was it “reckless misconduct” to grow, process, source and sell romaine lettuce from Yuma?

Certainly, as well cited above, leafy greens have been a source of E. coli-related illnesses for decades, and there have been concerns raised about lettuce grown in the Yuma region.  The CDC reports as of May 20, 2010, a total of 26 confirmed and 7 probable cases related to an E. coli O145 outbreak have been reported from 5 states since March 1, 2010 linked to shredded romaine grown in Yuma.[1] In the FDA’s “Environmental Assessment Report in December 2010,” the authors determined:

that the R.V. park is a reasonably likely potential source of the outbreak pathogen based upon the evidence of direct drainage into the lateral irrigation canal; the moist soil in this drainage area; the multiple sewage leach systems on the property; the presence of other STEC found in the lateral irrigation canal and in the growing fields of the suspect farm; and the fact that the section of the lateral canal downstream from the R.V. park supplies water to only one other farm in addition to the suspect farm.

Two pumps are located on the main Wellton canal near the lateral canal split that supplies water to fields of the suspect farm; one gasoline powered pump on a trailer and one permanent electric pump with an attached hose. The electric pump supplies canal water to an attached open-end hose. The site is not secured from vehicles and the hose pump is also unsecured. At the time of this investigation there were people living in recreational vehicles on undeveloped land within one mile of the hose pump. The fact that this area is open to vehicles and the pump and hose are unsecured make it possible for an R.V. owner to dump and rinse out their R.V. septic system into the main Wellton canal at the lateral canal split that supplies the farm. The ground near the hose pump shows erosion evidence of drainage into the Wellton canal. Soil collected from this erosion site tested positive for other Stx2-producing STEC but did not match the outbreak strain.

In a 2009 “Survey of Selected Bacteria in Irrigation Canal Water – Third Year” written by Jorge M. Fonseca, he correctly predicted the human and industry problems that were likely to plague the Yuma lettuce growers:

Despite the fact that no Arizona lettuce grower has been involved in any contaminated-lettuce outbreak, it is of paramount importance to determine the reasons why Arizona lettuce is regarded as safe. This can help lower possibilities of any emerging problem and prevent a catastrophic damage to the industry, as it has occurred in other regions when no control was taken to reduce risks of contaminated product.

A PowerPoint done by Dr. Fonseca again illustrated the varying risks of lettuce production in Yuma.  An example of a few of his points of concern:

And, then the 2018 romaine lettuce E. coli outbreak struck, sickening hundreds in the United States and Canada with dozens suffering from acute kidney failure with five reported deaths.  Once again, the Wellton Irrigation Canal was the focus of attention in the “Memorandum to File on the 2018 Environmental Assessment”:

During this EA, three samples of irrigation canal water collected by the team were found to contain E coli O157:H7 with the same rare molecular fingerprint (using whole genome sequencing (WGS)) as the strain that produced human illnesses (the outbreak strain). These samples were collected from an approximate 3.5-mile stretch of an irrigation canal in the Wellton area of Yuma County that delivers water to several of the farms identified in the traceback investigation as shipping romaine lettuce that was potentially contaminated with the outbreak strain. The outbreak strain was not identified in any of the other samples collected during this EA, although other pathogens of public health significance were detected.

 

Not surprisingly, the FDA in its full “Environmental Assessment of Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in a Multi-State Outbreak of E. coli O157:H7,”[2] concluded that the risk of environmental contamination was in fact a well-know and long-standing risk:

Food safety problems related to raw whole and fresh-cut (e.g., bagged salad) leafy greens are a longstanding issue. As far back as 2004, FDA issued letters to the leafy greens industry to express concerns about continuing outbreaks associated with these commodities. FDA and our partners at CDC identified 28 foodborne illness outbreaks of Shiga-toxin producing E. coli (STEC) with a confirmed or suspected link to leafy greens in the United States between 2009 and 2017. This is a time frame that followed industry implementation of measures to address safety concerns after a large 2006 outbreak of E. coli O157:H7 caused by bagged spinach. STEC contamination of leafy greens has been identified by traceback to most likely occur in the farm environment.

Contamination occurring in the farm environment may be amplified during fresh-cut produce manufacturing/processing if appropriate preventive controls are not in place. Unlike other foodborne pathogens, STEC, including E. coli O157:H7, is not considered to be an environmental contaminant in fresh-cut produce manufacturing/processing plants.

Well-established reservoirs for E. coli O157:H7 are the intestinal tract of ruminant animals (e.g., cattle, goats, and deer) that are colonized with STEC and shed the organism in manure. Ruminant animals colonized with STEC typically have no symptoms. In contrast, human infection with E. coli O157:H7 usually produces symptomatic illness often marked by severe, often bloody, diarrhea; severe adverse health outcomes or even death can result. Humans shed E. coli O157:H7 in the stool while ill and sometimes for short periods after symptoms have gone away, but humans are not chronic carriers. Various fresh water sources, including municipal well, and recreational water, have been the source of E. coli O157:H7 infections in humans, as has contact with colonized animals at farms or petting zoos. However, most E. coli O157:H7 infections in humans occur from consuming contaminated food.

In its summary of its environmental findings (also summarized in a November 1, 2018 to public officials) the “FDA [in part] identified the following factors and findings as those that most likely contributed to the contamination of romaine lettuce from the Yuma growing region with E. coli O157:H7 that caused this outbreak”:

  • FDA has concluded that the water from the irrigation canal where the outbreak strain was found most likely led to contamination of the romaine lettuce consumed during this outbreak.
  • There are several ways that irrigation canal water may have come in contact with the implicated romaine lettuce including direct application to the crop and/or use of irrigation canal water to dilute crop protection chemicals applied to the lettuce crop, either through aerial or ground-based spray applications.
  • How and when the irrigation canal became contaminated with the outbreak strain is unknown. A large animal feeding operation is nearby but no obvious route for contamination from this facility to the irrigation canal was identified. Other explanations are possible although the EA team found no evidence to support them.

Idaho Code Section 6-1603(4)(a) states that the statutory limit on non-economic damages in tort actions seeking damages for personal injury or death does not apply in cases where the cause of action arises “out of willful or reckless misconduct.” Idaho Pattern Civil Jury Instruction 2.25 provides the definition of “willful and wanton,” and notes that there is no distinction between “reckless” and “willful and wanton.” Hennefer v. Blaine County Sch. Dist. 61 158 Idaho 242, 248 (2015). According to the IDJI, “[t]he words ‘willful and wanton’…mean more than ordinary negligence. The words mean intentional or reckless actions, taken under circumstances where the actor knew or should have known that the actions not only created an unreasonable risk of harm to another, but involved a high degree of probability that such harm would actually result.” IDJI 2.25

While Idaho considers reckless or willful misconduct “simply a degree of negligence…that involves both intentional conduct and knowledge of a substantial risk of harm,” its courts have further elaborated that while “use of the words ‘intentional’ and ‘knowledge’ might indicate a purely subjective standard for recklessness…there is an objective element to the recklessness standard.” Hennefer 158 Idaho at 248.  Thus, while reckless misconduct can consist of a conscious choice of a course of action with knowledge of the serious danger to others, (subjective), it can also consist of a conscious choice of a course of action with knowledge of facts that would disclose the danger to any reasonable man (objective). Id. The serious danger mentioned in the standard is one that “involves a risk substantially greater in amount than that which is necessary to make the conduct negligent.” Id. Accordingly, a jury need only find that a defendant should have known that his actions created a high probability that harm would actually result; such a finding is considered sufficient to meet the standard espoused by Idaho Code section 6-1603. Id. at 249.

Using this standard, there is substantial evidence supporting the conclusion that growing, processing, sourcing, and selling romaine lettuce from Yuma constituted reckless misconduct. It is widely known that STEC infections are life-threatening to humans and the most common cause of infection is consumption of contaminated food. Additionally, STEC outbreaks associated with leafy greens are unsettlingly common occurrences as evidenced by the 28 identified outbreaks occurring between 2009 and 2017. The FDA, CDC, and other governmental agencies have sought to combat the frequency of these occurrences by issuing various communications with state officials, publishing the results of its investigations into the outbreaks, and advising on best practices to avoid such outbreaks.

Among the FDA’s many suggestions, it recommended that the leafy green industry should assess the need for and develop commodity-specific procedures, policies, and best practices to enhance the safety of leafy greens, including, at a minimum, address (1) how agricultural water directly contacting harvestable portions of the crop can be guaranteed safe and adequate for its intended use; (2) how risks related to land uses near or adjacent to growing fields that may contaminate agricultural water or leafy green crops directly (e.g., nearby cattle operations or dairy farms, manure, or composting facilities) can be assessed and mitigated; (3) how food safety procedures, policies, and practices are developed and consistently implemented on farms as well as regularly verified to minimize the potential for contamination and/or spread of human pathogens; and (4) how a root cause analysis should be performed to determine the likely source of any contamination by a foodborne pathogen identified in the agricultural environment, agricultural water, or in the fresh-cut ready-to-eat produce.

Given the available knowledge regarding STEC, its transmission to and effect on humans, as well as the nature—and demonstrated prior history— of STEC transmission from ruminant animal operations to leafy greens and the repeated government advisory and caution of that danger, the undeterred insistence of growing, processing, sourcing, and selling romaine lettuce from a region repeatedly plagued by STEC contamination and subsequent outbreaks is a considerably reckless activity. The findings from the 2018 romaine lettuce outbreak considerably enhance the veracity of that conclusion. Despite all the aforementioned knowledge, the source of the 2018 outbreak that affected hundreds and killed five was found to be a contaminated irrigation canal that supplied water to several farms identified in the traceback investigation who were downstream from a sizeable cattle operation. Such undeterred action in spite of the substantial available knowledge on the risks developed and disseminated over the years fits squarely within Idaho’s characterization of reckless misconduct and should accordingly be treated as such.

__________

[1] https://www.cdc.gov/ecoli/2010/shredded-romaine-5-21-10.html

[2] https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm624546.htm

And, they forgot the eight sick in Canada.

Today, the FDA came out with its “Environmental Assessment of Factors Potentially Contributing to the Contamination of Romaine Lettuce Implicated in a Multi-State Outbreak of E. coli O157:H7.”

I shortened it a bit and bolded the highlights.

In early April 2018, the Food and Drug Administration (FDA), in conjunction with the Centers for Disease Control and Prevention (CDC) and state partners, began to investigate a multi-state outbreak of E. coli O157:H7 infections. When this outbreak was declared over by the CDC two months later, it was the largest outbreak of E. coli O157:H7 infections in the United States since 2006, with 210 reported illnesses from 36 states, resulting in 96 hospitalizations, 27 cases of hemolytic uremic syndrome (HUS) and five deaths.

Traceback of the romaine lettuce consumed by ill people determined that it originated in the Yuma produce growing region which consists of farms in Imperial County, California, and Yuma County, Arizona. The traceback identified a total of 36 fields on 23 farms in the Yuma growing region as supplying romaine lettuce that was potentially contaminated and consumed during the outbreak. With the exception of one instance where one of the legs of the traceback led to a single farm, it was not possible to determine which, or how many, of these farms shipped lettuce that was contaminated with the outbreak strain of E. coli O157:H7.

The epidemiological and traceback analyses performed during this outbreak informed an FDA-led Environmental Assessment (EA) of the Yuma produce growing region in collaboration with CDC and state partners from June through August 2018. The EA was conducted to assist FDA in identifying factors that potentially contributed to the introduction and spread of the outbreak strain of E. coli O157:H7 that contaminated the romaine lettuce associated with this outbreak.

The EA team made several visits to the Yuma growing region to conduct its work. During these visits, the team collected numerous environmental samples. Three of these samples were found to contain E. coli O157:H7 with the same rare genetic fingerprint (by whole genome sequencing) as that which made people sick. These three samples were collected in early June from a 3.5 mile stretch of an irrigation canal near Wellton in Yuma County that delivers water to farms in the local area, including several identified in the traceback as having potentially shipped romaine lettuce contaminated with the outbreak strain.

The romaine lettuce that ill individuals consumed was likely harvested between early March and mid-April 2018 based on the fact that reported illness onset dates occurred from March 13 – June 7, 2018. The traceback indicates that the contaminated lettuce had to have been grown on multiple farms and processed at multiple off-farm fresh-cut produce manufacturing/processing facilities.

FDA considers that the most likely way romaine lettuce became contaminated was from the use of water from this irrigation canal, since the outbreak strain of E. coli O157:H7 was found in the irrigation canal and in no other sampled locations. How this process occurred is uncertain, but based on interviews with growers and pesticide applicators, plausible explanations include direct application of irrigation canal water to the lettuce crop or the use of irrigation canal water to dilute crop protection chemicals applied to the lettuce crops through both aerial and land-based spray applications.

Information collected by the EA team indicates that, among the Yuma area farms identified in the traceback and that were interviewed, irrigation canal water was only directly applied during germination. However, aerial and ground-based spraying of crop protection pesticides diluted with irrigation canal water occurred at various times during the growing season on a number of these farms, including after a freeze event that occurred in late February. This freeze event likely led to damage of some portion of the romaine lettuce crop, which may have rendered it more susceptible to microbial contamination.

It is uncertain how the outbreak strain of E. coli O157:H7 was introduced into this 3.5-mile stretch of irrigation canal water. The first illnesses in this outbreak occurred in March 2018, and therefore the outbreak strain may have been present in the irrigation canal months before the EA team collected the positive samples, or the outbreak strain may have been repeatedly introduced into the irrigation canal. A large concentrated animal feeding operation (CAFO) is located adjacent to this stretch of the irrigation canal. The EA team did not identify an obvious route for contamination of the irrigation canal from this facility; in addition, the limited number of samples collected at the CAFO also did not yield the outbreak strain.

Low-level E. coli O157:H7 contamination of the romaine lettuce from some of the growing fields identified in the traceback could have been amplified by commingling cut romaine lettuce in wash systems at fresh-cut produce manufacturing/processing facilities. Washing of romaine lettuce either at a fresh-cut produce manufacturing/processing facility or at home by consumers may reduce but will not eliminate pathogens, including STEC, from romaine lettuce. The commingling of romaine lettuce from various farm growing fields at fresh-cut produce manufacturing/processing facilities complicated traceback efforts and made it impossible for FDA to definitively determine which farm or farms identified in the traceback supplied romaine lettuce contaminated with the E. coli O157:H7 outbreak strain.

FDA recommends that growers and processors of leafy greens:

  • assure that all agricultural water (water that directly contacts the harvestable portion of the crop) used by growers is safe and adequate for its intended use (including agricultural water used for application of crop protection chemicals);
  • assess and mitigate risks related to land uses near or adjacent to growing fields that may contaminate agricultural water or leafy greens crops directly (e.g. nearby cattle operations or dairy farms, manure or composting facility);
  • verify that food safety procedures, policies and practices, including supplier controls for fresh-cut processors, are developed and consistently implemented on farms (both domestic and foreign) and in fresh-cut produce manufacturing/processing food facilities to minimize the potential for contamination and/or spread of human pathogens;
  • when a foodborne pathogen is identified in the growing or processing environment, in agricultural inputs (e.g., agricultural water), in raw agricultural commodities or in fresh-cut ready-to-eat produce, a root cause analysis should be performed to determine the likely source of the contamination, if prevention measures have failed, and whether additional measures are needed to prevent a reoccurrence; and
  • Local in-depth knowledge and actions are critical in helping resolve potential routes of contamination of leafy greens in the Yuma growing region, including Imperial County and Yuma County moving forward. FDA urges other government and non-government entities, produce growers and trade associations in Yuma and Imperial Counties to further explore possible source(s) and route(s) of contamination associated with the outbreak pathogen and with other foodborne pathogens of public health significance. This information is critical to developing and implementing short- and long-term remediation measures to reduce the potential for another outbreak associated with leafy greens or other fresh produce commodities.

Given the size of the outbreak, at least 218 in the US and Canada, and the number of unnamed farms and fields implicated, I am not surprised that the source of the outbreak was broad environmental contamination – like water.  As a study that was performed in the Yuma growing area from 2007-2009 said: “Despite the fact that Arizona leafy greens has never been associated with foodborne outbreaks, this study is contributing with relevant information that can be used for future regulatory guidelines”.  Well, that clearly has changed. Survey of Selected Bacteria in Irrigation Canal Water – Third Year_0

This outbreak appears to be over as of June 28, 2018.

Epidemiologic, laboratory, and traceback evidence indicated that romaine lettuce from the Yuma growing region was the likely source of this outbreak.

The FDA and state and local regulatory officials traced the romaine lettuce to many farms in the Yuma growing region. The FDA, along with CDC and state partners, started an environmental assessment in the Yuma growing region and collected samples of water, soil, and manure. CDC laboratory testing identified the outbreak strain of E. coli O157:H7 in water samples taken from a canal in the Yuma growing region. WGS showed that the E. coli O157:H7 found in the canal water is closely related genetically to the E. coli O157:H7 from ill people. Laboratory testing for other environmental samples is continuing. FDA is continuing to investigate to learn more about how the E. coli bacteria could have entered the water and ways this water could have contaminated romaine lettuce in the region.

As of June 27, 2018, 210 people infected with the outbreak strain of E. coli O157:H7 were reported from 36 states. Illnesses started on dates ranging from March 13, 2018 to June 6, 2018. Ill people ranged in age from 1 to 88 years, with a median age of 28. Sixty-seven percent of ill people were female. Of 201 people with information available, 96 (48%) were hospitalized, including 27 people who developed hemolytic uremic syndrome, a type of kidney failure. Five deaths were reported from Arkansas, California, Minnesota (2), and New York.  (PHAC) identified 8 ill people in several Canadian provinces infected with the same DNA fingerprint of E. coli O157:H7. On June 22, 2018, PHAC reported that the outbreak in Canada appears to be over.

Canada called the imported romaine lettuce E. coli outbreak over after eight people were sickened.  It is expected that the CDC will update the US part of the outbreak in the morning.  The numbers of ill are likely to be far above 200 and the number of deaths may likely rise as well.  Those with long-term complications – (HUS) will still be extraordinary high, as will be the percent of hospitalizations.

Thus far the FDA has been “somewhat silent” on the chain of distribution and will unfortunately remain so.  Here is what they have told the public as of the end of May:

We have been busy doing both a trace forward and trace back.  With over 100 clients, most can identify the specific place that they consumed romaine (point of service) in the 3-5 days before the onset of illness.  Some have multiple purchases and consumptions, which for now, make linking the supply chain a challenge.  But I like a challenge.

I expect that the various retailers (points of service) will continue to provide information on the supply chain (distribution center, processor, grower/harvester) – either willingly or by subpoena.  And, once we have that information (trace back), we can than trace forward to eliminate situations where E. coli culture matched victims had multiple purchases in the incubation period.

Check back for more information.

Retailers above, please give me a call.

I have spoken to and been retained by, people in Idaho, Missouri, Montana, New Jersey, New York and Pennsylvania. Also, I have spoken to people in California and Utah that also may be linked to the outbreak.

On Friday, according to the CDC, as of April 12, 2018, 35 people infected with the outbreak strain of E. coli O157:H7 have been reported from 11 states. Connecticut 2, Idaho 8, Illinois 1, Michigan 1, Missouri 1, New Jersey 7, New York 2, Ohio 2, Pennsylvania 9, Virginia 1 and Washington 1. Illnesses started on dates ranging from March 22, 2018 to March 31, 2018. Ill people range in age from 12 to 84 years, with a median age of 29. Sixty-nine percent of ill people are female. Twenty-two ill people have been hospitalized, including three people who developed hemolytic uremic syndrome, a type of kidney failure.

Today the Arizona Department of Health Services (ADHS) is advising residents to not eat and dispose of store-bought chopped romaine lettuce, including salads and salad mixes containing chopped romaine lettuce. The Centers for Disease Control and Prevention and the Food and Drug Administration indicated a multi-state outbreak of E. coli O157 is likely associated with chopped romaine lettuce from the Yuma, Arizona growing region. Three cases of E. coli in Arizona have been linked to this multistate outbreak.

Also, today the Montana Department of Health announced that there has been an increase in reports of STEC O157 cases in Montana, with onset dates between 3/28 and 4/7. These cases are linked to a multi-state outbreak of STEC O157 sickening at least 29 individuals in 11 states. This total includes three confirmed STEC O157 cases (2 in Missoula, 1 in Ravalli) with patterns matching the national outbreak strain. An additional five PCR positive cases are pending culture confirmation with the state laboratory (3 in Flathead, 1 in Lincoln, and 1 in Gallatin). Further analysis will be needed to determine if they part of the outbreak. Please see the information below for recommendations.

According to the CDC, epidemiologic evidence collected to date indicates that chopped romaine lettuce is the likely source of this outbreak. Most people reported eating a salad at a restaurant, and romaine lettuce was the only common ingredient identified among the salads eaten. The restaurants reported using bagged, chopped romaine lettuce to make salads.

Traceback investigations are ongoing to determine the source of chopped romaine lettuce supplied to restaurant locations where ill people ate. At this time, no common grower, supplier, distributor, or brand has been identified. However, preliminary information indicates that the chopped romaine lettuce was from the Yuma, Arizona growing region. Information collected to date indicates that chopped romaine lettuce from the Yuma, Arizona growing region could be contaminated with E. coli O157:H7 and could make people sick.