The thing about my practice is that I have been involved in the first E. coli lawsuit and will be involved in the next one.

E. coli Outbreak Lawsuits

Kentucky Cabinet for Health and Family Services reports that ten Kentuckians recently tested positive with a strain of E. coli O157:H7. Of the cases, two individuals developed a rare but serious condition called hemolytic uremic syndrome (HUS). Public health investigators have not yet identified the source of the outbreak but have noted that some sort of food distribution is likely.

The reported cases primarily include adults, many of whom reside in western Kentucky. No deaths linked to the outbreak have been reported but six people have been hospitalized. Health care providers have been notified of the outbreak and are advised to be alert for patients experiencing acute diarrheal illness, which could be associated with E. coli. This is a particular strain of E. coli that produces a type of toxin (Shiga toxin) that can be dangerous for those infected.

Symptoms of E. coli O157:H7 typically include stomach cramps and diarrhea, including bloody diarrhea, and people generally become ill two to five days after consuming contaminated food. E. coli O157:H7 sometimes leads to HUS, a serious complication that can cause kidney failure and can occur a week or more after the onset of diarrhea. Those most at risk of developing complications from E. coli infection include the very young, the elderly, and people with weakened immune systems. State health officials are working with staff at local health departments in the counties with suspected or confirmed cases to determine the source of the infections.

The public can help prevent E. coli infections by:

• Washing hands frequently for at least 20 seconds with soap and warm water, especially before eating, after going to the bathroom, handling raw meat and eggs, and after handling or petting animals;
• Thoroughly washing produce before eating;
• Thoroughly cooking meat;
• Cleaning and sanitizing food preparation areas;
• Avoiding swallowing lake or pool water;
• Drinking only pasteurized milk;
• Frequently cleaning and sanitizing restrooms, including door knobs and faucets; and
• Reporting diarrheal illnesses to your physician.

Import requirements for romaine lettuce from the United States (2021)

  1. Introduction

Romaine lettuce imported from the United States have been associated with several outbreaks of foodborne E. coli O157:H7 illnesses in Canada and the U.S. Food safety investigations from U.S. authorities have identified a recurring geographical area as the source of the outbreaks. This area encompasses the California Salinas Valley counties of Santa Cruz, Santa Clara, San Benito, and Monterey.

To decrease the risk associated with E. coli in romaine lettuce, the CFIA is implementing temporary Safe Food for Canadians (SFC) licence conditions for the importation of romaine lettuce originating from the U.S. Between September 30 and December 31, 2021, importers of romaine lettuce and products containing romaine lettuce from the U.S. must:

  • declare that the product does not originate from counties of Santa Cruz, Santa Clara, San Benito and Monterey in the Salinas Valley, California, U.S., or
  • submit an attestation form and Certificates of Analysis for each shipment to demonstrate that the romaine lettuce does not contain detectable levels of E. coli O157:H7

The complete details on the SFC licence conditions and other existing import requirements are outlined in this document.

The temporary SFC licence conditions are in addition to other existing import requirements.

  1. Requirements at time of import

If importers and the products they import comply with other Canadian legislation, the CFIA will allow the importation of romaine lettuce and products containing romaine lettuce from the U.S. if they comply with the temporary SFC licence conditions and other import requirements, as follows:

  1. the importer provides a Proof of Origin indicating the state and county where the romaine lettuce was harvested if the romaine lettuce is from outside of the California counties of Santa Cruz, Santa Clara, San Benito and Monterey
  2. romaine lettuce or products containing romaine lettuce from the California counties of Santa Clara, Santa Cruz, San Benito and Monterey is accompanied by an attestation (using form CFIA/ACIA 5961) that sampling was conducted according to the temporary SFC licence conditions and by the Certificate of Analysis demonstrating that the product does not contain detectable levels of  coliO157:H7
  3. if a Proof of Origin of the romaine lettuce is not available, the attestation and Certificate of Analysis must be provided
  4. romaine lettuce grown in California has been handled by a certified member of the California LGMA
  5. romaine lettuce grown in Arizona has been handled by a shipper that is a certified member of the Arizona LGMA
  1. Temporary SFC licence conditions

Temporary licence conditions pursuant to section 20 (3) of the Safe Food for Canadians Act will be in force for the period from September 30 to December 31, 2021.

During this period, the Canadian Food Inspection Agency will require importers of leafy greens to provide proof that romaine lettuce does not originate from counties of Santa Cruz, Santa Clara, San Benito, and Monterey in the Salinas Valley of California, U.S.

Alternatively, importers who import romaine lettuce or products containing romaine lettuce from the counties of Santa Cruz, Santa Clara, San Benito, and Monterey in the Salinas Valley of California, U.S., or who import products without a valid Proof of Origin, must conform with the following:

  1. The licence holder’s preventive control plan includes a written procedure describing how the sampling and testing requirement outlined below is implemented.
  2. Each shipment is accompanied by an attestation by the importer, in the form provided by the CFIA (CFIA/ACIA 5961), attesting that: they have an official Certificate of Analysis for each romaine-lettuce product in the shipment; sampling and testing was conducted according to the temporary SFC licence conditions (points d., e., and f. below); and  coliO157:H7 was not detected.
  3. Each shipment is accompanied by the Certificates of Analysis issued for the romaine products in the shipment.
  4. The imported product was sampled and tested for  coliO157:H7 according to one of the two sampling options described below and the testing conditions outlined in points e. and f. below:

Option 1: Finished-product sampling

  • Sampling and testing is conducted after all post processing and handling steps are completed, but before the product is imported into Canada.
  • A sampling lot is one type of romaine-lettuce product and a size no larger than the equivalent of 1 truckload of product(no more than 20,400 kilograms/45,000 pounds).
  • For each sampling lot, the minimum sampling and testing requirement is a total sample weight of 1,500 g consisting of 60 individual random sample units of 25 g each.

Option 2: Pre-harvest sampling

  • Sampling of romaine lettuce in the field is conducted no more than 7 days before harvest.
  • A sampling lot is a 2 acre field or less of homogeneous romaine lettuce crop that has been exposed to homogeneous agricultural conditions.
  • For each sampling lot, the minimum sampling and testing requirement is a total sample weight of 1,500 g consisting of 60 individual random sample units (grab specimens) of 25 g each.
  • This sampling option can be used for romaine lettuce that will be field-packed at the time of harvest. This option is also acceptable for romaine lettuce destined to further processing before export (for example, chopped or mixed with other products) if product is to be processed in separate batches, and a link can be established and documented between the Certificate of Analysis of the product sampled in the field and the finished product at the time of import.
  1. Testing with both screening and confirmation methodologies must be performed in a laboratory accredited by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA) as conforming to the requirements of ISO/IEC 17025:2017 for specific tests. The chosen method must be on the laboratory’s scope of accreditation. The “application” section of the method chosen must be appropriate for the intended purpose.
  2. A presumptive positive result from a screening method is treated as a positive result for  coliO157:H7 unless a confirmation test is performed on the original enrichment broth within 24 hours of the first test and produces a negative result (i.e. not detected). The confirmation test is a cultural method that is compatible with the screening method.
  1. Guidance on the temporary SFC licence conditions
  2. Scope

The temporary SFC licence conditions apply to all U.S. import shipments of romaine lettuce and products containing romaine lettuce, sold in bags, in bulk, or combined with other food items, in a fresh state. It applies to all varieties of mature and baby romaine.

  1. Proof of Origin

Shipments of romaine lettuce and products containing romaine lettuce from the U.S. but outside the California counties of Santa Clara, Santa Cruz, San Benito, and Monterey, must be accompanied by a declaration from the exporter on an official company letterhead which includes:

  • the signature of the exporter
  • the date the letter was signed by the exporter
  • the state and county where the romaine lettuce was harvested
  1. Certificate of Analysis

A Certificate of Analysis issued by the laboratory that conducted the test must be provided for each romaine product in an import shipment, demonstrating that the test result for E. coli O157:H7 is negative. The Certificate of Analysis must identify:

  • the date of sample collection
  • the certificate number
  • the laboratory that analysed the sample
  • the client
  • a product description
  • the methodology
  • the sample weight and number of units
  • the test result
  • the test date
  1. Sampling

The sampling level is based on International Commission on Microbiological Specifications for Foods (ICMSF) recommendations for E. coli O157:H7. The two sampling options are considered of similar value in achieving the required sampling level. The sample units must be collected aseptically and be representative of the lot being tested.

Refer to Appendix C: Pre-harvest Product Sampling and Testing Protocol (Version 8/27/2021) from the Western Growers Association for guidance on how to carry out the sampling option 2: Pre-harvest sampling.

Important: please note that to comply with the temporary SFC licence conditions, the following metrics must be met: sampling is conducted within 7 days of harvest; sampling size is 2 acres or less; and the number of sampling units is minimum 60 (grab specimens) for a minimal total mass of 1,500 g per designated lot.

Examples of appropriate sampling for Option 1: Finished-product sampling

When to sample:

  1. Field packaged romaine hearts can be sampled after cooling and just before they are loaded into a transport truck destined for Canada
  2. Bulk romaine lettuce can be sampled just before it is loaded into a transport truck destined for Canada
  3. Mixed salad sold in bags can be sampled during the packaging process at the processing facility or before it is loaded into a transport truck destined for Canada

Sampling lots:

  1. A shipment of 800 cartons of pre-packaged romaine hearts, 50 cartons of wrapped iceberg lettuce and 169 cartons of mixed bagged salad containing romaine lettuce:

This shipment should be considered 2 sampling lots. One (1) sampling lot is 800 cartons of pre-packaged romaine hearts. The other sampling lot is 169 cartons of mixed bagged salad containing romaine lettuce.

  1. A shipment of bulk romaine lettuce with a weight of 14,000 kilograms. The shipment will be delivered to numerous clients in Canada after import to Canada:

This shipment should be considered 1 sampling lot.

  1. An importer purchases 1,500 cartons of pre-packaged romaine hearts weighing less than 20,400 kilograms. This product will be shipped to Canada in 4 shipments headed to various distribution centers in Canada:

This product can be considered 1 sampling lot. The importer’s preventive control plan must include a system for tracking all shipments that are associated with the Certificate of Analysis.

All packages, cases or containers in the sampling lot must be equally represented in the sample. For example, a shipment of 800 cartons should have no more than 1 piece taken in a carton, and the 60 cartons sampled should be selected from various parts of the shipment. A shipment of 10 cartons should be sampled by collecting 6 pieces per carton. Product sampled during the packaging process should be sampled at the beginning, middle and end of the sampling lot.

Examples of appropriate sampling for Option 2: Pre-harvest sampling

When to sample:

  1. Sampling is conducted as close as possible to harvest day, but not more than 7 days before harvest. If the 7-day window is missed, the sampling lot can be re-sampled before harvest or the finished product can be sampled later according to Option 1: Finished-product sampling.

Sampling lots:

  1. A 3-acre plot of romaine lettuce intended for packaged romaine hearts:

Two (2) sampling lots must be taken as the field size from which the romaine lettuce was harvested exceeds the maximum 2-acre sampling size.

  1. A shipment of bulk romaine lettuce with a weight of 14,000 kilograms. The bulk romaine is from two farms:

This shipment should originate from at least two sampling lots (at least one from each farm). The number of sampling lot from each farm depends on field size from which romaine lettuce was harvested (maximum 2-acre sampling size).

  1. A shipment of 169 cartons of mixed bagged salad containing romaine lettuce:

This shipment could originate from one pre-harvest sampling lot provided all of the romaine lettuce was harvested from one field not exceeding 2 acres. The product must be processed in batches separate from other product with a clear break between production lots. A link must be established and documented between the Certificate of Analysis of the product sampled in the field and the finished product at the time of import.

  1. Legislative authority

The licence conditions are based on the following legislative authority.

Section 20(3) of the Safe Food for Canadians Act states: “The Minister may make a registration or licence subject to any additional conditions that the Minister considers appropriate.”

The import requirements are based on the following legislative authority.

Section 8 of the Safe Food for Canadians Regulations and Section 4 of the Food and Drugs Act.

Section 8(1) of the Safe Food for Canadians Regulations states:

“Any food that is sent or conveyed from one province to another or that is imported or exported

  1. must not be contaminated
  2. must be edible
  3. must not consist in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; and
  4. must have been manufactured, prepared, stored, packaged and labelled under sanitary conditions”

Section 4 of the Food and Drugs Act states: “No person shall sell an article of food that:

  1. has in or on it any poisonous or harmful substance;
  2. is unfit for human consumption;
  3. consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;
  4. is adulterated; or
  5. was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.”

Failure to comply with the temporary licence conditions and import requirements may result in enforcement action taken by the CFIA.

Jackson County Public Health is investigating an unusually high number of Shiga toxin-producing Escherichia coli (STEC) cases. Since August 8, 2021, 16 cases have been reported to Jackson County, and 12 (75%) of these cases have been hospitalized.

Jackson County Public Health is working with the Oregon Health Authority on this outbreak investigation.  “Right now, we do not have a definitive hypothesis on what the source of infection may be. The genome sequencing, performed at the state public health lab, has not matched any other cases in the state or nationally,” states Dr. Jim Shames, Health Officer for Jackson County Public Health. “Therefore, we continue to do in-depth interviews with those that have tested positive to help us identify a possible source of exposure.”

Jackson County Public Health is asking medical providers to be aware of the increases in STEC cases in Jackson County and collect and test stool specimens on patients suspected to have bacterial gastroenteritis. Shiga-toxigenic Escherichia coli (including 0157, HUS, and other serogroups) are reportable infections to local and state public health.

Escherichia coli (E. coli) bacteria normally live in the intestines of people and animals. Most E. coli are harmless and actually are an important part of a healthy human intestinal tract. However, some E. coli are pathogenic, meaning they can cause illness, either diarrhea or illness outside of the intestinal tract. The types of E. coli that can cause diarrhea can be transmitted through contaminated water or food, or through contact with animals or persons. Some kinds of E. coli cause disease by making a toxin called Shiga toxin. The bacteria that make these toxins are called “Shiga toxin-producing” E. coli, or STEC for short. This pathotype is the one most commonly heard about in the news in association with foodborne outbreaks.

There are everyday steps that can help you prevent E. coli infections:

  • Practice good overall hygiene with special attention to good handwashing.
  • Wash your hands after touching animals or their environments.
  • Keep what you eat and drink away from animals.
  • Cook meats thoroughly. Prevent raw meat from contacting other food. Do this by washing hands, utensils, cutting boards and surfaces after use to prepare meat.
  • Avoid consuming raw and unpasteurized dairy and juice products.
  • Avoid school and childcare attendance, food handling and patient care if you are ill. People with diarrhea should not go to school or child care, handle food, or care for patients.

Symptoms of Shiga toxin-producing E. coli (STEC) infection vary for each person, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. Some people may have a fever, which usually is not very high (less than 101˚F/38.5˚C). Most people get better within 5 to 7 days. Some infections are very mild, but others are severe or even life-threatening.

Most people with a STEC infection start feeling sick 3 to 4 days after eating or drinking something that contains the bacteria. However, illnesses can start anywhere from 1 to 10 days after exposure. Contact your healthcare provider if you have diarrhea that lasts for more than 3 days or diarrhea that is accompanied by a fever higher than 102˚F, bloody diarrhea, or so much vomiting that you cannot keep liquids down and you pass very little urine.

About 5 to 10% of people who are diagnosed with STEC infection develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). HUS develops about 7 days after symptoms first appear, when diarrhea is improving. Clues that someone is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids. People with HUS should be hospitalized because their kidneys may stop working and they may develop other serious problems. Most people with HUS recover within a few weeks, but some suffer permanent damage or die.

PRESS RELEASE

Since the outbreak was announced, Marler Clark has been contacted by families of two Mississippi children who remain hospitalized due to acute kidney failure and the families of Alabama and Louisiana children also stricken by E. coli O157:H7.  We have filed 2 lawsuits in Louisiana and Mississippi – others will be filed this week.

On August 9th, the Mississippi State Department of Health (MSDH) announced it had identified several cases of E. coli O157 infection associated with use of the swimming pool and/or splashpad at the Jellystone Park Camp Resort-Yogi on the Lake in Pelahatchie, Miss.

The cases identified so far have exposure dates on the weekend of July 30th through August 1st, but additional exposures may have occurred through August 9, 2021. The pool and splashpad were closed on August 9, 2021.

This is an evolving situation and MSDH is conducting an ongoing investigation to identify any additional cases.

Individuals who were swimming in the pool or splashpad at Yogi on the Lake in Pelahatchie between July 30 and August 9 should monitor for symptoms of stomach cramps, diarrhea, vomiting and fever. Consult a healthcare provider immediately if you do have symptoms and tell your provider about your exposure.

First Federal E. coli Lawsuit – 2021.8.17_Braud v. Great Escapes

Second State Court E. coli Lawsuit – [2] Complaint – Neely

Four cases of a toxin producing the bacteria and one case of a resultant blood syndrome stemmed from customers eating at the Portillo’s at 235 E. North Ave. in Glendale Heights on July 16 and 17, IDPH wrote in a health alert.

The “possible issue” came from four customers during that time period, Portillo’s spokeswoman Sara Wirth wrote in a Saturday statement. She said the company reexamined its food safety protocols after learning of the outbreak.

“Across Portillo’s, we have extensive sanitary and food handling guidelines in place, including daily deep cleanings of all restaurants,” Wirth said. “Once notified, we moved quickly and began assisting with the investigation and revisiting our food safety best practices with our team members to mitigate potential future risk.”

The health department is urging doctors to consider an E. coli diagnosis in symptomatic patients who have recently eaten at the location.

With an average incubation period of one to 10 days, the condition can include cramps and diarrhea and, in children and older adults, kidney failure and red blood cell destruction, IDPH said.

As of July 27, 2021, 16 people infected with the outbreak strain of E. coli O121 have been reported from 12 states. Illnesses started on dates ranging from February 26, 2021 to June 21, 2021.

Sick people range in age from 2 to 73 years, with a median age of 13, and 100% are female. Of 16 people with information available, 7 have been hospitalized. One person has developed a type of kidney failure called hemolytic uremic syndrome (HUS), and no deaths have been reported.

State and local public health officials are interviewing people about the foods they ate in the week before they got sick. Of the eight people interviewed, six (75%) reported tasting or eating raw batter made with a cake mix. People reported buying different varieties and brands of cake mix.

FDA is conducting a traceback investigation using purchase records from locations where sick people bought cake mix to try to determine a common cake mix brand or production facility.

CDC advises people not to eat raw cake batter, whether made from a mix or homemade. Eating raw cake batter can make you sick. Raw cake batter can contain harmful bacteriaBacteria are killed only when raw batter is baked or cooked.

Food Safety News reports that the CDC is working with other public health agencies to investigate an 11-state outbreak of E. Coli O121 infections.

As of July 15 a total of 15 patients had been confirmed with infections, a CDC spokesperson told Food Safety News. No other information from the agency was available for release.

The Food and Drug Administration reported on July 14 that it was investigating an E. Coli O121 outbreak involving 15 patients, but the agency did not release any other details except to say that no traceback or sample testing had been initiated.

Few details were available from the Centers for Disease Control and Prevention.

“We are working to determine a source of the infections. If we identify a source and an ongoing risk to the public, we will issue an outbreak notice,” the CDC spokesperson told Food Safety News.

Food Safety News reports that the CDC is working with other public health agencies to investigate an 11-state outbreak of E. Coli O121 infections.

As of July 15 a total of 15 patients had been confirmed with infections, a CDC spokesperson told Food Safety News. No other information from the agency was available for release.

The Food and Drug Administration reported on July 14 that it was investigating an E. Coli O121 outbreak involving 15 patients, but the agency did not release any other details except to say that no traceback or sample testing had been initiated.

Few details were available from the Centers for Disease Control and Prevention.

“We are working to determine a source of the infections. If we identify a source and an ongoing risk to the public, we will issue an outbreak notice,” the CDC spokesperson told Food Safety News.

Olivia Garrett of the Telegraph Herald reports:

MAQUOKETA, Iowa — Several Maquoketa children are receiving care at University of Iowa Stead Family Children’s Hospital in Iowa City after developing serious complications from E. coli.

But local health officials have not yet identified the source.

Multiple Maquoketa children developed hemolytic uremic syndrome, prompting the treatment in Iowa City. HUS is a serious complication that can be caused by shiga toxin-producing E. coli, also known as STEC.

The Jackson County Health Department, through Genesis VNA, is working to determine what might have caused the outbreak. Community Health Manager Michele Cullen said Monday that this process involves contact tracing, but a source has not yet been identified.

Two-year-old Calvin “Cal” Notz is one of the children suffering from the rare and serious illness.

His mother, Nichole Notz, said it started on May 21, when Cal was tired and wouldn’t eat. By May 23, more concerning symptoms had emerged, including bloody and loose stools.

“That’s when we knew it was something more than just a little bug,” Notz said.

Cal’s parents took him to urgent care, where he was quickly sent to the hospital. On May 25, Cal was transferred to the Iowa City hospital for more specialized care. Cal suffered from seizures and a stroke and was placed in a medically induced coma, Notz said.

“He is improving at this point now,” Notz said Monday. “He is coming off the coma. … Today, he is doing well.”

According to the Blue Mountain Eagle:

Members of the Maquoketa community gathered June 2 at the Grove Street Park for a prayer vigil to support Cal Notz and Briella Davis, two children stricken with a rare kidney illness caused by E. coli.

Tara Notz, the sister-in-law of Cal’s parents Matt and Nichole Notz, welcomed people and thanked everyone on behalf of the family for their prayers and support and for attending the vigil, which included singing and prayers led by Pastor Nathan Combs of Prairie Creek Church.

“We want people to know our hearts are so full,” Nichole Notz said during a phone call after the vigil. “We are feeling everyone’s love, prayers and well-wishes. We love Maquoketa and being back in our home town. The support we’ve felt just confirms we are supposed to be here. We are so blessed.” 

Maggie Ward and Caleb Davis, Briella’s parents, also expressed their thanks to the community for its support.

“It has been so heartwarming. We appreciate all the messages and offers to help in any way,” Ward said.

Since the vigil, a third child, Shane Howell, also has been diagnosed with the same illness. All three children are being treated at the University of Iowa Stead Family Children’s Hospital.

According to Nancy Mayfield of the Maquoketa Sentinel-Press:

Jessi Howell’s motherly instincts kicked in when she noticed her 12-year-old son Shane wasn’t acting quite like himself.

 “I would like to share with everyone to never second guess their instincts,” she said to the Sentinel-Press via Messenger Friday. Shane is one of three Maquoketa children hospitalized at the University of Iowa Stead Family Children’s Hospital with complications from a rare strain of E. coli.

“We knew something wasn’t right. Shane doesn’t like to complain about anything and doesn’t like going to doctors for even simple routine visits. When he stopped being his normal 12-year-old self and didn’t have a football in his hands, we knew it was bad, but we never could have dreamed of just how bad it was about to get,” she said.

His parents quickly got him medical attention. Shane is currently on dialysis as he battles Hemolytic Uremic Syndrome (HUS), a rare complication that can occur with a shiga toxin-producing Escherichia coli (STEC) infection. Briella Davis, 18 months, and Cal Notz, 2, both from Maquoketa, are also at the children’s hospital battling the same illness.

The parents of the three hospitalized children have been keeping friends and family updated through Facebook posts, from which they gave the Sentinel-Press permission to share information. They also have shared information with the newspaper via texts, phone calls and messenger.

Briella is progressing well, and her dialysis stopped earlier this week, said her mother, Maggie Ward, via text late Friday afternoon.

“She just got moved out of the Pediatric Intensive Care Unit to inpatient a few hours ago,” she wrote.

Howell reported Friday that Shane was still on dialysis and was able to take a small walk and about five laps around the children’s unit in a wheelchair. On Saturday morning she said she expected him to be moved from intensive care later in the day.

Cal’s condition is more serious, and he was in a medically induced coma due to seizures and receiving dialysis, his mother, Nichole Notz, reported. On Saturday morning, the family reported on the Facebook page Prayers for Cal that he had had a stable night with no seizures.

All three families are thankful for the community support and prayers, the mothers said.