Legal Cases

Subscribe to Legal Cases

I took the time to fully read FDA Warning Letter sent to Kerry, Inc., that manufactured Honey Smacks for Kellogg’s.  Here is the somewhat redacted beginning:

The United States Food & Drug Administration (FDA) inspected your Kerry, Inc. facility, located at 320 West Gridley Road, Gridley, IL 61744-8723 from June 14 to 29, 2018. The inspection was initiated as (b)(4) in three environmental swabs taken from your (b)(4) cereal (“cereal”) production rooms during FDA’s inspection. Further, FDA’s Whole Genome Sequencing (WGS) analysis of the three isolates of (b)(4).

Here are the highlights/lowlights of the Warning Letter:

Between September 29, 2016 and May 16, 2018, you repeatedly found Salmonella throughout your facility, including in cereal production rooms. During this time period, you had 81 positive Salmonella environmental samples and 32 positive Salmonella vector samples (samples taken in response to finding a positive on routine testing), including four Salmonella (b)(4) samples in the cereal coating room (Line (b)(4)) and one Salmonella (b)(4) sample in the cereal (b)(4) room (Line (b)(4)). Further, you had repeated findings of other Salmonella species in some production lines and rooms used for the manufacture of cereal. These repeated findings of Salmonella in your environment should have resulted in a reanalysis of your food safety plan as required by 21 CFR § 117.170(b)(4) and the identification of contamination of RTE cereal with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation preventive control).

So, in the coming days, as I explain to clients how a company, like Kerry, can seem to ignore 113 positive Salmonella samples and continue to manufacture and ship the Sugar Smacks. The Kerry, the FDA and Kellogg’s will need to explain this to the general public.  My clients and a part of the public is included in:

Total Salmonella Illnesses: 135
Hospitalizations: 34
Last illness onset: 8/29/2018

As of September 19, 2018, 18 people infected with the outbreak strain of E. coli O26 were reported from 4 states – Colorado (10), Florida (15), Massachusetts (1) and Tennessee (1). Illnesses started on dates ranging from July 5, 2018 to July 25, 2018. Ill people ranged in age from one year to 75, with a median age of 16. Sixty-seven percent of ill people were male. Of 18 people with information available, 6 (33%) were hospitalized, including one person who died in Florida.

Epidemiologic, laboratory, and traceback evidence indicates that ground beef from Cargill Meat Solutions was a likely source of this outbreak.

In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Fourteen (100%) of 14 people interviewed reported eating ground beef. Ill people purchased ground beef from several different grocery stores, including Publix Super Markets, Inc.

USDA-FSIS conducted traceback investigations from stores where ill people reported buying ground beef. Initial information collected from ill people in Florida indicated that the ground beef was purchased from various Publix grocery stores. On August 30, 2018, Publix Super Markets, Inc. recalled ground chuck products sold in several Florida counties.

Further traceback investigation by USDA-FSIS identified Cargill Meat Solutions in Fort Morgan, Colorado as the source of the contaminated ground beef linked to illness, including the recalled ground beef sold at Publix stores in Florida. On September 19, 2018, Cargill Meat Solutions recalled ground beef products that were produced and packaged on June 21, 2018. Products are labeled with the establishment number “EST. 86R” inside the USDA mark of inspection. The products were shipped to retailers nationwide.

Laboratory testing identified the outbreak strain of E. coli O26 in leftover ground beef collected from the home of one ill person in Florida. WGS analysis showed that the E. coli O26 strain identified in the leftover ground beef was highly related genetically to the E. coli O26 strain isolated from ill people.

Cargill Ground Beef 2018 – 17 Ill, 1 Death – E. coli O26

On Aug. 16, 2018, FSIS was notified of an investigation of E. coli O26 illnesses. FSIS, the Centers for Disease Control and Prevention, and state public health and agriculture partners determined that raw ground beef was the probable source of the reported illnesses. The epidemiological investigation identified 17 illnesses and one death with illness onset dates ranging from July 5 to July 25, 2018.  On August 30thPublix Super Markets Inc., a Lakeland, Fla., retail grocery store chain recalled an undetermined amount of ground beef products made from chuck that may be contaminated with Escherichia coli O26.  On September 19th, Cargill Meat Solutions, a Fort Morgan, Colorado establishment, recalled approximately 132,606 pounds of ground beef products made from the chuck portion of the carcass that may be contaminated with Escherichia coli O26,

A bit of History:

Cargill Ground Beef 2012 – 40 Ill – Salmonella

On July 22, 2012 Cargill Meat Solutions announced a recall of 29,339 pounds of fresh ground beef products due to possible contamination with Salmonella Enteritidis. Using epidemiologic and traceback data public health investigators in 8 states (MA, ME, NH, NY, RI, VA, VT, and WV) and the CDC linked 40 patients diagnosed with S. Enteritidis to consumption of Cargill ground beef sold at Hannaford grocery stores in Massachusetts, Maine, New Hampshire, New York and Vermont. Among 40 persons for whom information is available, illness onset dates ranged from June 6, 2012 to July 9, 2012. Eleven patients were hospitalized. The Vermont Department of Health isolated the outbreak strain in leftover product.

Cargill Meat Solutions Ground Turkey 2011 – 181 Ill – Salmonella

The U.S. Department of Agriculture’s Food Safety and Inspection Service(FSIS) issued a public health alert, on July 29, due to concerns about illnesses caused by Salmonella Heidelberg that associated with the use and the consumption of ground turkey. The alert was initiated after continuous medical reports, ongoing investigations and testing conducted by various departments of health across the nation determined an association between consumption of ground turkey products and illness. On August 3, Cargill Meat Solutions issued a recall of ground turkey products. The products subject to recall bear the establishment number “P-963” inside the USDA mark of inspection. On August 4, the Centers for Disease Control published their first outbreak summary. The Salmonella Heidelberg was multi-drug resistant, resistant to ampicillin, streptomycin, tetracycline, and gentamycin. The CDC began their investigation on May 23, after recognizing an “unusual clustering” of Salmonella Heidelberg cases. About the same time, routine surveillance by a federal food monitoring system found the same strain of Salmonella Heidelberg in ground turkey in stores. On July 29, the initial outbreak strain and a second, closely related, strain of Salmonella Heidelberg was isolated from a sample of leftover unlabeled frozen ground turkey from the home of an outbreak case in Ohio. Since February 27, 2011, a total of 23 ill persons were reported to Pulse Net with this second, closely related, strain. Eighty-four ill persons were infected with the initial strain. The consumer product sample originated from the Cargill Meat Solutions Corporation establishment in Springdale, Arkansas. On September 11, Cargill Meat Solutions recalled an additional, approximately 185,000 pounds, of ground turkey contaminated with an identical strain of Salmonella Heidelberg that had led to the earlier recall on August 3. As of September 27, no illnesses had been linked to the additionally recalled, ground turkey products.

Cargill Meat Solutions/BJ’s Wholesale Club Ground Beef 2010 – 3 Ill – E. coli O26

A recall of ground beef was issued on August 28 when three people developed illnesses caused by rare strain of E. coli O26 after they had eaten the product. The ground beef produced by Cargill Meat Solutions, of Pennsylvania and was distributed to BJ’s Wholesale Clubs in New York, Maine, Connecticut, Virginia, New Jersey, New Hampshire, Massachusetts, and Maryland.

Beef Packers, Inc., Cargill, Ground Beef 2009 – 2 Ill – Salmonella

In December, Beef Packers, Inc., owned by Cargill, recalled over 20,000 pounds of ground beef contaminated with a drug-resistant strain of Salmonella Newport. The company issued an earlier recall in August 2009, due to contamination of ground beef with the same strain of Salmonella Newport. This contaminated ground beef was produced in September and was distributed to Safeway grocery stores in Arizona and New Mexico. The Arizona Department of Health linked two illnesses to the ground beef.

Beef Packers, Inc., Cargill, Ground Beef 2009 – 68 Ill – Salmonella

A Beef Packers, Inc. plant in California owned by Cargill, distributed approximately 830,000 pounds of ground beef that was likely contaminated with Salmonella Newport. The beef was shipped to distribution centers in Arizona, California, Colorado, and Utah where it was repackaged into consumer-sized packages and sold under different retail brand names. The contaminated beef contained a strain of Salmonella resistant to several commonly used antibiotics (called MDR-AmpC resistance). Sixty-eight outbreak associated cases were reported by 15 states. Most of the ill in Colorado had purchased the ground beef at Safeway grocery stores.

Cargill Ground Beef Sold at Sam’s Club Stores 2007 – 46 Ill – E. coli O157:H7

A multistate outbreak of E. coli O157:H7 began in August and led to the eventual recall of 845,000 pounds of Cargill ground beef. Forty-six cases were reported by 15 states. Interviews with the case-patients found a common exposure of Cargill hamburger.

Emmpak/Cargill Ground Beef 2002 – 57 Ill – E. coli O157:H7

Wisconsin epidemiologists noted a cluster of E. coli O157:H7 cases. The health department interviewed case-patients and found a common exposure. All victims had eaten ground beef from Emmpak, a meat producer. The same strain of E.coli O157:H7 was isolated from the ground beef. The case investigation resulted in a 2.8-million-pound recall of Emmpak meat and resulted in related illnesses in at least six states. The responsible Emmpak plant was closed for inadequate sampling and testing procedures.

Cargill Deli Turkey 2000  – 29 Ill – Listeria

A case-control study implicated sliced, processed, turkey deli meat in a multistate (11 state) outbreak. A traceback investigation identified a single processing plant in Texas as the likely source of the outbreak. The company recalled 16 million pounds of processed meat. The same plant had been implicated in a Listeria contamination involving the same strain of Listeria more than a decade previously.

On Aug. 16, 2018, FSIS was notified of an investigation of E. coli O26 illnesses. FSIS, the Centers for Disease Control and Prevention, and state public health and agriculture partners determined that raw ground chuck was the probable source of the reported illnesses. The epidemiological investigation identified 18 case-patients, predominantly from Florida, with illness onset dates ranging from July 5 to July 25, 2018. Traceback information indicated that case-patients consumed ground chuck products purchased at various Publix Super Markets that was supplied by a yet-to-be determined source.

2018 Outbreak of E. Coli O26 Linked to Homegrown Restaurants, King County, Washington

  • Organism:
  • Non-O157 STEC
  • Vehicle:
  • Chicken pesto sandwich

On May 25, 2018 Public Health Seattle King County (PHSKC) announced an outbreak of E. Coli O26 associated with Homegrown Restaurants. Four cases were reported. Three were laboratory confirmed with a genetically indistinguishable strain of E. Coli …Read More »

2017 E. coli O157:H7 and E. coli O26 outbreak among Marine recruits, California

  • Organism:
  • coli O157:H7, Non-O157 STEC
  • Vehicle:
  • beef

In October 2017 an outbreak of E. coli O157:H7 and E. coli O26 occurred among recruits at the Marine Corps Recruit Depot in San Diego and the command’s field training facilities at Edson Range, Camp Pendleton, California. Investigators identified 62 …Read More »

2017 Outbreak of E. coli O26 in Multiple Counties, Colorado

  • Organism:
  • Non-O157 STEC
  • Vehicle:
  • Unknown

Six people residing in Adams, Arapahoe, Denver and Douglas counties, Colorado were laboratory confirmed with E. coli O26 between September 1, 2017 and October 15, 2017. One person was hospitalized. No one died. Three out of 6 cases consumed raw spina…Read More »

2015 Outbreak of E. coli O26 Linked to Chipotle Mexican Grill, Washington and Oregon

  • Organism:
  • Non-O157 STEC
  • Vehicle:
  • unknown

The CDC, FDA, USDA FSIS and public health officials in several states investigated two outbreaks of E. coli O26 linked to food sold at Chipotle Mexican Grill restaurants. Public health investigators used PulseNet to identify illnesses that were part …Read More »

2013 Multi-state Outbreak of E. coli O26 Suspected to be Caused by Iceberg Lettuce

  • Organism:
  • Non-O157 STEC
  • Vehicle:
  • Iceberg lettuce

In the spring of 2013 twenty six cases of E. coli O26 were reported by 13 states: Illinois (6), Minnesota (5), Wisconsin (3), Michigan (2), California (2) and Kentucky, Missouri, Mississippi, New Jersey, new York, Ohio, Washington and West Virginia, …Read More »

2011 Outbreak of E. coli O26 at Jimmy John’s Restaurants Linked to Raw Clover Sprouts

  • Organism:
  • Non-O157 STEC
  • Vehicle:
  • Vegetables, Sprouts, Clover Sprouts

On February 15, 2012, the Centers for Disease Control first announced an ongoing investigation into illnesses linked to the consumption of raw clover sprouts consumed at Jimmy John’s Restaurants in several states. The illnesses were caused by E. co…Read More »

Cargill Meat Solutions/BJ’s Wholesale Club Ground Beef 2010

  • Organism:
  • Non-O157 STEC
  • Vehicle:
  • Beef, Ground Beef

A recall of ground beef was issued on August 28 when three people developed illnesses caused by rare strain of E. coli O26 after they had eaten the product. The ground beef produced by Cargill Meat Solutions, of Pennsylvania and was distributed to B…Read More »

Thanks for Outbreak Database Dot Com.

And, there is some history to consider:

Last year (2010), the USDA’s Food Safety and Inspection Service (FSIS) was petitioned to declare six additional disease-causing and potentially life-threatening strains of E. coli, those referred to as non-O157 Shiga-toxin producing E. coli (STECs) or more succinctly, “the big six,”  as adulterants.Specifically, those six strains include E. coli O26, O11, O103, O121, O45 and O145. Those strains of the E. coli bacteria were targeted because of their capacity to produce the same deadly Shiga toxins as E. coli O157.

Today, despite much controversy and debate and after many months of waiting, those six dangerous strains of E. coli will now be banned from the nation’s meat supply and take their place with E. coli O157 to be classified as adulterants. Accordingly, it will be illegal for meat packers to sell meat contaminated with those pathogens.

William Neuman of The New York Times explained that in his report:

Under the rule, any meat that is found to contain the Big Six E. coli, in tests by government or industry, will have to be diverted for use in cooked products. The bacteria is killed by heating the meat to 160 degrees.

Previously, in 1994, FSIS declared E. coli O157 to be an adulterant an outbreak linked to tainted hamburger patties sold at Jack in the Box restaurants sickened more than 700 people in four states and led to 171 hospitalizations and four deaths. In 2010, in support of the petition to label “the big six” as adulterants, Bill Marler wrote: “the people of this nation do not deserve another Jack in the Box-sized catastrophe as a pre-requisite for currently needed agency action.”

According to a news story by MSNBC health reporter JoNel Aleccia:

The move was hailed as a long-sought victory by food safety advocates, who said they wondered why it took so long to require testing for bacteria that last year collectively caused more infections in the U.S. than E. coli 0157.

“I think what consumers can expect is less contaminated product making it into commerce,” said Nancy Donley, president of the agency STOP Foodborne Illness. “It’s fantastic news.”

Bill Marler, seasoned attorney and food safety advocate, also applauded the move by FSIS as a step in the right direction. In an interview with Aleccia, Marler said, “I am more than pleased. It’s a big recognition that there are other pathogens out there that cause human disease.”

As Aleccia noted in her report:

In 2010, for the first time, those rarer strains of E. coli were responsible for more infections in the U.S. than E. coli O157, according to a June study released by the Centers for Disease Control and Prevention. The non-STECs caused 451 confirmed infections last year, including 69 people who were hospitalized and one death. E. coli O157 caused 442 infections, 184 hospitalizations and two deaths.

However, CDC officials say many infections are never detected. The agency estimates that overall, as many as 265,000 STEC infections occur each year in the United States, with the non-0157 strains causing up to 113,000 illnesses and 300 hospitalizations annually.

Today’s decision will hopefully serve to better protect the public from foodborne illness. As Elisabeth Hagen, the head of food safety for the Department of Agriculture, told William Neuman, “This is one of the biggest steps forward in the protection of the beef supply in some time.” She added, “We’re doing this to prevent illness and to save lives.”

I have been thinking today about what growers in Yuma are going to do next season?  With the FDA and CDC fingering the water from an irrigation canal that flowed by a feedlot with some 100,000 cows, you have to wonder what is going to happen next season if nothing changes?  What are grocery stores and restaurants going to do?  What will consumers demand?

This Years Outbreak

In April 2018 local, state and federal public health and agriculture agencies announced an outbreak of E. coli O157:H7 linked to romaine lettuce from the Yuma, Arizona growing area. On June 28, 2018 the Centers for Disease Control and Prevention (CDC) declared the outbreak over.

The outbreak strain was identified as PulseNet strain EXHX01.0047/EXHA26.0626. A total of 210 people in the United States infected with the outbreak strain of E. coli O157:H7 were reported from 36 states.

States reporting outbreak associated case patients

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 years. 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 (HUS), a type of kidney failure. Five deaths were reported from Arkansas, California, Minnesota (2), and New York.

WGS analysis of isolates from 184 ill people identified antibiotic resistance to chloramphenicol, streptomycin, sulfisoxazole, tetracycline, and trimethoprim-sulfamethoxazole. Standard antibiotic resistance testing of eight clinical isolates by CDC’s National Antimicrobial Resistance Monitoring System (NARMS) laboratory confirmed these findings. Isolates from four of those ill people also contained genes for resistance to ampicillin and ceftriaxone.

In Canada there were eight illnesses of E. coli O157:H7 with a similar genetic fingerprint to illnesses reported in the U.S. investigation. The eight Canadian illnesses were reported in five provinces:  British Columbia (1), Alberta (1), Saskatchewan (2), Ontario (3), and Quebec (1). Individuals in Canada became sick between March and April 2018. One patient was hospitalized and no one died. Based on the evidence from the U.S. outbreak investigation and information provided by individuals who became sick, Canadian investigators concluded that the likely source of illness in Canada was contaminated romaine lettuce. All of the individuals reported having eaten romaine lettuce at home or in prepared salads purchased at grocery stores, restaurants and fast food chains before their illnesses occurred. Two Canadians did report traveling to the U.S. before getting sick and eating romaine lettuce while they were there.[1]

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 was closely related genetically to the E. coli O157:H7 isolated in ill people. Investigators believe this finding suggests that contaminated water coming into contact with produce, either through direct irrigation or other means, is a viable explanation for transmission of the bacteria to romaine lettuce. The FDA also notes that the canal is close to a Concentrated Animal Feeding Operation (CAFO), a facility that can hold in excess of 100,000 head of cattle at any one time. FDA traceback information showed a clustering of romaine lettuce farms nearby. The Environmental Assessment report will be made publicly when complete.[2]  

And a Bit(e) of Lettuce History

Date Vehicle Etiology Confirmed
Cases		 States/Provinces
July 1995 Leafy Greens E. coli O157:H7 74 1:MT
Sept. 1995 Romaine E. coli O157:H7 20 1:ID
Sept. 1995 Iceberg E. coli O157:H7 30 1:ME
Oct. 1995 Iceberg E. coli O157:H7 11 1:OH
May-June 1996 Mesclun Mix E. coli O157:H7 61 3:CT, IL, NY
May 1998 Salad Mix E. coli O157:H7 2 1:CA
Feb.-Mar. 1999 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 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 Salad Mix 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 Romaine E. coli O157:H7 32 3:MN, WI, OR
Sept. 2006 Spinach 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 58 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

 

[1] https://www.canada.ca/en/public-health/services/public-health-notices/2018/public-health-notice-outbreak-e-coli-infections-linked-romaine-lettuce.html

[2] https://www.cdc.gov/ecoli/2018/o157h7-04-18/0; and https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm604254.htm

The big takeaway is that this outbreak was caused by an environmental contaminate – a lot of cows in a feedlot near the water source used to irrigate crops.

So, if nothing changes environmentally and a similar E. coli outbreak happens, what is the responsibility of the growers, processors, shippers and “points of sale” – grocery stores and restaurants?

Perhaps we should take a look at Black’s Law Dictionary on punitive damages:

“Punitive damages are designed to not only discourage the defendant in question from engaging in similar behavior in the future, but are also meant to be a message sent to society at large. Civil courts that punish reckless or negligent behavior with punitive damages indicate to others that such behavior will not be tolerated and that that behavior can lead to monetary consequences.”

If next spring another E. coli outbreak happens in Yuma linked to the same cause and people get sick and/or die – count on punitive damages against against everyone – “Farm to Fork.”

When food makes people sick all around the country, an army of germ detectives jumps into action.

Listen here: https://one.npr.org/?sharedMediaId=641737545:641737661

CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration are investigating a multistate outbreak of Cyclospora infections. At this time, there is no evidence to suggest that this cluster of illnesses is related to the  Cyclosporaoutbreak linked to Del Monte fresh produce vegetable trays.

As of August 23, 2018 (12pm EDT), a total of 507 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states and New York City. Note, the Connecticut, New York City, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.

Illnesses started on or after May 20, 2018. The median illness onset date is June 29, 2018 (range: May 20 to July 21). Ill people range in age from 14 to 91 years old, with a median age of 52. Sixty-six percent (66%) are female. At least 24 people have been hospitalized; no deaths have been reported.

Illnesses that started after July 12, 2018 might not have been reported yet due to the time it takes between when a person becomes ill and when the illness is reported. For Cyclospora infections, this can take up to six weeks.

Epidemiologic evidence indicates that salads purchased from McDonald’s restaurants are one likely source of these infections. The investigation is ongoing, and FDA is working to determine the sources of the ingredients that were in common to the salads served at McDonald’s.

On July 26, 2018, FDA completed analysis of an unused package of romaine lettuce and carrot mix distributed to McDonald’s by the Fresh Express processor in Streamwood, IL. The analysis confirmed the presence of Cyclospora in that mix. On July 27, 2018, FDA informed Fresh Express of these results.

Fresh Express reported to FDA that the carrots in the mix went to McDonald’s restaurant locations only, and that the romaine lettuce was the only ingredient in the mix that was distributed to other locations. Romaine lettuce from the same lot that was positive for Cyclospora was distributed in pre-made salads and wraps distributed by Caito Foods LLC of Indianapolis, IN. Fresh Express also reported that no romaine lettuce from the lot that was positive for Cyclospora was packaged for direct retail sale to consumers.

On July 30, 2018, The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a public health alert about pre-made salads and wraps containing romaine lettuce that were distributed by Caito Foods LLC of Indianapolis, IN. The pre-made salads and wraps were shipped to distribution centers nationwide. The pre-made salads and wraps were produced July 15 to July 18, 2018 and have a “Best By,” “Enjoy by,” “Best if Sold By,” or “Sell By” date ranging from July 18 through July 23, 2018. See the product labels here. The pre-made salads and wraps have establishment number “EST. 39985” or “P-39985” inside or next to the USDA mark of inspection. See the full list of products, product labels, UPC code numbers, and other identifying information here.

1,060 laboratory-confirmed listeriosis cases have been reported from 01 January 2017 to 17 July 2018. The number of new cases reported each week has decreased since the implicated products were recalled on 04 March 2018 with no new cases of listeriosis reported during the week prior to release of this sitrep (Figure 1). Neonates ≤28 days of age are the most affected age group (42%, 443/1 060), followed by adults aged 15 – 49 years of age (32%, 334/1 060) – Figure 2. Most cases have been reported from Gauteng Province (58%, 614/1 060), followed by Western Cape (13%, 136/1 060) and KwaZulu-Natal (8%, 83/1 060) provinces. Final outcome (i.e. death or discharge) is known for 76% (806/1 060) of total cases to date; 27% (216/806) with known outcome died.

Prior to 2017, an average of 60 to 80 laboratory-confirmed listeriosis cases per year (approximately 1 per week), were reported in South Africa. In July 2017, an increase in laboratory-confirmed cases of listeriosis was reported to National Institute for Communicable Diseases (NICD) which triggered further investigation. On 05 December 2017, the listeriosis outbreak was declared by the Minister of Health, Dr. Aaron Motsoaledi. The source of the outbreak was identified as ready-to-eat processed meat products manufactured at Enterprise Foods’ Polokwane production facility. A recall of affected products was initiated on 04 March 2018.

Full Report

As of August 16, 2018 (3pm EDT), a total of 476 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states. Note, the Connecticut, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.  Illnesses started on or after May 20, 2018. The median illness onset date is June 29, 2018 (range: May 20 to July 20). Ill people range in age from 14 to 91 years old, with a median age of 53. Sixty-six percent (66%) are female. At least 21 people have been hospitalized; no deaths have been reported.

Epidemiologic evidence indicates that salads purchased from McDonald’s restaurants are one likely source of these infections. The investigation is ongoing, and FDA is working to determine the sources of the ingredients that were in common to the salads served at McDonald’s.

On July 26, 2018, FDA completed analysis of an unused package of romaine lettuce and carrot mix distributed to McDonald’s by the Fresh Express processor in Streamwood, IL. The analysis confirmed the presence of Cyclospora in that mix. On July 27, 2018, FDA informed Fresh Express of these results.

Fresh Express reported to FDA that the carrots in the mix went to McDonald’s restaurant locations only, and that the romaine lettuce was the only ingredient in the mix that was distributed to other locations. Romaine lettuce from the same lot that was positive for Cyclospora was distributed in pre-made salads and wraps distributed by Caito Foods LLC of Indianapolis, IN. Fresh Express also reported that no romaine lettuce from the lot that was positive for Cyclospora was packaged for direct retail sale to consumers.

On July 30, 2018, The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a public health alert about pre-made salads and wraps containing romaine lettuce that were distributed by Caito Foods LLC of Indianapolis, IN. The pre-made salads and wraps were shipped to distribution centers nationwide. The pre-made salads and wraps were produced July 15 to July 18, 2018 and have a “Best By,” “Enjoy by,” “Best if Sold By,” or “Sell By” date ranging from July 18 through July 23, 2018. See the product labels here. The pre-made salads and wraps have establishment number “EST. 39985” or “P-39985” inside or next to the USDA mark of inspection. See the full list of products, product labels, UPC code numbers, and other identifying information here.

The CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration are investigating a multistate outbreak of Cyclospora infections. As of August 9, 2018 (11am EDT), a total of 436 laboratory-confirmed cases of Cyclospora infection were reported in people who consumed salads from McDonald’s restaurants; the cases were reported by 15 states. Note, the Connecticut, Tennessee, and Virginia case-patients purchased salads while traveling in Illinois; the Florida case-patient purchased a salad while traveling in Kentucky.

Illnesses started on or after May 20, 2018. The median illness onset date is June 29, 2018 (range: May 20 to July 20). Ill people range in age from 14 to 91 years old, with a median age of 53. Sixty-six percent (66%) are female. At least 20 people have been hospitalized; no deaths have been reported.

On July 26, 2018, FDA completed analysis of an unused package of romaine lettuce and carrot mix distributed to McDonald’s by the Fresh Express processor in Streamwood, IL. The analysis confirmed the presence of Cyclospora in that mix. On July 27, 2018, FDA informed Fresh Express of these results.

Fresh Express reported to FDA that the carrots in the mix went to McDonald’s restaurant locations only, and that the romaine lettuce was the only ingredient in the mix that was distributed to other locations. Romaine lettuce from the same lot that was positive for Cyclospora was distributed in pre-made salads and wraps distributed by Caito Foods LLC of Indianapolis, IN. Fresh Express also reported that no romaine lettuce from the lot that was positive for Cyclospora was packaged for direct retail sale to consumers.

On July 30, 2018, The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a public health alert about pre-made salads and wraps containing romaine lettuce that were distributed by Caito Foods LLC of Indianapolis, IN. The pre-made salads and wraps were shipped to distribution centers nationwide. The pre-made salads and wraps were produced July 15 to July 18, 2018 and have a “Best By,” “Enjoy by,” “Best if Sold By,” or “Sell By” date ranging from July 18 through July 23, 2018. See the product labels here. The pre-made salads and wraps have establishment number “EST. 39985” or “P-39985” inside or next to the USDA mark of inspection. See the full list of products, product labels, UPC code numbers, and other identifying information here.

What is Cyclospora?

Cyclospora is a parasite composed of one cell, too small to be seen without a microscope. The organism was previously thought to be a blue-green alga or a large form of cryptosporidium. Cyclospora cayetanensis is the only species of this organism found in humans. The first known human cases of illness caused by cyclospora infection (that is, cyclosporiasis) were first discovered in 1977. An increase in the number of cases being reported began in the mid-1980s, in part due to the availability of better diagnostic techniques. Over 15,000 cases are estimated to occur in the United States each year. The first recorded Cyclospora outbreak in North America occurred in 1990 and was linked to contaminated water. Since then, several cyclosporiasis outbreaks have been reported in the U.S. and Canada, many associated with eating fresh fruits or vegetables. In some developing countries, cyclosporiasis is common among the population and travelers to those areas have become infected as well.

Where does Cyclospora come from?

Cyclospora is spread when people ingest water or food contaminated with infected stool. For example, exposure to contaminated water among farm workers may have been the original source of the parasite in raspberry-associated outbreaks in North America.

Cyclospora needs time (one to several weeks) after being passed in a bowel movement to become infectious. Therefore, it is unlikely that Cyclospora is passed directly from one person to another. It is not known whether or not animals can be infected and pass infection to people.

What are the typical symptoms of Cyclospora infection?

Cyclospora infects the small intestine (bowel) and usually causes watery diarrhea, bloating, increased gas, stomach cramps, and loss of appetite, nausea, low-grade fever, and fatigue. In some cases, vomiting, explosive diarrhea, muscle aches, and substantial weight loss can occur. Some people who are infected with Cyclospora do not have any symptoms. Symptoms generally appear about a week after infection. If not treated, the illness may last from a few days up to six weeks. Symptoms may also recur one or more times. In addition, people who have previously been infected with Cyclospora can become infected again.

What are the serious and long-term risks of Cyclospora infection?

Cyclospora has been associated with a variety of chronic complications such as Guillain-Barre syndrome, reactive arthritis or Reiter’s syndrome, biliary disease, and acalculous cholecystitis. Since Cyclospora infections tend to respond to the appropriate treatment, complications are more likely to occur in individuals who are not treated or not treated promptly. Extraintestinal infection also appears to occur more commonly in individuals with a compromised immune system.

How is Cyclospora infection detected?

Your health care provider may ask you to submit stool specimen for analysis. Because testing for Cyclospora infection can be difficult, you may be asked to submit several stool specimens over several days. Identification of this parasite in stool requires special laboratory tests that are not routinely done. Therefore, your health care provider should specifically request testing for Cyclospora if it is suspected. Your health care provider might have your stool checked for other organisms that can cause similar symptoms.

How is Cyclospora infection treated?

The recommended treatment for infection with cyclospora is a combination of two antibiotics, trimethoprim-sulfamethoxazole, also known as Bactrim, Septra, or Cotrim. People who have diarrhea should rest and drink plenty of fluids. No alternative drugs have been identified yet for people with Cyclospora infection who are unable to take sulfa drugs. Some experimental studies, however, have suggested that ciprofloxacin or nitazoxanide may be effective, although to a lesser degree than trimethoprim-sulfamethoxazole. See your health care provider to discuss alternative treatment options.

How can Cyclospora infection be prevented?

Avoiding water or food that may be contaminated is advisable when traveling. Drinking bottled or boiled water and avoiding fresh ready-to-eat produce should help to reduce the risk of infection in regions with high rates of infection. Improving sanitary conditions in developing regions with poor environmental and economic conditions is likely to help to reduce exposure.

Washing fresh fruits and vegetables at home may help to remove some of the organisms, but Cyclospora may remain on produce even after washing.

Marler Clark, The Food Safety Law Firm, is the nation’s leading law firm representing victims of Cyclospora outbreaks. The Cyclospora Attorneys and Lawyers have represented victims of Cyclospora and other foodborne illness outbreaks 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.

If you or a family member became ill with a Cyclospora infection after consuming food and you are interested in pursuing a legal claim, contact the Marler Clark Hepatitis A attorneys for a free case evaluation.