E. coli Lawyer. E. coli Attorney

frozen_veggies_6067346153_848f977616_bYesterday I was speaking to a prominent lawyer who defends companies that are caught up in foodborne illness outbreaks and the recalls of the food products that sickened consumers.  The lawyer was complaining (more on other lawyers complaining about the CDC below) about the CDC’s announcing deaths arguably related to the tainted product, specifically the recent CFR Foods frozen vegetable outbreak and massive recall. Here the CDC reported “[e]ight people infected with the outbreak strains of Listeria have been reported from three states from from September 13, 2013 to March 28, 2016. All eight people were hospitalized, including one from Maryland and one from Washington who died, although listeriosis was not considered to be a cause of death for either person.

The lawyer’s point is if the CDC did not consider listeriosis to be a “cause of death” then why mention the deaths at all?  Perhaps the lawyer has a point?  Perhaps the CDC should do a slightly better job explaining the cause of death and if the death was directly or indirectly linked to the the consumption of the product.

Looking back on some recent outbreaks and recalls had the CDC less equivocal about the link between the products and the deaths.  Take Dole’s Lettuce outbreak where the CDC reports that “[a]ll 19 (100%) ill people were reported as hospitalized, and 1 person from Michigan died as a result of listeriosis. One of the illnesses reported was in a pregnant woman. Illnesses ranged from from July 5, 2015 to January 31, 2016.”  However, Canada did appear to announce deaths that were less directly linked to the product:

In total, there were 14 cases of Listeria monocytogenes in five provinces related to this outbreak: Ontario (9), Quebec (2), New Brunswick (1), Prince Edward Island (1), and Newfoundland and Labrador (1). Individuals became sick between May 2015 and February 2016. The majority of Canadians cases (64%) are female, with an average age of 78 years. All cases have been hospitalized, and three people have died, however it has not been determined if Listeria contributed to the cause of these deaths.

In the Blue Bell outbreak, it seemed more evident that the CDC felt the deaths were in fact related to Listeria:

A total of 10 people with listeriosis related to this outbreak were reported from 4 states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). All ill people were hospitalized. Three deaths were reported from Kansas (3). Illness onset dates ranged from January 2010 through January 2015.

Perhaps the difficulty in expecting the CDC to say with certainty if the deaths are linked or not to Listeria and the product is best illustrated in the Jensen Farms Outbreak.  In that outbreak the CDC found thirty-three deaths from outbreak-associated cases of listeriosis had been reported to CDC with one woman pregnant at the time of illness having a miscarriage. However, the CDC also found that “[t]en other deaths not attributed to listeriosis occurred among persons who had been infected with an outbreak-associated subtype.”

So, 43 died, but the CDC determined that 10 of them died from other causes not directly attributable to Listeria.  The 10 did have listeriosis, but the cause of death might well have been another co-morbidity – like a heart attack, stroke, or other pre-existing health issue.

Remember, most of the people impacted by Listeria are the immune compromised and elderly or a woman who is pregnant.  Often, parsing out if Listeria caused the death or helped grease the skids of death may well be difficult – especially if the person with Listeria lingers for months after the acute illness and before their untimely death.

So, what should the CDC do?  My vote is to borrow the language from our friends to the North.  If there is a person with Listeria that dies and if the cause of death is not “more likely that not related” to listeriosis, simply say however, it has not been determined if Listeria contributed to the cause of the death.

o-CHIPOTLE-DELIVERY-facebookLawyers complaining badly.

I had heard rumblings a few months ago of a threatening letter from Chipotle counsel to the CDC.  After reading it, I am still left scratching my head as to why you would ever send it knowing that it likely would go public as would CDC’s response.

According to press reports, Chipotle had argued in December that the updates were inaccurate, confusing and “unnecessarily intensified the public’s concern” about the health risks associated with the company. It requested a correction. A lawyer for the company also complained that a CDC official had been quoted saying that tainted meat probably wasn’t the cause of the outbreak because vegetarians were among those who got sick. Chipotle, which called one CDC statement “patently inaccurate,” asked the agency to consider the company’s objections before issuing additional updates. The CDC formally responded to Chipotle in a letter dated April 15 that was made public on its website this week. “CDC believes that the Web postings served to protect and inform the public as well as inform public health and regulatory partners as the federal, state and local level about this ongoing outbreak investigation,” the agency said in the letter. “The Web postings provided information the public might use to protect themselves by choosing to avoid certain food exposures associated with the outbreak.”

CDC 1, Chipotle Lawyer 0.

Here is Chipotle’s counsel’s letter and here is the CDC responsive letter.

My thought:  “In 23 years being involved with every major food illness outbreak in the US, I have never seen a company take on the CDC or public health in this manner.  Frankly, it is bizarre given that Chipotle was involved in multiple Salmonella, Norovirus and E. coli cases in 2015.  As the CDC states in its responsive letter, it has to protect the public health and that is what it did.”

image-of-labelCDC, the U.S. Food and Drug Administration, the U.S. Department of Agriculture Food Safety and Inspection Service, and public health officials in several states are investigating an outbreak of Shiga toxin-producing Escherichia coli O157:H7 (STEC O157:H7) infections.

A total of 19 people infected with the outbreak strain of Shiga toxin-producing STEC O157:H7 have been reported from 7 states. The majority of illnesses have been reported from states in the western United States. The number of ill people reported from each state is as follows: California (1), Colorado (4), Missouri (1), Montana (6), Utah (5), Virginia (1), and Washington (1).

Among people for whom information is available, illnesses started on dates ranging from October 6, 2015 to November 3, 2015. Ill people range in age from 5 years to 84, with a median age of 18. Fifty-seven percent of ill people are female. Five (29%) people reported being hospitalized, and two people developed hemolytic uremic syndrome (HUS), a type of kidney failure. No deaths have been reported..

The epidemiologic evidence available to investigators at this time suggests that rotisserie chicken salad made and sold in Costco stores is a likely source of this outbreak. The ongoing investigation has not identified what specific ingredient in the chicken salad is linked to illness.

State and local public health officials are interviewing ill people to obtain information about foods they might have eaten and other exposures in the week before their illness started. Fourteen (88%) of 16 people purchased or ate rotisserie chicken salad from Costco.

On November 20, 2015, Costco reported to public health officials that the company had removed all remaining rotisserie chicken salad from all stores in the United States and stopped further production of the product until further notice.

The product was distributed to certain Brookshire Food Stores, Krogers and Walmarts in Louisiana and Texas, as well as certain Super 1 Foods Stores in Louisiana and Market Latina and Super 1 Foods Stores in Texas.
PFP Enterprises, a Fort Worth, Texas, establishment, is recalling approximately 15,865 pounds of beef products because they may be contaminated with E. coli O103, E. coli O111, E. coli O121, E. coli O145, E. coli O26 and E. coliO45, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.The following products are subject to FSIS recall:
  • 10.5-lb. boxes of Beef Outside Skirt Steak, with a pack date of “12/13/13”
  • 20-lb. boxes of Studio Movie Grill Beef Tenderloin Sliced, with a pack date of “12/05/13”
  • 15-lb. boxes of Preseasoned Beef for Fajita, with a use by date of “1/13/14”
  • 40-lb. boxes of Southwest Style Beef Skirts, with a pack date of “12/5/13”
  • 20-lb. boxes of Patterson Food Processors Beef Skirt Seasoned, with a pack date of “12/9/13”
  • 10-lb. boxes of Preseasoned Beef for Fajitas, with a pack date of “12/9/2013”
  • 40-lb. boxes of Preseasoned Beef for Fajitas w/Binder, with a pack date of “12/9/2013”
  • 12-lb. boxes of Seasoned Beef for Fajitas, containing 6 2-lb. packs, with a use by date of “1/15/14”
  • 12-lb. boxes of Mexican Style Beef for Fajita, containing 6 2-lb. packs, with a use by date of “1/11/14”

The products subject to recall bear the establishment number “Est. 34715” inside the USDA Mark of Inspection. The products were produced on Dec. 5, 2013, and distributed to retail stores and restaurants in Arizona, Oklahoma, Puerto Rico and Texas.

FSIS personnel became aware of the problem during a Food Safety Assessment when they discovered that beef trim tested presumptive positive for multiple non-O157 Shiga toxin-producing E. coli (STEC) strains through the company’s testing program. The company inadvertently did not carry the test out to confirmation, and not all affected product was held.

FSIS and the company have received no reports of illnesses associated with consumption of these products.

Many clinical laboratories do not test for non-O157 STEC, such as STEC O26, O103, O45, O111, O121 or O145, because it is harder to identify than STEC O157. People can become ill from STECs 2-8 days (average of 3-4 days) after consuming the organism. Most people infected with STEC O26, O103, O45, O111, O121 or O145 develop diarrhea (often bloody) and vomiting. Some illnesses last longer and can be more severe. Infection is usually diagnosed by testing of a stool sample. Vigorous rehydration and other supportive care is the usual treatment; antibiotic treatment is generally not recommended.

Most people recover within a week, but, rarely, some develop a more severe infection. Hemolytic uremic syndrome (HUS) is uncommon with STEC O26, O103, O45, O111, O121 or O145 infection. HUS can occur in people of any age, but is most common in children under 5 years old, older adults and persons with weakened immune systems. It is marked by easy bruising, pallor and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.

Over the years we have investigated, and pieced together, several leafy green outbreaks that are never publicly announced despite being the cause of severe illness.  Here is an outbreak from 2009 that should have prompted a multi-state public health warning and recall, but was instead quietly put under the “leafy green cone of silence” as a food safety leader adeptly calls these non-announcements.  The Denver Post had a few things to say about this outbreak earlier this year too.

In mid-September 2009, the Colorado Department of Public Health and Environment (CDPHE) identified two cases of E. coli O157:H7 cases with “matching” PFGE patterns.  In conjunction with local health officials, CDPHE began an investigation of the two Colorado cases.  During the early stages of the investigation, CDPHE officials were notified that Minnesota was reporting a person with an E. coli O157:H7 infection, also with a matching PFGE pattern.  Ultimately, it would be revealed that the cluster of E. coli O157:H7 infections with matching PFGE patterns encompassed 10 ill individuals in six states, Colorado (2) Connecticut (1), Iowa (2), Minnesota (3), Missouri (1), and North Carolina (1).

The cluster of illnesses sparked a multi-state investigation, conducted primarily by CDPHE, Minnesota Department of Health (MDH), Minnesota Department of Agriculture (MDA), Iowa Department of Public Health (IDPH) and the North Carolina Department of Health and Human Services (NCDHHS.)  The investigation by CDPHE revealed that the two Colorado cases had dined at the same restaurant in Pueblo, Colorado, Giacomo’s, on the same day, September 6, 2009.  In fact, both of the ill restaurant patrons had consumed a house salad, containing iceberg and romaine lettuce.  See April 30, 2010 CDPHE Report, Attachment No. 1.  Based on information coming in from other states, CDPHE officials conducted traceback on the lettuce and noted:

The restaurant in question obtains their romaine and iceberg lettuce from U.S. Foodservice under the name Cross Valley Farms.  This is an exclusive brand of U.S. FoodService.  US Foodservice receives both their romaine and iceberg lettuce from Tanimura and Antle in Salinas, CA.

See Email from Jennifer Sadlowski, 11/13/09, Attachment No. 2.

The investigation soon revealed a link to the same romaine lettuce for other states’ ill persons as well.  Both Iowa cases, and one of the three Minnesota cases ate at the same restaurant in Omaha, Nebraska on September 5, 2009.  See Attachment No. 3, CDPHE Records, 004, 0011.  These three all consumed lettuce at the restaurant.  See Attachment No. 4, CDPHE Records, 0013-0014.  Minnesota’s supervising epidemiologist Kirk Smith wrote in an email on October 28, 2009 with respect to the Colorado and Nebraska restaurants:  “invoices showed that they both get the same brand of romaine lettuce (Cross Valley Farms.).”  See Attachment No. 5, CDPHE Records, p. 0020.

This understanding of the connection to Cross Valley Farms lettuce is consistent with the records generated by Minnesota Department of Agriculture as well.  MDA officials kept a “Daily Outbreak Summary” throughout the investigation.  The update for October 21, 2009 states in reference to the CO and NE restaurant, “From comparing the invoices of these two restaurants, they both use Cross Valley Farms Romaine in salads that the cases ate.”  The October 30, 2009 update says “The restaurants in CO and NE that are associated with the cases in those states served Cross Valley Farms whole romaine lettuce heads.  Cross Valley Farms is a label of U.S. Foodservice.  The romaine for CO came from a U.S. Foodservice distributor in Denver, the romaine for NE came from a U.S. Foodservice distributor in Omaha.”  See Attachment No. 6, MDA Records, 0045-0047.

For the remaining members of the cluster for whom information was available, investigation also suggested romaine lettuce as the source. All of this led the lead investigators to conclude that romaine lettuce from Tanimura and Antle, distributed by U.S. Foodservice was the source of the cluster of E. coli O157:H7 infections.  The email from Minnesota’s Dr. Smith sums it up well while imploring CDC to further investigate the cluster:

Briefly, there are three people (2 Iowa residents and one Minnesota resident) who ate at the same exact Italian restaurant in Omaha, Nebraska on September 5.  Two Colorado residents ate (independently) at the same Italian restaurant in Pueblo [CO].  The Nebraska and Colorado restaurants are not part of the same chain.   All of the 5 cases had salads, and invoices from the two restaurants showed that they both get the same brand of romaine lettuce (Cross Valley Farms).  Again – rock solid…. (emphasis added).

See Attachment No. 7, Email IDPH Records, 0019.

For further information, See the full CDPHE Records, Attachment No. 8; Minnesota Department of Agriculture Records, Attachment No. 9; Iowa Department of Public Health Records, Attachment No. 10; Pueblo County Health Department Records, Attachment No. 11; Minnesota Department of Health Records, Attachment No. 12; North Carolina Department of Health and Human Services Records, Attachment No. 13; and Missouri Department of Health Records, Attachment No. 14.

The excuses you hear from both government and industry vary, but two themes are the same:

1.  By the time the outbreak is figured out all the product has been consumed so why announce the outbreak or recall the product since there is no more product in the market.

2.  The FDA and CALFERT no longer have the manpower to do a complete traceback to the specific field where the leafy greens were grown.

My thought is that the public has a right to know what has sickened them.  Consumers with knowledge help the marketplace weed out growers, shippers and retailers that manufacture and sell tainted food.  Knowing that allows consumers to “vote with their pocketbook.”  As for the lack of manpower for surveillance, outbreak investigation and traceback, I tend to agree that we need more resources.  Being able to trace an outbreak to a likely source allows for learning how to prevent the next one.

What are your thoughts?

Late last week we reached yet another (actually two) settlement(s) in (a) raw milk outbreak(s) – one, an E. coli O157:H7 outbreak and the other a Campylobacter outbreak.

In 2012 the Missouri State Department of Health and Senior Services reported 14 confirmed cases of E. coli O157:H7 linked to raw milk.  Two E. coli cases were from Boone and Marion counties. The 14 cases had similar lab results, geographic proximity and/or case history.  All drank raw milk or are family members of those who drank raw milk.  A 2-year-old Boone County child sickened with E. coli developed hemolytic uremic syndrome (HUS), a complication of E. coli infection that causes kidney failure.  Five cases were reported in Boone County, three in Cooper, three in Howard, and one each in Jackson, Marion and Callaway counties. The illnesses were linked to a farm owned by Sam Stroupe of Armstrong, Missouri.  We resolved the case of one young woman who unknowingly drank raw milk while at a friend’s home.

Also in 2012, raw milk produced at The Family Cow farm in Pennsylvania was the source of the most severe outbreak of sickness linked to raw milk in Pennsylvania in five years. The Pennsylvania Department of Health reported 76 confirmed cases of campylobacteriosis.  We resolved the case of one man who purchased the milk at a farmer’s market.

For more information on the risks of raw milk, see www.realrawmilkfacts.com.

I had a long talk today with a great barrister from Belfast Northern Ireland who asked that I send him a copy of the book Poisoned.

There are now 130 confirmed cases of E. coli in Northern Ireland’s worst ever outbreak, the Public Health Agency has confirmed.

There are a further 163 probable cases linked to Flicks restaurant in Belfast’s Cityside shopping complex.

Perhaps more people should read Poisoned – especially people that run restaurants.

So, for any first time subscribers to Marler Blog, sign up for a free subscription and email ldale@marlerclark.com that you did and she will send you a book – the first 100 anyway.