Seattle, WA – The Abbott infant formula recall could have been prevented. The FDA had reports of safety failures months before the contaminated formula sickened babies and caused two deaths.

William “Bill” Marler, sent these t-shirts to the Council of State and Territorial Epidemiologists, who are tasked to make recommendations as to what pathogens are reportable.  “I hope that these t-shirts will be a reminder of the awesome responsibility that this council has to protect the public,” said Marler.

The head of the FDA said in testimony to congress months ago:

“The CDC receives reports on foodborne disease outbreaks from state, local, and territorial health departments. On average, CDC receives two to four Cronobacter case reports annually; however, because Cronobacter infection is not reportable in most states, the total number of cases that occur in the United States each year is not known.”

Here is a bit of history about why having bacterial infections reportable can make a difference.

In 1992, from mid-November to mid-January, 9 cases of E. coli O157:H7-associated bloody diarrhea and the hemolytic-uremic syndrome had been reported in San Diego County, California and 1 child died. A total of 34 persons had bloody diarrhea, the hemolytic-uremic syndrome, or E. coli O157:H7 organisms isolated from stool during the period November 15, 1992, through January 31, 1993. E. coli O157:H7 was ultimately identified from 6 persons were indistinguishable from those of the Washington outbreak strain linked to Jack in the Box restaurants in Washington, Idaho, Nevada and California.  All the pre-formed frozen hamburgers were produced by Von’s in California and shipped to those restaurants in those states after the illness in California had already happened. According to public health officials:

Improved surveillance by mandating laboratory – and physician – based reporting of cases of E coli O157:H7 infection and the hemolytic uremic syndrome might have alerted health officials to this outbreak sooner, which could have resulted in earlier investigation and the institution of measures to prevent more cases.

Clearly, had E. coli O157:H7 been reportable, public health officials in California would have caught the illnesses and most likely prevented the hamburgers from being shipped to other states.  Hundreds of people – specifically children – would not have been sickened and three would likely not have died.

Make Cronobacter sakazakii reportable and save lives.

My law practice lives and breathes the science of foodborne illness epidemiology.  Stool cultures, incubation periods, case control studies and genetic fingerprinting make or break causation in cases.  I have a nurse and an epidemiologist on staff who investigate each case, so we know that the claims that we make are well-grounded in both science and the law.  As I tell my opponents, by the time we make a claim, causation and liability are a lock, and the issue to discuss is how much are the damages.

It is with frustration that I encounter lawyers and insurance companies across the table that are ignorant (willfully or by honest stupidity) of the law and the science.  Here are a few instances, one from the distance past and one from last week.

“Your clients are suspected by the ‘FBI’.”

In late June of 2002, residents of Monroe County, New York began to fall ill with Salmonella infections. As their illnesses were confirmed by laboratory testing, hospitals and doctors began reporting the illnesses to the Monroe County Health Department. By June 22, the total number of confirmed cases had reached 17. According to the Health Department, the Salmonella cases were linked to multiple events at the Brook-Lea Country Club (“Brook-Lea”) between June 1 and June 17. In response to the outbreak, the Monroe County Health Department inspected the Brook-Lea kitchen and reviewed its food-handling procedures. In addition, the kitchen was closed and disinfected by a commercial company. While the kitchen remained closed, the Health Department stated that it would review the possibility of allowing the club to have limited outside catering.

By June 24, the number of cases of salmonellosis linked to the Brook-Lea had risen from 17 to 53. These were just the confirmed cases. There were dozens of other cases still waiting culture confirmation. The Health Department had by this point in its investigation obtained stool and blood samples from about 50 kitchen-related staff. The club kitchen also remained closed.  Two days later, on June 26, the results of tests done on kitchen-staff stool samples showed that eight of the about 50 kitchen staff had Salmonella infections. According to the Health Department, it was unknown whether the staff represented the likely source of the outbreak, or whether they “might just be victims”. An additional food worker at Brook-Lea was later found to also be infected, bringing the total number of sick employees to nine.

Over the next three weeks the number of Salmonella cases linked to Brook-Lea soared from 57 to well over 100. At least 95 of the cases were both culture-confirmed and linked epidemiologically to the consumption of food at Brook-Lea between June 1 and June 18. It was also determined that the Salmonella associated with the outbreak was Salmonella enteritidis, a virulent strain often associated with contaminated eggs.

In early July, Brook-Lea management admitted that none of its employees had attended a six-hour voluntary course on safe food handling. The Health Department first offered the food safety course in 1997 and it was available to all foodservice operators and their employees. It was only after the Salmonella outbreak that about 30 Brook-Lea employees received training in safe food-handling practices.

Proving that lightning can strike in the same place twice, on July 30, there was a second, smaller outbreak of Salmonella illnesses at Brook-Lea, yielding six more cases. Four of the cases were Brook-Lea employees. Overall, there were now 106 confirmed cases of Salmonella food poisoning in people residing in Monroe County and the surrounding area. All these cases were linked to the Brook-Lea.

We represented most of the victims in this outbreak, some quite seriously sick. As is my practice, I supplied all the health department records, medical records, wage loss and all other relevant material to both prove causation and assess damages.

A few months after providing all the evidence above, we met with the lawyer and insurance adjuster for Brook-Lea.  Waiting in the conference room for them to arrive, the thought was how best to financially resolve the cases.  As the lawyer and insurance adjuster came in, they seemed a bit glum.  I took it that they might be reluctant to pay what would be needed to resolve the cases – goodness, was I mistaken.

After some stilted pleasantries, the lawyer said with authority that there we be no settlements to the smile of the insurance adjuster.  Perplexed, I ask “why?”  He gleefully pushed a piece of paper from the Monroe County Health Department (we had provided to them) across the table and told me, “we will not pay a penny to these people because they are suspected by the ‘FBI’.”  

It was a short meeting. A month later with a new defense lawyer and insurance adjuster involved, who understood that “Suspected FBI” meant “Suspected Foodborne Illness,” all the cases resolved to the satisfaction of my clients.

“Your client is a plumber.”

In the fall of 2021, the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), and state partners investigated an outbreak of Salmonella Oranienburg linked to whole, fresh onions. FDA identified ProSource Produce LLC (or ProSource Inc.) of Hailey, Idaho and Keeler Family Farms and Imported of Deming, New Mexico as suppliers of potentially contaminated whole, fresh onions imported from the State of Chihuahua, Mexico between July 1, 2021 and August 31, 2021. 

As of January 20, 2022, a total of 1,040 cases have been identified. Cases were identified in 39 states (AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV), the District of Columbia, and Puerto Rico. Of the 778 cases with information available, 260 reported hospitalizations. No deaths were reported. Illness onsets ranged from May 31, 2021 to January 1, 2022. Cases ranged from less than 1 year to 101 years in age (median 38). Fifty-eight percent of cases were female. 

Whole-genome sequencing (WGS) of 1,012 clinical isolates showed that bacteria from sick people’s samples were closely related genetically, implying that the cases in the outbreak likely got sick from the same source. During interviews with 407 cases, 72 percent of cases reported eating or maybe eating raw onions or dishes with raw onions prior to illness. Several ill people reported the same restaurants, indicating possible clusters. Twenty illness clusters were identified at restaurants where onions were served. One of these clusters occurred at a location at which the outbreak strain of Salmonella Oranienburg was identified in a condiment container with leftover lime and cilantro. It was reported that this container also contained onions, although none were left for testing. Traceback information identified onions distributed by ProSource Produce LLC and Keeler Family Farms as links in this outbreak. 

On October 20, 2021, ProSource Produce LLC voluntarily recalled whole, raw, red, yellow, and white onion imported from the State of Chihuahua, Mexico between July 1, 2021 and August 31, 2021. Additional onion types possibly implicated in this recall included jumbo, colossal, medium, summer, and sweet onions. The following distributors/retail brands were included in the recall: Big Bull, Peak Fresh Produce, Sierra Madre, Markon First Crop, Markon Essentials, Rio Bue, ProSource, Rio Valley, and Sysco Imperial. 

On October 22, 2021, Keeler Family Farms recalled red, yellow, and white whole, fresh onions imported from the State of Chihuahua, Mexico between July 1, 2021 and August 25, 2021. Onions were distributed to wholesalers, restaurants, and retail stores in all 50 states and the District of Columbia. These onions contain a labeled marked as “MVP (product of MX).”

Recalls were also initiated by companies that sold products containing the recalled onions (Pier-C Produce Inc., Potandon Produce, LLC, HelloFresh, and EveryPlate). The FDA published lists of retailers that received recalled products from ProSource Produce LLC and Keeler Family Farms on October 29 and November 2, respectively. These lists may not include all retail establishments that would have received recalled product, however. The FDA also published a list of additional companies that may have received recalled product from ProSource Produce LLC and/or Keeler Family Farms and further processed the onions by using them as ingredients in new products or repackaging them. As of February 2022, this outbreak is over. 

We represent Andrew Rose, and yes, he is a plumber.

The causal link between Andrew Rose’s confirmed Salmonella Oranienburg infection and the food that he consumed from August 20, 2021, in Oklahoma is clear. On August 20, Andrew consumed fajita chicken enchiladas and fresh salsa from the Los Cabos restaurant located at 300 Riverwalk Terrace, Suite #100, Jenks, OK 74037. The Riverwalk Los Cabos location received onions from Frontier Produce in Tulsa, OK. Frontier Produce provided Los Cabos with multiple shipments of onions—including jumbo red and jumbo yellow—in the weeks leading up to August 20, 2021. Frontier Produce received multiple shipments of recalled onions sourced by ProSource on July 29, 2021, and August 11, 2021.

Andrew had no other viable onion exposures in the week leading up to the onset of his Salmonella Oranienburg infection. He consumed a buffalo chicken sandwich from Arby’s on August 19, 2021 that did not contain onions and ate at two separate Whataburger locations; one on August 17, 2021, and one on August 19, 2021. Whataburger provided an affidavit stating that they did not receive onions from Prosource or Keeler Family Farms. Additionally, Andrew does not cook onions at home. Andrew was not in contact with anyone ill prior to his illness. 

Andrew began to experience symptoms consistent with Salmonella infection on August 22, 2021. An exposure on August 23 is consistent with a Salmonella incubation period that can range from 6 hours to 14 days and averages 12 to 72 hours. A stool specimen collected on September 1 tested positive for Salmonella at the Regional Medical Lab in Tulsa, Oklahoma. 

Further testing by the Minnesota Public Health Laboratory, on behalf of the Oklahoma Department of Health, determined that Andrew was infected with Salmonella Oranienburg and that his specimen was genetically linked to the multistate raw onions’ outbreak of 2021 (WGS ID: PNUSAS233169). The Oklahoma Department of Health interviewed Andrew with an outbreak questionnaire pertaining to the national onions outbreak (CDC Outbreak ID: 2109MLJJX-1) and included him in an outbreak titled “S. Oranienburg, National, 2021.” Andrew’s specimen was included by the CDC on the 2021 raw onions outbreak linelist (CDC Cluster Code: 2109MLJJX- 1). 

Given Andrew’s confirmed infection with Salmonella Oranienburg, his symptom onset within an evidence-driven Salmonella incubation period and during the national Salmonella Oranienburg onions outbreak, his exposure to an implicated source of the outbreak, and the genetic evidence connecting his infection to the outbreak, Andrew was classified as a confirmed case in the national Salmonella Oranienburg onions outbreak by the Oklahoma Department of Health and the CDC (CDC Outbreak ID: 2109MLJJX-1).

Like in the Brooke-Lea case, we supplied everything the counsel and insurance company for the onion supply chain – medical and health department records as well as CDC, FDA and Oklahoma records.  And yes, we supplied his wage loss, and yes, he is a plumber.

After waiting a few month for onion fellows to review the material, I finally was contacted that the insurance adjuster wanted to talk.  As this was a clear case of causation and liability, I expected that we would be able to resolve the case for Andrew.  However, the adjuster gave me the unexpected.  He carefully explained to me that the cause of Andrew’s illness was not the onions, but because my client “was a plumber.”  Perplexed (to put it mildly), I tried to explain that he was a WGS match to over 1,000 people with Salmonella Oranienburg and that Andrew ate onions that we part of the recall.  My explanation gained no traction.

I even tried to explain that even if Andrew did not eat onions (which he did), the onion suppliers were still liable, because even if Andrew picked up the WGS of Salmonella Oranienburg because he was a plumber, he still picked up the WGS of Salmonella Oranienburg from someone who ate the onion, and that the onion supplier was still the proximate cause of Andrew’s illness.

Proximate cause is generally a question of fact. Hertog v. City of Seattle, 138 Wn.2d 265, 275, 979 P.2d 400 (1999). Proximate cause consists of two elements–cause in fact (but for cause) and legal causation (legal policy). Schooley v. Pinch’s Deli Mkt., Inc., 134 Wn.2d 468, 478, 951 P.2d 749 (1998). Cause in fact is based on a “physical connection between an act and an injury” and is determined by the trier of fact. Id.; Hartley v. State, 103 Wn.2d 768, 778, 698 P.2d 77 (1985). Cause in fact requires a direct unbroken sequence between some act and the complained of event. Hertog, 138 Wn.2d at 282-83. This is generally a question for the jury. Legal cause, on the other hand, “reflects policy determinations as to how far the consequences of a defendant’s acts should extend.” Schooley, 134 Wn.2d at 478; Hartley, 103 Wn.2d at 779. Legal cause is a question of law. Schooley, 134 Wn.2d at 478.

In Almquist v. Finley Sch. Dist. No. 53, 114 Wn. App. 395 (2002), students eating a taco lunch in the Finley School District were infected by E. coli O157:H7. Marler Clark LLP represented the plaintiffs and tried the case to a successful verdict. On appeal by the District, the argument was advanced that the most severely injured child, Faith Maxwell, who did not consume the taco meal but had contact with two unrelated children who had, could not demonstrate that the District’s actions were the proximate cause of her injuries.  

The Court addressed both components of the proximate cause inquiry. Regarding cause-in-fact, the Court held, in sum, that the plaintiffs had presented sufficient evidence for a jury to conclude that Faith was sickened by E. coli O157:H7 as part of the same outbreak that had sickened the other children. The Court concluded:

Secondary cases are not uncommon, generally making up 1 to 10 percent of the total cases in any outbreak. RP at 623-24. Secondary infection generally results from person-to-person contact, most often via the fecal-oral route. RP at 88, 201-02, 245, 248.

To conclude that this is how Faith was infected is more than mere speculation. Faith spent time with two children who ate the taco meal. One had a confirmed case of E. coli infection. An infected child spent the night at Faith’s house and played with her, including dressing her up like a baby. 


These facts are consistent with the experts’ description of the typical secondary infection. And the District offered no plausible alternative explanation for her illness. The jury then had adequate evidence from which to infer that Faith’s illness was caused in fact by the tainted taco meal.

Almquist, 114 Wn. App. At 407.

I told the onion fellows the “I will see them in court.”  We need to teach more science to lawyers and insurance companies.

This fellowship was created in Dave’s honor after his sudden passing in 2017. It is a special opportunity for a young food scientist to work closely with Stop Foodborne Illness and learn from members who have experienced the consequences of failures in food safety firsthand. The Dave Theno Food Safety Fellowship is a partnership between Stop Foodborne Illness and Michigan State University Online Food Safety Program. The Fellow will work full-time for Stop Foodborne Illness and complete a 12-credit Online Food Safety Certificate with Michigan State University.

We have been honored to donate $200,000 to this worthy cause. I would ask that all that care about food safety to consider doing the same.

This is what I wrote about Dave before his untimely death:

In 2013, I wrote a piece on my blog about “Why I Love my Job.”  Its ironic how much of my job and my life over they last 25 years has been intertwined with Dave Theno.  I will miss the occasions we shared a good meal – Dave with a rare steak and mine well-done – with always a very good bottle of wine.  We will all miss his humanity and leadership.

Here is the piece I wrote:

A few months ago I was asked to write something by WSBA about my practice and life as a lawyer.  The ask was something like this:

Mr. Marler, I noted that you are a (“the” – I must admit I added that) preeminent litigator in food poisoning cases in our state (well, actually the “world” – I must admit I added that too). Our members would love an article from you describing a significant case or client that resonated with you, or a description of what it is like to practice in your area of law.

I thought a lot about the ask and my 20 plus years of practice, and the fact that I may well be at the downslope of a job that I truly love.  In a not so often-quite moment, I thought about the beginning of what became both my passion and my job.  Honestly, it has had very little to do with being a lawyer.

I had just turned 35-years-old and was only five years out of Law School, I was a young lawyer in a job that seemed quite dead-end, and then my world changed.

Lauren Beth Rudolph died on December 28, 1992 in her mother’s arms due to complications of an E. coli O157:H7 infection – Hemolytic Uremic Syndrome – also know as acute kidney failure.  She was only 6 years, 10 months, and 10 days old when she died. The autopsy described her perforated bowel as being the consistency of “jelly.”  Her death, the deaths of three other children, and the sicknesses of 600 others, were eventually linked to E. coli O157:H7 tainted hamburger produced by Von’s and served undercooked at Jack in the Box restaurants on the West Coast during late 1992 and January 1993.  I pushed myself to the front of the pack of lawyers.  Roni Rudolph, Lauren’s mom, I have known for nearly 20 years.

Dave Theno became head of Jack in the Box’s food safety shortly after the 1992-1993 outbreak. I too have known Dave for 20 years, mostly because I spent several days deposing (he would say – grilling/torturing) him over the course of the multi-year, multi-state litigation.  However, a decade after spending such quality time (for me anyway) with him, I only recently learned a significant fact about Dave – one that made me admire him even more – one that I think, that all leaders in corporate food safety, or any position of authority, should emulate.

Last year Dave and I shared the stage at the Nation Meat Association (NMA) annual “Meating” in Tampa as an odd pair of keynote speakers. The NMA is an association representing meat processors, suppliers, and exporters.  Dave, spoke just before I did and was rightly lauded as someone who takes food safety to heart.  However, it was his story about Lauren Rudolph and his relationship with Roni that struck me in a physical way.

Dave told the quiet audience about Lauren’s death. He too knew the same autopsy report.  Dave told the audience that the death of Lauren and his friendship with Roni had changed him also in a physical way. He told us all that he had carried a picture of Lauren in his briefcase everyday since he had taken the job at Jack in the Box. He told us that every time he needed to make a food safety decision – who to pick as a supplier, what certain specifications should be – he took out Lauren’s picture and asked, “What would Lauren want me to do?”

I thought how powerful that image was. The thought of a senior executive of any corporation holding the picture of a dead child seeking guidance to avoid the next possible illness or death is stunning, but completely appropriate.

I hugged Dave and we promised to get together again – sometime, someday.

Shortly after leaving Tampa, I spent time with a family in South Carolina whose 4 year old ate cookie dough tainted with E. coli O157:H7 and suffered months of hospitalizations, weeks of dialysis and seizures. She faces a lifetime of complications despite oversight by the Food and Drug Administration of the food she consumed.

After leaving South Carolina I headed to Cleveland, Ohio where I sat across the kitchen table with a family who lost their only daughter, Abby, because she died from an E. coli O157:H7 infection from meat inspected by the United States Department of Agriculture Food Safety Inspection Services.

Neither head of either agency, nor the president of either corporation, whose product took the life of one and nearly the life of the other, ever visited either family, and, that is a shame.

In 20 years of litigation, in 20 years of spending time with Lauren’s or Abby’s family, I am changed.  I see the world far differently than most do now.

If I had any advice to offer to corporate or governmental leaders – run your departments like Dave ran food safety at Jack in the Box. Go meet the families that Dave and I have met.  Sit across their kitchen tables. Go to their child’s hospital room and see more tubes and wires than you can count. Understand what these people have lived though. Take their stories into your heart.

It is hard, very hard, but it will give you a real reason to do your jobs and to love it.

This is what I wrote on the day I spoke at his memorial:

I’m not sure I will get through what I plan on saying today at Dave’s Memorial, so I thought I would put it here:

Funerals are painful, and our hearts go out to Jill and the entire Theno clan. We all share just a small part of your grief.

Funerals are also uncomfortable, because they remind us all of life’s fragile nature and of all the things we should have said too so many.  Especially as we grow older, we think of all the deeds that we have not done, and the ever – decreasing time to do them.

However, we are here today to honor our friend Dave, who unlike most of us, left nothing undone and leaves this life a hero.  Dave was honored by so many.  Here are just a few:

  • NSF Lifetime achievement award
  • American Association of Food Hygiene Veterinarians
  • American Meat Science Association
  • International Association of Food Protection
  • International Meat & Poultry HACCP Alliance
  • Institute of Food Technologists
  • National Advisory Committee on Meat & Poultry Inspection
  • National Advisory Committee for Microbiological Criteria for Foods
  • National Cattlemen’s Beef Association’s Beef Industry Food Safety Council
  • National Meat Association
  • Black Pearl Award by the International Association of Food Protection
  • Innovator of the Year Award from Nation’s Restaurant News
  • California Environmental Health Association’s Mark Nottingham Award
  • Nation’s Restaurant News “Top 50 Players”
  • STOP’s Hero Award and Scholarship

And, this coming year Dave was due for even more deserved recognitions.

Of course, many in the food safety community’s most poignant visual, and most vivid memory, is of Dave asking a picture of Lauren what was the right thing to do.  However, Dave always knew what the right thing to do was, and Lauren was always beside him to confirm it.

In the end, Dave’s profile will not be etched into Mount Rushmore or on the Washington D.C. Mall – but it should be.  Why?  Because Dave’s life’s work saved countless lives and will continue to do so long after all of us have attended our own funerals.

Dave is and will be missed, but he will always be a hero remembered.

This coming week the Food Safety Summit will come to Chicago. I have the privilege to speak at two sessions on the 10th and 11th. Please stop by the Food Safety News booth to see if they have any of the below T-shirts still available.

Since the beginning of my “Get the F out of the FDA” project, we have sent out over 1,000 of the T-shirts. I also recently sent a box of them to the leadership at the Food and Drug Administration.

For years I have advocated for vaccinating food service workers to help prevent the spread of the Hepatitis A virus. I also recently sent boxes of them to the National Restaurant Association and Advisory Committee on Immunization Practices.

It really is far past time to deem Salmonella an adulterant. I hope boxes of T-shirts to the National Chicken Council and Food Safety Inspection Service might encourage this significant change.

The Council of State and Territorial Epidemiologists is the body that decides what “bugs” are reportable to health authorities. The deadly bacteria, Cronobacter, is reportable in only two states. That is flying blind. I hope the Epidemiologists enjoy the box of T-shirts I just sent.

See you in Chicago.

gallatin

The Gallatin City-County Health Department, the Department of Public Health and Human Services (DPHHS), other local health departments, and federal agencies continue to investigate the foodborne illness outbreak linked to eating food at Dave’s Sushi in Bozeman.  

The investigational activities are ongoing, and DPHHS and the Gallatin City-County Health Department acknowledge that the investigation may not be able to identify a specific pathogen as the source of this outbreak. This outbreak appears to be isolated to people who ate at Dave’s Sushi between March 31 and April 17, 2023. The restaurant remains closed, and there does not appear to be any further risk to the public.

DPHHS recommends that individuals who experienced illness after eating at Dave’s Sushi in late March and April 2023 call and report their symptoms to their local health department so cases can be tracked as part of this outbreak investigation. Contact information for all local health departments is here.  

“DPHHS supports the Gallatin City-County Health Department with this investigation by coordinating with other local county health departments across the state who have reported illnesses associated with this outbreak. DPHHS is also working closely with federal partners assisting with this investigation, including the Centers for Disease Control and Prevention and Food and Drug Administration,” said DPHHS epidemiologist Rachel Hinnenkamp of the Communicable Disease and Epidemiology Section.

To date, the investigation has identified at least 30 individuals associated with this outbreak who ate at the restaurant between March 31 and April 17, 2023. Three individuals had severe outcomes, including hospitalizations, and the deaths of two individuals are being investigated after eating at the restaurant. 

The manner and cause of death for these two individuals will remain pending until autopsy and toxicology results are available. The pattern of illness identified through case investigation, to date, indicates individuals became sick within 30 minutes to 4.5 hours after their meal. Preliminary investigative findings indicate that food containing morel mushrooms may be the exposure of concern. Currently, no pathogen/toxin has been identified, and both state and federal partners continue to test clinical and food samples.

The DPHHS investigation has determined that the morel mushrooms served at the restaurant were not distributed to any other restaurants or businesses in Montana. The mushrooms were cultivated in China, shipped to a distributor in California, and subsequently sent to multiple states. There are no known associated illnesses in other states identified at this time.

“We remain dedicated to working together with our state partners to investigate the potential pathogen or cause of this foodborne illness outbreak. Our collective efforts in this investigation will continue to be thorough and extensive. We are deeply saddened and extend our sincerest condolences to all the families and friends of the two deceased, as well as all those affected by this outbreak,” stated Lori Christenson, Health Officer for the Gallatin City-County Health Department.

The Detroit Health Department is working with Detroit Public Schools Community District (DPSCD), and Michigan Department of Health and Human Services (MDHHS) to assess an apparent increase in illnesses amongst students at Marcus Garvey Academy located in Detroit.

After receiving reports of symptomatic students at Garvey, the Detroit Health Department responded by sending a team to the location to assist DPSCD leadership with evaluation, monitoring review of protocols for deep cleaning and disinfecting. In collaboration with the Department of Health, DPSCD has informed parents/caregivers of students that Garvey will be closed until Monday to allow for deep cleaning.

The Detroit Health Department is working closely with DPSCD, and MDHHS to monitor and trace all reported illnesses among students at that location. We do not yet have confirmation on the cause of the illness, and will share that information with Detroiters once that information has been confirmed.

Parents/caregivers of children ages 4-7 should monitor their children for symptoms and seek medical care promptly if their child experiences the following symptoms:

  • Fever
  • Headache
  • Lethargy
  • Nausea/vomiting
  • Abdominal pain

The Detroit Health Department offers vaccinations to children and adults to protect against many childhood diseases. Vaccinations are also available at pediatric centers and primary care providers.

Morel Mushrooms

Despite practicing law in the food safety space for over 30 years, I am always learning something new and that usually is bad.

With at least 30 sickened with 2 dead linked to Dave’s Sushi in Bozeman, Montana that appear to be linked to the consumption of morel mushrooms that Dave’s ownership has cited as being “FDA-inspected morel mushrooms [that] were purchased in two separate batches from a California distributor,…” The outbreak investigation is still underway, but it appears that there may be a lot more to learn.

Eating raw or undercooked morel mushrooms can be risky because they contain a small amount of a naturally occurring toxin called hydrazine, which can cause gastrointestinal distress if ingested in sufficient quantities. The toxin is destroyed by cooking, so it’s important to always cook morels thoroughly before eating.

Hydrazine is a toxic chemical that can cause a variety of side effects if ingested in sufficient quantities. Some of the most common side effects of hydrazine toxicity include:

1.     Gastrointestinal distress: Hydrazine can cause nausea, vomiting, and diarrhea, as well as abdominal pain and cramping.
2.     Central nervous system effects: Hydrazine can affect the brain and nervous system, causing symptoms such as headache, dizziness, confusion, and seizures.
3.     Liver and kidney damage: Hydrazine can cause damage to the liver and kidneys, leading to jaundice, dark urine, and decreased urine output.
4.     Respiratory effects: Hydrazine can cause respiratory distress, including coughing, wheezing, and shortness of breath.
5.     Cardiovascular effects: Hydrazine can affect the heart and circulatory system, causing chest pain, irregular heartbeat, and high blood pressure.

It’s important to note that hydrazine toxicity is relatively rare and typically only occurs if large quantities of hydrazine are ingested. Most people who consume undercooked or raw morels will not experience any significant side effects. However, if you do experience any symptoms after consuming morels, it’s important to seek medical attention right away.

Thanks to Chatgpt

HAVimage011

Perhaps I should send them a t-shirt?

The Marion County Health Department (MCHD), in cooperation with La Cocina Mexicana Restaurant in Salem, is investigating a report of Hepatitis A virus exposure.

As a preventative measure, MCHD is recommending that customers who consumed food, whether dine-in, or pickup, purchased on April 20th, 21st, 22nd, 23rd,24th, and 25th discuss the need for Hepatitis A vaccination with their healthcare provider.

Hepatitis A is a viral infection that can be transmitted person-to-person and/or by eating food or drinks contaminated with the virus. Hepatitis A vaccine can prevent infection, but only if given within 14 days of exposure to Hepatitis A.

The Hepatitis A vaccine can be given to persons over 12 months of age who have not completed the two-dose hepatitis A vaccination series. Persons over 40 years old may also receive immune globulin.

Symptoms of Hepatitis A usually start appearing within 4 weeks after exposure but can occur as early as 2 weeks, and even as late as 7 weeks after exposure.

Symptoms include jaundice (yellowing of the skin and eyes), diarrhea, pale-colored stools, stomach pain, dark urine, nausea, feeling tired, loss of appetite and fever.

Children less than 6 years of age generally do not have symptoms or have an unrecognized infection. Almost all people who get Hepatitis A recover completely.

It is rare for Hepatitis A to cause severe illness, but persons 50 years of age or older and those with other liver diseases (particularly chronic Hepatitis B) are more at risk.

The best way to prevent Hepatitis A is through vaccination. While two doses are recommended to complete the Hepatitis A vaccine series, even one dose provides nearly 95% immunity for at least several years.

Good hand hygiene, including thoroughly washing hands after using the bathroom, and avoiding high risk behaviors like needle-sharing, also play an important role in preventing the spread of Hepatitis A.

Here is a letter I recently wrote asking that a recommendation be given to vaccinate food service workers:

ACIP Secretariat

Advisory Committee on Immunization Practices 

1600 Clifton Road, N.E., Mailstop H24-8

Atlanta, GA 30329-4027

acip@cdc.gov

Dear ACIP Secretariat:

The Advisory Committee on Immunization Practices (ACIP) provides advice and guidance to the Director of the CDC regarding use of vaccines and related agents for control of vaccine-preventable diseases in the civilian population of the United States. Recommendations made by the ACIP are reviewed by the CDC Director and, if adopted, are published as official CDC/HHS recommendations in the Morbidity and Mortality Weekly Report (MMWR).

Presently, approximately 5% of all hepatitis A outbreaks are linked to infected food-handlers.

Here is what the CDC continues to say about vaccinating food-handlers:

Why does CDC not recommend all food handlers be vaccinated if an infected food handler can spread disease during outbreaks?

CDC does not recommend vaccinating all food handlers because doing so would not prevent or stop the ongoing outbreaks primarily affecting individuals who report using or injecting drugs and people experiencing homelessness. Food handlers are not at increased risk for hepatitis A because of their occupation. During ongoing outbreaks, transmission from food handlers to restaurant patrons has been extremely rare because standard sanitation practices of food handlers help prevent the spread of the virus. Individuals who live in a household with an infected person or who participate in risk behaviors previously described are at greater risk for hepatitis A infection.

The CDC misses the point; granted, food service workers are not more at risk of getting hepatitis A because of their occupation, but they are a risk for spreading it to customers. Food service positions are typically low paying, and certainly have the likelihood of being filled by people who are immigrants from countries where hepatitis A might be endemic or by people who have been recently experienced homelessness.

Over the past several years, there has been an ongoing outbreak of hepatitis A in the United States. As of February 2, 2023, there have been a total of 44,779 cases with a 61% hospitalization rate (approximately 27,342 hospitalizations). The death toll stands at 421. Since the outbreak started in 2016, 37 states have reported cases to the CDC.

The CDC recommends to the public that the best way to prevent hepatitis A is through vaccination, but the CDC has not explicitly stated that food service workers should be administered the vaccination. While food service workers are not traditionally designated as having an increased risk of hepatitis A transmission, they are not free from risk. 

24% of hepatitis A cases are asymptomatic, which means a food-handler carrying the virus can unknowingly transmit the disease to consumers. Historically, when an outbreak occurs, local health departments start administering the vaccine for free or at a reduced cost. The funding from these vaccinations is through taxpayer dollars. 

A mandatory vaccination policy for all food service workers was shown to be effective at reducing infections and economic burden in St. Louis County, Missouri.

From 1996 to 2003, Clark Country, Nevada had 1,523 confirmed cases of hepatitis A, which was higher than the national average. Due to these alarming rates, Clark County implemented a mandatory vaccination policy for food service workers. As a result, in 2000, the hepatitis A rates significantly dropped and reached historic lows in 2010. The county removed the mandatory vaccine rule in 2012 and are now part of the ongoing hepatitis A outbreak. 

According to the CDC, the vaccinations cost anywhere from $30 to $120 to administer, compared to thousands of dollars in hospital bills, and offer a 95% efficacy rate after the first dose and a 99% efficacy after the second dose. Furthermore, the vaccine retains its efficacy for 15-20 years.  

During an outbreak, if a food service worker is found to be hepatitis A positive, a local health department will initiate post-exposure treatment plans that must be administered within a two-week period to be effective. The economic burden also affects the health department in terms of personnel and other limited resources. Sometimes, the interventions implemented by the local health department may be ineffective. 

Though there are many examples of point-source outbreaks of hepatitis A that have occurred within the past few years around the country, a particularly egregious outbreak occurred in the early fall of 2021 in Roanoke, Virginia. The health department was notified about the outbreak on September 21, 2021, after the first case was reported by a local hospital. The Roanoke Health Department, along with the Virginia Department of Health, investigated this outbreak.

Three different locations of a local restaurant, Famous Anthony’s, were ultimately determined to be associated with this outbreak. The Virginia Department of Health published a community announcement on September 24, 2021, about the outbreak and the potential exposure risk. 

For purposes of the investigation, a case was defined as a “[p]erson with (a) discrete onset of symptoms and (b) jaundice or elevated serum aminotransferase levels and (c) [who] tested positive for hepatitis A (IgM anti-HAV-positive), and frequented any of three Famous Anthony’s locations, or was a close contact to the index case patient, during the dates of August 10 through August 27, 2021.”

As of November 2021, a total of 49 primary cases (40 confirmed and 9 probable) were identified in this outbreak. Two secondary cases were also identified. Cases ranged from 30 to 82 years of age (median age of 63). In all, 57 percent of cases were male. Thirty-one cases included hospitalizations, and at least 4 case patients died. Illness onsets occurred between August 25 and October 15, 2021.

Ultimately, the outbreak investigation revealed that a cook, who also had risk factors associated with hepatitis A, had been infected with hepatitis A while working at multiple Famous Anthony’s restaurant locations. This index case’s mother and adult son also tested positive for hepatitis A. Following an inspection, the outbreak inspector noted, “due to the etiology of hepatitis A transmission, it is assumed the infectious food handler did not perform proper hand washing or follow glove use policy.” It was determined that person-to-person spread was the most likely mode of transmission in this outbreak. Environmental contamination was also considered a possible mode of transmission. 

Overwhelmed by the number of victims who pursued legal action for their injuries, Famous Anthony’s filed for bankruptcy and several of its locations have been closed.

The tragedy of this preventable hepatitis A outbreak cannot be overstated. Four people died. In one family, two of its members lost their lives. Most of the victims were hospitalized. Many risked acute liver failures. At least one person required both a liver and kidney transplants. Medical bills for the victims totaled over $6,000,000 in acute costs with millions of dollars in future expenses.[1] And this all because one employee did not receive a $30-$120 hepatitis A vaccine.

Affordable prevention of future tragedies like the Famous Anthony’s outbreak is possible and necessary. The time has come to at least recommend vaccinations to food service workers to reduce the spread of hepatitis A.

Sincerely,

Bill Marler

On behalf of 31 hepatitis A victims and families

[1] Privately, via mail, I am providing medical summaries for 31 of the victims so there can be a clear assessment of the impacts of hepatitis A on consumers of food at the hands of one unvaccinated food service worker.

cantaloupe

In August 2022, the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and state partners conducted an outbreak investigation into a multistate outbreak of Salmonella Typhimurium linked to cantaloupe.

However, the public was not told about the outbreak until a few days ago.  Here are the numbers:

  • Total Illnesses: 88
  • Hospitalizations: 32
  • Deaths: 0
  • Last Illness Onset: September 11, 2022
  • States with Cases: Georgia (1), Illinois (5), Indiana (17), Iowa (39), Kentucky (3), Michigan (3), Minnesota (4), Missouri (2), Ohio (3), South Carolina (1), Wisconsin (10)

This is the explanation from the CDC why the outbreak this cantaloupe was not announced at the time it occurred:

A challenging part of communicating about an ongoing foodborne outbreak is deciding when to issue an outbreak notice. CDC works to balance the need for releasing information quickly with the need for an accurate, specific, and actionable message. CDC issues outbreak notices during foodborne outbreaks if there is an ongoing risk to the public and an actionable message for consumers or retailers.

CDC did not post an outbreak notice on the 2022 Salmonella outbreak linked to melons. By the time the source of the outbreak was identified, the contaminated melons were no longer available for sale in stores or in people’s homes. CDC reviewed FDA’s constituent update and supports the release of information about the 2022 outbreak to make the public aware of the findings from the investigation.

The outbreak response investigation found:

  1. In August 2022, CDC notified FDA about a multistate cluster of Salmonella Typhimurium illnesses with a potential signal for melon exposures. The cases were geographically distributed in the U.S. upper Midwest.
  2. The isolates in this cluster of illnesses were within 7 alleles / 11 single-nucleotide polymorphisms (SNPs) of two FDA soil swab samples collected from a 2020 outbreak investigation in Indiana. As a part of the 2022 investigation, FDA and state partners collected multiple samples, but none of the resulting isolates were a definitive match to the 2022 outbreak strain.
  3. FDA’s 2022 traceback investigation identified 11 points of service, of which 8 traced back to a common packinghouse. Although a common packinghouse was identified, there was no convergence to a single shipment of products, and therefore three farms that supplied the common packing house were identified as potential sources of cantaloupe.

As a result of the traceback, FDA conducted investigations in Indiana at all three farms, their common packinghouse and nearby public lands. Salmonella positive environmental samples were found at each location, but none of the resulting Salmonella isolates conclusively matched the outbreak strain by whole genome sequencing (WGS). 

No cantaloupes were recalled, and no public warning was issued due to the implicated products no longer being on the market.

Download the Full Report (PDF 14MB)

The U.S. Food and Drug Administration (FDA) has released a report on its investigation of the Salmonella Typhimurium outbreak that caused 88 reported illnesses and 32 hospitalizations in the U.S. between July and September 2022. The FDA worked with the U.S. Centers for Disease Control and Prevention (CDC) and state partners to investigate the outbreak, which was linked through epidemiology and traceback to cantaloupe grown in Southwest Indiana during the summer of 2022. The report released today includes an overview of the traceback investigation, investigation results, and various factors that potentially contributed to the contamination of cantaloupe with Salmonella.

As a result of the traceback, FDA conducted investigations in Indiana at three farms, their common packinghouse and nearby public lands. Salmonella positive environmental samples were found at each location, but none of the resulting Salmonella isolates conclusively matched the outbreak strain by whole genome sequencing (WGS). Although the investigation did not result in identification of a specific microbial source or route that resulted in this outbreak, the agency identified Salmonella spp. in on-farm, post-harvest, and off-farm environments.

In light of the investigational findings, FDA highlights the following recommendations and requirements applicable to firms, such as growers of melons and similar produce:

  • Review current conditions and practices to determine whether they are adequate or if additional prevention measures are warranted.
  • Understanding previous land use can help farms identify and address potential sources of pathogens that may affect their farming operations.  
  • Be cognizant of and assess risks that may be posed by adjacent and nearby land uses, especially as it relates to the presence of livestock, including poultry, and the interface between farmland, and other agricultural areas.
  • Consider additional tools such as pre-harvest and/or post-harvest sampling and testing of products to help inform the need for specific prevention measures.
  • Poultry manure, while valued for its fertilizer value, is a known reservoir for Salmonella spp.  Proper application of a manure that has been treated with a validated and verified process to reduce pathogens (e.g. composting with time and temperature measurements) can significantly reduce the potential for the integration of Salmonella or other human pathogens into soils (as compared to the use of raw manures).
  • Inspect, maintain, and clean and, when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used as frequently as reasonably necessary to protect against contamination.
  • When appropriate, use EPA-approved products according to the label for cleaning and sanitizing.
  • Inconsistent adherence to or deviation from existing SOPs for cleaning and sanitizing by farms can affect produce safety. Effective communication on farms about SOPs and any changes to those SOPs can help ensure that food safety practices are being followed.
  • Root cause analyses may be useful in identifying for growers how human pathogen sources in the broader agricultural environment may contribute to contamination.
  • Improve traceability through increased digitization, interoperability, and standardization of traceability records which would expedite traceback and help remove contaminated product from the marketplace more quickly, thereby preventing further illnesses. This is not only important for growers, but also critical for shippers, manufactures, and retailers as well, to improve overall traceability throughout the supply chain.

FDA will work in conjunction with the Indiana State Department of Health to increase awareness amongst the melon growing industry of pathogenic environmental strains in the region to develop and promote risk reduction strategies related to melon growing and harvesting to minimize the impact of these strains.

Food safety is a shared responsibility that involves food producers, distributors, manufacturers, retailers, and regulators. Recognizing the interconnection between people, animals, plants, and their shared environment when it comes to public health outcomes, we encourage collaboration among various groups in the broader agricultural community (i.e., produce growers, state government and academia) to address this issue. Over a decade ago I penned a post entitled “Towards a Policy of Secrecy or Transparency in Public Health.” Here is a bit of it:

A.  Although there is no written policy, it is the way we have done things for years;

Why do I hear my mom saying, “just because so and so does that does not mean you should too.” Like all government policies (and neckwear) – change is good.

B.  Since the outbreak has concluded, there is not an immediate public health threat.

Frankly, that is true in most foodborne illness outbreaks.  In nearly every single outbreak investigated by the CDC the outbreak is figured out far after the peak of the illnesses happened.  However, disclosure gives the public information on which companies have a strong or weak food safety record.

C.  Disclosing the name of the company jeopardizes cooperation from the company in this and future outbreaks; and

If a company will only cooperate if they are placed in a witness protection program and with promises of non-disclosure, it does not say much for our governments and the company’s commitment to safe food.

D.  Bad publicity may cause economic hardship on the restaurant.

True, but not poisoning your customers is a better business practice.

I would also add a couple more reasons that I have received via email (mostly anonymously):

1.  The source was an unknown supplier, so naming the restaurant might place unfair blame on the restaurant.

This one does make some sense.  However, is this the unnamed restaurants first problem with a faulty supplier, or is this a pattern?  And, even if it is the first time, perhaps some of the unnamed product is still in the market? 

2.  Since the outbreak involves a perishable item, by the time the CDC announces the outbreak, the tainted product has long been consumed.

This one I have heard a “bunch” of times – especially in leafy green outbreaks.  However, why should the public be left in the dark about the type of product that sickens as well as the likely grower and shipper so they can make future decision who to buy from?

3.  Going public with the name of the restaurant compromises the epidemiologic investigation by suggesting the source of the outbreak before the investigation is complete.

I completely agree with this one.  This is a tough call, and one that must create the most angst for public health officials – they decide the balance between having enough data to go forward to protect the public health or wait for more data.  The point is do not go forward until the investigation is complete.

4.  Public health is concerned of making an investigation mistake like, it’s the tomatoes, err, I mean peppers; and

See my answer to 3 above.  This is why under the law; public health officials are immune for liability for the decisions that they make in good faith to protect the public.

5.  Public health – especially surveillance – is under budgetary pressures and there is simply not the resources to complete investigations; and

There is no question that this is true.  I have seen it in dropped investigations over the last few years.  Labs are not doing genetic fingerprinting to help reveal links between ill people.  And many tracebacks are stopped by the lack of peoplepower to do the research necessary to find the “root cause” of an outbreak.

For me it is easy – the public has a right to know and to use the information as it sees fit, and people – especially government employees – have no right to decide what we should and should not know.

After its premiere at the Tribeca Film Festival June 9, “Poisoned” will show July 1 (4:30PM) and July 2 (6:30PM) on Bainbridge Island. The theatre seats 225 and the events will be used as a fundraiser for Helpline House. The author, Jeff Benedict will be around to sign books. There will be a short Question and Answer period after the movie.

The plan is to have an “after party” at the Treehouse Cafe next door. Where we will have some swag to give away.