— OPINION —



Repeat offenders – You have to wonder if the DOJ is paying attention (see far below)?



In 30 years of food safety litigation I have prided myself that our firm takes on well-researched and scientifically-based cases. We get dozens of emails and calls a day from people who believe that they have been sickened by food or drink. We vet all and take on perhaps 10% for further investigation. Most of the cases appear to be isolated, but sometimes they are part of a larger outbreak that makes it to the public conscious. Far too often, however, we uncover an outbreak (defined as more than two people) that for one bad reason or another the CDC, FDA or FSIS decide that the public does not have a right to know about. Here is one of those cases.



An outbreak of  E. coli  O121:H19 occurred in November 2021 in the states of Minnesota linked to Chipotle restaurants and Washington linked to Panera restaurants and was investigated by the Food and Drug Administration, the Centers for Disease Control and Prevention and state partners. This outbreak was given the outbreak code POB2112MLEXK-1. 



A total of four lab confirmed cases were included in the outbreak. Fifty percent of cases were female. Ages ranged from 18-32 years (median 23.5). All cases reported hospitalization and no cases died. Illnesses ranged from November 21, 2021 to November 26, 2021. All stool specimen cultures identified  E. coli  O121:H19. All four case stool samples were genetically matched by whole genome sequencing (0-2 SNPs apart). 







Traceback evidence collected from all four cases’ food histories linked the outbreak to romaine lettuce from California, specifically Taylor Farms in Salinas, California.  See  POB2112MLEXK-1.



The causal link between Nick Lowe’s confirmed  E. coli  O121:H19 infection and the romaine lettuce that he consumed at Panera Bread is clear. On November 19, 2021, Nick purchased and consumed a meal of a Green Goddess Cobb salad with chicken, a baguette, French Bistro Onion soup, and a Green Passion smoothie from Panera Bread located at 502 S Steele St Suite 125 in Tacoma, Washington.



Nick experienced symptoms consistent with  E. coli  infection, such as abdominal cramps and bloody diarrhea, beginning on November 21, 2021. An exposure on November 19 is consistent with a Shiga toxin-producing  E. coli  (STEC) incubation period that can range from 1 to 10 days. A stool specimen collected on November 24 tested positive for Shiga toxin-producing  E. coli  and Shiga toxin 2 at Swedish Edmonds Hospital in Edmonds, Washington. This specimen was found to be culture positive for  E. coli  O121:H19, allele code EC1.0-18.1.14.38.16, at the Washington State Public Health Laboratory (Specimen ID: WA0687014). Further genetic testing determined that Nick’s  E. coli  O121:H19 infection was a genetic match to at least three other cases in an outbreak coded POB2112MLEXK-1 (DOH Outbreak number: EC21-046, Nick’s PulseNet ID: PNUSAE090854). Nick was classified as a confirmed case in the outbreak, which was ultimately traced back to romaine lettuce from Taylor Farms in Salina, California. 



Given Nick’s confirmed infection with  E. coli  O121:H19 ,  his symptom onset within the normal  E. coli  incubation period, his exposure to Taylor Farms romaine lettuce, which was implicated in an outbreak, and the genetic evidence connecting his infection to other cases in the Taylor Farms romaine lettuce outbreak, Nick was identified as a confirmed  E. coli  O121:H19 case in the outbreak associated with Taylor Farm’s romaine lettuce by the Washington State Department of Health and Snohomish County Public Health.



Lawsuit to come in the coming weeks after Taylor Farms refused to consider resolving this case.



























So, what gives the government the right to charge a company and certain employees with either a felony or a misdemeanor?



Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce.  Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health.  The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.



Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:



Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.



A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.



As they say, see ya in Court. Here are some of the key documents:



https://www.marlerblog.com/files/2023/05/POB2112MLEXK-1-FDA-Records.pdf







https://www.marlerblog.com/files/2023/05/WDRS_record_Nick_Lowe.pdf



https://www.marlerblog.com/files/2023/05/PRR_D742.pdf



https://www.marlerblog.com/files/2023/05/Lowe-Nicholas-WA-Snohomish-County-Records.pdf



https://www.marlerblog.com/files/2023/05/Combined-Individual-Files-_Redacted.pdf



https://www.marlerblog.com/files/2023/05/C0B0D03AEDDC4FABBBEE719F73313A72_R.pdf



https://www.marlerblog.com/files/2023/05/5914EDC24534467A_Panera_Federal_Way_NEARS_POB2112M_PRDTOOL_NAMETOOLONG.pdf



https://www.marlerblog.com/files/2023/05/448E55B5C64D4C47_NORS_2021_POB2112MLEXK-1.pdf



https://www.marlerblog.com/files/2023/05/54FC4CE25F4D401A_Region_of_harvest_by_date_and_lot_number.pdf



https://www.marlerblog.com/files/2023/05/22C56B7936CB4533_E._coli_O121_Dec_2021.pdf



https://www.marlerblog.com/files/2023/05/22-01908_LineList-Redacted.pdf



https://www.marlerblog.com/files/2023/05/6CFF903FF3224673_Panera_Salad_Ingredients12.16.21-1.pdf



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