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How to Settle a Foodborne Illness Personal Injury Claim

Topics to DebateUnderstanding how each side assesses strengths and weaknesses of the claim to negotiate the best result.Determining liability of various parties involved manufacturer, distributer, supplier.Short-term v. long-term classification of a food-borne illness and what this means for settlement.Best practices for engaging in a valuation discussion when to begin the process and what to reveal.How delayed consequences and future medical expenses of foodborne illnesses affect a compensation package.

Strict Product LiabilityNegligenceAre you a product seller?Did you act reasonably?Strict LiabilityAre you a manufacturer?Was the product unsafe?Did product cause injury?Punitive Damages/Criminal LiabilityDid you act with conscious disregard of a known safety risk?

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Investigative PartnersLaboratory investigatorsMicrobiologic diagnosisMolecular analysis

Epidemiologic investigatorsIndividual case interviewsOutbreak investigationCohort studiesCase/control studies

Environmental investigatorsFacility investigationEnvironmental samplingProduct traceback

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EpidemiologyBasic Tools of the TradeSymptomsIncubationDurationFood HistoryMedical AttentionSuspected sourceOthers IllReal-time interviewing with a broad-based exposure questionnaire

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Pulsed Field Gel Electrophoresis (PFGE)Process separates chromosomal fragments of intact bacterial genomic DNA grown from patient isolateResults in 10 to 20 DNA fragments which distinguish bacterial strainsGenetic relatedness among strains is based on similarities of the DNA patternsOutbreak strains are those that are epidemiologically linked AND genetically linkedA Powerful Outbreak Detection Tool

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Questions to Consider in Assessing PFGE ClustersHow common is thePFGE subtype?How many cases are there?Over what time frame did cases occur?What is the geographic distribution of cases?What are the case demographics? Do any of the cases have a red flag exposure?

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Ill person

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Organism identified

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Ill person

Organism identified

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Epidemiologic investigation

Public Health Laboratory

If there are more ill persons than expected, an OUTBREAK might be underway.

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Ill person

Organism identified

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Epidemiologic investigation

Public Health Laboratory

Environmental investigation

Product Trace Back

Product Recall

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An Example of Outbreak DetectionSeptember 27, 2005Three E. coli O157:H7 isolates with indistinguishable PFGE patterns identified by Minnesota Public Health LaboratoryPFGE pattern new in Minnesota, rare in United States0.35% of patterns in National DatabasePatients reported eating prepackaged salad; no other potential common exposures evident

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E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce

Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctober

Initial cluster of 3 isolates among MN residents identified.

12This epicurve shows the illness onsets for the initial 10 cases, which were included in the case-control study.

The initial PFGE cluster of 3 isolates was first identified on Tuesday, Sept. 27.

Outbreak Investigation - MethodsSeptember 2829, 2005Additional O157 isolates received at the MDOH and subtyped by PFGE 7 isolates demonstrated outbreak PFGE subtype Supplemental interview form createdCase-control study initiated

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E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce

Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctoberInitial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

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E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce

Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctoberInitial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

Case-control study implicated Dole salad.

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E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce

Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctoberInitial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

Case-control study implicated Dole salad.

CDC, FDA notified.

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E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce

Date of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctoberInitial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

Case-control study implicated Dole salad.

CDC, FDA notified.

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MinnesotaAdditional statesDate of Onset 2005

1516171819202122232425Number of Cases26272829301234141234567

SeptemberOctober

WI

WI

ORE. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce (N=26)

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Shared common "Best if Used By Date and production codeDole Classic Romaine Salad Recovered from Case-Households

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Product Traceback

Single processing plant (Soledad, CA)Production Date of September 7, 2005Lettuce harvested from any 1 of 7 fields

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PFGE Patterns of E. coli O157:H7 Isolates from LettuceSource

Initial Minnesota Case-patientClassic RomaineBag #2Classic RomaineBag #1

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Are Things are Different Today?

Did We Cover It - QuestionsUnderstanding how each side assesses strengths and weaknesses of the claim to negotiate the best result.Determining liability of various parties involved manufacturer, distributer, supplier.Short-term v. long-term classification of a food-borne illness and what this means for settlement.Best practices for engaging in a valuation discussion when to begin the process and what to reveal.How delayed consequences and future medical expenses of foodborne illnesses affect a compensation package.

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