“What happens when your

restaurant becomes involved in liability

litigation?”

William D. Marler, Esq.

Food Production is a Risky Business

• Competitive Markets

• Wall Street and Stockholder Pressures for Increasing Profits

• Lack of Clear RewardFor Marketing and Practicing Food Safety

• Brand Awareness

• Risk of Litigation

Strict Product Liability

• Negligence– Are you a

product seller?– Did you act

“reasonably”?

• Strict Liability– Are you a

manufacturer?– Was the product

unsafe?– Did product

cause injury?

• Punitive Damages/Criminal Liability– Did you act with

conscious disregard of a known safety risk?

Who is a Manufacturer?

A “manufacturer” is defined as a “product seller who designs, produces, makes, fabricates, constructs, or remanufactures the relevant product or component part of a product before its sale to a user or consumer.”

RCW 7.72.010(2); see also Washburn v. Beatt Equipment Co., 120 Wn.2d 246 (1992)

• The only defense is prevention

• It does not matter if you took all reasonable precautions

• If you manufacture a product that makes someone sick you are going to pay

• Wishful thinking does not help

It’s called STRICT Liability for a Reason

Litigation as Incentive

OdwallaJack in the Box

Worthless Excuse No. 1

• If a document contains damning information, the jury will assume you read it, understood it, and ignored it

“I never read the memo.”

Bugs in Strange Places

• Listeria – Tainted Cantaloupe

• 146 Sickened with over 30 Deaths

• First Outbreak Linked with Cantaloupe and Listeria

But, We Have Seen This Before

• More that Two Dozen Salmonella Cantaloupe Outbreaks in last Decades

Strange Bugs – Non-O157 E. coli

• E. coli O104:H4

• 4,321 Ill, 852 with Hemolytic Uremic Syndrome

• 50 Dead

• Six U.S. Cases

• Egyptian Fenugreek Seeds Likely Source

To Put Things in Perspective

• According to the CDC, microbial pathogens in food cause an estimated 48 million cases of human illness annually in the United States

• 125,000 hospitalized

• Cause up to 3,000 deaths

Estimates Differ From Actual Counts

• Annual E. coli O157 estimates

– 62,000 illnesses

– 1,800 hospitalizations

– 52 deaths

• But, only 2,621 E. coli 0157 cases were reported in 2005

Ill person

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Organism identified

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.

Ill person

Organism identified

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Epidemiologic investigation

Public Health Laboratory

Environmental investigation

Product Trace BackPRODUCT RECALL

Typical Steps of an Outbreak Investigation

• Establish that an outbreak is occurring• Verify the diagnosis• Define and identify cases• Orient the data in terms of person, place,

and time• Develop and test the hypotheses• Refine the hypotheses and carry out additional

studies• Implement control and prevention measures• Report findings

Investigative Partners

• Laboratory investigators– Microbiologic diagnosis

– Virology/Parasitic Labs

– Molecular analysis

• Epidemiologic investigators– Individual case interviews

– Outbreak investigation

• Cohort studies

• Case/control studies

• Environmental investigators– Facility investigation

– Environmental sampling

– Product traceback

Epidemiology–Basic Tools of the Trade

• Symptoms• Incubation• Duration• Food History• Medical Attention• Suspected source• Others Ill

Real-time interviewing with a broad-based exposure questionnaire

Pulsed Field Gel Electrophoresis (PFGE)

• Process separates chromosomal fragments of intact bacterial genomic DNA grown from patient isolate

• Results in 10 to 20 DNA fragments which distinguish bacterial strains

• Genetic relatedness among strains is based on similarities of the DNA patterns

• Outbreak strains are those that are epidemiologically linked AND genetically linked

A Powerful Outbreak Detection Tool

Questions to Consider in Assessing PFGE Clusters

• How 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?

Outbreak Detection

September 27, 2005

• Three O157 isolates with indistinguishable PFGE patterns identified by Minnesota Public Health Laboratory

• PFGE pattern new in Minnesota, rare in United States

– 0.35% of patterns in National Database

• Patients reported eating prepackaged salad; no other potential common exposures evident

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

Date of Onset 2005

15 16 17 18 19 20 21 22 23 24 25

Num

ber

of

Case

s

26 27 28 29 30 1 2 3 414

1

2

3

4

5

6

7

September October

Initial cluster of 3 isolates among MN residents identified.

Outbreak Investigation - Methods

September 28–29, 2005

• Additional O157 isolates received at the MDOH and subtyped by PFGE

– 7 isolates demonstrated outbreak PFGE subtype

• Supplemental interview form created

• Case-control study initiated

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

Date of Onset 2005

15 16 17 18 19 20 21 22 23 24 25

Num

ber

of

Case

s

26 27 28 29 30 1 2 3 414

1

2

3

4

5

6

7

September October

Initial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

Case-Control Study Results

Exposure Cases Controls p-valueMatched OR*95% CI†

*OR = odds ratio† CI = confidence interval

Any lettuce9/10 17/26 3.5 0.5–25.0

9/10Prepackaged lettuce salad 10/26 8.4 1.2–59.6

Dole prepackaged lettuce salad9/10 5/23

0.17

0.01

0.00210.1 1.5–67.3

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

Date of Onset 2005

15 16 17 18 19 20 21 22 23 24 25

Num

ber

of

Case

s

26 27 28 29 30 1 2 3 414

1

2

3

4

5

6

7

September October

Initial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

Case-control study implicated Dole salad.

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

Date of Onset 2005

15 16 17 18 19 20 21 22 23 24 25

Num

ber

of

Case

s

26 27 28 29 30 1 2 3 414

1

2

3

4

5

6

7

September October

Initial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

Case-control study implicated Dole salad.

CDC, FDA notified.

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

Date of Onset 2005

15 16 17 18 19 20 21 22 23 24 25

Num

ber

of

Case

s

26 27 28 29 30 1 2 3 414

1

2

3

4

5

6

7

September October

Initial cluster of 3 isolates among MN residents identified.

Case-control study initiated.

Case-control study implicated Dole salad.

CDC, FDA notified.

Minnesota

Additional states

Date of Onset 2005

15 16 17 18 19 20 21 22 23 24 25

Num

ber

of

Case

s

26 27 28 29 30 1 2 3 414

1

2

3

4

5

6

7

September October

WI

WI

OR

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

Shared common "Best if Used By” Date and production code

Dole Classic Romaine Salad Recovered from Case-Households

Product Traceback

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

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

SourceInitial Minnesota Case-patient

Classic RomaineBag #2

Classic RomaineBag #1

Why Epidemiologic Links May Not be Identified for Cases in a PFGE Cluster

• Cases have imperfect recall

• Common exposures can be difficult to link (e.g., eggs, chicken)

• Secondary transmission

• Cross-contamination exposure

• There isn’t a common source

CDC 2005 Cluster Investigations

E. coli O157 SalmonellaPatterns Submitted 5,37629,168Clusters Identified 67 176Multi-state Clusters 36 152Epi Investigation 19 30Vehicle Implicated 4 8Regulatory Activity 4 8

Planning AGAINST Litigation – What Is Really Important

• Identify Hazards– HACCP

– Do you have qualified and committed people?

• What is the Culture?

• Involve Vendors and Suppliers– Do they really

have a plan?

– Ever visit them?

Planning AGAINST Litigation – Establish Relationships

They are your best friends!

Lessons Learned From An Outbreak

You can insure the brand’s and the company’s reputation

1. Arm yourself with good, current information

2. Since you have a choice between doing nothing or being proactive, be proactive

3. Make food safety part of everything you do

4. Treat your customers with respect

Questions?