Attorney and Food Safety Expert Bill Marler gives a webinar on foodborne illness litigation and liability for the Washington Restaurant Association

1. “What happens
when your
restaurant becomes
involved in liability
litigation?”
William D. Marler, Esq.

2. Food Production is a Risky Business
• Competitive Markets
• Wall Street and
Stockholder Pressures
for Increasing Profits
• Lack of Clear Reward
For Marketing and
Practicing Food Safety
• Brand Awareness
• Risk of Litigation

3. Strict Product Liability
• Strict Liability
– Are you a
manufacturer?
– Was the product
unsafe?
– Did product
cause injury?
• Negligence
• Punitive Damages
/Criminal Liability – Are you a
product seller?
– Did you act with
conscious disregard – Did you act
“reasonably”?
of a known safety risk?

4. 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)

5. It’s called STRICT Liability for a Reason
• 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

6. Litigation as Incentive
Odwalla
Jack in the
Box

7. Worthless Excuse No. 1
“I never read
the memo.”
• If a document
contains damning
information, the
jury will assume you
read it, understood
it, and ignored it

10. Bugs in Strange Places
• Listeria –
Tainted
Cantaloupe
• 146 Sickened
with over 30
Deaths
• First Outbreak
Linked with
Cantaloupe and
Listeria

11. But, We Have Seen This Before
• More that Two
Dozen
Salmonella
Cantaloupe
Outbreaks in
last Decades

12. 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

13. 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

14. 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

15. Pathway of a Foodborne Illness
Investigation

16. Pathway of a Foodborne Illness
Investigation
If there are more ill persons
than expected, an
OUTBREAK might be
underway.

17. Pathway of a Foodborne Illness
Investigation

18. 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

19. 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

20. Epidemiology–Basic Tools of the Trade
Real-time interviewing with a broad-based
exposure questionnaire
• Symptoms
• Incubation
• Duration
• Food History
• Medical Attention
• Suspected source
• Others Ill

21. Pulsed Field Gel Electrophoresis (PFGE)
A Powerful Outbreak Detection Tool
• 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

22. Questions to Consider in Assessing
PFGE Clusters
• How common is the
PFGE 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?

23. 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

24. E. coli O157:H7 Cases Associated
with Dole Prepackaged Lettuce
7
Number of Cases
6
5
4
3
2 Initial cluster of 3 isolates
among MN residents
1 identified.
14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4
September October
Date of Onset 2005

25. 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

26. E. coli O157:H7 Cases Associated
with Dole Prepackaged Lettuce
7
Number of Cases
6
5
4
Case-control study initiated.
3
2 Initial cluster of 3 isolates
among MN residents
1 identified.
14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4
September October
Date of Onset 2005

27. Case-Control Study Results
Exposure Cases Controls Matched OR* 95% CI† p-value
Any lettuce 9/10 17/26 3.5 0.5–25.0 0.17
Prepackaged
lettuce salad 9/10 10/26 8.4 1.2–59.6 0.01
Dole
prepackaged
lettuce salad 9/10 5/23 10.1 1.5–67.3 0.002
*OR = odds ratio
†
CI = confidence interval

28. E. coli O157:H7 Cases Associated
with Dole Prepackaged Lettuce
7
Number of Cases
6
5 Case-control study implicated Dole salad.
4
Case-control study initiated.
3
2 Initial cluster of 3 isolates
among MN residents
1 identified.
14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4
September October
Date of Onset 2005

29. E. coli O157:H7 Cases Associated
with Dole Prepackaged Lettuce
CDC, FDA notified.
7
Number of Cases
6
5 Case-control study implicated Dole salad.
4
Case-control study initiated.
3
2 Initial cluster of 3 isolates
among MN residents
1 identified.
14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4
September October
Date of Onset 2005

30. E. coli O157:H7 Cases Associated
with Dole Prepackaged Lettuce
CDC, FDA notified.
7
Number of Cases
6
5 Case-control study implicated Dole salad.
4
Case-control study initiated.
3
2 Initial cluster of 3 isolates
among MN residents
1 identified.
14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4
September October
Date of Onset 2005

31. E. coli O157:H7 Cases Associated with
Dole Prepackaged Lettuce (N=26)
Minnesota
Additional states
Number of Cases
7
6
5 OR
4
3
2 WI
1 WI
14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4
September October
Date of Onset 2005

32. Dole Classic Romaine Salad Recovered
from Case-Households
Shared common "Best if Used By”
Date and production code

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

34. PFGE Patterns of E. coli O157:H7
Isolates from Lettuce
Source
Initial Minnesota
Case-patient
Classic Romaine
Bag #1
Classic Romaine
Bag #2

35. 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

36. CDC 2005 Cluster Investigations
E. coli O157 Salmonella
Patterns Submitted 5,376 29,168
Clusters Identified 67 176
Multi-state Clusters 36 152
Epi Investigation 19 30
Vehicle Implicated 4 8
Regulatory Activity 4 8

37. 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?

38. Planning AGAINST Litigation –
Establish Relationships
They are your best friends!

39. 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

40. Questions?