Bill Marler 2012 Washington Restaurant Association Webinar
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
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
8.
9.
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
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
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
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
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?
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