Liability and Risk
William D. Marler, Esq.
bmarler@marlerclark.com
1
Lettuce and Spinach
• 19 E. coli outbreaks since
1995
– 409 reported illnesses
– two deaths
• Fresh or fresh-cut lettuce
or spinach implicated as
outbreak vehicle
• 8 outbreaks traced back
to produce from Salinas,
California
2
Recent Lettuce Outbreaks
• July 2002 – WA Dance
Camp
– 50 dance campers
sickened, several
hospitalized, one with
life-long kidney damage
– “Pre-washed” lettuce
• October 2003 – CA
Retirement Center
– 13 residents sickened, 2
died
– “Pre-washed” spinach
Lettuce from all three outbreaks came
from California’s Salinas Valley.
• September 2003 – CA
Restaurant
– 40 patrons ill
– Salads prepared with
bagged, “pre-washed”
lettuce
3
Prior FDA Warnings
• 1998 – FDA “Guide to Minimize
Microbial Food Safety Hazards for
Fruits and Vegetables.”
– Specifically designed to assist
growers and packers in the
implementation of safer
manufacturing practices.
• 2004 – FDA letter to the lettuce and
tomato industries
– To “make them aware of [FDA’s]
concerns regarding continuing
outbreaks associated with these
two commodities and to encourage
the industries to review their
practices.”
4
Dole Lettuce E. coli Outbreak
– Fall 2005
• September 22-29, 2005
– MN DOH lab receives 10
human E. coli O157:H7
isolates for subtyping
– PFGE shows that all 10 share
unique 2 restriction enzyme
combination
• September 28, 2005
– Illness linked
epidemiologically to
consumption of Dole prepackaged lettuce
5
Dole Lettuce E. coli Outbreak
– Fall 2005
• October 3, 2005
– MN Dept. of Ag isolates
E. coli O157:H7 in Dole
lettuce obtained from
households of casepatients
• October 5, 2005
– Oregon resident with O157, PFGE match to
“outbreak” strain. Reports eating lettuce prior
to symptom onset.
6
Dole Lettuce E. coli Outbreak
Summary
• 23 laboratory-confirmed cases of E. coli O157:H7;
7 epi linked cases
• September 16 to September 30 onset
• 2 cases of HUS
• Cases in MN, OR, and WI
• Statistically associated
with eating Dole prepackaged lettuce
• “Smoking Gun” –
found in bag
7
FDA – Adulterated – 2005
• FDA cited to research linking some or all of the
outbreaks to sewage exposure, animal waste, and
other contaminated water sources. The research
further indicated that industry practices, including
and field drainage
“Inirrigation
light of continuing
outbreaksmethods,
associatedmay
withhave
fresh and
led directly
to the
of the
lettuce with
fresh-cut
lettuce
and contamination
other leafy greens,
particularly
from
E. coli O157:H7.
California,
we are issuing this second letter to reiterate our
and to strongly
encourage firms in your industry to
•concerns
FDA considers
“adulterated”
review
their current
operations.”
any ready
to eat crops
produced under unsanitary
conditions §402(a)(4) of the
Food, Drug, and Cosmetic Act
8
CADOHS to Western Growers
- 2006
• A reassessment of current manure composting
regulations…in light of recent scientific findings.
• An assessment of…septic tank systems that may
leak/flow into agricultural ditches or creeks
bordering fields used to grow
ready-to-eat produce.
• An assessment of…farm worker
access to portable toilets and
hand washing facilities.
9
CADOHS to Western Growers
– 2006, cont.
• An assessment of the
locations of fields known
to flood frequently.
• An assessment of the
need for…mandatory GAPs
and/or HAACP Plans.
10
Dole and Natural Selections –
Fall 2006
• 199 persons infected with
outbreak strain of E. coli
O157:H7 from 26 states.
• 102 (51%) hospitalized
• 31 (16%) developed
hemolytic-uremic
syndrome (HUS)
• Three confirmed deaths
– Maryland investigating
possible fourth
11
Dole and Natural Selections –
Fall 2006
• E. coli O157:H7
– Isolated from 13 packages of DOLE
spinach
– “DNA fingerprints” of all 13 match the
outbreak strain
– Supplied by patients living in 10 states
– Eleven packages with lot codes
consistent with a single manufacturing
facility on a particular day
12
The Smoking Cow Pie
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Cross-Border Connection?
• E. coli sickens many in
Ontario
• TORONTO (CP) - More
than 30 people in two
Ontario cities may have
fallen ill from eating
lettuce tainted with
potentially deadly E. coli,
but there's no longer any
need for concern, health
authorities said Friday.
14
The Legal Standard: Strict
Liability
• The focus is on the product;
not the conduct
• They are liable if:
• The product was unsafe
• The product caused
the injury
STRICT LIABILITY IS LIABILITY WITHOUT REGARD
TO FAULT.
15
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)
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It’s called STRICT Liability for
a Reason
• The only defense is
prevention
• Wishful thinking
does not help
• If they manufacture a
product that causes
someone to be sick they
are going to pay IF they
get caught
17
Negligence
The legal standard applied to non-manufacturers
The reason for excluding nonmanufacturing retailers from strict
liability is to distinguish between
those who have actual control
over the product and those who
act as mere conduits in the chain
of distribution.
See Butello v. S.A. Woods-Yates Am. Mach.
Co., 72 Wn. App. 397, 404 (1993).
18
Punitive (or Exemplary)
Damages:
 Punish the defendant
for its conduct;
 Deter others from
similar conduct.
Historically, such damages were awarded to
discourage intentional wrongdoing, wanton and
reckless misconduct, and outrageous behavior.
19
Causation – Science
“Causation is an essential concept in
epidemiology, yet there is no single,
clearly articulated definition ….”
J Epidemiol Community Health
2001Dec;55(12):905-12;
Parascandola M, Weed DL.
Confidence Interval (CI) – Range
within which 95% of times
the true value of the estimated
association lies (95% CI)
20
Causation – The Law
“A proximate cause of an injury is a
cause which, in natural and
continuous sequence, produces the
injury, and without which the injury
would not have [likely] occurred.
The concept of proximate causation
has given courts and commentators
consummate difficulty and has in
truth defied precise definition.”
Prosser, Torts, pp. 311-313
However, “It really is what is more
likely than not. It is 50% and an
extra grain of sand.”
Marler on the law
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But, Causation Still Requires
Admissible Evidence
• Whether a theory or technique can be (and
has been) tested
• Whether it has been published and subjected
to peer review
• Whether it has a high potential rate of error
• Whether it enjoys general acceptance in the
scientific community
Daubert v. Merrell Dow Pharm., Inc.,
509 U.S. 579 (1993).
22
Will Industry Continue to
Learn from Outbreaks?
• Good Reasons
- Bad idea to poison
customers
- moral reasons
- business reasons
- Puts Trial Lawyers
out of business
- please!
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