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Liability and Risk

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Liability and Risk William D. Marler, Esq. bmarler_at_marlerclark.com – PowerPoint PPT presentation

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Title: Liability and Risk


1
Liability and Risk
William D. Marler, Esq. bmarler_at_marlerclark.com
2
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

3
Recent Lettuce Outbreaks
  • July 2002 WA Dance Camp
  • 50 dance campers sickened, several hospitalized,
    one with life-long kidney damage
  • Pre-washed lettuce
  • September 2003 CA Restaurant
  • 40 patrons ill
  • Salads prepared with bagged, pre-washed lettuce
  • October 2003 CA Retirement Center
  • 13 residents sickened, 2 died
  • Pre-washed spinach

Lettuce from all three outbreaks came from
Californias Salinas Valley.
4
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 FDAs concerns regarding
    continuing outbreaks associated with these two
    commodities and to encourage the industries to
    review their practices.

5
Dole Lettuce E. coli Outbreak Fall 2005
  • September 22-29, 2005
  • MN DOH lab receives 10 human E. coli O157H7
    isolates for subtyping
  • PFGE shows that all 10 share unique 2 restriction
    enzyme combination
  • September 28, 2005
  • Illness linked epidemiologically to consumption
    of Dole pre-packaged lettuce

6
Dole Lettuce E. coli Outbreak Fall 2005
  • October 3, 2005
  • MN Dept. of Ag isolates E. coli O157H7 in Dole
    lettuce obtained from households of
    case-patients
  • October 5, 2005
  • Oregon resident with O157, PFGE match to
    outbreak strain. Reports eating lettuce prior
    to symptom onset.

7
Dole Lettuce E. coli Outbreak Summary
  • 23 laboratory-confirmed cases of E. coli O157H7
    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
    pre-packaged lettuce
  • Smoking Gun
  • found in bag

8
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 irrigation and field drainage methods,
    may have led directly to the contamination of the
    lettuce with E. coli O157H7.
  • FDA considers adulterated any ready to eat
    crops produced under unsanitary conditions
    402(a)(4) of the Food, Drug, and Cosmetic Act

In light of continuing outbreaks associated with
fresh and fresh-cut lettuce and other leafy
greens, particularly from California, we are
issuing this second letter to reiterate our
concerns and to strongly encourage firms in your
industry to review their current operations.
9
CADOHS to Western Growers - 2006
  • A reassessment of current manure composting
    regulationsin light of recent scientific
    findings.
  • An assessment ofseptic tank systems that may
    leak/flow into agricultural ditches or creeks
    bordering fields used to grow ready-to-eat
    produce.
  • An assessment offarm worker access to portable
    toilets and hand washing facilities.

10
CADOHS to Western Growers 2006, cont.
  • An assessment of the locations of fields known to
    flood frequently.
  • An assessment of the need formandatory GAPs
    and/or HAACP Plans.

11
Dole and Natural Selections Fall 2006
  • 199 persons infected with outbreak strain of E.
    coli O157H7 from 26 states.
  • 102 (51) hospitalized
  • 31 (16) developed hemolytic-uremic syndrome
    (HUS)
  • Three confirmed deaths
  • Maryland investigating possible fourth

12
Dole and Natural Selections Fall 2006
  • E. coli O157H7
  • 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

13
The Smoking Cow Pie
14
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.

15
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.
16
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)

17
Its 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

18
Negligence The legal standard applied to
non-manufacturers
The reason for excluding non-manufacturing
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).
19
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.
20
Causation Science
  • Causation is an essential concept in
    epidemiology, yet there is no single, clearly
    articulated definition . J Epidemiol
    Community Health 2001Dec55(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)

21
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

22
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).

23
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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