Transcript Long-term Renal Outcomes in Diarrhea

9th Annual PulseNet
Seattle Update Meeting
May 9-11, 2005
Foodborne Illness CSI:
Cracking the Legal Code
To Put Things in Perspective
• Microbial pathogens
in food cause an
estimated 76 million
cases of human
illness annually in
the United States
• 325,000 hospitalized
• 5,000 deaths
Why what “WE” do is Important
“… contaminated food
products caused more
deaths each year than the
combined totals of all
15,000 products
regulated by the U.S.
Consumer Product Safety
Commission; these
products caused only
3,700 deaths in 1996.”
Buzby, et al. Product Liability and Microbial Foodborne Illness (2001)
Cracking the Legal Code –
What Marler Clark Actually Does
• Since 1993 Marler Clark has
represented thousands of food
illness victims in over 30
states.
• However, we only prosecute
a fraction of the cases that
contact our offices, some
examples of our “missed
opportunities:”
“Christening” the Carpet
“I opened a box of Tyson Buffalo wings and
dumped them out on a plate to be cooked in the
microwave. An unusually shaped piece caught my
eye and I picked it up. When I saw that the "piece"
had a beak, I got sick to my stomach. My lunch and
diet coke came up and I managed to
christen my carpet, bedding
and clothing. I want them
to at least pay for cleaning
my carpet etc.
What do you think?”
There is a Worm in my Freezer!
“I recently found a whole,
2-cm long worm packaged
inside a Lean Cuisine frozen
dinner. I have the worm in
my freezer. I'm interested in
discussing my rights in this
matter.
Could you please contact
me, or refer me to a firm
that may be able to give me
assistance? Thank you very
much for your attention.”
Lending a Helping Hand
“I have recently read
articles and lawsuits that you
have pursued regarding
contaminated food. I am
hoping that you may be able to
give me your professional
advice or recommendation.
My husband recently
opened a bottle of salsa and
smelled an unusual odor but
chose to eat it regardless,
thinking that it was just his
nose.
Lending a Helping Hand, cont.
After taking two bites
and tasting rather badly, he
found what appeared to be a
rather large piece (approx. the
size of the back of an adult's
fist) of human or animal flesh.
Even though he didn't
seek medical attention, he did
become very nauseated. I do
feel that the manufacturer
should be held responsible for
this mishap. Thank you for
your time and consideration.”
Civil Litigation - A Tort – Is NOT a Small
German Cake
• Strict liability
• It is their fault – Period!
• Negligence
• Did they act
reasonably?
• Punitive damages
• Did they act with
conscious disregard
of a known
safety risk?
Strict Liability for Food –
a Bit(e) of History
a manufacturer of a
food product under
modern conditions
impliedly warrants his
goods… and that
warranty is available to
all who may be damaged
by reason of its use in the
legitimate channels of
trade…”
“…
Mazetti v. Armour & Co.,
75 Wash. 622 (1913)
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 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.
Unsafe = CONSUMER EXPECTATION
• A product is unsafe
“or not reasonably safe”
• if it is unsafe beyond that
which would be expected by
the ordinary consumer
Do consumers expect to be
sold foods that make them
sick?
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
Why Strict Liability?
• It puts pressure on
those (manufacturers)
that most likely could
correct the problem
in the first place
• It puts the cost of
settlements and verdicts
directly on to those
(manufacturers) that
profit from the product
• Creates incentive not to
let it happen again
The Legal Standard: Negligence
FOUR REQUIREMENTS
– DUTY
– BREACH
– CAUSATION
– INJURY
“Negligent conduct is the failure to exercise
reasonable care under the circumstances”.
Negligence is 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).
Causation - Science
“Causation is an essential concept in
epidemiology, yet there
is no single, clearly articulated
definition ….”
Epidemiology
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)
Tracking the Bug!
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
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
scientific community
Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).
Example – How a Lawsuit Works
Almquist v. Finley School E. coli Outbreak
8 confirmed cases of E. coli O157:H7
3 probable cases, 1 secondary case, 8 PFGE matches
ill students in grades K-5
All but one ill child ate a taco meal (or, did she?)
No ill staff members
Food handling errors were noted
in the kitchen
• There was evidence of
undercooked taco meat
• No pathogen found in food samples
• A source of infection could
not be determined to a:
“statistical significance”
•
•
•
•
•
•
At Trial: The Plaintiffs’ Case
• The WDOH, CDC and the BFHD
conducted a fair and thorough
investigation.
• The Final report issued by the WDOH
concluded the undercooked taco meat was
the most likely cause of the outbreak.
• The conclusion reached as a result of the
investigation was the fair, unbiased and
correct one.
The School District’s Defense
• We were not a Manufacturer
• The taco meat was safe
to eat because:
– We love children.
– We are always careful to cook it a lot.
– We’ve never poisoned anyone before.
– The health departments botched
the investigation and jumped to
a hasty conclusion.
• Something else caused the
outbreak (“invasion of army worms”)
• It wasn’t us, but if it was, it is not our fault the USDA gave
us contaminated ground beef.
What Did the Jury Think?
• The investigation into the
cause of the outbreak was
fair and thorough.
• The investigators were
correct to conclude that,
more likely than not,
undercooked taco meat
caused the children to
become ill.
• The School District was
ultimately responsible for
ensuring the safety of the
food it sold to its students.
The Taco Meal Recipe Card
However, the Legal Reality
“Lawsuits would seem to provide important
feedback to these firms about how much they
should invest in food safety.”
“[However,] much of the costs of illness
borne by people who become ill … are not
reimbursed by food firms responsible for an
illness.”
“In short, the legal system provides limited
incentives for firms to produce safe foods.”
Buzby, et al. Product Liability and Microbial Foodborne Illness (2001)
Why Does the Legal System
Seem to Fail?
• Manufacturer not Caught
• No Known Cause
– What Food or Drink was It?
– Victims Stool not Tested
– What Bacteria or Virus?
– Apparent Isolated Case
– No Health Department Investigation
– No PFGE, No PulseNet
• Unequal Power Between
Victim and Manufacturer
Litigation Can Work – A Little History Lesson –
PFGE at Work Too and the Beginning of PulseNet
Jack in the Box - 1993
Odwalla - 1996
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.
Industry Standards
• In nearly every case,
industry standards
improve after a
outbreak of food-borne
illnesses
• However, it occurs only
after they are caught.
– Increased cook times
– Pasteurization of apple juice
PulseNet and Litigation 1996 - Present
Paramount Farms Almonds Salmonella Outbreak - 2003
• Increased Industry Awareness of Contamination Risk
Harmony Farms Salmonella Outbreak - 2003
• Warnings on Sprouts
Spokane Produce E. coli Outbreak - 2002
• Increased Industry Awareness of Lettuce Contamination
Conagra E. coli Outbreak - 2002
• Tipping Point in Meat Industry
Quality Inn Salmonella Outbreak - 2003
• Industry Change on use of Pooled Eggs – New FDA Rules
Shipley Sales Salmonella Outbreak - 2001
• FDA Change on import of Cantaloupes
PulseNet and Litigation 1996 - Present
Sun Orchard Salmonella Outbreak - 1999
• Pasteurization of Orange Juice
Supervalu E. coli Outbreak - 2000
• Better Grinding Records at Retail
Sizzler E. coli Outbreak - 2000
• Industry Awareness of Risk of Cross-Contamination
Senor Felix Shigella Outbreak - 2000
• Pressure from Major Purchaser to Increase Quality
White Water E. coli Outbreak - 1998
• Awareness of Need for Chlorination
PulseNet and Litigation 1996 – Present
What will be the next change?
Chi Chi’s Hepatitis A Outbreak - 2003
• ? Green Onions
Sheetz Salmonella Outbreak - 2004
• ? Tomatoes
Petting Zoo E. coli Outbreaks?
• ? Will they finally pay attention to CDC
recommendations
PulseNet and Litigation –
They Do Work Well Together
From 1996-2004, the incidence of:
• E. coli O157:H7 infections decreased 42 percent
• Campylobacter infections decreased 31 percent
• Cryptosporidium dropped 40 percent
• Yersinia decreased 45 percent
• Salmonella infections decreased 8 percent
Preliminary FoodNet Data on the Incidence of Infections
with Pathogens Transmitted Commonly Through Food –
Selected Sites, United States, 2004.
Morbidity and Mortality Weekly Report (April 15, 2005)
Questions?
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701 Fifth Avenue
Seattle, Washington 98104
1-206-346-1890
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