Marler Keynote Rocky Mountain Food Safety Conference - Will cover Civil and Criminal Liability with focus on Listeria Outbreaks

1. The “Rocky Ford”
Listeria Cantaloupe
Outbreak – The Good,
the Bad and the Ugly
William D. Marler, Esq.
Marler Clark LLP PS
The Food Safety Law Firm

2. Free Subscription to Food Safety News
• And, win:

3. In the Beginning – Long, Long Ago

4. Food Production is a Risky Business
• Competitive Markets
• Stockholder Pressures
for Increasing Profits
over Long-term Safety
• Lack of Clear Reward
For Marketing and
Practicing Food Safety
• Brand Awareness Risks

5. It is a Global Food Economy

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

7. 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)

8. • 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
It’s called STRICT Liability for a Reason

9. Pathway of a Foodborne Illness
Investigation

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

11. Pathway of a Foodborne Illness
Investigation

12. 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

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

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

15. Litigation as Incentive – 22 Years Later
Odwalla
Jack in the
Box

21. Ground Zero Listeria Outbreak 2011

22. First Listeria Outbreak Linked to Cantaloupe
• 147 persons infected with any
of the four outbreak-associated
strains of Listeria
monocytogenes.
• Alabama (1), Arkansas (1),
California (4), Colorado (40),
Idaho (2), Illinois (4), Indiana
(3), Iowa (1), Kansas (11),
Louisiana (2), Maryland (1),
Missouri (7), Montana (1),
Nebraska (6), Nevada (1), New
Mexico (15), New York (2),
North Dakota (2), Oklahoma
(12), Oregon (1), Pennsylvania
(1), South Dakota (1), Texas
(18), Utah (1), Virginia (1),
West Virginia (1), Wisconsin
(2), and Wyoming (4).

23. Largest Foodborne Death Toll in a Century
• Ages ranged from <1 to 96 years,
with a median age of 77 years.
• 99% were hospitalized.
• Thirty deaths were reported:
Colorado (8), Indiana (1), Kansas
(3), Louisiana (2), Maryland (1),
Missouri (3), Nebraska (1), New
Mexico (5), New York (2), Oklahoma
(1), Texas (2), and Wyoming (1).
• Number is at least 36 to date.
• Seven of the illnesses were related to
a pregnancy; three were diagnosed
in newborns and four were diagnosed
in pregnant women.

24. “Root Cause” Investigation

25. Blame enough to spread around
• Frontera – Broker – visited Jensen Farms during 2011
and suggested Primus to do audit.
• Primus Labs – Auditor - subcontracted audit to Bio
Food Safety, which gave Jensen Farms a “Superior”
rating of 96%!
• Pepper Equipment – Sold and installed equipment not
designed for cantaloupe.
• Retailers – Indemnity and Price Squeeze.

26. An Auditor’s Duty to Consumers?
Recent Federal Court ruling:
While the degree of certainty of harm to Mr. Beach is not decisively in favor of
imposing a duty in this instance, there is certainly moral blame that can be attached to
Primus Group's conduct due to the alleged large oversights committed during the July
25, 2011 audit.
Additionally, there is clearly a need to prevent future harm in situations like
this, where innocent consumers eat what they think to be healthy food, which turns out
to be contaminated with a potentially lethal pathogen. Further, imposing such a duty
neither places an inordinately heavy burden on food safety auditors, nor causes great
consequences to the community. In fact, the burden placed on food safety auditors
remains unchanged-had the audit not reflected that the packing facility was in total
compliance with food safety standards when it allegedly was not.
Finally, although not briefed on the issue, it certainly stands to reason that
there is insurance available for food safety auditors in conducting food safety audits, just
as there is malpractice insurance for doctors or lawyers.

27. 1938 Federal Food, Drug & Cosmetic Act
• Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to
growing public safety demands. The primary goal of the Act was to protect the
health and safety of the public by preventing deleterious, adulterated or
misbranded articles from entering interstate commerce. Under section 402(a)(4)
of the Act, a food product is deemed “adulterated” if the food was “prepared,
packed, or held under insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been rendered injurious to
health.” A food product is also considered “adulterated” if it bears or contains any
poisonous or deleterious substance, which may render it injurious to health. The
1938 Act, and the recently signed Food Safety Modernization Act, stand today as
the primary means by which the federal government enforces food safety
standards.
• Chapter III of the Act addresses prohibited acts, subjecting violators to both civil
and criminal liability. Provisions for criminal sanctions are clear:
Felony violations include adulterating or misbranding a food, drug, or device, and
putting an adulterated or misbranded food, drug, or device into interstate
commerce. Any person who commits a prohibited act violates the FDCA. A person
committing a prohibited act “with the intent to defraud or mislead” is guilty of a
felony punishable by years in jail and millions in fines or both.

28. How Are Things are Different Today?

29. And, It Does Not Always Require Intent
• A misdemeanor conviction
under the FDCA, unlike a
felony conviction, does not
require proof of fraudulent
intent, or even of knowing or
willful conduct.
• Rather, a person may be
convicted if he or she held a
position of responsibility or
authority in a firm such that
the person could have
prevented the violation.
• Convictions under the
misdemeanor provisions are
punishable by not more than
one year or fined not more
than $250,000 or both.

30. The DeCosters, Salmonella & Eggs
• Austin “Jack” DeCoster and his son, Peter
DeCoster acknowledge that, in August
2010, while they were in positions of
authority at Quality Egg, they introduced
shell eggs into interstate commerce that
were adulterated because they contained
a poisonous or deleterious substance in
the form of Salmonella that may have
rendered them injurious to health – nearly
2,000 sickened
• In exchange for their guilty pleas, the
DeCosters received three months in jail
each (being appealed) and personal fines
to $100,000.
• Jack DeCoster will also plead guilty to
three counts, including felony bribery of a
USDA inspector, on behalf of Quality Egg,
LLC, which owned the two egg production
facilities responsible for the largest shell
egg recall in U.S. history.
• In the plea agreement, Quality Egg agrees
to pay a fine of about $6.8 million for the
counts of bribery of a public official (a
USDA egg inspector) and introducing
misbranded food into interstate
commerce. The company will pay another
$100,000 fine for introducing adulterated
food into interstate commerce.

31. $11.2 Million Fine in Criminal Misdemeanor
• Federal criminal misdemeanor
charges related to the shipment of
adulterated peanut butter produced
in 2007 in Sylvester, GA, against
ConAgra Foods Inc.
• In 2007 Peter Pan and Great Value
peanut butters produced by ConAgra
at the Sylvester plant were recalled
because they were associated with a
multi-state Salmonella outbreak.
The contaminated peanut butter was
blamed for over 700 foodborne
illnesses in 39 states.
• The immediate investigation focused
on a faulty roof on the Sylvester
plant that may have allowed
moisture to invade the production
process.
• A criminal investigation was
launched in 2011 in a joint venture
between the U.S. Attorney’s Office
for Georgia and DOJ’s Consumer
Protection Branch.

32. What About Blue Bell Ice Cream?
• As of April 21, 2015, a total of ten
patients infected with several strains of
Listeria monocytogenes were reported
from four states: Arizona (1), Kansas
(5), Oklahoma (1), and Texas (3).
Illness onset dates ranged from
January 2010 through January 2015.
The patients with illness onsets ranging
from 2010-2014 were identified
through a retrospective review of the
PulseNet database for DNA fingerprints
that were similar to isolates collected
from Blue Bell ice cream samples.
Since the last update on April 8, 2015,
two additional patients, one each from
Arizona and Oklahoma, were confirmed
to be a part of the outbreak by whole
genome sequencing. All ten (100%)
patients were hospitalized. Three
deaths were reported from Kansas.
• Blue Bell ice cream has tested positive
for Listeria.

33. 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?

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

35. Lessons Learned From Litigation
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, your
suppliers and customers do
4. Treat your customers with respect

36. Questions?