This document provides an overview of food safety laws and litigation in the United States from 1906 to present day. It discusses key events that shaped food safety policy, such as Upton Sinclair's The Jungle exposing unsanitary conditions in meatpacking plants which led to the 1906 Pure Food and Drug Act. Major foodborne illness outbreaks in the 1990s from Jack in the Box hamburgers and Odwalla juice increased pressure for stronger regulations. The Food Safety Modernization Act of 2009 and 2011 E.coli outbreaks linked to peanut butter and eggs led to millions in fines against companies. The document examines how litigation has served as an incentive for food companies to improve safety practices in order to avoid liability.

1. FSMA – A Litigator’s
Perspective

2. In The Beginning
The Pure Food and
Drug Act of June 30,
1906 was the United
States Federal Law
that provided federal
inspection of meat
products and forbade
the manufacture, sale,
or transportation of
adulterated food
products.

3. The Jungle’s Unintended Consequences
“Pierces the thickest
skull and most
leathery heart.”
Winston Churchill
"I aimed at the
public's heart, and
by accident I hit it
in the stomach.”
Upton Sinclair

4. Food Safety By The Numbers
The CDC estimates
that 48 million
foodborne illness cases
occur in the United
States every year. At
least 128,000
Americans are
hospitalized, and
3,000 die after eating
contaminated food.

5. Northwest Connection
1992 and 1993
• Over 600 people
sickened in six
States
• Mostly children
• 50 acute kidney
failure
• 4 deaths

6. Impact On Public Policy
“Jack in the Box
today has the highest
quality ground beef
that
I believe is available
in North America. …
But our products,
I will not guarantee,
are free of pathogens
in the raw state.”
Dave Theno

7. Public Involvement
S.T.O.P.
C.S.P.I.
Make our Food Safe

8. The 1994 Revolution
Politics and Philosophy Matter

9. 2006 – Magic Moment?
• Spinach –
205 sickened
and 5 deaths
• Peanut Butter –
746 sickened
and 3 years
of product recalled
• House and Senate
party switch

10. Well, Not Quite So Fast
• 2007 E. coli-poisoned
(hamburger)
paralyzed dancer –
Front Page of New
York Times and a
Pulitzer Prize
• 2009 E. coli-poisoned
(cookie dough)
mother of six –
Front Page
Washington Post

11. What About Industry?
• Tomato,
errr, Pepper
Outbreak
• PB 2 - $1
Billion in
Recall and
Economic
Losses

12. 2009 – The Magic Moment
Consumers and Industry Coming Together

13. Well, Not So Fast

14. Working To The End

15. “WE” Won!

16. Well, Not Quite Yet
"I would not identify it as
something that will necessarily
be zeroed out, but it is quite
possible it will be scaled back if
it is significant overreach," said
Rep. Kingston, who is likely to
become chairman of the
subcommittee when Republicans
assume control of the House in
January.
"We still have a food supply
that's 99.99 percent safe," Rep.
Kingston said in an interview.
"No one wants anybody to get
sick, and we should always
strive to make sure food is safe.
But the case for a $1.4 billion
expenditure isn't there."

17. 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

19. 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?

20. • 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

21. Pathway of a Foodborne Illness
Investigation

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

23. Pathway of a Foodborne Illness
Investigation

24. Litigation as a Food Safety Incentive
Odwalla
Jack in the
Box

30. How Are Things are Different Today?

31. 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.

32. It Started with a Little Salmonella
• In 2009 714 persons infected with the
outbreak strain of Salmonella
Typhimurium were reported from 46
states. Among the persons with
confirmed, reported dates available,
illnesses began between September 1,
2008 and March 31, 2009.
• Patients ranged in age from <1 to 98
years. The median age of patients was
16 years which means that half of ill
persons were younger than 16 years.
21% were age <5 years, 17% were
>59 years. 48% of patients were
female. Among persons with available
information, 24% reported being
hospitalized.
• Nine deaths: Idaho (1), Minnesota (3),
North Carolina (1), Ohio (2), and
Virginia (2).

33. Then there were Congressional Hearings
• “Turn them loose,” Parnell had told his
plant manager in an internal e-mail
disclosed at the House hearing. The e-
mail referred to products that once were
deemed contaminated but were cleared in
a second test last year.
• Parnell ordered products identified with
salmonella to be shipped and quoting his
complaints that tests discovering the
contaminated food were “costing us huge
$$$$$.”
• Parnell insisted that the outbreak did not
start at his plant, calling that a
misunderstanding by the media and public
health officials. “No salmonella has been
found anywhere else in our products, or in
our plants, or in any unopened containers
of our product.”
• Parnell complained to a worker after they
notified him that salmonella had been
found in more products. “I go thru this
about once a week,” he wrote in a June
2008 e-mail. “I will hold my breath ……….
again.”

34. Now – Guilty And Sentenced
• Stewart Parnell, the former
owner of Peanut Corp. of
America – 28 Years
• Michael Parnell, who is
Stewart Parnell’s brother
and a former supervisor -
20 Years
• Samuel Lightsey, a onetime
plant operator – 3 Years
• Mary Wilkerson, a former
quality-assurance manager
– 5 Years
• Daniel Kilgore, plant
manager – 6 Years
• Convictions Included:
• Mail Fraud
• Wire Fraud
• Introduction of Adulterated
and Misbranded Food into
Interstate Commerce with
Intent to Defraud or
Mislead
• Conspiracy

35. 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.

36. 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.

37. $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.

38. 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.

39. What About Bidart Apples?
• On January 10, 2015, the CDC
reports a total of 35 people infected
with the outbreak strains of Listeria
monocytogenes had been reported
from 12 states: Arizona (5),
California (3), Colorado (1),
Minnesota (4), Missouri (5), Nevada
(1), New Mexico (6), North Carolina
(1), Texas (4), Utah (1), Washington
(1), and Wisconsin (3).
• Thirty-one ill people have been
hospitalized, and seven deaths have
been reported. Listeriosis
contributed to at least three of these
deaths.
• Eleven illnesses were pregnancy-
related (occurred in a pregnant
woman or her newborn infant), with
one illness resulting in a fetal loss.
• Three invasive illnesses (meningitis)
were among otherwise healthy
children aged 5–15 years.
• PFGE match between ill people,
apples and Bidart Bros. Plant

40. Chipotle?
• Seattle — E. coli O157:H7, July 2015 (unreported),
five sick people;
• Simi Valley, Calif. — Norovirus, August 2015, 234
people;
• Minnesota — Salmonella Newport, August and
September 2015, 64 sick people, source was
tomatoes;
• Nine states — E. coli O26, began October 2015 and
declared over Feb. 1, 55 sick people, states involved
are California, Delaware, Illinois, Kentucky, Maryland,
Minnesota, New York, Ohio, Oregon, Pennsylvania and
Washington;
• Boston — Norovirus, December 2015, 151 sick
people;
• Three states — E. coli O26, began December 2015
declared over Feb. 1, five sick people, states involved
are Kansas, Oklahoma and Nebraska.
• Perhaps also another three state outbreak
(unreported)?

41. 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?

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

43. 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

44. Questions?