The “Rocky Ford” Listeria Cantaloupe Outbreak – The Good, the Bad and the Ugly

William D. Marler, Esq.Marler Clark LLP PSThe Food Safety Law Firm

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• And, win:

In the Beginning – Long, Long Ago

Food Production is a Risky Business

• Competitive Markets

• Stockholder Pressures for Increasing Profits over Long-term Safety

• Lack of Clear RewardFor Marketing and Practicing Food Safety

• Brand Awareness Risks

It is a Global Food Economy

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?

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 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

Pathway of a Foodborne Illness Investigation

Pathway of a Foodborne Illness Investigation

If there are more ill persons than expected, an

OUTBREAK might be underway.

Pathway of a Foodborne Illness Investigation

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

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

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

Litigation as Incentive – 22 Years Later

OdwallaJack in the

Box

Ground Zero Listeria Outbreak 2011

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).

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.

“Root Cause” Investigation

Real People – Why what we do is important

Strict Product Liability

• Negligence

– Are they a product seller?

– Did they act “reasonably”?

• Strict Liability

– Are they a manufacturer?

– Was the product unsafe?

– Did product cause injury?

• Punitive Damages/Criminal Liability

– Did they act with

conscious disregard

of a known safety risk?

• The only defense is prevention.

• It does not matter if the manufacturer took all reasonable precautions.

• If they manufacture a product that makes someone sick they are going to pay.

• Wishful thinking does not help.

It’s called STRICT Liability for a Reason

Well, unless you are an “Innocent” Seller

In Colorado:

• “No product liability action shall be commenced or maintained against any seller of a product unless said seller is also the manufacturer of said product or the manufacturer of the part thereof giving rise to the product liability action.”

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.

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.

Knowingly Shipping Adulterated Food?

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.

What about You?

• On January 10, 2015, the CDC reports a total of 32 people infected with the outbreak strains of Listeria monocytogenes had been reported from 11 states: Arizona (4), California (2), 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.

• Ten 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

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?

Planning AGAINST Litigation –Establish Relationships

They are your best friends!

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

Even Comedians Like Safe Food

Questions?