Patti WallerMarler Clark May 17, 2011Boulder, CO

Recent and Emerging Trends in Foodborne

Illness Litigation

2011 Rocky Mountain Food Safety Conference

Putting It Into Perspective

48 million cases of foodborne illness each year in the US

128,00 hospitalizations

3,000 death

Scallan E, Hoekstra RM, Angulo FJ, et. al. Foodborne illness acquired in the United States – major pathogens. Emerg Infect Dis. 2011 Jan; http://www.cdc.gov/EID/content/17/1/7.htm

Foodborne Illness is Expensive

For five foodborne pathogens,* medical costs, productivity losses, and costs of premature death total:

$6.9 BILLION * Campylobacter, Salmonella (non-typhoidal), E. coli

O157:H7, Listeria monocytogenes, and other Shiga-toxin producing strains of E. coli.

$152 billion annual costs

This represents only a fraction of the total costs due to foodborne illness, which include some costs, such as pain and suffering, that are difficult to quantify, and other costs, such as costs of recalls, lost sales, loss of reputation, and public health expenditures, that are often overlooked.

More than just a stomach ache

According to the Food and Drug Administration, an estimated 2 to 3 percent of foodborne illness victims develop secondary long-term medical complications.

That’s 1 million lingering health problems each year.

See Frezen. Economic Research Service, USDA. The Economics of Food, Farming, National Resources & Rural America, www.ers.usda.gov

Meet Katelyn

Ate contaminated ground beef

E. coli O157:H7 Hemolytic Uremic

Syndrome 3 weeks hospitalization Pancreatitis Damage to central

nervous system Liver damage High blood pressure

Katelyn before E. coli

Long term consequences - Katelyn

Pancreas destroyed Type 1 diabetic, insulin

dependent Likely to progress to end

stage renal disease, requiring multiple kidney transplants Katelyn after E. coli

Since this horrific event occurred, people always ask me how our lives have changed and I don’t even know where to begin. Instead of getting into details, the answer I usually give is that “Everything has changed. Nothing is the same.” Katelyn’s mom

Marler Clark Law Firm

Formed in 1998 Seattle based 7 attorneys, and 10 staff Primary focus is representing people seriously

injured as a result of a foodborne illness Clients in all 50 states, settlements totaling

>$500,000,000 Advocates for food safety and public health

Bill Marler

Marler Clark Investigations

Contacted daily by persons who suspect they have a foodborne illness

Very few callers describe an event that warrants further follow-up

Individuals who meet screening criteria are sent “new client packets”

Isolated cases involving serious injury or death are often investigated in spite of the odds against identifying a source

Basic Tools of the Trade Symptoms Incubation Duration Food History Medical/Laboratory

Diagnostics Suspected source Others Ill

Health Department Involvement

Public Record Requests

A few of the basics

Plaintiff attorneys Defense attorneys Recovery of legitimate losses such as medical

expenses and wages Coverage for future needs due to injury

INSURANCE

Liability for Selling Contaminated Food

Strict liability

Focus is on the product-is it unreasonably dangerous or defective Negligence

Focus on the conduct did it meet the standard of care

Strict Liability

A manufacturer is liable if:1. The product had a defect

which rendered it unreasonably dangerous;

2. The defect existed at the time the product left the manufacturer’s control; and

3. The defect caused injury

Who is a Manufacturer?

The definition differs slightly in every state;

A “manufacturer” is defined as a “product seller who designs, produces, makes, fabricates, constructs, or remanufacturers the relevant product or component part of a product before its sale to a user or consumer…”

RCW 7.72.01 0(2); SEE ALSO Washburn v. Beatt Equipment Co., 120 Wn.2d 246 (1992)

Are restaurants manufacturers?

Yes. For example, a foodservice operation that thawed, cooked, and seasoned ground beef for sale as school lunch tacos was held to be a manufacturer.

The court ruled that there was no question that the defendant’s “cooking process falls neatly into the definition for “product,” “make,” “fabricate,” and “construct.” See Almquist v. Finley School District No. 53, 114 Wn. App. 395 (2002).

Why Strict Liability?

It puts pressure on the party (manufacturers) that most likely could correct the problem in the first place.

It puts the cost of settlements and verdicts directly on the party (manufacturers) that profited from the defective product’s sale.

NEGLIGENCE and 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).

Suppliers/Producers Held More Accountable

Defense strategy Underinsured No insurance Bankruptcy

Depending on laws in each state, these factors may put upstream suppliers and/or distributors at risk for liability.

Outbreaks of S. Baildon and S. Hartford

Salmonella serotype Hartford75 ill in 15 statesIllness onsets between April 30 and July 18, 2010

Salmonella serotype Baildon 80 ill in 15 statesIllness onsets between May 11 and July 19, 2010

Epidemiologic evidence points toward PRODUCE consumed at multiple Taco Bell restaurants

Peanut Corporation of America

2008-2009

Over 700 ill persons

Over 150 people hospitalized

9 deaths

4000+ products recalled

$12m has been applied to claims

BankruptcyFDA inspectors reported after spending 2 weeks at the Blakely, Georgia plant that the company knew its product was tainted with Salmonella but shipped them anyway after re-testing. This happened at least 12 times

in 2007-2008.

DeFusco’s Bakery – March 2011

Salmonella Heidelberg 79 ill persons 30 hospitalizations 2 deaths Bacteria found in empty boxes used

for raw eggs

NO LICENSE TO OPERATE!NO INSPECTIONS!NO INSURANCE!

SanGar Fresh Cut Produce, Texas

Outbreak of Listeria monocytogenes Texas Dept. of State Health Services and

FDA investigation 10 case-patients, 5 deaths 7 of 10 consumed chopped celery Product distributed to restaurants

and institutions (hospitals!) Indistinguishable PFGE between

patients, product, and environmental swabs Facility closed on October 21, 2010

NOW….

MISSING IN ACTION!!

Reliance on New Diagnostics

Pulsed Field Gel Electrophoresis (PFGE)

Multi-Locus Variable Tandem Repeat Analysis (MLVA)

JBS Swift and E. coli O157:H7, 2009

Linked to JBS Swift meat products 23 case-patients in 9 states

17 hospitalized 2 developed Hemolytic Uremic Syndrome

PFGE Pattern Combo – relatively COMMON! XBA – EXHX01.0074 BLN – EXHA26.0569

MLVA – Outbreak Pattern A1

BBBBBBb

EPIDEMIOLOGY still rules!

WRIGHT COUNTY EGGS INCFrom May 1 to November 30, 2010, approximately 1,939 illnesses of Salmonella Enteritidis infections occurred nationwide.

“New” Pathogens & Contaminated Foods

“New” pathogens– Non-O157 STECS

– Salmonella in meat

– MRSA and other antibiotic resistant bacteria

“New” routes of exposure – Intact vs. non-intact beef

“New” vehicles of transmission– Commercial Cookie Dough

– Nuts and nut products

– Celery and other vegetables/fruits

Food Safety Modernization Act of 2010

Allow the FDA to order a recall of tainted foods; Require larger food processors and

manufacturers to register with the FDA and create detailed food safety plans;

Require the FDA to create new produce safety regulations for producers of the highest-risk fruits and vegetables;

FDA Food Safety Modernization Act of 2010

Require CDC and state health departments to coordinate foodborne illness surveillance;

Establish stricter standards for the safetyof imported food;

Increase inspections of domestic and foreign food facilities, directing the most resources to those operations with the highest risk profiles.

Traceability FDA to establish a product tracing system to

receive information that allows FDA to effectively and rapidly track and trace food for consumption in US.

No specific timeline provided for establishing a product tracing system.

Improve surveillance with state public health authorities.

Does the FSMA mean the end of Marler?

Nah…we’ll still have “Sprout-breaks”

Jimmy Johns/Tiny Greens Alfalfa sprouts Nov 2010 – Feb 2011 Salmonella I 4,[5], 12:i:- 140 ill persons in 26

statesSprouters Northwest Clover sprouts December 2010 Salmonella Newport 6 ill persons in Washington

and Oregon

….and Raw Milk

RAW MILK OUTBREAKS, 2010

Month State Pathogen # ill Vehicle

Jan NY Campylobacter 5 Raw milk

Feb WA STEC 6 Raw milk

Feb WA Listeria moncytogenes 5 Queso fresco

Mar Multiple Campylobacter 12 Raw milk

Mar PA Campylobacter 10 Raw milk

Apr UT Salmonella 10 Raw milk

Apr UT Campylobacter 15 Raw milk

May WA E. coli O157:H7 2 Raw milk

May MN E. coli O157:H7 8 Raw milk

Jun DE Brucella & Listeria monocytogenes 2 Raw dairy products

Jun-Jul CO Campylobacter & E. coli O157:H7 30 Raw goat’s milk

Oct MN Campylobacter & Cryptosporidium parvum 7 Raw dairy products

Nov Multiple E. coli O157:H7 & Listeria monocytogenes 38 Raw gouda cheese

Dec Multiple E. coli O157:H7 8 Raw milk cheese

Bobby Ray “Pete”

Consumed Austin-brand peanut butter crackers

Ill on Sunday night Died on Wednesday

+ for Salmonella TyphimuriumPFGE match to PCA outbreak strainPete never spoke to me again. He was hooked up to a breathing machine. He had needles stuck in him, it seemed like there was 15 to 20 needles total. I told him I loved him. I asked him if he loved me and with a pitiful look, he shook his head yes. It broke my heart to see him in this condition.

Why what WE do is important

Questions, Comments?

Patti WallerMarler Clark 1301 Second Avenue, Suite 2800Seattle, WA 91801pwaller@marlerclark.com

www.marlerclark.comwww.foodsafetynews.comwww.outbreakdatabase.com