The Claim And The Claimant

How Do We Do It?

Just like health departments we need to quickly

and reliably recognize

unsupportable claims

? ? ?

Basic Tools of the Trade

• Symptoms

• Incubation

• Duration

• Food History

• Medical Attention

• Suspected source

• Others IllHealth Department Involvement

Matching Symptoms with Specific Characteristics of Pathogens

• E. coli O157:H7

• Hepatitis A

• Salmonella

• Shigella

• Campylobacter

• Vibrio

Campylobacter

E. coli O157:H7

Hepatitis A

Salmonella

Shigella

Vibrio

Matching Incubation Periods

Incubation Periods Of Common Pathogens

PATHOGEN INCUBATION PERIOD

Staphylococcus aureus 1 to 8 hours, typically 2 to 4 hours.

Campylobacter 2 to 7 days, typically 3 to 5 days.

E. coli O157:H7 1 to 10 days, typically 2 to 5 days.

Salmonella 6 to 72 hours, typically 18-36 hours.

Shigella 12 hours to 7 days, typically 1-3 days.

Hepatitis A 15 to 50 days, typically 25-30 days.

Listeria 3 to 70 days, typically 21 days.

Norovirus 24 to 72 hours, typically 36 hours.

Communicable Disease Investigation

• Reportable Disease Case Report Form

• Enteric/viral laboratory testing results

– Human specimens

– Environmentalspecimens

Medical Attention

• Health care provider

• Emergency Room

• Hospitalization

Epidemiologic Assessment

• Time

• Place

• Person association

• Part of a recognized outbreak?

Molecular Testing Results

• PFGE/MLVA

• PulseNet

Traceback Records

POS A

POS B

POS C

POS

D

FIRM

A

FIRM

B

FIRM

C

FIRM

D

FIRM

E

FIRM

G

FIRM

H

FIRM

F

FIRM

I

FIRM

J

FIRM

K

FIRM

L

FIRM

M

FIRM

N

FIRM

O

GROWERA

GROWERB

GROWERD

GROWERC

FOIA/Public Records Request

Case vs. Non-Case? In A Nutshell:

• CDC “confirmed” or “probable” case definitions

• Non-culture proven cases

• Product identification, proof of purchase, product exposure or likely product exposure

• Consistent medical symptoms occurring within epidemiological curve

• Strain prevalence/alternative causes

The Legal Standard: Strict Liability

STRICT LIABILITY IS LIABILITY WITHOUT REGARD TO FAULT

• The focus is on the product; not the conduct• You are liable if:

– The product was unsafe

– The product caused the injury

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….”

Causation - Science

“Causation is an essential concept in epidemiology, yet there is no single, clearly articulated definition ….” 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)

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

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).

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.

Negligence Is The Legal Standard Applied To Non-Manufacturers

See Butello v. S.A. Woods-Yates Am. Mach. Co., 72 Wn. App. 397, 404 (1993).

Some Recent Case Studies

• Spinach 2006 – 205 culture confirmed cases (5 deaths) – outbreak strain traced from finished product in sealed bagsto a single field in the Salinas Valley, yet 89 claims.

• Peter Pan Peter Butter 2007 – 714 culture confirmed cases,yet 25,000 claims.

• Peanut Corporation of America 2009 – 714 culture confirmed cases, yet 123 claims.

• Subway Shigella 2010 – 100 culture confirmed cases, yet 80 claims.

Once Causation Then Damages

• Past Medical Expenses

• Past Pain and Suffering

• Future Medical Expenses

• Future Pain and Suffering

• Punitive damages

• Parental Claims

• Loss of Consortium

What About Isolated – “One Off” Cases?

Yearly in the United States:

• 76,000,000 Sickened

• 325,000 Hospitalized

• 5,000 Deaths

• 1,097 Outbreaks 2007

• 497 Outbreaks with Confirmed Agent 2007

• 21,244 Confirmed Illnesses 2007

Prior Health Department Inspections

• Improper storage and cooking procedures

• Improper cooking procedures

• Improper refrigeration

Improper Cooking Procedures

• A young girl suffered HUS after eating a hamburger from a midsized southern California fast-food chain. 

• Her illness was not culture-confirmed.

• No food on site tested positive for E. coli O157:H7. 

• Review of health inspections revealed flaws in cooking methods.

Hamburger buns are toasted on the grill immediately adjacent to the cooking patties, and it is conceivable that, early in the cooking

process, prior to pasteurization, meat juices and blood containing active pathogens might possibly splash onto a nearby bun.

Improper Refrigeration

• A Chinese buffet-restaurant in Ohio was the suspected source of an E. coli O157:H7 outbreak.

• No contaminated leftover food was found. 

• A number of ill patrons were children. Jell-O was suspected as the vehicle of transmission.

• Health Department report noted “raw meat stored above the Jell-O in the refrigerator.” 

The likely source of E. coli O157:H7 in the Jell-O was from raw meat juices dripping on the Jell-O while it was solidifying in the refrigerator.

Improper Storage and Cooking

• A few banquet-goers tested positive for Salmonella.

• Leftover food items had been discarded or tested negative. 

• Restaurant had “pooled” dozens, if not hundreds, of raw eggs in a single bucket for storage overnight, then used them as a “wash” on a specialty dessert that was not cooked thoroughly. 

Ultimately - What Will a Jury Think?

A Jury = 12 Consumers

Questions?