The Legal Standard: Strict LiabilityThe Legal Standard: Strict Liability

Strict Liability Is Liability Strict Liability Is Liability Without Regard To Fault.Without Regard To Fault.

The focus is on The focus is on the product; the product; not the conductnot the conduct

They are liable if:They are liable if:

– The product The product was unsafewas unsafe

– The product The product caused the injurycaused the injury

Who is a Manufacturer?Who is a Manufacturer?

A “manufacturer” is defined A “manufacturer” is defined as a “product seller who as a “product seller who

designs, produces, makes, designs, produces, makes, fabricates, constructs, fabricates, constructs, or remanufactures the or remanufactures the

relevant product or relevant product or component part of a component part of a

product before its sale to product before its sale to a user or consumer….” a user or consumer….”

RCW 7.72.010(2); RCW 7.72.010(2); see alsosee also Washburn v. Beatt Equipment Washburn v. Beatt Equipment CoCo., 120 Wn.2d 246 (1992)., 120 Wn.2d 246 (1992)

It’s called It’s called STRICTSTRICT Liability for a Reason Liability for a Reason

The only defense The only defense is preventionis prevention

Wishful thinking Wishful thinking does not helpdoes not help

If they manufacture If they manufacture a product that a product that causes someone causes someone to be sick they are to be sick they are going to pay going to pay IF IF they get caughtthey get caught

NegligenceNegligenceThe legal standard applied to non-manufacturersThe legal standard applied to non-manufacturers

The reason for excluding The reason for excluding non-manufacturing retailers non-manufacturing retailers

from strict liability is to from strict liability is to distinguish between those distinguish between those

who have actual control over who have actual control over the product and those who the product and those who act as mere conduits in the act as mere conduits in the

chain of distribution.chain of distribution.

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

404 (1993).404 (1993).

Causation – Science Causation – Science

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

J Epidemiol Community Health J Epidemiol Community Health 2001Dec;55(12):905-12; 2001Dec;55(12):905-12;

Parascandola M, Weed DL.Parascandola M, Weed DL.

Confidence Interval (CI)Confidence Interval (CI) – – Range within which 95% of times Range within which 95% of times the true value of the estimated the true value of the estimated association lies (95% CI)association lies (95% CI)

Causation – The LawCausation – The Law

““A A proximate causeproximate cause of an of an injury is a cause which, in injury is a cause which, in natural and continuous natural and continuous sequence, produces the injury, sequence, produces the injury, and without which the injury and without which the injury would not have would not have [likely][likely] occurred. The concept of occurred. The concept of proximate causation has given proximate causation has given courts and commentators courts and commentators consummate difficulty and has consummate difficulty and has in truth defied precise in truth defied precise definition.”definition.”

Prosser, TortsProsser, Torts,, pp. 311-313 pp. 311-313

Lettuce and SpinachLettuce and Spinach

Over 23 Over 23 E. coliE. coli outbreaks since 1995outbreaks since 1995

– Hundreds of reported Hundreds of reported illnesses illnesses

– Several deathsSeveral deaths

Fresh or fresh-cut Fresh or fresh-cut lettuce or spinachlettuce or spinach

9 outbreaks traced 9 outbreaks traced back to produce from back to produce from Salinas, CaliforniaSalinas, California

2006 Wendy’s 2006 Wendy’s E. coliE. coli Outbreak Outbreak

Utah - June 2006Utah - June 2006

E. coli E. coli O21:H19 – only 3 O21:H19 – only 3 culture-positive cases, culture-positive cases, although over 50 cases although over 50 cases probableprobable

3 HUS, 2 adult women,1 3 HUS, 2 adult women,1 with 30 days, the other with 30 days, the other with 4 months of dialysiswith 4 months of dialysis

Likely lettuce from Likely lettuce from CaliforniaCalifornia

Dole and Natural Selections – Fall 2006Dole and Natural Selections – Fall 2006

205 persons infected 205 persons infected with outbreak strain with outbreak strain of of E. coli E. coli O157:H7 O157:H7 from 26 states. from 26 states.

102 (51%) hospitalized 102 (51%) hospitalized

31 (16%) developed 31 (16%) developed hemolytic-uremic hemolytic-uremic syndrome (HUS)syndrome (HUS)

Three confirmed Three confirmed deaths – likely fivedeaths – likely five

Dole and Natural Selections – Fall 2006Dole and Natural Selections – Fall 2006

E. coli E. coli O157:H7O157:H7– Isolated from 16 Isolated from 16

packages of DOLE packages of DOLE spinach spinach

– ““DNA fingerprints” DNA fingerprints” of all 16 match the of all 16 match the outbreak strainoutbreak strain

– Supplied by patients Supplied by patients living in 10 statesliving in 10 states

– Eleven packages with lot Eleven packages with lot codes consistent with a codes consistent with a single manufacturing single manufacturing facility on a particular dayfacility on a particular day

Taco Taco E. coliE. coli Litigation Status Litigation Status

Multiple lawsuits filed Multiple lawsuits filed in Courts in Courts in a 5 Statesin a 5 States

Taco Bell and Ready-Taco Bell and Ready-PacPac

Taco John’s Taco John’s and Bixand Bix

Lettuce Lettuce supplier to Bix - supplier to Bix - Outbreak PFGE found Outbreak PFGE found on on nearby Farmnearby Farm

Aunt Mid’s E. coli LettuceAunt Mid’s E. coli Lettuce At Least 40 At Least 40

cases in Illinois, cases in Illinois, Michigan, Ohio Michigan, Ohio and Canadaand Canada

Traceback Traceback looking at looking at Salinas, Salinas, Michigan, Michigan, and California and California Central ValleyCentral Valley

2006-07 Peanut Butter 2006-07 Peanut Butter Salmonella Salmonella OutbreakOutbreak

CDC Figures as of CDC Figures as of March 7, 2007March 7, 2007

714 culture-positive 714 culture-positive illnesses from 44 illnesses from 44 statesstates

71 hospitalized71 hospitalized

Illnesses reported Illnesses reported August 1, 2006 to August 1, 2006 to present – perhaps present – perhaps earlierearlier

3-D Area 1

29,640 ill Persons

Salmonella TennesseeSalmonella TennesseeAC Voetsch, “FoodNet estimate of the burden of illness caused by nontyphoidal Salmonella infections in the United States,”Clinical Infectious Diseases 2004;38 (Suppl 3):S127-34

CDC Baseline -CDC Baseline - Approximately 50 per yearApproximately 50 per yearCDC Outbreak Date -CDC Outbreak Date - 714 officially counted, however 13 additional cases in 714 officially counted, however 13 additional cases in

2006 and 30 additional cases in 2005 share the 2006 and 30 additional cases in 2005 share the same same

PFGE as one of the outbreak patternsPFGE as one of the outbreak patternsCDC Estimate -CDC Estimate - 38.6 multiple of reported cases of 38.6 multiple of reported cases of S. TennesseeS. Tennessee

S. Tennessee Cases By Month S. Tennessee Cases By Month 2005-20072005-2007

CDC BaselineCDC Outbreak DataEstimated Unreported Cases

The OutbreakThe Outbreak

Epidemic Curve of Confirmed Salmonella Tennessee Cases Epidemic Curve of Confirmed Salmonella Tennessee Cases Month/Year of OnsetMonth/Year of Onset

CDC DataCDC DataClient DataClient Data

October 2004October 2004Positive SamplePositive Sample

Pot PiesPot Pies

272 isolates of Salmonella 272 isolates of Salmonella I 4,[5],12:i:- with an I 4,[5],12:i:- with an indistinguishable genetic indistinguishable genetic fingerprint have been fingerprint have been collected from ill persons collected from ill persons in 35 states. To date, three in 35 states. To date, three of these patients’ pot pies of these patients’ pot pies have yielded Salmonella I4,have yielded Salmonella I4,[5],12:i:- isolates with [5],12:i:- isolates with a genetic fingerprint a genetic fingerprint indistinguishable from indistinguishable from the outbreak patternthe outbreak pattern

Outbreaks Linked To Unpasteurized MilkOutbreaks Linked To Unpasteurized Milk

Related IssuesRelated Issues

Comparative faultComparative fault

Releases and WaiversReleases and Waivers

Public EducationPublic Education

Where is Public Where is Public Health?Health?

Hamburger – It’s BackHamburger – It’s Back

In 2007 and 2008 - In 2007 and 2008 - 26 recalls, ground 26 recalls, ground beef companies beef companies have recalled more have recalled more than 44 million than 44 million pounds of pounds of E. coli E. coli O157:H7-O157:H7-contaminated meatcontaminated meat

Emerging PathogensEmerging Pathogens

E. coli E. coli O111 linked to O111 linked to over 300 illnesses and over 300 illnesses and one death in Oklahomaone death in Oklahoma

Appear linked to buffet-Appear linked to buffet-style restaurant and at style restaurant and at least one catered eventleast one catered event

E. coli E. coli O111 is NOT O111 is NOT listed as an adulterant listed as an adulterant under the Federal Meat under the Federal Meat Inspection ActInspection Act

Keeping up with the bugs Keeping up with the bugs – how do we do it?– how do we do it?

Melamine in MilkMelamine in Milk

At Least 55,000 At Least 55,000

IllnessesIllnesses

At Least 14,000 At Least 14,000

HospitalizedHospitalized

At Least 1,000 with At Least 1,000 with

Acute Kidney FailureAcute Kidney Failure

At Least At Least

4 Deaths4 Deaths

Marler Goes InternationalMarler Goes International

How to Put Me Out of BusinessHow to Put Me Out of Business

1. 1. Improve surveillance Improve surveillance and reporting of bacterial and reporting of bacterial and viral diseases.and viral diseases.

2. 2. Require real training Require real training and certification of food and certification of food handlers at restaurants handlers at restaurants and grocery stores.and grocery stores.

3. 3. Stiffen license Stiffen license requirements for large requirements for large farm, retail, and farm, retail, and wholesale food outlets.wholesale food outlets.

4. 4. Increase food inspections.Increase food inspections.

How to Put Me Out of BusinessHow to Put Me Out of Business

5. 5. Reorganize federal, state, and Reorganize federal, state, and local food safety agencies to increase cooperation local food safety agencies to increase cooperation and reduce wasteful overlap and conflicts.and reduce wasteful overlap and conflicts.

6. 6. Establish tax credits for companies with good food Establish tax credits for companies with good food safety records, and greater legal consequences for safety records, and greater legal consequences for sickening or killing customers with tainted food. sickening or killing customers with tainted food.

7. 7. Use our technology to make food more traceable.Use our technology to make food more traceable.

8. 8. Promote university research.Promote university research.

9. 9. Improve consumer understanding Improve consumer understanding of the risks of food-borne illness.of the risks of food-borne illness.

QuestionsQuestions