Bill Marler 2012 Washington Restaurant Association Webinar

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Attorney and Food Safety Expert Bill Marler gives a webinar on foodborne illness litigation and liability for the Washington Restaurant Association

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Bill Marler 2012 Washington Restaurant Association Webinar

  1. 1. “What happens when yourrestaurant becomes involved in liability litigation?”William D. Marler, Esq.
  2. 2. Food Production is a Risky Business • Competitive Markets • Wall Street and Stockholder Pressures for Increasing Profits • Lack of Clear Reward For Marketing and Practicing Food Safety • Brand Awareness • Risk of Litigation
  3. 3. Strict Product Liability • Strict Liability – Are you a manufacturer? – Was the product unsafe? – Did product cause injury? • Negligence • Punitive Damages /Criminal Liability – Are you a product seller? – Did you act with conscious disregard – Did you act “reasonably”? of a known safety risk?
  4. 4. 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)
  5. 5. It’s called STRICT Liability for a Reason • 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
  6. 6. Litigation as Incentive Odwalla Jack in the Box
  7. 7. Worthless Excuse No. 1 “I never read the memo.” • If a document contains damning information, the jury will assume you read it, understood it, and ignored it
  8. 8. Bugs in Strange Places • Listeria – Tainted Cantaloupe • 146 Sickened with over 30 Deaths • First Outbreak Linked with Cantaloupe and Listeria
  9. 9. But, We Have Seen This Before • More that Two Dozen Salmonella Cantaloupe Outbreaks in last Decades
  10. 10. Strange Bugs – Non-O157 E. coli • E. coli O104:H4 • 4,321 Ill, 852 with Hemolytic Uremic Syndrome • 50 Dead • Six U.S. Cases • Egyptian Fenugreek Seeds Likely Source
  11. 11. To Put Things in Perspective • According to the CDC, microbial pathogens in food cause an estimated 48 million cases of human illness annually in the United States • 125,000 hospitalized • Cause up to 3,000 deaths
  12. 12. Estimates Differ From Actual Counts• Annual E. coli O157 estimates – 62,000 illnesses – 1,800 hospitalizations – 52 deaths• But, only 2,621 E. coli 0157 cases were reported in 2005
  13. 13. Pathway of a Foodborne IllnessInvestigation
  14. 14. Pathway of a Foodborne IllnessInvestigation If there are more ill persons than expected, an OUTBREAK might be underway.
  15. 15. Pathway of a Foodborne IllnessInvestigation
  16. 16. Typical Steps of an OutbreakInvestigation• Establish that an outbreak is occurring• Verify the diagnosis• Define and identify cases• Orient the data in terms of person, place, and time• Develop and test the hypotheses• Refine the hypotheses and carry out additional studies• Implement control and prevention measures• Report findings
  17. 17. 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
  18. 18. Epidemiology–Basic Tools of the TradeReal-time interviewing with a broad-basedexposure questionnaire • Symptoms • Incubation • Duration • Food History • Medical Attention • Suspected source • Others Ill
  19. 19. Pulsed Field Gel Electrophoresis (PFGE)A Powerful Outbreak Detection Tool • 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
  20. 20. Questions to Consider in AssessingPFGE Clusters• How common is the PFGE subtype?• How many cases are there?• Over what time frame did cases occur?• What is the geographic distribution of cases?• What are the case demographics?• Do any of the cases have a “red flag” exposure?
  21. 21. Outbreak Detection September 27, 2005 • Three O157 isolates with indistinguishable PFGE patterns identified by Minnesota Public Health Laboratory • PFGE pattern new in Minnesota, rare in United States – 0.35% of patterns in National Database • Patients reported eating prepackaged salad; no other potential common exposures evident
  22. 22. E. coli O157:H7 Cases Associatedwith Dole Prepackaged Lettuce 7Number of Cases 6 5 4 3 2 Initial cluster of 3 isolates among MN residents 1 identified. 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4 September October Date of Onset 2005
  23. 23. Outbreak Investigation - Methods September 28–29, 2005 • Additional O157 isolates received at the MDOH and subtyped by PFGE – 7 isolates demonstrated outbreak PFGE subtype • Supplemental interview form created • Case-control study initiated
  24. 24. E. coli O157:H7 Cases Associatedwith Dole Prepackaged Lettuce 7Number of Cases 6 5 4 Case-control study initiated. 3 2 Initial cluster of 3 isolates among MN residents 1 identified. 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4 September October Date of Onset 2005
  25. 25. Case-Control Study ResultsExposure Cases Controls Matched OR* 95% CI† p-valueAny lettuce 9/10 17/26 3.5 0.5–25.0 0.17Prepackagedlettuce salad 9/10 10/26 8.4 1.2–59.6 0.01Doleprepackagedlettuce salad 9/10 5/23 10.1 1.5–67.3 0.002*OR = odds ratio† CI = confidence interval
  26. 26. E. coli O157:H7 Cases Associatedwith Dole Prepackaged Lettuce 7Number of Cases 6 5 Case-control study implicated Dole salad. 4 Case-control study initiated. 3 2 Initial cluster of 3 isolates among MN residents 1 identified. 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4 September October Date of Onset 2005
  27. 27. E. coli O157:H7 Cases Associatedwith Dole Prepackaged Lettuce CDC, FDA notified. 7Number of Cases 6 5 Case-control study implicated Dole salad. 4 Case-control study initiated. 3 2 Initial cluster of 3 isolates among MN residents 1 identified. 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4 September October Date of Onset 2005
  28. 28. E. coli O157:H7 Cases Associatedwith Dole Prepackaged Lettuce CDC, FDA notified. 7Number of Cases 6 5 Case-control study implicated Dole salad. 4 Case-control study initiated. 3 2 Initial cluster of 3 isolates among MN residents 1 identified. 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4 September October Date of Onset 2005
  29. 29. E. coli O157:H7 Cases Associated withDole Prepackaged Lettuce (N=26) Minnesota Additional statesNumber of Cases 7 6 5 OR 4 3 2 WI 1 WI 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 1 2 3 4 September October Date of Onset 2005
  30. 30. Dole Classic Romaine Salad Recoveredfrom Case-Households Shared common "Best if Used By” Date and production code
  31. 31. Product Traceback • Single processing plant (Soledad, CA) • Production Date of September 7, 2005 • Lettuce harvested from any 1 of 7 fields
  32. 32. PFGE Patterns of E. coli O157:H7Isolates from Lettuce Source Initial Minnesota Case-patient Classic Romaine Bag #1 Classic Romaine Bag #2
  33. 33. Why Epidemiologic Links May Not beIdentified for Cases in a PFGE Cluster • Cases have imperfect recall • Common exposures can be difficult to link (e.g., eggs, chicken) • Secondary transmission • Cross-contamination exposure • There isn’t a common source
  34. 34. CDC 2005 Cluster Investigations E. coli O157 SalmonellaPatterns Submitted 5,376 29,168Clusters Identified 67 176Multi-state Clusters 36 152Epi Investigation 19 30Vehicle Implicated 4 8Regulatory Activity 4 8
  35. 35. 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?
  36. 36. Planning AGAINST Litigation –Establish RelationshipsThey are your best friends!
  37. 37. Lessons Learned From An OutbreakYou can insure the brand’s and the company’sreputation 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 do 4. Treat your customers with respect
  38. 38. Questions?

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