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Real Events Happening Daily to Real People 76 million cases of foodborne illness annually* 325,000 hospitalizations* 5,000 deaths* Medical costs, productivity losses, costs of premature death costs $6.9 billion dollars a year May be as high as $200  billiondollars a year * The CDC updated this information in late 2010
Marler Clark, LLP PS Since 1993 Marler Clark has represented thousands of legitimate food illness victims in every State. Only a fraction of the victims who contact our office end up being represented. Who do we turn away? Why?
The Chaff Just like health departments we need to quickly and reliably recognize  unsupportable claims How Do We Do It?
Basic Tools of the Trade Symptoms Incubation Duration Food History Medical Attention Suspected source Others Ill Health Department Involvement
Matching Symptoms with Specific Characteristics of Pathogens E. coli O157:H7 Hepatitis A Salmonella Shigella Campylobacter Vibrio
Matching Incubation Periods Incubation Periods Of Common Pathogens
Epidemiologic Assessment Time Place Person association Part of a recognized outbreak?
Medical Attention Health care provider Emergency Room Hospitalization
Health Department Involvement
FOIA/Public Records Request
Prior Health Department Inspections Improper Cooking Procedures Improper Refrigeration Improper Storage and Cooking Procedures Improper Sanitation
Communicable Disease Investigation Reportable Disease Case Report Form Enteric/viral laboratory testing results Human specimens Environmentalspecimens
Molecular Testing Results PFGE/MLVA PulseNet
Traceback Records POS A FIRM A FIRM D FIRM I FIRM N GROWERA POS B FIRM E FIRM J GROWER B FIRM B FIRM F FIRM K POS C GROWERC FIRM G GROWERD FIRM O FIRM L POS D FIRM C FIRM H FIRM M No. of outbreaksAssoc. with firm/Total no. of outbreaks Firm Name Firms A,C,D,G, H,I,L,M,N Growers A&C Firms B,E,F,J,K Firm O, Grower D Grower B 1/4 1/4 2/4 3/4 4/4
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 flawsin 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 splashonto 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 Banquet-goers in 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. 
Civil Litigation –  A Tort – How it Really Works ,[object Object]
It is their fault – Period!
Negligence
Did they act reasonably?
Punitive damages
Did they act with conscious disregard of a known safety risk?,[object Object]
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 alsoWashburn v. Beatt Equipment Co., 120 Wn.2d 246 (1992)
The Legal Standard:  Strict Liability ,[object Object]
They are liable if:
The product was unsafe
The product caused the injurySTRICT LIABILITY IS LIABILITY WITHOUT REGARD TO FAULT.
It’s called STRICT Liability for a Reason The only defense is prevention Wishful thinking does not help If they manufacture a product that causes someone to be sick they are going to pay IF they get caught
Why Strict Liability? Puts pressure on those (manufacturers) that most likely could correct the problem in the first place Puts the cost of settlements and verdicts directly onto those (manufacturers) that profit from the product Creates incentive not to let it happen again
Bottom Line “Resistance is Futile”
Negligence Is The Legal Standard Applied To Non-Manufacturers – in some States 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).
Punitive (or Exemplary) Damages ,[object Object]
Deter others from similar conduct.Historically, such damages were awarded to discourage intentional wrongdoing, wanton and reckless misconduct, and outrageous behavior.  What about criminal conduct?
The Legal Arsenal Interrogatories Requests for production Requests for inspection Request for admission Third-party subpoenas Depositions Motions to compel
Litigation At Work – A Bit(e) of History Jack in the Box - 1993 Odwalla - 1996
A Real Life Example – A Real Trial Benton Franklin Health District OCTOBER 1998 Call from Kennewick General Hospital infection control nurse Call from elementary school principal
Preliminary Interviews Kennewick General Hospital Kennewick Family Medicine Interview tool Knowledge of community Asked questions from answers
Case Finding Established communication with area laboratories, hospitals and physicians Notified the Washington State Department of Health Epidemiology office Established case definition early and narrowed later
Finley Schools Finley School District K-5 Middle School High School Rural area Water supply Irrigation water Septic system Buses
Epidemiologic Investigation Classroom schedules Bus schedules Lunch schedules Recess schedules Case-Control Study Cohort Study of Staff Cohort Study of Meals Purchased
Environmental Investigation Playground Equipment Puddles Topography Animals Water system Sewage system
Hand Rails Dirty Can Opener Army Worms Stray dogs  Environmental Investigation
Environmental Investigation Kitchen inspection Food prep review Food sample collection Product trace back ,[object Object]
USDA,[object Object]
Results Ill students in grades K-5 All but one ill child at a taco meal No other common exposures detected No ill staff members
Results Food handling errors were noted in the kitchen There was evidence of undercooked taco meat No pathogen found in food samples
Conclusions Point source outbreak related to exposure at Finley Elementary School A source of infection could not be determined The most probable cause was consuming the ground beef taco
The Lawsuit Eleven minor plaintiffs: 10 primary cases, 1 secondary case Parents also party to the lawsuit, individually and as guardians ad litem  Two defendants: Finley School District and Northern States Beef
The Basic Allegations Students at Finley Elementary School were infected with E. coli O157:H7 as a result of eating contaminated taco meat The E. coli O157:H7 was present in the taco meat because it was undercooked The resulting outbreak seriously injured the plaintiffs, almost killing one of them
At Trial: The Plaintiff’s Case The State and the BFHD conducted a fair and thorough investigation Final report issued by the WDOH concluded the taco meat was the most likely cause of the outbreak The conclusion reached as a result of the investigation was the correct one
More of The Plaintiff’s Case There were serious deficiencies in the District’s foodservice operation There were reasons to doubt the District’s explanation of how the taco meat was prepared   The law only requires a 51% probability to prove the outbreak’s cause-in-fact
The School District’s Defense The taco meat was safe to eat because: No E. coli in it We love children We are always careful to cook it a lot
The Taco Meal Recipe Card
More of the School District’s Defense ,[object Object]
The health departments botched investigation
Something else caused the outbreak
Someone sold us contaminated meat,[object Object]
What Did This Jury Think? The investigation was fair and thorough More probably than not, undercooked taco meat caused the children to become ill The School District was ultimately responsible for ensuring the safety of the food it sold to its students
In The End After a six week trial, plaintiffs were awarded $4,750,000 The District appealed the verdict on grounds that it was a product seller and one child did not eat Taco We won on appeal and then in 2003 the WA State Supreme Court dismissed the District’s case Final award - $6,068,612.85
Salmonella Pot Pies 272 isolates of Salmonella I 4,[5],12:i:- with an indistinguishable genetic fingerprint were collected from ill persons in 35 states. Three of these patients’ pot pies yielded Salmonella I4,[5],12:i:- isolates with a genetic fingerprint indistinguishable from the outbreak pattern. Lesson - clear pattern of customer confusion over ready to eat and ready to cook – especially in microwaves.
Salmonella Veggie Booty? ,[object Object]

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Food Safety Litigation 101 with Bill Marler

  • 1.
  • 2. Real Events Happening Daily to Real People 76 million cases of foodborne illness annually* 325,000 hospitalizations* 5,000 deaths* Medical costs, productivity losses, costs of premature death costs $6.9 billion dollars a year May be as high as $200 billiondollars a year * The CDC updated this information in late 2010
  • 3. Marler Clark, LLP PS Since 1993 Marler Clark has represented thousands of legitimate food illness victims in every State. Only a fraction of the victims who contact our office end up being represented. Who do we turn away? Why?
  • 4. The Chaff Just like health departments we need to quickly and reliably recognize unsupportable claims How Do We Do It?
  • 5. Basic Tools of the Trade Symptoms Incubation Duration Food History Medical Attention Suspected source Others Ill Health Department Involvement
  • 6. Matching Symptoms with Specific Characteristics of Pathogens E. coli O157:H7 Hepatitis A Salmonella Shigella Campylobacter Vibrio
  • 7. Matching Incubation Periods Incubation Periods Of Common Pathogens
  • 8. Epidemiologic Assessment Time Place Person association Part of a recognized outbreak?
  • 9. Medical Attention Health care provider Emergency Room Hospitalization
  • 12.
  • 13. Prior Health Department Inspections Improper Cooking Procedures Improper Refrigeration Improper Storage and Cooking Procedures Improper Sanitation
  • 14. Communicable Disease Investigation Reportable Disease Case Report Form Enteric/viral laboratory testing results Human specimens Environmentalspecimens
  • 15. Molecular Testing Results PFGE/MLVA PulseNet
  • 16. Traceback Records POS A FIRM A FIRM D FIRM I FIRM N GROWERA POS B FIRM E FIRM J GROWER B FIRM B FIRM F FIRM K POS C GROWERC FIRM G GROWERD FIRM O FIRM L POS D FIRM C FIRM H FIRM M No. of outbreaksAssoc. with firm/Total no. of outbreaks Firm Name Firms A,C,D,G, H,I,L,M,N Growers A&C Firms B,E,F,J,K Firm O, Grower D Grower B 1/4 1/4 2/4 3/4 4/4
  • 17. 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 flawsin 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 splashonto a nearby bun.
  • 18. 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.
  • 19. Improper Storage and Cooking Banquet-goers in 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. 
  • 20.
  • 21. It is their fault – Period!
  • 23. Did they act reasonably?
  • 25.
  • 26. 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 alsoWashburn v. Beatt Equipment Co., 120 Wn.2d 246 (1992)
  • 27.
  • 30. The product caused the injurySTRICT LIABILITY IS LIABILITY WITHOUT REGARD TO FAULT.
  • 31. It’s called STRICT Liability for a Reason The only defense is prevention Wishful thinking does not help If they manufacture a product that causes someone to be sick they are going to pay IF they get caught
  • 32. Why Strict Liability? Puts pressure on those (manufacturers) that most likely could correct the problem in the first place Puts the cost of settlements and verdicts directly onto those (manufacturers) that profit from the product Creates incentive not to let it happen again
  • 34. Negligence Is The Legal Standard Applied To Non-Manufacturers – in some States 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).
  • 35.
  • 36. Deter others from similar conduct.Historically, such damages were awarded to discourage intentional wrongdoing, wanton and reckless misconduct, and outrageous behavior. What about criminal conduct?
  • 37. The Legal Arsenal Interrogatories Requests for production Requests for inspection Request for admission Third-party subpoenas Depositions Motions to compel
  • 38. Litigation At Work – A Bit(e) of History Jack in the Box - 1993 Odwalla - 1996
  • 39.
  • 40.
  • 41.
  • 42. A Real Life Example – A Real Trial Benton Franklin Health District OCTOBER 1998 Call from Kennewick General Hospital infection control nurse Call from elementary school principal
  • 43. Preliminary Interviews Kennewick General Hospital Kennewick Family Medicine Interview tool Knowledge of community Asked questions from answers
  • 44. Case Finding Established communication with area laboratories, hospitals and physicians Notified the Washington State Department of Health Epidemiology office Established case definition early and narrowed later
  • 45. Finley Schools Finley School District K-5 Middle School High School Rural area Water supply Irrigation water Septic system Buses
  • 46. Epidemiologic Investigation Classroom schedules Bus schedules Lunch schedules Recess schedules Case-Control Study Cohort Study of Staff Cohort Study of Meals Purchased
  • 47. Environmental Investigation Playground Equipment Puddles Topography Animals Water system Sewage system
  • 48. Hand Rails Dirty Can Opener Army Worms Stray dogs Environmental Investigation
  • 49.
  • 50.
  • 51. Results Ill students in grades K-5 All but one ill child at a taco meal No other common exposures detected No ill staff members
  • 52. Results Food handling errors were noted in the kitchen There was evidence of undercooked taco meat No pathogen found in food samples
  • 53. Conclusions Point source outbreak related to exposure at Finley Elementary School A source of infection could not be determined The most probable cause was consuming the ground beef taco
  • 54. The Lawsuit Eleven minor plaintiffs: 10 primary cases, 1 secondary case Parents also party to the lawsuit, individually and as guardians ad litem Two defendants: Finley School District and Northern States Beef
  • 55. The Basic Allegations Students at Finley Elementary School were infected with E. coli O157:H7 as a result of eating contaminated taco meat The E. coli O157:H7 was present in the taco meat because it was undercooked The resulting outbreak seriously injured the plaintiffs, almost killing one of them
  • 56. At Trial: The Plaintiff’s Case The State and the BFHD conducted a fair and thorough investigation Final report issued by the WDOH concluded the taco meat was the most likely cause of the outbreak The conclusion reached as a result of the investigation was the correct one
  • 57. More of The Plaintiff’s Case There were serious deficiencies in the District’s foodservice operation There were reasons to doubt the District’s explanation of how the taco meat was prepared The law only requires a 51% probability to prove the outbreak’s cause-in-fact
  • 58. The School District’s Defense The taco meat was safe to eat because: No E. coli in it We love children We are always careful to cook it a lot
  • 59. The Taco Meal Recipe Card
  • 60.
  • 61. The health departments botched investigation
  • 62. Something else caused the outbreak
  • 63.
  • 64. What Did This Jury Think? The investigation was fair and thorough More probably than not, undercooked taco meat caused the children to become ill The School District was ultimately responsible for ensuring the safety of the food it sold to its students
  • 65. In The End After a six week trial, plaintiffs were awarded $4,750,000 The District appealed the verdict on grounds that it was a product seller and one child did not eat Taco We won on appeal and then in 2003 the WA State Supreme Court dismissed the District’s case Final award - $6,068,612.85
  • 66. Salmonella Pot Pies 272 isolates of Salmonella I 4,[5],12:i:- with an indistinguishable genetic fingerprint were collected from ill persons in 35 states. Three of these patients’ pot pies yielded Salmonella I4,[5],12:i:- isolates with a genetic fingerprint indistinguishable from the outbreak pattern. Lesson - clear pattern of customer confusion over ready to eat and ready to cook – especially in microwaves.
  • 67.
  • 68.
  • 69. 9 hospitalized, and 179 sought medical care
  • 71. 28 employees tested positive for salmonella
  • 72. Depressed sales in region due to bad publicity
  • 73. 8 months after outbreak, store closed for good “The investigation revealed environmental factors such as loss of hot water, loss of all water, the large number of ill employees at the facility, a general lack of hand washing and dish-machine sanitizer failure …contributed to/exacerbated the spread….
  • 74.
  • 75.
  • 76. Castleberry’s manufacturing facility closed after decades in operation.
  • 77.
  • 78. E. coli and Hamburger – Together Again In 2007 and 2008 - 26 recalls; ground beef companies recalled more than 44 million pounds of E. coli O157:H7-contaminated meat. In 2006 – 186,000 pound recalled.
  • 79. Leafy Greens 25 E. coli outbreaks since 1995 with at least 1,000 reported illnesses and 7 deaths Fresh or fresh-cut lettuce or spinach implicated as outbreak vehicle - 8 outbreaks traced back to produce from Salinas, CA In 2006 alone, Dole Spinach, Taco Bell and Taco Johns - between 400 - 750 ill
  • 80. Imports - Hepatitis A Chi-Chi’s restaurant in Pennsylvania – 660 people sickened, 4 deaths, 100 hospitalized, liver transplant Bankruptcy Settlements - $50,000,000 Green Onions imported and grow “in conditions of squalor” Important --- don’t be too focused on imports
  • 81. Peanut Butter and Salmonella - Again Over 750 persons infected with the outbreak strains of Salmonella Typhimurium have been reported from 48 states Over 150 people hospitalized Nine Deaths Over 3000 products recalled Bankruptcy Criminal Prosecution Declaratory Judgment Lesson - ?
  • 83. To Learn More… Bill Marler Marler Clark, The Food Safety Law Firm 1301 2nd Avenue Suite 2800 Seattle, WA 98101 1 866-770-2032