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The Claim And The Claimant ? ? ? 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 ,[object Object]
Hepatitis A
Salmonella
Shigella
Campylobacter
Vibrio Campylobacter Hepatitis A E. coli O157:H7 Salmonella Vibrio Shigella
Matching Incubation Periods Incubation Periods Of Common Pathogens
Communicable Disease Investigation ,[object Object]
Enteric/viral laboratory testing results
Human specimens
Environmentalspecimens,[object Object]
Emergency Room
Hospitalization,[object Object]
Place
Person association
Part of a recognized outbreak?,[object Object]
PulseNet,[object Object]
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 ,[object Object]
You are liable if:
The product was unsafe
The product caused the injurySTRICT LIABILITY IS LIABILITY WITHOUTREGARD TO FAULT
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….”

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2010 Foodborne Illness Litigation Process with Bill Marler

  • 1.
  • 2. The Claim And The Claimant ? ? ? Just like health departments we need to quickly and reliably recognize unsupportable claims How Do We Do It?
  • 3. Basic Tools of the Trade Symptoms Incubation Duration Food History Medical Attention Suspected source Others Ill Health Department Involvement
  • 4.
  • 9. Vibrio Campylobacter Hepatitis A E. coli O157:H7 Salmonella Vibrio Shigella
  • 10. Matching Incubation Periods Incubation Periods Of Common Pathogens
  • 11.
  • 14.
  • 16.
  • 17. Place
  • 19.
  • 20.
  • 22. 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
  • 23.
  • 26. The product caused the injurySTRICT LIABILITY IS LIABILITY WITHOUTREGARD TO FAULT
  • 27. 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….”
  • 28. 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)
  • 29. 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
  • 30.
  • 31. Whether it has been published and subjected to peer review
  • 32. Whether it has a high potential rate of error
  • 33. Whether it enjoys general acceptance in scientific communityDaubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).
  • 34. Negligence Is The Legal Standard Applied To 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).
  • 35. 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.
  • 36. 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
  • 37. 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
  • 38.
  • 40.
  • 41. 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.
  • 42. 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. 
  • 43. Ultimately - What Will a Jury Think? A Jury = 12 Consumers