2. The Legal Standard: Strict Liability Strict Liability Is Liability Without Regard To Fault.  The focus is on the product; not the conduct  They are liable if: – The product was unsafe – The product caused the injury

3. 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)

4. 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

5. Negligence 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).

6. 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)

7. 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

8. Lettuce and Spinach  Over 23 E. coli outbreaks since 1995 – Hundreds of reported illnesses – Several deaths  Fresh or fresh-cut lettuce or spinach  9 outbreaks traced back to produce from Salinas, California

9. 2006 Wendy’s E. coli Outbreak  Utah - June 2006  E. coli O21:H19 – only 3 culture- positive cases, although over 50 cases probable  3 HUS, 2 adult women,1 with 30 days, the other with 4 months of dialysis  Likely lettuce from California

10. Dole and Natural Selections – Fall 2006  205 persons infected with outbreak strain of E. coli O157:H7 from 26 states.  102 (51%) hospitalized  31 (16%) developed hemolytic-uremic syndrome (HUS)  Three confirmed deaths – likely five

11. Dole and Natural Selections – Fall 2006  E. coli O157:H7 – Isolated from 16 packages of DOLE spinach – “DNA fingerprints” of all 16 match the outbreak strain – Supplied by patients living in 10 states – Eleven packages with lot codes consistent with a single manufacturing facility on a particular day

12. Taco E. coli Litigation Status  Multiple lawsuits filed in Courts in a 5 States  Taco Bell and Ready-Pac  Taco John’s and Bix  Lettuce supplier to Bix - Outbreak PFGE found on nearby Farm

13. 2006-07 Peanut Butter Salmonella Outbreak  CDC Figures as of March 7, 2007  714 culture-positive illnesses from 44 states  71 hospitalized  Illnesses reported August 1, 2006 to present – perhaps earlier

14. 29,640 ill Persons Salmonella Tennessee Salmonella Tennessee AC 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 - Approximately 50 per year CDC Outbreak Date - 628 officially counted, however 13 additional cases in 2006 and 30 additional cases in 2005 share the same PFGE as one of the outbreak patterns CDC Estimate - 38.6 multiple of reported cases of S. Tennessee S. Tennessee Cases By Month 2005-2007 CDC Baseline CDC Outbreak Data Estimated Unreported Cases

15. The Outbreak Epidemic Curve of Confirmed Salmonella Tennessee Cases Month/Year of Onset CDC Data Client Data October 2004 Positive Sample

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

17. Outbreaks Linked To Unpasteurized Milk

18. Related Issues  Comparative fault  Releases and Waivers  Public Education  Where is Public Health?

19. Hamburger – It’s Back  In 2007 and 2008 - 26 recalls, ground beef companies have recalled more than 44 million pounds of E. coli O157:H7- contaminated meat

20. Emerging Pathogens  E. coli O111 linked to nearly 300 illnesses and one death in Oklahoma  Appear linked to buffet- style restaurant and at least one catered event  E. coli O111 is NOT listed as an adulterant under the Federal Meat Inspection Act  Keeping up with the bugs – how do we do it?

21. How to Put Me Out of Business 1. Improve surveillance and reporting of bacterial and viral diseases. 2. Require real training and certification of food handlers at restaurants and grocery stores. 3. Stiffen license requirements for large farm, retail, and wholesale food outlets. 4. Increase food inspections.

22. How to Put Me Out of Business 5. Reorganize federal, state, and local food safety agencies to increase cooperation and reduce wasteful overlap and conflicts. 6. Establish tax credits for companies with good food safety records, and greater legal consequences for sickening or killing customers with tainted food. 7. Use our technology to make food more traceable. 8. Promote university research. 9. Improve consumer understanding of the risks of food-borne illness.

23. Questions