1. The Burden of Foodborne Illness William D. Marler 2. It is a Global Food Economy 3. To Put Things in Perspective 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 4. Strict Product Liability Negligence Are you a product seller? Did you act reasonably? Strict Liability Are you a manufacturer? Was the product unsafe? Did product cause injury? Punitive Damages /Criminal Liability Did you act with conscious disregard of a known safety risk? 5. 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) 6. 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 Its called STRICT Liability for a Reason 7. Gross-Out Claims I opened a box of Buffalo wings and saw an unusually shaped piece of chicken and I picked it up. When I saw that the piece had a beak, I got sick to my stomach. My lunch and diet coke came up and I managed to christen my carpet, bedding and clothing. I want them to at least pay for cleaning my carpet etc. 8. Pathway of a Foodborne Illness Investigation 9. Pathway of a Foodborne Illness Investigation If there are more ill persons than expected, an OUTBREAK might be underway. 10. Pathway of a Foodborne Illness Investigation 11. 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 12. EpidemiologyBasic Tools of the Trade Symptoms Incubation Duration Food History Medical Attention Suspected source Others Ill Real-time interviewing with a broad-based exposure questionnaire 13. Pulsed Field Gel Electrophoresis (PFGE) 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 A Powerful Outbreak Detection Tool 14. An Example of Outbreak Detection September 27, 2005 Three E. coli O157:H7 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 15. E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce Date of Onset 2005 15 16 17 18 19 20 21 22 23 24 25 NumberofCases 26 27 28 29 30 1 2 3 414 1 2 3 4 5 6 7 September October Initial cluster of 3 isolates among MN residents identified. 16. Outbreak Investigation - Methods September 2829, 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 17. E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce Date of Onset 2005 15 16 17 18 19 20 21 22 23 24 25 NumberofCases 26 27 28 29 30 1 2 3 414 1 2 3 4 5 6 7 September October Initial cluster of 3 isolates among MN residents identified. Case-control study initiated. 18. E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce Date of Onset 2005 15 16 17 18 19 20 21 22 23 24 25 NumberofCases 26 27 28 29 30 1 2 3 414 1 2 3 4 5 6 7 September October Initial cluster of 3 isolates among MN residents identified. Case-control study initiated. Case-control study implicated Dole salad. 19. E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce Date of Onset 2005 15 16 17 18 19 20 21 22 23 24 25 NumberofCases 26 27 28 29 30 1 2 3 414 1 2 3 4 5 6 7 September October Initial cluster of 3 isolates among MN residents identified. Case-control study initiated. Case-control study implicated Dole salad. CDC, FDA notified. 20. E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce Date of Onset 2005 15 16 17 18 19 20 21 22 23 24 25 NumberofCases 26 27 28 29 30 1 2 3 414 1 2 3 4 5 6 7 September October Initial cluster of 3 isolates among MN residents identified. Case-control study initiated. Case-control study implicated Dole salad. CDC, FDA notified. 21. Minnesota Additional states Date of Onset 2005 15 16 17 18 19 20 21 22 23 24 25 NumberofCases 26 27 28 29 30 1 2 3 414 1 2 3 4 5 6 7 September October WI WI OR E. coli O157:H7 Cases Associated with Dole Prepackaged Lettuce (N=26) 22. Shared common "Best if Used By Date and production code Dole Classic Romaine Salad Recovered from Case-Households 23. Product Traceback Single processing plant (Soledad, CA) Production Date of September 7, 2005 Lettuce harvested from any 1 of 7 fields 24. PFGE Patterns of E. coli O157:H7 Isolates from Lettuce Source Initial Minnesota Case-patient Classic Romaine Bag #2 Classic Romaine Bag #1 25. Litigation as Incentive 22 Years Later Odwalla Jack in the Box 26. How Are Things are Different Today? 27. And, It Does Not Always Require Intent A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation. Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000 or both. 28. 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? 29. Planning AGAINST Litigation Establish Relationships They are your best friends! 30. Lessons Learned From Litigation You can insure the brands and the companys reputation 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, your suppliers and customers do 4. Treat your customers with respect 31. Questions?