Foodborne Illness CSI: 9th Annual PulseNet Seattle Update Meeting May 9-11, 2005 Cracking the Legal Code

To Put Things in Perspective Microbial pathogens in food cause an estimated 76 million cases of human illness annually in the United States 325,000 hospitalized 5,000 deaths

Why what WE do is Important … contaminated food products caused more deaths each year than the combined totals of all 15,000 products regulated by the U.S. Consumer Product Safety Commission; these products caused only 3,700 deaths in Buzby, et al. Product Liability and Microbial Foodborne Illness (2001)

Cracking the Legal Code – What Marler Clark Actually Does Since 1993 Marler Clark has represented thousands of food illness victims in over 30 states. However, we only prosecute a fraction of the cases that contact our offices, some examples of our missed opportunities:

Christening the Carpet I opened a box of Tyson Buffalo wings and dumped them out on a plate to be cooked in the microwave. An unusually shaped piece caught my eye 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. What do you think?

There is a Worm in my Freezer! I recently found a whole, 2-cm long worm packaged inside a Lean Cuisine frozen dinner. I have the worm in my freezer. I'm interested in discussing my rights in this matter. Could you please contact me, or refer me to a firm that may be able to give me assistance? Thank you very much for your attention.

Lending a Helping Hand I have recently read articles and lawsuits that you have pursued regarding contaminated food. I am hoping that you may be able to give me your professional advice or recommendation. My husband recently opened a bottle of salsa and smelled an unusual odor but chose to eat it regardless, thinking that it was just his nose.

Lending a Helping Hand, cont. After taking two bites and tasting rather badly, he found what appeared to be a rather large piece (approx. the size of the back of an adult's fist) of human or animal flesh. Even though he didn't seek medical attention, he did become very nauseated. I do feel that the manufacturer should be held responsible for this mishap. Thank you for your time and consideration.

Civil Litigation - A Tort – Is NOT a Small German Cake Punitive damages Did they act with conscious disregard of a known safety risk? Strict liability It is their fault – Period! Negligence Did they act reasonably?

Strict Liability for Food – a Bit(e) of History …… a manufacturer of a food product under modern conditions impliedly warrants his goods… and that warranty is available to all who may be damaged by reason of its use in the legitimate channels of trade… Mazetti v. Armour & Co., 75 Wash. 622 (1913)

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 (2); see also Washburn v. Beatt Equipment Co., 120 Wn.2d 246 (1992)

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

Unsafe = CONSUMER EXPECTATION A product is unsafe or not reasonably safe if it is unsafe beyond that which would be expected by the ordinary consumer Do consumers expect to be sold foods that make them sick?

Its 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? It puts pressure on those (manufacturers) that most likely could correct the problem in the first place It puts the cost of settlements and verdicts directly on to those (manufacturers) that profit from the product Creates incentive not to let it happen again

The Legal Standard: Negligence FOUR REQUIREMENTS – DUTY – BREACH – CAUSATION – INJURY Negligent conduct is the failure to exercise reasonable care under the circumstances.

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). Negligence is the legal standard applied to non-manufacturers

Epidemiology 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) Tracking the Bug!

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 However, It really is what is more likely than not. It is 50% and an extra grain of sand. Marler on the law

But, Causation Still Requires Admissible Evidence Whether a theory or technique can be (and has been) tested Whether it has been published and subjected to peer review Whether it has a high potential rate of error Whether it enjoys general acceptance in scientific community Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).

Example – How a Lawsuit Works Almquist v. Finley School E. coli Outbreak 8 confirmed cases of E. coli O157:H7 3 probable cases, 1 secondary case, 8 PFGE matches ill students in grades K-5 All but one ill child ate a taco meal (or, did she?) No ill staff members Food handling errors were noted in the kitchen There was evidence of undercooked taco meat No pathogen found in food samples A source of infection could not be determined to a: statistical significance

At Trial: The Plaintiffs Case The WDOH, CDC and the BFHD conducted a fair and thorough investigation. The Final report issued by the WDOH concluded the undercooked taco meat was the most likely cause of the outbreak. The conclusion reached as a result of the investigation was the fair, unbiased and correct one.

The School Districts Defense We were not a Manufacturer The taco meat was safe to eat because: – We love children. – We are always careful to cook it a lot. – Weve never poisoned anyone before. – The health departments botched the investigation and jumped to a hasty conclusion. Something else caused the outbreak (invasion of army worms) It wasnt us, but if it was, it is not our fault the USDA gave us contaminated ground beef.

What Did the Jury Think? The investigation into the cause of the outbreak was fair and thorough. The investigators were correct to conclude that, more likely 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.

The Taco Meal Recipe Card

However, the Legal Reality Lawsuits would seem to provide important feedback to these firms about how much they should invest in food safety. [However,] much of the costs of illness borne by people who become ill … are not reimbursed by food firms responsible for an illness. In short, the legal system provides limited incentives for firms to produce safe foods. Buzby, et al. Product Liability and Microbial Foodborne Illness (2001)

Why Does the Legal System Seem to Fail? Manufacturer not Caught No Known Cause – What Food or Drink was It? – Victims Stool not Tested – What Bacteria or Virus? – Apparent Isolated Case – No Health Department Investigation – No PFGE, No PulseNet Unequal Power Between Victim and Manufacturer

Litigation Can Work – A Little History Lesson – PFGE at Work Too and the Beginning of PulseNet Jack in the Box Odwalla

Punitive (or Exemplary) Damages: Historically, such damages were awarded to discourage intentional wrongdoing, wanton and reckless misconduct, and outrageous behavior. Punish the defendant for its conduct; Punish the defendant for its conduct; Deter others from similar conduct. Deter others from similar conduct.

Industry Standards In nearly every case, industry standards improve after a outbreak of food-borne illnesses However, it occurs only after they are caught. – Increased cook times – Pasteurization of apple juice

PulseNet and Litigation Present Paramount Farms Almonds Salmonella Outbreak Increased Industry Awareness of Contamination Risk Harmony Farms Salmonella Outbreak Warnings on Sprouts Spokane Produce E. coli Outbreak Increased Industry Awareness of Lettuce Contamination Conagra E. coli Outbreak Tipping Point in Meat Industry Quality Inn Salmonella Outbreak Industry Change on use of Pooled Eggs – New FDA Rules Shipley Sales Salmonella Outbreak FDA Change on import of Cantaloupes

PulseNet and Litigation Present Sun Orchard Salmonella Outbreak Pasteurization of Orange Juice Supervalu E. coli Outbreak Better Grinding Records at Retail Sizzler E. coli Outbreak Industry Awareness of Risk of Cross-Contamination Senor Felix Shigella Outbreak Pressure from Major Purchaser to Increase Quality White Water E. coli Outbreak Awareness of Need for Chlorination

PulseNet and Litigation 1996 – Present What will be the next change? Chi Chis Hepatitis A Outbreak ? Green Onions Sheetz Salmonella Outbreak ? Tomatoes Petting Zoo E. coli Outbreaks? ? Will they finally pay attention to CDC recommendations

PulseNet and Litigation – They Do Work Well Together From , the incidence of: E. coli O157:H7 infections decreased 42 percent Campylobacter infections decreased 31 percent Cryptosporidium dropped 40 percent Yersinia decreased 45 percent Salmonella infections decreased 8 percent Preliminary FoodNet Data on the Incidence of Infections with Pathogens Transmitted Commonly Through Food – Selected Sites, United States, Morbidity and Mortality Weekly Report (April 15, 2005)

6600 Bank of America Tower 701 Fifth Avenue Seattle, Washington Questions?