Foodborne Illness CSI:

9th Annual PulseNet Seattle Update MeetingMay 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 1996.”

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 7.72.010(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?

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?• 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. 311-313

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 communityDaubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).

Example – How a Lawsuit WorksAlmquist 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 District’s 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.– We’ve 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 wasn’t 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 - 1993

Odwalla - 1996

Punitive (or Exemplary) Damages:

Historically, such damages were awarded to Historically, such damages were awarded to discourage intentional wrongdoing, wanton and discourage intentional wrongdoing, wanton and reckless misconduct, and outrageous behavior.reckless misconduct, and outrageous behavior.

Punish the defendant Punish the defendant for its conduct;for its conduct;

Deter others from Deter others from similar conduct.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 1996 - Present

Paramount Farms Almonds Salmonella Outbreak - 2003• Increased Industry Awareness of Contamination RiskHarmony Farms Salmonella Outbreak - 2003• Warnings on SproutsSpokane Produce E. coli Outbreak - 2002• Increased Industry Awareness of Lettuce ContaminationConagra E. coli Outbreak - 2002• Tipping Point in Meat IndustryQuality Inn Salmonella Outbreak - 2003• Industry Change on use of Pooled Eggs – New FDA RulesShipley Sales Salmonella Outbreak - 2001• FDA Change on import of Cantaloupes

PulseNet and Litigation 1996 - Present

Sun Orchard Salmonella Outbreak - 1999• Pasteurization of Orange Juice

Supervalu E. coli Outbreak - 2000• Better Grinding Records at Retail

Sizzler E. coli Outbreak - 2000• Industry Awareness of Risk of Cross-Contamination

Senor Felix Shigella Outbreak - 2000• Pressure from Major Purchaser to Increase Quality

White Water E. coli Outbreak - 1998• Awareness of Need for Chlorination

PulseNet and Litigation 1996 – Present

What will be the next change?Chi Chi’s Hepatitis A Outbreak - 2003• ? Green OnionsSheetz Salmonella Outbreak - 2004• ? TomatoesPetting Zoo E. coli Outbreaks?• ? Will they finally pay attention to CDC

recommendations

PulseNet and Litigation – They Do Work Well Together

From 1996-2004, 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, 2004.

Morbidity and Mortality Weekly Report (April 15, 2005)

6600 Bank of America Tower701 Fifth AvenueSeattle, Washington 981041-206-346-1890bmarler@marlerclark.com

Questions?