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FSMA A Litigators Perspective

In The BeginningThe Pure Food and Drug Act of June 30, 1906 was the United States Federal Law that provided federal inspection of meat products and forbade the manufacture, sale, or transportation of adulterated food products.

The Jungles Unintended ConsequencesPierces the thickest skull and most leathery heart. Winston Churchill

"I aimed at the public's heart, and by accident I hit it in the stomach. Upton Sinclair

Food Safety By The NumbersThe CDC estimates that 48 million foodborne illness cases occur in the United States every year. At least 128,000 Americans are hospitalized, and 3,000 die after eating contaminated food.

Northwest Connection

1992 and 1993 Over 600 people sickened in six States Mostly children 50 acute kidney failure 4 deaths

Impact On Public Policy

Jack in the Box today has the highest quality ground beef that I believe is available in North America. But our products, I will not guarantee, are free of pathogens in the raw state.Dave Theno

Public InvolvementS.T.O.P.C.S.P.I.Make our Food Safe

The 1994 RevolutionPolitics and Philosophy Matter

2006 Magic Moment?Spinach 205 sickened and 5 deathsPeanut Butter 746 sickened and 3 years of product recalledHouse and Senateparty switch

Well, Not Quite So Fast2007 E. coli-poisoned (hamburger) paralyzed dancer Front Page of New York Times and a Pulitzer Prize2009 E. coli-poisoned (cookie dough) mother of six Front Page Washington Post

What About Industry?Tomato, errr, Pepper OutbreakPB 2 - $1 Billion in Recall and Economic Losses

2009 The Magic MomentConsumers and Industry Coming Together

Well, Not So Fast

Working To The End

WE Won!

Well, Not Quite Yet"I would not identify it as something that will necessarily be zeroed out, but it is quite possible it will be scaled back if it is significant overreach," said Rep. Kingston, who is likely to become chairman of the subcommittee when Republicans assume control of the House in January.

"We still have a food supply that's 99.99 percent safe," Rep. Kingston said in an interview. "No one wants anybody to get sick, and we should always strive to make sure food is safe. But the case for a $1.4 billion expenditure isn't there."

Food Production is a Risky Business

Competitive MarketsStockholder Pressures for Increasing Profits over Long-term SafetyLack of Clear RewardFor Marketing and Practicing Food Safety

Strict Product LiabilityNegligenceAre you a product seller?Did you act reasonably?Strict LiabilityAre you a manufacturer?Was the product unsafe?Did product cause injury?Punitive Damages/Criminal LiabilityDid you act with conscious disregard of a known safety risk?

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The only defense is preventionIt does not matter if you took all reasonable precautionsIf you manufacture a product that makes someone sick you are going to payWishful thinking does not helpIts called STRICT Liability for a Reason

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Ill person

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Organism identified

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Ill person

Organism identified

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Epidemiologic investigation

Public Health Laboratory

If there are more ill persons than expected, an OUTBREAK might be underway.

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Ill person

Organism identified

Specimen collection

Pathway of a Foodborne Illness Investigation

Health Care Provider

Epidemiologic investigation

Public Health Laboratory

Environmental investigation

Product Trace Back

Product Recall

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Litigation as a Food Safety Incentive

Odwalla

Jack in the Box

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How Are Things are Different Today?

1938 Federal Food, Drug & Cosmetic ActCongress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands. The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce. Under section 402(a)(4) of the Act, a food product is deemed adulterated if the food was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A food product is also considered adulterated if it bears or contains any poisonous or deleterious substance, which may render it injurious to health. The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.

Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce. Any person who commits a prohibited act violates the FDCA. A person committing a prohibited act with the intent to defraud or mislead is guilty of a felony punishable by years in jail and millions in fines or both.

It Started with a Little SalmonellaIn 2009 714 persons infected with the outbreak strain of Salmonella Typhimurium were reported from 46 states. Among the persons with confirmed, reported dates available, illnesses began between September 1, 2008 and March 31, 2009.Patients ranged in age from