A deadly Listeria outbreak has swept across the United States in recent weeks, sickening at least 29 people and taking the lives of three.  This latest tragedy is reportedly linked to the sale of commercially produced, prepackaged caramelized apples. If recent media reports are accurate, the situation highlights the devastation a single breach in sanitation protocol can thrust on an otherwise remarkable wholesale and retail food distribution system in the United States. The situation also serves to remind food growers, manufacturers, distributors and retailers alike that exposure to liability for food-borne illnesses today goes well beyond civil fines and damages and is increasingly subject to criminal prosecution.

Listeria outbreaks are rare but dangerous. In 2011, listeria in cantaloupes killed 33 people and sickened 147 in 28 states, according to the CDC. In 2012, 22 people were infected and four died in an outbreak attributed to a brand of ricotta cheese imported from Italy. Besides the potential civil suits, one of which has already been filed in connection with the caramel apple outbreak (James Raymond Frey, Individually and on behalf of the Estate of Shirlee Jean Frey, et al. v. Safeway, Inc., et al., No. CISCV180721 (Cal. Sup. Santa Cruz Co.)), food manufacturers should be aware of the unprecedented criminal prosecutions of food-industry defendants in multiple states.

In 2010 the U.S. Food and Drug Administration (FDA) began warning the food industry, that federal criminal laws would be enforced in the fooded safety industry, including the potential liability for food industry executives for the shipment of contaminated food, even though it was outside of the executive’s knowledge or consent. In light of the strict liability laws, U.S. v. Eric Jensen and Ryan Jensen resulted in Colorado’s Jensen brothers each serving  six months of home confinement in 2014 after pleading guilty to six of the “strict liability” federal criminal misdemeanors. The only evidence necessary was that the company distributed cantaloupes with the deadly pathogen; knowledge of the contamination was irrelevant.

Similarly, in United States v. Parnell, No. 13-cr-12 (U.S. Dist. Ct., M.D. Ga., Albany Div.) the food company employees are awaiting sentencing for “strict liability” misdemeanors because their contaminated eggs became part of interstate commerce. In addition, the recent jury trial and conviction of former Peanut Corporation of America (PCA) officers and managers has captured the attention of the entire food industry.

Most recently, criminal charges have been brought against the owners and employees of a pharmaceutical company linked to the deadly 2012 meningitis outbreak. Two of the fourteen arrested were the owners of the company, each of whom were charged with second-degree murder and racketeering in connection with the 64 deaths that resulted from the outbreak. The 131 count indictment alleges that the employees were aware that they were producing medication in an unsafe and unsanitary manner, yet distributed it anyway.

Although the requisite knowledge standard of those involved with the meningitis outbreak differs from the strict liability standard for those in connection with the listeria outbreak,
Continue Reading New Era of Criminal Prosecution For Those in the Food Safety and Pharmaceutical Industry

Co-authored by Brian Gross

When people consider the potential sources of food borne illness, they commonly think of raw meat and contaminated produce.  Food, however, is not the only source of food borne illness.  In fact, one of the most common and dangerous sources of food borne illness is raw milk.  Recently, a group of sixteen fourth graders and two adults at a Wisconsin elementary school became ill after they consumed raw milk at a school function.  The individuals who consumed the raw milk had various symptoms, including diarrhea, abdominal cramping, nausea and vomiting.  Reportedly, a parent of one of the students brought raw milk to the event which was obtained from a bulk tank on the dairy farm of a relative.  Laboratory tests performed by the Wisconsin Department of Health Services linked the Campylobacter bacteria in the stool of the individuals who became ill with Campylobacter bacteria found in milk samples taken from the dairy farm from which the raw milk originated.

Raw milk is capable of causing serious illness or even death, as it commonly carries bacteria, salmonella, E. coli, parasites and/or viruses.  Unlike pasteurized milk, raw milk has not been heated in order to eliminate any potential illness causing germs.   Nevertheless, there exists a growing market for raw milk amongst consumers who believe that pasteurization eliminates valuable enzymes and nutrients.   In fact, dairy farms like the Organic Valley, an organic milk cooperative which includes approximately 1,600 dairy farms, now operate on a “dual system,” in which they supply raw milk both for pasteurization and for consumption.  Moreover, it is believed that in the United States nearly three million people regularly consume raw milk.

The danger of raw milk is that unlike meat, poultry and fish, it is a “ready to consume” product, which means that it is not expected to be cooked or prepared before consumption.   Thus, despite being produced in an environment which lends itself to fecal contamination, raw milk does not undergo any treatment to prevent illness associated with such contamination.   Moreover, milk is a main ingredient in many foods whose preparation does not involve cooking or other processes which would rid them of any contaminants, including unpasteurized cheese and yogurt.

The Centers for Disease Control and Prevention (CDC) reports that from 1998 to 2008 there were 86 outbreaks caused by consumption of raw milk or raw milk products, resulting in 1,676 illnesses, 191 hospitalizations and 2 deaths.   Furthermore, 82% of the dairy product related illnesses reported to the CDC between 1973 and 2008 involved the consumption of unpasteurized milk or cheese.   Clearly, raw milk is a common and dangerous source of food borne illness.

Raw milk is no different from any other source of food borne illness in that the best form of prevention, aside from pasteurization, is good hygienic practice during milking, packaging and transportation.   Unlike other foods, however, even the best practices cannot entirely eliminate illness causing contaminants from the product.   Accordingly, if you are going to sell, serve, or use
Continue Reading Raw Milk: The Dangerously Overlooked Source of Food Borne Illness