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New Era of Criminal Prosecution For Those in the Food Safety and Pharmaceutical Industry

Posted in All Practice Areas, Foodborne Illness, Pharmaceutical and Medical Devices

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, the message is the same: it is imperative, regardless of industry, that proactive measures with regard to quality control, safety and sanitization, be implemented to ensure adequate protection to both consumers and prevent potential liabilities of companies, particularly in this new era for food and pharmaceutical safety enforcement.