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

The parents of Joshua Kaye, an 8 year-old boy from Braintree, Massachusetts who died on July 7, 2014, after contracting an E. coli 0157:H7 infection that turned into hemolytic uremic syndrome, have filed suit against Whole Foods, the retail store from which they allege to have purchased the contaminated meat, and Rain Crow Ranch, a Missouri company that allegedly produced and sold the meat to Whole Foods. Joshua Kaye was one of three Massachusetts residents known to contract E. coli between June 13 and June 25, 2014, prompting an investigation by the U.S. Department of Agriculture Food Safety and Inspection Service (“FSIS”), in conjunction with the Center for Disease and Control Prevention (“CDC”) and the Massachusetts Department of Public Health. FSIS, which began its investigation on June 25, 2014, purportedly initially linked the E. coli contamination to Whole Foods stores in Newton and South Weymouth, Massachusetts, through epidemiological evidence. FSIS reports that laboratory testing performed on August 13, 2014, presumably Pulsed-field Gel Electrophoresis (“PFGE”), provided a link between the three Massachusetts cases and the Whole Foods markets. On August 15, 2014, Whole Foods initiated the voluntary recall of 368 pounds of ground beef products from its two stores.

Joshua Kaye’s father, Andrew Kaye, told New England Cable News (“NECN”) that DNA samples had linked their son to the E. coli outbreak. Furthermore, Plaintiffs’ Complaint asserts that a stool sample taken from Joshua Kaye resulted in an E. coli 0157:H7 positive culture that “identically matched the Whole Foods Market E. coli 0157:H7 outbreak strain.” Both Whole Foods and Rain Crow Ranch have denied any clear link between the Massachusetts E. coli illnesses and their respective businesses.

Plaintiffs have asserted claims against Whole Foods for: (1) Breach of Implied Warranty of Merchantability; (2) Breach of Warranty in Violation of M.G.L. ch. 93A; (3) Breach of M.G.L. ch. 93A; (4) Negligence; (5) Gross Negligence and Reckless Conduct; (6) Negligent Infliction of Emotional Distress; (7) Conscious Pain and Suffering; (8) Wrongful Death; and (9) Punitive Damages.

What Does It Mean for Whole Foods? As a non-manufacturing product seller, Whole Foods appears to have pass-through liability for the sale of contaminated beef. On that basis, we expect Whole Foods to tender the defense and indemnification of their claim to Rain Crow Ranch. Whole Foods’ success in getting their tender accepted, however, will depend upon the terms of their contract with Rain Crow Ranch for the purchase of ground beef, as well as their role, if any, in the production process in advance of sale. For instance, if Whole Foods’ handling or processing of the subject beef caused or contributed to the alleged E. coli contamination, its independent negligence would preclude a common law indemnification claim and potentially impede a claim for contractual indemnity.

Further, Whole Foods’ tender will be complicated, by Plaintiffs’ assertion of Massachusetts General Laws Chapter 93A claims (“93A”). 93A provides a cause of action for unfair or deceptive practices in the conduct of any trade or commerce. Entities found
Continue Reading Whole Foods Faces Tremendous Risk In Connection With The Death of an 8 Year-Old From E. Coli 0157:H7 Infection

FMSA Moving Forward

In the future, we might look back at 2013 as the year the Food Safety Modernization Act (FSMA) finally got some teeth.  In January, the Food & Drug Administration (FDA) released two long awaited proposed rules, one aimed at food manufacturers and the other at farmers. A third rule is still in the drafting process and will require food importers to comply with United States standards through a stringent verification process.

It has been two years since President Obama signed FSMA into law, but these new rules proposed in January would be the first which actually give the FDA enhanced authority in its efforts to prevent food-borne illness. A major motive behind FSMA and the new rules is to allow the FDA to be proactive, rather than reactive, which, in turn, should lead to a tangible decrease in the number of food-related illnesses.  Presently, one in every six Americans suffers from a food-borne illness annually, with 130,000 requiring hospitalization and 3,000 dying each year.  As a result of these eye popping numbers, and increased media coverage, outbreak awareness and food litigation have exploded in recent years.   From the perspective of attorneys involved in food litigation, there are likely several ways which these new rules will impact current and future client.  Let’s take a closer look:

Rule #1, Manufacturers:

This rule will require food manufacturers to formulate a plan to prevent its food products from causing food-borne illness, as well as a plan to deal with any contamination or outbreak.  The rule also requires that the plan include a detailed strategy related to recall procedures.  Manufacturers will be required to document the plan and keep records to verify that their preventive steps are working. Furthermore, each plan will be evaluated by the FDA, and it will use the plan as a key factor in determining “high risk” facilities, which will be subject to increased inspections.  The new rule also grants audit power to FDA inspectors to confirm compliance with safety standards established in a plan.  Additional scrutiny by the FDA means more opportunity for a problem to be found, which could lead to increased future litigation. As such, compliance with the new rule is of paramount importance to any of your clients who manufacture a food product (which includes products originally manufactured in a foreign country). Your clients must be advised that a well-crafted, detailed plan is essential to both minimize risk of a contamination event, and to reduce the possibility of FDA scrutiny through audits and inspections. 

Also, it may sound obvious, but your clients must be instructed that going forward, they must comply with the plan at all times.  Having a plan is the first step, but that plan must be followed.  It is almost worse for your client to have a plan, if they do not comply with it.  After the rule is formally enacted, it is easy to envision how a plaintiff could exploit any inconsistencies or failure to comply with the plan that your


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Certified Gluten Free Lable

The Food & Drug Administration (FDA) is preparing to release a regulation on the labeling of “gluten-free” food by the end of 2012. Although the regulation will provide much needed guidance to consumers and food manufacturers, it will also establish a standard that food manufactures will need to follow in order to use a “gluten-free” label.  If food manufacturers use the “gluten-free” label without properly following the regulation, they could face lawsuits from consumers purchasing their products.

An increasing number of people in the U.S. follow a gluten free diet.  Gluten is a protein contained in grains such as wheat, barley, rye and triticale.  Packaged Facts, a Maryland based research firm, estimates that U.S. retail sales of gluten-free products in 2010 was $2.3 billion dollars, up from $1 billion dollars in 2006.  The firm projects retail sales of gluten-free food to reach $2.6 billion in 2012, and $5.5 billion in 2015.

Although the recent increase in dollars spent in the gluten-free market presents opportunities to businesses, it also presents risks.  People choose to follow a gluten-free diet for a variety of reasons, and some individuals require that food they consume be prepared in a completely gluten-free environment. If individuals with Celiac disease consume gluten, they may suffer symptoms ranging from gastrointestinal issues to neurological problems and cancer (PDF download). According to a 2010 study, 10% of gluten-free consumers purchase gluten-free products because they or a member of their household have Celiac disease or an intolerance to gluten, wheat or other ingredients. Scientists estimate that approximately 18 million Americans have some degree of gluten sensitivity. This requires that businesses take food labeling and food handling procedures seriously.

Confusion over what is gluten and what type of special handling is required to comply with a “gluten free” label has made the universe of food labels confusing to both gluten-free consumers and manufacturers.  Food labels range from being marked “gluten-free,” “made with no gluten ingredients,” and “manufactured in a gluten-free environment.” Currently, a company can label a product as gluten-free regardless of whether the food has been tested for the presence of gluten.

McDonalds received a great deal of negative publicity in 2006 when the company admitted that the fries they had previously claimed were gluten-free, are actually prepared with an oil that uses hydrolyzed wheat bran.  After an outcry from gluten-free consumers, McDonald’s removed fries from their list of gluten-free options and began labeling them as containing the allergen wheat. Although lab results indicated that no gluten was present in the fries, McDonald’s has not relabeled the fries as gluten-free (and appears to no longer have a gluten-free list at all) possibly out of fear of more lawsuits.

The FDA has twice opened the comment period for the public to weigh in on the agency’s proposed rule on how to label food as gluten-free. The proposed rule may require, among other criteria, that food bearing the claim of gluten-free cannot contain 10 parts per million (ppm)
Continue Reading FDA Prepares to Release a Regulation on the Labeling of “Gluten-Free” Food by the End of 2012

Genetically modified organism lemons

California’s Secretary of State recently announced that the California Right to Know Labeling Initiative will be Proposition 37 on this November’s state ballot. If passed, this initiative would require labeling by food manufacturers of any genetically modified organisms (GMOs), also known as genetically engineered organisms (GEOs).

GMOs made their first public appearance in 1994, when a tomato became the first genetically engineered product sold. Since then, GMOs have become increasingly more common in everyday products. In fact, the Grocery Manufacturers of America estimates that approximately 70 to 75% of processed foods available in U.S. grocery stores contain a GMO.   Furthermore, the FDA, which oversees product labeling requirements, considers GMOs to be “generally regarded as safe” (GRAS) and does not require that they be identified on product labels.  Nevertheless, despite nearly two decades of main stream retailing, it seems that the American public remains largely unfamiliar with the both the benefits and commonality of GMOs, as well the scientific community’s support for their safety.

How will Prop 37 impact the food manufacturing industry?

Should California vote in favor of Proposition 37, the imposition of similar labeling requirements is likely to follow in other states around the country.  As a result, manufacturers will likely experience increases in operational costs, as they are forced to adjust their manner of handling and preparing their products to account for GMOs.  Furthermore, food companies will also see increased legal costs,  because increased labeling requirements would also increase the potential for litigation, namely false-labeling class actions, which are becoming increasingly more common.  These class actions are not only costly to defend, but also harmful to a food company’s brand.

Where will these impacts manifest?   

  • Food producers will need to implement a system for maintaining separate inventories of product, so as not to mix the GMOs and non-GMOs.
  • Companies will be forced to amend their HACCP plans to address the handling of GMOs.
  • Overhead may increase as a result of inconsistent GMO labeling requirements nationally.
  • Companies will be forced to choose between having one label which adheres to each state’s requirements and utilizing different labels depending on the state in which the GMO containing product will be sold.
  • In response to potential consumer backlash against products containing GMOs, food manufacturing companies may need to raise the price of their products, discontinue certain brands, or engage in costly marketing campaigns to ensure future profitability.
  • Increased labeling requirements would also increase the potential for litigation in the form of false-labeling claims.

In business, smart companies aim to do business ethically and place the health and safety of their consumers first; they have the ability to meet goals while still complying legally with an ever-changing legislative landscape.

What are smart companies in the California food industry doing to prevent consumer backlash and insulate themselves from potential lawsuits in a post-Proposition 37 market?

  • Communicating: In-house counsel and litigation counsel should be having frequent conversations regarding the short and long impact of this initiative. Great litigation firms not only understand


Continue Reading Are California Food Manufacturers Prepared for Proposition 37: Imposed Labeling Mandates For Genetically Modified Organisms?