On Jan. 28, 2009, Peanut Corporation of America (“PCA”) announced it was voluntarily recalling all peanuts and peanut products processed in its Blakely, Ga., facility since Jan. 1, 2007, because they have the potential to be contaminated with Salmonella. Further, on Feb. 12, 2009, the Texas Department of State Health Services ordered PCA to cease the manufacture and distribution of all food products from its Plainview, Texas, plant, and to immediately recall all products manufactured there since March 2005. On Feb. 13, 2009, PCA filed for chapter 7 bankruptcy in U.S. bankruptcy court in Virginia. Finally, on Feb. 20, 2009, PCA issued a statement in light of PCA’s bankruptcy and the recalls: “PCA is informing customers who received products from its Georgia or Texas plants not to distribute or further use those products and to contact the FDA regarding the proper disposition of recalled products and any other matters related to the recall….”2
This peanut recall follows a number of other high-profile outbreaks of food-borne illnesses involving Salmonella and other pathogens, such as E. coli and Listeria, in the past few years. For example, on Feb. 14, 2007, ConAgra Foods issued a voluntary recall of Peter Pan and Great Value peanut butters after the brands were linked to a Salmonella outbreak that had sickened 425 people in 44 states. According to the U.S.
Centers for Disease Control and Prevention (“CDC”), product testing confirmed the presence of the outbreak strain of Salmonella Tennessee in opened jars of peanut butter that were obtained from consumers who had become ill.3 On Dec. 13, 2006, the CDC reported that 71 people had become ill after eating at Taco Bell restaurants in five states.4 The CDC confirmed that at least 48 of the 71 patients tested positive for a single strain of E. coli that was traced to the restaurants. Just two months earlier, the CDC announced that 199 people had been infected with another strain of E. coli bacteria that was traced to the consumption of tainted spinach.5
These outbreaks are not isolated occurrences. The CDC estimates that food-borne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States each year.6 Thus, contaminated food products cause more deaths each year than the combined total of all 15,000 products regulated by the U.S. Consumer Products Safety Commission.7 Food-borne illnesses now account for approximately 1 percent of all hospitalizations and one out of every 500 deaths in the United States.8 In the aftermath of the more high-profile outbreaks and recalls, numerous lawsuits have been filed. These cases, like most food contamination lawsuits, include a laundry list of claims, especially breach of warranty, negligence and strict products liability. But, what really drives the litigation (as with most litigation in the toxic tort and products arena) are the core questions of corporate conduct and causation.
This article will explore these pressure points by outlining what steps a company should take to marshal the most effective defense possible. Synthesized to its core elements, a company facing a food contamination lawsuit should consider adopting the following game plan: first, conduct an internal investigation to determine the root of the problem; second, collect evidence to defend your processes; third, retain experts immediately; and fourth, develop the contours of your causation defense by understanding the science and the facts as they pertain to each plaintiff. The focus here is on food processors, but much of this advice applies equally to all potential food defendants.
Getting to the Root of Problem
As with most large food contamination outbreaks, the federal government gets involved quickly. That does not mean you should simply sit on the sidelines, waiting for the U.S. Department of Agriculture (“USDA”), the Food Safety and Inspection Service (“FSIS”) or the Food and Drug Administration (“FDA”) inspectors to finish their investigation. Instead, begin your own fact investigation immediately. First, interview employees in key departments. These would likely include the plant managers, production managers, those responsible for quality controls, customer service, and sales people, as well as the shipping and transportation personnel, and cleaning crews. And, do not forget your suppliers and distributors. While your suppliers and distributors may be reluctant to cooperate, they may be contractually obligated to assist you in your investigation and, at a minimum, may expose themselves to greater liability if they do not cooperate. All interviews should be conducted with in-house and/or outside counsel present in order to secure as much protection under the attorney-client privilege and work-product doctrine as possible.
Second, consider retaining an independent consultant and independent labs to identify and/ or rule out potential sources of contamination. The results of such investigations may be discoverable in subsequent litigation, but oftentimes there is little downside to doing your own analysis. While the government inspectors will likely be involved and companies should fully cooperate with those investigations, the government’s methodology and conclusions may be flawed or incomplete, resulting in your product or processes being improperly implicated. Moreover, the failure to conduct an independent analysis could be used against you in court. The proverbial “head in the sand” theme resonates with jurors and can spell doom to a company seeking to reduce its exposure.
Third, through the interview process and with the help of your consultants, begin collecting documents that may be discovered in litigation and documents that may help explain or rule out various sources of contamination. Once an outbreak of food-borne illness occurs, the threat of litigation exists. Reach out to your employees and place a litigation hold on documents and emails.9 A company cannot afford to be attacked both for the contamination, and for a perceived “discovery tort” as a result of the destruction of relevant documents. The hunt for documents should not simply be a hunt for the “bad” documents, but should include a collection of documents that demonstrate the company’s good practices and good conduct.
Finally, consider identifying a spokesperson to interface with (or at least vet communications with) federal officials, the media, suppliers, customers and consumers. Centralizing communication is critically important in the early stages of a suspected food-borne illness outbreak. It is not helpful in the throes of litigation to have to respond to questions about why one group of employees said one thing about the company’s practices (or the cause of the illnesses), while another group of employees articulated something quite different. Worse yet is when someone representing the company makes an absolutist proclamation about the com-pany’s innocence, about its unparalleled safety practices, about the real cause of the outbreak—but internally, the documents tell a different, more equivocal tale. Communication-disconnects undermine credibility and can even form the basis for a fraud claim that becomes an unnecessary sideshow, distracting judges and juries away from the core conduct and causation defenses you wish to present.
Marshalling a Conduct Defense
It may seem like a secondary concern—particularly given the thorny questions of causation raised by a food contamination lawsuit—but the conduct of a company more often than not will drive a jury’s understanding of the science. In any products or toxic tort suit (and food cases are no exception), plaintiffs lawyers will try to paint your company as callous. Whether the operative themes are profits over safety, the suppression of knowledge, or ostrich-like behavior, if you are not prepared to counter these bad conduct barbs, you risk having the jury tune out when it comes time for your science defense. A particularly ineffectual defense could also lay the foundation for a punitive damages award, often adding unnecessary insult to injury when the company has, in fact, implemented good processes and quality controls to prevent or mitigate the risk of food-borne contamination.
For these reasons, a company facing or anticipating litigation should as soon as possible marshal all the evidence it can to indicate steps taken to ensure quality. What does that mean? It means itemizing in detail the quality control steps that the company has documented and implements—from the purchase of raw ingredients, through the mixing process, to quality control testing, packaging and shipping. Companies should also collect information that demonstrates a commitment to process improvements, be it International Standards Organization (“ISO”) certifications, Hazard Analysis Critical Control Point (“HACCP”) systems, or structural improvements and upgrades.
Because the government is almost always a player in food-borne contamination cases, and because compliance with governmental regulations can become a cornerstone of any defense, it is also imperative to collect evidence demonstrating compliance with all FDA, USDA, and state regulatory requirements, as well as evidence demonstrating cooperation with the investigation at issue. While compliance with regulations and cooperation with investigations may not insulate you from liability, it is an important first step in reducing your exposure. Ideally, of course, your company will also be able to demonstrate that it is proactive; that the quality control processes in place are not simply consistent with regulatory requirements, but also offer protections above and beyond what may be prescribed. If your processes are state-of-the-art and in the vanguard compared with your competition, collect evidence that supports those points. If you have a good story to tell, tell it; that is the only way the jury will listen to your more technical defense.
Retaining the Experts
In developing your science defense, the first thing you should do is quickly retain consultants and potential testifying experts. Retain someone who can speak to quality control issues and federal safety compliance issues. This could be a local professor who has an expertise in food safety and can discuss the science, the relevant regulations, and industry practices. Many state universities have food safety experts and departments. At least retain someone as a consultant before the plaintiffs do, and consider using that person (if not someone in-house) as a credible spokesperson for the company.
Second, consider retaining an epidemiologist who can help raise questions about the causation evidence. While plaintiffs will likely call public health authorities involved in the outbreak investigation as fact witnesses, if you disagree with those officials’ conclusions and methodology, or if those conclusions are not definitive, retain an epidemiologist to help rebut them. Third, consider retaining a local clinician, such as an internist and/or gastroenterologist with some expertise in infectious diseases. This individual could be enlisted to review the medical records and do an independent medical examination, identifying alternative explanations for any one particular plaintiff’s ailments. Additionally, this physician could address the plaintiffs’ claimed damages, including the likelihood of longterm complications. Fourth, consider retaining a microbiologist or bacteriologist with a good lab from a local state university who has an expertise in the food poisoning at issue. Ideally, this person could identify all alternative sources of the particular bacteria to help prove that it did not come from you.
With your expert team in place, documents reviewed and witnesses interviewed, you are ready to develop your causation defense.10
Causation, Causation, Causation
For plaintiffs to successfully prosecute a products liability suit arising from an alleged exposure to a food contaminant, they must establish a causal connection between the ingestion of the allegedly contaminated food and the illness claimed.11 The best proof, undoubtedly, is for plaintiffs to produce a human specimen (a stool or blood sample) that matches what is found in the product. Short of that, plaintiffs can rely only on circumstantial evidence to establish causation. If the plaintiff fails to get a stool or urine sample and/or fails to save the food that allegedly injured them, they have a much tougher hill to climb.12 Importantly, however, many states allow causation to be inferred from circumstantial evidence, and you need to be prepared to respond.13 For example, plaintiffs often rely upon the medical testimony from an attending physician to prove causation by linking their claimed symptoms to those that are classic to the particular food poisoning in question. Those symptoms may include fever, abdominal cramps, headache and diarrhea. But because these types of symptoms have multiple causes (be they contemporaneous or pre-existing), companies would be wise to highlight relevant alternative explanations if they plausibly exist, such as viral syndromes, or problems with immune deficiency, irritable bowl syndrome, or even antibiotic use.14 And, when the symptoms do not line up, a company has an even stronger defense.15
Moreover, because most food-borne pathogens have well-recognized incubation and duration periods, if the lapse of time between exposure and symptoms is inconsistent with those incubation periods, or if the duration of the illness is inconsistent with what would be expected from the particular pathogen, then the pathogen likely did not cause the illness. In the case of Anderson v. Piccadilly Cafeteria, Inc., plaintiff did not have a medical test performed to establish the presence of bacterial poisoning toxins in her bloodstream, and the defendant successfully challenged causation by introducing evidence that the onset of plaintiff’s symptoms was inconsistent with the incubation period for food bacteria.16 The plaintiff’s treating physician and defendant’s expert in food-borne diseases both testified that the incubation period for the bacteria is at least one hour, whereas plaintiff testified that her symptoms began only 15 minutes after ingesting the allegedly “deleterious” food.17 One court even held that the plaintiff’s evidence of causation was insufficient precisely because she did not prove that the onset of her symptoms was consistent with the known incubation period for the illness.18
Another causation-defeating defense oftentimes available to companies is evidence that the alleged pathogen does not spread (or infrequently spreads) in the way claimed by the plaintiff. The argument could be that the food in question is not a commonly recognized vehicle for the pathogen, or that it was prepared in such a way that it is highly unlikely such a pathogen could have survived. For example, in Shaw v. Swift & Co., the defendant meat packing company processed chitterlings (pig intestines) that were eventually sold to the plaintiffs who became ill with bacillary dysentery.19 Plaintiffs alleged that the meat was contaminated with an organism that causes bacillary dysentery. The defendant successfully challenged causation by introducing expert testimony that the organism that allegedly caused the illness is not found in the intestinal tract of hogs, but lives in humans and is spread from person to person through the use of common sanitary facilities. The defendant offered further testimony that even if the chitterlings had become contaminated with the organism, the process by which plaintiff admitted she cooked the meat would have destroyed the organism. The court held that “there is no evidence from which the jury could have logically found a causal connection between their illnesses and the chitterlings processed or sold by defendant.”20
Finally, courts have held that plaintiffs fail to meet their burden with regard to causation where there is evidence of more than one possible food source for the alleged illness. In Thacker, for example, the court held that plaintiffs failed to prove causation because the consumed beef was never tested for E. coli, and there was evidence that plaintiff had also eaten hamburgers at a county fair prior to eating the beef at issue.21 Although affirmatively identifying alternative food sources as the cause of an illness may prove difficult (particularly in situations where there is a widespread outbreak), it makes eminent sense to still try to identify all the various sources of the particular types of poisoning. If some other food sources are more common for the type of poisoning at issue, marshal such evidence by obtaining a detailed history of foods that the plaintiff ate around the time he/she allegedly consumed the tainted food.
Recent recalls relating to a number of food-borne illness outbreaks have spawned dozens of lawsuits around the United States. Although plaintiffs have historically faced significant challenges in successfully prosecuting a food contamination claim, the steady stream of media reports about food contamination cases is likely to create plaintiff-friendly jury pools that make defending against such a lawsuit increasingly difficult. Acting quickly and deftly to develop an effective conduct and causation defense will go a long way toward minimizing your exposure and softening the blow to your bottom line.