Food Safety Counsel : Food Safety Defense Lawyer & Attorney : National Food Industry Counsel : National Food Regulatory Lawyer and Attorney, FDA Lawyer and Attorney. USDA Lawyer and Attorney : Gass Weber Mullins Law Firm

For over a decade, we have worked throughout the country with food companies (including producers, distributors, restaurants and grocers) defending high-profile outbreak litigation.

In our years of experience, we have discovered that many claims lack merit, and many others prove questionable at best.

Because some investigators, most claimants and virtually all plaintiffs’ attorneys continue to adopt mistaken conclusions regarding the source of an alleged illness or outbreak, we are proud to offer the following Food Safety Litigation Library to assist with the investigation and defense of these claims:

• An Introduction to Food-Borne Illness Litigation;

• Chapter 1: Understanding The Role Of Government Oversight;

• Chapter 2: Understanding How Food-borne Illnesses Are Tracked;

• Chapter 3: Understanding The Speed Of Developing Outbreak News;

• Chapter 4: Responding To The Complaint - Procedural Considerations;

• Chapter 5: Understanding The Pathogen At Issue;

• Chapter 6: Understanding The Circumstances Of Plaintiff's Illness;

• Chapter 7: Obtaining Public Records Relating To Outbreak Investigations;

• Chapter 8: Understanding The Likelihood Your Product Was A Source;

• Chapter 9: Understanding And Identifying Alternative Sources;

• Chapter 10: Making Use Of Interrogatories And Document Requests;

• Chapter 11: Making Effective Use Of Plaintiff's Deposition;

• Chapter 12: Identifying Potential Experts;

• Chapter 13: Defending Damages.

Although we enjoy one of the most plentiful, affordable and safest food supplies in the world, we also live in one of the most litigious societies. Thus, despite the fact that food-borne pathogens are (and likely always will be) an inherent part of our food supply, and despite the fact that individual risk can be greatly reduced through responsible consumer behavior, many individuals will continue to be affected by food-borne illness and, unfortunately, regardless of source or cause, many will continue to sue.

Thus, when your company is faced with a claim, we truly hope the information provided above will enable you, too, to uncover the truth in food-borne illness litigation. 

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Each year, approximately 325,000 Americans are hospitalized with a food-borne illness. As a result of improved governmental surveillance, more outbreaks are being identified and more people are bringing claims.

Unfortunately, however, most outbreak investigations fail to identify the real culprit, and some even identify the wrong source. In many cases, the claimants (who mistakenly think they got sick from “the last thing they ate”) sue the wrong party.

Given current trends in surveillance and a resulting increase in litigation, it will be essential for any company faced with potential or threatened food-borne illness claims to gain, at the very least, mastery of the following information:

• How food-borne illnesses are tracked, identified and confirmed;

• What to expect in a food-borne illness investigation;

• How to respond during an outbreak or recall;

• How to react when confronted with an alleged claim; and

• How to properly defend your business and reputation when lawsuits are filed.

Thus, we are proud to offer our food safety litigation library.  Through the advice and knowledge contained within the following chapters, you too can discover the information you need to defeat, or fairly resolve, food-borne illness claims.

Copyright 2009 by Shawn K. Stevens

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So, here we go again. Thinking about food rather than eating it. But, that's okay.

Because helping food companies decrease the risk of potential litigation, finding the real source of an outbreak (when it does occur), helping a faultless company avert a crisis, working to extract an innocent food producer from a stray investigation, or simply proving decisively before trial that a food-borne illness claim lacks all merit, is well worth the small sacrifice of delaying a meal.

For nearly a decade, we have worked nationally with food companies and food safety professionals preventing litigation, managing outbreaks and defending claims.

During this period, we have observed (first hand) what really happens inside our processing plants, grocery stores and restaurants, and are here to proclaim, without hesitation, that we are proud to eat the food you make. Additionally, while our food safety system may never be perfect, it is extremely well suited to identify problems when they arise, to encourage quick and effective solutions, and to help ensure that our food supply remains one of the most plentiful, affordable and safest in the entire world.

Thank you for a job well done!

Welcome to www.foodsafetycounsel.com.

• Return to Defending Claims.

Defending a food-borne illness claim requires a thorough understanding of how our food is regulated.  Because many governmental agencies (both state federal) play a role in the regulation of virtually all of the foods we eat, it is critical in every case to understand: (1) the role of each regulatory agency in the production of the food at issue; and (2) the specific laws, regulations and rules that apply to the particular product.  Although the history of federal oversight over our food supply is quite long and storied, the following discussion summarizes generally the progression and current status of the federal regulation governing the food we eat.

At the dawn of the last Century, our nation, through advances in science and technology, began to gradually understand the processes through which we could make food more accessible. Due to the emergence of rapid transnational shipping, improved preservation techniques and the ability of media to reach an increasing number of consumers, the food industry revolutionized. For the first time, food processors could viably ship perishable products anywhere in the nation.

As interstate shipment of food began to increase, however, food safety regulations were inadequate. In the absence of a federal approach (there had not yet been a need) America’s food laws were implemented primarily at the state and local level. As can be expected within a growing nation, industrial advances were quickly outpacing limited state and local regulations. In the meat industry, in particular, laws defining what constituted “adulteration” or “misbranding” were determined, if at all, by each individual state. Moreover, what was forbidden in one state was entirely lawful in another. This hodgepodge of inconsistent regulation soon inspired concerned citizens, consumer groups and social reformers to voice their concerns. Without a national approach to food safety (and a single set of rules), American citizens in the various States had no confidence in the origins or safety of the food they were eating.

During this period, technological advances outside of the food industry were also instrumental to inspiring incredible change. The emergence of inexpensive newspapers that reached across the nation gave individuals and consumer groups greater opportunity to voice their concerns. Social reformers, who otherwise would have remained unheard, could now reach a broad audience. The most famous example, of course, was Upton Sinclair. In his 1906 novel, The Jungle, Sinclair described the unsanitary conditions prevalent in large slaughter plants. The book described unwholesome carcasses being processed for use in food, processing taking place in unhealthy conditions, and meat and other food products coming into contact with contaminants present in the plants. Such conditions outraged the public, and the growing demand for change soon became too loud for Congress to ignore. Inspired by this national chorus, the federal government realized that a uniform food safety policy (i.e., a single set of rules) was essential to protect both the national economy and the health of American citizens.

The federal approach to food safety was, for all practical purposes, solidified in 1906, when the United States Congress passed the Wholesome Meat Act and the Pure Food and Drugs Act. These Acts (along with their successors) formed the framework for the national food safety policy that continues to exist to this day.

The 1906 Wholesome Meat Act (now known as the Federal Meat Inspection Act, 21 U.S.C. § 601, et seq.) was originally enacted in response to The Jungle. With the sweep of a pen, the federal legislation required continuous federal inspection within meat packing plants to ensure that all meat products sold in interstate commerce would be: (1) produced under sanitary conditions; (2) not adulterated; and (3) properly labeled. Today, the Federal Meat Inspection Act (“FMIA”) is enforced by the Food Safety Inspection Service (“FSIS”), an agency falling within the jurisdiction of the United States Department of Agriculture (“USDA”). In meat packing plants, the FMIA continues to require continuous, on-site inspection of the entire slaughter and processing process. In addition to its inspection responsibilities, the USDA also closely regulates product labeling. Over the decades, USDA’s authority has expanded to oversee poultry production under the Poultry Products Inspection Act (21 U.S.C. § 451, et seq.) and egg production under the Egg Products Inspection Act (21 U.S.C. § 1031, et seq).

Like the FMIA, the original Pure Food and Drug Act was also enacted in response to social pressure. While the Wholesome Meat Act was designed to oversee the production of meat, the Pure Food and Drug Act was created to increase confidence in many other foods. Here too, Congress was inspired to action following a number of well-publicized scandals involving the food industry, including one where American soldiers serving in the Spanish-American war were allegedly sickened by embalmed foods. Additionally, with advances in chemistry, it was becoming more common for business to use various additives to preserve foods. These activities, of course, also triggered additional debates involving the merits of substitute foods, such as margarine for butter, and the use of questionable “ingredients” such as coal tar, borax, and various food colors. In response, the 1906 Pure Food and Drugs Act, as originally enacted, forbade adulteration and misbranding of foods in interstate commerce. This Act was amended several times before being replaced in 1938 by the more stringent Federal Food, Drug and Cosmetic Act (“FDCA”). 21 U.S.C. § 301 et seq. Today, the FDCA is enforced by the Federal Food and Drug Administration (“FDA”), an agency falling under the jurisdiction of the Department of Health and Human Services (“DHHS”). Currently, the FDA has jurisdiction over approximately 78 percent of the domestic and imported foods sold in interstate commerce, and seeks to ensure that such products are safe, nutritious, wholesome, and adequately labeled. Although the FDA, unlike FSIS, does not provide continuous inspection in food processing facilities, it has jurisdiction (and conducts periodic inspections) where food is processed, packaged, stored and sold.

Although the USDA and the FDA share most of the regulatory responsibility for food safety in America, the following additional federal agencies are also responsible for food safety as part of their federal mandate:

• The Centers for Disease Control and Prevention (“CDC”), within the DHHS, gathers data on food-borne illnesses, investigates food-borne illness outbreaks, and monitors the effectiveness of numerous prevention and control initiatives. As part of these efforts, CDC also helps state and local epidemiologists (and state health laboratories) identify and prevent food-borne illness and other outbreaks. The CDC engages in these activities under the general authority of the Public Health Service Act. 42 U.S.C. § 201, et seq.

• The Environmental Protection Agency (“EPA”) protects the nation’s water supply by setting standards for drinking water under the Safe Drinking Water Act. 42 U.S.C. § 300g, et seq. The EPA also regulates pesticide products and establishes tolerances for residues on various food commodities and animal feed. The EPA operates under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), 7 U.S.C. § 136, et seq., and the FDCA.

• The Animal and Plant Health Inspection Service (“APHIS”) is another agency which falls within the USDA umbrella. The APHIS is responsible for administering various federal laws and regulations to enhance the health and care of animals and plants. The APHIS assists with food safety on a national level by coordinating needed research and other efforts to protect the industry against pathogens or diseases that are a risk to humans.

• The Grain Inspection, Packers and Stockyards Administration (“GIPSA”) is another agency, within the USDA, which helps establish quality standards for food products. The GIPSA also coordinates a national inspection system for grain and related products (and reports its findings to the FDA) to ensure compliance with the FDCA, the United States Grain Standards Act, 7 U.S.C. § 71, et seq., and the Agricultural Marketing Act (“AMA”) 12 U.S.C. § 1141, et seq.

• The Agricultural Marketing Service (“AMS”), another agency within the USDA, is responsible for establishing quality and grading standards for various dairy, egg, fruit, meat, poultry, seafood and vegetable products. As part of the grading process, the AMS considers various safety factors, such as the cleanliness of the product. The AMS operates programs under a number of federal laws relating to food safety, including the AMA and the EPIA.

• National Marine Fisheries Service (“NMFS”), an agency within the United States Department of Commerce, administers voluntary seafood quality inspection programs. In addition to the inspection and certification of fish products for human consumption, the NMFS also provides inspection of animal feeds and pet foods derived from fish products. The NMFS operates under the AMA and the Federal Fish and Wildlife Act. 16 U.S.C. §742, et seq.

• The Federal Trade Commission (“FTC”) enforces the Federal Trade Commission Act, 15 U.S.C. § 41, et seq., which prohibits unfair or deceptive practices. The FTC’s food safety objective is to prevent the dissemination of false advertising which has the purpose of inducing the purchase of food.

Improving food safety is and always will be a scientific endeavor. As such, it will be important for our government to remain flexible as new technologies emerge and discoveries are made. The federal government understands this, and is constantly working to improve and enhance existing capabilities. The federal government expends vast resources in the fields of applied research and risk assessment as it relates to food safety. Research is conducted in a wide variety of disciplines, by a number of different entities. These include efforts by, among others, the National Institutes of Health, the National Institute for Food Safety Technology (MOFFET Center), the National Advisory Committee on Microbiological Criteria for Foods (“NACMCF”) and the USDA’s Agricultural Research Services.

In addition to extensive research, the federal approach to food safety has in recent years also focused on consumer and industry education. The federal government has developed food safety educational programs that span the entire farm-to-table continuum. This includes educating farmers, producers, distributors, food-handlers and consumers. An excellent example is the “FightBAC!” campaign, sponsored by the Partnership for Food Safety Education, which was created to help educate consumers about the potential food-borne illness hazards associated with improperly handling and cooking raw meat and poultry products.

Together, these agencies (and initiatives) promote food safety and attempt to reduce food-borne illness through inspections, surveillance, enforcement, research, risk assessment, pre-market approval, controls for safe processing, and education. The federal approach to food safety has evolved into a vast, multi-pronged food safety system managed by thousands of caring and dedicated Americans.

Copyright 2009 by Shawn K. Stevens

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In addition to understanding how our food is regulated, it is absolutely critical, when faced with a potential food-borne illness claim, to understand and appreciate how food-borne illnesses are identified, investigated and confirmed by relevant governmental public health agencies. Without this information, it will be virtually impossible to adequately defend any food-borne illness claim.

Indeed, to gain a better understanding of the extent of food-borne illness in America, the federal government in recent years has developed comprehensive initiatives to help federal, state and local governments identify, track and solve food-borne illness cases. In 1993, for instance, a large outbreak of food-borne illness caused by E. coli O157:H7 sickened more than a hundred people in the western United States. In this outbreak, pulsed-field gel electrophoresis (“PFGE”) was used to determine the source of the outbreak by matching the DNA of the implicated E. coli to hamburgers from a national restaurant chain.

PulseNet

In the years that followed the 1993 multi-state E. coli O157:H7 outbreak, numerous surveillance programs increased the federal government’s ability to detect food-borne illness cases on a national scale. Following the 1993 outbreaks, for example, the CDC created PulseNet so that scientists and public health laboratories throughout the country could upload and then rapidly compare the PFGE patterns of bacteria isolated from ill persons.

From 195 PFGE patterns in the mid-1990s, the database has grown to over 120,000 patterns today. All 50 state public health departments participate in PulseNet, along with several local public health laboratories and the USDA and FDA. PulseNet Canada and PulseNet USA exchange DNA fingerprints and associated information in real time. Having real-time access to such information has helped investigators determine: (1) whether reported food-borne illness cases are genetically similar; and (2) whether they likely originated from a common source. Today, PulseNet links the CDC, state health departments, and food regulatory agencies so that multi-state outbreaks can be rapidly detected and investigated.

Bacterial pathogens analyzed include E. coli O157:H7, Listeria, Salmonella and other food-borne bacteria. When a PulseNet participating laboratory logs on to the PulseNet server, it will display a “recent match” message if two or more laboratories submit identical or closely related patterns within a specified time. A universal naming system was developed to help compare and interpret molecular subtyping information, using a 10-character code: XXXYYY.0000. The first three characters represent the bacterial pathogen, the next three denote the enzyme used for DNA restriction, and the last four characters represent the pattern designation. For example, in the pattern EXHA26.0026, EXH represents E. coli O157:H7, A26 represents restriction endonuclease AvrII, and 0026 is the pattern number.

OutbreakNet

Once a cluster of illnesses is identified that share a common PFGE pattern, epidemiologists interview patients in an effort to find or exclude a common source. Sources might be food, environmental elements or another person carrying and shedding the bacteria. The Outbreak Network for Food-borne Diseases Surveillance and Response, “OutbreakNet,” is a network of public health epidemiologists at the local, state and federal level who investigate food-borne and diarrheal disease outbreaks. OutbreakNet participants use standardized interview methods and forms, seeking to assess whether there are statistically significant common exposures among the patients. Information is shared rapidly via email, conference calls and website postings, and updated constantly during outbreaks so that if a common source can be identified, corrective action can be taken to minimize further illnesses.

An example of multi-state sharing among epidemiologists is this email from a recent outbreak suspected to be associated with ground beef:

FoodNet

The third part of the CDC surveillance network is The Food-borne Diseases Active Surveillance Network, “FoodNet,” which compiles evidence to draw broader conclusions about the extent of food-borne illnesses. FoodNet is a collaborative project of the CDC, 10 states (California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon and Tennessee), the USDA, and the FDA. This network collects data regarding diseases caused by enteric pathogens transmitted commonly through food. FoodNet staff routinely contact all clinical laboratories in the 10 FoodNet sites to collect information on every laboratory-confirmed case under surveillance. FoodNet surveillance in the 10 participating states includes nearly 45 million people, or approximately 15% of the United States’ population. For 2006, FoodNet reported rates of infection per 100,000 people as follows:

1. Salmonella:  14.81
2. Campylobacter: 12.71
3. Shigella: 6.09
4. Cryptosporidium: 1.91
5. E. coli O157:H7: 1.31
6. non-O157:H7 STEC: .46
7. Yersinia: .35
8. Vibrio: .34
9. Listeria: .31
10. Clycolspora: .09

FoodNet also estimates the burden and trends over time for food-borne infections, and conducts studies to better understand the epidemiology of food-borne diseases. Its goal is to develop better prevention strategies at each step of the farm-to-table continuum so as to reduce the burden of food-borne illness. Proper handling at each step, including food preparation, is always stressed.

Aided by new initiatives such as PulseNet, OutbreakNet and FoodNet, the CDC estimates that, annually, nearly 76 million people continue to be affected by some type of food-borne illness. Of these, more than 300,000 are hospitalized and about 6,000 people die. Although most people affected by food-borne illness develop only mild symptoms (or remain asymptomatic), food-born illness can cause greater concern for those with compromised or weakened immune systems, such as the very young or old. Because food-borne pathogens continue to exist naturally in many raw foods such as raw meat and poultry, and because there is no technology to eliminate them during production (with the exception, of course, of irradiation or cooking), today’s challenges with respect to the food supply remain as real as they are complex. As consumers, we must individually take care to avoid the potential hazards associated with raw foods. As industry representatives, insurers and lawyers, we must remain cognizant of the role food-borne illness will likely continue to play in our professional disciplines.

In any event, as food safety lawyers, it is and will always remain critical to be intimately familiar with these and other surveillance programs, and to stay abreast of new developments.  Indeed, as surveillance continues to improve, the number of illness identified, and claims filed, will likely increase as well.

Copyright 2009 by Shawn K. Stevens

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After federal and state health officers have done their jobs (1) finding common patterns in bacterial infections, (2) using the tools of epidemiology to find statistically significant connections between patients and common exposures, and (3) requiring companies to recall the suspect product (and often, a great deal more), the media and lawyers go to work.

In the meat industry, for example, the first step after a likely source is confirmed is a Press Release sent out by the USDA’s Food Safety Inspection Service (FSIS) announcing the meat producer, the approximate number of pounds recalled, the production dates at issue and the names under which the product was distributed. The following is an excerpt from a recent press release:

Once these Press Releases are issued, expect to see significant press coverage and blog entries on the leading plaintiffs’ lawyers’ sites, including www.marlerblog.com. Because the FSIS provides email alerts about recalls, very little time passes between the Press Release itself and its appearance in the press and on the web.

Companies, therefore, must immediately consider how they wish to present themselves in the media. A company spokesman should be selected, keeping in mind that this person will likely be deposed and/or his remarks used at trial. It may also be appropriate to have your lawyer respond to press inquiries, especially if you are responding to a statement by a plaintiff’s attorney. A press release that includes quotes on behalf of the company can also work, and may be the most prudent course in rapidly evolving circumstances where much remains unknown. In all events, it is necessary to have in mind what the company’s themes will be at trial, so that early statements will be consistent with arguments that may be made months and years later.

Claims and lawsuits, legitimate and not, of course follow promptly. 

Copyright 2009 by Shawn K. Stevens

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Once a claim is filed in state court, the first decision should always be whether to remove the lawsuit to federal court. Often times, because food-borne illness cases are fraught with emotion, and because many aspects of the food industry may be governed exclusively by federal rules and regulations, removal should be seriously considered. Additionally, regardless of whether a case is removed, the same federal rules and regulations (or, simply the facts of the case) may also support a motion to dismiss as well.

1.     Considering The Potential Of Federal Removal

When considering removal, the most obvious factor is federal diversity. If available, use it. If not, you should also be aware that, depending upon the claims asserted and the nature of your client’s operations, there may be certain federal rules and/or regulations that would nevertheless support “federal question” or “federal officer” removal. Although the applicability of these doctrines will depend upon the nature of your client’s business, and the facts and circumstances of each case, they may create additional removal opportunities even in the absence of complete diversity.

2.     Considering Potential Grounds For Dismissal

Regardless of whether a case will be litigated in state or federal court, you should also consider the merits of an early motion to dismiss. Beyond statutes of limitation or other procedural considerations, some or all of the plaintiff’s claims may be subject to a motion to dismiss on other grounds as well – such as federal preemption.

Although there are other federal laws that may act to preempt food-borne illness claims, the Federal Meat Inspection Act ("FMIA") is one example of federal statutory law that has a preemptive effect. This is because the FMIA is designed to regulate virtually every aspect of meat production in America. To ensure that the FMIA is not usurped by the individual states, the FMIA contains an express preemption provision which prevents states from adopting or enforcing any laws that are “different” from the federal standards. Thus, under the FMIA, any claims which attempt to penalize a food producer for doing what federal law permits (whether the claims relate to alleged adulteration or product labeling) may be strictly preempted.

As noted, in addition to the FMIA, other federal laws may operate to preempt state law in similar contexts. For example, the Poultry Products Inspection Act (21 U.S.C. § 451, et seq.), the Egg Products Inspection Act (21 U.S.C. § 1031, et seq.), the Food Drug and Cosmetic Act (21 U.S.C. § 301, et seq.) and the National Labeling and Education Act (21 U.S.C. § 343-1) each contain provisions that can operate, under the doctrines of express or implied preemption, to bar to claims implicating the relevant federal food or labeling standards.

Copyright 2009 by Shawn K. Stevens

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As one might expect, everything in your case (from discovery, to dispositive motions, to trial) will be driven by the type of pathogen at issue. When a claim is filed, take some time to understand completely the science relating to the specific pathogen at issue. This should include identifying where the pathogen is commonly found, whether it is an adulterant in the food product at issue, how easily the pathogen is destroyed (i.e., through cooking), the incubation period and symptomology associated with infection, and the nature and scope of potential damages that can result.  The following chart, for instance, identifies some common pathogens and the corresponding incubation periods:

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Once you have an understanding of the pathogen at issue, it will be critical to understand the true nature of plaintiff’s allegations. As soon as any food-borne illness case is filed, the following resources should be analyzed to help you better understand plaintiff’s illness:

• Pleadings and Demands: Plaintiffs' own pleadings and demands will often provide a wealth of information. From the pleadings, you can typically identify the nature of the illness, the pathogen at issue, the date of the meal, and the potential illness onset date. In turn, this information is often reinforced by the plaintiff’s recitation of events in his or her demand. In addition to the plaintiff’s own summary, demands will typically contain medical records relating to the plaintiff’s treatment. Here too, these records will be very helpful to confirm the plaintiff’s exposure history, onset date and symptomology within days of the alleged meal in question.

• Media Resources: In more serious cases, media resources may also provide additional information relating to the plaintiff and his or her illness. Here too, additional information can often be gathered from statements made by the plaintiff or relatives familiar with his or her case. Additionally, you should search media references for reports of other cases in time and proximity to the events alleged in the complaint. This, too, will help identify whether the plaintiff is an isolated case or potentially linked to other illnesses.

• Medical Records: The moment a case is filed, it will be important to obtain medical records authorizations from the plaintiff. Once medical records are obtained, they should be carefully analyzed to identify the plaintiff’s history, the onset date of the plaintiff’s illness, the progression of the illness, whether any confirmatory tests were obtained, and any information regarding the plaintiff’s exposure to other potential sources. Such records are critical when assessing the merits of plaintiff’s claims.

• Governmental Resources: Additionally, as soon as a case is filed (or sooner if you are already aware of potential claims), you should move as quickly as possible to obtain records from any relevant federal, state and local health authorities. If the case involves a pathogen that is reportable, documents should be obtained through a public records request from any city, county or state health departments overseeing the geographical location where the plaintiff resides. In addition, records should also be requested from the Centers for Disease Control, and either the USDA/FSIS and/or the FDA (depending upon the product and establishment at issue). Although these records can take weeks (and sometimes longer) to obtain, they will often provide critical information relating to the plaintiff and other, potentially related, illnesses.

In the event the plaintiff confirmed positive for the pathogen at issue, additional records relating to the plaintiff and his or her illness will exist at some or all of these levels. Not only can you gain information about the plaintiff’s case, but if his or her illness was linked to other illnesses, you will be able to obtain useful information regarding these cases as well. Such records typically include food-borne illness questionnaires, exposure histories, food consumption histories, illness information, important product information, communications between health authorities, potential sources or exposures that have been excluded and any findings or conclusions that may have been reached. As a result, such information can be very useful, if analyzed appropriately, to either confirm your product as a potential source, or to establish a strong argument that the source of the alleged illnesses was likely a different source altogether.

Alternatively, in the event there was no confirmatory testing, such records may nevertheless be helpful to show that there were also no reported illnesses in time and proximity to the plaintiff. These records (or the absence of such records) may also help to establish that the plaintiff’s infection was an isolated event, and likely originated from a source other than your product.

Although this list is by no means exhaustive, these are just some of the resources which will help you better understand the nature of plaintiff’s illness from the outset of the case. Importantly, this information will also help confirm very early in a case whether: (1) your client’s product was likely involved; or (2) whether it can be excluded as a potential source. 

Copyright 2009 by Shawn K. Stevens

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Governmental records are often the best source of information when investigating food-borne illness claims.

As soon as a case is filed (or sooner if you are already aware of potential claims), you should move as quickly as possible to obtain records from any relevant federal, state and local health authorities.  If the case involves a pathogen that is reportable, documents should be obtained through a public records request from any city, county or state health departments overseeing the geographical location where the plaintiff resides.

If an individual (or group) confirms positive for Botulinum, Campylobacter, Cryptosporidium, E. Coli O157:H7, Hepatitis A, Salmonella or Shigella, his or her healthcare provider is generally required to report the case to authorities. Once reported, local and state health departments will initiate an investigation. Similarly, whenever a group of individuals confirm positive for pathogens not generally considered “reportable,” the cases are still typically reported and will often result in some type of investigation. 

For this reason, it is always critical to obtain documents potentially generated by the following governmental agencies to understand fully the cause of an illness or outbreak:

• Any state, county and/or city health departments in the location where claimant either resides or was likely exposed. For requests to state and local government agencies, please visit www.foiadvocates.com to identify the relevant public records laws, and to obtain additional helpful information on issuing FOIA requests to these authorities.

• The CDC whenever the illness involves Campylobacter, E. coli O157:H7, Listeria, Salmonella and/or Shigella.

CDC/ATSDR
Attn: FOIA Office, MS-D54
1600 Clifton Road, N.E.
Atlanta, GA 30333

• The USDA/FSIS whenever the illness or outbreak involves an alleged meat, poultry or egg product:

Freedom of Information Act Officer
USDA, Food Safety and Inspection Service
Room 1140-South Building
1400 Independence Avenue, SW
Washington, DC 20250

• The FDA whenever the illness outbreak involves any food products other than meat, poultry or eggs (i.e., produce and vegetables):

Food and Drug Administration
Office of Management Programs
Division of Freedom of Information (HFI-35)
5600 Fishers Lane
Rockville, MD 20857

For requests to the CDC, USDA and/or FDA, cite 5 U.S.C. § 552 (the Freedom of Information Act) to support your request. 

Although these records can take weeks (and sometimes longer) to obtain, they will often provide critical information relating to the plaintiff and other, potentially related, illnesses.

Copyright 2009 by Shawn K. Stevens

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Once the pathogen, the plaintiff’s history and other potential sources are identified, a determination can be made regarding the likelihood that your client’s food product was the source of plaintiff’s illness. The following information can be used to disprove plaintiff’s claims:

Incubation Periods: Unfortunately, most plaintiffs believe, when they become sick, that their illness was caused by “the last thing they ate.” In a case involving E. coli O157:H7, for example, a plaintiff may allege in her complaint that she fell violently ill within “a few hours” of the meal in question. Because the incubation period for E. coli O157:H7 is typically 3 to 4 days (and can never be less than 24 hours), the allegations, as stated, would be scientifically impossible to prove. In addition, assuming your records search disclosed that there were no other illnesses associated with your product, grocery store or restaurant, it will be very difficult for plaintiffs to establish that your client’s business or product caused her illness. As noted, under these circumstances, you will already be able to establish that other sources (such as food consumed in the 3 to 10 days before the meal at issue) was a more likely source.

Production Records: In addition to considering incubation periods, you may also be able to establish that your client’s production methods and interventions make it extremely unlikely that the pathogen could have originated from your product. In this regard, some food producers test for pathogens such as E. coli O157:H7, and will not distribute such products unless such tests are negative. Additionally, the product at issue may have been treated with a kill-step (such as cooking) prior to distribution. Here too, such evidence, if scientifically valid and well-documented, can often serve to diminish the likelihood that your client’s product was a source. This might include, for instance, the following information:

• Any Hazard Analysis and Critical Control Point (“HACCP”) plans and related documents;

• Any Standard Sanitation Operating Procedures (“SSOPs”) and related documents;

• Any production related documents, from raw material receiving to final, pre-shipment reviews;

• Any microbiological testing and related data;

• Any transportation documents/cooler logs;

• Any NRs (Non-compliance Reports), if applicable, and related correspondence for the relevant time periods;

• Any Food Safety Corrective Action Reports (“FSCARS”), if applicable, for the relevant time periods;

• Any correspondence, to the extent it exists, between the production facility and the USDA/FSIS (or any other responsible oversight agencies such as the FDA) for the relevant time periods; and

• Any records from any federal/state/local government agencies regarding product testing and causes/sources of an alleged illness.

Distribution Records: In addition to production records, distribution records may also serve to disprove plaintiff’s claims. At its most basic level, your client may not distribute or sell product to the locations where plaintiff reported purchasing or consuming food. In addition, if you discover that additional cases are genetically linked (by PFGE testing) to the plaintiff’s illness, you should be able to obtain investigative records and exposure histories (from the relevant health authorities discussed above) for each of those cases as well. If the other cases appear in geographical locations where you do not supply or sell product, it will be extremely difficult for the plaintiff to establish that your product caused her illness. Finally, the opposite can be said as well. If your client distributes product nationwide, and only a few illnesses appear in a single geographical location (or, the plaintiff’s illness was an isolated event), it also will be extremely unlikely for the plaintiff to convince a jury, in light of your national distribution system and no other reported illnesses, that your product somehow caused her to get sick.

Preparation Records: In the event your case involves the preparation and consumption of raw animal foods (such as beef and poultry), some of the most important information will revolve around how the product at issue was prepared. This is because most pathogens, to the extent they exist in food, are readily killed if the product is thoroughly cooked. In some cases, plaintiffs will readily admit that the food product at issue was undercooked (despite the existence of federally-mandated safe-handling labels warning consumers that raw meat and poultry products may contain harmful bacteria that could cause illness if improperly handled and cooked). In most cases, however, plaintiffs are aware of such warnings and (even if they knowingly undercooked the product) will testify under oath that it was well-prepared.  Not only does such testimony diminish the likelihood that a pathogen could survive the cooking process (it could not), it also diminishes the likelihood that the illness resulted from the particular meal in question.

The same, of course, can be said for cases involving restaurants. If the food at issue was thoroughly cooked, and this can be convincingly established through testimony, internal procedures or documents, this too can go a long way toward excluding the plaintiff’s meal as a likely source.

Other Illnesses: Finally, it will also be important to identify whether any additional illnesses resulted from the meal (or shift, if a restaurant) in question. If others consumed the product, and the plaintiff suffered the only reported illness following the meal in question, it again becomes very unlikely that the particular meal (or restaurant) was a source.

Following this comprehensive analysis, you should have a good understanding of the probability that your client’s product caused the plaintiff’s illness. If plaintiff’s illness likely originated from another source, you will be able to identify additional evidence needed to support your defense, and use formal discovery to establish the same. 

Copyright 2009 by Shawn K. Stevens

• Return to Defending Claims.

Although, in some cases, a governmental investigation results in a probable link to a particular product, the reality is that the source of many illnesses remains uncertain. In the event no clear (or likely) link is established to your product, you should begin outlining other potential sources that may have caused plaintiff’s illness. This will usually require a thorough review of other meals consumed along with other environmental exposures. Did the plaintiff travel recently, did she eat at other restaurants or shop at other grocery stores, did she eat other foods, did she visit a beach or swimming pool, did she have exposure to animals or pets, did she have exposure sources in or near her home, and could her infection be secondary – i.e., caused by exposure to another person who carried the bacteria (whether symptomatic or not)?

Once other potential sources are identified, CDC records should also be analyzed thoroughly to determine whether any other, unrelated outbreaks, clusters or illnesses were reported in time or proximity to the plaintiff’s illness. Careful analysis of such records may disclose, for instance, that the plaintiff’s alleged illness is actually related to an outbreak or cluster which his or her attorney simply overlooked. If not, information gained from the pleadings, demands, media resources, medical records, health authorities and production and distribution records will nevertheless be critical to demonstrate to the plaintiff (and, potentially, to a judge and/or jury) that the plaintiff’s illness likely originated from something other than your client’s product. 

Copyright 2009 by Shawn K. Stevens

• Return to Defending Claims.

Although serving discovery requests early in a food-borne illness case can be helpful, written discovery in these matters should always be approached with extreme caution. This is because offensive discovery, depending upon the facts of your case, always has the potential to weaken a solid defense strategy.  Over the years, we have developed a comprehensive list of specialized interrogatories and requests for production of documents that can be extremely useful in separating the "wheat from the chaff" and,where cases potentially have merit, reinforcing a winning defense. Thus, regardless of the facts in your case, great care should always be used when developing and serving any written discovery requests in a food-borne illness lawsuit. 

For more information, please contact Shawn K. Stevens directly at stevens@gasswebermullins.com.

Copyright 2009 by Shawn K. Stevens

• Return to Defending Claims.

Once you have identified the potential weaknesses in a plaintiff’s case, and have armed yourself with some basic discovery, the plaintiff’s deposition should be designed not as a “discovery tool,” but as an opportunity to reinforce known weaknesses and, where possible, supplement the argument for, or perhaps even confirm, your client's innocence. 

Here too, during our years of experience, we have developed a very thorough and comprehensive approach to these depositions.  Although we would love to share the intimate knowledge we have gained by virtue of litigating a vast array of food-borne illness matters, we would rather ask, in this instance, that you simply give us a call. 

For more information, please contact Shawn K. Stevens directly at stevens@gasswebermullins.com.

Copyright 2009 by Shawn K. Stevens

• Return to Defending Claims.

Obviously, the facts of the case and specific food-borne pathogen at issue will determine the types of experts needed. The following discussion, however, provides some basic framework for the types of experts that you may wish to consider:

Product I.D. If, based upon your development of the case, you have reason to believe your client’s business or product may not be involved, it will likely be important to retain an expert epidemiologist. Ideally, this expert will be someone who has a wealth of experience handling, or even leading, food-borne illness investigations. Be careful, however, to select an epidemiologist who can demonstrate expertise, from an epidemiological standpoint, with the pathogen at issue. Ideally, such an expert would be able to review the plaintiff’s allegations, medical records and testimony, along with any records collected from the relevant federal, state and local governmental entities (discussed above), and confirm the likelihood that your client’s business or product was not involved. This expert will also likely be able to opine about other potential, and possibly more likely, food and/or environmental sources that could have caused plaintiff’s illness.

In addition, you may also want to look internally at your own processes, or perhaps challenge a positive finding by the government (or a private lab) on a product not conclusively linked to your facility. In these instances, a microbiologist may be important as well. Such microbiologists, depending upon the circumstances of the case, could:

• Critique your client’s own internal microbiological testing records (internal environmental testing, incoming raw material audits and product sampling), to confirm that it is unlikely that any contaminated product left your facility;

• If the test results on a product allegedly produced by your client are in question, critique and or challenge the quality of the lab or testing protocol used on the product at issue; or

• If evidence is still available, use alternative and more precise genetic testing than standard PFGE testing currently allows, to determine the likelihood the suspect samples carried the same strain. In some cases, although two samples may “appear” under PFGE methodology to match by two-enzymes, this additional testing could disclose that the suspect samples are indeed not identical.

Negligence / Standard Of Care (your own client): In most cases, you will likely want to retain an industry expert to testify, based upon your client’s operations, including any available production and/or preparation records (including documents such as HACCP programs or SSOPs), that your client met or exceeded the standard of care applicable to the industry.

Negligence / Standard Of Care (plaintiff): In cases which the plaintiff prepared the product personally, you might also consider retaining a food-safety expert to address consumers’ knowledge of and familiarity with food-borne pathogens and the need for proper handling and preparation. Such a witness could speak generally about food safety, the ease of avoiding illness if foods are properly handled and prepared and to offer an opinion about the likelihood that the meal in question (in light of the methods of preparation) could have caused the plaintiff’s illness.

Negligence/Standard of Care (third-parties): Depending upon the facts of your case, you may also want to retain an industry expert in food handling, storage and/or preparation to testify regarding food safety science, industry standards and practices, and the failure of third parties, if any, to adhere to such standards. Third-party negligence, for example, may have contributed to improper microbiological growth, cross-contamination and/or improper handling and cooking practices.

Damages: In any case involving significant injuries, you may also need to retain a medical doctor to assess permanency and future medical expenses. This may also require vocational and economic experts as well.

Although each case is different, such experts can often help a jury understand the rapidly developing science underlying the production, distribution, preparation and consumption (and, occasionally, investigation and testing) of potentially implicated foods. 

Copyright 2009 by Shawn K. Stevens

• Return to Defending Claims.

Whether liability can be proven easily, or will likely be questionable, most cases will involve a dispute over damages. Here too, depending upon the facts and circumstances of your case, you might want to consider the following:

Third-parties (Indemnity): Whether your client is a food manufacturer, distributor, grocer or restaurant, you should determine, as soon as a claim is filed, the existence and scope of any relevant contractual documents governing damages and indemnity. While often overlooked, such documents may enable you to tender the claims or seek indemnity from other, potentially more responsible parties.

Plaintiffs: In every case, inquire as soon as a complaint is filed whether plaintiff’s allegations comport with known symptomology and potential complications. Although plaintiff may allege serious complications such as HUS, these allegations may prove untrue. Additionally, although plaintiffs may allege permanency, including the need for continuing observation or organ transplants, science may prove such allegations to be unfounded. Thus, in more serious cases, qualified experts will likely be essential.

Additionally, regardless of the existence or non-existence of long-term effects, plaintiffs will, as they always do, exaggerate their suffering in an attempt to elicit sympathy and increase the value of their claim. It goes without saying, however, that in many cases the plaintiff’s own medical, employment and other records will disprove these allegations. As discovery progresses, ensure that you, at the very least, obtain the following:

    1.  Potential Records:

• Medical records (certified records, pre/post occurrence);
• Employment records;
• Unemployment records;
• School records;
• Social Security records; and
• Tax information (state/federal).

    2.  Potential Witnesses:

• Hospital personnel;
• Family members/friends (spouse and children); and
• Persons familiar with plaintiff’s recovery (i.e., co-workers).

In addition to these resources, be sure to check statements made to the media, internet pages or blogs authored by the plaintiff (or family), and any healthcare facilitated websites the families of ill patients may have used to communicate and report progress. With this information, you should be able to counter any attempts by plaintiffs to grossly exaggerate symptoms and allege long-term suffering.

Copyright 2009 by Shawn K. Stevens