Courts set standards for food-industry contamination control

Courts set standards for food-industry contamination control

Even a single contamination event in the food industry will potentially impact far more people and pose a far greater and widespread health hazard than ever before.

By John Haystead

A product-contamination event is by definition a system failure — caused by an unknown or unplanned-for circumstance or series of events regardless of the sophistication and efficiency of a food company`s quality control plans and procedures. Any subsequent litigation will therefore start from this baseline.

Yet, while, a company cannot deny that an event occurred, there is a huge difference in the eyes of the court regarding the culpability of a company that did all that was “reasonably possible” to prevent the incident and one that did not. “There is also a world of difference between a company that in general followed good quality control procedures and did its best to minimize harm after an unfortunate incident and a company with a history of problems or where there is any evidence of coverup or deceit,”says James O`Neal, partner in the Law Firm of Faegre & Benson (Minneapolis, MN), specialists in food-industry litigation.

Although, to a degree, many of the legal and business challenges resulting from a contamination problem are inherently unpredictable, and there will always be unforeseen issues, O`Neal emphasizes that “how a company is treated in court depends heavily on how the facts of the situation are presented and how they reacted to and dealt with the problem.” Also, while the circumstances of individual cases will certainly vary, there are a number of common pitfalls that food companies regularly fall victim to.

According to O`Neal, plaintiff attorneys particularly like to zero-in on a company`s compliance with the “state-of-the-art” in the field. “It`s not at all uncommon, for example, for attorneys to ask company representatives about the number and kinds of publications they subscribe to, the industry associations they belong to, their attendance record at meetings, as well as their personal awareness and knowledge of published regulations, notices and directives.”

It may not be at all surprising that, like most industries, key managers and employees in the food industry are extremely busy just running their day-to-day businesses and understandably may not be up on the latest technological or procedural developments, or the very latest in quality-control thinking. This is particularly true in smaller food companies, where most of employees` efforts are expended on immediate business and profitability matters and only find out when a problem arises that they should have paid more attention in advance.

This argument will carry little weight in court, however. In fact, according to O`Neal, “it is typical for judges to instruct juries that it is the duty of manufacturers to keep up with the latest developments in their field, and jurors are usually not receptive to hearing that company managers were just `too busy to keep up` with the state-of-the-art in quality control. It is far better to be able to respond authoritatively or at least with some kind of knowledgeable answer.”

Under the legal microscope

Once in court, food-contamination cases get down to an excruciating level of detail regarding facilities, processes and procedures. As described by O`Neal, although the type and manner of evidence presentation may not be very satisfactory or relevant from an engineer`s or quality-control manager`s perspective, “such cases are not heard by engineers, and they tend to take a very different approach from a technical seminar or research paper. “This is a very big deal in the lives of jurors, and although engineers typically don`t like the way they, or their technical testimony, are characterized in court, jurors do not take these matters for granted,” O`Neal adds.

Plaintiffs` attorneys will inevitably obtain “expert” witnesses to testify critically about a defendant`s procedures or lack of procedures, HACCP plans in place, uniformity of enforcement, history of citations by the FDA or other monitoring agencies, and so on. Regardless of the technical credibility of their testimony, or the general-regard held outside the courtroom for their credentials, the testimony of these witnesses will be heard and placed into evidence for the jury to consider.

In plain sight

Documentation, as in many areas of the law, can work in favor of or against a food company`s case, but in general, a company that has a recorded history of good performance will be treated better than one that has not been as strict about its record keeping. In particular, “failure to keep organized, accurate records that allow companies to track contamination by particular lots will inevitably be a huge problem,” O`Neal says.

`Fully-defensible` is the best way to describe the requirement for documentary evidence to be presented in court, explains Dr. Francis Busta, head of the Department of Food Science and Nutrition at the University of Minnesota. Busta is frequently called upon to review and evaluate food company procedures and/or documentary evidence in litigation cases.

According to Busta, fully-defensible means “good, hard, reliable technical data that can be backed up and supported with detailed descriptions of proper methodology and sampling documentation.” In addition, all procedures must be generally accepted by the industry, FDA and other regulatory agencies and must be shown to have been done by qualified individuals with appropriate positive and negative controls in place.

Busta points out that in several cases in which he was involved, the company`s position collapsed when the methodology was not well described. “The data immediately became questionable, and whatever documentation there was went right down the tube.”

In the case of microbiological contamination, frequently the problem areas tend be in systems that can support the growth of the contaminating organism. Ultimately, however, the biggest area of concern is when final, ready-to-eat product is handled, or those stages where no further processing or cooking will take place. “This is the stage in the process that is most vulnerable and therefore where any slippage in the controls will show up,” says Busta.

Still, Busta believes most large food companies are “doing the right things” in terms of maintaining proper documentation and have adequate quality control, management, or assurance department personnel dedicated to these functions. If they are using HACCP or ISO-9000, for example, he points out that the documentation procedures are very specific and for more-specific testing such as chemical analysis, the practices would be defined by organizations such as the Association of Official Analytical Chemists (AOAC). “Smaller companies, however, sometimes cut corners that can`t be justified,” Busta says, “presumably to protect their profits.”

The cost of court

In terms of the number and cost of injury claims that can result from food-product contamination lawsuits, the financial exposures are great. As observed by O`Neal, there are both individual claims and the potentially far more costly class-action suits to consider. In class-action suits, one lawyer or firm represents the interests of basically everyone who has been affected by the contaminated product which can exponentially increase a company`s financial exposure.

A number of recent pharmaceutical and medical-device industry cases, as well as some high-visibility tobacco- and HIV-related cases have been deemed unsuitable for treatment as class-action cases by the courts, but as observed by O`Neal, “there is a fair body of precedent in recognizing class-action lawsuits in food-contamination cases.”

Another major legal expense that is often not fully appreciated by companies, however, is the cost in time and manpower that must be devoted by its senior executives and quality control personnel to deal with the problem. Sometimes this involves years of dealing with recall-decision issues, federal and state agencies, court appearances, and depositions, among others.

An extremely expensive situation

Even if a food-contamination incident never results in personal injury or litigation, the cost to companies can be enormous. According to O`Neal, “it`s not hard to paint a very frightening scenario developing from contamination in a high-volume process line with some events costing companies in excess of a hundred million dollars.”

To begin with, there is the cost of disposing of the affected product which is often very difficult to isolate to a particular portion of an inventory. For example, because many microbial contaminants don`t distribute uniformly, a sample tested from a vat, tank or individual container may be free of contaminants and yet there could be a pocket of contamination at a different level of the same container. The result is that to have a high degree of confidence that the contamination has been completely contained, much more product will have to be thrown away than was probably actually affected.

If a product leaves the processing plant before the contamination is discovered, costs escalate exponentially. In addition to the cost of advising customers of a recall through newspaper, radio and television notices and store-by-store announcements, the long-term ripple effects on a company`s reputation and subsequent sales can be inestimable.

Although the food industry is extremely sensitive to this last factor, and will go to great lengths to ensure that the public trusts them to take swift and complete recall action in the event of a contamination problem, many companies are far less aware of the total implications and challenges associated with actually getting it done.

For example, O`Neal recalls one situation where although the company thought it had an adequate recall plan in place, they had in fact not fully taken into account the actions and reactions of their retail customers. When a problem arose, they discovered that one of their national distributors had its own policy on recalled product. Since the retailer was not willing to commit the time of its employees to reading lot numbers and sorting out problem items, its policy mandated that all products from the vendor be taken off their shelves for a period of several months, which of course devastated the vendor`s sales. As observed by O`Neal, had the supplier arranged in advance to have its own personnel go to the retailer`s outlets to handle the sorting and collection process, this situation could have been avoided.

There are also environmental concerns associated with disposing of contaminated product, which involve significant management issues and costs, and which are often not considered adequately by food companies. For example, one company found that after pulling a contaminated product from store shelves, it had no idea how to ship it back in compliance with the federal Hazardous Materials Transportation Act and other environmental statutes.

Litigation is inevitable

Although most large food processors are very sophisticated in terms of food safety and quality control practices and policies and are increasingly sensitive to contamination issues as a result of media exposure and more aggressive activities by regulatory agencies, many still don`t adequately prepare themselves for the immediate financial and long-term legal impact of a contaminated product event. “When something does go wrong, it is such an overwhelming problem,” says O`Neal, that it puts a huge and immediate strain on top-level resources. As time goes on, it gets harder and harder for the required level of attention to be paid to these matters.”

Some companies consult with legal advisers to anticipate problems and ensure that operations are effectively prepared to deal with product contamination litigation, but most don`t seek help until they already have a problem. While O`Neal doesn`t necessarily see a great increase in food-product liability litigation, he adds “this doesn`t mean that you won`t get sued in the event of a contamination-related injury, because you will.” n

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It has happened here

In a 1996 food-poisoning epidemic, characterized by the World Health Organization as “unprecedented in modern history,” at least seven people died and more than 9,000 were made ill across the nation of Japan. The first known cases occurred in a fishing village west of Osaka in May, but attained epidemic status in July when the disease appeared in elementary school children in Sakai, near Osaka. Nearly one of eight school children was infected and Japanese Prime Minister Ryutaro Hashimoto, described the epidemic as a “nationwide issue.”

Escherichia coli O157:H7, a particularly virulent strain of E-coli bacterium produces a toxin which causes hemolytic-uremic syndrome (HUS) in humans, a sometimes-fatal condition characterized by extensive bleeding in the colon, bowel and kidneys, which may ultimately fail. The same bacterium first appeared in the U.S. in 1982, but although the source was never identified, it was believed to come from contaminated meat. Infection is also possible, however, from contaminated water, fruit and vegetables.

Four children died from HUS and over 500 other people were sickened by the bacteria in the U.S. in 1993 after eating at Jack in the Box Restaurants. The precise origin of this contamination was also never pinpointed but resulted in the first new meat and poultry contamination safeguards in nearly 100 years. “The bottom line is that we really need to prevent this, since we can`t get a good grasp on how to treat it,” says I. Kaye Wachsmuth, deputy director of the U.S. Food and Drug Administration.

According to Japanese observers, that country`s food-contamination risk-level has increased dramatically in the past decade, as Japan`s food-processing and distribution systems have become international in scale, with its regulatory system not keeping up. Today as much as 46 percent of all food consumed in the country is imported, and 25 percent of the beef comes from the U.S.

Japanese officials now believe that the E-coli contamination originated in radish sprouts served both in school lunches in Sakai and at an Osaka nursing home. “The only food that virtually all the Sakai students had in common was milk, bread and radish sprouts, and only the sprouts came from one supplier,” according to Health Minister Naoto Kan. The same supplier distributed sprouts to the nursing home in Osaka.

The radish sprouts, similar to alfalfa sprouts used in salads in the U.S., were grown in beds of water which experts speculate were somehow contaminated, although they were unable to find evidence of the bacteria at the farm where they were grown. Yoshinori Minamino, vice president of the farm says, “The goverment`s announcement is irresponsible and my farm is clean and safe. The government should not make accusations without hard evidence.” The investigation is continuing. — JH


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