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From: Food Quality & Safety magazine, April/May 2012

Food Companies Should Plan for Outbreak Response Before it Occurs, Act Quickly to Shape Outcome

by Shawn Stevens

A longtime industry colleague and friend recently told me it was the things he couldn’t see that he feared most. Lurking somewhere in his processing equipment or on a product sitting in a sales cooler, there are a few colonies of pathogenic bacteria waiting to wreak havoc in our business and lives.

Over the past decade, foodborne illness outbreak surveillance has improved significantly. As a result of improved surveillance, more illnesses are being identified, and more outbreaks are being reported. By extension, many of these outbreaks are being associated with an increasing number of food products, ranging from waffles to cookie dough, and more companies are being affected. While these improvements have had an overall positive impact on public health, they have also had a tremendous—and sometimes less than positive—impact on the food industry.

Indeed, thousands of “spotlights” are continuously crisscrossing the nation, searching for problems in our food products. They take the form of verification testing by processors, incoming product testing by customers, regulatory sampling by federal inspectors, and patient isolate testing ordered by concerned physicians. With such vast resources dedicated to looking for problems in today’s food, the question is not if your product will be caught in the spotlight, but when.

Assuming contamination is inevitable, and assuming that it will be found once a product leaves your control, all food companies should begin planning for how they will react when an outbreak or recall occurs.

Fortunately, with planning, a company can begin limiting the fallout from an outbreak-related crisis the moment it learns about a potential problem. After learning that its product may be associated with an emerging outbreak, any company should immediately and directly engage federal, state, and local health investigators. Proactive engagement is essential to (1) quickly identify and contain the problem; (2) help solve the immediate public health issue; and (3) ensure that the investigation is conducted appropriately. These steps are critical for numerous reasons.

First, in the food industry, we know that the potential downstream consequences of any upstream food safety problems can also be catastrophic. Consider the processing of ready-to-eat food products. If a single raw material supplier unknowingly introduces contaminated ingredients into the supply stream, each of the downstream products manufactured with those ingredients will be affected. When product contamination is suspected, it is critical to identify all potentially affected lots and notify all customers to contain all affected product. Doing so will help alleviate the impact of any possible contamination, while demonstrating to investigators that your company is committed to protecting the public. (In addition to being the “right thing” to do, this will also pay significant dividends in your dealings with the regulators following the recall.)

In addition, recognize that public health officials are increasingly being asked to investigate and solve a growing number of overlapping outbreaks. With limited resources to conduct investigations properly and methodically, federal and state investigators will sometimes embrace incorrect assumptions about the source of an outbreak. And, whether it happens because of inadequate resources, time limitations, or lack of individual expertise, once an incorrect hypothesis is adopted, it becomes very difficult for public health officials to admit possible errors, set aside potential bias, and identify alternative sources.

The moment any association is suspected, a food company should (1) engage public health officials to address their immediate questions and concerns; (2) learn as much as possible about the status, scope, and direction of the investigation; (3) aggressively identify the full range of potential causes and alternative sources; (4) politely but forcibly challenge (where issues are identified) developing assumptions and hypotheses; and (5) persuasively demonstrate, where possible, that the company’s product is not likely involved. Investigators tend to be more open and thorough when all parties are actively engaged and at least someone—even if only emblematically—is looking over their shoulders.

In those circumstances in which a company’s product is ultimately linked to an outbreak and a recall is warranted, management should also begin anticipating and planning for the claims and lawsuits that will follow. This includes enlisting experienced food safety regulatory and litigation counsel as early as possible in the investigative and recall process.

In addition to assisting with the recall, counsel should also be used to help address the regulatory issues that will follow. Once a recall is announced, federal investigators will often perform a comprehensive assessment of a food company’s operations to seek and “find” at least one problem. These findings will, in most instances, be documented in an FDA Warning Letter or USDA Notice of Intended Enforcement. Unfortunately, this happens even if a company is operating to virtual perfection.

In turn, when responding to the government’s criticisms, whether warranted or not, it is critical for management to consider how each of the comments it makes could affect future litigation. Certain regulatory “terms of art” often used in these communications may be understood by government and industry to have one meaning, but these same terms can be mischaracterized by opposing counsel or misunderstood by a jury.

Management should carefully draft responses that (1) put the recall into context; (2) articulate clearly the company’s position with respect to the alleged problem, even if it may differ from the government’s position; (3) detail each of the positive elements of the company’s food safety programs; and (4) address the governmental requests appropriately and artfully, in a way that will be appreciated and understood by a jury. Appreciating how the company’s post-recall communications with the government may be used by opposing counsel in lawsuits months or years later can significantly reduce a company’s potential litigation exposure.

When claims are eventually asserted, food companies should work with experienced food safety litigation counsel. This is because many companies (and their lawyers) managing a recall and outbreak for the first time are not equipped to effectively challenge any one of the complex epidemiological, microbiological, and long-term damage issues often present in these cases.

In many lawsuits, significant questions also exist about the true source of a claimant’s illness. Unfortunately, most people incorrectly believe that they got sick from the “last thing they ate.” In those cases in which the target defendant is not at fault, the key to proving the company’s innocence often turns on a painstaking analysis of health department records, patient questionnaires, shipping records, witness interviews, and key depositions.

The emotional edge a plaintiff brings to the table can also be tempered in some cases by raising challenges to the source of the alleged illness. If we can show significant problems with an outbreak investigation and its conclusions, or demonstrate that our client produced and distributed thousands of safe and wholesome meals the week it processed the meal in question—and the plaintiff was the only person who allegedly became ill—a jury will likely be more disposed to set aside emotion and focus instead on what really made the plaintiff sick.

Most jurors will also understand and appreciate a plaintiff’s obligation to exercise reasonable care for his or her own safety. Depending upon the circumstances, a plaintiff may have admitted to health department investigators to eating a rare or undercooked hamburger despite the federally-mandated safe handling labels warning her not to. Where a plaintiff shows no appreciation of the inherent risk, a jury will be more disposed to set aside sympathy and attribute fault to the plaintiff.

Additionally, many claimants and their attorneys will also significantly inflate and exaggerate damage claims to maximize potential recovery at settlement or trial. When a plaintiff’s overreaching is challenged appropriately and tactfully, his or her dishonesty in many cases will significantly diminish the potential sympathy a jury might otherwise be inclined to feel. While emotion is always a factor, it can in many instances be effectively controlled.

In the end, our own mantra is “proudly defending the hard-working people who feed our families.” We believe strongly in this statement and what it means. Having worked with food companies for nearly a decade, we have observed firsthand the valiant efforts of the hard-working individuals and food companies who labor tirelessly to improve the safety of our food. In most cases, we will also have a great story to tell about the significant efforts our clients undertake to ensure that the food they sell—and feed to their families—is as safe as it can be.

Although we enjoy one of the safest and most affordable food supplies in the world, we continue to face incredible risk. Because of improved surveillance, increased scrutiny from regulators, and the swelling interest of the media and lawyers, fewer mistakes are avoiding detection. It is critical for all companies to remember that, if there is a chance that your product can be contaminated, there is a significant chance that the contamination, whether through downstream testing or an emerging outbreak, will be found.

If it also critical for all food companies to begin planning and preparing for this contingency today. No matter how hard you try, there are—and perhaps always will be—a few colonies of pathogenic bacteria in your equipment or coolers waiting patiently to wreak havoc in your business and lives.

Stevens, an attorney at Gass Weber Mullins LLC in Milwaukee, Wis., counsels food industry clients nationally on food safety regulatory and liability issues. He can be reached at stevens@gasswebermullins.com or (414) 224-7784.

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