Foodborne Illness Litigation – ONLINE EXCLUSIVE

Steven R. Kramer, Esq.

Foodborne illness litigation moves like regularly paced litigation; what is not regularly paced, however, are the events leading up to the commencement of litigation. Reports of illness surface, local health officials become involved, reports are escalated to state health officials and soon the federal FDA and CDC intervene. This system is known as “notifiable disease surveillance program.” These events can take place in a matter of weeks. Indeed, the FDA itself states “[q]uick action is critical…” At some point, the FDA arrives for an unannounced inspection of a food entity’s facility and testing takes place. The FDA then calls the entity, advises of the results of the testing, and demands it undertake a recall.

Litigation has not even started at this point. But negative publicity begins and events take off. Plaintiff lawyers quickly mobilize and file a wave of lawsuits piggy-backed on the government’s work. Indeed, the FDA in its recently proposed Food Safety Modernization Act (FSMA) regulations acknowledges, “the Foodborne Outbreak Online Database (FOOD) allows the public direct access to information on foodborne outbreaks reported to the CDC.” Food entity defendants should also search electronic databases: FOOD, Reportable Food Registry (RFR), National Outbreak Reporting System (NORS), Food Emergency Response Network (FERN), and Foodborne Disease Active Surveillance Network (FoodNet).

The wave of lawsuits is premised on two critical assumptions: (1) All of the entity’s food product was contaminated; and (2) plaintiffs’ injuries were caused by the food product. These two assumptions must be rigorously analyzed and, if appropriate, challenged.

In some cases, for example, food product is contaminated well after it left an entity’s control. A good example of this fact is salad bars, which are touched and handled by numerous customers and employees. Contamination can occur due to human interaction. The CDC admits this phenomenon. In its study entitled “Salmonella Litchfield Outbreak associated with a Hotel Restaurant—Atlantic City, New Jersey, 2007,” MMWR, July 18, 2008/57(28); 775-779, the CDC stated: “[T]he cause of the outbreak was an ill restaurant worker who handled the fruit salad, and possibly other food.”

Some media reports suggested the entire food product was contaminated. That simply is not true in almost every instance. Food product testing is a function of sample-based testing. Lots are tested and, of the lots, samples are tested. Different tests results are common when testing lots. The key is to determine which lots tested positive for the presence of contamination and then trace the lots backwards and forwards (from “farm to fork”).

Legal Framework

A plaintiff must prove the food product was defective (i.e. adulterated). In the past, they proceeded on traditional negligence, breach of warranty, and strict liability theories. Which of these theories are the most dangerous to an entity depends upon the substantive law of a particular state (i.e. whether due care principles are considered or strict liability imposed). Plaintiffs have begun to push and assert a private right of action based on the Food Drug and Cosmetic Act’s (FDCA) non-adulteration provision.

Strict Liability – Private Right of Action. According to the FDCA, the following acts are prohibited.

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

The Act has a criminal enforcement mechanism, but plaintiff lawyers have latched on to the statute because it imposes strict liability. There is a vigorous legal debate whether plaintiffs can allege a private right of action under the Act or whether plaintiffs can boot-strap the Act by alleging a negligence per se claim (violation of a statute can constitute negligence).

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