Foodborne Illness Litigation – ONLINE EXCLUSIVE

One might think the hazard guidelines are restricted to manufacturers, but the Advisory Committee placed the following burden upon importers:

“Each facility should assure that its suppliers have in place effective GMP and food safety programs. These may be the subject of continuing supplier guarantee and supplier HACCP system verification.”

“All raw materials and products should be stored under sanitary conditions and the proper environmental conditions such as temperature and humidity to assure their safety and wholesomeness.”

“Supplier control” is a huge issue because an importer under the FSMA is now charged with verifying the GAPs and GMPs of their suppliers. Stated bluntly, importers cannot (and should not) turn a blind eye to the sanitary conditions of their supplier’s fields, manufacturing plants and packaging operations. As the FDA notes, “We determined that 36.9 percent of the 960 Class I and Class II recalls were directly linked to lack of supplier controls.”

It follows then that an importer should anticipate a discovery request and deposition question asking, “What did you do to verify your supplier’s level of GAPs/GMPs?” A real example follows: One of the fresh produce outbreaks was caused by pickers’ children being present in the field and their fecal matter contaminating the produce during harvesting/packaging. Plaintiffs asserted the importers failed to exercise due care in selecting and monitoring their supplier. The claims had “class warfare” overtones—you picked this supplier because of its low cost and knew the low cost was driven by lack of money being spent on housing and sanitary stations.

Since an importer cannot physically visit each of its foreign suppliers, an entire industry has emerged—third-party auditors. Now, the FSMA provides that the government will decide who is “accredited” to be a third-party auditor. The FDA plans to establish a system in which it recognizes accreditation bodies, which in turn would accredit eligible third-party auditors.

FSMA was supposed to take foreign supplier verification to the “next level.” The FDA was required as of Jan. 4, 2012 to promulgate regulations and the FDA advises its program might include “[m]onitoring records for shipments and lot-by-lot certification compliance…”

The government missed the 2012 deadline. As we write, the FDA still has not promulgated FSVP regulations. But the appendix to the FDAs recently proposed FSMA regulations sheds light on the FDAs thinking. The FDA stated:

“A facility receiving raw materials or ingredients from a supplier must ensure that the supplier (or a supplier to the supplier) has implemented preventive controls to significantly minimize or prevent hazards that the receiving facility has identified as reasonably likely to occur in that raw material or other ingredient unless the receiving facility will itself control the identified hazard.”

Challenging the Assumptions

The determination of likely sources of contamination (when and where) is challenging. It certainly is not as straightforward as some suggest. As we noted, plaintiffs will piggy-back on the government’s work. This makes a defendant’s causation defense very difficult. Like most technical cases, experts (and early retention of them) will be key.

The following disciplines should be retained: (1) an epidemiologist, (2) a standard of care expert in food handling requirements, regulatory requirements and industry practices, and (3) a medical causation clinician with expertise in infectious diseases. Depending on the scope of the outbreak and severity of reported illness, consideration should be given to challenging the plaintiffs’ number one underlying presumption—the government’s conclusions were correct. An expert may be needed to determine the reliability or shortcomings of an FDA investigation.

When and Where Did The Contamination Enter The Food Chain? One must trace the food product from “farm to fork” and examine each physical and human interaction. An example provides insight on real-world sleuthing for the source of contamination: A food product is harvested in a foreign country and shipped in sealed bags to the U.S. The importer does not re-package the product, but ships it to a number of downstream purchasers. Testing reveals contamination of lots at each purchaser. None of the downstream purchasers re-packaged the product. Working backwards, the source of contamination can be likely eliminated—the downstream purchasers. That would lead to the question did the contamination occur during manufacture, packaging, or shipping? One must examine the specifications of the manufacture process (application of heat, amount of heat and its duration) to determine if contamination could have been “killed” during the manufacture process. If so, that would point the source of contamination to the packaging facility (or during shipping).