Phyllis Entis, perhaps better known as the foodbuglady and for her excellent coverage of food safety issues on the eFoodAlert blog, recently invited her readers to weigh in on Del Monte’s current lawsuit against the U.S. Food and Drug Administration (FDA). The company filed suit against the agency after a collaborative epidemiologic investigation conducted by the Centers for Disease Control and Prevention (CDC) along with public health officials in a number of states, including California, Maryland, Oregon, and Washington revealed that Del Monte cantaloupes were the likely source of a multistate outbreak of at least 20 Salmonella Panama infections that occurred between February and April 2011.
Although the agencies involved in the investigation did not recover the outbreak strain from Del Monte’s cantaloupes, they did gather strong evidence to link the cantaloupes to the outbreak epidemiologically. Subsequently, Del Monte voluntarily recalled 4,992 cartons of cantaloupes, each containing 4 plastic mesh sleeves with 3 cantaloupes per sleeve, because they have the potential to be contaminated with Salmonella Panama. Since the recall, FDA has issued an Import Alert against Del Monte cantaloupes imported from the company’s farm in Asuncion Mita, Guatemala.
However in its complaint, Del Monte claims that these officials reached their conclusion without a sufficient factual basis to support it. In addition, Del Monte asserts that FDA demanded that the company either perform a recall of its cantaloupes or suffer the consequences of an FDA consumer advisory questioning the products’ wholesomeness. Accordingly, Del Monte has requested that FDA lift the Import Alert it issued on July 15, 2011.
Entis asked her audience to respond to the following question: “If you were on the jury, what would be your verdict?” According to the survey results:
- 79% (57/72) voted in favor of FDA
- 14% (10/72) supported Del Monte Fresh Produce
- 7% (5/72) chose “Don’t know”
She then asked, “Should FDA have to find the outbreak bug in a food sample before requesting a recall?”
- 72% (52/72) voted “No”
- 22% (16/72) voted “Yes”
- 6% (4/72) chose “Don’t know”
Yet, in reviewing the timeline of events, Entis herself disagrees with the findings of the “jury.” She explains that the products affected by Del Monte’s recall were those sold in Costco stores in several states between March 10 and March 21, 2011. However, the majority of Salmonella Panama illnesses occurred prior to March 10. She wrote:
In case you missed it, the cantaloupes that Del Monte Fresh Produce recalled WERE NOT EVEN IN THE COUNTRY during the bulk of the outbreak. In fact, by the time the outbreak was detected, the cantaloupes that were thought to be contaminated with the outbreak strain had passed their expiration date and were no longer available for sale.
[W]hile I would ordinarily support recalling a food product implicated by epidemiological evidence and traceback investigation, in this specific instance, I do not believe that the Del Monte Fresh Produce recall was appropriate. I was uneasy with the rationale then, and I’m uneasy with it now.
I’m not in possession of the full story; only the direct participants know everything that has been going on. Nevertheless, based on the information available to me at this time, I believe that Del Monte Fresh Produce is justified in filing suit against FDA to have the Import Alert set aside.
In contrast, Entis believes that Del Monte’s other recent lawsuit against the Oregon Public Health Division and its Senior Epidemiologist, Dr. William Keene, is not justified. As Entis states:
Public health officials must be allowed to use their best professional judgment without fear of litigation or reprisal. Any errors of judgment – and there will be errors – should be on the side of public safety.
Only time will tell how these cases will resolve.