On March 30, 2011, I reported on an outbreak of Salmonella Panama that eventually sickened – when all the dust settled – 20 people in 10 states. Twelve victims (out of 16 interviewed) reported eating cantaloupe in the week before they became ill. Eleven of the twelve purchased their cantaloupes from eight different Costco locations.
The melons implicated during the outbreak investigation were supplied to Costco by Del Monte Fresh Produce, and were grown on a single farm in Guatemala. But the outbreak strain never was recovered from the implicated cantaloupes.
By the time the outbreak was detected and the probable source of the infections determined by the federal and state epidemiologists (through patient interviews and product traceback investigations), the implicated cantaloupes had passed their useable shelf life and were no longer on the market. Nevertheless, Del Monte Fresh Produce decided to recall the remaining stock of Guatemalan cantaloupes that it had supplied to Costco in states where outbreak cases has been confirmed.
In addition to the recall action, the FDA issued an Import Alert (#22-03), authorizing its District Offices to “…detain, without physical examination, all raw fresh and raw fresh refrigerated cantaloupes, frozen and processed cantaloupe, including fresh-cut cantaloupe (i.e., sliced/chopped), offered for importation that appear to originate from …” Asuncion Mita, the Guatemalan farm that grew the implicated melons.
At the time of the recall, Del Monte Fresh Produce chose to cooperate with FDA. Now, however, the company has had second thoughts. On August 22, 2011, Del Monte filed a lawsuit against the FDA, claiming that the federal agency had “…imposed harmful restrictions on Del Monte’s importation of cantaloupes from a major source in Guatemala, based upon an erroneous speculative assumption, unsupported by evidence, that cantaloupes previously imported from that source were contaminated with the pathogen Salmonella.” The lawsuit asks the Court to issue “…declaratory judgment holding that FDA’s actions restricting importation are unlawful, set aside the actions, and issue a permanent injunction prohibiting FDA from enforcing or effectuating them in the future.”
And that’s not all. Del Monte also has notified the state of Oregon that the company intends to file suit against the state’s Department of Public Health and its senior epidemiologist, Dr. Bill Keene, who played a major role in the outbreak investigation.
This is the first time that I can remember that a food company has sued FDA over a regulatory decision such as an Import Alert or a recall recommendation. If this case goes forward – even if it is ultimately decided in favor of FDA – I strongly fear that the agency will be more timid in future when faced with potentially controversial recall recommendations.
I know what Del Monte Fresh Produce thinks – that’s clear from their Court filing.
I know what food poisoning attorney and blogger Bill Marler thinks – that’s eminently clear from his blogs on the subject since the lawsuit was filed on August 22nd.
But, I want to know what my readers think. Here’s your chance to have your say. Just answer the two poll questions below, and add any comments you care to in the comments field at the bottom of this post.
I look forward eagerly to reading your replies.
eFoodAlert 
As a regulator working in a country which allows the public to sue it’s Ministry of Health, we have been the brunt of several cases where the manufacturer thought we were being “overprotective” of the public. All of those cases we have won. The judges (not a jury trial) have never “presumed” to be medical professionals and have deferred to our judgement. On the other hand, there was a case here where the regulators relied on the manufacturer’s judgement as to the safety of their product, causing several children to die. The regulators in that case are facing criminal punishment with possible prison time. In my opinion, a person’s life always comes before a few dollars.
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Ms. Entis, unless you have a copy of what Del Monte Fresh Produce sent to the State of Oregon, it appears to me from your statement, “Del Monte also has notified the state of Oregon that the company intends to file suit,” and its link that you are relying too heavily upon Bill Marler for what has occurred. Just as is true in matters of science, I suggest that skepticism is warranted. Bill wants strict liability for food producers from farm to table but has shown no interest in any accountability, much less liability, for regulators. As the traceback done by the epidemiologist frequently makes his clients cases for him, Bill has a vested interest in supporting them.
According to Del Monte Fresh’s notice under “Investor Relations” on its website, it has only “filed a notice to sue Oregon Health Authority’s Public Health Division and one of its officials. The Notice to Sue alerts the Oregon Health Authority’s Public Health Division of its conduct and misleading allegations regarding Del Monte Fresh’s imported cantaloupes as the source of a Salmonella outbreak earlier this year despite the lack of sufficient factual basis.”
This does not appear to be a notice of intention to sue; rather, it is a notice that Del Monte Fresh Produce is taking the matter so seriously that it is considering a lawsuit. Thus, Oregon is alerted and might very well find ears within its government that can hear the legitimacy in Del Monte Fresh Produce’s complaints when the Public Health Division has not been able to.
Also, I agree completely with Tom Lopez’s first sentence and Bill Riedel’s first 2 sentences.
I see zero evidence that Margaret Hamburg (nor, for that matter, any other person at the FDA) is actually interested in FDA and its employees being truly accountable for their actions. Also, I have personally experienced its unwillingness to accept input and very careful CYA. Thus, I am waiting with great interest to see how Del Monte Fresh’s lawsuit against the FDA and its discussions with Oregon turn out.
Finally, I urge you to re-read carefully what you wrote about being concerned about the FDA becoming more “timid” as a result of Del Monte Fresh’s actions. What I heard you say is that you have little confidence in the integrity of the FDA’s leaders. Otherwise, if it was right, it was right and why should it change. On the other hand, If FDA was wrong, it was wrong and needs to change. Being a regulator requires courage not timidity
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Neville McNaughton notes that “there is every reason to allow good judgement to prevail”; but what assurance do we have that good judgement will be used and prevail. As a former regulator I was often impressed with what I now call ‘enforcer adrenalin’ which very quickly develops. Only after I retired did I start to study some of these areas; specifically the academic literature ‘on bullshit’. This led me to write and present the following:
Truthiness, Scientification and Bullshit in Communication – From Public Health to Politics. (THAT THAT IS IS. THAT THAT IS NOT IS NOT.
BUT WE KNOW NOT WHAT IS AND WHAT IS NOT SO WE BULLSHIT A LOT!)
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My comment is based upon the knowledge I have of the case, realizing I do not have full disclosure. Without any confirmatory microbiological data, in light of a voluntary recall which took place, it makes no sense to stop imports, and sets a very tenious precedent for over reaction within the FDA. When and who decides to re-introduce importation of cantaloupes? On how much data? As for the lawsuit, open communication between Del Monte and the FDA scientifically should have eliminated the need for litigation. Fact based actions, not assumptions, are indicated for successful resolution. The level of emotion is directly proportional to the financial as well as health insult to both producer and user.
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When you consider that contamination is not necessarily distributed evenly within a lot there is every reason to allow good judgement to prevail and require action even when there is no hard evidence.
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