Del Monte’s legal cannon shot fired at the U.S. Food and Drug Administration and the Oregon Public Health department over the past week was heard clearly by food safety officials around the country, from Washington state to Washington D.C.  And they don’t like what they hear.

Public health authorities and consumer activists described the complaint filed by Del Monte Fresh Produce as an attempt to intimidate food safety programs across the country.

But experts close to the food industry described it as one large corporation declaring: “Enough is enough.” 

Either way, the lawsuit is a response to a finding by the FDA earlier this year that a Salmonella Panama outbreak that had sickened 20 people in 10 states was likely caused by contaminated cantaloupes grown in Guatemala and imported by Del Monte Fresh Produce.

At the time, the Florida-based company voluntarily recalled nearly 5,000 cartons of cantaloupes, and since then the FDA has banned further cantaloupe imports from the company’s site in Asuncion Mita, Guatemala.

However, public health authorities never established a positive match — a genetic “fingerprint” — linking Del Monte’s cantaloupes to the Salmonella infections. Instead, the investigation was based on established epidemiological procedures — interviews with the victims and a process of elimination that concluded there was a high probability that cantaloupes were the culprit. Traceback information from Costco indicated the suspect brand was Del Monte Fresh Produce. 

The company’s 25-page complaint, filed in Maryland, questions the findings of that investigation and seeks to lift the FDA’s restrictions on cantaloupe imports from Guatemala. And it challenges the federal import alert, which empowers FDA to detain goods without physical examination, and requires the company to show its melons are safe.

The company also served notice it will sue Oregon Public Health, and senior epidemiologist Dr. William Keene, who was one of several investigators from different states who worked on the case last March.

Del Monte Fresh Produce’s complaint says the FDA forced it to recall its cantaloupes or “suffer the consequences of an FDA consumer advisory questioning the wholesomeness” of its product. The subsequent ban on imports is unlawful, the company claims, because it is not supported by the facts.

The company now claims its cantaloupes were wrongly blamed for the outbreak.

One lawyer who represents U.S. companies in food poisoning cases said companies like Del Monte are frequently frustrated with being forced into costly recalls despite a lack of what they consider to be conclusive evidence.

Companies are notified by the FDA with little or no warning, explained the lawyer, who asked not to be quoted by name. “”You get a day or two heads-up that it appears to be your product, and there is not much opportunity to have a conversation … There is not enough collaboration, and it comes across as not even-handed.”

Keene, in particular, has antagonized companies with his outspoken style, the lawyer said.

However, food safety advocates pointed out that the public health system is primarily responsible for protecting consumers, not companies.

“Del Monte appears to be asking for the almost impossible before the FDA can issue an alert,” warned Caroline Smith DeWaal, a lawyer and food safety specialist at the nonprofit Center for Science in the Public Interest. “The company wants the FDA to require a smoking gun, a positive genetic test, before taking action.  That is unrealistic and it puts a burden on investigators that is unmanageable.”

Dr. Tim Jones, the Tennessee state epidemiologist, does not expect the case to go far.  “But just the threat could have a chilling effect on public health agencies.”

Health departments should not be immune from lawsuits, Jones said. But Keene is an example of a public servant who is also a disciplined scientist.  “He is outspoken, but his comments are always justified,” Jones said. “It’s not a matter of cockiness. His job is to protect the public and that is what he tries to do. He is one of a small group of people willing to be blunt and honest with the industry, and I trust what he says.”

He and others stressed that Keene and others employ investigative tactics that are statistically sound and fully tested after many years of epidemiology.

When they can, authorities use genetic fingerprinting, the popular term for pulsed field gel electrophoresis, or PFGE, to establish a virtually certain link between an outbreak of illness and a specific food. But PFGE is limited because investigations usually occur weeks after the outbreak, and perishable food is likely to have been either consumed or discarded, making it impossible to test for contamination.

Keene explained the problem earlier this year in an interview with Food Safety News. “It would be great if we could just buy the product, take it to the lab and find Salmonella,” he said at the time.  “That’s something anybody can understand.  But when you offer up P values and probabilities, people want to say: ‘That’s just  statistical mumbo jumbo.’ “

In fact, epidemiologists have been tracking outbreaks for decades by interviewing victims, looking for foods that all or most of them have consumed, and employing basic statistics to zero in on a probable source.

Statistically, those findings can be just as powerful and persuasive as the lab results, according to food safety experts.

Their credibility was damaged, however, by the 2008 Salmonella outbreak that was originally blamed on tomatoes in a Mexican salsa, but later turned out to be peppers used in the same salsa. That error cost the tomato industry millions of dollars, and soured relations between the food industry and health agencies.

“I still don’t think the wrong thing was done there,” said Jones of the tomato misidentification. “There were nuances over how information was communicated.  But no one was being malicious or irresponsible. We would not be able to live with ourselves if a child died from food poisoning in the three days that we dilly-dallied around looking for that last piece of  conclusive evidence.”

Americans contradict themselves, he said, in that they “want their food to be 100 percent safe and they get angry when it isn’t…. and they also want 100 percent conclusive evidence before issuing a recall.”

(Marler Clark, the food safety law firm that sponsors this site, has filed suit against Del Monte Fresh Produce on behalf of several people sickened in last spring’s Salmonella outbreak.)

  • Art Davis

    Marler / Clark and other legal firms hold food producers accountable under law for the quality (In terms of safety) of their products. Del Monte through their legal counsel is attempting to hold the FDA and State of Oregon et al accountable under law for the quality of their decisions that, right or wrong, have had huge negative effects on Del Monte. It is unlikely that either side (Government or business) is infallible so off to (Also not infallible) court they go for a third party best guess as to ultimate truth. The base issue is accountability for actions that affect the lives and business interests of others and that sword must cut both ways.

  • Carlo Silvestri

    Regardless of where you stand on the question of the size of government, government must, first and foremost, protect the people governed and look out for the welfare of the governed. If all signs point towards Del Monte’s product being the cause of the Salmonella outbreak, IRRESPECTIVE OF ABSOLUTE PROOF POSITIVE, Del Monte should be liable for the recall and all costs associated therewith.
    I would ask the principals at Del Monte, “if it were loved ones of yours who got ill from this Salmonella, rather than an unknown who shops at Costco, would you just sit back and say, ‘well, tough?'” I don’t think so.
    To me, this is another blatant example of a large company attempting to shelter its profits at the expense of the public.

  • Art Davisa

    Del Monte, in terms of the people associated with it, would, I presume, be included in the class of “The governed” and therefore entitled to some level of governmental concern for their welfare. The question is very rarely one of “Absolute proof positive”, certainly not in this case. The question is whether the evidence in hand supported the decisions made by the FDA and Oregon authorities. It is not clear what level of “Proof” or “All signs point towards” is required, from a legal standpoint, to make those decisions. Clearly the consumer must get the benefit of the doubt but just as clearly there must be some level of certainty that the problem has been properly identified prior to damaging a company and those whose lives will be affected by such damage. Apparently the folks at Del Monte feel that such a level was not achieved in this case and are, as they have every right to do, questioning the decisions of the FDA and State of Oregon. Win or lose, and I (From what has appeared in the media) suspect Del Monte will lose, I think it is a useful exercise in reminding the FDA and Oregon (As well as other states) that their actions have consequences and they are accountable. This case might also provide some clarification as to what sort of evidence and what level of statistical “Certainty” is required for regulatory action in food born disease outbreaks.

  • Dan Cohen

    The problem with Del Monte’s lawsuit is not just legal if it threatens the brand’s integrity in consumer perceptions.
    The strengths of epidemiology are impressive and crucial to public health. The weaknesses can come from the framing or assumptions going in to an investigation. The questions on a food survey questionnaire reflect this framing: ask about tomatoes but not about salsas for example; or leave sprouts off a questionnaire to prevent false positives.
    It also can be difficult for people to accept that while a positive result detecting an outbreak strain can be determinative, it is really a confirmation of the epidemiology, and can be rare for food and facilities with high turnover.
    But a negative result for an outbreak strain is not determinative. For O104:H4, for example, it has been taken to mean inadequate detection and culture methodology (over 10,000 samples, no positives). In many cases management has time to clean up water supplies, facilities etc before an investigation, or enough time has passed that a transient contamination is gone (for the time being).
    So a negative result for detecting the outbreak strain is ambiguous and not determinative. This can be pretty frustrating because one might hope that a negative result “clears” you or suggests innocence. It gets worse, more ambiguous, when a non-outbreak strain is found. With Spanish cucumbers, the detection of non-outbreak strain E. coli in a few samples was not great, but meant that the withdrawal of cucumbers from the market before confirmation did nothing to stop the outbreak. The same for Dutch beet sprouts, which at least were withdrawn for their own sins and not linked to O104:H4; unlike the Spanish cucumbers, authorities waited for the (non) confirmation of the outbreak strain.
    The epidemiologists have the primary goal of stopping an outbreak. Any legal action that compromises or threatens them in achieving this goal, directly or indirectly, comes at the expense of public health.
    In some major cases I am aware of, the use of criminal investigation techniques at the start of an outbreak, or at the first indication of an outbreak source, could well have provided primary evidence against a facility or company. If the Del Monte suits are successful, public health authorities may have to use such police or criminal investigatory powers in every outbreak to protect themselves. Some powers they have, some they can have by working with other agencies such as the US Attorney and FBI, and some they may seek.
    Food companies may be sorry that Del Monte ever filed, even if it fulfills a revenge fantasy, and even if Del Monte should win.
    Public health epidemiologists lose nothing by reviewing assumptions, and clearly evaluating and stating the goals of recalls, embargoes and other actions and the basis on which they are made.
    It might be more useful for everyone involved to be engaged in learning the lessons of an outbreak, and taking steps based on what is learned to prevent future outbreaks.
    As Bill Marler says: put the lawyers out of business. There’s always other branches of the law for them to wok on.
    Dan Cohen
    Maccabee Seed Company
    Davis, CA

  • Del Monte’s suit is a frivolous shakedown.
    I have seen the records from the states, FDA and CDC, and the epidemiology is rock solid. Plus, to put this on Oregon alone is silly. Remember, according to the CDC, 20 ill people infected with the outbreak strain of Salmonella Panama were reported from Arizona (1), California (2), Colorado (1), Maryland (1), Montana (1), Nevada (1), Oregon (6), Pennsylvania (1), Utah (1) and Washington (5). That means that not only Oregon, but all the other state and the CDC and the FDA pointed at Del Monte imported cantaloupes as the likely source of the illnesses.
    True, product did not test positive, but remember, in most outbreaks there is no product to test – because they ate it to become ill or it is perishable and the contaminated fruit is long gone. Also, not all cantaloupes in a given field or lot are contaminated. So, small outbreaks are common.
    And, it is not like we have not had a few cantaloupe outbreaks in the past:
    Del Monte has no legal basis for attacking public servants doing their job of protecting the public. Del Monte, you should be ashamed and your lawyers fired.

  • Dog Doctor

    Why isn’t mentioning this was a voluntary recall?
    “At the time, the Florida-based company voluntarily recalled nearly 5,000 cartons of cantaloupes, and since then the FDA has banned further cantaloupe imports from the company’s site in Asuncion Mita, Guatemala.”
    Del Monte was informed of the reasoning behind the request for the recall and the information. They agreed to recall after being provided the evidence. Why are they changing their minds now?
    They could have refused the recall, if they didn’t agree. This was Not a Mandatory Recall.
    So Del Monte is suing FDA, because they don’t like the decision their executives made?
    I also noticed they are not offering tours of the farm or the surrounding environment to show folks that Salmonella couldn’t have contaminated the crops.
    Cantaloupes have a long history of Salmonella contamination since they are typically grown on the ground in contact with the soil. There are other factors as well. I will refer to the following article and wonder why no one is asking if Del Monte didn’t believe why did they agree to a voluntary recall?
    An Outbreak of Salmonella Serogroup Saphra Due to Cantaloupes from Mexico
    Janet C. Mohle-Boetani1, Roshan Reporter3, S. Benson Werner1, Sharon Abbott1,
    Jeff Farrar2, Stephen H. Waterman1 and Duc J. Vugia1
    + Author Affiliations 1California Department of Health Services, Berkeley 2California Department of Health Services, Sacramento 3County of Los Angeles, Department of Health Services, Los Angeles, California
    More information about Cantaloupe and food borne outbreaks can be found in
    “Chapter III: Incidence, Growth, and Survival of Pathogens in Fresh and Fresh-Cut Produce” COMPREHENSIVE REVIEWS IN FOOD SCIENCE AND FOOD SAFETY—Vol. 2 (Supplement), 2003
    3.2.3. Melons. Cut cantaloupe is considered a potentially hazardous food in the FDA Food Code because it is capable of supporting the growth of pathogens due to low acidity (pH 5.2 to 6.7) and high water activity (0.97 to 0.99). The FDA investigated the frequency of Salmonella isolated from cantaloupe imported from Mexico (Table I1). In 1990, 11 of 1,440 (0.76%) cantaloupes were positive for eight different Salmonella serotypes. In 1991, 24 of
    2,220 (1.08%) were positive with 12 different Salmonella serotypes isolated. More recently, the FDA isolated Salmonella from eight (5.3%) and Shigella from three (2.0%) of 151 cantaloupe samples collected from nine countries exporting to the United States (FDA 2001). These results suggest that melons may be naturally contaminated with Salmonella.
    Outbreaks of salmonellosis have been associated with the consumption of cut cantaloupe and watermelon (Table 9). At least two of these outbreaks have been relatively large and have involved multiple states and/or provinces. For most outbreaks, it has been assumed that Salmonella was present on the rind, presumably contaminated in the field or during washing in a packinghouse, and that the edible surface became contaminated during final preparation. Improper storage temperature combined with the favorable conditions for growth on the surface of cut melons were factors that likely contributed to the outbreak (Table 10).
    Finally here is 222 page report from the UK’s Food Standards Agency which includes investigations of Salmonella associated outbreaks.
    A review of the published literature describing foodborne illness outbreaks associated with ready to eat fresh produce and an overview of current UK fresh produce farming practices.
    From the reference list in the report includes
    Mohle‐Boetani,J.C., Reporter,R., Werner,S.B., Abbott,S., Farrar,J., Waterman,S.H. and Vugia,D.J. (1999) An outbreak of Salmonella serogroup Saphra due to cantaloupes from Mexico. J Infect Dis 180, 1361‐1364.
    Centers for Disease Control and Prevention CDC (2002) Multistate Outbreaks of Salmonella Serotype Poona Infections Associated with Eating Cantaloupe from Mexico ‐‐‐ United States and Canada, 2000‐‐2002. pp. 1044‐1047.
    Finally as a consumer, I am disappointed by Del Monte’s actions. I had a considered Del Monte a high quality brand which I was willing to pay a little more because of the band. After this action, I will have to rethink that opinion.