Unusual Lawsuit May Pose Hazards

In the wake of a U.S. Food and Drug Administration (FDA) ban on cantaloupe imports from Guatemala after a Salmonella outbreak earlier this year, Florida-based Del Monte Fresh Produce has filed suit against the FDA in federal court to get the alert lifted. The legal challenge, which experts say is extremely rare, claims that cantaloupes from the targeted farm represent almost a third of its cantaloupe imports and accuses the FDA of “erroneous speculative assumption, unsupported by evidence.”

Del Monte has also threatened to sue Oregon Public Health and its senior epidemiologist, William Keene, for its part in gathering evidence against the company.

The controversy began after the U.S. Centers for Disease Control and Prevention (CDC) determined in March that the Guatemalan cantaloupes were linked to a dozen cases of Salmonella poisoning. Del Monte recalled the produce in March. As of June, according to the CDC, 20 people had gotten sick in the outbreak; in July, the FDA took the added precaution of an import alert.

“Responsible government agencies must be careful to protect public confidence and not inflame public fears by making statements about the safety of a particular food product or producer without sufficient evidence or without conducting a reliable investigation,” said Dennis Christou, vice president for marketing at Del Monte, in a statement released after the suit was filed Aug. 22.

Michael Doyle, PhD, Regents Professor of food microbiology and director of the Center for Food Safety at the University of Georgia in Griffin, said that he cannot recall a prior lawsuit against the FDA involving such a case. He pointed to a 2000 case in which Kraft was implicated in a recall when FDA sampling pointed to E. coli 0157 contamination in its Breakstone cottage cheese. “It really didn’t make sense for several reasons, and further analysis of the control strain in the FDA lab revealed that it was probably lab contamination,” he said. “But Kraft took the high road. It cost them millions to recall the product, but there was no question that they’d sue the government. They want the FDA to be recognized as a public health authority, nationally and internationally.”

Dr. Doyle fears that if the suit is successful, it could have a chilling effect on epidemiologists’ efforts to identify the foods involved in outbreaks. “They may want more evidence that a specific food is the cause of an outbreak before initiating a public announcement and recall of the product, which could lead to more cases of illness and potential deaths.”

He said that it is best to err on the side of caution when dealing with public health. “When there are questions about making people sick, and there’s clear evidence that contamination has occurred—which there was in this case—you also need clear evidence that the problem has been rectified. You can’t go overboard, of course, but the FDA and the CDC are most concerned about public health and looking out for the public good. If successful, a suit like this could weaken the FDA’s stature as a national and international leader.”

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