Fruit company brings lawsuit against FDA
WASHINGTON (AP)--A major fruit company's lawsuit against the Food and Drug Administration could have a chilling effect on regulators' efforts to get tainted food off the market.
Florida-based Del Monte Fresh Produce is striking back at the FDA with a lawsuit after the agency halted imports of its Guatemalan cantaloupes, saying they may be contaminated with salmonella. Such a lawsuit is extremely rare, and the threat of litigation could make officials more reluctant to tell the public about the possibility of contamination in food.
"If this case is successful from an industry perspective, it will change the attitude of regulators,'' said former FDA assistant commissioner David Acheson, now a food safety consultant. "They will obviously be more reluctant.''
Michael Doyle, the director for the Center for Food Safety at the University of Georgia who has advised the FDA on food safety issues, said the lawsuit could set a dangerous precedent.
"More often than not the public health authorities and the epidemiologists are correct,'' Doyle said. "If you start putting public health officials in the crosshairs of the lawyers it's probably going to have a major dampening effect on whether foods are recalled in time to prevent a substantial amount of illnesses.''
The case could also become a major test for the imperfect science of epidemiology that is used to traced out breaks and determine what is causing a series of illnesses.
Del Monte conducted a voluntary recall of the cantaloupes, imported from a farm in Guatemala, in March after the federal Centers for Disease Control and Prevention and FDA determined they were linked to 12 cases of salmonella poisoning. In July, the FDA went a step further and issued an import alert, halting imports of the cantaloupes from Guatemala.
In a suit to get a court to lift the alert, filed Aug. 22 in federal court in Maryland, Del Monte said cantaloupes from the targeted Guatemalan farm represent almost a third of the cantaloupes they import. Del Monte complained the FDA officials based their decision on "erroneous speculative assumption, unsupported by evidence.''
The company has threatened to sue Oregon Public Health and its senior epidemiologist, William Keene, for playing a part in gathering evidence against the company.
"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, a vice president at Del Monte.
The FDA, which relies on the CDC and state health departments to do much of the investigation in foodborne illness outbreaks, declined to comment because of the pending litigation. Keene also declined to comment.
Led by CDC scientists, the government conducts foodborne illness investigations by interviewing victims who are confirmed to have a similar strain of illness and attempt to connect the dots. CDC has also started using shopper card information to pinpoint exactly what the victims purchased and consumed, a method that was used in the cantaloupe investigation.
The CDC said on March 29 that 11 of the people who fell ill had eaten cantaloupes purchased at eight different locations of an unnamed national warehouse club, and information from membership card records helped determine those sickened all purchased cantaloupes sourced from a single farm in Guatemala.
As this epidemiology has developed and been perfected, there is less of a need for a "smoking gun'' or direct evidence that a pathogen exists in food, like a sample of the salmonella itself. That is often hard to find in fresh produce, where the evidence may be long gone. Government scientists have to determine when they have enough evidence to urge a company to recall its food and warn the public.
Former officials say it is often a hard call for the regulators who make those decisions.
"That is the difficulty FDA is dealing with--when do you warn, when do you not warn, when do you urge a recall,'' says Fred Degnan, a former FDA lawyer who now specializes in food law in private practice. "This is a brave new world for FDA and for industry.''
Acheson said the lawsuit sends "the appropriate message to everybody that if you are going to make these decisions and put pressure on companies to recall, you ought to be right.''
Public health officials have occasionally stumbled in their efforts to identify the source of an outbreak quickly. In 2008, FDA and CDC investigators struggled for weeks to identify the cause of a salmonella outbreak initially blamed on tomatoes. No contaminated tomatoes were found, and the outbreak strain eventually was discovered in hot peppers from Mexico.
The Agriculture Department was criticized in August for taking months to identify the source of a salmonella outbreak in ground turkey. Though illnesses began in March, the CDC and USDA did not positively identify the source of the outbreak as Cargill ground turkey until they found a positive sample in late July. The recall came in early August, after one person had died.
In the end, tracking down the source of an illness is a difficult, complicated business and those making the calls say they are aware of the risks. Kirk Smith, a senior epidemiologist for the Minnesota Department of Health, said lawsuits won't affect his work.
"We always make sure our evidence is rock-solid before we go public with information that might trigger a recall or impact a company,'' he said.