FDA may have swayed investigation


Campers possibly influenced by July's E. coli lettuce warning

State and local health officials tried to stop the U.S. Food and Drug Administration from issuing a nationwide warning about Spokane Produce romaine lettuce last July, internal e-mails show.

The health officials thought the warning would hurt their ongoing investigation of the E. coli outbreak at a dance camp and they felt the risk to the public was over.

"We both then basically groveled for them to not send out anything until we had a chance to do more investigation . . ." state communicable disease epidemiologist Dr. Jo Hofmann wrote in an e-mail three days after the July 29 FDA alert.

The FDA posted the alert prominently on its Web site and sent out news releases. It advised consumers to toss out the product and to "ask at the place of purchase in order to assure that they do not consume Spokane Produce brand romaine lettuce until this health emergency is resolved."

The FDA action possibly tainted one of the key pieces of evidence in the outbreak investigation, according to the health officials' e-mails.

Food surveys are crucial in pinpointing the source of foodborne illness. The food survey of campers contained a mistake.

It asked campers if they ate "Caesar salad" July 11, the first night of camp. But there were two salads served that night, not one. The other salad was a tossed salad with cucumbers and a choice of three dressings.

When the FDA issued its alert, the health officials were beginning to realize there might be two salads and were awaiting clarification from Eastern Washington University, where the camp took place. Indeed, they discovered they would have to recontact the campers and recalculate the relative risk of their food choices.

Two weeks after the meal, the campers' memories were fading. News reports about romaine lettuce and Caesar salad may have influenced campers' answers.

"So now we knew we had to go back and re-interview everyone to determine exactly which salad they ate -- in the midst of all the publicity that implicated Romaine. So we are doing that -- but anyone could reasonably argue that the data are tainted," state epidemiologist Hofmann wrote in her Aug. 1 e-mail to Washington state Department of Health Secretary Mary Selecky.

The source of lettuce in the second salad is unclear from local health officials' reports on their investigation.

In a recent interview, Spokane Produce owner Craig Higashi said the FDA alert hurt his business. A few customers still won't buy his lettuce. And Spokane Produce expects to be sued by the family of Angela Hadley, one of the dance campers.

The now 16-year-old girl was the hardest hit of the more than 50 girls sickened in the outbreak. She developed hemolytic uremic syndrome and was hospitalized for a month. Today she is feeling better, but still tires easily and must undergo further testing for possible long-term kidney problems, her mother said.

"This little Hadley girl has a 40 percent chance of losing her kidneys because of Spokane Produce and what happened," said Seattle attorney William Marler, an expert on foodborne illness lawsuits who is working on the case on behalf of the Hadleys.

Whether the FDA jumped the gun with its alert doesn't matter, the attorney said. The investigation, which also included genetic fingerprinting and product invoice tracing, led to Spokane Produce.

"It's absolutely overwhelming evidence," Marler said. "It's way more than I normally get in a lawsuit."

Marler said controversy surrounding another E. coli outbreak the same month may have influenced the FDA to act quickly. Another federal agency, the U.S. Department of Agriculture, was widely criticized for sitting on important findings before it finally forced a recall of ConAgra beef.

"There's no question in my mind, the FDA was sensitive to the firestorm that USDA was under and acted accordingly," Marler said.

State and local health officials believed the FDA alert made Spokane Produce less inclined to cooperate with the investigation, the e-mails show.

On July 30, Dr. Kim Thorburn of the Spokane Regional Health District sent an e-mail to Hofmann in which she suggested they all document in writing what they remembered about a conference call the day before with the FDA.

"By all indications, Spokane Produce is going to fight this tooth and nail," Thorburn wrote. "And why not? The other option is to die."

Spokane Produce's attorneys have been reading through boxes of documents about the investigation in preparation for a possible lawsuit against the company.

They have found other evidence they say raises doubts about the investigation. They point to cases of E. coli infection that match the genetic fingerprint of the outbreak but that could not be traced to Spokane Produce romaine. They also say one dance camper who got sick on the first day of camp was ill too soon to be affected by the salad.

Marler, the attorney working for Angela Hadley's parents, said Spokane Produce and its insurance company are -- like any defendant -- looking for a way out.

"Eventually," he said, "I'll crush them anyway."