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Special Edition IX — Salmonella Saintpaul Outbreak…Concerns About FDA/CDC

Getting Our Money Back:
Waive Sovereign Immunity

Jim Prevor’s Perishable Pundit, July 3, 2008

Dr. Robert Tauxe, M.D., M.P.H., was representing CDC on the most recent conference call. He is both smart and knowledgeable; he has contributed additional information to articles we have run on the Pundit, as you can see here.

During the CDC’s most recent conference call, he was at pains to point out the complexity of figuring out the cause in an outbreak such as this and so compared the role of the CDC to that of a detective.

Dr. Tauxe is both articulate and frank and so we accept his description. We, do, however, wonder if he has been reading the papers lately:

U.S. to Pay Millions in Lawsuit Over Anthrax Innuendo

The U.S. government will pay $4.6 million to settle a lawsuit brought by Steven Hatfill, a former U.S. Army biodefense researcher who was intensively investigated as a “person of interest” in the deadly anthrax letters of 2001, the Justice Department announced Friday.

The settlement, consisting of $2.825 million in cash and an annuity worth $1.8 million that will pay Hatfill $150,000 a year for 20 years, brings to an end a five-year legal battle.

Hatfill, who worked at the army’s laboratory at Fort Detrick in Frederick, Maryland, in the late 1990s, was the subject of a flood of news media coverage beginning in mid-2002, after television cameras showed FBI agents in biohazard suits searching his apartment near the army base. John Ashcroft, then the attorney general, later called him a “person of interest” in the case on national television.

In a news conference in August 2002, Hatfill tearfully denied that he had anything to do with the anthrax letters and said irresponsible news media coverage based on government leaks had destroyed his reputation….

Mark Grannis, a lawyer for Hatfill, said his client was pleased with the settlement.

“The good news is that we still live in a country where a guy who’s been horribly abused can go to a judge and say, ‘I need your help,’ and maybe it takes a while, but he gets justice,” Grannis said….

“As today’s settlement announcement confirms, this case was botched from the very beginning,” Holt said. “The FBI did a poor job of collecting evidence, and then inappropriately focused on one individual as a suspect for too long, developing an erroneous theory of the case that has led to this very expensive dead end.”

The parallels to the Salmonella Saintpaul outbreak are pretty clear. A botched investigation, with the CDC failing to do control group tracebacks, led them to inappropriately narrow their focus to tomatoes prematurely.

There is, however, a difference. In both cases, the government, acting as a detective, came to a conclusion. In the case of the Anthrax situation, the government violated all the procedural safeguards put in to protect victims against the capricious use of governmental authority.

So the detective is obligated to present his case to the prosecutor… if the prosecutor does not think the case strong enough, it goes no further. If he thinks the case has merit, the prosecutor has to persuade a grand jury to bring an indictment. If the grand jury won’t indict, the case goes no further. Then there must be a trial and a judge or jury must be convinced. Finally there are several opportunities for appeal.

This is a very difficult and expensive system. However, we, as a people, are skeptical of governmental authority and so would not accept a system whereby the detective gets to also be the prosecutor, grand jury, judge and jury and appellate court on his case.

Yet this is precisely the way the CDC/FDA work on food safety outbreaks. Without any checks on their judgment or power, they do what they please regardless of the cost to others. In this case, it’s the cost to the tomato industry — although by vaguely implying other produce items may be at fault, they are already spreading the costs to other items as consumer confidence is surely being diminished.

Now we have suggested various plans to reduce the likelihood of a bad decision as well as to limit the discretionary use of governmental power. For example, we proposed the use of a Team B approach, modeled after a CIA effort to improve analytical quality and avoid mistakes.

Another way to make less likely mistakes such as we have seen in the Salmonella Saintpaul investigation is to use the power of the courts.

Right now the problem is that CDC and FDA personnel can be horribly wrong, yet neither the organizations nor the people involved will experience any consequences.

In the current case, hundreds of millions of dollars of losses have been incurred with a very dubious benefit to public health. If tomatoes are not the cause, then the losses had no public health benefit at all.

Now in the case of the anthrax “person of interest,” the government settled a lawsuit without admitting guilt. Presumably the government wouldn’t pay $4.6 million if it didn’t think it was in the wrong.

Now the question is where do the tomato growers go to get their compensation?

One possibility is for industry to ask Congress to waive the doctrine of sovereign immunity — which generally precludes suing the state. This would open the door for an industry lawsuit against CDC and FDA.

This would have three beneficial effects:

  1. Those who lost money due to the way CDC and FDA handled this matter would have an opportunity to get it back.
  2. The discovery process would reveal many problems in CDC and FDA, and we could use that information to build a better food safety system.
  3. There would be negative consequences for having made a bad decision, which will serve as a useful tonic to improve future decision-making.

What is clear is this: The detectives at CDC cannot be allowed to become some fanatical Inspector Javert relentlessly pursuing Salmonella or other pathogen without regard to cost. One good way to ensure this would be to make sure mistakes have consequences.

A Congressional waiving of sovereign immunity would be a fine way to teach that lesson.

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