Case of Sour Grapes Shows Suing the FDA Doesn't Pay
Knight-Ridder Financial News, January 4, 1996
There are certain fights that the prudent are ill-advised to pick, and suing the
Food and Drug Administration falls into this category.
The FDA has been called "the agency that never loses," and it just proved itself
After six years of litigation, the Supreme Court recently declined to hear the
appeal of 2,400 Chilean fruit growers and shippers in the infamous Chilean
In March 1989, an anonymous caller to the U.S. Embassy in Chile announced that
fruit headed to the U.S. had been injected with cyanide.
FDA inspectors searched and found some suspicious-looking grapes. Two had
puncture marks and white rings. A third was slashed.
The grapes were analyzed at labs in Philadelphia and Cincinnati. The
Philadelphia lab found cyanide. The Cincinatti lab found none.
Since the Philadelphia sample had been destroyed during testing, there was no
way of finding out whether the contamination was the result of mishandling by
Now, if you injected grapes with cyanide, all the grapes in the case would be
contaminated. So would the wood in the crate and the wrapping paper.
The other grapes, the wood and the wrapping paper were all analyzed. Nothing
was found. The FDA scientists also knew that cyanide doesn't produce light
circles. Instead, it produces an ugly yellow-purple blotch.
The scientists also knew that over the two-week boat trip, the cyanide would
have dissipated. The Philadelphia lab had found so much cyanide, there was no
way the grapes could have been contaminated in Chile. Everything pointed to a
contamination in the lab itself. The FDA had botched its own testing.
And the white rings? The Cincinnati lab said they weren't cyanide.
Chilean grape growers use talc as a stabilizer in their pesticide sprays. When
the spray hits the grape, it forms a water droplet. When the water evaporates,
all that's left is the talc residue from the edges of the droplet.
"The Chilean Grape Scare of 1989, which was first perceived as an averted
tragedy, and then as a severe overreaction by the FDA, eventually proved to be
nothing less than a farce," reports Herbert Burkholz, author of The FDA
An expensive farce, though. The FDA urged small groceries and the public to
dump any Chilean fruit they had. The FDA also impounded 2 million crates of
fruit nationwide. Between 20,000 and 50,000 Chileans lost their jobs.
In January 1990, two FDA agents and three Chileans died in a plane crash in
Chile. They were going to inspect security measures in a Chilean vineyard.
They were the only casualties of the crisis.
But this is what the FDA calls erring on the side of safety. Future events
revealed that the skeptics were right.
In a recently declassified phone conversation, the anonymous caller called back
and told the Embassy phone operator, "There was nothing. . . . A lie, seņorita,
the biggest lie. . . . We have laughed . . . and I am seeing all the foolish
things they have done."
About 2,400 growers and shippers of Chilean fruit sued the FDA for $240 million
for having effectively decimated an entire season's worth of Chilean fruit.
The basic law that allows you to sue the government is called the Federal Tort
Under FTCA, before taking an agency to court, you first have to exhaust all
possible administrative remedies. This means you have to file a claim with the
FDA and see if they reject it.
The Chileans had to file 2,400 individual claims. The FDA took the entire six
months the law allowed and denied all 2,400. This is when the Chileans filed a
suit in federal court.
The FDA's defense was that the case shouldn't even go to court because of the
"discretionary function exemption."
This means that the government is immune from challenges to stupid policy
decisions, like impounding grapes. The FDA was saying, in effect, "Even if we
were stupid, you can't sue us."
Not so, said the Chilean grape folks -- you were sloppy for having botched the
lab tests and found cyanide where there was none.
The discretionary function exemption doesn't protect sloppiness, only stupidity.
But the FDA argued that the discretionary decision impounding the grapes was a
"supervening event" that removes the lab negligence from the chain of causation.
As David Holzworth, the Chileans' attorney, puts it, "In layman's terms, this
means that if you're sloppy and then stupid, you're off the hook."
The Chileans lost the case, but appealed it all the way to the Supreme Court.
And now they've lost again.
A case of sour grapes? Not yet. The Chilean government may now intervene in
the growers' favor, taking the case to international law courts or using it as a
bargaining chip in trade negotiations.
Most likely, though, justice isn't going to be served. It rarely is, even when
the FDA admits that it screwed up.
But this just goes to show what happens when you sue the FDA. David vs. Goliath
confrontations make good copy, but the smart money bets on Goliath.
Industry folklore has it that Peter Barton Hutt, FDA's chief counsel in the
1970s, could win any case by coming into court and saying, "The Food and Drug
Administration is the expert scientific agency charged by the U.S. Congress and
the president to protect the safety of pregnant women and small children."
Almost no one sues the FDA, and when they do, the FDA almost always wins. It's
big. It uses complicated science. Judges defer to it most of the time and you,
the taxpayer, are paying its legal tab.
Alexander Volokh is a policy analyst at the Reason Foundation, a public policy
think tank based in Los Angeles. His views are not necessarily those of Knight-
Ridder Financial News.
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