| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-08 | VERSION NO.:1.1 | Section 8 - Courtroom Testimony | EFFECTIVE DATE: 10/01/2003 | REVISED: 06/27/2008 |
8.4 The Scientific Witness
An FDA analyst's role in the courtroom is to serve as a scientific witness. The
analyst needs to attest to what took place while examining a product in the
laboratory. He or she provides an explanation of the underlining science
and scientific testing procedures used to test the product. Most analysts
serves as witnesses of fact.
8.4.1 Witness: Fact vs. Expert
Witnesses presenting scientific testimony fall into two categories: witnesses
of fact and expert witnesses. Fact witnesses, even those who have scientific
training, can testify only to matters of fact that they have witnessed. They
cannot give opinions. The expert witness is one who, by special study, practice,
and experience, has acquired special skill and knowledge in relation to some
particular science, art, or trade. Obviously, therefore, a fact witness does
only what his or her oath charges, namely, to tell the truth, the whole truth,
and nothing but the truth.
Qualifying as an expert involves an examination of the individual's academic
credentials and the duties connected with his or her career, past and present,
such as various professional achievements and the publication of original scientific
papers. The possession of a bone fide degree from a State university or employment
of some duration by a State or Federal agency in the scientific field covered
by the testimony practically ensures that the judge will admit a person as
an expert. If a person is trained in a State's educational system and presented
with a diploma, the State's judicial institutions cannot deny these credentials
without good cause. Previous expert testimony also helps to qualify a person
as an expert witness.
The main reason for expert testimony is to interpret difficult-to-comprehend
facts to the jury. The judge usually explains to the jury that the court will
permit the expert to evaluate the evidence and explain its significance to
the case being examined. Even though an expert witness is entitled to give
opinions, usually more than a mere statement of opinion is usually needed for
maximum impact. The expert witness should know or conclude that certain conditions
or findings prove the statements he or she makes.
8.4.2 Scientific Defense
One of the burdens of proof in a case involving scientific testimony is that
the science is sound and accurate. For example, in a case involving misbranding
or adulteration, the prosecution demonstrates, beyond a reasonable doubt, that
the product is actually misbranded. If the charge is subpotency of a drug,
the science first shows that the drug in question is actually subpotent, if
this is the basis of the allegation. This type of proof usually is provided
by the analyst who analyzed the sample in question. The proof may be provided
in the form of written results on the worksheet or verbal testimony of the
analyst. In many cases the defense may stipulate to the report of the analyst.
In other words the defense is saying that they do not contest the report, nor
do they question the integrity of the analysis performed. In such cases, the
analyst may not be asked to testify.
In other instances the entire basis of the defense may be that the results
found are totally inaccurate. For example, the insect fragment in the soup
was not actually an insect but an exotic vegetable; the drug analyzed was not
subpotent because the chemist did not know what he or she was doing; the Salmonella
found in the cheese was actually a result of cross contamination in the laboratory
caused by a technique error made by the microbiologist. In these situations
the analyst may be asked to testify.
The basis of a scientific defense is to cast doubt on the conclusions drawn
from the analysis. This type of defense can be difficult to perform because
the defense attorneys may not know enough about the subject to ask the right
questions. Even if they learn enough to ask the right questions or are knowledgeable
about the science, the jury may not understand what is being said. In cases
where the defense brings in expert scientific witnesses to contradict the testimony
and the conclusions of the prosecution's scientific witness, there is always
the problem of whom the jury will believe.
Scientific defenses are generally a last resort when no other defense is feasible,
or when the science is poor enough to warrant a court challenge. Nonetheless,
an attorney who decides to use this defense will do his or her homework and
at least gain an understanding of the principles behind the primary tests performed
by the analyst. Without this knowledge the defense has no way of impeaching
the expert witness.
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