FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

ORA Laboratory Manual Volume III Section 8

Document Number:

III-08

Revision #: 02

Revision Date:

08/13/2019

Title: 

Courtroom Testimony Page 1 of 10

For the most current and official copy, check QMiS.

Sections in This Document

1. Introduction................................................................................................................................. 1

2. The Basics.................................................................................................................................. 2

2.1. Pre-Trial Conference ....................................................................................................... 2

2.2. Chain of Custody ............................................................................................................. 3

2.3. The Analysis .................................................................................................................... 3

2.3.1. The Tests........................................................................................................... 3

2.3.2. The Method ....................................................................................................... 4

2.3.3. The Worksheet.................................................................................................. 5

2.3.4. Quality Controls................................................................................................. 5

3. Giving Testimony........................................................................................................................ 6

4. The Scientific Witness................................................................................................................ 6

4.1. Witness: Fact vs. Expert.................................................................................................. 6

4.2. Scientific Defense............................................................................................................ 7

5. General References ................................................................................................................... 8

6. Document History....................................................................................................................... 8

7. Change History........................................................................................................................... 9

8. Attachments................................................................................................................................ 9

Attachment A - How to be a Good Witness ............................................................................. 10

1. Introduction

Science plays an increasingly significant role in many types of legal 

proceedings. The regulatory analyst is aware that their analytical methods and 

findings may be challenged in a court of law. The Food, Drug, and Cosmetic 

Act deals with government's attempts to protect public health and individual 

welfare by regulating the development and marketing of essential 

commodities. Analysts, engineers, inspectors, and investigators all play a part 

in the regulatory process, working in concert to uncover and document 

violations of the law. These violations of the law may stimulate a variety of 

responses, such as the warning letters, injunctions, seizure, civil and criminal 

charges and voluntary actions by the food industry and other responsible 

parties. 

If subpoenaed to appear as a witness in a court case, the analyst should try to 

gain as much information as possible about the trial process and what to 

expect. The potential witness should know the basics of the work performed, 
FOOD AND DRUG ADMINISTRATION

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ORA Laboratory Manual Volume III Section 8

Document Number:

III-08

Revision #: 02

Revision Date:

08/13/2019

Title: 

Courtroom Testimony Page 2 of 10

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be aware of proper deportment in the courtroom, and understand the elements 

of the scientific defense. A prospective witness, who is particularly nervous 

about testifying in court, should "sit in" on a trial where scientific testimony is 

being given. Most court sessions are open to the public. Local court cases 

regarding illicit drug use, possession, or sale, which sometimes involve 

scientific testimony, occur almost daily in most moderately sized communities. 

Call the local district attorney's office or courthouse to find out when such 

cases will be tried. This document includes an attachment, " How to be a Good 

Witness," which offers helpful suggestions for potential witnesses. 

Analysts who expect to testify should contact others in the field or 

headquarters who have experience in testifying in agency-related matters; 

analysts, compliance officers, General Counsel, and others can provide 

valuable information and insight. Staging a mock trial with laboratory 

personnel, investigations, and/or compliance personnel can be an excellent 

preparation exercise. Take advantage of oral reviews to practice answering 

questions related to analytical work if conducted at the district office or 

laboratory.

This chapter provides general guidelines and suggestions for the potential 

witness. Additional sources on science-based testimony are given in Section 5 

General References. 

2. The Basics

The basics include those factors that are most familiar to Food and Drug 

Administration (FDA) analysts such as the chain of custody of samples, the 

analysis performed on the product including the results, and quality control 

procedures associated with the product or sample analysis. Since an FDA 

analyst represents the Agency and its enforcement efforts in court, every effort 

will be made to provide the proper training, guidance, and preparation prior to 

court room testimony.

2.1. Pre-Trial Conference

A. The witness will have the opportunity to discuss testimony with the 

government attorney at a pre-trial conference. This is the time to ask 

questions and to ensure that the government attorney fully understands 

the analyst's testimony. Any unresolved concerns and issues, such as 

problems with sample integrity, should be settled by this stage. The 

witness's answers at trial should not be changed without the prior 

knowledge of government counsel. 

B. The pre-trial conference is also the time to ask any logistical questions. 

Witnesses should ask the attorney whether they are expected to go 

directly to the courtroom or to another room while waiting to give 
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ORA Laboratory Manual Volume III Section 8

Document Number:

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Revision #: 02

Revision Date:

08/13/2019

Title: 

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testimony. Witnesses also need to know where they should go after 

testifying; should they remain in the courtroom or in the building, or are 

they free to leave? 

C. Whether testifying as a fact witness or an expert witness (see Section 

4.1), analysts will be asked about their qualifications and professional 

history. Knowledge of a witness's schooling, experience, and 

professional achievements, including specialty certifications, training, 

and areas of expertise, may have a positive effect on the jury by lending 

credibility to responses. However, recounting every detail of one's 

professional life may bore the jury. The witness, therefore, should 

discuss with the attorney which accomplishments should be disclosed. 

2.2. Chain of Custody 

One of the first areas of testimony will involve the chain of custody. "Is the 

sample that was analyzed in the laboratory the same sample that the 

investigator picked up at the firm?" "Was the sample tampered with, or 

contaminated, at any point?" The analyst can testify only to that about which 

he or she has actual knowledge. Most likely the first contact with the sample 

occurred when it was picked up from the sample custodian. This may have 

been followed by completion of the sample accountability record, breaking the 

official seal(s), performing the analysis, resealing the sample, and returning it 

to the sample custodian. See ORA Laboratory Manual, Volume III, Section 2 

(Chain of Custody – Sample Handling) for a complete discussion of sample 

accountability. The analyst may be asked about the conditions under which the 

sample was stored while in the analyst's care. "Who, besides yourself, had 

access to the sample?" Remember the legal position of “presumption of 

regularity”; i.e. this is the way the employee always does his/her work.

2.3. The Analysis

2.3.1. The Tests

A. It is very important for the analyst who is to give scientific testimony 

understand the basic principles of the tests performed and the 

instruments used. The analyst may have performed the same analysis 

for twenty years, but if clear, concise, and confident answers cannot be 

given to basic questions the impression is that poor work has been 

done for the past twenty years. The fact that an analyst runs a gas 

chromatograph every day does not mean that he or she understands 

the basic theory and principles of operating the instrument. 

B. The analyst should avoid being coerced into detailed explanations of 

methods and equipment. Stating that the method or equipment is widely 

accepted for use by Federal and State laboratories can help to keep 
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Revision Date:

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Title: 

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detailed descriptions to a minimum. If directed by the judge or counsel 

to provide details or additional explanation, the simplest, clearest 

answer should be given; for example, rather than providing an 

exhaustive account of the Association of Official Analytical Chemists 

(AOAC) collaborative process, stating that AOAC INTERNATIONAL 

methods are recognized as the official methods of analysis would 

suffice. 

C. The jury is the audience. The use of jargon and scientific terms 

unfamiliar to jurors should be avoided. A jury that does not understand 

the terms used by a witness will not understand the message given in 

the testimony. The scientist is trained by experts in his or her chosen 

field, by reading professional journals, and through conversations with 

colleagues. Repeating lengthy conversations or communications, 

although meaningful to associates, may be difficult or impossible for the 

layman or non-scientist to understand. The scientific witness presents 

analytical findings so that all members of the jury, the judge, and the 

attorneys can easily grasp the significance of the testing and results. 

Technical expressions are clearly and carefully explained. A jury may 

know very little, if anything, about the laws of science, the accumulation 

of evidence, precautions taken to avoid error, and statistical 

interpretations. 

D. The analyst should practice giving explanations of methodologies and 

techniques. The analyst may be very familiar with the procedures used 

but may have less experience explaining the procedures to those 

unfamiliar with the scientific principles involved. When possible, the 

analyst should describe the principles in understandable, everyday 

terms without being condescending. For example, capillary action by 

which a solvent migrates up a thin layer chromatography plate can be 

compared to the mechanism by which water travels up a dry paper 

towel. 

2.3.2. The Method 

The analyst is to understand the method used. Why was it chosen? How or 

why does it work? Responses such as, "Because my supervisor told me to," or 

"We always use that method," are not acceptable responses. The FDA policy 

has always been that, when in existence, official methods are used for sample 

analyses that are the basis for regulatory action. See ORA Laboratory Manual, 

Volume II, Chapter 5.4.5 (Methods, Method Verification and Validation) for an 

explanation of Official Compendia and Analytical Manuals, respectively. The 

analyst may need to explain the meaning of a method's official status. 

Remember, use of official methodology does not relieve the analyst of the 
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ORA Laboratory Manual Volume III Section 8

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Title: 

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responsibility of proving method performance through quality controls, positive 

and negative controls, and recovery and reproducibility studies. Be prepared to 

explain why recoveries or certified reference materials were run; how they 

were run; and what they proved. Be prepared for questions concerning 

shortcomings of the methodology used and possible alternative methods that 

others may consider more reliable. 

2.3.3. The Worksheet 

A. One of the most important things the FDA analyst can do to ensure 

smooth testimony in court is to establish good analytical habits. Many 

analysts may hear senior coworkers state that they have been with the 

government for "X" number of years and have never been called to 

testify. Although this may be true, it is important to maintain credible, 

high quality science and documentation in the laboratory. Experience is 

not a substitute for good quality control. Before a case can proceed to 

trial, the veracity of the analytical findings is supported through the use 

of Quality Assurance/Quality Control (QA/QC) procedures. The 

analyst's worksheets will be subjected to many layers of review before 

they become introduced in a court of law. The analysis and 

documentation must be complete and meet agency standards of quality 

to survive the scientific and legal scrutiny in the courtroom. 

B. Proper documentation will be the basis for much of the analyst's 

testimony. By the time a case gets to court many months, if not years,

may have passed since the analysis was performed. It is very unlikely 

that the analyst would recall details about the case or details of the 

analysis. 

2.3.4. Quality Controls 

A. Analysts must have knowledge of their local laboratory quality system. 

For example, if part of the analysis involved recording a critical 

temperature, the analyst is to document that the thermometer was 

checked for accuracy on a regular basis and the thermometer met the 

specifications before it was used in the analysis. This quality control 

applies to other instruments and equipment as well, and the local quality 

system should address the conditions for operation and specifications. 

B. If the method used was not studied collaboratively or validated for the 

matrix in question, the analyst should be prepared to explain what types 

of validation were performed. Validation factors such as the use of 

method blanks, system suitability, certified reference material, and 

recoveries may be incorporated into the method. (See ORA Laboratory 
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Title: 

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Manual, Volume II, ORA-LAB.5.4.5 Methods, Method Verification and 

Validation).

3. Giving Testimony 

A. One of the best means of anticipating what questions the defense will 

ask is simply to see the case from the defense perspective. "What 

questions would I ask myself to invalidate this testimony?" The District 

should set up a mock trial involving fellow analysts, supervisors, and 

compliance officers. Hold an informal roundtable discussion or a more 

formal setup where peers can provide the inquisition the analyst may 

face on the witness stand. This can be one of the most helpful 

experiences before trial. Unanticipated questions may come to light and 

in some instances may provide the analyst with a better understanding 

of how he or she will react under pressure. 

B. The principles enumerated in the Attachment “How to be a Good 

Witness” are the result of observations in court of some of the things 

that witnesses could have done to make their appearance on the stand 

and the presentation of their testimony more effective.

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 underlying science and 

scientific testing procedures used to test the product. Most analysts serve as 

witnesses of fact.

4.1. Witness: Fact vs. Expert

A. 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, profession, or 

trade. 

B. 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, employment of some duration by a State 

or Federal agency in the scientific field covered by the testimony, 
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Revision Date:

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Title: 

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recognition by other institutions and organizations, and previous 

testimony in other cases helps to qualify a person as an expert witness. 

C. The main reason for expert testimony is to interpret difficult-tocomprehend 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. 

4.2. Scientific Defense 

A. 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. 

B. 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. 

C. 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 
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Title: 

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conclusions of the prosecution's scientific witness, there is always the 

problem of whom the jury will believe. 

D. 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.

5. General References 

A. U.S. Food & Drug Administration, Office of Regulatory Affairs.(current 

edition). Investigations operations manual or the website address, 

http://www.fda.gov/ICECI/Inspections/IOM/default.htm

B. “Court Testimony” ST-1910 Federal Law Enforcement Training Center, 

Office of General Training, Legal Division 8-82 

C. U.S. Food & Drug Administration, (current edition). Regulatory 

Procedures Manual, Chapter 6, Judicial Actions or the website 

address, 

http://inside.fda.gov:9003/PolicyProcedures/GuidanceRegulations/RPM

MasterList/default.htm

D. ORA U Course FDA46 (Version 1.2), Courtroom Testimony.

E. 28 United States Code 1746.

6. Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.2 R 02/06/12 LMEB LMEB

1.3 R 01/29/13 LMEB LMEB

02 R 08/13/2019 LMEB LMEB

* - D: Draft, I: Initial, R: Revision
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ORA Laboratory Manual Volume III Section 8

Document Number:

III-08

Revision #: 02

Revision Date:

08/13/2019

Title: 

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7. Change History

Revision 

# Change

1.2

8.2.1 – changed “at” to “by” in third sentence of first paragraph; added “need to” to 

last sentence of second paragraph

8.2.2 – added last sentence

8.2.3.3 changed “is to” to “must” in last sentence of first paragraph

8.2.4 – deleted “general” from first sentence of first paragraph; deleted last sentence 

of last paragraph and added ORA LM reference

8.3 – changed “me” to “myself” in second sentence and revised third sentence

8.4.1 – deleted last sentence of first paragraph; revised second paragraph

8.5 – deleted outdated references and added reference

Attachment – deleted Attachment I and II; added “How to be a Good Witness”

8.6 – added

1.3

Header – Division of Field Science changed to Office of Regulatory Science

8.5 – Division of Field Investigations and Office of Enforcement removed

02 The document was reformatted and few minor clarification changes were made.

8. Attachments

List of Attachments

Attachment A - How to be a Good Witness ................................................................. 10
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Attachment A - How to be a Good Witness

Do...

Be alert. Beware when opposing counsel either attacks or strokes your ego. He or she may be trying to 

spur emotion to the detriment of the government case. Ignore this tactic. Be wary of forced, rapid 

questioning by opposing counsel. You have a right to have clear, understandable questions asked one at 

a time. Watch out for multiple questions phrased as one question. Ask for separate questions, if 

necessary. Be alert to opposing counsel re-phrasing your answer and asking if you agree. The change 

may sound innocuous, but it may soften what you said, sometimes to the detriment of the case. 

Be objective. Do not tailor or slant your answers. You are here to testify the facts as you know them, 

without any bias. Be fair to the defendant. 

Be brief. If a question can be answered in one word, do so and stop. Avoid volunteering information. Do 

not make unnecessary elaborations to your answer. If a question is so vague or ambiguous that it cannot 

be answered with a simple “yes” or “no,” answer it fully, but succinctly. 

Be truthful. If you do not know the answer to a question, be truthful and say so. Do not guess at the 

answer. If a question requires a “yes” or “no” answer, but that would be misleading, explain that. Give the 

responsive one-word answer and then explain your answer. 

Be direct. An evasive answer will indicate that you are trying to hide something. Do not give any 

ambiguous answers, and do not “beat around the bush.” If you must give an estimate for your answer, 

make it clear that you are giving an estimate. 

Do not...

Do not accept re-wording unless it is exactly what you want to say. Often the defense may try to use your 

answers to questions asked during the deposition to change the meaning of what you are saying on the 

witness stand. Make sure you have thoroughly read your deposition transcription before trial, as the 

question asked during the trial may be different from, or out of context with what was asked during the 

deposition. 

Do not take documents or other exhibits to the stand with you. They must be formally introduced, on the 

record. The Court allows you to use your notes to refresh your memory but, if used, they must have been 

made available to defense counsel for his or her review as part of the discovery process, may be marked 

as evidence, and retained as an exhibit. Only use your notes if the question involves a level of specificity 

that a normal person would not be expected to remember. Make certain that the government attorney 

presenting your testimony has reviewed all notes beforehand and agrees that they can be used.