By Ronald J. Levine
Each month EAS answers one question sent in by a reader. This month’s question on how to choose an expert witness for FDA legal proceedings is answered by Independent Consultant, Ronald J. Levine. Ron has had a successful career history as a litigator at one of the top New York law firms and is available to EAS clients for assistance with compliance questions and risk assessments. We were interested in hearing Ron’s thoughts since EAS provides consultants who can become a part of a legal team, by writing expert opinions, participating in depositions or being called to the stand as an expert witness. You can view EAS’ Expert Witness Services Sheet to learn more. If you would like to ask a question of our independent consultants, please contact us.
How Do Legal Teams Find and Identify Good Expert Witnesses?
Thank you for an excellent question. As a litigator who has retained many expert witnesses during my 40- year career as a lawyer, I have found that finding the right expert for a case can make all the difference in the world.
In almost any investigation or litigation involving regulated products, an expert can help explain your position to the fact-finder and render opinions which an average person would not have the knowledge or experience to offer. The FDA expert’s ability to offer a deep understanding of complex regulations and production protocols, such as Good Manufacturing Practices (GMP); and assistance with developing strategy in responding to the FDA; can make the expert a valuable extension of the legal team.
Where are the Legal Teams Looking?
Once the legal team has identified the subject area and credentials of the expert required for the task, they will begin the search.
The team may well begin with publications, articles and websites in the practice area and will be most interested in the positions the expert has taken in the past on the topic at issue – to see whether the opinion aligns with the legal team’s stance.
Experts who have testified previously, with names appearing in published court opinions, may be found by attorneys who are researching the legal authority in the area. Also, legal teams may send out queries via bar groups and industry associations.
How can I find a “Good” Expert?
There are at least three qualities of a “good” expert witness.
First and foremost, experts should be able to articulate what makes them an expert. Expertise could be based upon academic and professional credentials and on the job experience. In some cases, experience as an academic provides extra credibility, particularly those who have published in peer-reviewed journals.
Secondly, a “good” expert is one who is able to articulate his or her opinions in a manner which lay people will understand and accept. The expert will not be addressing peers who talk the same language. They will be trying to convince a jury, who may have limited educational credentials and no experience in the field. Legal teams will also be looking for experts who are poised and make others feel comfortable. They are going to avoid those who arrogant or not willing to listen.
Finally, legal teams are looking for experts who are able to handle themselves under intense cross-examination. They need to be able to listen to questions. The expert must be on the alert for trick questions, and know how to answer questions posed by experienced trial lawyers. Legal teams want to work with a seasoned expert who are familiar with the courtroom.