A person who has undergone a sufficient amount of education and has gained enough experience and skills from certified training courses in any specialized field and can give an opinion over a matter in the court in front of the judge is an expert witness. His point of view is accepted by the court but challenged or contradicted by the opposite party who has claimed. FDA hires these expert witnesses who give valuable suggestions regarding food and drug administration. They also provide other opinions within the organization like:-
• They give suggestions regarding public health and medicine by focusing on clinical experiments, observational studies, and statistical data. Public health an ethical term that focuses on population. Medicine is a specialized term focused on the individual. The expert has to answer vital questions regarding the biomedical experiments conducted on a small group of human contenders.
• They discuss the strengths and weaknesses of legal action and advice in an advisory and unbiased way to make enormous changes in the policy formulations of the FDA.
• They also include engineers who design CAD drawings and illustrations of 3D accurate dimensions to make the non-technical staff understand a complicated subject easily.
• The physician's specialists review the medical records to check any deviation from the standard of care.
• They offer services in testing, sampling, and documentation of failed equipment and perform accident, safety, and environmental audits. Environmental audits are performed to check whether a particular process or product is matching the environmental standards or not. The safety parameter is most important when it comes to forming the side of the consumers. Quality degradation directly puts impact on the safety of the public.
To be an FDA expert witness, the following points must be remembered:
• The expert should remain calm and composed during cross-examinations. Any kind of aggressiveness may hamper the trial process. It is not required to argue with the jury.
• Presentation shortly and directly will create a good impression. Breaking the complex matter into sub-topics and using analogical concepts will make the session run smoothly. He should avoid scientific terminologies and use layman terms in front of the court.
• A well-documented report consisting of all opinions valid on reasoning, claims, allegations should be prepared.
• The qualifications and experience of the expert should be brought properly. This will improve the overall body language and boost the confidence of the expert.
• Any rule or regulatory standard that is violated by the claimed product should be presented without any hesitation. This will increase the faith of the opposite counsel for doing justice.
• To act as a negotiator is not the duty of an expert witness.
When a party in dispute appoints the Gadolinium Expert Witness, he must help the court and plead in favor of the party. The court uses the concept of a Dauber challenge. In this method, the judge hears the statements and justification of the witness expert. The opposing counsel has the right to disqualify his statements if proved weak. This conflict of interest may be avoided or at least lowered if the qualifications of the expert are properly known to the opposition party. To reach a constructive solution to the case, all the valid and essential documents should be presented on time before the court. Hence any disqualification should be properly addressed before the trial begins. Since medical law and pharmacological studies are highly complex subject matter, it is only possible for FDA experts to tackle every situation that comes under FDA law. They may also be entrusted with the responsibility of giving valuable suggestions for incorporating reforms in the training program of the staff. In this way, they are useful formations that can contribute equally within and outside the organization. It is itself a big responsibility on the shoulders of the FDA to take great care of the expert witness team. Not only hiring them but also giving them an independent working environment where they can act and perform on their own. This will create a sense of responsibility within the expert team, and they will do their best to perform the task most efficiently help the court to give justice in every possible manner.