Consultants as Part of the Legal Team
By Ronald J. Levine and Amy Scanlin
Litigation can be a long and arduous process, especially with regard to collecting relevant information, developing an overall strategy, and ultimately, if necessary, preparing for trial. These tasks are all the more challenging where the issues are governed by complex regulatory schemes such as those that fall under the U.S. Food and Drug Administration’s (FDA) purview. Navigating the controlling regulatory requirements, and understanding how they are applied, can make all the difference in ensuring a successful litigation or settlement outcome.
Attorneys often enlist the assistance of consultants during the discovery and trial stages. Consultants may be asked to render reports and testify at trial. Throughout the entire process, consultants can act as valuable scouts in helping the attorney travel through unfamiliar and complex regulatory terrain.
This article briefly reviews the many potential benefits in retaining an FDA consultant and provides some tips for retaining a consultant who may testify at trial.
The FDA consultant’s ability to offer a deep understanding of complex regulations, expertise in production protocols, such as Good Manufacturing Practices (GMP), and strategy assistance with FDA expectations can make the consultant a valuable extension of the legal team. An added advantage is that the participation of a consultant can provide objective opinions that assist the process.
FDA Regulatory Authority
FDA’s regulatory authority is vast and the ability to find an expert who has specific knowledge in a given area can provide a unique and valuable window into FDA’s expectations. An in-depth understanding of how FDA is organized, how regulations are developed, and the agency’s oversight is especially critical. After all, Title 21 of the Code of Federal Regulations pertaining to FDA regulation of foods, drugs, and cosmetics has eight chapters and 1,299 parts.
Approximately 4,190 Guidance Documents reflect FDA’s current thinking on enforcement policies and, though non-binding, FDA’s expectation is that the pathways stated within these documents will be followed unless there is a suitable alternative that meets the requirements.
Of course, in addition to regulations, there are also notifications, such as Generally Recognized as Safe (GRAS), New Dietary Ingredients (NDI), and 510(k) premarket notifications for devices. There are other legally binding examples of product characterizations, such as Self-GRAS determinations, that are never even submitted to the FDA.
The countless regulations and their many nuances create significant challenges, particularly early on during strategy development and discovery. Understanding how FDA interprets the law, the pathway to compliance, and the responsibilities of the party in question may not always be immediately clear to a commercial litigator who does not specialize in food and drug law. Consultants with many years of regulatory experience can bring significant benefit to a legal team and help resolve complicated issues.
Consultants who work on both sides of the litigation fence can offer a unique understanding of FDA’s expectations or identify critical gaps in a defendant’s protocol or a plaintiff’s argument. For example, consultants can conduct desk audits to help shape a defense or settlement strategy and review compliance and quality assurance programs, such as batch records and master manufacturing records of raw materials.
Consultants also can advise on topics to cover during discovery, including documents to request and key exhibits that should be used in evidence. Since cases often settle before trial, the development of the record during the discovery phase is often determinative of the outcome.
In the case of food products, regulatory consultants can serve an important function by helping trial lawyers understand which agency has authority over a specific food, the scope of that authority, and how it is exercised. For example, many consumer class actions attacking food labeling have taken aim at the term “natural” used in meat or poultry products that were inspected by the U.S. Department of Agriculture (USDA). What some of the class action attorneys did not understand is that such labeling, including the use of “natural,” is reviewed and approved by USDA officials before a product is allowed into the market. Foods that are under FDA jurisdiction do not undergo such premarket clearance. The fact that the use of “natural” had premarket regulatory review helped convince some private plaintiffs that suits against the term “natural” on meat and poultry products was a losing battle.
GMPs and Scientific Reviews
The scientific issues underlying a lawsuit may be unfamiliar territory for a trial attorney. A seasoned consultant can provide the background and context to facilitate regulatory compliance and claims substantiation. Some examples include understanding how pathogens and other unintended contaminants can result in adulterated products, test methods that best result in product integrity, and the use of appropriate safety protocols. These insights can provide peace of mind that a company is operating soundly, and help companies understand the ramifications of missteps that may require immediate remediation and damage control. Attorneys who turn to consultants can gain a better understanding of where fault lines exist.
FDA audits can cause a huge heartache for firms operating with incomplete and/or inaccurate information, especially for those firms that genuinely do not realize they are doing so. Consultants can help define the scope of a problem with a scientific eye and help firms to execute swift and thoughtful recall strategies. A consultant with a background in compliance, quality, and auditing will provide immeasurable benefit.
Serving as Expert Witnesses
While consultants can provide many benefits, one of the most recognized and most valued is serving as expert witnesses. A good expert witness adds strength to fact witnesses and can provide an authoritative opinion on the proper protocol and business practices in question. In many cases, former FDA compliance officials are sought after experts as they offer a perspective on FDA’s thinking, having participated in regulatory actions and recommendations on the agency side during their tenure. In the court room, expert witnesses can assist in developing questions to ask adverse lay and expert witnesses.
It is important to choose an expert whose background, education, and experience will stand up in court, and who will be qualified to testify. It is also important to choose an expert witness who communicates well. Even the most knowledgeable expert may be perceived as less credible if they do not have good communication skills.
As you assess your options, ask for recommendations. Look for an expert with whom you have a good rapport, who responds to inquiries in a timely manner, provides well written and thoroughly documented reports, and would present well in court.
Bottom line: Take care when choosing consultants. Their work product is a professional reflection of yours.
Retaining a Consultant
Conducting due diligence prior to engaging a regulatory consultant will pay dividends in ensuring their skills and knowledge most closely match the requisite expertise.
Before engaging consultant services, first determine your needs. Will they be providing testimony? If so, is a consultant working as a non-testifying adviser sufficient, or do you also need a consultant who is able to provide expert opinions? Those who may be asked to provide expert opinion require greater vetting.
Before retaining a consultant, seek information about the following:
- Education level: While higher education does not necessarily equate to a greater knowledge of the issues before the court, additional credentials may add to the weight of the expert’s opinion in the eyes of the jury.
- Career progression: Did the consultant work in the area in which assistance is required?
- Special skills or certifications: Pursuance of specialty certifications can demonstrate an increased level of both personal and professional interest and development in a given topic.
- Experience as an expert witness: While not a requirement, previous experience as an expert witness demonstrates not only a recognized expertise in a given area but prior recognition as an expert.
- Creativity: The attorney should look for consultants who can help develop and advocate themes and arguments, and who are open-minded.
- Good listener: If the expert is going to testify, the expert needs to know how to listen to questions and respond in a manner which will help the trial team, while not going off the reservation.
- Availability: Litigation can operate on a very tight timetable. The consultant must be available for inspections, depositions, and trial.
- Conflicting positions: Due diligence on the consultant must also be undertaken to determine whether there are any conflicts between the expert’s position in the case at hand and past opinion pieces, published articles or previous testimony that could be used to impeach the expert. In addition to doing your own homework, ask the consultants directly if they have any contradictory positions that would hinder the case.
Presentation in the courtroom: If the consultant is working behind the scenes, this may not be as important. However, in cases where the expert will be testifying, choosing a consultant who presents well cannot be over stated.