1. June/July 2018 Update 37FDLI
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. Navigat-
ing 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 ren-
der 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 re-
taining 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 regu-
lations 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 cur-
rent thinking on enforcement policies and, though non-bind-
ing, 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 notifi-
cations, 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 de-
velopment 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
2. 38 www.fdli .orgUpdate June/July 2018
help shape a defense or settlement strategy and review com-
pliance and quality assurance programs, such as batch records
and master manufacturing records of raw materials.
Consultants also can advise on topics to cover during dis-
covery, 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.
Agency Jurisdiction
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 “nat-
ural” 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 ter-
ritory 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 re-
call 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 regula-
tory 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. FDLI
Ronald J. Levine is the co-chair of
Herrick, Feinstein LLP’s Litigation
Department. Ron advises consumer
products companies in complex
commercial litigation, with a focus on
class actions and other multi-party
litigation.
Amy Scanlin is a marketing
coordinator and staff writer for EAS
Consulting Group, LLC, providing
support and coordination of EAS
educational seminars, webinars and
communications.
Working with Consultants
