Whether you are outside counsel retained in a pharmaceutical product liability case or in-house counsel responsible for a chemical manufacturer in a high-profile government investigation, having the right regulatory expert can be the difference between remarkable success and high stakes failure.
What should you look for in an expert?
In selecting the best regulatory expert, you are looking for an individual who understands the inner workings of specific government agencies, including how they apply to the case at hand, and to then effectively convey these concepts to a judge or jury in the form of clearly organized and compelling written reports and testimony.
Regulatory experts are notably different from other scientific and medical experts because they tend to straddle two very discrete worlds:
(1) the scientific arena; and
(2) the government rules and oversight that regulate business activity.
It’s not just knowledge, connections count too.
The intersection of skill and expertise makes regulatory experts notoriously difficult to identify and recruit. Add to this complexity of knowledge, the fact that it is also desirable to recruit an expert with past employment in a specific regulatory agency or department, often with senior standing in that office.
Even when you find a well-credentialed, knowledgeable expert, he or she is often unwilling to provide testimony in a case involving a courtroom appearance.
Consultants in this arena often spend their time helping companies meet business challenges in the form of new innovations and crisis management. Getting on the stand and giving testimony is often not very appealing to most knowledgeable and experienced regulatory experts.
Curating highly qualified expert teams takes finesse.
ISS has a long history of success building expert teams for some of the largest toxic tort and product liability, and commercial litigation in recent history. We work with counsel to understand the needs and nuances of their case, identify the candidates with regulatory expertise in the right domain, determine their interest and availability for testimony, and make the appropriate introductions.
In the sections below, we highlight some recent examples and case studies where the right regulatory expert played a critical role in a specific litigation context.
FDA Expert for a Pharmaceutical Case
A client was facing a legal challenge from several insurance companies alleging products manufactured at a specific manufacturing plant during a specific time, were wholly deficient because they were not produced under current Good Manufacturing Practices (cGMP).
Based on these allegations, companies represented by plaintiff counsel requested reimbursement for all costs associated with the coverage for those products.
Our client sought to identify an expert in the cGMP arena who may have relevant enforcement or policy experience at the FDA and experience assisting the pharmaceutical industry in all aspects of cGMP compliance. This expert would be required to provide broad context to the process by which companies comply with cGMP regulations and assure that the product is in conformity with claims and label information.
ISS was retained to recruit a team of regulatory experts to assist with this area of testimony and provide context to the facts in the case.
There were many obstacles to identifying and recruiting an expert with specific knowledge relevant to the timeline of facts who was also free from the perception of conflicts of interest. Nevertheless, we successfully introduced the client to a number of candidates well suited to the needs of the joint defense team, providing them with a sufficient variety of candidates from which to select their testifying expert.
USDA Expert for a Consumer Fraud Action
Outside counsel for a major food manufacturer faced allegations that they were making fraudulent representations in their consumer advertising.
As the defense team contemplated the breadth of options to vigorously defend the case and present all relevant scientific information they determined several disciplines for which they would need experts, including nutrition, epidemiology, toxicology, and some specific medical disciplines.
However, one of the most important areas of expertise desired was a regulatory expert who would be in a position to discuss insight into the US government food and nutrition regulations. The goal of this testimony would be to provide the important public health benefits of the products manufactured by this company.
ISS identified several highly qualified individuals formerly in senior positions at FDA as well as the US Department of Agriculture. These experts were in a position to put the company’s advertising into the proper perspective from a public health context, convey the long history of compliance and collaboration with the government regulators and potentially to have a meaningful impact on the outcome of the case.
EPA Expert for a Case Against a Pesticide Manufacturer
Outside counsel for a major agrochemical manufacturer faced allegations that its product was causing adverse health outcomes in a large personal injury action. Because the product at issue was registered with EPA and had a long and detailed regulatory history, it was critical to find an expert who could put this regulatory history into the appropriate context and perspective for a judge or jury.
This expert was expected to describe the detailed regulatory landscape, evaluate whether the product had the appropriate level of oversight, and ultimately testify as to whether the product had the requisite benefit-risk profile.
All of the above cases highlight the importance of the regulatory expert in various types of legal actions. Whether your case involves product liability claims, consumer fraud, or government actions, if the product is regulated, odds are the right regulatory expert will provide an invaluable aspect of testimony that can help you prevail.
NEED A REGULATORY EXPERT?
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