In this episode…

Learning from your mistakes is crucial, according to Mr. Steve Silverman. As a new expert witness, it is easy to jump into your first engagement relying solely on expertise, but doing your homework is just as important. He recommends a proactive approach—question your attorney before accepting an engagement to make sure expectations are clear.

Check out the entire episode for our discussion on remote etiquette, billable research, and expertise as a trainable skill.

Episode Transcript:

Note:   Transcript has been lightly edited for clarity

Host:   Noah Bolmer, Round Table Group

Guest: Steve Silverman, President of Silverman Group

Noah Bolmer: Welcome to Engaging Experts. I’m your host, Noah Bolmer, and today’s guest is Steve Silverman. Mr. Silverman is the President of the Silverman Group, a consultancy that serves medical product companies on regulatory strategy and policy issues. He is also an expert consultant for NDA Partners. Additionally, he has over two decades in federal service, including senior roles at the FDA. Mr. Silverman holds a JD from the University of Pennsylvania. Mr. Silverman, thank you for joining me here today on Engaging Experts.

Steve Silverman: It’s a pleasure to be here, and the podcast can’t go forward unless you call me Steve.

Noah Bolmer: All right, Steve. With an extensive history in the FDA and medical device regulatory affairs, how did you first become involved in expert witnessing?

Steve Silverman: It was an easy transition for me from the point where I decided to start my own consultancy, which happened three and a half or four years ago. I didn’t initially plan to work as an expert witness, but digging into the consultancy, doing some traditional straight consulting work, and then thinking about other business opportunities, I thought, I’ve got litigation experience. I’ve deposed witnesses and presented witnesses at trial. I think have the basic competency to be an effective expert witness, and I layered that work stream into my consultancy. That’s the genesis story.

Noah Bolmer: Were you seeking expert witness engagements through your consultancy, or did you get a call one day?

Steve Silverman: Honestly, a bit of both, but to be truthful, I got a call one day from an attorney at a law firm who was referred to me by one of his partners, whom I had worked with professionally. He said, “I have this work, and we need an FDA expert regulatory witness. Is this something you are interested in doing?” I said with great confidence, and little ability, “Sure, no problem. I can do it.” I can tell you definitively that engagement was a hard fail. I’m happy to say there have been subsequent positive experiences, but the hubris I brought into the process assuming that I could be an effective expert witness simply because of my prior litigation experiences, training as a lawyer, etcetera. Not knowing what I know now, it was ridiculous that I blithely assumed that I could do a good job without doing basic homework.

Noah Bolmer: Some of the most helpful stories are the negative things because it happens to everyone. Everyone has a bad engagement and often enough, it is their first or among their first few engagements. Let’s break it down a little. What were some of the mistakes you made and more importantly, or as importantly, what did you do to rectify them forward?

Steve Silverman: Your point about negative lessons is well taken and the lessons that I remember unfortunately are usually the ones that came with pain, and I don’t want to live life where I’m constantly getting beaten up in learning things, but those are the lessons that tend to stick. In this case, I told the lawyer who had retained me, “I haven’t done this before, and I believe that I can do a good job. You let me know what you need, and we’ll go from there. You will advise what you’re looking for, and I’ll respond to that.” That was a mistake. What I needed to do was to affirmatively, and proactively conform and shape the engagement, including timing and then proactively advise the attorney, “If this is what you want, these are the materials that I am looking for, if you can provide them. This is what I would expect to review, [and] this is what my deliverable is going to be, etcetera.” The onus was on me to be the professional and to shape the engagement. I didn’t know because I hadn’t had prior expert experience, what that looked like, then the onus was on me to figure it out. I assumed incorrectly that I would get clear guidance from the attorney about what he was looking for, including timing. Things went sideways and candidly, the things that went wrong, they were on me. I failed to do what I needed to do, and there was pain, and there were lessons learned.

Noah Bolmer: it’s gracious of you to take it on the chin. Is there something as an attorney, or yourself, is there something that attorneys could be doing or should be doing with new expert witnesses to make sure that they’re adequately prepared? Is it not partially their responsibility, working for the end client, to make sure that their expert witness is not only an expert, but ready to go?

Steve Silverman: That’s true. If I were advising an attorney, I would say to him or her, “If you retain an expert, you have to make sure that you are proactively doing the things to shape the expert testimony in a way that works for your case. To make sure the expert has the information that they need, be proactive.” In the abstract, those are things that experts should be able to rely on. My experience is that oftentimes that’s not the case, and that’s fine. I don’t want to be an expert, but I don’t like surprises. I don’t want to be the person who gets a call saying, “We need to get report in a week.” Then being nowhere close to having done the research, the preparation etc. to get the deliverable to him or on time. If I’m not getting what I need from the attorney, in my view, it’s on me to define what’s necessary to provide a competent expert input to a case.

Noah Bolmer: Let’s talk about depositions and trials. Have you been in a trial setting or a deposition setting yet?

Steve Silverman: I have been in a deposition setting as an expert which is to say, I have published expert reports, been deposed, but I have not been to trial yet. I’ve been doing expert witness work for the last three and a half years. It’s not a terribly long time and it’s civil litigation and most civil litigation settles. It’s not a huge surprise that I haven’t been to trial. In my past life as an attorney for the government, I have been to trial and have done many depositions. In those cases, I was sitting there as the government’s representative. I was a lawyer that was either taking or defending a deposition. The advantage for the work that I do right now is that none of the things that I see are particularly surprising. I know what it’s like to be in a deposition, and frankly, I know what it’s like to be in a trial setting.

Noah Bolmer: As somebody who has put other expert witnesses in the hot seat as an attorney, how does it feel to have the shoe on the other foot? What’s it like getting deposed?

Steve Silverman: It’s interesting to me because my role as an expert is not adversarial. For example, when I’m being deposed by opposing counsel, which is different than the mindset I had when I was an attorney representing the government, where my job was to litigate and win cases. This is different. I have expertise in FDA regulatory practice, and my job is to explain what the answer is to the regulatory issue I have been asked to look at. If my quote-unquote client or constituent is the judge, or the Trier of Fact, I need to explain to them what’s going on. For example, if I am being deposed by opposing counsel, and they are asking me questions about my expert report, sure, they’re trying to poke holes, testing, prodding, and misbehaving, but at the end of the day, my job is to stick by my expert opinion is explain that expert opinion. Then the underlying litigation follows the course that it follows.

Noah Bolmer: Tell me about your preparation for getting into a deposition for instance. I have interviewees who have a pre-deposition or pre-trial ritual. They like to meditate. They like to drink lots of coffee. They like a big meal, no meal or heavy metal. What’s your pre-deposition regimen? If you have one?

Steve Silverman: There’s a lot of incense burning. I’m not going to admit on mike to animal sacrifice, but I’m not saying that doesn’t happen. Truthfully, I do not have a formal ritual that I follow, although I think that your other guests who do so are very smart and it makes sense. I would say this, not surprisingly, getting ready for a deposition involves a lot of preparation with the attorney whose client I’m representing. Trying to get as much information as I can about what the opposing counsel is like, what they are looking for, the manner they have conducted themselves, and even looking at their depositions of other witnesses in the matter to get a sense of how it is that they operate so that when I walk into a deposition I feel like I am cognizant of the points that I want to make. Why are those points well supported? How I would answer questions about them. It’s more a function of being comfortable with and on top of the statements and expert conclusions that I have previously reached.

Noah Bolmer: Let’s talk a little bit about etiquette when you are being deposed. How do you like to present yourself? Are there guidelines that might be useful to newer expert witnesses regarding demeanor and etiquette?

Steve Silverman: I have one good piece of advice that was given to me. At this point, because I’m old, given to me decades ago, which is to say, stand up. While I am talking to you, I am standing. I have a nice riser for my laptop, and I raise it up and I stand on my feet. In depositions, many of which are conducted remotely much like this podcast is being done, there’s no impediment to standing, and it’s not rude to be standing while being deposed by opposing counsel. I believe that there’s a physical and psychological benefit to being on my feet. It tends to make me more alert, more focused, less tired. In some respects, the simple statement stand up is trite. On the other hand, it works, and it’s an easy thing to do. That’s my tip.

Noah Bolmer: Are you able to do that over [extended] periods of time? I’ve heard expert witnesses tell me that they’ve been deposed for six hours, eight hours at a time. Are you able to stand for that long?

Steve Silverman: Being on your feet for an extended period of time could be tiring. There’s no sense in doing it if it’s going to be physically punishing. By the same token, even in long depositions breaks are frequent. If I need to take a break and decide that I’m going to sit down for a while, it’s fine. It’s a manageable process. Just because I built the habit of standing during most of my workday. It’s nothing terribly unusual.

Noah Bolmer: Earlier, you mentioned cases going to settlement in civil litigation. With more cases going to settlement, how does that affect your role as an expert witness?

Steve Silverman: I gave that question some thought prior to our taping today because you were nice enough to give me a heads up about it and here’s what I would say. I don’t think that the number of cases that settle or the settlement trajectory radically changes my role as an expert. Part of the reason is because of the work that I’m doing. For example, I am not responsible for calculating monetary damages. That’s not my expertise. It’s not my expertise to advise what the cost of a particular business transaction was. My role, and this is true for many experts, is to say, ‘This is what the facts and events indicate, given the information that has been presented to me. This is my view of the situation, and these are the reasons I support my opinion. It’s on the lawyer representing the client to say, “We had this testimony and it’s compelling testimony. Here is what our expert would be prepared to say if this case were to go forward with trial to a judge or a jury. As a result, we believe, for example, that we are well-positioned to win at trial and therefore we want to settle the case.” The settlement takes the course that settlement often does between attorneys.

Noah Bolmer: Do you see the role evolving in the future? Are there any trends that you’ve noticed from the past couple of years that you’ve been doing this?

Steve Silverman: Yes. Comfort with technology is going to be an important attribute for experts, which is not to say that experts need to be computer engineers, or they need to understand how exactly artificial intelligence or machine learning works. When a deposition is conducted, as has been the case for me, remotely and online, each person in the deposition myself, the lawyer I’m working for, opposing counsel, even the stenographer, are in different locations, and the deposition is moving forward, it’s important to understand that that creates a different nature dynamic. For me, that’s going to impact the way that I engage. How do I feel about the interaction? I feel under those circumstances, I need to be more alert, and more careful because there’s not as much focus or adrenaline as I might find in an in person setting. There is basic blocking and tackling, making sure that I have a strong signal talking to counsel in advance, and say, “If the call drops where things go sideways, what do you want to do?” Then if those things occur being comfortable with those types of events.

Noah Bolmer: Do you have a process so if you lose power are you ready to go with tethering to your cell phone? Do you have a backup solution?

Steve Silverman: I have my DoD level generator. No, to your point, the only precautions I take are the basic precautions, which is to say, I don’t know enough to create my own Wi-Fi connections, but I have a good person who does. I work with him to make sure that I have a strong Wi-Fi connection. I have confidence in my laptop. It’s a good laptop, and I know enough to know that if I’m being deposed and I have other applications open on my laptop that I should close them because it will improve bandwidth. I don’t want them to mysteriously appear during the deposition. There is nothing magical about what I am doing, but it’s worth a bit of basic due diligence about what’s different when depositions or other types of interactions are happening virtually. The other thing that I will say is, and this is truly a personal preference thing, when I am being deposed or I am talking for the first time with counsel, or witnesses, I will put on my big boy clothes, meaning I’m having a conversation with you where I’m wearing a dress shirt. I decided not to wear a sports coat because I knew that none of his was going to be recorded for me. The process of putting on professional clothes and standing in the way that I have said helps to get me into the right mindset. That’s a personal preference. I don’t think it’s a magic formula, but when I am in a deposition setting, I want to be the best version of me, the most present, the most focused, and as ridiculous as it sounds, the quote-unquote suiting up does make sense.

Noah Bolmer: You’re not the first person who’s said so. Let’s talk about some of the cases you’ve done. Have you been in any cases that have either reinforced the way that you do something or changed the way that you go about doing something as an expert witness? Beyond the bad first case.

Steve Silverman: Let me take a step back and talk about what I do because many of your guests won’t know. I am an FDA regulatory expert. What does that mean? I worked at the FDA, and I’ve worked in that regulatory space for a long time. Most of my work focuses on medical devices, but I also do some work with drugs and other types of medical products. My job uniformly involves explaining to counsel, the Triers of Fact, what have you, what do FDA regulatory requirements mean? That makes sense because the FDA regulatory requirements are not intentionally confusing, but they’re a little arcane. If you look at any variety of government agencies, whether it’s the Department of Energy or the Department of Defense, or border security, their regulatory requirements potentially are going to be confusing. People who are unfamiliar with those organizations, for good reason, are not going to understand what those regulatory requirements. It makes sense to bring in people from the outside who have lived within those regulatory environments for a long period of time to say, “What does X regulatory provision mean?” Or “If a company does A, B, and C, did they meet regulatory requirements? Did they not? If they didn’t meet the regulatory requirements, what does that mean?” One of the questions I often get asked is, “If there are quality requirements for device manufacturers that exist very broadly for all their products that have already made it to the market and the FDA comes in, does an inspection, finds some quality requirements have not been properly satisfied properly”- right? So there is a violation- “Does that mean that the products produced at the facility where the violation was found is unsafe or ineffective?” Often, that will be the allegation and for reasons I’m not going to bore you with, the answer is no. There is no reason attorneys who don’t do FDA work all the time or other individuals who are not familiar with FDA regulations would know the answer to that question. I do because this is the world that I’ve lived in for a couple of decades. My job is to explain to the attorney, to opposing counsel, and others that this is what the regulatory requirements [states]. Here’s what it means for the medical device, the drug, or other products that come to consumers.

Noah Bolmer: In your field is there a certain amount of dynamism? Does the law change frequently? Do you have to stay on top of changing regulations, and trends in that manner or is it static?

Steve Silverman: That’s a great question and I can see on video I see you smiling. Let me compliment you on the excellence of your question. Profound. It’s a good question because the answer is yes, things change, in at least two respects, which I’ll explain. It’s important to pay attention, and I will also talk about the fact that there are some things that are a bedrock and don’t change. Let me start with that. The bedrock. The FDA has a bedrock requirement for medical products that need to be safe and effective before they come to market. There needs to be some type of determination by the agency about product safety and advocacy. That is a prerequisite for getting the products onto the market. You cannot go into the pacemaker business and start selling your products, ignoring the fact that all those products must go through FDA review before you start selling.

Noah Bolmer: Sure.

Steve Silverman: That’s bedrock and it is in the FDA DNA to say we want safe and effective medical products coming to market. Right? Now, what that means in 2025 in terms of the evolution of technology and the extraordinary change that we have seen in the political environment is variable. Even leaving politics to the side, looking back in the device context over the last decade there have been absolutely transformative changes in medical devices. The impact of technology on devices has been a tectonic shift for the industry. For example, if you look at heart pacemakers, I believe that I can confidently say there are no longer pacemakers being sold that do not have high technology software capability. That means there is software that helps pacemakers’ to function properly in the heart, but there is advanced communication between the pacemaker and the company that makes it so that there is a constant feed of information to the company, which can be provided to the healthcare provider. There is real time date monitoring to see what’s happening with the pacemaker when it has been implanted. That is one of a basketful of examples, and diagnostic space. There are huge changes in terms of the ability for doctors to read and interpret that are powered by [large] computing capability and artificial intelligence. Instead of having a thousand images that a doctor can get access to that builds on his or her years of experience looking at films, knowing what’s a problem or what’s not a problem. Suddenly, they have hundreds of thousands of images, and they are not the ones who are initially looking for those images. It’s not to say that the doctors are ceding responsibility to technology because they’re not. But the scope of information and the relevance and the references that can be drawn for the technology are jaw-dropping.

Noah Bolmer: How do you stay on top of it all? Do you stay informed? Do you read journals in your field? How do you remain current?

Steve Silverman: The way to do it, I think, is to be thoughtful about where it is that I want to dig in and where I may want to simply know that something exists, but I’m not going to be somebody who has a lot of knowledge closely at hand. For example, I like talking about artificial intelligence, machine learning and other technological issues as they relate to devices, because they are incredibly interesting. In my expert work and in my consulting work, the huge minority of matters that I handle involve artificial intelligence, machine learning, quantum computing, what have you. They don’t. Still, it’s incredibly interesting, so yes, when I look at journal articles or trade publications for the device industry and they speak to those topics, I’m likely to read them if somebody is doing a webinar on topics that fall within those categories. I’m likely to tune in. There are other things that are important, like changes in how clinical trials are being conducted for devices and other FDA regulated products. That’s an example of something I know a little about, but if I have an attorney who says I need to know about an issue in this area, I’m going to have to study up.

Noah Bolmer: That’s something that many experts have to do. You’re not going to have the entire wealth of knowledge that might be pertinent to your field at your fingertips. If you have to do some additional research into something that is in your area, is that billable occurrence in your opinion?

Steve Silverman: That it absolutely is billable. Frankly, it’s basic responsible practice to be very transparent with the attorney about the fact that I’m going to do the work and bill for it. I’ve never had a problem with any attorney that I’m talking to saying, “I need five or six hours to go back and learn about this topic in order to speak about it competently. I want to let you know, and it’s going to be part of my preparation process.” The attorneys who I’ve dealt with uniformly have said, “Okay, that’s fine.” If they had a problem with it, I’d have the conversation but that hasn’t happened. Again, speaking for me, I have had jobs in the past where I have walked into a room and have been asked to speak about topics where I felt like walking into the room with heavy levels of imposter syndrome, and I don’t like that feeling. If I had an attorney who said to me, “I don’t want you to do the background work.” I’m not sure that it’s an engagement that I want to pursue.

Noah Bolmer: Along those lines, have you had to say no to a significant number of engagements?

Steve Silverman: The answer to that question is no. I have not had to say no to a significant number of engagements, but the reason is that I’ve been able to clearly define what it is that I’m interested in doing and what I’m not on the front end, and what I’m willing to say and not on the front end. For example, there is a lot of product liability litigation involving medical products. Plaintiffs are suing medical product manufacturers claiming that the product that they used failed, and they were harmed. I don’t work in that area. It’s a personal choice. I don’t want to be an expert in that context. What that means is during a representation, I have to turn down or turn away lawyers because I don’t do that kind of work. By the same token, I’m able at an early point in time tell counsel what my position is going to be, I have to learn what I need to know, and here’s what I’m going to dig into. I give them a 10,000 foot answer. Sometimes that will happen even before I’m engaged and if that’s not the answer that works for the attorney, then they don’t engage me. That’s okay.

Noah Bolmer: Let’s back up and talk about a few general ideas regarding expert witnessing. Why are expert witnesses important to jurisprudence overall? Why do we have expert witnesses? Why is the work that we do important and significant?

Steve Silverman: The best answer that I can give you, Noah, is what I was talking about before in terms of, I know a lot about a narrow band of law and regulatory practice. If you need someone to explain how the FDA regulates medical products and devices, I can do a good job to tell you about that. It’s unreasonable to expect an attorney who is more of a generalist and is handling a commercial matter, for example, that individual is going to develop the same level of knowledge and expertise. They are going to understand a lot of the things that I will talk about, but not with the same depth and to the extent that it is unreasonable to expect them to develop that expertise. I think it’s even more unreasonable to expect that a judge or a jury is going to have the expertise. Inevitably, there is going to be litigation in which parties are arguing about the significance of an FDA regulation or FDA legal practice in fact. They need somebody to come in and say, “This is what it means, or it doesn’t mean. Here’s the landscape” and then that information informs the overall trial process. The other thing is, let’s say, Noah, that’s interesting for me at least is, I would be hard pressed to think of a single matter that I’ve been involved in where the issues that I am testifying about are the only issues in play.

Noah Bolmer: Sure.

Steve Silverman: I am a piece of the puzzle. Either the plaintiff or the defendant has said, “Our case is supported in part by FDA statute or regulatory practice in the following ways.” It’s an argument, and the attorney that is dealing with that argument needs to competently get enough information to manage it. But that’s not the only thing that they’re going to have to deal with. Fine. I’m part of a larger piece of the puzzle, and I can make management of that piece of the puzzle a little bit easier so that the attorney can then focus on all the others.

Noah Bolmer: Speaking of being on a team, have you been on larger teams that have expert witnesses, consultants, other parties, and if so, what are those interactions like? To what extent do expert witnesses work with other members of the trial team besides the attorney?

Steve Silverman: In my experience, as far as I have been involved in larger teams, it is a function of working with the trial team. The individuals who I have come to know and engage with the most are part of a discrete team of lawyers that I have worked with over the course of the litigation. There are a number of firms, including the firm that is kindly hosting this podcast, aggregate experts, and make them available to attorneys and others so that when they have particular expert needs, rather than having to go out individually and search the earth for the right person, they’re able to go to a consultancy. They say, “This is basically what I am looking for and this is what I need. Do you have somebody who can fit the bill?” I have that relationship with NDA partners with other consultancies and when my skillset is one that meets the needs of counsel, then put my name forward. What I will tell you is in some respects, Noah, what I’m thinking is like, okay big deal. People know this, and the takeaway for the folks listening to this podcast is to be clear about what I can do and what I can’t. It’s incredibly important to say both to the quote-unquote aggregator and to counsel like these, “I don’t know exactly about the issue that you’re raising, but I think I can learn enough to [produce] an answer” or say, “I’ve got this and here’s what my answer would be.” Or to say, “I don’t know about it. I can’t do it.” Then, if it happens as is often the case to say, “I’m not the person, I know a person” and that’s gold. I have had lawyers come back to me later saying, “This is a different matter, but I remember talking to you and I appreciated the recommendation, and now I want to work with you.” It’s a great dynamic.

Noah Bolmer: Before we wrap up, do you have any advice for expert witnesses, particularly newer expert witnesses, or attorneys working with expert witnesses?

Steve Silverman: I do, Noah and I will chunk my response into the advice that I would give to newer attorneys or to attorneys and the advice that I would give to newer experts. Let me start with those experts and say emphatically being an expert witness is a skill. It is not something that you are born with. It is not like your ability to play pro basketball. You don’t need to grow up to 6 foot-8 inches and to be able to shoot three-point shots regularly. It is a skill, and it can and must be acquired, and there are lots of resources out there that are available to expert witnesses to get better at writing concise and compelling expert reports. To get better at giving depositions and delivering testimony, and like anything else associated with our professional work, it requires diligence and practice. For the individuals who are expert witnesses on U.S. nuclear regulatory policy, great, you’re a genius and you know how nuclear bombs and other devices are built. That means you’re amazing. That doesn’t mean that you can do a great job talking about it to your own lawyer, to a judge, to opposing counsel. So, that is okay. It means that you just need to learn and that is a function of proactively going out, figuring what resources are needed, and then gathering and applying those resources. Don’t make the mistake that I made, which was to assume that the attorney that I was working for would give me what I needed to do a good job. That is the new consultant chunk.

For the attorney, all I would say is this. I get it, I get that you are busy. I get that you have 100 plates that you are trying to keep spinning. I am just one of those plates. Your job is not to ensure that all my needs are met in the timeline that works best for me. Understood. My job is to make things easier for you, and to give you what you need so that you can have the best outcome that you want to achieve for your client. To do that, let’s get clear very early on in terms of what the deliverable is. How it’s going to be delivered? What is a good outcome for you? What does a good product look like and when do you need it? Invest the time on the front end to clarify those basic issues in consultation with the experts, so that there is a clear view as to what the expert will be providing and if there is any discrepancy between what you’re trying to develop in terms of your case theory and what the expert can credibly say, bring that to the surface soon. Create an environment in which that information is communicated by the expert at an early point in time.

Noah Bolmer: Sage advice. Thank you for joining me today.

Steve Silverman: I was a pleasure. I enjoyed it. Thank you for giving me the chance to prattle on.

Noah Bolmer: Absolutely. And thank you as always to our listeners for joining us for another episode of Engaging Experts.

Steve Silverman, President of Silverman Group

Our guest Steve Silverman is the President of Silverman Group, a consultancy that serves medical product companies on regulatory strategy and policy issues, and an expert consultant for NDA. Additionally, he has over two decades of experience in federal service, including senior roles at the FDA. Mr. Silverman holds a JD from the University of Pennsylvania.