7 Easy Ways to Enhance Your Expert Witness Practice

by Gerry H. Goldsholle

Last year, ExpertPages released the Attorneys Survey Report, a key expert resource detailing how Attorneys search for, find, and interact with expert witnesses. The report contains survey data that points to attitudinal changes amongst attorneys with regard to experts and reveals that some long-held assumptions made by experts are no longer true. Overall, the data reveals that attorneys have become more demanding and more involved in what their retained experts do and how they do it.

The ExpertPages report uncovers data that is highly informative and useful, but the critical question for most expert witnesses is: “What can I learn from the data to help me enhance and grow my practice and generate more income?” Based on the data in the report, here are the key lessons I learned.

Here are the 7 steps every expert should take to enhance his or her practice.

1. Triple Check Your CV

If you think that nobody goes over your CV with a fine tooth comb, think again. ExpertPages’ survey shows that a majority (61%) of attorneys who consider hiring an expert Always (40%) or Generally (21%) check out the expert’s CV. And it’s important to remember that if an attorney sees something amiss – even a harmless oversight, such as not updating a resume to reflect you no longer hold a particular position, or a typo (which an attorney may regard as a sign of lack of attention to detail or carelessness) – that may disqualify you in the attorney’s mind. Attorneys who hire experts know any error, no matter how trivial, can be seized upon by opposing counsel who will characterize the error as a deliberate falsehood or evidence of sloppiness, making you seem untrustworthy or worse, sloppy. And that’s being kind. Get it right and update it frequently.

2. Expose Your True Self

Who are you? What do you look like? Do you speak clearly, composed, and with conviction? Attorneys definitely want to know. We know that because eight out of ten attorneys (80%) said that one of their most vexing problems in choosing a new expert is “Having a sense of the Expert’s appearance/demeanor at depositions or trial.”

Clearly, this is an issue for attorneys, and yet far too many experts rely exclusively on their CV and an outdated photo to reveal who they are and what they know. With relatively little cost and effort, experts can easily add videos to their profiles, giving prospective clients a better sense of how they might appear at deposition and/or trial. ExpertPages provides its members with an easy way to create and add videos to their profile pages. All you need is a video camera on your laptop, tablet or phone and an ExpertPages membership and you’re good to go.

3. Be Proactive On the Terms of Your Engagements

Do you have a written retainer agreement? If not, there are at least three excellent reasons why you should. First, attorneys, on average, are requiring signed retainer agreements in almost three out of four engagements (73%). Interestingly, their insistence on such agreements applies almost equally to experts that they have worked with previously, as well as to experts that they are engaging for the first time.

Second, and at least as important, if you do not have your own, you will undoubtedly be asked to sign an agreement drafted by the attorneys retaining you in the matter. Having your own retainer agreement helps you to protect your interests while also demonstrating your professionalism.

Third, a well-drafted retainer agreement need not cost you thousands of dollars. There are many good examples online, including at ExpertPages.com.

4. Set Your Rates Using Data and Don’t Cheat Yourself

Are your Rates (Hourly Fees) competitive with your peers?

Having rates that are too low may send a signal that you’re not as confident, qualified, or competent as others, while having rates that are too high – whether you set them too high or because a referral bureau marks them up – may eliminate you from consideration. In the ExpertPages 2018 Survey of Attorneys, we learned that attorneys drop consideration of a particular potential expert more than a third of the time (38%) because the expert’s rates were too high.

Do you know where your rates are in relationship to your peers? If you do not, referral bureaus, trial testimony transcripts, and your relevant trade association can be excellent sources of real data.

ExpertPages’ authoritative Expert Witness Fees & Practices Report also provides ExpertPages members excellent data on expert witness rates. ExpertPages has been conducting a biennial study that is the basis for this report for more than 20 years. Visit the Expert Witness Fees & Practices Report and download the page for a complimentary copy of the most current Executive Summary.

5. Communicate Clearly and Often About the Assignment, the Budget, and Your Bill

Attorneys reported that they think experts are guilty of “overbilling” in half (50%) of cases. Nothing can sour a relationship – and future referrals – more than an attorney thinking the expert is deliberately cheating them. Yet when ExpertPages followed up with attorneys, it turned out that most of what attorneys had regarded as “overbilling” was simply a result of the attorney and expert not having a clear understanding, in advance, of the anticipated budget and the nature and scope of the work the attorney expected the expert to carry out.

Not all cases are equal. While Attorneys always expect competence, they do not expect an expert to expend the same amount of time and effort in a relatively minor matter as would be required in major, high stakes litigation. Additionally, as circumstances often change as a case moves forward, and the potential for settlement always exists, attorneys expect experts to regularly confer with them as to where things stand relative to the agreed upon scope of the assignment and budget. Almost all of what attorneys otherwise might view as “overbilling” could be eliminated with good communication as the case moves forward.

6. Act Like a Businessperson, Not a Rock Star

We have all heard the stories of the extravagant requests that some Rock Stars demand on tour, and while they’re not that surprising, the out-of-pocket expenses demanded by some experts clearly are over the line. Attorneys reported experts insisting on First Class on all flights, including short hops such as NY to Boston or LA to San Francisco, and accommodations at ultra-luxury hotels with meal allowances to match.

One can only imagine how a plaintiff’s attorney, carrying these expenses in a contingency case, reacts to these requests, or how a defense attorney forced by the insurance company retaining her to fly coach and stay in a Holiday Inn Express would react. Many attorneys reported that an expert requesting above average (and not merely extravagant) expenses serves as a warning signal that this is an expert they don’t want to deal with, and simply look for an alternative rather than even try to negotiate.

7. Think Twice, Talk Three Times, Write Once

Experts would be well advised to ask the retaining attorney if he or she has any written guidelines setting out the procedures the attorney expects the expert to follow when reviewing material (such as keeping a log of each document the expert reviews during the course of the assignment) and preparing reports.

Writing too much, too soon, is also a potential problem that can be avoided, as more than four out of five (82%) attorneys reported having to ask their experts to reconsider, revise, or expand their draft reports. Once again, as discussed with the issue of billing, clear and ongoing communication between expert and attorney as to the effort the expert is expected to devote to preparing a written report, and what the attorney expects to be included in that report, could go a long way towards reducing any “surprises” when the expert’s draft report is delivered.

About the Author

Gerry H. Goldsholle – A practicing attorney, expert witness, and serial entrepreneur, Goldsholle is Founder and CEO of the Advice Company, a San Francisco area-based internet publisher whose properties include: FreeAdvice.com, ExpertPages.com, AttorneyPages.com, and SeniorCareAdvice.com.

The Digital World, Medical Devices, and FDA.

The guidance documents listed here are FDA guidances with Digital Health content and are intended to help industry and FDA staff understand FDA's regulation of digital health products.

Please note that the 21st Century Cures Act (12/13/2016) clarified FDA's regulation of medical software. The new law amended the definition of "device" in the Food, Drug and Cosmetic Act to exclude certain software functions, including some of those in the guidance documents below.

If you have questions about how the 21st Century Cures Act affects your products, or if you have comments on how the FDA should regulate medical software, please email digitalhealth@fda.hhs.gov.

List of FDA Guidance Documents with Digital Health Content


OPPORTUNITY: Medical Device Design Engineer [012090]

The FDA Group is recruiting

We have a client in the Seattle-metro area who is looking for a medical device mechanical design engineer with the following qualifications

More than 5 years professional experience.

Education: Bachelor's Degree in Mechanical Engineering over equivalent.

Performs engineering duties; develops, designs, and tests mechanical devices. Writes technical reports, handbooks, and bulletins for use by staff or customers. Researches designs and makes recommendations based on appearance, safety, budget, and function.

RCA and Quality improvement activities a plus.
Works well in team environment but can also work independently.
Creo 3.0 experience preferred.
Knowledge of working with outside suppliers both domestic and foreign.

Te position is to start as soon as possible and last 18 weeks with the possibility of extension.  This is a highly competitive opportunity and rate is a very important factor. 

If you can help with this engagement please contact Brie Stoianoff, 
bstoianoff@thefdagroup.com, +1 5037509178 with a brief 1-2 paragraph statement of your expertise as it relates to this matter as well as the rate you would be willing to accept.  If you know of someone else who may be a good fit, please share that with me as well.  Please keep in mind that if you respond to this opportunity and want to get an update, simply click on this link https://fdagroup.force.com/s/ and enter the project number located in the subject line. 

Being an Expert Witness

I am very fortunate that my over 40 years of FDA Medical Device experience has allowed me to serve as an expert witness in cases involving FDA regulation of medical devices.   The experience is one that is quite unique and does present significant challenges.

I want to thank The Expert Institute for the guidance they provide to assist expert witnesses.  This is from a recent article by The Expert Institute.  

Top 15 Tips for Testifying as an Expert Witness

1.) Draft a Comprehensive Retainer Agreement
The foundation of any solid attorney-expert witness relationship is a comprehensive retainer agreement. The retainer agreement should specify all pertinent terms and obligations of both the attorney and expert. The services to be performed, the general preparation required, and the expert’s fees should all be clearly stated in writing. If the expectations of both parties are established, they are less likely to have misunderstandings down the road.

2.) Discuss Any Potential Disqualification Issues Beforehand
Before preparation for trial commences, it is important for the expert to disclose any potential disqualification issues. An expert’s testimony may be disqualified for substantive reasons, for example, if the science behind the expert opinion is considered novel and untested. Other disqualifications may occur because of conflicts of interest, such as the expert having been previously employed by or hired as an expert for the opposing party. Because the disqualification of an expert can be detrimental to a case, it is important to discuss these issues as early on as possible.

3.) Find Out the Specifics of What You Are Testifying About
While a retainer agreement should state the general subject matter at issue in the case, experts should always verify the exact nature of the testimony that the attorney is seeking. Particularly in regard to highly complex scientific matters, a greater degree of specification may be necessary so that the experts may tailor their testimony accordingly. In addition, any experiments or testing that needs to be conducted should be stated, so that the expert may be fully prepared.

4.) Update Your Curriculum Vitae
While experts will have the opportunity to establish their credentials in court, a concise, up-to-date curriculum vitae that showcases their expertise in the subject matter at issue is vital. A curriculum vitae that strongly conveys the witness’ qualifications may even result in the uncontested declaration of the witness as an expert prior to trial, saving both the time and effort of conducting a voir dire.

5.) Obtain and Review Any and All Necessary Materials
In order to reach a fully formed opinion, all necessary file materials must be obtained and reviewed in a timely manner. Any materials that an expert will need should be provided by the attorney as soon as practically possible. In addition, any rules and regulations governing the dissemination of the materials should be disclosed, such as whether they are under a protective order by the court.

6.) Find Out if a Written Report is Needed
In federal courts (and certain state jurisdictions), expert witnesses are required to provide a written report pursuant to Rule 26 of the Federal Rules of Civil Procedure. Under Rule 26, expert witnesses must disclose a report previewing the expert’s proposed testimony to the opposing party. The report must contain “all opinions the witness will express and the basis and reasons for them.” As such, experts should be aware of this requirement well before the due date of the report.

 7.) Be Careful with Written Communications
If the above rule is applicable, experts must be mindful of all written communications. In addition to laying out the basis of the expert’s opinion, Rule 26(a)(2)(B) of the Federal Rules of Civil Procedure also mandates disclosure of facts or data considered by the witness, any exhibits the expert intends to use, the witness’ qualifications, a list of other cases in which the witness testified, and a statement regarding the expert’s compensation for testifying. Therefore, any documents created by the expert may be discoverable.

8.) Inquire as to Other Expert Witnesses
Knowing whether other experts are testifying can help narrow down the scope of the expert’s own testimony. If other experts will be handling different aspects of the subject matter, then each expert is free to focus on one specific area. Particularly in regard to highly complex or technical issues, it may be helpful that each expert concentrates on its own sub-topic, opposed to one expert flooding the jury with testimony that may overlap with the subsequent testimony of another expert.

9.) Outline a Case Theory
The general purpose of the expert’s testimony is to clearly explain a particular issue of fact. Understanding the case theory, and how the expert’s testimony fits within that narrative, ensures that the expert will remain on track. If the one basic purpose of the testimony remains in the forefront of the expert’s mind, it is easier to craft testimony that concisely addresses the issues.

10.) Prepare, Prepare, Prepare!
Whether an expert is experienced in testifying before a jury or not, it can still be unnerving. Also, all attorneys – including opposing counsel – have their own style, which an expert may need some time to get used to. Once the general outline of the direct examination is finished, the attorney and expert should dedicate time to reviewing the material. This can prevent mistakes from occurring inside the courtroom.

11.) Practice Your Demeanor and Non-verbal Cues
In the same regard, it is vital to practice how one comes across to a jury. The actual testimony presented is only half the battle. An expert’s demeanor, posture, phrasing, tone, and other verbal and non-verbal cues are all taken into account when a jury is determining credibility. Overall, an expert should appear experienced but also likeable and trustworthy in the eyes of a jury.

12.) Be Prepared for a Daubert Challenge
A Daubert motion, named after Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the Supreme Court case upon which the standard for expert testimony is based, seeks to exclude the testimony of an expert witness that is not relevant or reliable. When deciding whether to admit the testimony, a judge will consider the factors outlined in Daubert. While the factors enumerated by the Daubert Court are non-exhaustive, all experts should familiarize themselves with the case, if testifying in a jurisdiction that follows that standard. A Daubert challenge is typically made before trial has commenced, and one of the first ways in which opposing counsel may disqualify the expert.

13.) Be Mindful of the Voir Dire Process
A Daubert challenge is not the only time that an expert may be disqualified. The voir dire process, notably different from a Daubert challenge, centers on whether the expert is qualified to testify as to the subject matter at hand. At the beginning of the direct examination, the expert testifies to his educational background, work experience, training, and other qualifications. After this initial inquiry, opposing counsel then gets the opportunity to question the expert. Once the court rules that the witness is qualified to testify as an expert, the direct examination can continue. Opposing counsel may be able to disqualify the expert if the expert’s qualifications are weak, or if a conflict of interest exists. Therefore, an expert’s qualifications should be clearly established at the onset of the direct examination, and any conflicts of interest should be discovered well before trial.

14.) A Direct Examination that Flows
While there are many ways to conduct a successful direct examination, the main goal is to ensure that the jury better understands the facts at issue. Therefore, an expert’s testimony on direct should not just be a rote repetition of scientific terminology. The expert should use lay terms whenever possible, and explain the material by breaking it down into sub-topics or using analogies. Presentation is also important – speaking in a slow and concise manner is much easier to understand.

15.) Surviving Cross Examination – Always Remain Calm
Cross examinations have a reputation for being combative. However, that does not mean that the expert should fight or struggle with opposing counsel. Sometimes, it is not what is said but how it is said that matters. Although opposing counsel may attack the expert’s direct testimony, a calm response will always trump an aggressive one. If an expert remains in control of his testimony, it is likely he may be able to sidestep or pivot a question and still maintain credibility. After all, it is opposing counsel’s job to discredit the expert in any way possible, but how the expert handles the situation can make all the difference.



Management Review for FDA ????



Those of you in the medical device industry are aware that management reviews are required by FDA regulation, specifically in the Quality System Regulation, 21 CFR Part 820.  

The specific regulation is Part 820.20 (c) which states “Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.”

So, we perform Management Reviews because FDA regulations require it? (Hence the question mark after the title of this article.) In fact, if you are performing management reviews only to satisfy FDA, you may be complying but you are probably wasting your time. Effective management reviews should have tangible value to the senior executives performing the review. In this post, we will review how to perform effective management reviews, that will assist in the effective management of the company.

In the mid 90’s I was selected to be the Vice President of Regulatory Affairs and Quality Assurance for a major manufacturer of cardiovascular devices. The Management Review QSR requirement was relatively new, and I took on the responsibility of the Management Representative (as defined in the QSR) and established a Management Review procedure. I first met with the CEO and explained to him that the he would chair the Management Review meetings, and I wanted to make sure he received the information he considered valuable. He remarked that he would see the value of the effort if it allowed him to better manage the company. I proceeded to work with his staff to establish measurable quality indicators for each of their functions. Once that was accomplished, I took on the responsibility of collating the indicators and preparing presentation in graphical format.

We began having quarterly management reviews, per the approved procedure, and documented. The number of quality indicators was kept to less than 20, and the meetings served the purpose of identifying potential quality issues early and directing follow up.

At the end of my first year as the VP or RA/QA at my annual performance evaluation, I received the greatest compliment of any review I had experienced. My boss, the CEO said to me “Larry I see you more than just the VP or RA/QA, I see you as a business partner. The reviews you set up have made me a better leader, and I thank you for that.”  I certainly got clear picture of the value of the management reviews, but also accomplished something that that I think all VP’s of RA/QA should strive for, specifically to be seen as a member of the business team, and a valuable contributor to the success the business.

This brevity of this post does not allow for a detailed explanation of how to set up and accomplish effective management reviews. It is important for your company to understand FDA expectations for management review, and I stand ready to assist you establishing or fine tuning your management reviews, and providing clear value to your company.

Contact me at larry@fdadeviceexpert.com  or 314-499-5148

Why use external quality auditors?

We know that FDA's Quality System Regulation requires registered device firms to have regular internal quality audits.  Let's see what the regulation says.

"Sec. 820.22 Quality audit.
Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented."

I have highlighted the section regarding how FDA describes the individuals who perform the audits.  Most mid to large companies attempt to meet this requirement by hiring one or more internal auditors and assigning them various systems to audit, so that over a year all major quality systems have been audited.  But this is not what the regulation requires.  Their is no requirement to hire internal auditors.  As a former VP or RA/QA at several large companies I now how much it costs to employ just one internal auditor.  Lets assume the annual salary of the auditor is $60,000, add the that the normal 30% overhead and you have a annual cost of $80,000 for one internal quality auditor.

Are you getting your moneys' worth?  Lets assume the internal auditor has 5 years of auditing experience and training in Part 820.   Using that knowledge they can know what procedures are necessary and determine if employees are following the procedures.  Audit observation are typically reference to not following a procedures.   You get all of this for $80,000 per year.

Now let look at using a well qualified outside quality auditor.  Typically this person will have 20+ years of experience (In my case 40+ years).  That experience will come from several employers and allow the auditor to dig deeper.  A bonus would be for the auditor to also have experience with FDA, thus very familiar with FDA expectations and procedures.  For deep audits of major systems the outside auditor would require two weeks. But more importantly the outside auditor will not be limited to observing if procedures are being followed, the outside auditor will comment on deficient procedures, which is beyond the scope of almost all internal quality auditors.

The typical two week outside audit would cost the firm $35,000.    Two of these two week audits would then be a $70,000 annual cost, but more importantly you will receive an expert opinion your FDA compliance.  The numbers speak for themselves, the company can save money and have a higher level of auditing coverage, and greater possibility of FDA compliance, by using outside quality auditors rather than employing internal quality auditors.

Give us a call at 314-499-5148, or email larry@fdadeviceexpert.com.   We can talk more about this.