May 18, 2012

Guidelines for Your Subject Matter Expert: The Document Review Phase

Our series on guidelines for first time expert witnesses and seasoned witnesses alike continues. This posting covers the main part of the engagement – the document review.

This work is important, not only because it prepares you for the deposition, but in many cases your reviews and opinions will contribute to a settlement in the case and there will be no deposition. This is to say that testimony is not always needed from the SME. Realize that you will provide opinion and a report but not always testimony. Usually you don’t know, unless the case reaches an impasse and neither side is satisfied. At that time, the attorneys determine that depositions will be required.

1- Document Review:  The client will provide the remainder of relevant documents for your review and evaluation. This can be via e-mail or FedEx or UPS. You will be told what documents they are. At that time you may ask for additional documents. For example, if this is a pharmaceutical case, you may ask for the batch record of the lot of product in question and the batch records of the lots produced before and after that one. You may also ask for the results of the latest Food and Drug Administration (FDA) inspection, and the results of the last company internal quality audit. You advise that after you review all the documents, you may ask for more. This is common since document review leads not only to conclusions, but also to additional questions.

2- Other Experts: You want to know what other experts are involved and let your client decide whether you should talk to them. Most times you will not need to talk to any of them, but you want to know their opinions so that you do not make any statements that could be thought to contradict them in any way. If you are a pharmaceutical chemist who is an expert on FDA regulations, then there may be other experts who are physicians, microbiologists, engineers, and others.

3- Work Schedule: Your work will be intermittent, several hours or days followed by nothing (during which other documents are being obtained) and then more work. You will likely write a detailed report which will be notarized before sending to your client. You can actually start the report and then add to it as more documents are evaluated by you. Some of the documents may be other persons’ depositions. At this point keep it a rough report. Some of your opinions may change as you evaluate more documents. It is completed after all the documents have been read.

4- Report: You and your client talk about the report that you will prepare. This report is a document expressing your Expert Opinion. It will begin with a few pages stating who you are, what experience you have and essentially why the readers should believe what you say here. The report is not disseminated until after you and your client have discussed it. Being very smart, you will have read it over the phone to your client before printing.  Whatever discussion takes place, it is still your report. Your client does not write it and have you sign it. It’s yours and it represents your professional opinion - your conclusions reached after reviewing all the documents. A list of documents reviewed is contained in the body of the report or as an attachment. This way, the readers know what documents you’re talking about. Remember that your report will be read first by your client and then will be given to the opposition and the court. After printing and signing, it is placed in a really good binder and sent to the client.

5- Deposition/Settlement: The case can settle at any time or it can continue on to your deposition.  In either case, your work has provided value to both your client (the attorney) and their client (the plaintiff or defendant).  Separate guidelines for deposition and preparation can be found in our earlier blog posting. 

The author has been a Subject Matter Expert in cases involving pharmaceutical products, laboratory results, medical devices, and foods. He has testified in personal injury cases and in cases involving disputes between two or more firms. For more information, view the CECON consultant profile: Former FDA Employee, Regulatory Consultant, Expert Witness and Pharmaceutical Chemist




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