Practice Tip: Prepare Yourself and Your Employee Witness for the 'Regulatory' Deposition

A very basic, yet critical, component of the successful defense of a product in product liability litigation is the thorough preparation of the defendant company's employee witnesses who may be called to testify about regulatory compliance. Although such witnesses may be well versed in the regulations that govern the product at issue, they often walk into depositions woefully unprepared to deal with deposition “tactics.” So how can one thoroughly prepare a company witness who will be asked to testify regarding the company's compliance with governing regulatory schemes? First, learn the regulations yourself well in advance of your meeting with the witness. Become familiar with the regulatory scheme that governs the registration and marketing or sales of your client's product. Obtain and read all documents that reflect contacts between your client and the regulatory authority. Second, have the witness walk you very carefully through his/her understanding of the regulations and the company's compliance with them. This is important so that you can assess the witness's knowledge, as well as to further your own education about the company's regulatory compliance. Review the regulatory documents with the witness. Know which documents he has specific knowledge of and which ones he does not. Third, make sure that the witness is familiar with the deposition process itself and understands the mechanics of the deposition, eg, what to do when you object, not to speculate when giving answers, etc. Fourth, and perhaps most important, prepare your witness well for the “trap” questions. These are questions that assume regulatory requirements, which often are not imposed in the manner suggested by the question. Consider the following deposition question typical of one posed by plaintiffs in a pharmaceutical product liability case: