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Practice Tip: Prepare Yourself and Your Employee Witness for the 'Regulatory' Deposition
During the course of discovery in product liability matters, a key liability theme is often whether the defendant company complied with its regulatory obligations in connection with the product at issue. For example, in product liability litigation concerning chemical compounds, the focus might be on whether the company properly registered the compound with the EPA or with state environmental agencies. Likewise, in a pharmaceutical or medical device product liability case, plaintiffs will often focus on whether the product complied with FDA regulatory requirements. Plaintiffs' approach to such liability issues will often result in depositions that focus on whether, how, and when the defendant company informed the appropriate regulatory agencies of any risks potentially associated with use of the product at issue. Did the company submit the requisite scientific data; did it properly report known adverse events associated with the product at issue, and did it seek appropriate approval from the regulatory agency regarding the nature of its warnings to users and consumers? To that end, plaintiffs will often notice depositions of fact witnesses whom they think can provide testimony on the company's regulatory compliance or they may seek depositions pursuant to Fed. R. Civ. P. 30(B)(6) of witnesses “with knowledge” of the company's regulatory compliance.
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:
Q: Do you have an understanding that an ethical pharmaceutical corporation in the United States has responsibility for proposing drug interaction language to be included in the package insert when it becomes aware of a potential drug interaction with clinically significant implications?
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