June 05, 2013 Articles

    Discovery and Pharmaceutical Litigation: Know Your Client

    By Matthew Jackson

    The evolution of discovery of electronic information over the last decade has dramatically changed the litigation landscape. The proliferation of electronic data in the corporate workplace has made discovery bigger, more complicated, and more expensive. It is also fraught with peril— you cannot win a case in discovery, but you can lose it. Common characteristics of pharmaceutical companies and the current regulatory scheme for new drug development raise the level of difficulty and present unique challenges during discovery. This article will explore a few of those characteristics and suggest approaches for dealing with a number of them.

    The early Meet and Confer sessions now mandated by the federal rules present an important opportunity to shape the scope of discovery. To maximize this opportunity, consider the following suggestions:

    Define Issue- and Witness-Specific Time Periods for Document Production
    The most common way to limit the scope of discovery is by selecting custodians and crafting search terms. However, the smart negotiator will pay particular attention to the relevant time period for defining responsive documents. Because of the extended development and approval process for new drugs in the Unites Stated, it is often the case that the relevant time period for research and clinical testing documents stretches back several decades. See http://www.ftc.gov/be/workpapers/wp262.pdf. However, that does not mean that all custodians or document repositories need to be searched for documents dating back that far. In most cases, it would be extremely burdensome to do so. More importantly, it is not likely to increase the number of truly relevant documents. Counsel should carefully carve out separate extended relevant time periods for specific categories of documents, such as documents relating to clinical testing and development and a representative custodian or two involved in the development phase of the drug. Relevant time periods for remaining custodians or data sets can often be defined in a much narrower window.

    Master Your Client's IT Structure and Its History Before the Meet and Confer
    It is essential for litigation counsel to understand the IT structure of their clients and counsel is expected to apply their understanding to facilitate the effective discovery of relevant documents. (See http://apps.americanbar.org/litigation/committees/technology/articles/spring2012-0412-e-discovery-collaboration-clients-counsel.html). Pharmaceutical companies typically have complex technology infrastructures to support their extensive operations that may be difficult to master without a significant time investment by counsel. Additionally, because of the possibility of an extended relevant time frame, often the company has had shifts in technology platforms, archiving systems, or applications that affect the ability to collect and recover responsive documents. It is best for counsel to gain a complete understanding of the IT structure and history prior to Meet and Confer sessions so that he or she is in the best position to manage expectations about what is possible to collect, review, and produce.

    Identify Any Relevant Foreign Jurisdictions and Their Limits on the Scope of Discovery
    Pharmaceutical companies are often large multinational affairs who regularly seek regulatory approval in foreign countries and market their products globally. This has the potential to further complicate the discovery process to the extent documents relevant to domestic litigation reside in foreign jurisdictions. Besides the logistical concerns of physically collecting, searching, and processing data in those countries, many foreign countries also have data privacy laws or other legislative restrictions on physically moving data into the United States. See http://apps.americanbar.org/litigation/committees/technology/articles/071310-ediscovery-tips-international.html. Working around those obstacles can be very costly and time-consuming, and may not be possible. The best advice is to negotiate around the need for foreign collection if at all possible and, if foreign data collection cannot be avoided, seek the advice of counsel experienced in this practice area and in the foreign jurisdictions.

    Keep U.S. Privacy Regulations in Mind when Negotiating Production
    Pharmaceutical companies are bound by Federal Regulations to protect the identity of patients. Because of the extensive clinical testing and ongoing monitoring of adverse events, most productions in this type of litigation include massive amounts of patient-identifying information. Counsel must make sure that document productions do not contain patient-identifying information or that federal and state laws governing the production of such information are satisfied. Violations of these regulations can carry steep penalties, so the stakes are high. See http://www.thefederation.org/documents/R%20-%20SHALOUB.pdf. In many cases, what is really important to the litigation is the underlying data from clinical studies or adverse event reports. It may be possible and more practical for the parties to agree to export and produced data from native database applications excluding patient information rather than dealing with scores of study tables or adverse event reports that identify patients.

    Early recognition of the common challenges mentioned above will allow counsel to effectively navigate the discovery pitfalls of pharmaceutical litigation. The best practice is to formulate ways to address these issues early on and lay the groundwork to work around them with opposing counsel during the Meet and Confer process.

    Keywords: litigation, products liability, pharmaceutical, discovery, document production, federal rules, Meet and Confer process, patient-identifying information, privacy regulations, foreign jurisdictions

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