Drug & Medical Device Newsletter

February 2006

Electronic Document Discovery Issues in a Post Zubulake World
By Stephen M. Gracey, Jack B. Harrison and James D. Schoeny

As we all know, the scope of discovery is and must be broad.  The broad scope of discovery is particularly troublesome, however, in the context of electronic discovery.  E-mail usage and electronic file generation have increased over the last ten years at an astounding rate.  The Sedona Group estimate that over 90 percent of information created today is first generated in digital format, that 70 percent of corporate records may be stored in electronic format, and that 30 percent of electronic information is never printed to paper.  The Sedona Principles: Best Practices, Recommendations & Principles for Addressing Electronic Document Production, 3 (Jan. 2004).  These figures reinforce the need for legal hold policies as discussed below. They also highlight the complicated nature of modern-day discovery and the substantial costs that can be associated with gathering, recovering, reviewing, and producing records considering the availability of information using backup tapes, metadata, defragmentation and similar resources. 

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Case Briefs: Waiving the Attorney-Client  and Work Product Privileges
By Joseph A. Tomain

In 2005, the Southern District of New York published two opinions focusing on whether the attorney-client privilege and/or work product privilege was waived.  One case concerned waiver when information is shared with a testifying expert.  The other case addressed waiver when a company discloses information to a governmental agency.  These cases have relevance for attorneys and clients involved in drug or medical device litigation because the use of expert testimony and interaction with governmental agencies are common occurrences.  The cases illustrate that before a party shares any information with its testifying expert or with a governmental agency, it must be aware that such information will most likely lose the protections provided by the attorney-client and work product privileges.  

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Recent Developments in Pharmaceutical Federal Preemption
By Neil Desai

Federal preemption is an important defense available to drug manufacturers defending product liability lawsuits.  The question of whether certain federal laws conflict with and preempt state laws is a highly litigated one.  Courts throughout the country continue to address the issue and their decisions bear monitoring.  This article highlights some key preemption opinions issued in the pharmaceutical context as well as the government’s most recent stance on the issue.

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Recent Developments In Pharmaceutical Product Direct To Consumer Advertising
By Stephen M. Gracey

In 1997, the FDA changed the rules governing direct to consumer advertising (“DTC”) for pharmaceutical products.  The changes allowed pharmaceutical companies to use television and print ads to inform consumers about their products.  The use of television and print ads came in three forms: 1) Help-seeking ads, which may mention the name of a company but not a particular drug, inform consumers about certain diseases or conditions and recommend seeing a physician; 2) Reminder ads, which mention the name of a particular drug but not any diseases or conditions; and 3) Product claim ads, which name the product and the disease or condition that it is used to treat.  Under current guidelines, reminder and help-seeking ads are not required to contain information about risks associated with a specific product.  On the other hand, product claim ads require a fair balance of risks and benefits associated with the product.  Print product claim ads must inform the reader about the risks associated with the product, while television and radio ads must contain a major statement of all the important risk information related to the product or provide for adequate distribution of this information by referring consumers to websites, print ads or call-in numbers where additional information may be obtained.

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