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Click here to read the Spring 2008 issue of Health Law Monitor.
At EU level, there are essentially two routes to obtaining an authorization from the EMEA to place a product on the market more quickly than through the usual marketing authorization route. The first is an application for a conditional authorization that is available where clinical trials have not been fully completed. This is not a full marketing authorization, but, as its name suggests, has conditions attached. The intention is that once the conditions are fulfilled, the authorization can become a full and unconditional marketing authorization. The other route is through an application to the EMEA for an accelerated or exceptional authorization. For this application, full data is available and a full marketing authorization is obtained, but the decision-making process occurs more quickly. In addition to these EU routes, some individual member states have their own legislation allowing products, subject to controls, to be marketed without a full marketing authorization in specified circumstances. This national legislation is the subject of a harmonizing guideline issued by the EME1, although significant differences still remain in how the member states operate these compassionate-use programmes.
Continue Reading...This post was written by Melissa A. Geist and Steven B. Roosa.
On May 29, 2008, the U.S. District Court for the District of Maryland issued a lengthy and noteworthy ruling regarding the discovery of “electronically stored information” or “ESI.” The court held that the defendants waived the attorney-client privilege and work-product doctrine with respect to 165 separate documents. See Victor Stanley Inc. v. Creative Pipe Inc., Civil Action No. KJG-06-2662, 2008 WL 2221841 (D.Md. 2008). The case is particularly instructive because it describes in detail the multiple steps that a litigant should take in order to (1) protect against the inadvertent disclosure of privileged ESI; (2) preserve the privileged status of ESI in the event that it is inadvertently disclosed; and (3) defend the methodology used to search for relevant ESI.
Continue Reading...Lawyers representing clients as plaintiffs in litigation often overlook the fact that a cross-complaint or counterclaim may give rise to an obligation by the client’s liability insurer to provide a defense. A recent decision in favor of Hewlett-Packard, awarding it $51 million, serves as a reminder that insurance coverage must be examined when a cross-complaint or counterclaim is filed.
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