Shook Associates Jason Harmon and Claire Hillman have authored an article for Corporate Counsel Business Journal detailing a change to discovery rules that provides companies with grounds to argue against the discoverability of foreign regulatory files. "[I]t is now commonplace for lawyers representing pharmaceutical and medical device manufacturers to get requests from plaintiffs for foreign regulatory communications–even though the product at issue is sold across the globe under dozens of regulatory schemes that have no impact on the case," they explain. "To combat these issues, lawyers representing pharmaceutical and medical device manufacturers need to be armed with a firm understanding of the new Rule and the obligations and limitations it imposes."
The rule change added consideration of whether a discovery request is proportional to the needs of the case, Harmon and Hellman say. They list a number of factors that courts can weigh, noting, "When analyzing these factors for courts, lawyers defending manufacturers should keep them in their true context: discovery must be proportional to the needs of the case–it need not be proportional to the defendant’s resources or the litigation’s size or seriousness. If not properly put into context for courts, these plaintiff arguments have the potential to swallow the proportionality limitation on the scope of discovery."