Proactive Preparation of Defense of Post-Recall Litigation

In the present environment, it is not surprising that a pharmaceutical or medical device recall may lead to litigation. Recalls often generate a large amount of media attention. In addition, attorneys representing plaintiffs frequently monitor the Food and Drug Administration (FDA) Web site for new recall information to solicit clients. After a pharmaceutical or medical device manufacturer initiates a recall, its duties pursuant to FDA laws and guidelines do not end there. The FDA has set out certain responsibilities and steps that a manufacturer must or should follow after initiating a recall. Pharmaceutical and medical device manufacturers, however, can effectively combine their post-recall duties and responsibilities with a proactive preparation of a defense of potential litigation.