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.
Proactive Preparation of Defense of Post-Recall Litigation
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.
By
Lori Cohen And Christiana C. JacxsensThis premium content is locked for LawJournalNewsletters subscribers only
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