As we previously reported, Kelly Faglioni, a partner in our Product Liability group, authored an article identifying and discussing approaches for managing risk that arises from complexity and ambiguity in product regulatory schemes including approaches to the question: “To recall or not to recall?”
Parts 1 and 2 of the article illustrate that regulatory complexity makes it tough to know the right questions to ask, much less to get straight answers, and ambiguity prevents accurate predictions for purposes of setting accounting reserves. Nevertheless, a business that wishes to do business must project and plan in the face of complexity and uncertainty. That typically means budgeting for potential risk scenarios, planning for recall scenarios and in some cases, grappling with the ultimate question whether to recall or not to recall your product.
Remember that as an initial matter, your product group asked legal for input on the product regulatory and risk landscape. How will you give it to them?