Your product group is planning for the debut of the company’s most exciting new widget. Being responsible company citizens, the group checks in with the legal department to confirm the product regulatory and risk landscape. They start with the seemingly simple questions: “What are the applicable laws and regulations?” and “What are the foreseeable risk scenarios and associated damage potential?” Rather than answers, questions ensue. For example, what are the product components and/or ingredients? Will the product or its components contain anything toxic, corrosive, irritating, sensitizing, flammable or combustible? What are the foreseeable dangers associated with the product? What kind of product claims are envisioned? And so on.
So begins the process of navigating the complexities of potentially applicable regulatory schemes and prognosticating the risk and damage scenarios in a world in which ambiguity seems to be a purposeful tool in the regulatory enforcement tool belt.
Kelly Faglioni, a partner in our Product Liability group, authored an article, highlighting the complex regulatory web that touches even the “simplest” of products, including approaches to the question: “To recall or not to recall?”