You work in risk management for the manufacturer of a bone cement. A major newspaper recently published an article in which three unnamed physicians reported cement deterioration approximately six months after the product's use. In all of these cases, the patients required repeat surgery, and at least one case led to serious and permanent debilitation. All of the physicians were using the product off label.

Discuss whether a report to the FDA is required, and the statutory/regulatory basis. How sales persons should respond to questions from orthopedic surgeons about the article and whether the company has received other adverse event reports. Whether the company must notify shareholders and why or why not.