Robins & Robins immediately issued a massive recall for the tainted medication upon learning of the situation. Despite the recall, 1,400 children and 350 adults have been hospitalized after becoming very ill upon taking the tainted medication. Each of them had failed to note the recall after having already purchased the medication. It is quickly determined that they will need liver transplants and many of them are on a waiting list. During the wait, to date, 12 children have died. Their families are considering suing for both 402A and negligence. The attorneys stated that but for the lobbying efforts, the recall process would have been automated and the people would not have gotten sick or died.
You are an employee with the FDA. You are drafting a memo to your boss analyzing the FDA’s liability and explaining why the FDA did the right thing in deciding not to pass the original tracking bar (UPC) rule. You are specifically being told to respond to the issue of the deaths and illnesses. What would you write? Include (and fully explain) any defenses you feel that the FDA could use against any negligence or public relation cases. Explain what liability (if any) the FDA could have to the victims and their families. (Points: 30)