MGMT 520 Week 8 Final Exam
MGMT 520 Final Exam 4
1. TCO D Short Answer Question and Facts for Page 1 Questions: A well known pharmaceutical company, Robins & Robins, is working through a public scandal. Three popular medications that they sell over the counter have been determined to be tainted with small particles of plastic explosive. The plastic explosives came from a Robins & Robins supplier named Casings, Inc., that supplies the capsule casings for the medication pills. Casings, Inc., also sells shell casings for ammunition. Over $8 million in inventory is impacted. The inventory is located throughout the Western United States, and it is possible that it has also made its way into parts of Canada. Last fall, the FDA had promulgated an administrative proposed rule that would have required all pharmaceutical companies that sold over-the-counter medications to incorporate a special tracking bar code (i.e., UPC bars) on their packaging to ensure that recalls could be done with very little trouble. The bar codes cost about 35 cents per package. Robins & Robins lobbied hard against this rule and managed to get it stopped in the public comments period. They utilized multiple arguments, including the cost (which would be passed on to consumers). They also raised “privacy” concerns, which they discussed simply to get public interest groups upset. (One of the drugs impacted is used for assisting with alcoholism treatment – specifically for withdrawal symptoms – and many alcoholics were afraid their use of the drug could be tracked back to them.) Robins & Robins argued that people would be concerned about purchasing the medication with a tracking mechanism included with the packaging and managed to get enough public interest groups against the rule. The FDA decided not to impose the rule. Robins & Robins' contract with Casings, Inc., states, in section 14 B.2.a., "The remedy for defects in supplies shall be limited to the cost of the parts supplied plus any and all damages caused by the defects, including loss of good will to Robins & Robins, as valued by the accounting firm selected by Robins & Robins." The accounting firm determines the loss of "good will" value to Robins & Robins as a result of this disaster is $140 million. This clause was buried on page 285 of the contract in small, 9-point type. List any defenses Casings, Inc., may have in trying to avoid the results of this clause of their contract. (short answer question)(Points: 15)
2. TCO B. The FDA discovers that, during the public comment process, Robins & Robins bribed one of the members of the administrative panel that decided to pull the rule from consideration. The member of the panel was removed and is being charged criminally. As a result, the FDA immediately implements an emergency order that puts into effect the “tracking bar” requirement and makes the rule retroactive, but only to Robins & Robins. Provide two arguments Robins & Robins can make to have the rule determined to be invalid under the Administrative Procedures Act. Explain your answer. (Points: 30) Name one argument that Robins & Robins could have used to fight against the imposition of a tracking bar (UPC) requirement in the event their lobbying efforts during public comments had failed. Explain the argument and the procedural method Robins would use to fight it. If Robins had not gotten involved in the public comments period, would your answer change? Why?
3. TCO C. 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 the public relations advisor for Robins & Robins, and your boss tells you to write him a memo that he will use to draft a public announcement. He needs you to explain to him why Robins & Robins should not be found negligent for these deaths and illnesses. Draft the memo utilizing the elements of 402A and negligence. Include (and fully explain) any defenses you feel that Robins & Robins may have. Recall that your boss needs all pertinent information for him to write an announcement to the public after reading your memo.(Points: 30) Set 3 Questions: 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)