The Legal Environment Of Business: A Critical Thinking Approach
12-7
Answers to Critical Thinking about the Law Questions, Case Summaries,
Answers to Review Questions, Review Problems, and Case Problems
Suggested Answers to Critical Thinking about the Law Questions
1. There are two primary differences between the cases. First, in Katherine’s case, Katherine
interacted with the product. She bought the product and removed the cap, whereas the other
2. The idea of security is shaping the judge’s thought. The definition of security should be
revised and made consistent with thoughts of safety. Consumers should be confident that
3. It would be helpful to have the date because the exact cause of the problem can be explored.
Knowing the date might help one see whether the manufacturer has a design defect (are all
cans defective no matter when they were manufactured?) or are only some defective (which
Case Summary—Mutual Pharmaceutical Company, Inc. v. Bartlett
This case involved the Food and Drug Administration’s approval of the nonsteroidal anti-
inflammatory pain reliever sulindac, sold under the brand name of Clinoril. The FDA also approved
its labeling, which included warnings of potential side effects. After the drug patent expired, Mutual
Pharmaceutical Company produced generic versions of the drug. Karen Bartlett used Mutual’s
generic version of the drug and developed toxic epidermal necrolysis, becoming severely disfigured
and blind as a result. The drug label had not warned of the potential for the disease. Subsequently,
the FDA recommended changing all NSAID labeling to contain a more explicit toxic epidermal
necrolysis warning. Bartlett sued Mutual and won, with the jury awarding her over $21 million in
damages. The First Circuit Court of Appeals affirmed the decision. Mutual appealed.