Karen Bartlett was given a generic version of Sulindac,an anti-inflammatory drug.The result was that she developed toxic epidermal necrolysis,a disease that disfigured and blinded her.She brought suit alleging that there were warnings that should have been put on the generic version of the drug because issues with the skin infections were being reported.However,the manufacturer to Sulindac did not have FDA approval to place the warning on the product.The jury awarded Ms.Bartlett $21 million,and the generic manufacturer appealed the decision.Which of the following theories would be the best approach for the generic manufacturer to take in order to have the verdict reversed?
A)The Commerce Clause
B)Preemption
C)Due process because of the excessive size of the verdict
D)Substantive due process

Question

Quizplus · Accepted Answer

The best approach for the generic manufacturer to take in order to have the verdict reversed would be to argue preemption. Preemption is the principle that federal law trumps state law, and in this case, the generic manufacturer could argue that because they were following FDA regulations for their product labeling, they were preempted from adding additional warnings. This argument has been successful in similar cases and could potentially result in the verdict being reversed.

Karen Bartlett Was Given a Generic Version of Sulindac,an Anti-Inflammatory