Essay on Learning Team Reflection

693 Words Nov 29th, 2014 3 Pages
Learning Team Reflection
Issue
The issue in this case is whether Mutual Pharmaceuticals should refrain from making the generic equivalent of Clinirol which is a nonsteroidal anti-inflammatory drug sulindac or change the label on the drug to “contain a more explicit toxic epidermal necrolysis”, warning which was recommended by the FDA. Although the New Hampshire had a design-defect clause which forces progressive duties on manufacturers the federal law states that the drug company cannot modify the label or composition of the drug that a generic version of another drug. Since both of these laws contradict each other Mutual was left with only one option to discontinue the production of said product.

Rule
The FDA requires that all
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Mrs. Bartlett sued the generic drug manufacturer Mutual Pharmaceutical for damages, because the label of the medicine did not have a warning about toxic epidermal necrolysis.
This case started at the New Hampshire State Court and was later moved to the Federal District Court where the court examined two accusations, one for failure to warn and another for design defect. The court dismissed the claim for failure to warn because she did not read the instructions of the medicine, but it found Mutual Pharmaceutical liable and awarded $21 million in damages for the claim of design-defect (Supreme Court Of The United States).
The Supreme Court reversed the decision of the District Court based on the impossibility of Mutual Pharmaceutical to meet the requirements from the State and Federal Law. The Supreme Court made this decision because in cases where there is a conflict between Federal and State Laws, Federal Laws have precedence under the Supremacy Clause.
The New Hampshire State Law requires drug manufacturers to ensure their products are safe to consume before marketing. Mutual Pharmaceutical was not able to change the composition or the drug label, for restrictions of a Federal Law that prohibits generic manufactures from making changes to their drug labels (Supreme Court of the United States).

Conclusion
Explanation
There are three factors that the

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