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 drugs be manufactured approved by the FDA before it engages in interstate commerce. When a new brand name is created that drug must be submitted as a New Drug Application (NDA). The NDA compiles all materials and must be submitted to the FDA with a full report. This can be an expensive and lengthy process, so then congress created an easier path for generic drugs to be issued to the public. In 1984 the Hatch-Waxman Act was created which allots for generic drugs to be approved for use without so many provisions. The drug is a mirror image of the name brand drug.
The Supreme Court ruled in favor of Mutual Pharmaceutical reversing Bartlett’s initial argument of failure-to-warn and design-defect claims. The courts denied her failure-to-warn claim because she did not read the box nor label. The other claim of design-defect was found to stand and held Mutual liable for $21 million in damages. Mutual did appeal.

Analysis
The case of Mutual Pharmaceutical Co. v. Bartlett, exhibits the conflicts that may arise between Federal and State Laws in regards to liability of generic drug manufactures. Mrs. Karen Barlett took a generic medicine in place of the brand name medicine called Clinoril. As a result of taking this medicine, she developed serious side effects that included the Stevens-Johnson syndrome and toxic epidermal necrolysis. 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 courts look at in these types of cases: 1. What was the usefulness and desirability of the product? 2. Could the risk of danger be reduced without affecting the manufacturing cost or, effectiveness of the product? 3. Where there unforeseeable uses and or hidden dangers that would cause unreasonable risk of harm? The Federal Food and Drug Associations (FDA) Requires that any company selling and /or distributing, any type of product whether it be nutritional, prescriptions, generic drugs, vitamins etc., that none of the labels should be printed with false information, nor should it make any false claims of what the product will or will not do, such as cure an illness.

REFERENCES
Supreme Court Of The United States. (October, 2012). Mutual Pharmaceutical Co. v. Bartlett. Retrieved from http://www.supremecourt.gov/opiniion/12pdf/12-142_8njq.pdf