In order to comply with the Federal Food, Drug, and Cosmetic Act (FDCA), it is a requirement that manufacturers obtain Food and Drug Administration(FDA) approval before proceeding to market any brand-name or generic drug in interstate commerce. The generic drug must have the same chemical counterparts as the approved brand-name drug. Once the drug is approved, the manufacturer is not allowed to make any vital changes to the overall quantifiable formulation of the drug product such as the active ingredients and the detailing provided in the approved application(). In the year 2004, the respondent Karen Bartlett, a resident of New Hampshire was prescribed a brand-named drug known as Clinoril also known as Sulindac. This drug is a nonsteroidal
