Implementing Generic And Generic Drugs

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INTRODUCTION Over the last few years, the United States Supreme Court has struggled to determine when a manufacturer is liable, and should be held accountable, for violating the duty to warn consumers about the dangers associated with brand and generic drugs through their labeling. Further, the Court has grappled with determining which channels are available to consumers when a drug manufacturer breaches their duty. With the swarm of inconsistencies set forth by the Court in each newly decided case, and a proposed rule regarding generic “changes being effected” preparing to take effect Fall 2015, it is difficult to determine if the necessary guidance for drug manufacturers and consumers has been provided. Pharmaceutical drug…show more content…
Second, laws such as the “learned intermediary doctrine” state, and courts have widely held, that a prescription drug manufacturer 's duty to warn runs to the physician, the ‘learned intermediary ', not directly to the patient. Only one state, New Mexico, has rejected the doctrine calling it “outdated” due to the recent increase in direct-to-consumer marketing. The Court has struggled to define the distinction, if any, between generic and branded drugs in terms of state tort liability and failure to warn claims. In Wyeth v. Levine, the Court decided that the FDA’s drug labeling requirements for brand drugs do not preempt state tort claims related to the dissemination of safety information. In essence, brand name manufacturers will be held liable for failure to update their warning labels in an effective and efficient manner. Just two short years later, the Court contradicts its decision in Wyeth, and defines a distinction for generic drug products, which applies federal preemption principles in Pliva v. Mensing. Finally, in Mutual Pharamceutical v. Bartlett, the Court effectively barred generic failure to warn, and defective design claims in state courts. Currently, under state law, generic drug product
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