Federal Preemption of State Law Remedies in the American Pharmaceutical Industry

Description
Federal preemption - addressed within the United States Constitution’s Supremacy Clause - is the legal doctrine pursuant to which federal law supersedes state law. As it pertains to the American pharmaceutical industry, the Food and Drug Administration (FDA) supersedes state

Federal preemption - addressed within the United States Constitution’s Supremacy Clause - is the legal doctrine pursuant to which federal law supersedes state law. As it pertains to the American pharmaceutical industry, the Food and Drug Administration (FDA) supersedes state tort laws regarding the regulation of pharmaceutical research, development, and distribution. However, federal preemption within the pharmaceutical industry has engendered conflicts between pharmaceutical manufacturers and consumers in pursuit of state law remedies after becoming injured by the administration of a generic pharmaceutical. An exploration of the brand name pharmaceutical regulatory process and the generic pharmaceutical regulatory process implemented by the FDA within this thesis highlights the abbreviated pathway offered to generic pharmaceutical manufacturers to lower the cost of production. Brand name pharmaceutical manufacturers must satisfy arduous FDA regulatory requirements for the approval of a brand name pharmaceutical - sometimes taking up to 15 years. Conversely, generic pharmaceutical manufacturers must prove bioequivalence - biochemical equivalence - among other things, in order to be granted industry entry. This process can take as little as 6 months. As a result of this disparate regulatory landscape between brand name pharmaceuticals and generic pharmaceuticals, consumers may be led to believe that generic pharmaceuticals offer no legal recourse in the event that they produce inimical effects. Examples of this occur in the Supreme Court cases PLIVA v. Mensing (2011), and Merck Sharp & Dohme Corp. v. Albrecht (2019). In contrast, the Supreme Court case Wyeth v. Levine (2009) and the state court case Franzman v. Wyeth (2015) are examples of consumers’ state tort law claims proceeding, as their claims were not barred on the basis of federal preemption. These cases emphasize manufacturer liability for failure to comply with FDA regulatory requirements. The comparison between brand name pharmaceuticals and generic pharmaceuticals underscores the complexities of federal preemption, and its success in upholding safety and efficacy standards implemented by the FDA.
Date Created
2024-05
Agent

Unveiling Governance Failures: A Case Study on FTX

Description
This project serves to provide a comprehensive analysis of the business failures and criminal behavior that ultimately led to the collapse of FTX in November 2022. The general theme illustrated in the case study is the significance of effective governance

This project serves to provide a comprehensive analysis of the business failures and criminal behavior that ultimately led to the collapse of FTX in November 2022. The general theme illustrated in the case study is the significance of effective governance structures and ethical leadership in an organization, and FTX serves as a primary example of the potential repercussions for stakeholders when such principles are not prioritized. The study analyzes the sequence of events that triggered FTX's downfall and identifies its contributing factors. By doing so, it clarifies the poor business practices and illegal activity that took place, and how the lack of effective governance structures enabled the criminal activity. The case study not only serves as an analysis of business failures, but additionally provides actionable insights for other organizations to consider when implementing governance structures and managing risk. In effect, the case study serves as a valuable resource for business leaders and investors by underscoring the critical role of effective governance in sustaining organizational health.
Date Created
2023-12
Agent

A Young Person’s Comprehensive Guide on How to Properly Interact with the Law:
The Responsibilities of Understanding and Compliance Placed on Law Abiding Citizens

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Description

In this project I created a series of infographics as comprehensive resources for students to reference as educational guides. As a business law student I have been able to accumulate knowledge through all of my law courses to better understand

In this project I created a series of infographics as comprehensive resources for students to reference as educational guides. As a business law student I have been able to accumulate knowledge through all of my law courses to better understand our society and its laws, albeit this knowledge is not yet complete. Other students are not always given this same opportunity to understand their rights and the laws that govern them and have clearly indicated to me through my survey that they would feel better prepared to become young adults in society if they were given additional resources. Therefore, my thesis consists of research based on the results of my survey regarding the areas of law that students indicated interest in along with a series of seven infographics with easy to understand information about the First Amendment, the Sixth Amendment, women’s rights, arbitration, legal offenses and consequences, Arizona State University’s legal and emergency resources, and the main constitutional amendments students should be aware of. Students should understand the laws they must abide by as members of society as well as the constitutional rights they are guaranteed if they are expected to fully obey and use both as incoming adults of the United States of America.

Date Created
2022-05
Agent

YouTube and Copyright Infringement

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Description
The Internet has slowly over the past couple of decades has evolved greatly while also growing into its own community. Websites such as Facebook, Twitter, and even YouTube have developed their own trends, cultures, and communities. Certain people have chosen

The Internet has slowly over the past couple of decades has evolved greatly while also growing into its own community. Websites such as Facebook, Twitter, and even YouTube have developed their own trends, cultures, and communities. Certain people have chosen to earn their livelihood over the Internet through websites and deals with companies. In these dealings, legal matters start to take a major role as people try to review and utilize other peoples’ work to supplement their own. As a Business Law major, I aimed to delve into the legal troubles and dealings of those who wish to form a career on the website YouTube. While the intent of the work is to be informational, I will conclude with what I believe to be improvements possible for the system based on information found. With all the evidence considered, I will advocate for changes to the manual claim system by increasing human moderation as well as necessitating manual review prior to deletion of channels.
Date Created
2020-05
Agent

Incarceration and Its Effect on Political Beliefs

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Description
This paper investigates whether incarceration has an effect on political orientation, addressing the hypothesis that the experience of incarceration also shapes the political behavior and attitudes of those who have been confined (Manza, Uggen 2006; Clear 2007; Travis 2005). The

This paper investigates whether incarceration has an effect on political orientation, addressing the hypothesis that the experience of incarceration also shapes the political behavior and attitudes of those who have been confined (Manza, Uggen 2006; Clear 2007; Travis 2005). The primary aim of the research is to identify what role, if at all, the penal system plays in how incarcerated individuals think about politics. The data relied on to reach conclusions about the incarcerated population derives from voluntary responses to a survey implemented within a company that hires formerly and currently incarcerated persons. I find that the majority of the sample I surveyed became more politically liberal as a result of incarceration and a vast majority want to participate in the political process. These findings corroborate my hypotheses regarding the effects of incarceration on political beliefs, but contradict my assumption regarding the effect of social capital on their desire to participate in politics.
Date Created
2020-05
Agent

Artificial Intelligence & Its Implications for the Modern American Legal System

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Description
It is interesting to reflect that the American legal system has not seriously applied any significant technological advances in many decades. It is fascinating that the same processes used to draft a will or estate plan are virtually the same

It is interesting to reflect that the American legal system has not seriously applied any significant technological advances in many decades. It is fascinating that the same processes used to draft a will or estate plan are virtually the same as they were in the 1960’s. This seems to be a problem that should be concerning in this modern age. We would be hard pressed to observe doctors in the U.S. currently performing medical procedures as they would have in 1960 considering the technological advancements that have taken place in society since then. Many of the processes in the legal system are extremely static and even archaic. It seems to be an opportune time to revolutionize the whole system as advancements continue; but, this revolution must take into account both the positive and negative repercussions that are possible moving forward.
Date Created
2020-05
Agent

Sustainability in Supply Management: An Analysis of Intelligent Supply Chain Designs in Promoting the Triple Bottom Line

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Description
Sustainable supply chain management has become increasingly more important for companies over the last decade. The need to create socially and environmentally sustainable supply chains that are also efficient and profitable is no longer something companies should do, but rather

Sustainable supply chain management has become increasingly more important for companies over the last decade. The need to create socially and environmentally sustainable supply chains that are also efficient and profitable is no longer something companies should do, but rather something they must do to stay competitive and successful in the long run. Through the examination of scholarly supply chain literature, case studies, and industry reports with an emphasis on digital technology, supply chain, and sustainability, a conceptual model was created to begin the research in the area of cost savings through the use of digital technologies to enable companies to be more sustainable. This paper works to define the terms sustainability, sustainable supply chain management, and intelligent supply chain designs. It focuses on the positive social and environmental impact of the implementation of leading-edge digital technologies in supply management processes by creating transparency, efficiency, and reliability throughout the supply chain. Through an applied analysis of Mattel, Rana Plaza, Nike, and Coca-Cola and a cost-benefit analysis, it is concluded that companies that implement blockchain technology into their supply management process designs may create more sustainable supply chains while increasing savings and increasing profits. Blockchain may provide the reliability and transparency needed to better manage the supply management process which will evoke better business decisions. Intelligent supply chain designs improve the environmental and social sustainability of a company while maintaining a competitive edge.

Keywords. Supply Chain Management, Social Responsibility, Sustainability, Economics, Supply Management, Blockchain, Intelligent Technology
Paper Type. Conceptual Paper
Date Created
2019-05
Agent