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A Brand-Name Drug Company May Violate Section Two Of The Sherman Act By Mislabeling A Submitted Patent In The Orange Book: An Implication From In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), Ping-Hsun Chen 2019 Brooklyn Law School

A Brand-Name Drug Company May Violate Section Two Of The Sherman Act By Mislabeling A Submitted Patent In The Orange Book: An Implication From In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), Ping-Hsun Chen

Brooklyn Journal of Corporate, Financial & Commercial Law

The Hatch-Waxman Act encourages generic drug companies to submit an abbreviated new drug application (“ANDA”) for a generic version of a drug approved by the U.S. Food and Drug Administration (“FDA”). Nevertheless, a mechanism exists for a brand-name drug company to adjudicate a patent infringement dispute before the FDA approves an ANDA. The mechanism includes the regulatory scheme of patent information submission implemented by the FDA. 21 U.S.C. § 355(b)(1) requires that patent information be correct. False patent information destroys the objectives of the Hatch-Waxman Act. In re Actos End-Payor Antitrust Litigation, 848 F.3d 89 ...


The Case For Contraceptives: The Legislative History Of The Aca’S Birth Control Mandate, Julia Grant 2019 University of Mississippi

The Case For Contraceptives: The Legislative History Of The Aca’S Birth Control Mandate, Julia Grant

The University of Mississippi Undergraduate Research Journal

This paper seeks to outline the legislative and judicial history of the Affordable Care Act’s contraception coverage mandate. It begins by explaining the justifications and specifications of the provision. It then highlights the three phases of litigation that have surrounded the mandate: closely held, for-profit companies; religious nonprofit organizations; and state attorney generals. This paper provides context for the litigation by describing the opposing stances towards the mandate of the Obama and Trump Administrations and the different modifications to the provision made under each administration. In the wake of last week’s finalization of the controversial rules the Trump ...


Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert 2019 Brooklyn Law School

Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert

Brooklyn Law Review

Milk is one of the most ubiquitous and heavily regulated substances on the planet—and perhaps one of the most contested. It is tied closely to notions of purity, health, and femininity, and is seen as so central to human civilization that our own galaxy—the Milky Way—is named after it. But despite its wholesome reputation, milk has long had a sinister side, being bound up with the exploitation of the (human and nonhuman) bodies it comes from and being a symbol of and tool for white dominance and superiority. The word itself, in verb form, means “to exploit ...


Clinical Decision Making: A Case Study Of The Effects Of Evidence Based Medicine And Past Empirical Experience In The Emergency Department, Olivia Zeman-Renner 2019 University of Nebraska at Omaha

Clinical Decision Making: A Case Study Of The Effects Of Evidence Based Medicine And Past Empirical Experience In The Emergency Department, Olivia Zeman-Renner

Theses/Capstones/Creative Projects

With a growing number of medical malpractice suits and the passage of policy that focuses on patient advocacy, an emphasis has been placed on research regarding the decision-making processes of physicians in everyday practices. Over the past decades, scholars have looked to specific clinical decision-making philosophies, how they can be implemented into practice, and the effects of such implementation, but little research has been done into the culmination of decision-making philosophies on a day-to-day basis. By focusing on single-case study of a Midwestern Emergency Department and asking Attending physicians to self-report their decision-making philosophies, this study serves as a transition ...


Bank On We The People: Why And How Public Engagement Is Relevant To Biobanking, Chao-Tien Chang 2019 National Chiao Tung University School of Law

Bank On We The People: Why And How Public Engagement Is Relevant To Biobanking, Chao-Tien Chang

Michigan Technology Law Review

Biobanks emerged in the early 2000s and now facilitate scientific research through the provision of resources for research that requires a large scale of biospecimens and data. Biobank projects have also become intertwined with complicated socio-economic initiatives to boost economic development or to shape community identity. While legislators continue to debate the ethical and regulatory challenges associated with biobanks, the federal regulation over research involving human subjects, the Common Rule, is based on a traditional research model that fails to address the complex challenges unique to biobanking. Through an examination of the proposed revisions to the Common Rule concerning research ...


Puffing Away Parental Rights: A Survey And Analysis Of Whether Secondhand Smoke Exposure Is Child Abuse, Karly Huml 2019 Cleveland-Marshall College of Law

Puffing Away Parental Rights: A Survey And Analysis Of Whether Secondhand Smoke Exposure Is Child Abuse, Karly Huml

Journal of Law and Health

The steps taken thus far to protect children in public areas, custody cases, and in vehicles show the legislature's awareness of the chemical harms of secondhand smoke for children. This article will analyze those steps and discuss what they mean for both parents' and children's constitutional rights. This article proposes that the legislature take a vital fourth step by including secondhand smoke exposure in child abuse laws. Section II of this article provides the history of smoking tobacco and its transition from a trendy social status to an unpopular, harmful habit. Section II also introduces the steps that ...


Keep Your Friends Close And Your Medical Records Closer: Defining The Extent To Which A Constitutional Right To Informational Privacy Protects Medical Records, Lauren Newman 2019 Georgia State University College of Law

Keep Your Friends Close And Your Medical Records Closer: Defining The Extent To Which A Constitutional Right To Informational Privacy Protects Medical Records, Lauren Newman

Journal of Law and Health

The following Article discusses the extent to which the constitutional right to informational privacy protects medical data from improper acquisition or dissemination by state agents. Part I provides background on Whalen v. Roe, the Supreme Court case that has been understood to establish the right to informational privacy. Part I also discusses the variations across the circuit courts as to what medical information is afforded protection by the right. Part II analyzes the well-established approaches adopted by the Second and Third Circuits as they present opposing interpretations of Whalen, one wholly protecting medical information and the other protecting scarcely any ...


Congress Prescribes Preemption Of State Tort-Reform Laws To Remedy Healthcare "Crisis": An Improper Prognosis?, Jason C. Sheffield 2019 Texas A&M University School of Law

Congress Prescribes Preemption Of State Tort-Reform Laws To Remedy Healthcare "Crisis": An Improper Prognosis?, Jason C. Sheffield

Journal of Law and Health

Say what you want about the tort-reform debate, but it has staying power. Over the last half-century, legislators and commentators have extensively debated every aspect of tort reform and the litigation "crisis" arguably giving rise to it, without resolving much of anything. Despite this ideological stalemate, tort-reform proponents have managed to push measures through every state legislature. With fifty tries come fifty results, and for the most part, fifty failures. But have all these efforts been in vain? As of yet, no. Although the healthcare system does not appear to be improving, the numerous tort-reform measures states have adopted provide ...


The Bell Has Rung: Answering The Door For Student-Athlete Concussion Issues In The National Collegiate Athletic Association, Aaron Caputo 2019 Cleveland-Marshall College of Law

The Bell Has Rung: Answering The Door For Student-Athlete Concussion Issues In The National Collegiate Athletic Association, Aaron Caputo

Journal of Law and Health

This Note examines the NCAA's unwillingness to enforce the requirement that all NCAA institutions must implement a concussion management plan; the NCAA's refusal to apply its appropriate enforcement mechanism when member institutions violate their concussion management plans, which are instituted in order to protect student-athletes from concussions; how both of these failures result in more concussions and a higher probability of debilitating long-term effects; and solutions to remedy this grave injustice. Part II describes what a concussion is, the long-term effects of concussions, the NCAA's management of concussions, and lawsuits challenging the NCAA in relation to concussions ...


Solving The Opioid Epidemic In Ohio, Lacy Leduc 2019 Cleveland-Marshall College of Law

Solving The Opioid Epidemic In Ohio, Lacy Leduc

Journal of Law and Health

On May 31, 2017, Ohio Attorney General Mike DeWine took a step in fighting Ohio's opioid epidemic, bringing the first of many lawsuits against five top pharmaceutical companies. However, under Federal and State law, there is an exception called the Learned Intermediary Doctrine, which can absolve drug manufacturers of liability from any misconduct that might be found and transfer that liability to a treating physician. This exception is the way many drug manufacturers were able to avoid being held responsible in the past. This Note proposes that with the current pending lawsuit in the State of Ohio, an exception ...


“Big” Food, Tobacco, And Alcohol: Reducing Industry Influence On Noncommunicable Disease Prevention Laws And Policies, Belinda Reeve, Lawrence O. Gostin 2019 The University of Sydney Law School

“Big” Food, Tobacco, And Alcohol: Reducing Industry Influence On Noncommunicable Disease Prevention Laws And Policies, Belinda Reeve, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The food, tobacco and alcohol industries have penetrated markets in low- and middle-income countries (LMICs), with a significant impact on these countries’ burden of noncommunicable diseases (NCDs). Tangcharoensathien and colleagues describe the aggressive marketing of unhealthy food, alcohol and tobacco in LMICs, as well as key tactics used by these industries to resist laws and policies designed to reduce behavioural risk factors for NCDs. This commentary expands on the recommendations made by Tangcharoensathien and colleagues for preventing or managing conflicts of interest and reducing undue industry influence on NCD prevention policies and laws, focusing on the needs of LMICs. A ...


Law And Power In Health Care: Challenges To Physician Control, Mary Anne Bobinski 2019 Emory University School of Law

Law And Power In Health Care: Challenges To Physician Control, Mary Anne Bobinski

Buffalo Law Review

No abstract provided.


The Web Of Legal Protections For Participants In Genomic Research, Leslie E. Wolf, Erin Fuse Brown, Ryan Kerr, Genevieve Razick, Gregory Tanner, Brett Duvall, Sakinah Jones, Jack Brackney, Tatiana Posada 2019 Selected Works

The Web Of Legal Protections For Participants In Genomic Research, Leslie E. Wolf, Erin Fuse Brown, Ryan Kerr, Genevieve Razick, Gregory Tanner, Brett Duvall, Sakinah Jones, Jack Brackney, Tatiana Posada

Leslie E. Wolf

The identification and arrest of the Golden State Killer using DNA uploaded to an ancestry database occurred shortly before recruitment for the National Institutes of Health’s (NIH) All of Us Study commenced, with a goal of enrolling and collecting DNA, health, and lifestyle information from one million Americans. It also highlighted the need to ensure prospective research participants that their confidentiality will be protected and their materials used appropriately. But there are questions about how well current law protects against these privacy risks. This article is the first to consider comprehensively and simultaneously all the federal and state laws ...


The Web Of Legal Protections For Participants In Genomic Research, Leslie E. Wolf, Erin Fuse Brown, Ryan Kerr, Genevieve Razick, Gregory Tanner, Brett Duvall, Sakinah Jones, Jack Brackney, Tatiana Posada 2019 Selected Works

The Web Of Legal Protections For Participants In Genomic Research, Leslie E. Wolf, Erin Fuse Brown, Ryan Kerr, Genevieve Razick, Gregory Tanner, Brett Duvall, Sakinah Jones, Jack Brackney, Tatiana Posada

Erin C. Fuse Brown

The identification and arrest of the Golden State Killer using DNA uploaded to an ancestry database occurred shortly before recruitment for the National Institutes of Health’s (NIH) All of Us Study commenced, with a goal of enrolling and collecting DNA, health, and lifestyle information from one million Americans. It also highlighted the need to ensure prospective research participants that their confidentiality will be protected and their materials used appropriately. But there are questions about how well current law protects against these privacy risks. This article is the first to consider comprehensively and simultaneously all the federal and state laws ...


Regulating Sugar-Sweetened Beverages, Tyler Rauh 2019 University of Miami Law School

Regulating Sugar-Sweetened Beverages, Tyler Rauh

University of Miami Business Law Review

American waistlines are an international punchline, and United States taxpayers spend hundreds of billions of dollars each year to combat medical complications resulting from obesity. The personal costs are financial, emotional, and mortal. Projections insist that it will become worse. Section I details the obesity epidemic and ponders why the United States is uniquely unhealthy.

The reason could be that America consumes more sugar than any other country. In recent years, some municipal policymakers have attempted to restrain America’s sweet tooth by taxing sugar-sweetened beverages. Initial responses are polarizing. Chicago’s tax did not last three months before its ...


Section 1332 State Innovation Waivers: Waiving Goodbye To Cooperative Federalism And Hello To Collaborative Federalism, Brittany Hynes 2019 University of Miami Law School

Section 1332 State Innovation Waivers: Waiving Goodbye To Cooperative Federalism And Hello To Collaborative Federalism, Brittany Hynes

University of Miami Business Law Review

No abstract provided.


The Quantified Self Movement: Legal Challenges And Benefits Of Personal Biometric Data Tracking, Timothy S. Hall 2019 Selected Works

The Quantified Self Movement: Legal Challenges And Benefits Of Personal Biometric Data Tracking, Timothy S. Hall

Timothy S. Hall

This article explores some of the potential pitfalls associated with collection of detailed individual biometric or health-related information, and demonstrates that current laws and regulations are not well designed to protect users of these devices and apps from unauthorized use or misuse of their data. Health information is among the most sensitive, intimate, and potentially damaging personal information one may possess, and health policymakers have made health information privacy a priority for decades for good reason. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was one of the major health policy legislative achievements of the 1990s. However, HIPAA ...


The Dark Side Of The Pharmaceutical Industry: A Compound Of Issues, Geoffrey A. Marcus 2019 University of Miami Law School

The Dark Side Of The Pharmaceutical Industry: A Compound Of Issues, Geoffrey A. Marcus

University of Miami Inter-American Law Review

No abstract provided.


The Impact Of H.B. 214: A Critical Analysis Of The Texas "Rape Insurance" Bill, Lucie Arvallo 2019 St. Mary's University School of Law

The Impact Of H.B. 214: A Critical Analysis Of The Texas "Rape Insurance" Bill, Lucie Arvallo

St. Mary's Law Journal

Texas House Bill 214 (H.B. 214) is subject to challenge under the Supreme Court precedent protecting a woman’s right to choose. Passed in 2017, H.B. 214 regulates Texas insurance markets by prohibiting coverage for an elective abortion unless a woman affirmatively opts into such coverage through a separate contract and pays a separate premium. Similar restrictions on insurance coverage for elective abortion in other states have been met with mixed results in the courts. What sets H.B. 214 apart from other regulations of insurance coverage for abortion is that it does not include any exceptions for ...


Narrowing In On The Problem: A Component-Level Analysis Of "Hybrid" Medical Devices, Jillian Friedmann 2019 Boston College Law School

Narrowing In On The Problem: A Component-Level Analysis Of "Hybrid" Medical Devices, Jillian Friedmann

Boston College Law Review

The Medical Device Amendments of 1976 (“MDA”) classify medical devices into three categories, each of which represents a different level of risk, and requires a different level of federal oversight. Class III devices, which pose the most risk, are subject to the highest level of oversight. Those devices are protected from any claims based on state laws that differ from or add to the requirements imposed by the MDA. On March 1, 2018, the United States Court of Appeals for the Third Circuit, in Shuker v. Smith & Nephew, PLC, considered the application of preemption under the MDA to a “hybrid ...


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