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Articles 1 - 9 of 9
Full-Text Articles in Medical Jurisprudence
Perfecting Pregnancy Via Preimplantation Genetic Screening: The Quest For An Elusive Standard Of Care, Jolene S. Fernandes
Perfecting Pregnancy Via Preimplantation Genetic Screening: The Quest For An Elusive Standard Of Care, Jolene S. Fernandes
UC Irvine Law Review
No abstract provided.
Generic Entry Jujitsu: Innovation And Quality In Drug Manufacturing, W. Nicholson Price Ii
Generic Entry Jujitsu: Innovation And Quality In Drug Manufacturing, W. Nicholson Price Ii
IP Theory
The manufacturing side of the pharmaceutical industry has been neglected in innovation theory and policy, with the unfortunate result of stagnant manufacturing techniques driving major problems for the healthcare system. This innovation failure has roots in ineffective intellectual property incentives and high regulatory hurdles to innovative change. Changes in pure regulation or intellectual property incentives have significant potential to help the innovation deficit, but are not the only possibility for change. A relatively minor regulatory change could harness the powerful dynamics of pioneer/generic competition surrounding generic drug market entry. If pioneer firms were permitted to make label claims committing to …
Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski
Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski
Journal Articles
All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …
Consciousness And Futility: A Proposal For A Legal Redefinition Of Death, Christopher Smith
Consciousness And Futility: A Proposal For A Legal Redefinition Of Death, Christopher Smith
Christopher R Smith
Recent controversies in Texas (with the Marlise Muñoz case) and in California (with the Jahi McMath case) have highlighted a lamentable flaw in the current legal conception of human death, and the difficulty of defining when death finally occurs. The unworkable notion of “brain-death” remains the law in every state in the union, yet the philosophical and scientific foundations of this notion remain open to attack. This article posits that death is a fundamentally social construct, and that it is society at large (through its laws, public opinions, religious attitudes, etc.) that actually defines death. This essay then argues that …
Foreseeability Decoded, Meiring De Villiers
Foreseeability Decoded, Meiring De Villiers
Meiring de Villiers
The Article reviews the conceptual and doctrinal roles of the foreseeability doctrine in negligence law, and analyzes its application in cases where a new technology or unexplored scientific principle contributed to a plaintiff’s harm. It adopts the common law definition of foreseeability as a systematic relationship between a defendant’s wrongdoing and the plaintiff’s harm, and demonstrates translation of the concept into the language of science so that the common law meaning of the foreseeability doctrine is preserved. An analysis of the foreseeability of HIV/AIDS as a blood-borne risk illustrates application of the concept to contemporary issues in medical science.
Pinwheel Of Fortune, 13 J. Marshall Rev. Intell. Prop. L. 761 (2014), James Ming Chen
Pinwheel Of Fortune, 13 J. Marshall Rev. Intell. Prop. L. 761 (2014), James Ming Chen
UIC Review of Intellectual Property Law
This paper examines public health law in the context of prospect theory, the leading behavioral account of risk aversion and risk-seeking. The paper first demonstrates how international environmental law can be mapped along prospect theory’s risk-seeking axis. It then completes this picture of prospect theory by examining National Federation of Independent Business v. Sebelius, which upheld the constitutionality of the Patient Protection and Affordable Care Act (“PPACA”). Although Sebelius upheld the PPACA as an exercise of the federal government’s taxing authority, it reasoned that a directive aimed at uninsured individuals to buy health insurance lay beyond the power of Congress …
A Scientific Approach To Intellectual Property And Health: Innovation, Access, And A Forgotten Corner Of The Universal Declaration Of Human Rights, 13 J. Marshall Rev. Intell. Prop. L. 794 (2014), Adam Houston
UIC Review of Intellectual Property Law
For years, there has been vigorous debate over the relationship between intellectual property and health, especially in the context of pharmaceutical patents. Despite numerous attempts to strike a balance between innovation and access, however, few have looked to Article 27 of the Universal Declaration of Human Rights for guidance. Article 27, and its further elaboration and codification under Article 15 of the International Covenant on Economic, Social, and Cultural Rights, explicitly address this balance by pairing the right of everyone “to share in scientific advancement and its benefits” with a similarly universal right of authors to “material interests resulting” from …
Uncle Sam Knows What’S In Your Medicine Cabinet: The Security And Privacy Protection Of Health Records Under The Hitech Act, 30 J. Marshall J. Info. Tech. & Privacy L. 667 (2014), Ranjit Janardhanan
Uncle Sam Knows What’S In Your Medicine Cabinet: The Security And Privacy Protection Of Health Records Under The Hitech Act, 30 J. Marshall J. Info. Tech. & Privacy L. 667 (2014), Ranjit Janardhanan
UIC John Marshall Journal of Information Technology & Privacy Law
No abstract provided.
Toward A Jurisprudence Of Drug Regulation, Matthew Herder
Toward A Jurisprudence Of Drug Regulation, Matthew Herder
Articles, Book Chapters, & Popular Press
Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e. product approvals) or negative (i.e. abandoned products, product refusals, and withdrawals) — are …