Law Commons^™

Bridging The Gap Between Intent And Status: A New Framework For Modern Parentage, Yehezkel Margalit

Hezi Margalit

The last few decades have witnessed dramatic changes in the conceptualization and methodologies of determining legal parentage in the U.S. and other countries in the western world. Through various sociological shifts, growing social openness and bio-medical innovations, the traditional definitions of family and parenthood have been dramatically transformed. This transformation has led to an acute and urgent need for legal and social frameworks to regulate the process of determining legal parentage. Moreover, instead of progressing in a piecemeal, ad-hoc manner, the framework for determining legal parentage should be comprehensive. Only a comprehensive solution will address the differing needs of today’s …

From Baby M To Baby M(Anji): Regulating International Surrogacy Agreements, Yehezkel Margalit

Hezi Margalit

In 1985, when Kim Cotton became Britain’s first commercial surrogate mother, Europe was exposed to the issue of surrogacy for the first time on a large scale. Three years later, in 1988, the famous case of Baby M drew the attention of the American public to surrogacy as well. These two cases implicated fundamental ethical and legal issues regarding domestic surrogacy and triggered a fierce debate about motherhood, child-bearing, and the relationship between procreation, science and commerce. These two cases exemplified the debate regarding domestic surrogacy - a debate that has now been raging for decades. Contrary to the well-known …

Can Dna Be Speech?, Jorge R. Roig

Jorge R Roig

The Treatment For Malpractice – Physician, Enhance Thyself: The Impact Of Neuroenhancements For Medical Malpractice, Harvey L. Fiser

Harvey L. Fiser

No abstract provided.

Promoting “Academic Entrepreurship” In Europe And The United States: Creating An Intellectual Property Regime To Facilitate The Efficient Transfer Of Knowledge From The Lab To The Patient, Constance Bagley, Christina Tvarno

Constance E. Bagley

In 2014, the European Commission announced the launch of a study of knowledge transfer by public research organizations and other institutes of higher learning “to determine which additional measures might be needed to ensure an optimal flow of knowledge between the public research organisations and business thereby contributing to the development of the knowledge based economy.” As the European Commission has recognized, the EU needs to take action to “unlock the potential of IPRs [intellectual property rights] that lie dormant in universities, research institutes and companies.” This article builds on our earlier work on structuring efficient pharmaceutical public-private partnerships (PPPPs) …

Is The Turkey Halal? Genetically Modified Animal Feed Regulation Where East Meets West, Jennifer Spreng

Jennifer E Spreng

Turkey’s Biosafety Law (2010) imposes some of the world’s most stringent restrictions on the import, release and marketing of genetically modified foodstuffs. The Biosafety Board has not approved a single food event; the Council of State has suspended approval of MON 810; Turks have endured meat and milk price spikes; herders are going bankrupt for lack of affordable feed; and importers have been arrested and prosecuted for trace contamination with unapproved GMOs. It’s a pox an all their houses: Turks want nothing do with GM foodstuffs.

The culprit? The “precautionary principle,” which authorizes taking precautions in the face of scientific …

Teaching The Biological Clock: Age-Related Fertility Decline And Sex Education, Kerry Macintosh

Kerry L Macintosh

Fertility in women declines significantly at age thirty-two and takes a sharp downward turn at age thirty-seven. Miscarriages also increase with age. In vitro fertilization cannot reverse the effects of aging, and embryo screening, egg freezing, and egg donation are imperfect solutions.

Unfortunately, many women fail to grasp these facts until it is too late. Various factors are to blame, including physicians who shy away from the topic of age-related fertility decline, persistent messaging about the need for pregnancy prevention (implying that conception is easy), and media accounts of celebrities who are pregnant in their forties.

This Article argues that …

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 …

Synaptic Plasticity In Neurological Deficit As A Form Of Indemnification: The Utility Of Analogical Thinking, Madeleine Schachter, Madeleine Schachter

Madeleine Schachter

The need for creative problem-solving is as infinite as are the ways in which to engage in it. This article posits that one useful, albeit not flawless, mechanism in which to seek scientific advancements is through the use of analogical thinking. The technique has been invoked in virtually all disciplines, sometimes successfully and sometimes not. The utility of thinking by analogy lies, paradoxically, in its capacity to conceptualize a solution or a viable avenue of further inquiry as much as in its capacity to expose flaws in the analogical concept hypothesized. As such, it is an important means of stimulating …

"Introduction" (Chapter 1) Of Stories About Science In Law: Literary And Historical Images Of Acquired Expertise (Ashgate 2011), David S. Caudill

David S Caudill

This is the introductory chapter of Stories About Science in Law: Literary and Historical Images of Acquired Expertise (Ashgate, 2011), explaining that the book presents examples of how literary accounts can provide a supplement to our understanding of science in law. Challenging the view that law and science are completely different, I focus on stories that explore the relationship between law and science, and identify cultural images of science that prevail in legal contexts. In contrast to other studies on the transfer and construction of expertise in legal settings, the book considers the intersection of three interdisciplinary projects-- law and …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

The New Frontier Of Advanced Reproductive Technology: Reevaluating Modern Legal Parenthood, Yehezkel H. Margalit Dr., John D. Loike Dr., Orrie Levy Adv.

Hezi Margalit

Assisted reproductive technologies (ARTs) have challenged our deepest conceptions of what it means to be a parent by fragmenting traditional aspects of parenthood. The law has been slow to respond to this challenge, and numerous academic articles have proposed models for adapting parentage laws to ARTs. In the coming years, however, scientific advancements in reproductive technologies, such as somatic cell nuclear transfer and stem cell technologies, will challenge both parentage laws and proposed legal models for traditional ARTs in new and fascinating ways. For instance, these advanced technologies could allow two women to create a child without any male genetic …

Towards Determining Legal Parentage By Agreement In Israel, Yehezkel Margalit

Hezi Margalit

In Israel as in other parts of the world, families, parenthood, and relations between parents and children have changed dramatically over the past few decades. So, too, developments in modern medicine have enhanced the ability to separate sexuality from fertility and parenthood. Many researchers feel that the legal system has not kept pace with these changes, and that traditional models of familial relationships no longer provide adequate tools for dealing with them. In order to bridge the gap between a desired social status and current law, a growing number of parents seek to regulate the status, rights, and obligations of …

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …

The Biotechnology Revolution And Its Regulatory Evolution, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.

"Introduction" (Chapter 1) Of Stories About Science In Law: Literary And Historical Images Of Acquired Expertise (Ashgate 2011), David S. Caudill

Working Paper Series

This is the introductory chapter of Stories About Science in Law: Literary and Historical Images of Acquired Expertise (Ashgate, 2011), explaining that the book presents examples of how literary accounts can provide a supplement to our understanding of science in law. Challenging the view that law and science are completely different, I focus on stories that explore the relationship between law and science, and identify cultural images of science that prevail in legal contexts. In contrast to other studies on the transfer and construction of expertise in legal settings, the book considers the intersection of three interdisciplinary projects-- law and …

Somebody's Watching Me: Protecting Patient Privacy In De-Identified Prescription Health Information, Christopher R. Smith

Christopher R Smith

Increasingly, legal scholars, state legislatures and the federal courts are examining patient privacy concerns that arise in the context of the dissemination, distribution and use of patient prescription information. However, less attention has been paid to the sharing of de-identified or encrypted patient prescription information versus identifiable patient prescription information. Though many patients may not realize it, identifiable, de-identified and encrypted patient prescription information is being used for a host of purposes other than insurance reimbursement and treatment, most notably for pharmaceutical marketing purposes. Existing state and federal laws and ethical guidelines provide some protection for the privacy of patient …

The Rise, Fall And Rise Again Of The Genetic Foundation For Legal Parentage Determination, Yehezkel Margalit

Hezi Margalit

Recently, we have witnessed dramatic changes in the formation of the family and parenthood. One of the results of those shifts is a growing number of children growing up outside of the traditional marriage framework. Therefore, the dilemma of determining a child's parentage, which was usually resolved by a legal fiction as to the child's legal parents, is becoming increasingly problematic. It is appropriate that any discussion of the establishment of legal parentage should start with a study of the rise of the most popular modern model, the genetic model.

It is relevant to point out that from the beginning …

A Defense Of Stem Cell Research, Gregory Dolin

Gregory Dolin

Isolation of human embryonic stem cells in 1998 simultaneously caused great excitement and concern in the scientific community and the population at large. The great promises that the discovery held were viewed with suspicion by many, because the isolation of these stem cells involved destruction of an embryo, and thus, according to some, destruction of innocent human life. Full ten years later, the debate still rages. The present Article proposes a solution to this debate.The solution concedes that the embryo is a human being entitled to full moral protection. Having made that concession, however, the Article proceeds to argue that …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Brain Imaging And Privacy: How Recent Advances In Neuroimaging Implicate Privacy Concerns , David P. Finn

ExpressO

This paper deals with recent advances in neuroimaging technologies which could begin to implicate privacy concerns in the near future.

In Sickness, Health, And Cyberspace: Protecting The Security Of Electronic Private Health Information, Sharona Hoffman, Andy Podgurski

ExpressO

The electronic processing of health information provides considerable benefits to patients and health care providers at the same time that it creates serious risks to the confidentiality, integrity, and availability of the data. The Internet provides a conduit for rapid and uncontrolled dispersion and trafficking of illicitly-obtained private health information, with far-reaching consequences to the unsuspecting victims. In order to address such threats to electronic private health information, the U.S. Department of Health and Human Services enacted the HIPAA Security Rule, which thus far has received little attention in the legal literature. This article presents a critique of the Security …

Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu

ExpressO

The constitutional purpose of intellectual property is to “promote the progress of science and useful arts.” Given the utilitarian basis of patents, it is critical that policies and laws must be continually adjusted to reflect the needs of new technologies. When the law tries to shield itself from rather than confront the realities of underlying technologies, patents end up actually subverting rather than promote technological progress. This paper explores why the natural extracts doctrine belongs to the class of doctrines that subvert progress. The doctrine, established over a century ago to enable the patenting of purified compounds for use as …

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

Stealing What's Free: Exploring Compensation To Body Parts Sources For Their Contribution To Profitable Biomedical Research, Jo-Anne Yau

ExpressO

It is undisputed in the biotechnology industry that human body parts play a vital role in research. The body parts donors, referred to as "Sources" in this article, are subjected to physical and financial exploitation. Forbidding the explosion of profits from trickling down to the Source presents an irrational inequity. Despite established law, it is evident from case analysis, prevailing social practices, and constitutional interpretation that Source compensation is a plausible solution.

This article proposes a model of compensation for Sources, whereby Sources are compensated based on a proportionate share of the research profits set aside for the Source as …

The Children Of Science: Property, People, Or Something In Between?, Star Q. Lopez

ExpressO

How should states classify embryos? The war has often waged between two classifications, people versus property. But what if a state assumed something in between, finding the embryo to be a potential person entitled to special respect? If a state adopted this position, how would the law affect medical research?

Presuming embryos constitute potential persons, the debate would continue with how to define “special respect.” The status of a potential person runs along a spectrum between property and personhood. How one defines “special respect” determines where the potential person falls along this spectrum. Special respect would create a spectrum of …

The Expressive Impact Of Patents, Timothy R. Holbrook

ExpressO

Patents represent a quid pro quo between the public and the inventor: in exchange for disclosing the invention, the inventor receives the right to exclude others from practicing her invention. They therefore serve as a source technical information. Patents also communicate information to markets and companies that serve to reduce various transaction costs, allowing more efficient transactions and investment. Patents consequently communicate various types of information beyond the technical.

There is no reason, however, that such messages must be limited to the technical or the pecuniary. This Article explores whether patents, like other governmental acts such as legislation, can create …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …