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Articles 31 - 60 of 1041

Full-Text Articles in Health Law and Policy

The Price Tag On Designer Babies: Market Share Liability, Boston College Law Review Staff Jan 2018

The Price Tag On Designer Babies: Market Share Liability, Boston College Law Review Staff

Boston College Law Review

The prospect of genetically modifying humans has loomed over the public for decades. Now, science fiction is becoming reality. New technology and expanding research are positioned to make genetic alteration a routine, pre-conception appointment. For several years, China has been experimenting with germline editing on non-viable human embryos. In April 2016, the UK also approved a group of scientists to begin similar research. In the United States, genetic engineering is a multibillion-dollar industry. Although ethical debates over human genetic modification have checked the industry, the potential for clinical trials has become a reality as companies race to dominate the technology ...


Noa V. Doa: Increasing Medical Diagnostic Patentability After Mayo, Karen Mckenzie Jan 2018

Noa V. Doa: Increasing Medical Diagnostic Patentability After Mayo, Karen Mckenzie

Marquette Intellectual Property Law Review

The medical diagnostics market is expected to reach 65 billion by 2018. In March 2012, in Mayo Collborative Services v. Prometheus Labs, Inc. , ("Mayo") the U.S. Supreme held that the Mayo Clinic (the "Clinic") had not infringed on Prometheus Labs’ (“Prometheus”) diagnostic patent because the Prometheus patent involved ineligible subject matter, and was therefore invalid. Section 101 of the Patent Act defines eligible subject matter an “any new and useful process, machine, manufacture, or composition of matter” as patentable subject matter. Courts have held that Section 101 contains an implicit exception, making laws of nature, natural phenomena, and abstract ...


Baby M Turns 30: The Law And Policy Of Surrogate Motherhood, Eric A. Feldman Jan 2018

Baby M Turns 30: The Law And Policy Of Surrogate Motherhood, Eric A. Feldman

Faculty Scholarship at Penn Law

This article marks the 30th anniversary of the Supreme Court of New Jersey’s Baby M decision by offering a critical analysis of surrogacy policy in the United States. Despite fundamental changes in both science and society since the case was decided, state courts and legislatures remain bitterly divided on the legality of surrogacy. In arguing for a more uniform, permissive legal posture toward surrogacy, the article addresses five central debates in the surrogacy literature.

First, should the legal system accommodate those seeking conception through surrogacy, or should it prohibit such arrangements? Second, if surrogacy is permitted, what steps can ...


Removing Obstacles To A Peaceful Death, Kathy L. Cerminara, Barbara A. Noah Jan 2018

Removing Obstacles To A Peaceful Death, Kathy L. Cerminara, Barbara A. Noah

Faculty Scholarship

We all will die, but the American health care system often impedes a peaceful death. Instead of a quiet death at home surrounded by loved ones, many of us suffer through overutilization of sometimes-toxic therapeutic interventions long past the time when those interventions do more good than harm. This article proposes revisions to health professional training and payment policy to eliminate as much as possible physical and existential suffering while progressing through the terminal phase of illness. The solution lies in seamless progression from treatment with integrated palliative care to hospice before death, but provider attitudes and payor practices must ...


Cancer's Ip, Jacob S. Sherkow Jan 2018

Cancer's Ip, Jacob S. Sherkow

Articles & Chapters

The state of publicly funded science is in peril. Instead, new biomedical research efforts — in particular, the recent funding of a “Cancer Moonshot” — have focused on employing public-private partnerships, joint ventures between private industry and public agencies, as being more politically palatable. Yet, public-private partnerships like the Cancer Moonshot center on the production of public goods: scientific information. Using private incentives in this context presents numerous puzzles for both intellectual property law and information policy. This Article examines whether—and to what extent — intellectual property and information policy can be appropriately tailored to the goals of public-private partnerships. It shows ...


Access To Knowledge And The Global Abortion Policies Database, Joanna Erdman, Brooke Johnson Jan 2018

Access To Knowledge And The Global Abortion Policies Database, Joanna Erdman, Brooke Johnson

Articles & Book Chapters

Research shows that women, healthcare providers, and even policy makers worldwide have limited or inaccurate knowledge of the abortion law and policies in their country. These knowledge gaps sometimes stem from the vague and broad terms of the law, which breed uncertainty and even conflict when unaccompanied by accessible regulation or guidelines. Inconsistency across national law and policy further impedes safe and evidence‐based practice. This lack of transparency creates a crisis of accountability. Those seeking care cannot know their legal entitlements, service providers cannot practice with legal protection, and governments can escape legal responsibility for the adverse effects of ...


Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim Jan 2018

Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim

Washington University Law Review

Mr. X suffers from recurrent glioblastoma, a type of deadly brain cancer. One of his physicians reads a study reporting a novel immunotherapy, which uses the chimeric antigen receptor T cell (CAR-T) technology, leading to regression of glioblastoma in a small number of patients. Although the therapy has recently been approved by the U.S. Food and Drug Administration (FDA) and is now offered by two major pharmaceutical companies, it is only approved for certain hematological cancers. In addition, Mr. X’s cancer does not express the biomarker that is necessary for the CAR-T therapy used in the published glioblastoma ...


2018 Legal Update: Npdb Reporting, Retaliation, Physician Well Being, And Medical Staff Litigation, Preparing For A Successful Judicial Review Hearing, Rick D. Barton, Natalie V. Mueller Jan 2018

2018 Legal Update: Npdb Reporting, Retaliation, Physician Well Being, And Medical Staff Litigation, Preparing For A Successful Judicial Review Hearing, Rick D. Barton, Natalie V. Mueller

CHLB Scholarship

No abstract provided.


Dignity In Choice: A Terminally Ill Patient's Right To Choose, Cody Bauer Jan 2018

Dignity In Choice: A Terminally Ill Patient's Right To Choose, Cody Bauer

Mitchell Hamline Law Review

No abstract provided.


Depression: The Often Overlooked Sequela Of Head Trauma, Samuel D. Hodge Jr., Jack E. Hubbard Dec 2017

Depression: The Often Overlooked Sequela Of Head Trauma, Samuel D. Hodge Jr., Jack E. Hubbard

Cleveland State Law Review

Depression is a common sequela of head trauma. Approximately half of all individuals with a cranial injury will experience depression within the first year, regardless of the severity of the injury. The ailment is characterized clinically as a mood disorder, often associated with intense feelings of sadness. However, depression is more complex than mood disorders, as many mental and bodily complaints—such as insomnia, fatigue, anxiety, appetite changes, aches and pains, and lack of interest in previously enjoyable activities—are associated with depression. These intense feelings, particularly when combined with despair and hopelessness, can lead to suicide, a dreaded potential ...


Hiv And The Ada: What Is A Direct Threat?, Dawn-Marie Harmon Dec 2017

Hiv And The Ada: What Is A Direct Threat?, Dawn-Marie Harmon

Maine Law Review

Anne, a surgical technician at a local hospital, recently learned that she was HIV-positive. She works in the emergency room and, as a part of her job, she hands surgical instruments to doctors performing emergency surgery. It is a fast paced and unpredictable environment. Her hands often come in contact with sharp instruments. Although Anne has never put her hands into a patient's body cavity, there is a remote possibility that she may need to do so in the future. There is always a possibility, however small, that she will cut herself and come into blood-to-blood contact with a ...


A Deliberate Departure: Making Physician-Assisted Suicide Comfortable For Vulnerable Patients, Browne Lewis Oct 2017

A Deliberate Departure: Making Physician-Assisted Suicide Comfortable For Vulnerable Patients, Browne Lewis

Arkansas Law Review

On an episode of Marvel’s Jessica Jones, Kilgrave uses his mind control powers to get Jack Denton to give him both of his kidneys. After he loses his kidneys, Denton goes on dialysis and has a stroke. Therefore, when private investigator Jessica Jones tracks down Denton, she discovers that he is wheelchairbound and unable to speak. Denton goes to great lengths to write a note asking Jones to kill him. This fictionalized story may be the reality for some people. Everyone wants to live a happy life and to have a good death. Some people have the privilege of ...


Confronting The Ghost: Legal Strategies To Oust Medical Ghostwriters, Deanna Minasi Oct 2017

Confronting The Ghost: Legal Strategies To Oust Medical Ghostwriters, Deanna Minasi

Fordham Law Review

Articles published in medical journals contribute significantly to public health by disseminating medical information to physicians, thereby influencing prescribing practices. However, the information guiding treatment decisions becomes distorted by selective publishing and medical ghostwriting, which negatively affects overall patient care. Although there is general consensus in the medical community that these practices of publication bias represent a moral failing, the issue is rarely framed as a wrong that necessitates legal consequences. This Note takes the stance that medical ghostwriting constitutes an act prohibited under the Racketeer Influenced and Corrupt Organizations Act (RICO) and argues that physicians fraudulently named as authors ...


A Deliberate Departure: Making Physician-Assisted Suicide Comfortable For Vulnerable Patients, Browne C. Lewis Sep 2017

A Deliberate Departure: Making Physician-Assisted Suicide Comfortable For Vulnerable Patients, Browne C. Lewis

Browne C Lewis

This Article is divided into four parts. Part I discusses the history and evolution of the "right to die movement" in the United States. The current legal landscape in the United States is examined in Part II. In Part III, I analyze some of the relevant ethical concerns caused by the availability of physician-assisted suicide. My analysis primarily focuses on the Oregon statutes because it is the oldest physician-assisted suicide law in the United States and has served as a model for laws in the United States and abroad. For example, Lord Falconer's Bill, which was defeated by the ...


Distinctive Factors Affecting The Legal Context Of End-Of-Life Medical Care For Older Persons, Marshall B. Kapp Jul 2017

Distinctive Factors Affecting The Legal Context Of End-Of-Life Medical Care For Older Persons, Marshall B. Kapp

Georgia State University Law Review

Current legal regulation of medical care for individuals approaching the end of life in the United States is predicated essentially on a factual model emanating from a series of high-profile judicial opinions concerning the rights of adults who become either permanently unconscious or are clearly going to die soon with or without aggressive attempts of curative therapy.

The need for a flexible, adaptable approach to medically treating people approaching the end of their lives, and a similar openness to possible modification of the legal framework within which treatment choices are made and implemented, are particularly important when older individuals are ...


Trading Safety For Innovation And Access: An Empirical Evaluation Of The Fda’S Premarket Approval Process, George Horvath Jul 2017

Trading Safety For Innovation And Access: An Empirical Evaluation Of The Fda’S Premarket Approval Process, George Horvath

BYU Law Review

Congress created the premarket approval process (PMA) to provide a rigorous safety evaluation of high-risk medical devices before they may be sold on the U.S. market. Evaluating a PMA application requires the Food and Drug Administration (FDA) to conduct a lengthy, complex, and costly assessment of the extensive data a manufacturer must submit. But other policy concerns, notably a fear of hampering innovation and a desire to assure timely access to new technologies, have led Congress to relax some of the rigorous data requirements the PMA process imposes on manufacturers. Congress mandates that the FDA employ the “least burdensome ...


Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S. Jul 2017

Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S.

Journal of Law and Health

On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs—Recombinant DNA, in vitro fertilization, Cloning, Stem Cells—to better analyze how Congress is, and should, regulate this exciting and promising science.


Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen Jul 2017

Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen

Journal of Law and Health

The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’s patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or ...


Yours, Mine, Or Ours: Resolving Frozen Embryo Disputes Through Genetics, Carinne Jaeger Jun 2017

Yours, Mine, Or Ours: Resolving Frozen Embryo Disputes Through Genetics, Carinne Jaeger

Seattle University Law Review

Part I of this Note provides some background on the current frameworks being used by courts in dual-progenitor disputes, while Part II presents the only two cases to deal with sole-genetic progenitor disputes and details how the courts conducted their analyses. Part III explains how courts establish legal parentage and how these legal parentage standards apply to frozen embryo disputes, specifically ones that involve only one genetic progenitor. Part IV proposes a new genetic framework to assist in the resolution of these issues. This Note concludes with a recommendation for future legislative intervention to aid in the widespread and uniform ...


In The "Best Interests" Of The Disabled: Legislating Morality And The Power To Initiate Support Orders For Disabled Adults In Ohio, Kalynne Proctor Jun 2017

In The "Best Interests" Of The Disabled: Legislating Morality And The Power To Initiate Support Orders For Disabled Adults In Ohio, Kalynne Proctor

Cleveland State Law Review

Today’s reality is that many families have children who are faced with disabling conditions that prevent them from relinquishing their dependency on others. Often, the need for specialized treatment and care does not terminate once a severely disabled child reaches adulthood. While typically parents are relieved of their legal parental obligations to their adult-aged children, this is not the same case for parents with severely disabled children. In some respects, Ohio has recognized the financial difficulties divorced parents face when they are the sole caregivers of disabled adult children. Although Ohio law requires that the noncustodial parent in a ...


Beyond Canterbury: Can Medicine And Law Agree About Informed Consent? And Does It Matter?, 45 J.L. Med. & Ethics 106 (2017), Marc Ginsberg Apr 2017

Beyond Canterbury: Can Medicine And Law Agree About Informed Consent? And Does It Matter?, 45 J.L. Med. & Ethics 106 (2017), Marc Ginsberg

Marc D. Ginsberg

For those of us whose scholarship focuses on medico-legal jurisprudence, the law of informed consent is a gift. It has been a fertile topic of discussion for decades, with no end in sight. Although it is not difficult to acknowledge that patient autonomy is at the core of informed consent, the doctrine is not static - it has evolved in scope and continues to engage courts in thought provoking analysis.


The Relation Between Autonomy-Based Rights And Profoundly Disabled Persons, Norman L. Cantor Apr 2017

The Relation Between Autonomy-Based Rights And Profoundly Disabled Persons, Norman L. Cantor

Norman Cantor

“The Relation Between Autonomy-based Rights and Profoundly Mentally Disabled Persons” Competent persons have fundamental rights to decide about abortion, methods of contraception, and rejection of life-sustaining medical treatment. Profoundly disabled persons are so cognitively impaired that they cannot make their own serious medical decisions. Yet some courts suggest that the mentally impaired are entitled to “the same right” to choice regarding critical medical decisions as competent persons. This article discusses the puzzling question of how to relate autonomy-based rights to never-competent persons. It argues that while profoundly disabled persons cannot be entitled to make their own medical decisions, they have ...


On Kamisar, Killing, And The Future Of Physician-Assisted Death, Norman L. Cantor Apr 2017

On Kamisar, Killing, And The Future Of Physician-Assisted Death, Norman L. Cantor

Norman Cantor

In a famous 1958 article, Yale Kamisar brilliantly examined the hazards of abuse and of slippery slope extensions that subsequently, for 46 years, served to thwart legalization of physician-assisted death (PAD). This paper shows that during the same period law and culture have effectively accepted a variety of ways for stricken people to hasten death, with physicians involved in diverse roles. Those ways include rejection of nutrition and hydration, terminal sedation, administration of risky analgesics, and withholding or withdrawal of medical life support. If these existing lawful modes of hastening death were widely acknowledged, the pressure to legalize voluntary active ...


On Hastening Death Without Violating Legal Or Moral Prohibitions, Norman L. Cantor Apr 2017

On Hastening Death Without Violating Legal Or Moral Prohibitions, Norman L. Cantor

Norman Cantor

While the vast majority of fatally afflicted persons have a powerful wish to remain alive, some stricken persons may, for any of a host of reasons, desire to hasten death. Some persons are afflicted with chronic degenerative diseases that take a grievous toll. Chronic pain may be severe and intractable, anxiety about a future treatment regimen may be distressing, and helplessness may erode personal dignity and soil the image that the afflicted person wants to leave behind. A dying patient’s interest in hastening death is often said to be in tension with a bedrock social principle that respect for ...


Changing The Paradigm Of Advance Directives To Avoid Prolonged Dementia, Norman L. Cantor Apr 2017

Changing The Paradigm Of Advance Directives To Avoid Prolonged Dementia, Norman L. Cantor

Norman Cantor

For some people, the specter of being mired in progressively degenerative dementia is an intolerably degrading prospect. One avoidance tactic is to take steps to end one's existence while still competent. That risks a premature demise while still enjoying a tolerable lifestyle. The question arises whether an alternative tactic -- an advance directive declining all life-sustaining intervention once a certain point of debilitation is reached -- might be preferable. This article describes the legal and moral foundation for an advance directive declining even simplistic interventions at a relatively early stage of decline. My own model directive is included.


Dietary Supplements Are Not All Safe And Not All Food: How The Low Cost Of Dietary Supplements Preys On The Consumer, Joanna K. Sax Mar 2017

Dietary Supplements Are Not All Safe And Not All Food: How The Low Cost Of Dietary Supplements Preys On The Consumer, Joanna K. Sax

Joanna K Sax

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco -- a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) only has limited ability to regulate the entry of new ...


Can The Right To Stop Eating And Drinking Be Implemented By A Surrogate? Mar 2017

Can The Right To Stop Eating And Drinking Be Implemented By A Surrogate?

Norman Cantor

This piece continues my exploration of the options available to avoid being mired
in deep dementia.  Previously, I spoke to actions while still competent, such as stopping
eating and drinking (SED). Here, I examine whether the right of a competent person to
stop eating and drinking can be exploited at a post-competence stage of decline by use
of an advance instruction.


Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa Mar 2017

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Faculty Scholarship

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more ...


A Healthy Amount Of Privacy: Quantifying Privacy Concerns In Medicine, Ignacio N. Cofone Mar 2017

A Healthy Amount Of Privacy: Quantifying Privacy Concerns In Medicine, Ignacio N. Cofone

Cleveland State Law Review

With recent developments in e-health, concerns have been raised regarding the privacy of patients who are monitored with such treatments. I propose a simple method to incorporate these concerns into a standard health impact evaluation, based on quality-adjusted life years and the incremental cost-effectiveness ratio. This method provides a way to objectively value privacy concerns and balance them with health benefits. Hence, it can guide doctors and policymakers into incorporating privacy considerations and making better choices regarding e-health programs. This method can also be tested on existing economic evaluations to compare outcomes and gauge the extent to which privacy issues ...


Beyond Canterbury: Can Medicine And Law Agree About Informed Consent? And Does It Matter?, 45 J.L. Med. & Ethics 106 (2017), Marc Ginsberg Jan 2017

Beyond Canterbury: Can Medicine And Law Agree About Informed Consent? And Does It Matter?, 45 J.L. Med. & Ethics 106 (2017), Marc Ginsberg

UIC John Marshall Law School Open Access Faculty Scholarship

For those of us whose scholarship focuses on medico-legal jurisprudence, the law of informed consent is a gift. It has been a fertile topic of discussion for decades, with no end in sight. Although it is not difficult to acknowledge that patient autonomy is at the core of informed consent, the doctrine is not static - it has evolved in scope and continues to engage courts in thought provoking analysis.