Law Commons^™

3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom

Evan R. Youngstrom

Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must be …

How Did You Know That? Protecting Privacy Interests Of Research Participants Via Certificates Of Confidentiality, Jonathan S. Miller

Jonathan S Miller

Answering novel medical hypotheses requires investigators to have robust and demographically diverse biospecimens and genetic data to facilitate their research. Doing so however also requires adequate participation by human subjects willing to consent to the donation and use of their biospecimens and genetic data for future unforeseen research. Although advances in scientific methodologies and technologies to understand the etiology of diseases and facilitate the development of improved therapeutics are critical to enhancing the common good; these advances pose informational risks associated with the re-identification of individuals. The conundrum exists about how to mitigate the privacy concerns associated with potential re-identification …

A Traumatic Brain Injury Is A Headache In Both Medical And Legal Circles, Samuel D. Hodge Jr.

Samuel D. Hodge Jr.

A traumatic brain injury (TBI) is the most feared consequence of head trauma. The reason is simple - the brain is who we are, our essence, including our memories of past times, how we respond to the environment with its stresses and challenges, and how we dream and plan for the future. A TBI has become one of the hottest and most controversial areas in personal injury litigation. More and more suits are being filed asserting claims for such problems and it is the signature injury of the Afghanistan and Iraq wars. Much publicity has also been generated about the …

Ivf And The Law: How Legal And Regulatory Neglect Compromised A Medical Breakthrough, Steve Calandrillo

Steve P. Calandrillo

The rise of assisted reproductive technology like in vitro fertilization (IVF) as a method of human reproduction represents a remarkable medical achievement. It has allowed millions of infertile and same-sex couples to have children who were previously only the subject of their unrequited dreams. Live births and success rates have increased dramatically in the past decade, so much so that many fertility clinics “guarantee” a baby to clients who sign up. But with success comes inevitable downsides. Everyone knows that the price tag is steep, but given the demand, that obstacle seems to deter relatively few determined individuals. More insidious …

Invalid Testimony: Disability And Voice In The Criminal Procedure (Co-Authored With Osnat Ein-Dor) (Hebrew), Sagit Mor

Sagit Mor

This Article discuses the sociolegal reality that people with developmental and mental disabilities experience in their interaction with the criminal justice system and the challenges that the criminal system faces when it comes to deal with a case which involves a disabled person. It maintains that the barriers that disabled people face in criminal proceedings do not exist only in pre-trial stages, but also during the trial itself, since courts, too, are impacted by exclusionary legal rules and by cognitive schemas that express negative stereotypes. In 2005 a new law was introduced in Israel: Investigation and Testimony Proceedings (Accommodations for …

From Absence To Presence: A Critique Of Intersex Surgeries (Co-Authored With Maayan Sudai And Or Shai) (Hebrew), Sagit Mor

Sagit Mor

This is the first Article in Israeli legal scholarship that addresses the rights of intersex persons, who were born with "a reproductive or sexual anatomy that doesn’t seemto fit the typical definitions of female or male" (INSA). The common practice in most Western countries today is to operate intersex infants in order to assign them to one of the “conventional” sexes: either male or female. The Article lays the foundations for an intersex critique of law that supports the rights of intersex persons and lays out the ground for the critique of the current legal arrangement and the design of …

Caremark's Irrelevance, Mercer E. Bullard

Mercer E Bullard

In re Caremark Int’l Inc. Derivative Litig. is commonly held out as the iconic corporate law case on liability for a failure of legal compliance, but the true source of corporate law as to legal compliance is the higher standard established by other sources of law. The expected cost of liability, both criminal and civil, for violations of federal healthcare regulations, for example, is a far stronger determinant of corporate compliance systems than potential liability under Caremark. Other areas of industry-specific regulation, such as for financial services, telecommunications and energy, similarly play a greater role than state corporate law in …

Caremark's Irrelevance, Mercer E. Bullard

Mercer E Bullard

In re Caremark Int’l Inc. Derivative Litig. is commonly held out as the iconic corporate law case on liability for a failure of legal compliance, but the true source of corporate law as to legal compliance is the higher standard established by other sources of law. The expected cost of liability, both criminal and civil, for violations of federal healthcare regulations, for example, is a far stronger determinant of corporate compliance systems than potential liability under Caremark. Other areas of industry-specific regulation, such as for financial services, telecommunications and energy, similarly play a greater role than state corporate law in …

Nudging People To Become Organ Donors: An Opt-Out System That Does Not Presume Anyone’S Consent, Alex P. Garens

Alex P. Garens

Faced with a dire organ shortage, many state legislatures have recently explored alternatives to the current system of registering organ donors. One promising proposed alternative is to switch from an “opt-in” to an “opt-out” model of recording organ donation preferences on forms administered in connection to state-regulated task, such as obtaining a driver’s license or identification card. Unfortunately, these proposed “opt-out” models garnered little support as they were largely misunderstood and improperly likened to the archetypal presumed consent systems in Europe. Crucially, this paper distinguishes the proposed “opt-out” model from presumed consent systems in key ways, thus demonstrating that the …

Interoperable Electronic Healthcare Record: A Case For Adoption Of A National Standard To Stem The Ongoing Healthcare Crisis, Deth Sao, Amar Gupta, David A. Gantz

Deth Sao

Interoperable electronic health records (EHR) have the capacity to deliver health care at optimal costs and quality in the United States, but current private and public initiatives have delayed nationwide implementation by failing to overcome several obstacles. These obstacles include: widespread reluctance in adopting health information technology (HIT); differing technical and semantic standards for communication between vendor systems; and legal challenges, which are mainly based on liability, privacy, and security concerns. This paper examines these challenges and the inadequacies of current HIT-EHR implementation strategies, questioning in particular the validity of privacy and security-based concerns. A comparison with the U.S. finance …

"How's My Doctoring?" Patient Feedback's Role In Physician Assessment, Ann Marie Marciarille

Ann Marie Marciarille

A society-wide consumer revolution is underway with the rise of online user-generated review websites such as Yelp, Angie’s List, and Zagat. Service provider reviews are now available with an intensity and scope that attracts increasing numbers of reviewers and readers. Health care providers are not exempt from this new consumer generated scrutiny though they have arrived relatively late to the party and as somewhat unwilling guests.

The thesis of this article is that online patient feedback on physicians is relevant and valuable even though it is also uncomfortable for health care providers. This is because the modern physician-patient relationship is …

Relational Malpractice, Sagit Mor, Orna Rabinovich-Einy

Sagit Mor

Legal scholarship in recent decades has devoted considerable attention to the "malpractice crisis." Surprisingly, however, the vast majority of this literature has overlooked a fundamental aspect of the problem: the deterioration of the doctor-patient relationship. So far, mainstream legal writing on malpractice has tended to frame the situation as either an insurance crisis or a litigation crisis. Although others have acknowledged that the current malpractice regime has negatively affected the doctor patient relationship, they have narrowly framed the scope of the problem, focusing on the aftermath of a medical error. We argue that contemporary doctor-patient interactions often resemble a battle …

Equal Rights For Disabled People In Employment Law – A Critical Assessment (Hebrew), Sagit Mor

Sagit Mor

This article presents a pioneering research project, which seeks to explore whether and to what extent the Equal Rights for People with Disability Law, 1998, had an impact on courts' rulings on matters related to disability employment discrimination. In particular, it seeks to examine (1) whether a consistent and instructive legal doctrine has evolved, one that reflects the principles that guided the framers of the legislation, and (2) whether the legal discourse on disability has changed. The article presents the emerging theory of disability legal studies and its unique and original contribution to legal scholarship. Disability legal studies seeks to …

Smoked Success? Social, Cultural, And Legal Changes In The United States, Japan, And France Have Led To A Decline In Tobacco Use. Yet, Teenagers Refuse To Budge!, Dalila V. Hoover

Dalila V Hoover

Once considered a part of everyday life, tobacco consumption has become a global public health crisis that has transcended national borders. By the end of 2011, tobacco will have killed nearly six million people, including more than 600,000 of people exposed to tobacco smoke. If current smoking patterns continue, the toll will nearly double by 2030 with more than 8 million deaths. To safeguard the public’s health, the United States, Japan, and France have taken action to change the acceptability of smoking. Although they have adopted a different approach, they have successfully altered and redefined their cultural perception of tobacco …

Catching Flies With Vinegar: A Critique Of The Centers For Medicare And Medicaid Self-Disclosure Program, Jean W. Veilleux Prof.

Jean W Veilleux Prof.

The article argues that the current approach of the Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) to enforcement of the Ethics in Patient Referrals Act (the “Stark Law”) is unnecessarily punitive and discourages health care providers from self-disclosing even very minor violations of the Stark Law. The article suggests a number of specific changes to encourage provider self-disclosure and proposes that CMS create a demonstration project under the authority of the Patient Protection and Affordable Care Act to test the reforms. A demonstration project provides the perfect vehicle to prove that increased …

Resolving Medical Futility Disputes, Thaddeus M. Pope, Donna Casey

Thaddeus Mason Pope

No abstract provided.

Review Of "Health Law And Bioethics: Cases In Context", Michele L. Mekel

Michele L Mekel

A review of the book "Health Law and Bioethics: Cases in Context"

Intensive Care For Health Care Service Plans: Addressing The Growing Problem Of Post-Claims Underwriting And Rescissions By Plan Providers, Kenneth R. Shurtz

Kenneth Shurtz, J.D.

In recent years, thousands of patients have been left without health care coverage – their plans rescinded or canceled after health care providers investigated the patients’ prior medical histories. These rescission investigations are often conducted after the patient has become ill or injured, receives treatment and files a claim. This practice, commonly known as post-claims underwriting, leaves vulnerable patients without coverage at a time when coverage is needed most. Although states have increasingly enacted statutes that specifically prohibit post-claims underwriting, state enforcement agencies have varied widely in their interpretation and enforcement of such statutes. Through a case study of a …

Emerging Issues In Health Care Regulation: Protecting Patients Or Punishing Providers, Michele L. Mekel

Michele L Mekel

No credible claim can assuage the assertion that medical errors beleaguer the health care industry and pose grave danger to patients. As with any issue that impacts both a significant segment of the population and a sizable component of the economy, the government has a vested interest. To that end, governmental forces, both state and federal, increasingly have turned toward the enactment of quality of care and patient protection regulation. Yet, such a command-and-control solution, although comparatively easy to institute, may not provide the optimal resolution. In fact, such top-down regulatory responses to health care quality and patient safety concerns …

“Supplementing” The Dshea: Congress Must Invest The Fda With Greater Regulatory Authority Over Nutraceutical Manufacturers By Amending The Dietary Supplement Health And Education Act. 98 Cal. L. Rev. 493., Rahi Azizi

Rahi Azizi

ABSTRACT This paper addresses serious deficiencies in the Dietary Supplement Health and Education Act, or "DSHEA." In it, I argue that the DSHEA (a federal statute passed by Congress in 1994, superseding the Food Drug and Cosmetics Act as the applicable law governing the sale of nutraceutical products) gives impermissible latitude to manufacturers of dietary supplements by allowing them to sell products without establishing whether they are safe or effective. The DSHEA also allows manufacturers to employ unsubstantiated and misleading labeling claims in marketing their products. I assert that the DSHEA promotes deceptive labeling practices. I also suggest that the …

The Supreme Court's Assault On Litigation: Why (And How) It Might Be A Good Thing For Health Law, Abigail R. Moncrieff

Abigail R. Moncrieff

In recent years, the Supreme Court has narrowed or eliminated private rights of action in many legal regimes, much to the chagrin of the legal academy. That trend has had a significant impact on health law; the Court’s decisions have eliminated the private enforcement mechanism for at least three important healthcare regimes: Medicaid, employer-sponsored insurance, and medical devices. In a similar trend outside the courts, state legislatures have capped noneconomic and punitive damages for medical malpractice litigation, weakening the tort system’s deterrent capacity in those states. This Article points out that the trend of eliminating private rights of action in …

I'M Interested In Health Law - Now Where Can I Get A Job?, Jennifer Bard

Jennifer Bard

Health care is a trillion-dollar industry that has grown exponentially over the past ten years with very little sign of slowing. The demand of legal services has tracked the growth of the industry. As a result, individuals in the health care field are increasingly thinking of expanding their career opportunities by getting law degrees and students already enrolled in law schools are interested in pursuing opportunities within health law. This article is intended to serve as a guide to both groups about the wide variety of job opportunities for lawyers within health care, where to find these jobs and how …

I’M Interested In Health Law—Now Where Can I Get A Job?, Jennifer Bard

Jennifer Bard

Health care is a trillion-dollar industry that has grown exponentially over the past ten years with very little sign of slowing. The demand of legal services has tracked the growth of the industry. As a result, individuals in the health care field are increasingly thinking of expanding their career opportunities by getting law degrees and students already enrolled in law schools are interested in pursuing opportunities within health law. This article is intended to serve as a guide to both groups about the wide variety of job opportunities for lawyers within health care, where to find these jobs and how …

Three Ways Of Looking At A Health Law And Literature Class, Jennifer Bard

Jennifer Bard

The authors of this Article participated in a panel at the American Society of Law, Ethics & Medicine Conference in 2008 that discussed the use of literary materials in law school to teach medical ethics (and related matters) in a law school setting. Each author comes at the topic from a different perspective based on his or her own experience and background. This Article and the panel on which it was based reflect views on how literature can play a valuable role in helping law students, as well as medical students, understand important legal and ethical issues and concepts in …

The Kidney Donor Scholarship Act: How College Scholarships Can Provide Financial Incentives For Kidney Donation While Preserving Altruistic Meaning, Jake Linford

Jake Linford

In the United States, lives are lost on a daily basis due to a significant shortfall in the availability of kidneys for transplantation. The current debate over possible solutions has primarily taken place at two theoretical poles—open markets and pure altruism. This article provides a timely and original response, bridging the gulf between the poles by proposing an educational scholarship to encourage kidney donation, and presenting data which indicates that the scholarship incentive may well increase the availability of transplantable kidneys in a way that preserves altruistic donation and mitigates potentially coercive market pressures. In making this case, this article …

Up In Smoke, Simon P. Serrano

Simon P Serrano

This essay is a full discussion on the FCTC (Framework Convention for Tobacco Control); it treats the method of implementation, strengths, and weaknesses of the treaty. The essay also aims to suggest methods to strengthen the current version of the document through the author's suggestions.

Federally Mandated Informed Consent: Has Government Gone Too Far?, Linda P. Mckenzie

Linda P. McKenzie

In 2003, President George W. Bush signed legislation targeted at preventing what lawmakers said was a single, specific abortion procedure. The bill banned a method that is known outside of the medical community as "partial birth abortion." Lower courts, however, struck down the law as a violation of the Supreme Court's requirement that state limits on abortion must include an exception for the life or health of the pregnant woman. The lower courts were upheld by the three circuit courts who reviewed the Partial Birth Abortion Ban Act of 2003. The U.S. Supreme Court accepted certiorari and recently heard oral …

What’S The Value Of A Billboard? Billboards, Takings, Eminent Domain, And The Environment, Simon P. Serrano

Simon P Serrano

What’s the Value of a Billboard? Billboards, Takings, Eminent Domain, and the Environment is an essay which treats the issue of land use and its relation to billboards. The essay discusses the history of this issue, beginning with decisions rendered within territories of the US in the early 20th century. Other central issues include the right to use the land to advertise, as countered by the value of the advertisement arriving from the use of public thoroughfares, takings issues, easements, and many more. The issues juxtapose the rights of the owner of the billboard to the right of privacy for …