Law Commons^™

Exception From Informed Consent Requirements For Human Subjects In Emergency Medicine Research, Laura J. Sanger

Laura J Sanger

Research involving emergency care can present special issues with regards to obtaining informed consent. An emergency research subject may be considered a candidate for an emergency research under circumstances in which traditional informed consent can not be obtained before the therapeutic window for the research closes. In these cases there may be an exception for emergency research enrollment that waives traditional informed consent for participation in research. As informed consent forms a foundation for medical research studies, this waiver is predicated on very specific criteria. This paper explores the historical background for informed consent, the criteria for obtaining the waiver …

Stopping For Death: Re-Framing Our Perspective On The End Of Life, Ruth C. Stern, J. Herbie Difonzo

J. Herbie DiFonzo

How we die is increasingly becoming a matter of law and public policy. We grapple with issues of patient autonomy, the proper parameters of doctor-patient discussions on the end of life, the right to hasten death, and the right to control our own medical treatment. But it is physicians and patients, not judges and legislators, who are the principal actors in events at the end of life. Palliative medicine is just beginning to probe the multi-dimensional totality of suffering in dying and seriously ill patients. What we learn will influence our options at the end of life and tell us …

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 …

The Effectiveness Of Pandemic Preparations: Legal Lessons From The 2009 Influenza Epidemic, Bradly Condon, Tapen Sinha

Bradly Condon

The A(H1N1) influenza epidemic provided the first indication of the effectiveness of the pandemic preparations that countries and international organizations initiated in the wake of the 2003 SARS epidemic. In the case of SARS, China was criticized for not reporting the outbreak quickly enough. This led to new reporting requirements under WHO regulations. In the case of the 2009 influenza epidemic, Mexico and the United States complied with their obligations to report outbreaks to the WHO as soon as they detected a problem. The WHO declared a public health emergency of international concern within 48 hours of laboratory confirmation that …

Needles And Notebooks: The Limits Of Requiring Immunization For School Attendance, Allan J. Jacobs

Allan J. Jacobs

The constitutional requirements for compulsory vaccination are analyzed in the context of the release of a vaccine against human papillomavirus, a virus associated with development of various kinds of cancer, requiring many years after infection for cancer to develop. Examination of the requirements of Jacobson v. Massachusetts suggests that proposed vaccination programs be subjected to a balancing test that considers the severity of the disease, the risks of the vaccine, the amount of overall clinical experience with the vaccine, and alternate methods of prevention. It is argued that there are further constraints if vaccination is to be a requirement for …

State Authority To Regulate Toxins In Children's Consumer Products, Doug Farquhar

Doug Farquhar

The rapid rise over the last several years in the number of recalled children's toys along with media coverage of foreign-manufactured products containing lead and other toxins created a public groundswell demanding stricter controls on toys and other children's products. In response, lawmakers have tightened existing toy safety standards, increased enforcement capability of state and federal authorities, and expanded the number of regulated substances, first by state lawmakers, followed by Congress with the enactment of the Consumer Product Safety Improvement Act of 2008. This article explores the extent to which the Consumer Product Safety Improvement Act of 2008 preempts existing …

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 Smack On The Chin Or A Nibble? Content Analysis Of The Impact Of The Oakwood Trilogy, Tyler S. Gibb

Tyler S Gibb

On September 29, 2006 the National Labor Relations Board (NLRB) issues a trio of important decisions. These decisions, called the Oakwood Trilogy, represented the latest attempt by the NLRB to clearly define what it means to be a supervisor under the National Labor Relations Act (NLRA). Supervisors are outside the protection of the NLRA and are unable to unionize or participate in collective bargaining units. The Oakwood trilogy was widely criticized labor and management advocates. Some critics foresaw dire consequences resulting from the trilogy. However, management advocates praised the trilogy. One author declared that it had saved the NLRA.

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Childhood Immunizations: Paralysis On Parental Rights, Demand On Taxpayer Dollars, Rena L. Holmes Jones

Rena L Holmes Jones

The rise in the incidence of Autism Spectrum Disorder (ASD) is one of the most serious public health issues in recent years. The current statistics suggests that roughly one child out of every 150 has autism or an autistic-like disorder, compared to earlier estimates placing the rate at four or five children out of every 10,000. Autism is a condition that typically reveals itself within the first 0-4 years of life. The wide continuum of associated cognitive and neurobehavioral disorders have three core-defining features: impairments in socialization, impairments in verbal and nonverbal communication, and restricted and repetitive patterns of behaviors. …

Navigating Uncharted Waters: Intellectual Property Rights Surrounding Genomics Research & Development Information, Lawrence M. Sung

Lawrence M. Sung

No abstract provided.

The Employment Non-Discrimination Act: An Argument For H.R. 3685, Deborah L. Cook

Deborah L Cook

This article examines the language of H.R. 3685 and compares it to an earlier version of the Employment Non-Discrimination Act that was introduced in April of 2007 as H.R. 2015. Drawing upon arguments from both conservative and liberal perspectives challenging the Act, this article argues that the latest version of the Employment Non-Discrimination Act, proposed in September of 2007 as H.R. 3685, offers greater promise for protecting gay, lesbian and bisexual Americans from discrimination in the workplace. The revised Employment Non-Discrimination Act will act to ensure that individuals will be protected regardless of their sexual orientation by the same fundamental …

The Countervailing Interests Of The Progression And Application Of Biotechnological Innovation Supporting The Modification Of Current Exclusionary Property Rights, Sebastian Ohanian

Sebastian Ohanian

This paper will describe current hurdles in stem cell research and determine the legal landscape necessary to facilitate advancements in the field with a specific emphasis on Moore v. Regents of the University of California, its progeny, and applicable federal policies. This article will begin with an introduction to the scientific significance of stem cells and the tools that scientists require to perform genetic research, describe the barriers impeding research, examine recent changes in policy, and propose modifications to policies to maximize growth in the field.

The Countervailing Interests Of The Progression And Application Of Biotechnological Innovation Supporting The Modification Of Current Exclusionary Property Rights, Sebastian Ohanian

Sebastian Ohanian

This paper will describe current hurdles in stem cell research and determine the legal landscape necessary to facilitate advancements in the field with a specific emphasis on Moore v. Regents of the University of California, its progeny, and applicable federal policies. This article will begin with an introduction to the scientific significance of stem cells and the tools that scientists require to perform genetic research, describe the barriers impeding research, examine recent changes in policy, and propose modifications to policies to maximize growth in the field.

Combating Health Care Fraud With Audits And Education, Thomas B. Noonan

Thomas B Noonan

Fraud disrupts any and all operations in which it plagues. The disruptions manifest financially in increased costs and waste, and also by impairing trust and honesty that should base transactions within a system. Health care fraud acts like any other fraud in these regards, but it can be resisted like any other fraud. The financial world relies on audits to ensure that corporate financial statements accurately reflect what they intend to illustrate. Auditing a health care provider’s control activities would reveal whether the providers have reliable control activities to prevent and detect fraud. In addition, any policy to audit health …

American With Disabilities Act Amendments Act: The Effect On Employers And Educators, Paul Anthony Race

Paul A Race

The American with Disability Act Amendment Act became law in 2009. In passing the Act, Congress moved to correct a trend by Courts and the EEOC to weaken the coverage of the ADA. The American with Disability Act Amendment Act became law in 2009. In passing the Act, Congress moved to correct a trend by Courts and the EEOC to weaken the coverage of the ADA. In this article, we look at the effects of the ADAAA upon both employers and educators within post-graduate school programs. Pursuant to the Act, institutions will be required to consider accommodations for an increasing …

Legalizing Marijuana: California's Pot Of Gold?, Michael Vitiello

Michael Vitiello

Legalizing Marijuana: California’s Post of Gold? Abstract: In early 2009, a member of the California Assembly put a bill in the hopper that would have legalized marijuana in an effort to raise tax revenue and to reduce prison costs. While the bill’s proponent withdrew the bill, he vowed to renew his efforts in the next term. Other prominent California officials, including Governor Schwarzenegger, have indicated their willingness to study legalization in light of California’s budget shortfall. For the first time in over thirty years, politicians are giving serious consideration to a proposal to legalize marijuana. But already, the public debate …

Pharma’S Strategies On Fighting Generics And Healthcare Reform, Rongxiang Liu

Rongxiang Liu

This article first briefly reviews the Hatch-Waxman Act. The Act authorizes a scheme to make it much easier to obtain marketing approval for generics, as well as gives incentives to generic makers to bring generics to the market. The article then discusses the four strategies and their future impacts on drug market. Lastly, to eliminate these impacts, it proposes two legislations to ensure cheap generics be more widely available in order to reduce the healthcare cost.

Pcbs In Schools And Corporate Responsibility For Remediation: Yorktown Central School District V. Monsanto Company, Valerie J. Watnick

Valerie J. Watnick

From 1950 to 1977, thousands of school buildings in the United States were constructed or renovated using materials containing man-made materials called poly chlorinated bi-phenols, commonly known as “PCBs.” In 1977, Congress banned most uses of PCBs in construction, recognizing the adverse health effects of these man-made compounds. Despite this ban and the now widely held belief that PCBs are known animal carcinogens, probable human carcinogens and have other toxic effects on the human reproductive, immune, endocrine and neurological systems, these compounds are still commonly found in school buildings throughout the United States. This article asserts that just as concerns …

Preserving Human Potential As Freedom: A Framework For Regulating Epigenetic Harms, Fazal Khan

Fazal Khan

Epigenetics is a rapidly evolving scientific field of inquiry examining how a wide range of environmental, social, and nutritional exposures can dramatically control how genes are expressed without changing the underlying DNA. Research has demonstrated that epigenetics plays a large role in human development, and disease causation. In a sense, epigenetics blurs the distinction between “nature” and “nurture” as experiences (nurture) become a part of intrinsic biology (nature). Remarkably, some epigenetic modifications are durable across generations, meaning that exposures from our grandparents’ generation might affect our health now, even if we have not experienced the same exposures. In the same …

Enabling Responsible Public Genomics, John M. Conley, Daniel B. Vorhaus, Adam K. Doerr

John M Conley

As scientific understandings of genetics advance, researchers require increasingly rich datasets that combine genomic data from large numbers of individuals with medical and other personal information. Linking individuals’ genetic data and personal information precludes anonymity and produces medically significant information—a result not contemplated by the established legal and ethical conventions governing human genomic research. To pursue the next generation of human genomic research and commerce in a responsible fashion, scientists, lawyers, and regulators must address substantial new issues, including researchers’ duties with respect to clinically significant data, the boundary between genomic research and commerce and the practice of medicine, and …

Integration, Litigation, And Transformation: Using Medicaid To Address Racial Inequities In Health Care, Ruqaiijah A. Yearby

Ruqaiijah A Yearby

Using nursing home care as an example, this article applies a public health policy perspective to the problem. I use empirical data to prove the persistence of racial inequities in health care, analyze the government policies that allow racial inequities to continue, and provide a solution of regulatory integration. Specifically, I propose that civil rights enforcement be integrated with the nursing home enforcement system, which has been aggressively enforced and monitored. There are many strategies that may lead to the adoption of this system. One such strategy is using the Medicaid Act to induce the government to fulfill its non-race …

Legal Reading And Success In Law School: Law Students With Attention Deficit Disorder (Add), Leah M. Christensen

Leah M Christensen

The new reality in legal education is that a certain percentage of our students will come to us with ADD or with another learning disability, either disclosed or undisclosed. Yet there has been little empirical research on how law students with learning disabilities read and understand the law. This study examined how three law students with ADD read a judicial opinion. The results suggested a relationship between successful law school performance and the use of problematizing and rhetorical reading strategies; and less successful law school performance and the use of default reading strategies. Further, the results suggest that law students …

The History Of Wisconsin’S Alcohol Laws: A Drunk Culture Or Lobbyists Drunk With Power?, Mark Gaber

Mark Gaber

Wisconsin leads the nation in a bevy of alcohol consumption statistics—from binge drinking to admitted drunk drivers to liquor licenses—and has among the most lenient alcohol laws in the nation as well. It is the only state that does not criminalize the first offense of drunk driving, one of a handful that does not permit drunk driving checkpoints, and the only state where children can be served alcohol at bars with the consent of their parents. Many point to the state’s German heritage to explain its affinity for alcohol. While this might explain the genesis of the state’s drinking culture, …

Prioritizing Justice: Combating Corporate Crime From Task Force To Top Priority, Mary K. Ramirez

mary k ramirez

Inadequate law enforcement against corporate criminals appears to have created perverse incentives leading to an economic crisis – this time in the context of the subprime mortgage crisis. Prioritizing Justice proposes institutional reform at the Department of Justice in pursuing corporate crime. Presently, corporate crime is pursued nationally primarily through the DOJ Corporate Fraud Task Force and other task forces, the DOJ Criminal Division Fraud Section, and the individual U.S. Attorney’s Offices. Rather than a collection of ad hoc task forces that seek to coordinate policy among a vast array of offices and agencies, the relentless waves of corporate criminality …

Re-Thinking Liability For Vaccine Injury, Jeffrey A. Van Detta, Joanna B. Apolinsky

Jeffrey A. Van Detta

In April 2009, the first cases of the novel influenza A (H1N1) virus were detected in humans in the United States. To date, there have been 17,855 confirmed or probable cases of H1N1 infection and 45 deaths in the United States alone. More than 70 countries have now confirmed human infection with novel H1N1 flu. On June 11, 2009, the World Health Organization raised the worldwide pandemic alert level to Phase 6. At this time, as H1N1 is a new virus, there is little human immunity to it. Moreover, there is no vaccine to prevent the spread of the virus. …

Rethinking Liability For Vaccine Injury, Joanna B. Apolinsky, Jeffrey A. Van Detta

Joanna B Apolinsky

In April 2009, the first cases of the novel influenza A (H1N1) virus were detected in humans in the United States. To date, there have been 17,855 confirmed or probable cases of H1N1 infection and 45 deaths in the United States alone. More than 70 countries have now confirmed human infection with novel H1N1 flu. On June 11, 2009, the World Health Organization raised the worldwide pandemic alert level to Phase 6. At this time, as H1N1 is a new virus, there is little human immunity to it. Moreover, there is no vaccine to prevent the spread of the virus. …

Science, Public Bioethics, And The Problem Of Integration, Orlando Carter Snead

O. Carter Snead

Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decisionmaking. It has captured the attention of officials in every branch of government, as well as the American public. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decisionmaking) continue to roil the public square.

This article examines the question of how scientific methods and principles can and …

Science, Public Bioethics, And The Problem Of Integration, Orlando Carter Snead

O. Carter Snead

Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decisionmaking. It has captured the attention of officials in every branch of government, as well as the American public. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decisionmaking) continue to roil the public square.

This article examines the question of how scientific methods and principles can and …

Physicians And Patients Who “Friend” Or “Tweet”: Constructing A Legal Framework For Social Networking In A Highly Regulated Domain, Nicolas P. Terry

Nicolas P Terry

Social networks connect intimates, friends, and acquaintances that share history, strangers who share interests, or businesses and the customers they serve. This article explores how participation in online social networks blurs the boundaries between personal and professional relationships or commentary, while making available “private” information in what only appears to be a secluded area. These issues are explored within the framework of the highly regulated health domain, casting doubts on the appropriateness of some professional activities and identifying considerable risks for patients and their health-related information.

State Constitutionalism And The Right To Health Care, Elizabeth Leonard

Elizabeth A. Weeks

This Article examines state constitutions and health care rights. Notably, close to a third of states’ constitutions recognize health while the U.S. Constitution contains no reference. Ample scholarly commentary exists on the absence of a right to health care under the U.S. Constitution but little attention has been paid to state constitutional law. This Article begins by explaining the absence of a federal right and the rationale for looking to state constitutional protections for health. The Article then provides a comprehensive survey of state constitutional provisions and judicial decisions enforcing or interpreting them. The survey reveals certain common themes and …