Health Law and Policy Commons^™

Taking From Trailblazers: Learning From Those Who Have Gone Before When Approving Biosimilars, John A. Little, Jr.

Georgia Law Review

The creation of an approval pathway for biosimilar biologicalproducts holds tremendous promise for increased competition in the biopharmaceutical market and financial savings to the health care system. Yet, safely achieving these promised benefits depends heavily on the Food and Drug Administration's ability to evaluate and compare these complicated molecules to previously approved products. Because biosimilars are different than generic drugs, the FDA's current practice of considering only its prior finding of safety and efficacy of a reference product is ill-suited for approval of biosimilars. Unfortunately, the new pathway included in recently enacted health care reform legislation ignores this distinction and …

State Of Emergency: Why Georgia's Standard Of Care In Emergency Rooms Is Harmful To Your Health, Jason R. Graves

Georgia Law Review

Patients injured by medical negligence have historically
been able to recover for the injuries they sustained. In
2005, however, the Georgia General Assembly passed
Georgia Senate Bill 3, which gave virtual immunity to
emergency room doctors and those practicing in obstetrics
wards. The Bill requires a showing of gross negligence by
clear and convincing evidence to prevail on a medical
malpractice claim against those protected by the statute.
The law prevents injured patients who cannot meet this
standard from recovering any damages, even
compensation for medical bills arising from the negligent
act. The legislature enacted the Bill in an effort …

Much Ado About Possibly Pretty Little: Mccarran-Ferguson Repeal In The Health Care Reform Effort, Christopher L. Sagers

Law Faculty Articles and Essays

Since 1945, the McCarran-Ferguson Act (MFA) has shielded the “business of insurance” from antitrust liability, so long as the challenged conduct is “regulated by State Law” and does not constitute “boycott, coercion, or intimidation.” This law, like the dozens of other statutory antitrust exemptions that still exist for other industries, has more or less always been controversial, and efforts to repeal it date back more than thirty years. This Essay asks two questions: (1) what consequences the pending repeal measures might have if one of them becomes law; and (2) what a close examination of this effort might teach us …

Healthcare Reform & The Missing Voice Of Complementary And Alternative Medicine, Gwendolyn R. Majette

Law Faculty Articles and Essays

Given the high prevalence of complementary and alternative medicine (CAM) use by Americans, coupled with the emphasis placed on prevention in many of the healthcare reform proposals, this article argues that CAM should play a role in the healthcare reform conversation. Part I provides the background information on CAM including its definition, CAM use, and its cost. This section also broadly outlines the contours of the early healthcare reform proposals, those in existence as of January 2009. Part II describes how CAM would ideally be integrated into the United States healthcare system. Part III outlines the reasons CAM has been …

Cutting The Fat Out Of Health-Care Costs: Why Medicare And Medicaid Write-Offs Should Not Be Recoverable Under Oklahoma’S Collateral Source Rule, Michael W. Cromwell

Oklahoma Law Review

No abstract provided.

Last Stand? The Criminal Responsibility Of War Veterans Returning From Iraq And Afghanistan With Posttraumatic Stress Disorder, Thomas L. Hafemeister, Nicole A. Stockey

Indiana Law Journal

As more psychologically scarred troops return from combat in Iraq and Afghanistan, society's focus on and concern for these troops and their psychological disorders has increased With this increase and with associated studies confirming the validity of the Posttraumatic Stress Disorder (PTSD) diagnosis and the genuine impact of PTSD on the behavior of war veterans, greater weight may be given to the premise that PTSD is a mental disorder that provides grounds for a "mental status defense, " such as insanity, a lack of mens rea, or self-defense. Although considerable impediments remain, given the current political climate, Iraq and Afghanistan …

Discrimination Out Of Dismissiveness: The Example Of Infertility, David Orentlicher

Indiana Law Journal

In recent years, antidiscrimination theory and doctrine have rested heavily on the "anticaste" principle first invoked in Strauder v. West Virginia According to this principle, equal protection law and antidiscrimination statutes should eradicate public-and private-policies that subject some persons to ongoing stigma and subordination and therefore to second-class status in society. This Article argues that while a focus on stigma and subordination is important, it misses a key source of discrimination-the discriminationt hat arises from dismissiveness. Antidiscrimination law has recognized the need to overcome the discrimination that results from invidious bias, unfair stereotyping, irrational fear accumulated myths, or simple neglect.A …

Contraception, Abortion, And Health Care Reform: Finding Appropriate Moral Ground, Dena S. Davis

Law Faculty Articles and Essays

In this essay, I make the argument that abortion and contraception are fundamentally different actions that occupy fundamentally different moral space, and that justify fundamentally different political action. I conclude that, while it is morally licit, even morally obligatory, for people who believe that embryos are people like us, to attempt to impede access to abortion, it is morally illicit to attempt to block access to contraception (including sterilization).

Can There Be A Progressive Bioethics?, Richard O. Lempert

Book Chapters

Progressive bioethics-the words are not an oxymoron. Far from it; they are more redundant than oppositional. Yet they leave me almost as uneasy, as if they were contradictory. My unease exists because bioethics should be neither progressive nor regressive, neither right wing nor left wing, neither liberal nor conservative. It should be just good, sound ethics applied to the often difficult moral problems posed by present-day medicine and the genomic revolution.

I do not mean to suggest by this that all bioethicists need agree. Respectable ethicists using established modes of ethical analysis have long disagreed on and argued for different …

What Are The Policy Implications Of Use Of Epidemiological Evidence In Mass Torts And Public Health Litigation, Christopher Ogolla

St. Thomas Law Review

The distinctions between the standards of proof employed in epidemiology and in law inform the central thesis of this paper. This analysis began by describing the role of epidemiology in mass torts and public health litigation. It later argues that because mass torts cover such a wide area, there are several problems related to epidemiology in litigation, particularly scientific uncertainty and inconsistent factual claims. Part II discusses recent cases where epidemiological evidence was raised and debated, distinguishing between vaccine-related and non-vaccine-related cases. Courts have differentiated vaccine-related cases from non-vaccine-related cases, principally because Congress enacted a vaccine act designed to compensate …

Pursuing Health As Foreign Policy: The Case Of China, Yanzhong Huang

Indiana Journal of Global Legal Studies

Eastphalia Emerging?: Asia, International Law, and Global Governance, Symposium. Indiana University Maurer School of Law, Bloomington, Indiana, 2009

Diagnosing American Health Care: Economic Stakeholders And Bioethical Considerations, Jonathan Will

Journal Articles

Cost. Access. Quality. These are three objectives that must drive a responsible discussion regarding reform of the delivery of health care in this country, and specifically, decreasing (or at least controlling) cost while increasing access and quality.

From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah

Faculty Publications By Year

Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competence to decide complex policy issues related to science and health care such as those involved in establishing an expanded access program. Congress and FDA should allow only limited access to unapproved therapies because there are significant concerns about the safety and efficacy of unapproved drugs. Moreover, many of the proposals to widen access …

Crossroads And Signposts: The Ada Amendments Act Of 2008, Jeannette Cox

Indiana Law Journal

Although the apparent purpose of the 2008 amendments to the Americans with Disabilities Act (ADA) is solely to broaden the ADA 's protected class, the manner in which the amendments achieve this purpose erodes the statute's explicit textual support for understanding persons with disabilities as a politically subordinated minority. The amendments also strengthen the statutory link between the biological severity of a person's disability and that person's right to sue for ADA accommodations. Accordingly, for some courts, the amendments will reinforce the perception that the ADA differs from traditional civil rights law.

Federal courts' understanding of the ADA 's relationship …

What Parents Don't Know: Informed Consent, Marriage, And Genital-Normalizing Surgery On Intersex Children, Samantha S. Uslan

Indiana Law Journal

No abstract provided.

Courts' Struggle With Infertility: The Impact Of Hall V. Nalco On Infertility-Related Employment Discrimination, Kerry Van Der Burch

University of Colorado Law Review

This Note focuses on a recent Seventh Circuit case of first impression, Hall v. Nalco, which held that Title VII prohibits an employer from firing an employee for absenteeism related to infertility treatments. Because Hall is the first circuit court decision to rule that fertility-treatment discrimination can be a form of sex discrimination under Title VII, it represents a victory for infertile employees suffering from workplace discrimination. Yet Hall tells a tale of missed opportunities. This Note highlights how both the Seventh Circuit and the plaintiff, Cheryl Hall, missed opportunities to expand legal protection for employees undergoing infertility treatments. First, …

Too Good To Be True: Second Thoughts On The Proliferation Of Mental Health Counts, H Archibald Kaiser

Articles, Book Chapters, & Popular Press

The last two decades have witnessed the proliferation of mental health courts, proffered by governments as an efficacious and sometimes exclusive response to the complex social dynamics causing the criminalization of persons who live with mental health problems. the ready embrace of this variant of the problem-solving-courts genre has diverted policy-makers and citizens from confronting the root causes of the challenging intersection of mental illness and crime. the new courts have acquired a legitimacy that belies a wide range of doubts about their existence and operation. this commentary will offer a counterpoint to the accelerating momentum of mental health courts. …

Watch Your Language: A Review Of The Use Of Stigmatizing Language By Canadian Judges, Jocelyn Downie, Michelle Black

Articles, Book Chapters, & Popular Press

Despite ongoing advances in understanding the causes and prevalence of mental health issues, stigmatizing language is still often directed at people who have mental illness. Such language is regularly used by parties, such as the media, who have great influence on public opinion and attitudes. Since the decisions from Canadian courtrooms can also have a strong impact on societal views, we asked whether judges use stigmatizing language in their decisions. To answer this question, we conducted a qualitative study by searching through modern Canadian case law using search terms that were indicative of stigmatizing language. We found that, although judges …

Caveat Emptor, Venditor Et Praescribor: Legal Liability Associated With Methyplenidate Hydrochloride (Mph) Use By Postsecondary Students, Jocelyn Downie, Fiona Campbell, Simon Outram

Articles, Book Chapters, & Popular Press

For years, students have endured the physical and mental stress that comes as a result of the demands of post-secondary education. All -night cramming for exams and marathon paper writing sessions are considered, by many, to be a rite of passage, endured by generations of students. For many years, students have also turned to stimulants (from coffee to energy drinks and caffeine pills) to extend their physical and cognitive limits in order to better cope with the demands of school and life. In this sense, the use of stimulants as study-aids is not a new phenomenon nor has it been …

Canadian Parliament Must Act On Assisted Human Reproduction, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In the past three months, three members of the Board of Directors of Assisted Human Reproduction Canada (AHRC) have resigned. Their resignation letters include the following statements: '[that following requests for information about the Agency's spending and budget] there was much reluctance and procrastination in providing information, and that when the information was provided, there were inconsistencies in what I received and what was originally presented. This raises concerns in my mind about the prudence and diligence in managing public funds'; 'I have encountered difficulties as a board member in receiving satisfactory replies to concerns and questions I have raised …