Law Commons^™

A Health Care Autopsy, Marc Gans

Marc Gans

This paper analyzes each of the factors responsible for the rapid rise in health care spending in this country. This includes an in-depth analysis of prescription drug expenditures, which has been the fastest growing component of health care costs. Lastly, this paper will address whether there is anything particularly unique about health care spending in California.

Public Health Legal Services: A New Vision, David I. Schulman, Ellen Lawton, Paul R. Tremblay, Randye Retkin, Megan Sandel

Paul R. Tremblay

In recent years, the medical profession has begun to collaborate more and more with lawyers in order to accomplish important health objectives for patients. That collaboration invites a revisioning of legal services delivery models and of public health constructs, leading to a concept we develop in this article, and call "public health legal services." The phrase encompasses those legal services provided by non-government attorneys to low-income persons the outcomes of which when evaluated in the aggregate using traditional public health measures advance the public's health. This conception of public health legal services has emerged most prominently from innovative developments in …

Bio-Banks As A Tissue And Information Semi-Commons: Balancing Interests For Personalized Medicine, Tissue Donors And The Public Health, Ken Gatter

Ken Gatter

Tissue biobanks are critical to realizing the promise of personalized medicine. Unlike tissue repositories of the past, biobanks combine tissue with clinical and tissue derived molecular information. They are searchable, organized data-rich entities that can make lending decisions to qualified researchers. Biobanks have a green light and are growing in number, size, complexity and investment money, but forge ahead with many ethical and legal issues unsettled. The current approach has excessive redundancy, overlap and waste because tissue is often collected for a single purpose and information proprietary.

This essay will examine the advantages and shortcomings of current law describing human …

Proxy Consent To Participation Of The Decisionally Impaired In Medical Research - Maryland's Policy Initiative, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.

Judging Genes: Implications Of The Second Generation Of Genetic Tests In The Courtroom, Diane E. Hoffmann, Karen H. Rothenberg

Diane Hoffmann

The use of DNA tests for identification has revolutionized court proceedings in criminal and paternity cases. Now, requests by litigants to admit or compel a second generation of genetic tests – tests to confirm or predict genetic diseases and conditions – threaten to affect judicial decision-making in many more contexts. Unlike DNA tests for identification, these second generation tests may provide highly personal health and behavioral information about individuals and their relatives and will pose new challenges for trial court judges. This article reports on an original empirical study of how judges analyze these requests and uses the study results …

The Influence Of Law And Lawyers On Patient Care, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.

Physicians Who Break The Law, Diane E. Hoffmann

Diane Hoffmann

This paper takes as its starting point a recent article by Prof. Sandra Johnson, Regulating Physician Behavior: Taking Doctors “Bad Law” Claims Seriously. In the article, Johnson focuses on doctors who comply with the law despite their belief that the law is “bad”, i.e., causes them to behave in ways that are harmful to their patients. In Physicians Who Break the Law, I explore cases where physicians break the law claiming that it is “bad”. In this exploration, I focus on two areas of physicians’ lawbreaking: (1) violations of business-related laws, in particular, insurance fraud; and (2) violations of laws …

Treating Pain V. Reducing Drug Diversion And Abuse: Recalibrating The Balance In Our Drug Control Laws And Policies, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.

The Maryland Health Care Decisions Act: Achieving The Right Balance?, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.

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

Diane Hoffmann

No abstract provided.

Introduction To The Tenth Anniversary Issue Of The Journal Of Health Care Law & Policy , Karen H. Rothenberg, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.

Emergency Care And Managed Care - A Dangerous Combination, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.

Who Decides Whether A Patient Lives Or Dies?, Diane E. Hoffmann, Jack Schwartz

Diane Hoffmann

No abstract provided.

The Girl Who Cried Pain: A Bias Against Women In The Treatment Of Pain, Diane E. Hoffmann, Anita J. Tarzian

Diane Hoffmann

In general, women report more severe levels of pain, more frequent incidences of pain, and pain of longer duration than men, but are nonetheless treated for pain less aggressively. The authors investigate this paradox from two perspectives: Do men and women in fact experience pain differently - whether biologically, cognitively, and/or emotionally? And regardless of the answer, what accounts for the differences in the pain treatment they receive, and what can we do to correct this situation?

Achieving Quality And Responding To Consumers - The Medicare Beneficiary Complaint Process: Who Should Respond?, Diane E. Hoffmann, Virginia Rowthorn

Diane Hoffmann

No abstract provided.

Are Health Care Conflicts All That Different? A Contrarian View, Diane E. Hoffmann

Diane Hoffmann

No abstract provided.

Testing Children For Genetic Predispositions: Is It In Their Best Interest?, Diane E. Hoffmann, Eric A. Wulfsberg

Diane Hoffmann

No abstract provided.

Commerce Games And The Individual Mandate, Leslie Meltzer Henry, Maxwell L. Stearns

Leslie Meltzer Henry

While the Supreme Court declined an early invitation to resolve challenges to the Patient Protection and Affordable Care Act (“PPACA”), a recent split between the United States Courts of Appeals for the Sixth Circuit (sustaining the PPACA’s “individual mandate”) and the Eleventh Circuit (striking it down) virtually ensures that the Court will decide the fate of this centerpiece of the Obama Administration’s regulatory agenda. Whatever the Court’s decision, it will likely affect Commerce Clause doctrine- and related doctrines - for years or even decades to come. Litigants, judges, and academic commentators have focused on whether the Court’s “economic activity” tests, …

Electromagnetic Pulse And The U.S. Food Security Paradigm: Assumptions, Risks, And Recommendations, Maximilian Leeds

Maximilian Leeds

This paper analyzes the systemic dangers posed to the U.S. economy by an electromagnetic pulse (EMP), either naturally occurring or maliciously generated, from a food security perspective. Section I examines the modern structure of the U.S. food supply chain, analyzing the just-in-time international distribution model and criticizing it as vulnerable to systemic shock and cascade failure. Section II examines the function and history of the electromagnetic pulse, assesses its potential to serve as a catalyst for systemic breakdown in the domestic food supply chain, and explores the current state of food security planning in the United States pertaining to this …

Individual Mandates: A Founder-Approved Means Under The Necessary And Proper Clause, Eli Alcaraz

Eli A Alcaraz

The Affordable Health Care Act’s (“ACA”) individual mandate requiring most Americans to purchase healthcare was challenged as unconstitutional even before the ACA was passed. Challengers to the ACA assert that the federal government has never been allowed to force an individual to make a purchase from a private entity and that the ACA’s requirement that an individual do so is unconstitutional. This Comment takes issue with those asserting that an “individual mandate” is a contemporary invention and unconstitutional. As a matter of fact, there is at least one historical example where the federal government has forced individuals to makes purchases …

Individual Mandates: Congress’ Power To Force Individuals To Purchase Goods From Private Entities Is Older Than You Think, Eli Alcaraz

Eli A Alcaraz

The Affordable Health Care Act’s (“ACA”) individual mandate was challenged as unconstitutional since before the passing of the ACA. Challengers to the ACA assert that the federal government has never been allowed to force and individual to make a purchase from a private entity and that the ACA’s requirement that an individual do so is unconstitutional. This Article takes issue with those asserting that an “individual mandate” is a contemporary invention. In fact, there has been at least one instance where the federal government has forced individuals to makes purchases from private entities in the Uniform Militia Act of 1792. …

Learning From Our Past To Help Save Our Future: Historical Public Health Crises And How These Lessons Will Help Solve Obesity, Kate M. Emminger

Kate M Emminger

The obesity epidemic continues to plague the United States. Debates regarding strategies to solve the obesity crisis are constant but little has been accomplished by public health officials. Obesity is a multi-faceted, stigmatized problem, but it is not beyond the reach of public health. To prove that public health strategies must be utilized to solve the obesity crisis, this paper makes a comparative analysis between past successful public health campaigns and the obesity epidemic. Enlightening parallels exist between the bubonic plague, tobacco cessation and obesity. The bubonic plague parallels obesity because the plague lacked a pill or vaccine cure, was …

Quo Vadis Wto? The Threat Of Trips And The Biodiversity Convention To Human Health And Food Security, Kojo Yelpaala

Kojo Yelpaala

Abstract Just a few years following the coming into force of the World Trade Organization (WTO) and the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreements, the risks they posed to human health and food security became self-evident. This problem has been acknowledged by the WTO in the Doha Declaration, by other United Nations Organs and commentators. Joined at the hip the WTO and TRIPS system, as implemented, seems to have aggravated the severe and debilitating disease burden and food insecurity of many of its member developing countries that existed prior to TRIPS. Although the WTO and its Council …

Life, Death & The God Complex: The Effectiveness Of Incorporating Religion-Based Arguments Into The Pro-Choice Perspective On Abortion, Stacy A. Scaldo

Stacy A Scaldo

While speaking on the issue of healthcare in August of 2009, President Barrack Obama told a meeting of Jewish rabbis, “We are God’s partners in matters of life and death.” While the President’s message was expressly targeting choices in healthcare and end of life decisions, the statement is representative of a shift in the public rhetoric reflective of all matters concerning life - including abortion. This, indeed, would be a remarkable change in both express policy and argument identification – one that appears to be a new weapon in the arsenal of those who identify themselves with the pro-choice movement. …

Toward A Precautionary Principle: Regulatory Inadequacies Under The Ffdca And Fqpa In Addressing Cumulative Body Burdens And Chemical Synergies, Maximilian Leeds

Maximilian Leeds

This paper analyzes regulatory inadequacies in addressing environmental exposure as a likely source of disease, with a particular focus on chemicals within the food supply. Section I explores the statutory powers of the EPA, FDA, and USDA in setting and enforcing tolerance levels for chemicals in food, and discusses deficiencies in the current approach. Section II discusses the EPA’s understanding and enforcement of an individual’s exposure to multiple chemicals, both cumulatively and synergistically, and delves into science’s increasing understanding of how such exposure affects human health. Section III provides recommendations for regulatory changes, and especially emphasizes the adoption of a …

Gene Probes As Unpatentable Printed Matter, Andrew Chin

Andrew Chin

In this Article, I argue that the most problematic kind of gene patents — those claiming short DNA molecules used to probe for longer gene sequences — should be held invalid as directed to unpatentable printed matter. This argument, which emerges from recent developments in biotechnology and information technology, is grounded in the printed matter doctrine’s structural role of obviating patentability inquiries directed to inapposite information-management considerations. Where the inventive contribution in a claimed gene probe subsists solely in stored sequence information, these inapposite considerations lead the novelty and nonobviousness analyses to anomalous results that the printed matter doctrine was …

Fda Oversight Of Autologous Stem Cell Therapies: Legitimate Regulation Of Drugs And Devices Or Groundless Interference With The Practice Of Medicine?, Mary Ann Chirba, Stephanie M. Garfield

Mary Ann Chirba

No abstract provided.

Drug User Fees, Health Priorities, Politics, The Deficit And Reform Directions, Margaret Gilhooley

Margaret Gilhooley

The Food and Drug Administration now depends on user fees paid by drug companies to support more than half the salaries of the medical reviewers who advise the agency on the appropriateness of approving the drug. The funding creates a substantial risk of "capture" of the agency by the industry. Under the program,which started in 1992, drug companies pay a fee that permits the agency to hire additional reviewers to make more timely reviews on whether a drug can be approved. Under the law the agency seeks to meet performance goals for the timing of reviews, giving the program the …

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 …

Moving Upstream: The Merits Of A Public Health Law Approach To Human Trafficking, Jonathan Todres

Jonathan Todres

Human trafficking, a gross violation of human rights and human dignity, has been identified by numerous government leaders as one of the priority issues of our time. Legislative efforts over the past decade have produced a patchwork of criminal laws and some assistance programs for victims. There is no evidence, however, that these efforts have reduced the incidence of trafficking. This lack of meaningful progress prompts questions as to what the best framework is for addressing human trafficking. This Article begins with a discussion of the limitations inherent in the current law-enforcement-centric approach to the problem. It then explores the …