Health Law and Policy Commons^™

Regulating Innovative Medicine: Fitting Square Pegs In Round Holes, Mark Lavender

Duke Law & Technology Review

Increasingly, innovative medical products are creating a quandary for the Food and Drug Administration ("FDA") because they often transcend the FDA's traditional categorical approach to regulating medical products. In a recent attempt to simplify this process, the FDA has proposed a new rule for regulating "combination products." This iBrief discusses the FDA's current approach and analyzes the possible affects of the proposed regulation. Because of the many shortcomings of both systems, this iBrief concludes that the FDA should instead stop assigning center jurisdiction based on a product's "primary mode of action," and give the Office of Combination Products internal agency …

Punishing Tobacco Industry Misconduct: The Case For Exceeding A Single Digit Ratio Between Punitive And Compensatory Damages, Sara D. Guardino, Richard A. Daynard

ExpressO

This article addresses large punitive damages awards that juries have granted to plaintiffs in recent cases against the tobacco industry, and demonstrates why such high awards are a warranted and necessary incentive for the companies to change their dangerous course of conduct.

In State Farm v. Campbell, the United States Supreme Court announced that “few awards exceeding a single-digit ratio between punitive and compensatory damages” will be constitutional. In a subsequent smoking and health case brought against Philip Morris, however, a state appeals court allowed a punitive damages award that was almost 97 times the compensatory damages award. This decision …

Apology And Medical Mistake: Opportunity Or Foil?, Lee Taft

Annals of Health Law and Life Sciences

An innovative examination of the true nature of apology and its ameliorative properties, this article discusses the difficult situations arising in the wake of medical error. An interesting blend of psychology, sociology, and jurisprudence, the author responds to one physician's account of his tragic error, and offers evidence suggesting that the incidence of medical malpractice litigation may be diminished by physicians and hospitals taking responsibility and apologizing for their mistakes.

Consumer-Driven Health Care In South Africa: Lessons From Comparative Health Policy Studies, Timothy Stoltzfus Jost

Scholarly Articles

Consumer-driven health care, based on health savings accounts and high deductible health insurance policies, seems to be the next big thing in U.S. health policy. Long supported by conservative and libertarian advocacy groups, it received a big-boost with the HSA tax subsidy provisions of the Medicare Modernization Act. The question remains, however, whether consumer-driven health care can really bring down health care costs while improving quality and access, as its supporters claim that it will.

This article examines the experience of South Africa, where medical savings accounts have long been available and are widely used. It concludes that South Africa's …

Volunteer Health Professionals And Emergencies: Assessing And Transforming The Legal Environment, James G. Hodge Jr, Lance A. Gable, Stephanie H. Cálves

Law Faculty Research Publications

No abstract provided.

Note: A Painful Catch-22: Why Tort Liability For Inadequate Pain Management Will Make For Bad Medicine, James R. Blaufuss

William Mitchell Law Review

Part I of this note reviews current issues relating to pain treatment. Part II examines theoretical justifications of proposed tort liability for inadequate pain management. Part III examines how pain mismanagement does not fit within traditional notions of medical malpractice. Part IV studies the issues relating to a physician’s role as “gate-keeper” for opioids and suggests why tort liability could compromise this legislatively imposed role. Part V examines the issue of pain management in the context of end-of-life care. Part VI discusses current shifts in pain management philosophies and explains how these movements will effectuate the changes suggested by advocates …

Is Justice For One Justice For All? The Dilemma Of Public Health Enforcement In An Interconnected World, John D. Blum

Loyola University Chicago Law Journal

No abstract provided.

New Governance Norms And Quality Of Care In Nonprofit Hospitals, Thomas L. Greaney

Annals of Health Law and Life Sciences

A critical look at the "three-legged stool" of hospital governance and the impact it has upon quality of care.

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Foreword, Sarah Guyton, John Blum

Annals of Health Law and Life Sciences

No abstract provided.

The Medsouth Joint - (Ad)Venture The Antitrust Implications Of Virtual Health Care Networks, Andrew S. Oldham

Annals of Health Law and Life Sciences

Winner of Epstein Becker & Green's 6th Annual Health Law Writing Competition, this article is a detailed examination of physician joint ventures and their impact on managed care. The author analyzes the Federal Trade Commission's surprising endorsement of a Denver individual practice association, comments on the FTC's apparent lack of consideration of antitrust regulation, and eagerly anticipates the competition inevitably entering the managed care industry as a result.

A Primer On The Law And Ethics Of Treatment, Research, And Public Policy In The Context Of Severe Traumatic Brain Injury, Stacey A. Tovino, William J. Winslade

Annals of Health Law and Life Sciences

This article addresses the legal and ethical implications of treatment, research, and public policy decisions in the context of severe traumatic brain injury. Examining the tragic circumstances of a fifteen year-old boy from Connecticut who remained in a near vegetative state for almost three years, the authors provide a thorough discussion of the diverse legal and ethical issues encountered by those close to traumatic brain injury victims as they consider treatment options, research activities, and public policy decisions.

Reconsidering The Model State Emergency Health Powers Act: Toward State Regionalization In Bioterrorism Response, Matthew E. Brown

Annals of Health Law and Life Sciences

This article takes a critical look at the Model State Emergency Health Powers Act, legislation developed quickly as part of the country's "War on Terror." The author examines the potential bioterrorist threat, criticizes protocols currently in place under the Act, and offers his suggestions for a more effective, more efficient response to bioterrorism in light of technological advances affecting warfare tactics and pathology.

An Rx For The Modification Of The Medicare Prescription Drug, Improvement, And Modernization Act Of 2003: Toward A Reform With Results, Daniel Katz, Monica Deshpande

Annals of Health Law and Life Sciences

This article provides a thorough analysis of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and examines its impact on the efficiency of prescription drug coverage. The authors explain the plan slated to take effect in January of 2006, highlight its inefficiencies, and offer their suggestions regarding potential improvements to eliminate problems in advance of the Act's implementation.

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

The Effect Of Hospital Charges On Outlier Payments Under Medicare's Inpatient Prospective Payment System: Prudent Financial Management Or Illegal Conduct?, R. Brent Rawlings, Hugh E. Aaron

Annals of Health Law and Life Sciences

An innovative examination of Medicare's outlier payment procedures, this article discusses the payment calculation in detail and offers an analysis of the legality of such calculations in the context of the allegations against Tenet Healthcare Corporation. The article examines the circumstances of the allegations and suggests that perhaps fiscal responsibility can be confused with illegal conduct on occasion.

Foreword, Sarah Guyton, John Blum

Annals of Health Law and Life Sciences

No abstract provided.

The Offshoring Of American Medicine: Scope, Economic Issues And Legal Liabilities, Thomas Mclean

Annals of Health Law and Life Sciences

This article addresses the legal, economic, and technological implications of telemedicine and cybersurgery. A thorough discussion of the growing trend of outsourcing American medical procedures to foreign countries, the article provides a unique examination of and commentary on a potentially serious problem that is virtually ignored by the majority of the population.

The Scope Of A Physician's Medical Practice: Is The Public Adequately Protected By State Medical Licensure, Peer Review, And The National Practitioer Data Bank?, William P. Gunnar

Annals of Health Law and Life Sciences

This article takes a critical look at physician credentialing and licensure from the unique legal perspective of a licensed cardiac surgeon. Describing the present system of credentialing in detail and offering strong suggestions to improve it, Dr. Gunnar provides an uncommon examination of the issue of health care quality.

An Appropriate Legislative Response To Cloning For Biomedical Research: The Case Against A Criminal Ban, Adam Gusman

Annals of Health Law and Life Sciences

An interesting approach to an oft-discussed bioethical issue, Mr. Gusman's article describes the processes of therapeutic and reproductive cloning, discusses the potential for technological and medical advancement, and suggests that a criminal ban on such scientific research would be less effective and more constitutionally questionable than other alternatives, such as tight legislative regulation or voluntary compliance with aspirational, industry-wide standards.

Darling V. Charleston Community Memorial Hospital And Its Legacy, Mitchell J. Wiet

Annals of Health Law and Life Sciences

An in-depth discussion of the historic decision in a landmark case regarding the evolution of hospital liability.

A New Quality Challenge: Coordinating Credentialing And Corporate Compliance, Mark A. Kadzielski

Annals of Health Law and Life Sciences

An examination of the post-Darling process of centralized credentialing.

Looking At Accountability 40 Years After Darling, Nathan Hershey, Christine M. Jarzab

Annals of Health Law and Life Sciences

An examination of the ramifications of the Darling decision.

The Role Of State Regulation In Consumer-Driven Health Care, Timothy Stoltzfus Jost, Mark A. Hall

Scholarly Articles

The Consumer-directed health care movement has recently been given a major boost by section 223 of the Medicare Modernization Act, which provides federal income tax subsidies for health savings accounts coupled with high deductible health plans. The federal tax subsidy, however, will only be available in states whose program of insurance regulation permits high deductible health plans to exist. The MMA represents, therefore, a new approach to federalism in health insurance - offering tax incentives for states to change their approach to insurance regulation rather than preempting state regulation or imposing federal regulation. To date the states have generally responded …

Genetic Enhancement: Plan Now To Act Later, Maxwell J. Mehlman

Faculty Publications

No abstract provided.

State Ballot Initiatives In The Federal Preemption Equation: A Medical Marijuana Case Study, K.K. Duvivier

Sturm College of Law: Faculty Scholarship

As with the political reform initiatives, this second type of ballot initiative represents a category for which the initiative process is especially appropriate: issues requiring experimentation in the area of health, traditionally a topic of strong concern at the state level. Furthermore, this category of initiative does not suffer from the ills that detractors note in other contexts. These initiatives expand personal rights and do not infringe on others' rights, and they address elemental issues, so citizens can be sufficiently informed to cast votes representing their convictions. These types of initiatives, however, confront a significant problem. They frequently involve areas …

Health Savings Accounts: Increasing Health Care Access In America?, J. M. Razor

Loyola Consumer Law Review

No abstract provided.

Access To Health Care: A Conference Introduction, John Blum

Loyola Consumer Law Review

No abstract provided.

Stemming The Tide Of Stem Cell Research: The Bush Compromise, 38 J. Marshall L. Rev. 1061 (2005), Patrick Walsh

UIC Law Review

No abstract provided.

Pelvic Examinations Under Anesthesia: An Important Teaching Tool, Jennifer Goedken

Journal of Health Care Law and Policy

No abstract provided.