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Compulsory Water Fluoridation: Justifiable Public Health Benefit Or Human Experimental Research Without Informed Consent, Rita Barnett Jan 2014

Compulsory Water Fluoridation: Justifiable Public Health Benefit Or Human Experimental Research Without Informed Consent, Rita Barnett

Rita Barnett-Rose

Most Americans are under the impression that compulsory water fluoridation is a safe and effective public health measure to fight tooth decay, and courts have routinely upheld compulsory water fluoridation schemes as legitimate exercises of police power to ensure the dental health of communities. Yet the evidence is steadily mounting against water fluoridation, with recent scientific studies suggesting that not only is fluoridation not effective at achieving the stated public health goal of combating dental caries, but also that excess exposure to fluoride contributes to a host of far more serious health concerns, particularly in the very population the public …


Rebuttable Presumption Of Public Interest In Protecting The Public Health—The Necessity For Denying Injunctive Relief In Medically Related Patent Infringement Cases After Ebay V. Mercexchange, Lance E. Wyatt Jr. Jan 2014

Rebuttable Presumption Of Public Interest In Protecting The Public Health—The Necessity For Denying Injunctive Relief In Medically Related Patent Infringement Cases After Ebay V. Mercexchange, Lance E. Wyatt Jr.

Lance E Wyatt Jr.

The public’s interest in medicine and good health is substantial. However, this interest is harmed when important medical devices or pharmaceuticals, although infringing on valid patents, are suddenly taken off the market after a court grants a permanent injunction. While permanent injunctions were automatically granted by the Federal Circuit before the Supreme Court’s holding in eBay v. MercExchange, courts now have more discretion to deny injunctive relief. Now that courts have this newfound discretion after eBay, the public should no longer expect to be harmed by the sudden removal of medical supplies. Unfortunately, this has not been the course that …


California Egg Toss - The High Costs Of Avoiding Unenforceable Surrogacy Contracts, Jennifer Jackson Dec 2013

California Egg Toss - The High Costs Of Avoiding Unenforceable Surrogacy Contracts, Jennifer Jackson

Jennifer Jackson

In an emotionally charged decision regarding surrogacy contracts, it is important to recognize the ramifications, costs, and policy. There are advantages to both “gestational carrier surrogacy” contracts and “traditional surrogacy” contracts. However, this paper focuses on the differences between these contracts using case law. Specifically, this paper will focus on the implications of California case law regarding surrogacy contracts. Cases such as Johnson v. Calvert and In Re Marriage of Moschetta provide a clear distinction between these contracts. This distinction will show that while gestational carrier surrogacy contracts are more expensive, public policy and court opinions will provide certainty and …


Compelling Product Sellers To Transmit Government Public Health Messages, Stephen D. Sugarman Dec 2013

Compelling Product Sellers To Transmit Government Public Health Messages, Stephen D. Sugarman

Stephen D Sugarman

No abstract provided.


Loopholes In The Affordable Care Act: Regulatory Gaps And Border Crossing Techniques And How To Address Them, Timothy Stoltzfus Jost Nov 2013

Loopholes In The Affordable Care Act: Regulatory Gaps And Border Crossing Techniques And How To Address Them, Timothy Stoltzfus Jost

Timothy S. Jost

Not available.


The Real Constitutional Problem With The Affordable Care Act, Timothy Stoltzfus Jost Nov 2013

The Real Constitutional Problem With The Affordable Care Act, Timothy Stoltzfus Jost

Timothy S. Jost

Not available.


Is Medicaid Constitutional?, Timothy Stoltzfus Jost Nov 2013

Is Medicaid Constitutional?, Timothy Stoltzfus Jost

Timothy S. Jost

Not available.


The Most Important Health Care Legislation Of The Millennium (So Far): The Medicare Modernization Act, Timothy Stoltzfus Jost Nov 2013

The Most Important Health Care Legislation Of The Millennium (So Far): The Medicare Modernization Act, Timothy Stoltzfus Jost

Timothy S. Jost

Whether or not one believes that the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) in fact improves or modernizes Medicare, the legislation obviously changes the program radically. The extent and nature of these changes make the MMA the most important piece of health care legislation to be adopted by Congress to date in this young millennium. The MMA also contains what are arguably the most important amendments to the Medicare program since its creation. This Essay first describes the identifying characteristics of the current Medicare program, then examines the significant changes that the MMA makes in the program, and …


Medicare And Medicaid False Claims: Prohibitions And Sanctions, Timothy Stoltzfus Jost Nov 2013

Medicare And Medicaid False Claims: Prohibitions And Sanctions, Timothy Stoltzfus Jost

Timothy S. Jost

Both state and federal agencies are cracking down on health care professionals who file false Medicare claims, but physicians who make good faith attempts to comply with the law are fairly secure from prosecution, since both criminal and civil penalties must be based on willful or knowing breaches of the law.


The Supreme Court And The Future Of Medicaid, Timothy Stoltzfus Jost Nov 2013

The Supreme Court And The Future Of Medicaid, Timothy Stoltzfus Jost

Timothy S. Jost

Not available.


The Role Of Competition In Health Care: A Western European Perspective, Timothy Stoltzfus Jost, Diane Dawson, André Den Exter Nov 2013

The Role Of Competition In Health Care: A Western European Perspective, Timothy Stoltzfus Jost, Diane Dawson, André Den Exter

Timothy S. Jost

The Federal Trade Commission and Department of Justice 2004 report Improving Health Care: A Dose of Competition expresses a clear allegiance to competition as the organizing principle for health care. In Europe, by contrast, the key organizing principle of health care systems is solidarity. Solidarity means that all have access to health care based on medical needs, regardless of ability to pay. This is not to say that competition is not important in Europe, but competition must take place within the context of solidarity. This article critiques the report from a European perspective, describes the role of competition in Europe …


Pharmaceutical Research And Manufacturers Of America V. Walsh: The Supreme Court Allows The States To Proceed With Expanding Access To Drugs, Timothy Stoltzfus Jost Nov 2013

Pharmaceutical Research And Manufacturers Of America V. Walsh: The Supreme Court Allows The States To Proceed With Expanding Access To Drugs, Timothy Stoltzfus Jost

Timothy S. Jost

On May 19, 2003, the Supreme Court in Pharmaceutical Research and Manufacturers of America v. Walsh affirmed a court of appeals decision allowing for the implementation of the Maine Act to Establish Fairer Pricing for Prescription Drugs.' The Maine program attempted to leverage the considerable market power of the Medicaid program to force drug companies to offer the state a discount on pharmaceuticals. The state in turn would pass the savings on to its uninsured residents. Manufacturers that refused to negotiate a discount with the state would face the prospect of their products being available to Maine Medicaid recipients only …


The Independent Medicare Advisory Board, Timothy Stoltzfus Jost Nov 2013

The Independent Medicare Advisory Board, Timothy Stoltzfus Jost

Timothy S. Jost

It is a common realization that neither unconstrained markets nor our current political institutions are capable of governing our health care system. The cost of health care is spinning dangerously out of control, yet market forces alone cannot manage these costs because of a host of relatively well-understood market failures. Moreover, our traditional political institutions - Congress and the executive administrative agencies - have also failed us in this respect. These institutions are too driven by special interest politics and too limited in their expertise and vision to control costs. Both Medicare payment formulas and coverage determinations often seem to …


The Uses Of The Social Transformation Of American Medicine: The Case Of Law, Timothy Stoltzfus Jost Nov 2013

The Uses Of The Social Transformation Of American Medicine: The Case Of Law, Timothy Stoltzfus Jost

Timothy S. Jost

Not available.


Professional Sovereignty In A Changing Health Care System: Reflections On Paul Starr's The Social Transformation Of American Medicine, Timothy Stoltzfus Jost, Keith Wailoo, Mark Schlesinger Nov 2013

Professional Sovereignty In A Changing Health Care System: Reflections On Paul Starr's The Social Transformation Of American Medicine, Timothy Stoltzfus Jost, Keith Wailoo, Mark Schlesinger

Timothy S. Jost

Not available.


The American Right-Wing Policy Agenda, Timothy Stoltzfus Jost Nov 2013

The American Right-Wing Policy Agenda, Timothy Stoltzfus Jost

Timothy S. Jost

Right-wing health policy is alive and well in the United States. Pro-business and libertarian health policy advocacy groups, generously funded by right-wing foundations (and, in some instances, by the health care industry), produce a continuous stream of press releases, policy-statements, books, articles, and symposia, as well as testimony before legislative and administrative bodies. Their positions are taken very seriously by the American media, who make certain that right-wing policy experts are represented in any discussion of current health policy issues.


Pregnant Pause: The Exclusion Of Pregnant Women From Clinical Research As Sex Discrimination, Richard M. Weinmeyer Nov 2013

Pregnant Pause: The Exclusion Of Pregnant Women From Clinical Research As Sex Discrimination, Richard M. Weinmeyer

Richard M Weinmeyer

Since the early 1990s, legislative and policy reforms have spurred the inclusion of women of childbearing potential in clinical research overseen by the National Institutes of Health and the U.S. Food and Drug Administration. Pregnant women have received no such help, however, despite the tremendous medical needs of this important demographic. This article argues that the exclusion of pregnant women from biomedical research in the United States constitutes sex discrimination as a matter of public policy given the interpretation of existing regulations governing human subjects protections. The current regulations that are in place guiding research on human subjects treat pregnant …


Doctors, Patients, And Pills--A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski Oct 2013

Doctors, Patients, And Pills--A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski

Michael J. Malinowski

This article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century, and regulatory necessity due to the limits of science and innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based upon genetic expression). Although both factors have changed immensely, the standard for drug approval has …


The Natural Rights Of Children, Walter E. Block Oct 2013

The Natural Rights Of Children, Walter E. Block

Walter E Block

No abstract provided.


Taxation Without Limitation: The Prohibited Pretext Doctrine V. The Sebelius Theory, Brett W. Hastings Oct 2013

Taxation Without Limitation: The Prohibited Pretext Doctrine V. The Sebelius Theory, Brett W. Hastings

Brett W Hastings

The Article posits that the Supreme Court erred in its ruling regarding the Affordable Care Act by overlooking a well established constitutional principle, dubbed the Prohibited Pretext Doctrine. This doctrine, which prohibits the exercise of a prohibited power through the pretextual use of a power granted, faded from memory due to the post Lochner era expansion of the Commerce Clause. Nevertheless, the doctrine remains valid law. In overlooking the Prohibited Pretext Doctrine, the Supreme Court established a new and contradictory doctrine, dubbed the Sebelius Theory. The Sebelius Theory turns the Prohibited Pretext Doctrine on its head by explicitly allowing the …


"Rfra Exemptions From The Contraception Mandate: An Unconstitutional Accommodation Of Religion", Frederick Mark Gedicks, Rebecca G. Van Tassell Sep 2013

"Rfra Exemptions From The Contraception Mandate: An Unconstitutional Accommodation Of Religion", Frederick Mark Gedicks, Rebecca G. Van Tassell

Frederick Mark Gedicks

Litigation surrounding use of the Religious Freedom Restoration Act to exempt employers from the Affordable Care Act’s “contraception mandate” is moving steadily towards eventual resolution in the U.S. Supreme Court. Both opponents and supporters of the mandate, however, have overlooked Establishment Clause limits on such exemptions. The fiery religious-liberty rhetoric surrounding the mandate has obscured that RFRA is a “permissive” rather than “mandatory” accommodation of religion—that is, a voluntary government concession to religious belief and practice that is not required by the Free Exercise Clause. Permissive accommodations must satisfy Establishment Clause constraints, notably the requirement that the accommodation not impose …


Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj. Sep 2013

Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.

Lisa C. Blanton BS., MJ.

The Food and Drug Administration (FDA) is the executive branch regulatory agency primarily responsible for protecting the nation’s drug products.[1] The FDA recently made highly inconsistent decisions surrounding a new drug for the prevention of pre-term birth, Makena™ (hydroxyprogesterone caproate). During a lengthy approval process, FDA made laudatory public announcements and demonstrated high programmatic preference to expedite approval of Makena by assigning orphan status[2] and granting accelerated “fast-track” approval time-frames.[3] Despite these actions, within weeks of the approval, the FDA issued aggressive public statements against the product’s efficacy and safety and made supportive comments about a non-FDA …


Public Assistance, Drug Testing And The Law: The Limits Of Population-Based Legal Analysis, Candice Player Aug 2013

Public Assistance, Drug Testing And The Law: The Limits Of Population-Based Legal Analysis, Candice Player

Candice T Player

In Populations, Public Health and the Law, legal scholar Wendy Parmet urges courts to embrace population-based legal analysis, a public health inspired approach to legal reasoning. Parmet contends that population-based legal analysis offers a way to analyze legal issues—not unlike law and economics—as well as a set of values from which to critique contemporary legal discourse. Population-based analysis has been warmly embraced by the health law community as a bold new way of analyzing legal issues. Still population-based analysis is not without its problems. At times Parmet claims too much territory for the population-perspective. Moreover Parmet urges courts to recognize …


The Dangerousness Of The Status Quo: A Case For Modernizing Civil Commitment Law, Daniel A. Moon Aug 2013

The Dangerousness Of The Status Quo: A Case For Modernizing Civil Commitment Law, Daniel A. Moon

Daniel C Moon

The states, private healthcare organizations, and those with psychiatric disorders are poorly served by the vague “dangerousness” standard endorsed by the United States Supreme Court in O’Connor v. Donaldson, as well as the state statutes that adhere to the high bar set in its holding. This paper explores involuntary civil commitment from a variety of perspectives in order to highlight these issues and to identify where improvements can be made. Specifically, this article proposes that the American Law Institute or the American Bar Association promulgate model rules intended to correct the system’s shortcomings and protect the various interested parties.


The Aca’S Tobacco Use Rating: Implementation, Inconsistencies And Ironies, Mary Ann Chirba, Alice Noble Aug 2013

The Aca’S Tobacco Use Rating: Implementation, Inconsistencies And Ironies, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

As the Affordable Care Act continues toward full implementation, the law’s complexity is on full display. As we have noted in earlier writings, the ACA continues the federal tradition of using a fragmented approach to allocating oversight responsibilities among federal and state regulators, while maintaining the role of private actors in health care insurance and delivery systems. The result is a dizzying array of plan types (self-insured, fully insured, small market, individual market, large market, grandfathered) subject to an equally dizzying blend of ACA, ERISA, and individual state requirements.


Erisa Preemption Of State “Play Or Pay” Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba Aug 2013

Erisa Preemption Of State “Play Or Pay” Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba

Mary Ann Chirba

From the introduction: Although ERISA preemption was ranked among the top "eight pertinent issues" that needed to be addressed in order to achieve comprehensive health care reform, Congress opted to avoid it when it passed the Patient Protection and Affordable Health Care Act on March 23, 2010, and the Health Care and Education Reconciliation Act just one week later ("PPACA" or the "Act", collectively). Currently 180 million Americans receive employer-sponsored health benefits, and millions more will do so once PPACA takes full effect over the next few years. This expansion of employer based coverage, coupled with what the Act does …


Medical Malpractice, The Affordable Care Act And State Provider Shield Laws: More Myth Than Necessity?, Mary Ann Chirba, Alice Noble Aug 2013

Medical Malpractice, The Affordable Care Act And State Provider Shield Laws: More Myth Than Necessity?, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, …


The Supreme Court On The Affordable Care Act: What We Are Waiting For, Mary Ann Chirba, Alice Noble Aug 2013

The Supreme Court On The Affordable Care Act: What We Are Waiting For, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

From the introduction: With the U.S. Supreme Court poised to rule on the Affordable Care Act (ACA) it is worth reminding ourselves of what, exactly, we have been waiting for. We await a judicial opinion that could deliver a decisive blow to all or part of a massive piece of legislation and the hard-fought battles that led to its enactment, or salvage the near-century-old quest for health care reform. At the same time we await an opinion that may reshape our fundamental understanding of the Court, the power of Congress, and long-standing principles of federalism.


The Supreme Court Upholds The Individual Mandate: But Who Are We Talking About?, Mary Ann Chirba, Alice Noble Aug 2013

The Supreme Court Upholds The Individual Mandate: But Who Are We Talking About?, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

From the introduction: While the Affordable Care Act’s individual mandate survived constitutional scrutiny in NFIB v. Sebelius, a Republican president and/or changes in the House or Senate this fall could lead to its demise. As campaigns shift into high gear, the law’s opponents will undoubtedly draw on the strident and jointly authored dissent of Justices Scalia, Kennedy, Thomas, and Alito. Despite the value of robust debate, relying on the dissent may be problematic due to its misperceptions about the ACA and the realities of health care. Thus, while we considered what we were waiting for in the weeks before the …


Our Bodies, Our Cells: Fda Regulation Of Autologous Adult Stem Cell Therapies, Mary Ann Chirba, Alice Noble Aug 2013

Our Bodies, Our Cells: Fda Regulation Of Autologous Adult Stem Cell Therapies, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated …