Law Commons^™

Announcing Remedies For Medical Injury: A Proposal For Medical Liability Reform Based On The Patient Protection And Affordable Care Act, Steven Raper

Steven E Raper MD

Recently reaffirmed, the Patient Protection and Affordable Care Act holds the promise of sweeping change in many critical aspects of the United States’ system of delivering health care. Indeed, medical liability reform is embedded into the DNA of the Obama presidency. Further, a Sense of the Senate statement raised a number of concerns over the current medical malpractice regime. These concerns led to the enactment of a small but conceptually important provision of the Affordable Care Act. Congress intends, however, to allow the states to develop liability reform through the allocation of 50 million dollars for State Demonstration Projects.

From …

Road Rules And Rights: The Irreconcilable Pursuits Of Adolescent Life, Liberty, . . . And Licensure, Vivian E. Hamilton

Vivian E. Hamilton

Employers United: An Empirical Analysis Of Corporate Political Speech In The Wake Of The Affordable Care Act, Elizabeth Weeks Leonard, Susan Scholz, Raquel Meyer Alexander

Elizabeth A. Weeks

Is the Patient Protection and Affordable Care Act (ACA) bad for business? Did the countries' most prominent companies game the Securities and Exchange Commission (SEC) disclosure process to make negative political statements about ObamaCare? Immediately following the ACA's enactment on March 23, 2010, a number of companies drew scrutiny for issuing SEC filings writing off millions – and in AT&T's case, one billion dollars – against expected earnings for 2010 alone, based on a single, discrete tax-law change in the ACA. Congressional and Administration officials accused the firms of being “irresponsible” and using “big numbers to exaggerate the health reform's …

Saving Small Employer Health Insurance, Daniel Benjamin Schwarcz

Daniel Benjamin Schwarcz

Health care reform devotes substantial attention to resuscitating the small group health insurance markets that serve employers with fewer than fifty full time employees. Unfortunately, a number of interweaving provisions embedded within the Affordable Care Act create strong incentives that, starting in 2014, will tend to undermine this market and, in the process, increase the fiscal cost of reform. First, small employers with predominantly low-income employees will tend to opt out of the small group market. Second, small employers with mixed-income employees will have strong incentives to offer coverage that is neither technically “affordable” or of “minimum value” in order …

When The Tenth Justice Doesn’T Bark: The Unspoken Freedom Of Health Holding In Nfib V. Sebelius, Abigail Moncrieff

Abigail R. Moncrieff

There was an argument that Solicitor General Donald B. Verrilli could have made—but didn’t—in defending Obamacare’s individual mandate against constitutional attack. That argument would have highlighted the role of comprehensive health insurance in steering individuals’ health care savings and consumption decisions. Because consumer-directed health care, which reaches its apex when individuals self insure, suffers from several known market failures and because comprehensive health insurance policies play an unusually aggressive regulatory role in attempting to correct those failures, the individual mandate could be seen as an attempt to eliminate inefficiencies in the health care market that arise from individual decisions to …

Does The Individual Mandate Coerce?, Sergio Campos, Raphael Boleslavsky

Sergio J. Campos

The Patient Protection and Affordable Care Act includes an individual mandate which penalizes individuals who do not purchase health insurance. Critics of the individual mandate, including a majority of justices on the Supreme Court, contend that Congress cannot use its Commerce Clause power to coerce individuals to buy a product. Supporters concede that the mandate coerces but argue that it is otherwise permissible under the Commerce Clause. This Essay questions whether the individual mandate coerces. It uses a simple economic model to show that, under certain conditions, the individual mandate induces insurers to sell health insurance at a price each …

The Lawlessness Of Sebelius, Gregory Magarian

Gregory P. Magarian

After the U.S. Supreme Court in National Federation of Independent Business v. Sebelius held nearly all of the Patient Protection and Affordable Care Act constitutional, praise rained down on Chief Justice John Roberts. The Chief Justice’s lead opinion broke with his usual conservative allies on the Court by upholding the Act’s individual mandate as a valid enactment under the Taxing Clause. Numerous commentators have lauded the Chief Justice for his courage and pragmatism. In this essay, Professor Magarian challenges the heroic narrative surrounding the Chief Justice’s opinion. He contends that the opinion is, in two senses, fundamentally lawless. First, the …

Where’S The Beef? An Examination Of The ‘Pink Slime’ Controversy And The Implications Of The Real Beef Act On State Truth-In-Menu Laws, Crystal Williams

Crystal Williams

Recent criticism concerning the use of lean finely textured beef (“LFTB”), commonly referred to as “pink slime,” has sparked a national debate about whether LFTB should be included on the label of ground beef products sold to the end consumers. On March 30, 2012, the Requiring Easy and Accurate Labeling Beef Act (the “REAL Beef Act”) was introduced to Congress. If passed, the Act would require that “labels on packages of meat include a statement on whether the meat contains [LFTB].” It is not clear from the express language of the REAL Beef Act and its legislative history whether the …

The Health Care Cases And The New Meaning Of Commandeering, Bradley Joondeph

Bradley W. Joondeph

The Supreme Court’s decision in the Health Care Cases to sustain the central provisions of the Affordable Care Act (or ACA) was hugely important in several ways. Most commentators have focused on the Court’s upholding of the ACA’s minimum coverage provision. But the Court’s Medicaid holding—that the ACA coerced (and thus commandeered) the states by making their preexisting Medicaid funds contingent on the states’ expanding their programs—may actually be more significant as a matter of constitutional law.

The basic thesis of this article is that, in finding the ACA’s Medicaid expansion provisions coercive, the Court has re-conceptualized what constitutes a …

Not Getting Hired Because You Are Obese, But Not Getting Fired Because You Are Obese: How The New Changes To The Ada Have Set A Double Standard, And What’S To Prevent Companies From Trimming The Fat At The Office, Joshua Forman

Joshua Benjamin Forman

This article examines how the recent amendments to the Americans with Disabilities Act fail to afford people who are classified as obese the protection against employment discrimination they deserve. Part I outlines the development of the history of protections afforded to individuals who are disabled. Part II concentrates on obesity as a medical condition and the way in which society perceives those who are obese. Part III focuses on whether or not obesity can be classified as a disability under the ADAAA. Part IV provides a pragmatic solution, which identifies safeguards for an obese person at each level of the …

Preventing Sex-Offender Recidivism Through Therapeutic Jurisprudence Approaches And Specialized Community Integration, Michael L. Perlin

Michael L Perlin

Preventing Sex-Offender Recidivism Through Therapeutic Jurisprudence Approaches and Specialized Community Integration

Abstract

The public’s panic about the fear of recidivism if adjudicated sex offenders are ever to be released to the community has not subsided, despite the growing amount of information and statistically-reliable data signifying a generally low risk of re-offense. The established case law upholding sex offender civil commitment and containment statutes has rejected challenges of unconstitutionality, and continues to be dominated by punitive undertones. We have come to learn that the tools used to assess offenders for risk and civil commitment still have indeterminate accuracy, and that the …

Regulating Data Mining Post-Sorrell: Using Hipaa To Restrict Marketing Uses Of Patients' Private Medical Information, Beverly Cohen

Beverly Cohen

On June 23, 2011, the United States Supreme Court in Sorrell v. IMS Health Inc determined that Vermont's law prohibiting pharmacies from selling prescription data to "data mining" companies violated the Free Speech Clause of the First Amendment. Data miners purchased the prescription data to aggregate and re-sell it to pharmacy manufacturers for marketing purposes. Drug manufacturers used the information to target physicians for face-to-face visits ("detailing") by salesmen to convince the physicians to prescribe more of the manufacturers' costly brand-name drugs. The prescription information purchased from the data miners enabled the manufacturers to target particular physicians who were not …

Legal Impediments To The Diffusion Of Telemedicine, Diane E. Hoffmann, Virginia Rowthorn

Diane Hoffmann

No abstract provided.

The Individual Mandate Tax Penalty, Jeffrey Kahn

Jeffrey H Kahn

In 2010, President Obama signed legislation that significantly altered the healthcare and health insurance markets in the United States. An integral part of that reform is the individual mandate, a provision that requires individuals to purchase and maintain healthcare insurance. Failure to maintain such coverage subjects an individual to a tax penalty. The Supreme Court recently heard oral arguments on the constitutionality of that provision in particular which, if found unconstitutional, could lead the Court to strike down the entire reform legislation. Whichever way the Court rules, fundamental questions will remain. This article addresses the question of whether the use …

Confine Is Fine: Have The Non-Dangerous Mentally Ill Lost Their Right To Liberty? An Empirical Study To Unravel The Psychiatrist's Crystal Ball, Donald Stone

Donald H. Stone

This article will examine the reverse trend in civil commitment laws in the wake of recent tragedies and discuss the effect of broader civil commitment standards on the care and treatment of the mentally ill. The 2007 Virginia Tech shooting and the 2011 shooting of Congresswoman Giffords have spurred fierce debates about the dangerousness of mentally ill and serve as cautionary tale about what happens when warning signs go unnoticed and opportunities for early intervention missed. This article will explore the misconception about the role medication and inpatient civil commitments should play in prevention of dangerousness and undermine the belief …

Embryo Disposition Agreements: The Effect Of Personal Autonomy, Constitutional Rights, And Public Policy On Enforceability, Damages, And Remedies, Nicholas Seger

Nicholas D. Seger

No abstract provided.

Patent Chokepoints In The Influenza-Related Medicines Industry: Can Patent Pools Provide Balanced Access?, Dana Beldiman

Dana Beldiman

This paper illustrates the fact that when biological materials are used for development of pharmaceuticals, the patent system may function sub-optimally and may give rise to patent “thickets” and “anti-commons” which prevent commercialization of adequate amounts of product. These circumstances include inventions based on the same biological resource, patenting of largely similar functionalities, gene patents and patents that are narrow and fragmented. As a result, in order to obtain freedom to operate, drug developers must license-in multiple patents, often from competitors. This situation gives rise to uncertainty and is prone to hold-outs. The number of players actually developing drugs is …

Global Health Justice: Towards A Framework Convention On Global Health—A Transformative Agenda For Global Governance For Health, Lawrence O. Gostin

Lawrence O. Gostin

Global health inequities cause 20 million deaths annually, mostly among the world’s poor. Yet, international law to reduce these inequalities is sparse. We propose a new global health treaty, a Framework Convention on Global Health (FCGH), based on the human right to health. Already endorsed by the UN Secretary-General, the FCGH would re-imagine global governance for health, offering a new post-Millennium Development Goals vision. A global coalition of civil society and academics has formed an international campaign to advocate for an FCGH—the Joint Action and Learning Initiative (JALI). This article provides the first systematic account of the goals and justifications …

Global Health Justice: Towards A Framework Convention On Global Health—A Transformative Agenda For Global Governance For Health, Lawrence O. Gostin

Lawrence O. Gostin

Global health inequities cause 20 million deaths annually, mostly among the world’s poor. Yet, international law to reduce these inequalities is sparse. We propose a new global health treaty, a Framework Convention on Global Health (FCGH), based on the human right to health. Already endorsed by the UN Secretary-General, the FCGH would re-imagine global governance for health, offering a new post-Millennium Development Goals vision. A global coalition of civil society and academics has formed an international campaign to advocate for an FCGH—the Joint Action and Learning Initiative (JALI). This article provides the first systematic account of the goals and justifications …

Patent Chokepoints In The Influenza-Related Medicines Industry: Can Patent Pools Provide Balanced Access?, Dana Beldiman

Dana Beldiman

Release of samples of biological materials with high imminent commercial potential, such as the influenza virus samples, is likely to cause a “race” to patent and to gain market share among recipients. This “race” may give rise to sub-optimal functioning of the patent system, in the nature of patent thickets and hold-outs, prompted by conditions such as multiple parties inventing based on a single biological resource, high growth markets, a congested patent scene and narrow and fragmented patents. This paper examines the causes of the sub-optimal functioning of the patent system under these circumstances, using the WHO Pandemic Influenza Preparedness …

Reconciling Liberty And Equality In The Debate Over Preimplantation Genetic Diagnosis, Jessica Knouse

Jessica A. Knouse

This article draws on postmodern theory to develop a framework for analyzing situations in which liberty and equality appear to conflict. It uses the debate over non-therapeutic preimplantation genetic diagnosis (PGD) as an example. While PGD is, at present, almost entirely unregulated within the United States, there seems to be relative consensus that “therapeutic” or “medical” trait selection – e.g., selection against certain genetic and chromosomal disorders – should per permitted. There is, however, substantial disagreement as to whether “non-therapeutic” trait selection – e.g., selection based on parental preference for a particular sex, disability, eye color, hair color, or skin …

All For One And One For All: Informed Consent & Public Health, Jessica Berg

Jessica Berg

Could you be vaccinated against H1N1 influenza without your consent? Do you need to consent to the chlorination of your drinking water? May public health authorities access your personal medical information without your permission? Informed consent is a bedrock principle of bioethics, but its application in the context of public health is unclear. This article explores the various justifications for allowing public health interventions without individual informed consent. Drawing from an analysis of political philosophy, it argues that there is no single “public health exception,” rather multiple rationales that lead to different requirements in different public health settings. The suggestions …

Why Roe V. Wade Is Wrong, Richard Maloy

Richard Maloy

No abstract provided.

Penny Wise But Pound Foolish In The Heartland: A Case Study Of Decriminalizing Domestic Violence In Topeka, Kansas, Shelley Santry

Shelley M. Santry

The Origins Of American Health Libertarianism, Lewis A. Grossman

Lewis A. Grossman

This Article examines the persistent American demand for freedom of therapeutic choice as a popular constitutional movement originating in the nation’s earliest years. It also shows how multiple concepts of freedom, in addition to bodily freedom, have contributed to the concept of a constitutional right to medical liberty.

There is a deep current of belief in the United States that people have a right to choose their preferred treatments without government interference. Cries of “Death Panels” are routinely directed against health care reform proposals that might limit patients’ access to medical products and procedures. FDA is furiously attacked, on freedom …

Formulating A Soda Tax Fit For Consumption: A Pragmatic Approach To Implementing The Failed New York Soda Tax., Joseph Desantis

Joseph Angelo DeSantis

Previous attempts to levy a one-cent per-ounce tax on sodas, or sugar-sweetened beverages (SSB), have failed because they are modeled after a sin tax. This article proposes a different approach. An SSB tax should have two limited aims: (1) avoid implicitly demonizing soda consumption and (2) offset the cost of treating diseases attributed to SSB consumption. To these ends, this article explores using the basic principles of insurance to offset costs associated with risky behavior, without implicitly condemning that behavior. It further explores the link between SSB consumption and direct health costs to estimate a proper offset. Finally, this article …

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …

Health Cover(Age)Ing, Rebecca Rausch

Rebecca L. Rausch

This article posits that the emerging employer-imposed health insurance fat tax regime subverts the public policy goal of achieving actual health and evidences two important systemic phenomena: first, that these fat taxes force fat people to cover their fatness, and second, that current legal structure permitting this practice ensures that society continues to cover up its anti-fat bias. American society, through the health care system and other mechanisms, has created a fat-thin dichotomy within which thin is good and fat is bad. Recently, employers began reinforcing this dichotomy by imposing on employees whose weight renders them “obese” on the Body …

The New First Amendment And Its Implications For Combating Obesity Through Regulation Of Advertising, Tamara R. Piety, Samantha Graff

Tamara R. Piety

This chapter reviews the recent decisions of the Supreme Court as they bear on attempts to combat childhood obesity through regulating marketing and concludes that attempts to regulate marketing will face substantial First Amendment obstacles in the courts.

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …