Law Commons^™

Are You My Mother? Determining "Parentage" In Gestational Surrogacy Cases, Ashton Botts

Ashton Botts

ABSTRACT This casenote examines the 2012 Maine Supreme Court gestational surrogacy case Nolan v. Labree. This case was uncontested and the Court reached a logical and satisfying conclusion that the intended parents should be named the legal parents of the child in question. In more complex situations, though, the decisions are not so simple. This note examines the legal background of gestational surrogacy cases and state courts’ call to legislatures for guidance in deciding this legal question that becomes more prevalent every day. Courts are sending a clear message that they will not be the ones to decide issues of …

Are You My Mother? Determining "Parentage" In Gestational Surrogacy Cases, Ashton Botts

Ashton Botts

ABSTRACT This casenote examines the 2012 Maine Supreme Court gestational surrogacy case Nolan v. Labree. This case was uncontested and the Court reached a logical and satisfying conclusion that the intended parents should be named the legal parents of the child in question. In more complex situations, though, the decisions are not so simple. This note examines the legal background of gestational surrogacy cases and state courts’ call to legislatures for guidance in deciding this legal question that becomes more prevalent every day. Courts are sending a clear message that they will not be the ones to decide issues of …

Determining The Fair And Reasonable Value Of Medical Services: The Affordable Care Act, Government Insurers, Private Insurers And Uninsured Patients, George A. Nation Iii

George A Nation III

Hospitals' chargemaster prices are grossly inflated; no one should be required to pay them. Thia article offers a formula to determine the fair and reasonable value of medical services.

Affordable Care Act Changes In The Medicare Program: More Of The Same But Better, Eleaonr D. Kinney

Eleaonr D. Kinney

The Patient Protection and Affordable Care Act (“ACA”), as amended by the Health Care and Education Reconciliation Act of 2010, has made many changes in the Medicare program as part of comprehensive health reform for the US health care sector. This article reviews the changes that ACA is making and will make in the Medicare program in the years to come. Described in detail are the changes to improve the quality and efficiency of Medicare services as well as to improve program integrity and transparency. The article evaluates the past and current efforts of the Medicare program to reduce Medicare …

Affordable Care Act Changes In The Medicare Program: More Of The Same But Better, Eleaonr D. Kinney

Eleaonr D. Kinney

The Patient Protection and Affordable Care Act (“ACA”), as amended by the Health Care and Education Reconciliation Act of 2010, has made many changes in the Medicare program as part of comprehensive health reform for the US health care sector. This article reviews the changes that ACA is making and will make in the Medicare program in the years to come. Described in detail are the changes to improve the quality and efficiency of Medicare services as well as to improve program integrity and transparency. The article evaluates the past and current efforts of the Medicare program to reduce Medicare …

The Campaign For Universal Denial: Contraception Coverage And State Pharmacist Refusal Clauses, Samantha Reid Gross

Samantha Gross

Although the Affordable Care Act has made many positive steps toward providing contraceptive products and services for women, the United States Congress must pass legislation addressing state pharmacist refusal laws. Refusal, or conscience, clauses undermine the vital goal of national health reform to provide preventive measures free of charge. Unless the pharmacist refusal loophole is addressed by providing additional protections for patients, underserved women will continue to lack access to necessary, and life saving, medications, which the Federal government has guaranteed to all women, free of charge. The United States Congress should address this problem by passing legislation providing patients …

Affordable Care Act Changes In The Medicare Program: More Of The Same But Better, Eleaonr D. Kinney

Eleaonr D. Kinney

The Patient Protection and Affordable Care Act (“ACA”), as amended by the Health Care and Education Reconciliation Act of 2010, has made many changes in the Medicare program as part of comprehensive health reform for the US health care sector. This article reviews the changes that ACA is making and will make in the Medicare program in the years to come. Described in detail are the changes to improve the quality and efficiency of Medicare services as well as to improve program integrity and transparency. The article evaluates the past and current efforts of the Medicare program to reduce Medicare …

The Best Of Both Worlds: Applying Federal Commerce And State Police Powers To Reduce Prescription Drug Abuse, Stacey L. Sklaver

Stacey L. Sklaver

This article addresses the prescription drug abuse epidemic in the United States. In particular, it highlights that prescribers, as the gatekeepers of controlled substances, often lack the necessary education and training to properly prescribe such medications and to spot signs of abuse. This deficiency leads to patient overdoses and death, and resultant prescriber exposure to both civil and criminal liability.

Some states require controlled substance prescribers to obtain education on safe prescribing and abuse prevention methods, but many do not, yielding the need for a federal solution. The solution must address patient health, safety, and welfare under the purview of …

Conflict In The Courts: The Federal Nursing Home Reform Amendment And Section 1983 Causes Of Action, Susan J. Kennedy Ms.

Susan J Kennedy Ms.

Conflict in the Courts: The Federal Nursing Home Reform Amendment and Section 1983 Causes of Action Susan J. Kennedy The cases interpreting the Federal Nursing Home Reform Act of 1987 (FNRAH) exemplify judicial wrangling over the application of statutory language conferring federally protected rights and defining the consequences of violating those rights. In passing FNHRA, Congress endeavored to enact legislation requiring nursing homes to provide quality care by coupling participation in federal Medicare and Medicaid programs with adherence to certain standards. Courts interpreting FNHRA have arrived at conflicting interpretations of its provisions. While most U.S. courts have adopted limited interpretations …

Securing Advantages In Global Markets: The Example Of Stem Cell Technology, Amanda Warren-Jones Dr

Amanda Warren-Jones Dr

The potential of innovation to spur economic growth is central to determining how markets in new medical developments, such as stem cell technology, can be maximised within Europe and the USA. Promoting innovation is reliant upon nurturing technological development and at root this necessitates an effective regulatory environment. Existing academic discourse generally fragments the regulatory landscape to consider the effectiveness of discrete aspects of oversight measures and systems. This article argues that working towards a regulatory landscape which effectively shepherds technology to interim- and end-consumers in order to maximise market potential must begin from an understanding of the interrelationship of …

Direct And Enhanced Disclosure Of Researcher Financial Conflicts, Roy G. Spece Jr.

Roy G Spece Jr.

Abstract of DIRECT AND ENHANCED DISCLOSURE OF RESEARCHER FINANCIAL CONFLICTS OF INTEREST: THE ROLE OF TRUST In earlier writing I recommended direct disclosure of a major researcher financial conflict of interest, per capita funding—i.e., providing a fixed sum per subject recruited and enrolled in a study. This article adds a recommendation for enhanced direct disclosure. The enhancement in the disclosure is a summary of why per capita and excess payments are being discussed. The reason they are being discussed is because of their risk of introducing bias into researchers’ decisions regarding study design, implementation, and interpretation as well as concerning …

Evading Emergency: Strengthening Emergency Response Through Integrated Pluralistic Governance, Lance Gable

Lance Gable

This Article examines the significant governance challenges that arise during responses to public health emergencies and proposes a new multifaceted strategy—integrated pluralistic governance—to address these challenges. Emergency preparedness is an inherently complex problem that entails the integration of scientific and medical expertise, good logistical planning, and clear laws and policies. The governance function has particular import for public health emergencies because pandemics, hurricanes, and other disasters can have profoundly divisive social and political consequences. Moreover, recent disasters like Hurricane Katrina and the BP Deepwater Horizon Oil Spill revealed an emergency preparedness and response infrastructure in the United States that was …

Malpractice Liability And The Future Of Clinical Practice Guidelines For Independent Physicians, Ronen Avraham, Bill Sage

ronen avraham

In this paper we explore the question of how to create and implement clinical practice guidelines in the new health care environment, including the Patient Protection and Affordable Care Act of 2010 (“Obamacare”). In the course of our analysis, we provide the first case review in almost two decades of how courts regard and apply clinical practice guidelines, primarily in malpractice litigation, and discuss recent reports on CPGs by the Institute of Medicine issued in 2011 and by the Agency for Healthcare Research and Quality (AHRQ) issued n 2012. These reports both endorse a model of legal governance based on …

Constitutional Newspeak: Learning To Love The Affordable Care Act Decision, A. Christopher Bryant

Aaron Christopher Bryant

Constitutional Newspeak: Learning to Love the Affordable Care Act Decision In his classic dystopian novel, 1984, George Orwell imagines a world in which language is regularly contorted to mean its opposite – as in the waging of war by the Ministry of Peace and infliction of torture by the Ministry of Love. A core claim of Orwell’s was that such abuse of language – which in his novel he labeled “Newspeak” -- would ultimately channel thought. Whatever the merits of this claim as a theory of linguistics, constitutional developments too recent to be called history demonstrate that as a practical …

“Unmistakably Clear” Coercion: Finding A Balance Between Judicial Review Of The Spending Power And Optimal Federalism, Dale B. Thompson

Dale Thompson

This article proposes a new tier of scrutiny, “unmistakably clear,” for conducting judicial review of congressional authority under the Spending Clause. Under this standard, a condition would be unconstitutional only if it was “unmistakably clear” that it was coercive. In order to develop this proposal, this article traces the debate over the spending power from the Federalist Papers up through the decision in the Affordable Care Act Case, finding strong arguments for granting significant deference to Congress’s Spending Clause authority. Careful analysis of the opinions in the Affordable Care Act Case yields not only the name for the new standard …

A Shot In Arm: Can Chemical Castration Statutes Cure Sex Offenders Legally And Ethically?, Robert Watters

Robert Watters

At least seven states currently have sex offender castration statutes. This article examines the legal and ethical appropriateness of those statutes against the successful and unsuccessful European models.

“Unmistakably Clear” Coercion: Finding A Balance Between Judicial Review Of The Spending Power And Optimal Federalism, Dale B. Thompson

Dale Thompson

This article proposes a new tier of scrutiny, “unmistakably clear,” for conducting judicial review of congressional authority under the Spending Clause. Under this standard, a condition would be unconstitutional only if it was “unmistakably clear” that it was coercive. In order to develop this proposal, this article traces the debate over the spending power from the Federalist Papers up through the decision in the Affordable Care Act Case, finding strong arguments for granting significant deference to Congress’s Spending Clause authority. Careful analysis of the opinions in the Affordable Care Act Case yields not only the name for the new standard …

“Unmistakably Clear” Coercion: Finding A Balance Between Judicial Review Of The Spending Power And Optimal Federalism, Dale B. Thompson

Dale Thompson

This article proposes a new tier of scrutiny, “unmistakably clear,” for conducting judicial review of congressional authority under the Spending Clause. Under this standard, a condition would be unconstitutional only if it was “unmistakably clear” that it was coercive. In order to develop this proposal, this article traces the debate over the spending power from the Federalist Papers up through the decision in the Affordable Care Act Case, finding strong arguments for granting significant deference to Congress’s Spending Clause authority. Careful analysis of the opinions in the Affordable Care Act Case yields not only the name for the new standard …

Clarifying State Action Immunity Under The Antitrust Laws: Ftc V. Phoebe Putney Health System, Inc., Angela Diveley

Angela Diveley

The tension between federalism and national competition policy has come to a head. The state action doctrine finds its basis in principles of federalism, permitting states to replace free competition with alternative regulatory regimes they believe better serve the public interest. Public restraints have a unique ability to undermine the regime of free competition that provides the basis of U.S.- and state-commerce policies. Nevertheless, preservation of federalism remains an important rationale for protecting such restraints. The doctrine has elusive contours, however, which have given rise to circuit splits and overbroad application that threatens to subvert the state action doctrine’s dual …

Mistake-Proofing Medicine: Legal Considerations And Healthcare Quality Implications, Arlen W. Langvardt

Arlen W Langvardt

MISTAKE-PROOFING MEDICINE: LEGAL CONSIDERATIONS

AND HEALTHCARE QUALITY IMPLICATIONS

Authors: John R. Grout, John W. Hill, Arlen W. Langvardt (corresponding author).

Abstract

In 1999, the Institute of Medicine estimated that approximately 98,000 deaths resulted annually from medical errors. This shocking number does not appear to have lessened during the intervening years. Although mistake-proofing techniques similar to those that have proven useful in the product liability context hold great promise for reducing the number of medical errors, the adoption of such techniques in healthcare settings has not occurred to the extent it should have.

This article examines potentially useful mistake-proofing techniques, explores …

“Unmistakably Clear” Coercion: Finding A Balance Between Judicial Review Of The Spending Power And Optimal Federalism, Dale B. Thompson

Dale Thompson

This article proposes a new tier of scrutiny, “unmistakably clear,” for conducting judicial review of congressional authority under the Spending Clause. Under this standard, a condition would be unconstitutional only if it was “unmistakably clear” that it was coercive. In order to develop this proposal, this article traces the debate over the spending power from the Federalist Papers up through the decision in the Affordable Care Act Case, finding strong arguments for granting significant deference to Congress’s Spending Clause authority. Careful analysis of the opinions in the Affordable Care Act Case yields not only the name for the new standard …

The Flaws Of Stem Cell Legislation: Sherley, Brustle, And Future Policy Challenges Posed By Induced Pluripotent Stem Cells, Nicholas J. Diamond

Nicholas J Diamond

In this article, I first contextualize the origins of disagreement over the nature and extent of human embryonic stem cell (hESC) research regulation. By analyzing two key pieces of hESC legislation as considered in two landmark court decisions—one from the United States and one from the European Union—I argue that current stem cell policies are deeply flawed. After surfacing the flaws of these policies, I examine novel challenges for policymakers posed by the newest advancement in stem cell science, induced pluripotent stem cells. In view of these novel challenges, I contend that current policies, which are hESC-focused and deeply flawed, …

Putting Boomers To Pasture: Does The 2010 Mippa Legislation Reinforce The Nursing Home Bias?, Robert S. Bloink

Robert S Bloink

Unfunded health care expenses pose one of the greatest threats to the postretirement income security of seniors in America today. It is estimated that the average couple retiring in 2012 will require savings of approximately a quarter million dollars dedicated solely to their unfunded postretirement health care expenses, but this estimate does not factor in the expensive long-term care that most retirees will require toward the end of their lives. That the quarter-million dollar figure does not include the rapidly increasing cost of long-term care should alarm both retirees and those baby boomers approaching retirement age today. Controversial healthcare reform …

Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich

Janet Freilich

This article fills a gap in the literature by conducting a comprehensive analysis of patent infringement in the context of follow-on biologics. Patent infringement is an important topic because, like small molecule generic drugs, follow-on biologics are likely to begin their life facing infringement suits. Because it is tremendously expensive to develop a follow-on biologic, it is vital that there be consistency in how they are treated in the courts once the inevitable patent infringement suits arrive. If follow-on biologics companies cannot predict how their product will be received in court, they may decide it is not worth the risk …

Putting Boomers To Pasture: Does The 2010 Mippa Legislation Reinforce The Nursing Home Bias?, Robert S. Bloink

Robert S Bloink

Unfunded health care expenses pose one of the greatest threats to the postretirement income security of seniors in America today. It is estimated that the average couple retiring in 2012 will require savings of approximately a quarter million dollars dedicated solely to their unfunded postretirement health care expenses, but this estimate does not factor in the expensive long-term care that most retirees will require toward the end of their lives. That the quarter-million dollar figure does not include the rapidly increasing cost of long-term care should alarm both retirees and those baby boomers approaching retirement age today. Controversial healthcare reform …

The Paradox Of Legal Equivalents And Scientific Equivalence: Reconciling Patent Law’S Doctrine Of Equivalents With The Fda’S Bioequivalence Requirement, Janet Freilich

Janet Freilich

Contrary to popular perception, generic drugs often enter the market before the patents covering their brand-name counterparts have expired by making slight changes the drug to avoid the brand-name patent. These generics face a paradox: the FDA requires that the generic “not show a significant difference” from the reference product while patent law requires that the generic have “substantial differences” as compared to the reference product. The generic must be bioequivalent but not legally equivalent to the brand-name drug. This paradox occurs frequently in the courts but has never been discussed in the literature. This article analyzes every case involving …

Act Up, Fight Back, Fight Aids! The Legacy Of Act Up’S Policies And Actions From 1987-1994, Nathan H. Madson

Nathan H Madson

The AIDS Coalition to Unleash Power (ACT UP) was founded in 1987 after a speech by Larry Kramer implored people to address the widespread destruction and deaths caused by HIV/AIDS. Since its founding, ACT UP has worked to improve the public’s awareness of the disease and to push for legislation that not only protected People With AIDS (PWAs), but also improved their access to medications and treatments. The way in which ACT UP achieved these goals, however, has provided a framework for other marginalized groups to make a similar impact. Some of the tools ACT UP used include: zaps, political …

Putting Boomers To Pasture: Does The 2010 Mippa Legislation Reinforce The Nursing Home Bias?, Robert S. Bloink

Robert S Bloink

Unfunded health care expenses pose one of the greatest threats to the postretirement income security of seniors in America today. It is estimated that the average couple retiring in 2012 will require savings of approximately a quarter million dollars dedicated solely to their unfunded postretirement health care expenses, but this estimate does not factor in the expensive long-term care that most retirees will require toward the end of their lives. That the quarter-million dollar figure does not include the rapidly increasing cost of long-term care should alarm both retirees and those baby boomers approaching retirement age today. Controversial healthcare reform …

Plunging Into Endless Difficulties: Medicaid And Coercion In The Healthcare Cases, Kevin Outterson

Kevin Outterson

Of the four discrete questions before the Court in National Federation of Independent Business v. Sebelius, the Medicaid expansion held the greatest potential for destabilization from both a statutory and a constitutional perspective. As authors of an amicus brief supporting the Medicaid expansion, and scholars with expertise in health law who have been cited by the Court, we show in this article why NFIB is likely to fulfill that promise.

For the first time in its history, the Court held federal legislation based upon the spending power to be unconstitutionally coercive. Chief Justice Roberts’ plurality (joined for future voting purposes …

Will Fda Data Exclusivity Make Biologic Patents Passé?, Vincent J. Roth Esq

Vincent J Roth Esq

Much controversy has ensued over the current 12 year data exclusivity period afforded biosimilars pursuant to the Biologics Price Competition and Innovation Act of 2009 (the “BPCI”) that was recently enacted in March 2010, as part of President Obama’s Patient Protection and Affordable Care Act (the “PPACA”), to create a biosimilar market in the US. In fact, the BPCI, itself, has been controversial and just barely survived judicial scrutiny when the US Supreme Court upheld the PPACA on June 28, 2012 in a 5-4 vote. Many commentators speculate whether data exclusivity will overtake patents as the preferred method of intellectual …