Law Commons^™

A Policy In Flux: New York State’S Evolving Approach To Human Subjects Research Involving Individuals Who Lack Consent Capacity (Forthcoming), Valerie Gutmann Koch

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No abstract provided.

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

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The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.

As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to …

Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin

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As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …

Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge

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In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.

“Of Vital Importance”: The New York State Task Force On Life And The Law’S Report And Recommendations For Research With Human Subjects Who Lack Consent Capacity (With Susie A. Han), Valerie Gutmann Koch

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No abstract provided.

Cultural Collisions And The Limits Of The Affordable Care Act, Jasmine E. Harris

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National Federation of Independent Business v. Sebelius (“NFIB”) settled the central constitutional questions impeding the rollout of the Patient Protection and Affordable Care Act (“ACA”): whether the federal government’s “individual mandate” to purchase or hold health insurance and the federal government’s authority to retract existing federal dollars if states fail to expand Medicaid eligibility violate the Constitution. However, a number of residual questions persist in its wake. While most of the focus this year has been on related constitutional issues — such as religious exemptions from offering contraceptive coverage to employees — NFIB also clears the path for a discussion …

Conditional Spending And The Conditional Offer Puzzle, Mitchell N. Berman

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No abstract provided.

Layers Of Law: The Case Of E-Cigarettes, Eric A. Feldman

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This paper, written for a symposium on "Layers of Law and Social Order," connects the current debate over the regulation of electronic cigarettes with socio-legal scholarship on law, norms, and social control. Although almost every aspect of modern life that is subject to regulation can be seen through the framework ‘layers of law,’ e-cigarettes are distinguished by the rapid emergence of an unusually dense legal and regulatory web. In part, the dense fabric of e-cigarette law and regulation, both within and beyond the US, results from the lack of robust scientific and epidemiological data on the behavioral and health consequences …

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

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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 …

Health Care Spending And Financial Security After The Affordable Care Act, Allison K. Hoffman

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Health insurance has fallen notoriously short of protecting Americans from financial insecurity caused by health care spending. The Patient Protection and Affordable Care Act (“ACA”) attempted to ameliorate this shortcoming by regulating health insurance. The ACA offers a new policy vision of how health insurance will (and perhaps should) serve to promote financial security in the face of health care spending. Yet, the ACA’s policy vision applies differently among insured, based on the type of insurance they have, resulting in inconsistent types and levels of financial protection among Americans.

To examine this picture of inconsistent financial protection, this Article offers …

A Vision Of An Emerging Right To Health Care In The United States: Expanding Health Care Equity Through Legislative Reform, Allison K. Hoffman

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When asked to write a chapter on how litigation has advanced a right to health in the U.S., I responded skeptically, both because evidence of the existence of any such right is weak and the role of litigation in promoting its development is small at best. A snapshot of the U.S. health care system evinces the absence of even a more narrow right to health care – a guarantee of equitable access to basic medical care. Instead, it reveals a fragmented picture of public and private financing that leaves many people lacking meaningful access to care. More so, the places …

When Is A Change Going To Come?: Separate And Unequal Treatment In Health Care Fifty Years After Title Vi Of The Civil Rights Act Of 1964, Ruqaiijah A. Yearby

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ON June 19, 1963, when the Civil Rights Act was first introduced, President John F. Kennedy said in a message to Congress:

Events of recent weeks have again underlined how deeply our Negro citizens resent the injustice of being arbitrarily denied equal access to those facilities and accommodations, which are otherwise open to the general public. That is a daily insult, which has no place in a country proud of its heritage-- the heritage of the melting pot, of equal rights, of one nation and one people. No one has been barred on account of his race from fighting or …

Medicaid, Marketplaces, And Premium Assistance: What Is At Stake In Arkansas? The Perils And Pitfalls Of Medicaid Expansion Through Marketplace Premium Assistance, Sidney D. Watson

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On September 27, 2013, Arkansas became the first state to obtain federal approval for a Section 1115 demonstration waiver to require adults eligible for the Affordable Care Act's (ACA) Medicaid Expansion to enroll in private plans offered through the State's new Health Insurance Marketplace rather than traditional Medicaid.² Hailed as a "game changer," Republican lawmakers dubbed this Marketplace Premium Assistance approach a new Medicaid "private option."' ³ Others described it as a potential "middle ground" in efforts to expand Medicaid that may be more politically palatable for those who oppose "Obamacare."...

Money, Sex, And Religion--The Supreme Court's Aca Sequel, George J. Annas, Theodore Ruger, Jennifer Prah Ruger

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The Supreme Court decision in the Hobby Lobby case is in many ways a sequel to the Court's 2012 decision on the constitutionality of the Affordable Care Act (ACA). The majority decision, written by Justice Samuel Alito, is a setback for both the ACA's foundational goal of access to universal health care and for women's health care specifically. The Court's ruling can be viewed as a direct consequence of our fragmented health care system, in which fundamental duties are incrementally delegated and imposed on a range of public and private actors. Our incremental, fragmented, and incomplete health insurance system means …