HealthLawProf Blog

Published This Week

Rabia Belt, When God Demands Blood: Unusual Minds and the Troubled Juridical Ties of Religion, Madness, and Culpability, SSRN.

Deborah Tuerkheimer, Flawed Convictions: 'Shaken Baby Syndrome' and the Inertia of Injustice: Introduction, Oxford University Press, (Forthcoming 2014).

Rebecca Dresser, Building an Ethical Foundation for First-in-Human Nanotrials, 40 J. of Law, Med. & Ethics 802 (2013).

Jennifer A. Chandler, Legally-Coerced Consent to Treatment in the Criminal Justice System, Homes, Jacob and Perron eds. Power and the Psychiatric Apparatus, Ashgate Publishing Ltd. (Forthcoming 2014).

Charity Scott, Ethics Consultations and Conflict Engagement in Health Care, 15 Cardozo J. of Conflict Resolution 363 (2014).

Rebecca Dresser, Alive and Well: The Research Imperative, 40 J. of Law, Med. & Ethics 915 (2013).

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16th Annual SIH/SIU Health Policy Institute

The 16^th annual Southern Illinois Healthcare/Southern Illinois University Health Policy Institute will be held on Friday, May 16, 2014. This year’s Institute is entitled “From Critical Shortage to Critical Mass: Addressing the Lack of Donor Organs.” The program, which runs from 8:30 am to 3:30 pm will be held at the SIU School of Law in Carbondale. It will also be video cast to Springfield and Chicago. Five hours of both CLE and CME credit are offered for attendees. More information can be found here. Online registration can be found here. 

Hamline Symposium Call for Papers: Health Care Reform: Implementation in Minnesota

With the help of Medica Health Plans, the Health Law Institute at Hamline University School of Law and the Hamline Law Review seek proposals for presentations and papers for our all-day CLE/CEU Symposium that will examine the outstanding challenges confronting the implementation of healthcare reform.  The Symposium will take place on Friday, October 24, 2014, at Hamline University’s main campus in Saint Paul, Minnesota.

Anyone interested in speaking at the Symposium and/or publishing in the Hamline Law Review's Symposium issue should submit both a CV and a 500-word abstract to [email protected] by April 15, 2014.  While the primary focus of the presentation or paper need not be Minnesota-specific, please explain the regional relevance of your topic and thesis.

Additional information can be found here.

Guest Blogger Professor Jonathan Kahn: Race in a Bottle

In my recent book, Race in a Bottle:  The Story of BiDil and Racialized Medicine in a Post-Genomic Age (Columbia U. Press), I examine how law, science, and commerce converge in the field of biomedicine to produce distinctive understandings and uses of race as a central organizing concept in the development of pharmaceuticals and related medical practice in a post-genomic age. I take an interdisciplinary approach that builds out from a case study of BiDil, the first drug ever approved by the FDA with a race-specific label – for the treatment of heart failure in a “black patient”.  It extends this case study to illuminate the larger phenomenon of the emergence of race-based medicine and the continuing, indeed increasing, use of racial categories in biotechnological research and product development. It examines how the use of race in biomedicine is shaped by a complex interplay among commercial, legal, political and scientific forces.  The book argues that many people using race in biomedical research and product development are doing so with good intentions but without taking sufficient care to understand the potential of such use to reify race as genetic and/or reinforce stigmatizing racial stereotypes.  It considers, in particular, how commercial and legal imperatives have driven the rising use of race is a manner that distorts framing and presentation of underlying scientific information about the place of race in biomedical research and practice.

On June 23, 2005, the U.S. Food and Drug Administration formally approved the heart failure drug BiDil to treat heart failure in “self-identified black patients.”  Widely hailed throughout the media and professional journals as the first “ethnic” drug, it has also has been touted by the FDA and others as a significant step toward the promised era of personalized pharmacogenomic therapies.  Upon closer examination, however, BiDil’s story is far more complex. Race in a Bottle explores how its emergence as a racially marked drug reveals a multifaceted interplay of legal, commercial, and technoscientific interventions driving its framing as a racial drug. The book uses this story to provide a gateway to exploring much broader phenomena involving the strategic use of race as a genetic category to obtain patent protection and drug approval and a fuller consideration its implications for the politics of addressing race-based health disparities.

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Symposium: Race, Research, and Rights: The Legacy of the Tuskegee Syphilis Study

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Details and registration are here.

Contraception, Corporations and Conscience

Do corporations have a right to religious expression? As the U.S. Supreme Court considers whether Hobby Lobby is exempted from the Affordable Care Act’s contraception mandate because of its religious beliefs, the Court first must decide whether for-profit corporations even have rights of religious freedom.

While the Supreme Court should impose appropriate limits on the First Amendment rights of corporations, there are important reasons to recognize corporate claims of religious freedom. We often call on corporations to act in ethically and socially responsible ways, and it is important that they do so. If we want corporations to inculcate an ethos of ethics, then we undercut that goal when we deny corporations their ability to act on the basis of conscience.

To be sure, there are nuances. It is much easier to speak of the religious freedom of a family-owned business such as Hobby Lobby than of a publicly-owned business such as General Electric. Moreover, we must draw a good balance between corporate rights and the public welfare (as I’ve argued about corporate speech and public health here).

Recognizing corporate rights of religious expression would not settle the Hobby Lobby case. We still would have to balance the public’s interest in access to contraception with the corporation’s interest in religious freedom. But that is where the debate should lie.

[cross-posted at orentlicher.tumblr.com]

Published This Week

Sylvester C. Chima, Evaluating the Quality of Informed Consent and Contemporary Clinical Practices by Medical Doctors in South Africa: An Empirical Study, 14 BMC Medical Ethics 1 2013.

Richard F. Storrow, The Erasure of Egg Providers in Stem Cell Science, 34 Frontiers: A J. of Women Stud. 189 (2013).

Henry T. Greely, David H. Kaye, A Brief of Genetics, Genomics and Forensic Science Researchers in Maryland v. King, 53 Jurimetrics 43 (2013).

Joanna Shepherd, Biologic Drugs, Biosimilars, and Barriers to Entry, SSRN.

Rebecca Dresser, Subversive Subjects: Rule-Breaking and Deception in Clinical Trials, 41 J. of Law, Med. & Ethics 829 (2013).

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O'Neill Institute: Accepting Applications for 2014-2015 Fellows

The O’Neill Institute for National and Global Health Law is seeking exceptionally qualified candidates to serve as O’Neill Institute Law Fellows. Housed at Georgetown University Law Center in Washington, D.C., the O’Neill Institute is a leading research institute for health law. For more details about O’Neill and its ongoing work please visit www.oneillinstitute.org.

Law Fellows are based at the O’Neill Institute and report to the O’Neill Executive Director and Faculty Director.  Fellows work on academic legal research and scholarly projects.  Duties include working closely with faculty to produce scholarly works for publication, in some cases leading to joint publication.  Allocation of time is primarily determined by O’Neill Institute faculty needs; additionally, limited time may be allocated to independent research and O’Neill Institute projects.

Fellowship terms are one year, with possible extension to two years, and will begin in Fall 2014.  Fellows receive an annual salary of $65,000 with outstanding benefits.

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Halbig, King, Coercion, and the ACA Tax Credit Ligitation

Tomorrow, the D.C. Circuit will hear oral arguments in Halbig v. Sebelius.  This is the litigation in which parties hostile to the ACA are challenging the IRS rule that makes tax subsidies available in federally run health insurance exchanges.  Abbe Gluck has posted a deconstruction of the challengers' legislative and historical arguments at Balkinization, including a new post this morning discussing factual and historical inaccuracies in the appellants brief.  I want to address one of those arguments here: the analogy that the health insurance exchanges are somehow like the Medicaid expansion ruled unconstitutionally coercive in NFIB v. Sebelius. This comparison is so far off the mark, it reveals the underlying goal, which is to test the breadth of NFIB's coercion holding at every opportunity and to challenge federal power writ large.

The ACA expanded Medicaid eligibility to everyone up to 133% of the federal poverty level, and the states challenged that expansion in NFIB on the theory that they could lose all of their funding under the terms of the Medicaid Act if states refused to expand. The Court found that the expansion of Medicaid was a change in "kind" rather than "degree" and that the funding for the "old Medicaid" program could not be jeopardized for state refusal to comply with the "new Medicaid" program as envisioned in the ACA. As I have written elsewhere, the Court's unconstitutional coercion analysis was full of holes. One of those holes was nonsensical statutory interpretation, namely that the Medicaid expansion was too different from the Medicaid Act for coercion analysis purposes, but that it was similar enough for purposes of limiting the Secretary's authority to withhold or withdraw state Medicaid funding. But, that authority was not in the ACA (contrary to popular perception), it was in the language of the original Medicaid Act. The new/old Medicaid distinction was statutorily nonsensical, and yet it led to a newly recognized coercion doctrine that limits Congress's power to influence state policy through federal spending.

The Halbig appellants want federal courts to engage in this new coercion analysis by virtue of similarly absurd statutory interpretation. They ask the D.C. Circuit to deem the federal exchange funding offered to states to be struck down as coercive; but, they argue it is coercive not because of the money offered to states to create exchanges, but rather because of the tax credits that would not be available to individuals in exchanges established by the federal government. This causal chain is too attenuated; the claim is basically that the states were influenced not by the federal offer of funds but by the unavailability of tax credits for their citizens in federal exchanges. If this indirect coercion were possible, it is hard to imagine that two-thirds of states would have rejected the option to run state exchanges. It also breaks the link between the federal funding, the condition, and the supposed coercion (which is really a germaneness problem). States do not receive insurance premium tax credits, individuals do. States were offered moderate sums to establish their exchanges, and the loss of that moderate sum did not change the state's status at all. The appellants have mischaracterized the nature of the funding and the result of state rejection of that federal funding.

In addition, this argument can easily be turned on its head. Consider, for example, the Amicus Brief for the Commonwealth of Virginia in King v. Sebelius, recently filed in the Fourth Circuit's version of this tax credit litigation. Virginia argues that it was not aware that its citizens would lose access to tax credits if it rejected the funding to create its own exchange, thereby creating the polar opposite clear notice problem because Virginia believed its citizens would still have access to affordable health insurance if they invited the federally run exchange into the state. (See Kevin Outterson's post on Virginia's brief at The Incidental Economist.)

Clearly, exchange funding is different from Medicaid conditional spending. The ACA offered money to persuade states to participate in the establishment of exchanges, but the federal government will proceed without the states in the effort to establish near-universal insurance coverage. Congress would have dismantled its own goal of near-universal insurance coverage if it denied tax credits in federally run exchanges. This is the hope of the Halbig challengers, that the D.C. Circuit will dismantle the ACA's tax credit structure for federal exchanges and gut access to health insurance. Unfortunately, if they succeed, real people will be harmed.

Guest Blogger Associate Professor Ann Marie Marciarille: The New Hampshire Solution

Although various versions of New Hampshire SB 413 have been circulating for some time, it was not until this month that a deal really seemed to come together: that Medicaid expansion under the ACA would take a stepped approach and that some measure of bi-partisan support for SB 413 would make it real. This has been tremendously interesting to observe.

First, we see the New Hampshire-style decision to expand Medicaid under the ACA as soon as possible under the Bridge to Marketplace Premium Assistance Program. Essentially buying in to ACA Medicaid expansion as outlined in the ACA (extending eligibility to adults with incomes up to 138% of the federal poverty level) but sunsetting the expansion on either June 30, 2015 or December 31, 2015 while the state seeks the federal waiver necessary to establish a premium assistance program.

Second, we see the outlines of a Marketplace Premium Assistance Program designed to drive this same population to insurance coverage in the Federally Facilitated Exchange between January 1, 2016 and December 31, 2016.

Finally, we see the requirement that any continuation of the ACA Medicaid Expansion after December 31, 2016 would require further legislative authorization.

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Video Debate: Richard Epstein and Ryan Abbott on FDA Involvement in Off-Label Drug Use

On January 13, 2014 the Southwestern Law School Federalist Society student chapter hosted a debate about the FDA’s role in regulating off-label drug use featuring Professor Richard Epstein, the Laurence A. Tisch Professor of Law at NYU and the Kirsten Bedford Senior Fellow at the Hoover Institution, and Ryan Abbott, Associate Professor of Law at Southwestern Law School and Visiting Assistant Professor of Medicine at the David Geffen School of Medicine at UCLA.

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Guest Blogger Professor Jonathan Kahn: Regulating Direct-to-Consumer Genomics

Consumer genomics company 23andME wants you to be able to Google your genome to find out all sorts of things, ranging from your ancestry to your ear wax type to your risk of contracting diabetes. Spit into a tube, send it in along with a payment of $99 and before you know it you can log onto their web site to get a personalized readout of key aspects of your genetic makeup. It is all big data so it is perhaps not surprising to find that its CEO, Anne Wojcicki, is the wife of Google founder Sergei Brin who has invested heavily in the company. 23andME had been riding fairly high as a standout in the field of direct-to-consumer genomics until last November when it received what amounted to a cease-and-desist letter from the FDA, ordering 23andMe to “discontinue marketing” its Personal Genome Service until such time as it can provide evidence to substantiate its broad marketing claims. In a nutshell, the FDA was concerned that 23andME was providing medically actionable information through a product that had not been “analytically or clinically validated.” 

Responses have been varied with many applauding the FDA’s intervention into this relatively unregulated field while others decry the action as premature and unwarranted. I would like to address some of the criticisms of the FDA’s actions here. The concerns are various but tend to cluster around three themes.

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Conference: “Neuroscience and Law: Injury, Capacity and Illness”

March 28, IU Robert H. McKinney School of Law, Indianapolis. The Hall Center for Law and Health and the Indiana Health Law Review present a major conference on neuroscience and the law. Speakers include:

• Oliver R. Goodenough, Professor of Law, Vermont Law School
• Geoffrey K. Aguirre, Associate Professor of Neurology, Perelman School of Medicine, University of Pennsylvania
• Brenna C. McDonald, Assistant Professor of Radiology and Neurology, Stark Neurosciences Research Institute, Indiana University School of Medicine
• Matthew Mitten, Professor of Law and Director, National Sports Law Institute, Marquette University Law School
• Jean M. Eggen, Distinguished Professor of Law, Widener University School of Law
• Tracy D. Gunter, Associate Professor of Clinical Psychiatry, Indiana University School of Medicine
• Robert M. Pascuzzi, Professor and Chairman, Department of Neurology, Indiana University School of Medicine
• Leslie A. Hulvershorn, Assistant Professor of Psychiatry, Indiana University School of Medicine
• Amanda C. Pustilnik, Associate Professor of Law, University of Maryland Francis King Carey School of Law
• Jennifer A. Drobac, Professor of Law, Indiana University McKinney School of Law
• Andrew J. Saykin, Raymond C. Beeler Professor of Radiology and Director, Indiana University Center for Neuroimaging, Department of Radiology, Indiana University School of Medicine
• Rebecca S. Dresser, Daniel Noyes Kirby Professor of Law and Professor of Ethics in Medicine, Washington University School of Law
• Eric Racine, Director, Neuroethics Research Unit, University of Montreal and McGill University

More details and registration. For further information contact Nicolas P. Terry, Hall Render Professor of Law & Director, Hall Center for Law and Health

 

 

Hot Off the Press: Medicaid Matters Symposium

I am pleased to share the Medicaid Matters symposium issue that has just been published in Volume 102, Book 2, of the Kentucky Law Journal.  This special issue includes articles from Brietta Clark, Mary Crossley, John Jacobi, Elizabeth Weeks Leonard, Laura Hermer (with Merle Lenihan), Sallie Sanford, and Sidney Watson (and me).  This is an excellent collection of thoughtful articles that resulted from a day-long workshop on Medicaid in the post-ACA world.  Many thanks to the participants in the workshop, and I hope you will enjoy the fruits of their labors!

At the Intersection of Health Law and Civil Rights

 

Health Law Prof Extraordinaire  Nina Kohn of Syracuse University, now visiting at Maine, shared this link with me http://www.cbc.ca/thecurrent/episode/2014/03/11/why-are-family-members-being-banned-from-visiting-their-relatives-in-nursing-homes/ because of an experience I had involving the ICU staff when my mother was hospitalized last year and I expressed concern about emerging pressure sores from compression socks that were not being monitored.  I don't think this problem is unique to Canada.

I received wonderful help and advice from two very different groups--the National Center for Medicare Advocacy-a terrific resource for navigating a complex and often not very patient centered health care system--and Texas Right to Life which is promoting the Will to Live document as a counter to the assumption that the possession of an "advance directive" is the equivalent of a decision to forgo care in order to hasten death.

 

Washington School of Law Summer Institute

The University of Washington School of Law will be holding a week-long Global Health Law Summer Institute, from July 14-18, 2014.  The theme is “The Access Challenges.”  The summer institute will focus on the following:

• Access to Global Health:  The role of international law and global health actors
• Access to Health Services: The workforce challenge and whether technology can help
• Access to Health Care Products: Intellectual property law and innovation
• Access to Sustainable Clean and Healthy Environments: International environmental law as a driver for global health
• Realizing Access:  What does it take to achieve sustainable improvements in global health?

More information can be obtained here.

Guest Blogger Professor Jonathan Kahn: Pills for Racism?!

Recent developments in cognitive psychology and neuroscience have illuminated new and complex aspects of bias and racism in society.  Beginning in the 1990s with the development of the Implicit Association Test and related theories of aversive racism and implicit bias, cognitive psychology has provided new insights into diverse aspects of what have variously been termed implicit\automatic\subconscious processes of social cognition that shape attitudes and behaviors toward perceived outgroups – with particular attention to racial minorities in the United States.  This research has demonstrated pervasive implicit bias against racial minorities throughout the U.S. population.  Emerging in tandem with these developments since 2000, cognitive neuroscientists have been conducting studies of the brain itself, most often through the use of technologies such as functional magnetic resonance imaging (fMRI) to identify specific portions of the brain that demonstrate increased levels of activity in responses to racialized primes, usually presented to the test subject in the form of photographs and/or words.    Taken together, such findings have broad legal and policy implications, including such areas as addressing health disparities, employment discrimination, affirmative action and criminal justice.

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Guest Blogger Associate Professor Ann Marie Marciarille: Who Is Wasting What?

A purchasing alliance among hospitals interested in quality improvement is reported [1] to have developed a “waste index” for participating facilities, designed to give them information to eliminate waste while maintaining a high level of care.  Articles that sound a little like press releases do not usually get that much of my attention, but I read on because the lead example of savings from the application of the “waste index” nearly took my breath away.

At four Adventist Midwest Health hospitals, for instance, patients with asthma and other respiratory conditions were often treated with prepackaged metered-dose inhalers. By switching some to equivalent generic drugs delivered via a nebulizer that turns medications into a fine mist for inhalation, Adventist shaved $100,000 in costs last year. [2]

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USNews 2015 Health Law Program Rankings

1 University of Maryland (Carey)

2 St. Louis University

3 Case Western Reserve University

3 Loyola University Chicago

5 Boston University

5 Seton Hall University

7 Georgetown University

8 Georgia State University

9 University of Houston

10 Harvard University

10 Indiana University—Indianapolis (McKinney)

OIG's Shocking New Report: “Adverse Events in Skilled Nursing Facilities" and the New Book "Litigating the Nursing Home Case"

The Department of Health and Human Services Office of Inspector General (OIG) just released it's shocking report - “Adverse Events in Skilled Nursing Facilities: National Incidence Among Medicare Beneficiaries.” 

The OIG investigation found that one third of skilled nursing home residents are being harmed, and in some cases, even dying, as a result of “adverse or temporary harm events” - instances where harm results due to the care provided - or not provided - by the facility. Examples of such events include excessive bleeding due to medication, falls, infections, pressure ulcers, blood clots, acute kidney injury and worsening of preexisting conditions due to lack of care.  

In addition to a high level of harm, the OIG found that almost 60% of these events were preventable and resulted from substandard care, inadequate resident monitoring and failure or delay of necessary care.

The release of my new book Litigating the Nursing Home Case (2 ed. 2014), co-authored with James T. O'Reilly, is timely in light of the results of the OIG's report. A major theme running through this second edition of the book is the provision of guidance on how nursing home administrators can enhance regulatory compliance to both avoid litigation and improve quality of care.

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