The other oral argument on Tuesday

By Kevin Outterson

Cross posted from The Incidental Economist:

The opponents of the Affordable Care Act certainly know their way around a courtroom. Oral arguments in the contraception mandate case (Hobby Lobby) will be heard on Tuesday at the Supreme Court. That same day, another challenge will be heard in a federal courtroom nearby, in the Court of Appeals for the DC Circuit (the WSJ photo identifies the wrong court).

To the Cato Institute, the tax credit cases (Halbig v. Sebelius and a related case in the Fourth Circuit, King v. Sebelius) represent their last shot to cripple the four-year-old law by wiping out health insurance subsidies to millions of people in the 36 states that did not create state exchanges. (I’ve blogged about these cases before, and Cato folks have also posted summaries of the anti-ACA amicus briefs. Sunday’s WSJ ran an editorial following the Cato line).

Today, I wanted to highlight the amicus brief filed on Thursday March 20, 2014 by the Commonwealth of Virginia in King v. Sebelius (the 4th Circuit case, not the one up for oral argument on Tuesday). I appreciate the beauty of this argument, for it uses a conservative victory in federalism to support the federal government, and it comes from the newly-elected attorney general who replaced an early opponent of the ACA. (Mark Herring won by only 165 votes, but #electionsmatter).

I’m talking about the Pennhurst doctrine, which requires Congress to give states “clear notice” if conditions on states are attached to federal spending. So Virginia asks the very interesting question: Did Congress give “clear notice” that the penalty for failing to build a state exchange would be the loss of billions of dollars of health insurance subsidies?  When you put it that way, Cato’s argument collapses. From the brief:

For no one can reasonably claim that the federal government gave Virginia clear notice that its citizens would be denied premium tax-credit assistance as punishment for the Commonwealth’s decision to forgo building its own health insurance exchange.

And later:

 [The Plaintiffs argue] that everyone in Congress silently but mistakenly assumed that every State would create its own Exchange. (Appellants’ Br. 6, 42.) That claim finds no support in the record. The ACA was controversial when it was debated and adopted, and it was well known that numerous States objected to it and would not go along willingly.

The brief also notes that no Member of Congress expressed such a view and even the architects of this litigation (Cannon and Adler) were surprised by this “glitch” after the fact. The brief also reviews the official correspondence to and from the Governor on this issue; any notice whatsoever is lacking, much less “clear notice.”

What bothers me the most about this litigation is Cato’s willingness to try to hurt millions of vulnerable people in order to score political points, even after losing the 2012 Presidential election and the first bite of the Supreme Court apple in NFIB v. Sebelius. The Virginia brief puts the emphasis on the people:

Two sovereign interests compel the Commonwealth of Virginia to file this brief. First, the Commonwealth represents the interests of the hundreds of thousands of Virginians who depend on federal premium tax-credit assistance to afford the health insurance that is now available under the Patient Protection and Affordable Care Act of 2010 (the “Affordable Care Act” or “ACA”). Their interests are not represented by the Appellants here, four individual Virginians who do not want health insurance. Second, the Appellants’ legal theory contradicts the fundamental assumption on which the Commonwealth elected to forgo building its own health insurance exchange in favor of a federally-facilitated exchange: that doing so would not harm the interests of Virginians. The Appellants’ theory must be rejected under the Pennhurst doctrine, which prevents Spending Clause statutes like the ACA from being used to impose unusual conditions about which States were not provided “clear notice.” What is more, if Congress had actually done what Appellants claim — made State citizens financial hostages in a scheme to force State governments to adopt State-based exchanges —it would have violated the Tenth Amendment’s prohibition on coercing States to carry out federal policies. Accordingly, this Court should reject Appellants’ arguments and affirm the ruling of the District Court.

h/t Tim Jost

@kevinoutterson

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.

De-extinction

A few weeks ago, the New York Times Magazine ran a fascinating piece titled “The Mammoth Cometh,” which tells the story of a growing number of scientists around the world who are working on projects of “de-extinction.”   Significant progress has been made, and some scientists estimate that we will be able to revive certain species, such as the dodo or the passenger pigeon, within 10-15 years.

But is reviving species from extinction a good thing to do?  The way in which this normative question is treated in the NYT article is interesting.   While some of the key dangers of reviving extinct species are identified and discussed, the underlying narrative seems to accept that if these dangers could be avoided, de-extinction would be a good thing.   What its value is, however, is never spelled out in particularly clear terms.

The primary value identified by many advocates of de-extinction is the environmental value of “conservation.”   Steward Brand, for example, states that de-extinction could provide “a beacon of hope for conservation.”  But two different conceptions of conservation appear to be at work in the entangled arguments about the value of reviving extinct species. Read More

New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives

By Timo Minssen

Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard.  The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.

I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.

Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.

Read More

4/2: Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

Hot Topics in European Bio-Patent Law: Stem Cells, Genes, and More

April 2, 2014, 12:00 PM

Langdell, Vorenberg Classroom – North (225), Harvard Law School, Cambridge, MA

Please join us for this esteemed panel of leading patent experts, including members of the European Patent Office. Discussion will address U.S. and European perspectives on patenting stem cells, genes, and medical uses, as well as other ethical and legal issues.

Panelists:

  • Aliki Nichogiannopoulou, Director, Biotechnology, EPO
  • Anja Schmitt, Examiner, EPO
  • Maaike van der Kooij, Examiner, EPO
  • Tom Kowalski, US Patent Attorney
  • Moderator: Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Associate Member, Broad Institute

This event is free and open to the public, but space is limited and registration is required. Register here.

Lunch will be served. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

Cosponsored by the Broad Institute of MIT and Harvard.

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

By Ryan Abbott

Video: Here.

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.

Before a drug can be sold legally in the United States, the Food and Drug Administration (FDA) must approve it as safe and effective for a particular indication or use — the use then appears on the drug’s label. Federal law, however, allows doctors to prescribe drugs that the FDA has approved for one indication for any other indication, even though the FDA never evaluated the safety or efficacy of the drug for that use.

Off-label prescribing is an integral part of modern-day medicine. Patients may benefit when they receive drugs or devices in contexts not approved by the FDA. In fact, in some instances an off-label use may be the standard of care for a particular health problem. However, off-label prescribing can also harm patients, especially when an off-label use lacks a solid evidentiary basis.

For this reason, the FDA forbids drug companies from promoting their own products for off-label use, except for certain activities such as disseminating research literature and sponsoring educational programs. In recent years, civil and criminal actions against drug companies for illegal promotion for off-label use have proliferated, leading to many large settlements. For example, in July 2012, GlaxoSmithKline pled guilty and paid $3 billion to resolve criminal and civil liability arising from the company’s unlawful prescription drug promotion, failure to report safety data, and false price reporting practices.

As a result of this recent litigation, many have questioned the FDA’s current role in regulation of off-label use and whether more or less intervention is needed. This debate sought to address these very issues.

Both Professors have written about FDA regulations. For example, Professor Epstein in his book, Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation, and in an article in the Minnesota Law Review, “Against Permititis: Why Voluntary Organizations Should Regulate the Use of Cancer Drugs.” Professor Abbott has written about FDA regulations in the Iowa Law Review, Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety, and he has an article forthcoming with Ian Ayres at Yale Law School on Mechanisms for Regulating Off-Label Drug Use.

Call for Applications: 2014-2015 Petrie-Flom Student Fellowship

THE PETRIE-FLOM CENTER

STUDENT FELLOWSHIP PROGRAM, 2014-2015

CALL FOR APPLICATIONS

 

The Center and Student Fellowship.  The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas.  For more information on our current fellows and their work, see our website.

Eligibility. The student fellowship program is open to all Harvard graduate students who are committed to undertaking a significant research project and fulfilling other program requirements without exception during the year of their fellowship:  Read More

Call for applications: Brocher Summer Academy 2014: Ethical Choices for DALYs and the Measurement of the Global Burden of Disease

Confirmed speakers: Christopher Murray (IHME)—Keynote, Matt Adler (Duke), Greg Bognar (La Trobe U), John Broome (Oxford), Dan Brock (Harvard), Richard Cookson (York U), Owen Cotton-Barratt (Oxford), David Evans (WHO), Marc Fleurbaey (Princeton U), Ned Hall (Harvard), Dan Hausman (U of Wisconsin, Madison), Elselijn Kingma (U of Eindhoven), Jeremy Lauer (WHO), Colin Mathers (WHO), Erik Nord (Norwegian Institute of Public Health, Oslo), Ole Norheim (U of Bergen), Andreas Reis (WHO), Joshua Salomon (Harvard and IHME), Abha Saxena (WHO), Erik Schokkaert (KU Leuven), Drew Schroeder (Claremont McKenna), Alex Voorhoeve (LSE), James Woodward (U of Pittsburgh).

Organizers: Daniel Wikler (Harvard), Nir Eyal (Harvard), Samia Hurst (U of Geneva)

The biennial Summer Academy in the Ethics of Global Population Health is hosted by the Brocher Foundation on the shores of Lake Geneva June 9-13 2014, introducing faculty and advanced graduate students to population‐level bioethics. This fast‐developing academic field addresses ethical questions in population‐ and global health rather than ones in individual patient care.

The Global Burden of Disease (GBD) project is a systematic, scientific effort to quantify the comparative magnitude of health loss due to diseases, injuries, and risk factors. From its inception in the early 1990s, scientists and philosophers recognized that ethical and philosophical questions arise at every turn. For example, it must be decided whether each year in the lifespan is to count alike, and whether future deaths and disabilities should be given the same weight as those in the present. These choices and decisions matter: the share of disease burden due to myocardial infarction could vary as much as 400% depending on what position is adopted on two of the ethical choices described in the GBD 2010 report.  Read More

Medical Malpractice Decision of the Year: Florida Supreme Court voids the $1M cap on noneconomic damages for a patient’s wrongful death

By Alex Stein

We are just in mid-March, but yesterday’s decision of the Florida Supreme Court, McCall v. United States, — So.3d —-, 2014 WL 959180 (Fla. 2014), is – and will likely remain – the most important medical malpractice decision of 2014.

The case at bar presented a particularly egregious example of medical malpractice: a young woman died after delivering a healthy baby as a result of preventable loss of blood. This tragic event took place at an air-force base hospital. The victim’s survivors therefore filed their medical malpractice suit with a federal court pursuant to the Federal Tort Claims Act (FTCA). Under FTCA, the suit was governed by Florida law. Following bench trial, the United States District Court found the United States liable, but applied Florida’s $1,000,000 cap on wrongful-death noneconomic damages recoverable for medical malpractice. On appeal, the victim’s survivors challenged the cap’s constitutionality. The Eleventh Circuit affirmed the District Court’s decision, but certified questions of Florida constitutional law with regard to the cap.

The Florida Supreme Court rephrased the certified questions as follows:
Does the statutory cap on wrongful death noneconomic damages, Fla. Stat. § 766.118, violate the right to equal protection under Article I, Section 2 of the Florida Constitution?

Read More