Antibiotics in animal feed and thin statutory interpretation: NRDC v. EPA

By Guest Contributor Diana R. H. Winters

Legal commentators have spent a lot of time this week sparring over statutory interpretation and the contrasting readings of the ACA by the Halbig and King courts.  The potential consequences of these cases demonstrate just how high the stakes of this enterprise can be.

With less fanfare, the Second Circuit decided a case yesterday that may too have large consequences for the health and welfare of the public.  In NRDC v. EPA, the court reversed a district court’s decision to require FDA to hold hearings on the withdrawal of approval for the use of two antibiotics—penicillin and tetracyclines—in animal feed.  This issue has enormous public health consequences, but the consequences of this case extend beyond antibiotic use, to agency practice in general.  The opinion sanctions egregious agency delay and a tremendous lacuna in decision making.

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A Mixed Message on Obamacare from Two Federal Circuits

By Greg Curfman and Holly Fernandez Lynch

It was as if lightning had struck twice in the same place.

On Tuesday two pivotal federal circuit court opinions that could dramatically impact the future of Obamacare were unexpectedly issued within hours of each other. And what’s more, the two opinions reached opposite conclusions on the same question, setting the stage for further appeals and possible Supreme Court review, potentially bringing the Affordable Care Act (ACA) before the high court for the third time since its passage.

At issue in both circuit court cases was the legality of providing subsidies in the form of Internal Revenue Service tax credits for the purchase of health insurance on the federal exchange (Healthcare.gov).

In a decision that stunned Obamacare supporters–but elated opponents–a three-judge panel of the Federal Appeals Court for the DC Circuit ruled in Halbig v. Burwell that the purchase of health insurance on the federal exchange may not be subsidized by IRS tax exemptions. This judgment would leave millions of Americans with earnings between 133% and 400% of the federal poverty level without affordable health insurance, and it would also threaten the viability of the employer mandate.

In contrast, in a unanimous (3-0) opinion in a nearly identical case, King v. Burwell, the Federal Appeals Court for the Fourth Circuit in Richmond, VA, came to the opposite conclusion.

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Don’t Buy the Cooperative-Federalism-Makes-Halbig-Logical-Argument

By Abbe Gluck

Cross-posted at Balkinization and Election Law Blog

I had hope to take a day off blogging about Halbig and King (the ObamaCare Subsidies cases), but I cannot allow another new, and inaccurate, narrative about ObamaCare to take hold. Over at Volokh, Ilya Somin argues that the holding in Halbig is not absurd because Congress uses statutory schemes all the time that try to incentivize states to administer federal law (and penalize them if they don’t).  It is true we see schemes like that all the time–Medicaid is a prime example–but the insurance exchange design at issue in these cases is NOT one of them.  This federalism argument was made before the D.C. Circuit and even Judge Griffith didn’t buy it in his ruling for the challengers.  I tried to dispel this myth back in March, when I wrote the following on Balkanization. As I said there, this isn’t Medicaid—it’s the Clean Air Act.

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The ObamaCare Subsidies Rulings–and the D.C. Circuit’s Disappointing Misreading of the ACA

By Abbe R. Gluck

As most readers know by now, two federal appeals courts on Tuesday reached the opposite conclusions about the validity of the critical financial subsidies on the ACA’s federal health insurance exchanges. The Fourth Circuit in Virginia upheld the subsidies—indicating the government had the better argument, but regardless applying the longstanding rule that when a statute is not clear, courts defer to the agency administering the statute (in this case, the IRS). The D.C. Circuit, however, ruled the other way, reading one provision of this massive and complex federal law out of context. That opinion not only misinterprets the statute—with enormous practical consequences—but also does a deep disservice to conservative jurists and lawyers who have spent the last 30 years arguing that text-based interpretation is sophisticated, not literalistic, and serves democracy.

The stakes are enormous: If the D.C. Circuit’s opinion ultimately carries the day, more than $36 billion dollars in financial relief will be denied to the approximately 7 million people expected to be insured with the help of this financial assistance. It also places Republicans in a real dilemma, especially as the election cycle heats up: The result, if the ruling stands, would be massive red-state/blue-state disparity, as millions of middle-class Americans are deprived in red states of access to medical care, because it is mostly the red states whose subsidies are now at issue.

As I wrote yesterday on Balkinzation, the opinion is terribly disappointing from a statutory interpretation perspective. It relies in part on irrelevant legislative history (from the HELP committee, whose bill wasn’t even the basis for these provisions–the Finance committee’s was) and gets it wrong anyway (as I argued here); it bends over backwards to come up with reasons why Congress might have intended this result (which we all know it certainly did not); and it attaches far too much significance to a line in the statute that expressly deems exchanges in the territories to be state exchanges and does not replicate the special deeming language for the federal exchanges. The territories language is boilerplate language used by Congress when talking about territories in statutes even beyond the ACA, and should have been attached no significance here.

For a more detailed legal and political analysis, check out my op-ed on the cases.

Health Care Decisions in the New Era of Health Care Reform

The North Carolina Law Review has just released its symposium issue on Health Care Decisions in the New Era of Health Care Reform, featuring several Bill of Health contributors and friends of the Petrie-Flom Center.  Take a look at the description and contents below. [HT: Richard Saver, who served as faculty advisor for this issue, alongside Joan Krause.]

Optimal decision making in health care often proves challenging. Health care providers often confront multiple treatments for each condition with limited evidence as to which interventions work best; moreover, treatment decisions can implicate questions of ethics and personal values that may not be answerable by clinical expertise alone. Fragmented delivery systems lead to insufficient coordination among providers in managing patients’ overall care. Patients face significant informational disadvantage not only in dealing with clinical information, but also in making choices regarding health care insurance coverage. Payers must make reimbursement and coverage decisions with incomplete information about the value and cost effectiveness of many treatments. Governmental officials must make complex regulatory decisions in managing a health care system with seemingly endless demand, escalating costs, and limited resources.

According to some optimistic accounts, the new era of health care reform will radically improve health care decisions. The Patient Protection and Affordable Care Act includes many reform initiatives aimed at improving health care decision making. For example, the law encourages the formation of integrated delivery systems that share information and coordinate care, fosters the development of shared decision-making between providers and patients, develops a more comprehensive evidence base through comparative effectiveness research, and creates insurance exchanges where patients as consumers can choose between plans offering standardized benefits and compared in standardized formats. But there are also reasons for concern that, in the new era of health care reform, decision making will become all the more complex and daunting. This symposium will consider both the promise and limitations of recent reform efforts, highlighting the important issues that are likely to emerge as the health care system tries to improve decision making.

Contents:   Continue reading

Just “Fix-It”

Guest post by Gretchen Schwarze (Vascular Surgeon)

Cross-posted from GeriPal

She seemed awfully angry and at the very least dubious that I couldn’t do more for her father. After 7 hours of surgery trying to salvage her father’s leg, I tried patiently to explain that this new (third) bypass we had just successfully completed was unlikely to provide her dad with a long-term solution. Ultimately, he would lose the leg, if we were lucky he’d have it for another year or two. Accounting for the “unlucky” side of the coin was even more depressing; immediate wound or graft infection, a postoperative heart attack from the liter of blood I had just lost or early graft failure which few surgeons would attempt to reverse given the tenuous nature of the graft to begin with. I didn’t have the heart to mention these things too, she was already upset.

It’s conversations like these that make me feel like there is something intrinsically wrong with the way we conceptualize modern medicine, and by “we” I mean both doctors and patients. I worry that a much deeper issue – a larger social construct – plays a role in decision-making and influences treatment choices because it obscures the limits and boundaries of what health care can provide.

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Holly Fernandez Lynch: After Hobby Lobby, ACA Exceptions May Become The Rule

9.25.12StaffHLS0025In a video interview with Reuters in conjunction with Harvard School of Public Heath’s Health Reform Watch, Petrie-Flom Center Executive Director Holly Fernandez Lynch analyzes the impact of the Supreme Court’s recent decisions in Hobby Lobby and Wheaton College.

To watch the interview please click here.

Michelle Meyer: Misjudgements Will Drive Social Trials Underground

Michelle Meyer has a new piece in Nature – an open letter on the Facebook study signed by a group of bioethicists (including PFC’s Executive Director Holly Fernandez Lynch) in which she argues that a Facebook study that manipulated news feeds was not definitively unethical and offered valuable insight into social behavior.

From the piece:

“Some bioethicists have said that Facebook’s recent study of user behavior is “scandalous”, “violates accepted research ethics” and “should never have been performed”. I write with 5 co-authors, on behalf of 27 other ethicists, to disagree with these sweeping condemnations (see go.nature.com/XI7szI).

We are making this stand because the vitriolic criticism of this study could have a chilling effect on valuable research. Worse, it perpetuates the presumption that research is dangerous.”

Read the full article.

Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

Human Subjects Research Regulations Book CoverThe Petrie-Flom Center is pleased to announce publication of Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive Director, Holly Fernandez Lynch.  This edited volume stems from the Center’s 2012 annual conference, which brought together leading experts in a conversation about whether and how the current system of human subjects research regulation in the U.S. ought to change to fit evolving trends, fill substantial gaps, and respond to identified shortcomings.

The book is currently available from MIT Press and Amazon, in hardcover and paperback.  We will be hosting a book discussion at Harvard Law School on October 22, and in Baltimore on December 5 at Public Responsibility in Medicine and Research (PRIMR)’s annual Advancing Ethical Research Conference.  Details will be announced shortly.

 From the book jacket:

 The current framework for the regulation of human subjects research emerged largely in reaction to the horrors of Nazi human experimentation, revealed at the Nuremburg trials, and the Tuskegee syphilis study, conducted by U.S. government researchers from 1932 to 1972. This framework, combining elements of paternalism with efforts to preserve individual autonomy, has remained fundamentally unchanged for decades. Yet, as this book documents, it has significant flaws—including its potential to burden important research, overprotect some subjects and inadequately protect others, generate inconsistent results, and lag behind developments in how research is conducted. Invigorated by the U.S. government’s first steps toward change in over twenty years, Human Subjects Research Regulation brings together the leading thinkers in this field from ethics, law, medicine, and public policy to discuss how to make the system better. The result is a collection of novel ideas—some incremental, some radical—for the future of research oversight and human subject protection.

After reviewing the history of U.S. research regulations, the contributors consider such topics as risk-based regulation; research involving vulnerable populations (including military personnel, children, and prisoners); the relationships among subjects, investigators, sponsors, and institutional review boards; privacy, especially regarding biospecimens and tissue banking; and the possibility of fundamental paradigm shifts.

Contributors
 Adam Braddock, Alexander Morgan Capron, Ellen Wright Clayton, I. Glenn Cohen, Susan Cox, Amy L. Davis, Hilary Eckert, Barbara J. Evans, Nir Eyal, Heidi Li Feldman, Benjamin Fombonne, Elisa A. Hurley, Ana S. Iltis, Gail H. Javitt, Greg Koski, Nicole Lockhart, Holly Fernandez Lynch, Michael McDonald, Michelle N. Meyer, Osagie K. Obasogie, Efthimios Parasidis, Govind Persad, Rosamond Rhodes, Suzanne M. Rivera, Zachary M. Schrag, Seema K. Shah, Jeffrey Skopek, Laura Stark, Patrick Taylor, Anne Townsend, Carol Weil, Brett A. Williams, Leslie E. Wolf

For a more information, including the full table of contents, check out the book on the MIT Press website

AALS Call for Papers for a special Works-in-Progress for New Law School Teachers Program

Call for Papers
 AALS Section on Law, Medicine & Health Care
Works-in-Progress for New Law School Teachers
AALS Annual Meeting, Washington, DC
Saturday, January 3, 2015

The AALS Section on Law, Medicine and Health Care is pleased to announce a Call for Papers for a special Works-in-Progress for New Law School Teachers Program. The Section will run the Program from 5:15 to 6:30 p.m. on Saturday, January 3, at the AALS 2015 Annual Meeting in Washington, DC.

This program will bring together junior and senior health law scholars for a lively discussion of the junior scholar’s’ works-in-progress. Junior health law scholars will submit papers that they expect to submit in the spring 2015 law review submission cycle. After they briefly present their papers in a concurrent roundtable setting, senior scholars will provide oral comments and critiques. This new program presents an opportunity for the audience to hear cutting edge health law scholarship by recent members of the academy.

We will limit our selection to two or three papers.  Continue reading

Introducing New Blogger Robert Field

FieldRobert Field is joining Bill of Health as a regular contributor.

Robert I. Field, JD, MPH, PhD is a nationally known expert in health care regulation and its role in implementing public policy.  He holds a joint appointment as professor of law at the School of Law and professor of health management and policy at the School of Public Health at Drexel University.  He is also a lecturer in health care management at the Wharton School of the University of Pennsylvania and a senior fellow of Penn’s Leonard Davis Institute of Health Economics.

Professor Field is the author of Mother of Invention: How the Government Created Free-Market Health Care, just released by Oxford University Press.  It presents an historical overview of four key health care sectors to demonstrate the underlying importance of government programs in creating and maintaining the health care system and to place health reform in the context of an ongoing evolutionary process.  He is also the author of Health Care Regulation in America: Complexity, Confrontation and Compromise, a comprehensive overview of health care regulation, also published by Oxford University Press.

Professor Field’s recent scholarly work has focused on health reform and is effects on the structure of the health care system, ethical issues in vaccines, and policy implications of genetic databases.  His work has appeared in the University of Pennsylvania Law Review, the Villanova Law Review, the Drexel Law Review, Health Affairs, Vaccine, and the Journal of Clinical Oncology.  He writes a blog for the Philadelphia Inquirer on health policy entitled the Field Clinic, which features 14 prominent Philadelphia health care leaders as regular contributors.

Professor Field speaks nationally on health care topics. He is frequently quoted in the press, including stories in the New York Times, Wall Street Journal, Washington Post, Boston Globe, Philadelphia Inquirer, and BusinessWeek and has discussed health policy issues on CNN, NPR, ABC, and numerous local television and radio stations.  He has also been a frequent commentator on WHYY, the NPR affiliate in Philadelphia.

Before joining the faculty of Drexel University, Professor Field founded and chaired the Department of Health Policy and Public Health at University of Sciences in Philadelphia, where he was also professor of health policy.  Previously, he led business planning and development for the primary care network of the University of Pennsylvania Health System. He has also conducted health policy research at the Institute of Medicine of the National Academy of Sciences and the Center for Law and Health Sciences at Boston University, practiced health law with the Philadelphia firm of Ballard Spahr, LLP, and directed public policy research for Cigna Corporation.

Professor Field earned a Ph.D. in psychology from Boston University, an M.P.H. from the Harvard School of Public Health, a J.D. from the Columbia Law School, where he was associate editor of the Columbia Journal of Environmental Law, and an A.B. magna cum laude from Harvard College.

Selected Publications

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Art Caplan New Op-Ed: When Does Human Life Begin?

Art Caplan has a new Op-Ed on The Council for Secular Humanism about when human life begin.

From the piece:

“When does human life begin? For those in the “personhood” movement in the United States, there is no doubt about when that happens—it is at conception, when the sperm meets the egg. The personhood movement has gained a foothold among antiabortion activists who are looking to pass laws that define embryos as people with full rights. Personhood advocates aim to outlaw all abortions, along with in vitro fertilization, embryonic stem-cell research, and emergency contraception. Granting embryos personhood would also mean that someone who killed a pregnant woman at any stage in her pregnancy would be at risk of prosecution for a double homicide. And in those states that restrict a woman’s right to utilize a living will if she is pregnant, no living will could apply from the moment of conception..”

Read the full article.

Introducing New Blogger Amanda C. Pustilnik

Amanda C. Pustilnik is joining Bill of Health as a regular contributor.

Pustilnik Amanda C. Pustilnik is an Associate Professor of Law at the University of Maryland School of Law, where she teaches Criminal Law, Evidence, and Law & Neuroscience. Her current research includes work on models of mind in criminal law, evidentiary issues presented by neuroscientific work on memory, and the role of pain in different legal domains. Prior to joining the University of Maryland, she was a Climenko fellow and lecturer on law at Harvard Law School. Before entering the legal academy, she practiced litigation with Covington & Burling and with Sullivan & Cromwell, where she focused on white collar criminal matters. Prof. Pustilnik also clerked for the Hon. Jose A. Cabranes on the United States Court of Appeals for the Second Circuit. She graduated Yale Law School and Harvard College, and has been a visiting scholar at the University of Cambridge, Emmanuel College, in the History and Philosophy of Science department. Prof. Pustilnik has also worked at McKinsey & Company as a management consultant and is a member of the board of directors of the John Harvard Scholarships. During Spring 2015, Professor Pustilnik will be serving as a Senior Fellow in Law & Neuroscience of the Center for Law, Brain & Behavior at Massachusetts General Hospital.  This Center is a collaboration between Massachusetts General Hospital and Harvard Law School.

Selected Publications
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Limelight v. Akamai: Implications for Medical Method Patents

By Rachel Sachs

Last month, as it wrapped up the 2014 Term, the Supreme Court decided a patent law case that could have a major impact on method patents in the medical arena. No, I’m not talking about Alice Corp. v. CLS Bank, the most Rorschach-like of the Term’s many patent opinions. I’m talking about Limelight Networks v. Akamai Technologies, Inc., in which the Supreme Court unanimously reversed the Federal Circuit’s ruling on the scintillating question of divided infringement under 35 U.S.C. § 271(b).

In Limelight, a splintered en banc decision, a majority of the Federal Circuit had overturned prior case law in ruling that liability for induced infringement of a method claim under § 271(b) was possible where no single entity had performed all the steps of that claim, but where those steps were divided between two or more parties, one of whom had induced the other(s) to infringe. (Previously, various opinions had held that induced infringement under § 271(b) required a single actor, just like direct infringement under current § 271(a) precedent.) In a unanimous opinion by Justice Alito, the Supreme Court reversed, essentially reinstating the single entity rule by holding that direct infringement under § 271(a) is required for inducement liability under § 271(b). Continue reading

Translating “ELSI” into Policy

by Guest Blogger Wylie Burke MD, PhD.

When the Human Genome Project began in 1990, the National Center for Human Genome Research – now the National Human Genome Research Institute (NHGRI) – created a research funding program for evaluation of the ethical, legal, and social implications (ELSI) of genomics. ELSI scholars study a wide range of issues, from the responsible conduct of genomic research, to implementation and outcomes of genetic testing programs, to intellectual property challenges.  But how should this research be evaluated? In particular, what impact should we expect for this kind of research? These questions are particularly challenging for those of us who work in the multidisciplinary Centers of Excellence in ELSI Research (CEERs) funded by the NHGRI, because these centers have been given a programmatic charge to consider policy-relevant questions and help to inform the policy-making process. A group of ELSI researchers, representing seven CEERs, have been deliberating these questions and recently published a paper with recommendations.

We noted, first of all, that policy-making occurs in many venues. Although discussions often focus on governmental policies, policy-making in other venues often influences genomic translation, including actions as diverse as Institutional Review Board (IRB) decisions about consent and return of results; guidelines promulgated by professional organizations; funding decisions of health insurers; and investment decisions of venture capital.   In addition, policy-making in one arena may influence the need for policies in another. For example, practice guidelines influence the use of genetic testing and may in turn influence how clinical data are accessed to evaluate test outcomes, or how IRBs decide what genetic results should be returned to research participants. Continue reading

Call for Submissions: Journal of Law and the Biosciences

JLB coverCall for Submissions: Journal of Law and the Biosciences

Deadline: Rolling.

The Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, responses, essays, and book reviews devoted to the examination of issues related to the intersection of law and biosciences, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB welcomes submissions of varying length, with a theoretical, empirical, practical, or policy oriented focus.

JLB is the first fully open access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.

For more information about JLB, click here. To submit a manuscript, click here.

Art Caplan: Facebook Experiment Used Silicon Valley Trickery

Art Caplan has a new opinion piece on NBCNews about a recently published study in The Proceedings of the National Academy of Sciences, where a  Facebook scientist teamed up with two academics to subtly tweak the news feeds of nearly 700,000 Facebook users.

From the piece:

“The question of whether or not an experiment is ethical hinges upon the question of “informed consent.” Generally, this means that a subject in a study needs to have basic information about the study he’s participating in, understand the nature of the experiment and its risks and benefits, and have the ability to withhold his consent without fear of harm or retribution.

The authors of the study argue that they obtained subject consent: Their manipulation of Facebook users’ emotions was “… consistent with Facebook’s Data Use Policy, to which all users agree prior to creating an account on Facebook, constituting informed consent for this research.” This is nonsense; it’s not informed consent. It is an old Silicon Valley trick for systematically eliminating the legal rights of its customers.”

Read the full article.

Justice Breyer and Wheaton College v. Burwell

By Gregory Curfman

Tom Goldstein, Publisher of SCOTUSblog, has opined on why Justice Stephen Breyer apparently joined the majority opinion in Wheaton College v. Burwell, which the Court released last Thursday. The majority granted Wheaton a temporary injunction exempting the College from the contraceptive mandate, which was spawned by the Affordable Care Act and which the College claimed violates its religious principles. The vote was 6 to 3, with Justice Scalia filing a concurrence (agreeing “in the result”) and Justices Sotomayor, Ginsburg, and Kagan issuing a forceful dissent. The opinion was unsigned, leaving ambiguous whether Justice Breyer actually did join the majority, though the numbers leave little doubt that he did.

Tom Goldstein believes that Justice Breyer joined the majority because, in doing so, he gained more than he lost. In addition to granting the College an injunction, the majority opinion also states that nothing in the opinion prohibits the government from taking steps to provide women access to contraceptive agents without a copayment. The specific language in the opinion is:

“Nothing in this order precludes the Government from relying on this notice, to the extent it considers it necessary, to facilitate the provision of full contraceptive coverage under the Act.”

Thus, Tom Goldstein believes that in joining the majority, Justice Breyer accomplished the pragmatic objective of preventing the loss of contraceptive coverage for the nation’s women who are employed by nonprofit organizations.

Without comment from Justice Breyer himself, we of course cannot know why he (presumably) joined the majority in Wheaton College v. Burwell, despite the fact he dissented when the Court granted Wheaton College a brief (two-day) injunction earlier in the week. And despite the fact that he also joined Justices Ginsburg, Sotomayor, and Kagan in issuing a very strong dissent in Hobby Lobby v. Burwell. Continue reading

Informed consent in social media research

Guest post by Winston Chiong, MD, PhD

Cross-posted from Geripal

facebook research ethics

I’m simultaneously a behavioral researcher, an ethicist, and a hopeless Facebook addict, so I’ve been thinking a lot about last week’s controversial study (Kramer et al, PNAS 2014) in which researchers manipulated the emotional content of 689,003 Facebook users’ News Feeds. In summary, users who saw fewer of their friends’ posts expressing negative emotions went on to express more positive and fewer negative emotions in their own posts, while users who saw fewer posts expressing positive emotions went on to express more negative and fewer positive emotions in their posts.

This provides evidence for “emotional contagion” through online social networks—that we feel better when exposed to other people’s positive emotions, and worse when exposed to negative emotions. This finding isn’t obvious, since some have suggested that seeing other people’s positive posts might make us feel worse if our own lives seem duller or sadder in comparison.

The journal and authors clearly did not anticipate a wave of online criticism condemning the study as unethical. (Full disclosure: one of the authors is also a researcher at UCSF, though I don’t think I’ve ever met her.) In particular, the authors claimed that participants agreed to Facebook’s Data Use Policy when they created their Facebook accounts, and this constituted informed consent to research. Looking at the Common Rule governing research on human subjects, it’s clear that the requirements of informed consent (including a description of the purposes of the research, expected duration, risks/benefits, compensation for harms…) are not met just because subjects click “Agree” to this sort of blanket terms of use. There are exceptions to these requirements, and some people have suggested that the research could have qualified for a waiver of informed consent if the researchers had applied for one. I’m not so sure about that argument, and in any case the researchers hadn’t.

While the online discussion about this study has been fascinating, I think there are a few points that haven’t received as much attention as I think they deserve:  Continue reading