Check out the latest news from the Petrie-Flom Center!

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Check out the December 19th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

Harvard Law School 2013-05-03 Petrie-Flom Center Food ConferenceOutbreak: Developing New Medical Products for Epidemics, A lecture by Peter Hutt                                                                                                            Thursday, January 15, 2015, 12:30pm                           Hauser Hall 102,                                                   1575 Massachusetts Avenue, Cambridge, MA

The recent outbreak of Ebola has called attention to the substantial difficulties associated with developing and testing new products for time-sensitive epidemics. What are the legal, ethical, and economic barriers to getting essential treatments and preventative measures from the lab into the hands of patients – and how can they be overcome?

Please join the Petrie-Flom Center for a discussion of these issues by Peter Barton Hutt, Partner at Covington & Burling, LLP, and Lecturer on Law at HLS. Rachel Sachs, Petrie-Flom Center Academic Fellow, will respond.

For more on news and events at Petrie-Flom, see the full newsletter.

Art Caplan: Support Nurse Who Resisted Force-Feeding at Guantanamo

Art Caplan has a new piece supporting the nurse who resisted force-feeding at Guantanamo, on NBC News:

Lost in all the talk about the CIA’s history of brutal interrogation tactics after Sept. 11 is this: A real live case involving a U.S. Navy nurse on trial for what he did not do at the notorious Guantanamo prison.

The nurse, in his 18th year in the Navy, volunteered to serve at Guantanamo, where some of those being held prisoner went on hunger strikes. They were following a long tradition going back to the H-Block Irish hunger strikers in Britain who found no other way to protest their internment and prison conditions but to refuse food.

The Navy brass at Gitmo decided that these prisoners were going to eat. They dragged them out of their cells, put them in full body restraints, shoved a tube through their nose and down into their stomachs and force-fed them with artificial food.

Read the full article here.

2015 Edition of the International Compilation of Human Research Standards Released

The 2015 edition of the International Compilation of Human Research Standards has just been released and is available online.

The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 113 countries, as well as standards issued by a number of international and regional organizations. Six new countries are included in the 2015 edition: Ghana, Guinea, Liberia, Malaysia, Saudi Arabia, and Sierra Leone.  The 2015 edition also includes hundreds of updates from the previous edition.

The listings are organized into seven categories: Continue reading

Arthur Caplan on Hyperbaric Oxygen Therapy

Art Caplan has a new piece on hyperbaric oxygen therapy over at NBC News:

Hyperbaric oxygen therapy. Have you ever heard of it? The Internet sure has.

Centers and clinics tout the benefits of sitting in a tank breathing 100 percent oxygen at higher than atmospheric pressure for treating autism, infant brain trauma, multiple sclerosis, chronic fatigue, cerebral palsy and many other conditions.

There’s just one problem: There is no solid evidence that hyperbaric oxygen therapy does anything for any of these disorders.

Read the full article here.

Introducing Joan H. Krause

We are pleased to introduce our newest contributor, Joan H. Krause, to Bill of Health.

Joan Krause PhotoProfessor Joan H. Krause is Associate Dean for Faculty Development and Dan K. Moore Distinguished Professor of Law at the University of North Carolina School of Law; professor (secondary appointment) in the Department of Social Medicine, UNC School of Medicine; and adjunct professor of health policy and management in the UNC School of Public Health. She previously served as George Butler Research Professor of Law and Co-Director of the Health Law & Policy Institute at the University of Houston Law Center, where she joined the faculty in 2001. From 1997-2001, Professor Krause was a member of the health law faculty at Loyola University Chicago School of Law. Before attending law school, Professor Krause worked as a medical writer/editor in the pharmaceutical industry. After law school, she served as a law clerk for the Honorable Dorothy W. Nelson of the United States Court of Appeals for the 9th Circuit. Following her clerkship, Professor Krause was an associate in the Health Practice Group of Hogan & Hartson in Washington, D.C., where her work focused on regulatory and administrative health care matters with an emphasis on health care fraud and abuse. She teaches a variety of health law courses, as well as Criminal Law for first-year students. Her research interests include Health Law, Criminal Law, and Women and the Law. Her co-authored book, HEALTH LAW AND BIOETHICS: CASES IN CONTEXT, was published in 2009.

Professor Krause received her B.A. with Honors in Political Science from Yale University, where she graduated summa cum laude. She received her J.D. with distinction from Stanford Law School, where she was elected to the Order of the Coif and served as Senior Articles Editor of the Stanford Law and Policy Review, as well as a Writer and Copy Editor for the Stanford Law Journal.

Representative Publications:  Continue reading

Clinical Trials Regulation in India

An op-ed from our friends Mark Barnes and Barbara Bierer at Harvard’s Multi-Regional Clinical Trials Center on recent legal changes to India’s clinical trial requirements, arguing that using the clinical trial context to promote a social or political policy agenda in India may sacrifice scientific integrity in the service of social justice.  A quick snippet:

The overbreadth of these requirements, and how poorly tailored they are to achieve the specific goal of protecting clinical trial participants from risks directly caused by trials themselves, leaves one wondering whether the regulatory authorities fully comprehend the clinical trial process and the nuances of complex medical and biological processes. One further wonders whether what animates these measures may be less a concern for specific justice in individual cases than the goal of righting social wrongs and achieving social justice, unrelated to but prompted by clinical trial experiences. Achieving social justice and a more just allocation of social resources may be completely laudable – even desirable – as social or political policy, but unconsciously using the clinical trial context to promote this agenda threatens to corrupt science and to undermine health, with results that may create more social distress than social justice.

Read the full piece here.

And more commentary from MRCT on this issue:

Art Caplan on Companies Paying for Egg Freezing

Over at Medscape, Art Caplan has a new video critiquing some companies’ new policies to pay for women to freeze their eggs:

Facebook and Apple recently announced a new perk for female workers. They will pay to freeze their eggs, a benefit that has sparked an appropriate ethical controversy.

There is no doubt that some women at these companies will think it is a great benefit, and they are glad to have it. But I am afraid that things aren’t so simple.

Part of the reason that those companies offer egg freezing is that they don’t want women distracted from their careers by having children. One way to manage both career and motherhood is to freeze your eggs. But freezing eggs is not simple, nor is the choice to do so…

Watch the full video here.

United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part II)

By Joan H. Krause
[Cross-posted at HealthLawProf Blog]

In a prior post, I discussed the Seventh Circuit’s decision in United States v. Nayak, one of the first major “honest services” mail and wire fraud cases to arise since the Supreme Court decidedSkilling v. United States in 2010. In Skilling, the Court found clear Congressional intent to limit honest services prosecutions to “offenders who, in violation of a fiduciary duty, participated in bribery or kickback schemes.” (Skilling at 407, emphasis added) As I warned in a 2012 article, the Court’s focus on bribery and kickback activity within the context of a fiduciary duty might have wide-ranging consequences in the health care field given the nature of the physician-patient relationship.

The structure of honest services cases differs from that of more traditional forms of mail and wire fraud, which usually involve perpetrators who defraud victims of money or property. In contrast, these “intangible rights” cases eliminate the requirement that the victim suffer a financial loss to the perpetrator. Nonetheless, such fraud is actionable only when the perpetrator in fact owes a heightened duty to provide “honest services” to the victim. While Skilling grounded that duty in a fiduciary relationship, the majority offered little guidance as to which aspects of the relationship were most important. As Justice Scalia noted in his concurrence: “None of the ‘honest services’ cases . . . defined the nature and content of the fiduciary duty central to the ‘fraud’ offense. There was not even universal agreement concerning the source of the fiduciary obligation – whether it must be positive state or federal law . . . or merely general principles, such as the ‘obligations of loyalty and fidelity’ that inhere in the ‘employment relationship.’” (Skillingat 416-17)

The indeterminacy of the fiduciary requirement has particular relevance in the medical context. While the physician-patient relationship is commonly described as a fiduciary one, the characterization is far more complex than may first appear. The disparities in medical knowledge, as well as the inability of patients to access many services (such as prescription drugs) without physician involvement, give physicians a great deal of power over their patients – a characteristic fiduciary responsibility. Yet the relationship lacks other fiduciary hallmarks; the physician, for example, lacks the fiduciary’s traditional control over the beneficiary-patient’s money. Skilling offered little guidance as to which of these characteristics is most relevant to the honest services duty.  Continue reading

Call for Abstracts: 2015 Petrie-Flom Annual Conference – Law, Religion, and American Health Care

Abstracts due next Monday, December 1, 2014:

SCOTUSfrontThe Petrie-Flom Center invites abstracts for its 2015 Annual Conference: “Law, Religion, and American Health Care.” The conference will be held at Harvard Law School on May 8 and 9, 2014.

This conference, and anticipated edited volume, will aim to: (1) identify the various ways in which law intersects with religion and health care in the United States; (2) understand the role of law in creating or mediating conflict between religion and health care; and (3) explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

For a full conference description, including the call for abstracts and registration information, please visit our website.

The conference seeks to address the following topics. Please note that this list is not meant to be exhaustive; we hope to receive papers related to the conference’s general theme, but not specifically listed here:  Continue reading

United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part I)

By Joan H. Krause
[Cross-posted at HealthLawProf Blog]

Since the early 1900’s, the federal mail and wire fraud statutes have been applied to schemes to defraud victims not just of money or property, but also of “intangible rights” such as the right to the “honest services” of an employee or public servant. 18 U.S.C. §§ 1341, 1343, 1346. This expansive theory of honest services fraud has been applied to public officials and private businessmen, although only rarely to physicians or others in the health care system. In 2010, the Supreme Court used the case of former Enron CEO Jeffrey Skilling to impose significant limits on the reach of the honest services fraud theory. Skilling v. United States, 561 U.S. 258 (2010).Skilling itself had nothing to do with health care, arising instead from a prosecution for conspiracy, securities fraud, wire fraud, false representations to auditors, and insider trading in connection with Enron’s massive financial meltdown. Yet in rejecting Skilling’s vagueness challenge to the honest services wire fraud theory underlying his conspiracy conviction, the Court read the statute to limit honest services prosecutions to cases involving bribery and kickbacks – activities with particular salience in the health care context. In a 2012 article, I predicted that while Skilling generally was viewed as narrowing the scope of honest services fraud, the decision might have the paradoxical effect of inviting additional prosecutions in the health care industry.

While intangible rights cases date back to the early 1900’s, modern prosecutions were derailed in 1987 when the Supreme Court ruled that the mail and wire fraud statutes applied only to the deprivation of property rights. McNally v. United States, 483 U.S. 350 (1987). In response, Congress quickly enacted 18 U.S.C. § 1346 to clarify that the statutes did indeed prohibit “a scheme or artifice to deprive another of the intangible right of honest services.” The amendment did not include a definition of honest services, nor offer any other indication as to when the prohibition might apply. In his appeal, Skilling asserted that the provision was unconstitutionally vague because it failed to adequately define the prohibited behavior and granted nearly unfettered prosecutorial and judicial discretion. The Court, however, declined to overturn the statute, finding clear Congressional intent to return to the state of the law prior to McNally: a “solid core . . . involv[ing] offenders who, in violation of a fiduciary duty, participated in bribery or kickback schemes.” (Skilling at 407)

Given the prominence of kickback concerns in health care, I warned that the Court’s focus on kickbacks and bribery might well have the effect of reinvigorating the prosecution of health care intangible rights violations. And indeed on October 20, 2014, the Seventh Circuit decided one of the first major post-Skilling honest services fraud cases involving health care providers, United States v. Nayak. Continue reading

Upcoming Deadline: Submissions for The Journal of Law and Biosciences

JLB coverThe Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish The Journal of Law and Biosciences (Oxford University Press), an online, open-access, peer-reviewed journal.  JLB includes a New Developments section, comprised of brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools.  The Petrie-Flom Center is responsible for providing the New Developments for one issue per annual volume.  Last year’s contributions may be viewed here.

We are currently seeking Harvard graduate students to contribute New Developments for JLB’s Volume 2, Issue 2 (2015). Interested students from any Harvard school should submit a topic proposal (1 paragraph to 1 page) outlining the new development they wish to cover, along with their current CV, and a short writing sample (5-10 pages), by November 30, 2014. Update: Student contributions may be co-authored, particularly with students from different schools within Harvard. Proposals should be sent to Holly Fernandez Lynch, hlynch@law.harvard.edu.

Four proposals will be selected by December 15, 2014, with one alternate.  Outlines will be due January 19, 2015.  First drafts will be due February 16, 2015, with edits returned by March 2, 2015, and final submissions due to the publisher by April 30, 2015 for publication in July.

New Developments are limited to 4500 words, inclusive of footnotes and references, and formatted according to Blue Book style.  Students will be responsible for reviewing the drafts of other student contributors, and will also receive feedback from the Petrie-Flom Center.  Please keep in mind that New Developments are not full student Notes.  They should focus on describing the policy issue at hand, why it is relevant to scholars and practitioners, and providing analysis/questions for further consideration.

Questions?  Please contact Holly Fernandez Lynch, hlynch@law.harvard.edu

More Than Just the ACA at Stake in King v. Burwell

Guest post by Erin Fuse Brown
[Cross-posted from Center for Law, Health and Society Blog]

Commentators have been weighing in since the Supreme Court decided it would hear King v. Burwell, the case challenging the ability of millions of Americans to receive subsidies to purchase health insurance on federally operated Exchanges under the ACA.  Debate swirls over whether a decision striking down these subsidies will gut the ACA or not, but at the very least a ruling in favor of the petitioners would have grave consequences for ACA the and the millions that currently receive these subsidies.

There is, however, more at stake in the King case than the ACA.  If the Court takes this opportunity to cut down the ACA, it does so at the cost of the principle of separation of powers and the Supreme Court’s institutional legitimacy and credibility.

Chevron

The question in King will be resolved under the Chevron framework, which provides that if a statutory provision is ambiguous, then the court must defer to the agency’s interpretation, so long as it is permissible.  Reasonable, learned minds have been disagreeing on the meaning of the statutory provision. As Adrian Vermeule has pointed out, of the 9 federal judges that have reviewed this question, 6 have agreed with the government’s interpretation or concluded the statute is ambiguous, and 3 have concluded that the statute unambiguously precludes subsidies. This type of judicial disagreement is evidence itself of statutory ambiguity.  Continue reading

Tomorrow: “Patients With Passports” Book Launch

Cohen_Medical_TourismBook Launch: Patients with Passports: Medical Tourism, Law, and Ethics

Wednesday, November 19, 2014

Harvard Law School Library
Langdell Hall, Caspersen Room
1557 Massachsetts Ave., Cambridge, MA [Map]

This event is free and open to the public. A light lunch will be served.

I. Glenn Cohen‘s new book Patients with Passports: Medical Tourism, Law, and Ethics  (Oxford University Press, 2014) is the first comprehensive legal and ethical analysis of medical tourism. Examining both the legal and ethical issues raised by medical tourism and how the two interact, it provides the best currently available data and explanations of the industry and tackles the most prevalent legal and ethical issues facing medical tourism today.

Co-sponsored by the Harvard Law School Library.

Upcoming Deadline: Submissions for The Journal of Law and Biosciences

JLB coverThe Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish The Journal of Law and Biosciences (Oxford University Press), an online, open-access, peer-reviewed journal.  JLB includes a New Developments section, comprised of brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools.  The Petrie-Flom Center is responsible for providing the New Developments for one issue per annual volume.  Last year’s contributions may be viewed here.

We are currently seeking Harvard graduate students to contribute New Developments for JLB’s Volume 2, Issue 2 (2015). Interested students from any Harvard school should submit a topic proposal (1 paragraph to 1 page) outlining the new development they wish to cover, along with their current CV, and a short writing sample (5-10 pages), by November 30, 2014. Update: Student contributions may be co-authored, particularly with students from different schools within Harvard. Proposals should be sent to Holly Fernandez Lynch, hlynch@law.harvard.edu.

Four proposals will be selected by December 15, 2014, with one alternate.  Outlines will be due January 19, 2015.  First drafts will be due February 16, 2015, with edits returned by March 2, 2015, and final submissions due to the publisher by April 30, 2015 for publication in July.

New Developments are limited to 4500 words, inclusive of footnotes and references, and formatted according to Blue Book style.  Students will be responsible for reviewing the drafts of other student contributors, and will also receive feedback from the Petrie-Flom Center.  Please keep in mind that New Developments are not full student Notes.  They should focus on describing the policy issue at hand, why it is relevant to scholars and practitioners, and providing analysis/questions for further consideration.

Questions?  Please contact Holly Fernandez Lynch, hlynch@law.harvard.edu