New York’s Highest Court Summarily Rejects a Constitutional Challenge to New York’s Ban on Physician-Assisted Suicide

By Norman L. Cantor

Justice Cardozo, the legendary jurist from New York, would turn over in his grave upon reading the New York Court of Appeals’ per curiam (unsigned) opinion in Myers v. Schneiderman, 2017 WL 3897181 (9/17/17).  The lawsuit was filed by several terminally ill patients (and physicians serving such patients) challenging New York’s ban on physician assistance to a competent, terminally ill medical patient seeking a lethal prescription.  The deficiency that would upset Cardozo was not so much the Court’s conclusion that application of assisted suicide laws to a dying patient does not violate constitutional rights of liberty and equal protection, but rather the Court’s perfunctory, over-simplified handling of the constitutional issues.

The most plausible constitutional challenge in this context is equal protection – a claim that states act arbitrarily in allowing terminal patients certain means of hastening a grueling dying process (rejection of life-sustaining medical intervention, use of risky analgesics or sedatives to relieve suffering, and voluntarily stopping of eating and drinking (VSED)) while banning a physician’s provision of a more expeditious means of hastening death – a lethal medication.   The per curiam opinion’s dismissive response to this equal protection claim was that New York’s laws don’t differentiate among persons.   From the Court’s perspective, every competent patient is entitled to reject medical intervention and every person is forbidden to assist a suicide.  There are no invidious “discriminations” present.  This myopic formulation of the equal protection issue ducks the complex distinctions made by state laws in the context of dying medical patients.

The issue of controlling the time and manner of death derives from medical science’s newfound (mid-20th century) capacity to prolong a fatally stricken patient’s dying process – sometimes beyond the patient’s tolerance for suffering or indignity.  Patient choice and some medical management of the dying process became an accepted norm in confronting irremediably fatal pathology.   The initial accepted means of controlling the timing of unavoidable death was through patients’ control of life-sustaining medical intervention  (including chemotherapy, respirators, dialysis, or artificial nutrition and hydration).  A competent patient’s prerogative to reject medical life support has been recognized as a basic legal right in every jurisdiction.  Continue reading

Introducing New Blogger Leslie Griffin

We are pleased to introduce our newest contributor, Leslie Griffin, to Bill of Health.

Dr. Leslie C. Griffin is the William S. Boyd Professor of Law at the University of Nevada, Las Vegas, William S. Boyd School of Law. She holds a Ph.D. in Religious Studies from Yale University and a J.D. from Stanford Law School. She is author of the Foundation Press casebook, Practicing Bioethics Law (2015), which was co-authored with Joan H. Krause, Dan K. Moore Distinguished Professor of Law at the University of North Carolina School of Law, and Bill of Health blogger. Before becoming a law professor, Professor Griffin clerked for the Honorable Mary M. Schroeder of the U.S. Ninth Circuit Court of Appeals and was an assistant counsel in the Department of Justice’s Office of Professional Responsibility, which investigates professional misconduct by federal prosecutors. Before joining the UNLV faculty, Professor Griffin held the Larry & Joanne Doherty Chair in Legal Ethics at the University of Houston Law Center and was a tenured member of the faculty at the Santa Clara University School of Law.

Representative Publications Continue reading

Introducing New Blogger Anthony W. Orlando

Anthony W. Orlando is joining Bill of Health as a regular contributor.

Anthony is an Assistant Lecturer in the Sol Price School of Public Policy at the University of Southern California, where he is completing his PhD in Public Policy and Management. He also contributes to the Huffington Post. He hosts the podcast “Our American Discourse,” sponsored by the USC Bedrosian Center. He received his bachelor’s degree in economics from The Wharton School of the University of Pennsylvania, as well as a master’s in economic history from the London School of Economics and Political Science. He is a member of the American Society of Law, Medicine & Ethics.

Representative publications:

Please join us in welcoming Anthony!

REGISTER NOW! Behind Bars: Ethics and Human Rights in U.S. Prisons

Behind Bars: Ethics and Human Rights in U.S. Prisons
November 30 – December 1, 2017
Harvard Medical School campus
Longwood Medical Area, Boston, MA

The United States leads the world in incarceration. The “War on Drugs” and prioritizing punishment over rehabilitation has led to mass imprisonment, mainly of the nation’s most vulnerable populations: people of color, the economically disadvantaged and undereducated, and those suffering from mental illness. Although these social disparities are striking, the health discrepancies are even more pronounced. What can be done to address this health and human rights crisis?

This conference will examine various aspects of human rights and health issues in our prisons. In collaboration with educators, health professionals, and those involved in the criminal justice system—including former inmates, advocates, and law enforcement—the conference will clarify the issues, explore possible policy and educational responses, and establish avenues for action.

Registration for the conference is required. To learn more and to register, please visit the HMS Center for Bioethics website.

This event is cosponsored by the Center for Bioethics at Harvard Medical School, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Human Rights Program at Harvard Law School.

American Beverage Association v. San Francisco: When the First Amendment Jeopardizes Public Health

Crossposted from the Public Health Law Watch blog

By Micah BermanWendy E. Parmet, and Jason A. Smith

Last week, while the health law world focused on the Republicans’ renewed attempt to repeal and replace the ACA, the Ninth Circuit struck an ominous blow to public health. As we have noted previously, federal courts in recent years have relied on an increasingly expansive interpretation of the First Amendment to prioritize the rights of commercial speakers over the health and safety of the public.  This new-found appreciation for commercial speech has resulted in decisions striking down a wide-range of public health regulations and has led food and beverage companies to make “ever-bolder arguments aimed at limiting longstanding government authority to protect the public’s health.” In American Beverage Association v. City and County of San Francisco, those bolder arguments were accepted by the court, putting public health regulations in greater peril.

American Beverage Association concerned a challenge to a 2015 San Francisco ordinance requiring certain advertisements of sugar-sweetened beverages (SSBs) to display over at least 20% of the area of the advertisement a warning stating: “Warning: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.”

Continue reading

Understanding the Neuroscience and Philosophy of Consciousness

By Yusuf Lenfest

Think of the last few times you’ve had a very lifelike dream. Running, reading, or having conversations with others, are all activities that might happen during a particularly vivid dream. But would this be considered consciousness? Surely being in a state of sleep is not the same as being in a waking state; but if you are able to communicate, to attend a lecture, perhaps even to give a lecture whilst you sleep, what does this mean in terms of your brain’s activity? Very deep in the sleep cycle, a person may not respond immediately to touch or sound or any other sensory stimulus. That is, they may not wake up, though it cannot be ruled out that an external stimulus might influence the sub-conscious mind and hence their dream. We’ve all had the experience of hearing an alarm “in our dream” which is really our real alarm, yet our mind re-interprets it and incorporates it into our dream until we regain consciousness, i.e., wake up. What if you couldn’t wake up from your unconscious state? And if so, what would this mean for how your brain processes your thoughts? In effect, what would it mean for your lived reality if you could only live in your mind?

Beyond being a fun thought experiment, these may be some very relevant questions now that doctors have treated a vegetative-state patient with an experimental therapy leading him to regain partial consciousness.

It was reported yesterday in National Geographic, Popular Science, the Guardian, and elsewhere that a 35-year-old man who had been in a persistent vegetative state (PVS) for 15 years has shown signs of consciousness after receiving a pioneering therapy involving nerve stimulation. The French researchers reported their findings to the journal Current Biology. Led by Angela Sirigu, a cognitive neuroscientist and director of the Institut des Sciences Cognitives Marc Jeannerod in Lyon, France, a team of clinicians tried an experimental form of therapy called vagus nerve stimulation (VNS) which involves implanting a device into the chest designed to stimulate the vagus nerve. It works by giving off miniscule electrical shocks to the vagus nerve, a critical brain signal that interfaces with parasympathetic control of the heart, lungs, and digestive tract.

So again, what does it mean to be conscious?

Continue reading

Book Launch: Law, Religion, and Health in the United States

Book Launch: Law, Religion, and Health in the United States
September 27, 2017 12:00 PM
Wasserstein Hall, Milstein West A (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In July 2017, Cambridge University Press will publish Law, Religion, and Health in the United States, co-edited by outgoing Petrie-Flom Center Executive Director Holly Fernandez Lynch, Faculty Director I. Glenn Cohen, and Elizabeth Sepper, Professor of Law at Washington University School of Law. This edited volume stems from the Center’s 2015 annual conference, which brought together leading experts to identify the various ways in which law intersects with religion and health care in the United States, examine the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

About the book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else – patient or physician, secular or devout – interested in how US law interacts with health care and religion.

Continue reading

“The real possibility of an AIDS-free generation:” HIV Prevention and the Internet

By Clíodhna Ní Chéileachair

Last November, the National Health Executive (NHS) in the UK lost an appeal in the UK Court of Appeal regarding their failure to fund PrEP for individuals at risk of contracting HIV. PrEP, or Pre-Exposure Prophylaxis is a common term for regimes of anti-viral medication taken by individuals to lower their risk of being infected with HIV. Marketed as Truvada, clinical test results published by the National institute of Health in 2010 declared that the treatment could reduce the risk of contracting HIV by up to 90%, a rate that seemed farcical even in a world where information about HIV is more accessible than ever, and medical experimentation with cures has been steadily gaining steam. Based on those results, the U.S. Center for Disease Control issued interim guidelines for using the drug, despite the fact that it was over a year away from FDA approval, aware that doctors had been prescribing it off-label for HIV treatment. The titular quote is from former President Obama, speaking on World AIDS Day in 2011 about the breakthrough that PrEP represented. The story raises some fascinating questions about how doctors interact with experimental medicines when facing down diseases that will otherwise seriously compromise quality of life for patients, and even kill, but nonetheless remain unsanctioned by national healthcare providers and largely available through backchannels.

Continue reading

Call For Abstracts! Beyond Disadvantage: Disability, Law, and Bioethics – PFC’s 2018 Annual Conference

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1973).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

disability-law-bioethics_slideHistorically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood. Continue reading

Precision Medicine for All? The Need for Disability Inclusion

By Maya Sabatello

Stakeholders’ engagement is key to achieving the promises of precision medicine research. It is needed in order to establish a sufficiently powered cohort of diverse groups that will allow tailoring disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It is also needed to ensure that research priorities are in sync with the health needs of participants and for curtailing health disparities in the US.

Cognizant of these issues, precision medicine initiatives, including are increasingly investing time and resources to engage potential participants in their studies. the All of Us Research Program (AoU) is exemplary in this regard, focusing in particular on racial and ethnic minorities as well as Native Americans who have been historically underrepresented in genomic research.

But what about people with disabilities?

This question may seem to be off target. After all, persons with disabilities have long been prime targets of genotyping, and their enrollment in genomic research is ongoing.

Continue reading

Five Years of Bill of Health: Student Fellow Contributions

This month we’re celebrating five years of Bill of Health, the success of which would not have been possible without the great contributions of our Student Fellows. Each year, as part of their Fellowship, these diverse students post regularly on issues related to their areas of research and interest, and several have stayed on as regular contributors after the completion of their Fellowships. We’re excited about this year’s contributions, and thank all of our former Fellows for their excellent work!

Below is a list of the top three Student Fellow posts by year, measured by total unique page views (note: one per author selected if multiple posts; older posts have more weight based on more time online): Continue reading

The 21st Century Trolley

By Gali Katznelson

Here’s a 21st century twist on the classic ethics trolley dilemma: The trolley is a car, you are the passenger, and the car is driving itself. Should the autonomous car remain on its course, killing five people? Should the car swerve, taking down a different bystander while sparing the original five? Should the car drive off the road, and kill you, the passenger, instead? What if you’re pregnant? What if the bystander is pregnant? Or a child? Or holds the recipe to a cure for cancer?

The MIT Media Lab took this thought experiment out of the philosophy classroom by allowing users to test their moral judgements in a simulation. In this exercise, participants can decide which unavoidable harm an autonomous car must commit in difficult ethical scenarios such as those outlined above. The project is a poignant perversion of Philippa Foot’s famous 1967 trolley dilemma, not because it allows participants to evaluate their own judgements in comparison with other participants, but because it indicates that the thought experiment actually demands a solution. And fast.

Several companies including Google, Lyft, TeslaUber, and Mercedes-Benz are actively developing autonomous vehicles. Just last week the U.S. House of Representatives passed the SELF DRIVE (Safely Ensuring Lives Future Deployment And Research In Vehicle Evolution) Act unanimously. Among several provisions, the act allows the National Highway Traffic Safety Administration to regulate a car’s design and construction, and designates states to regulate insurance, liability and licensing. It also paves the way for the testing by car manufacturers of 25 000 autonomous cars in the first year, and up to 100 000 cars within three years. Continue reading

Medicine and Ethics: Religious or Secular?

By Yusuf Lenfest

There is no lack of controversy when talking about religion and medicine in America today. Medicine is studied, practiced, and firmly rooted in the corporal world while religion draws inspiration from texts, traditions, and the incorporeal. Yet from an historical perspective, religious pasts do shape the present, particularly in the realm of ethics and moral reasoning. Indeed, whatever one’s spiritual or philosophical predilections, religion continues to play a major role in the dialogue on medicine and health care in Western society.

Bioethics in particular has become a topic of growing interest in America, but there has been little critical discussion about its contextual underpinnings, which stem largely from a Western Christian perspective. This is not to say that another religion would arrive at radically different system of morals. While differences do exist amongst religious traditions, across both space and time, experience and common sense tell us that diverse religious traditions do in fact share in much of the same moral principles and foundations. So what might other religious traditions say about, or contribute to, the discourse on bioethics? Should religion even be included in the conversation, especially given that health care and healing belong to the sphere of medicine?

Continue reading

IRBs Advise Physician Involvement in Informed Consent

By Nadia N. Sawicki

Much has been written about the Supreme Court of Pennsylvania’s recent decision in Shinal v. Toms, in which the court held that a physician’s duty to obtain informed consent, as codified in Pennsylvania’s MCARE Act, is non-delegable. According to the court, a physician faced with an informed consent suit cannot defend himself on the grounds that the patient was adequately informed of the risks and benefits of treatment by a physician assistant, nurse, or other intermediary acting under the physician’s direction. Pennsylvania is not the first state to adopt this view – courts in other jurisdictions (Connecticut, Louisiana, South Dakota, Texas, New Mexico) have similarly held that the duty to secure informed consent rests with the treating physician alone.

The MCARE (Medical Care Availability and Reduction of Error) Act was passed in 2002 to reform Pennsylvania’s medical malpractice laws, and refers to the duties and rights of “physicians” and “patients.” Shinal, likewise, addressed the issue of informed consent in the context of medical treatment. Thus, I was very surprised to learn that some commercial institutional review boards (IRBs), in reliance on the Pennsylvania Supreme Court’s decision, have been advising clinical trial investigators to revise their consent forms and processes to ensure that physician-investigators – and not recruitment coordinators, nurses, or other study staff – secure the consent of research participants.

Schulman, one of the most well-known commercial IRBs, recently posted about the Shinal case on its website; while noting that the case focused on medical malpractice “and does not address consent in the research context,” it advised investigators to “discuss with their legal counsel the impact of this decision on their consent process.” Sterling IRB had a similar post, advising investigators to “consider drafting consent form updates to clearly require that only physician members of the research team may obtain informed consent from a research subject.” In an e-mail that went directly to investigators and study staff, Sterling also suggested that they submit updated consent forms that “make clear that the only person who can obtain consent is the PI/physician.” A recent article in the Journal of Clinical Research Best Practice, titled “What Impact will the Shinal Case have on Informed Consent in Clinical Research?,” offered a more detailed analysis of the case, and concluded that “there is little to suggest that courts would not uniformly apply the same informed consent standards used in the medical practice to clinical research.” Continue reading

Book Launch: Law, Religion, and Health in the United States

Book Launch: Law, Religion, and Health in the United States
September 27, 2017 12:00 PM
Wasserstein Hall, Milstein West A (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In July 2017, Cambridge University Press will publish Law, Religion, and Health in the United States, co-edited by outgoing Petrie-Flom Center Executive Director Holly Fernandez Lynch, Faculty Director I. Glenn Cohen, and Elizabeth Sepper, Professor of Law at Washington University School of Law. This edited volume stems from the Center’s 2015 annual conference, which brought together leading experts to identify the various ways in which law intersects with religion and health care in the United States, examine the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

About the book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else – patient or physician, secular or devout – interested in how US law interacts with health care and religion.

Continue reading

2017 Petrie-Flom Center Annual Open House

2017 Petrie-Flom Center Annual Open House
September 13, 2017 5:30 PM
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics to learn about what the Petrie-Flom Center does and how people can get involved. Faculty Director I. Glenn Cohen will review our sponsored research portfolio, introduce our staff and fellows, including new Executive Director Carmel Shachar, and describe various opportunities for students and others. In addition, our partners including colleagues from the Center for Bioethics at Harvard Medical School and the Center for Law, Brain & Behavior at Massachusetts General Hospital spoke about their programs and activities, including the Master of Bioethics program in the Center for Bioethics at Harvard Medical School. And of course we will eat, drink, and make merry!

This event is free and open to the public.

The Open House reception will immediately follow the lecture “The Neurolaw Revoltion” by Francis X. Shen, Senior Fellow in Law and Applied Neuroscience, at 4pm. Learn more about the lecture here!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School.

The Neurolaw Revolution: A lecture by Francis X. Shen

The Neurolaw Revolution: A lecture by Francis X. Shen
September 13, 2017 4:00 PM
Wasserstein Hall, Milstein East A (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Rapid advances in the brain sciences offer both promise and peril for the law. In light of these developments, Dr. Francis Shen will explore how neuroscientific analysis of law may revolutionize legal doctrine and practice.

 Dr. Shen is the third Senior Fellow in Law and Neuroscience in the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center. Dr. Shen directs the Shen Neurolaw Lab at the University of Minnesota, is co-author of the first Law and Neuroscience casebook, and serves as Executive Director of Education and Outreach for the MacArthur Foundation Research Network on Law and Neuroscience.

This lecture will be followed at 5:30pm by the Petrie-Flom Center’s 2017 Open House reception.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Federal “Right to Try” Legislation – Perpetuating a Misguided Skepticism Towards the FDA

Cross-posted from the CRITical Thinking blog.

By Jeanie Kim

The “right to try” (RTT) movement presents a narrative that pits patients against the FDA. Supporters of RTT, powered by the libertarian Goldwater Institute, have pushed for laws that let terminally ill patients bypass regulators to access unapproved treatments.

As of September 2017, 37 states have enacted RTT laws. Earlier this year, the Senate and the House introduced federal RTT bills, and on August 3, 2017, the Senate unanimously passed an amended RTT bill without an opportunity for debate. There is pressure on the House to follow suit, but it is unclear whether the House will consider the originally introduced RTT bill (“RTT 1.0”) or the Senate’s amended version (“RTT 2.0”), or even take up the legislation at all.

Despite the recent legislative backing, RTT is not a new concept. It is a variation on an age-old skepticism towards the FDA that has been around as long as the agency’s inception. At the core of RTT is the previously rejected, yet persistent argument that the FDA’s approval standards for safety and efficacy should not matter for terminally ill patients who have nothing to lose [1]. Continue reading

Thank You for Five Great Years!

Five years ago today, the first post went up on Bill of Health. Since then, the blog has received over 980,000 unique page views from 220 countries, helping to further the discussion of issues in health law policy, biotechnology, and bioethics and to publicize opportunities in the field. Over 3,100 posts have covered everything from ethical issues with bioengineered interspecies organ transplants to potential medical malpractice concerns with artificial intelligence to fetal personhood and the Constitution to analysis of surrogacy arrangements gone awry to food safety issues in China.

As the field has changed over the past five years, so too has the blog. We’ve developed collaborations with other organizations and blogs, hosted a series of blog symposia, blogged “live” from conferences, and expanded the participation of our center’s diverse Fellows. In celebration of our anniversary, this month we will feature posts that highlight these past contributions and new posts that explore the development of issues in health law policy, biotechnology, and bioethics over the past five years.

Our most popular posts, based on total unique page views, reflect the diversity of topics Bill of Health covers: Continue reading

Current trends in clinical negligence litigation in the National Health Service (NHS)

By John Tingle

NHS Resolution (the new operating name for the NHS LA, National Health Service Litigation Authority) occupies a central role in the NHS clinical negligence claims environment. They manage clinical negligence claims on behalf of NHS trusts (hospitals) and other bodies. They also provide indemnity cover and have an increasing role in assisting the NHS with risk management and patient safety.

NHS Resolution have recently published their Annual Report and Accounts which contains important data, trends, case studies and other information on clinical negligence and patient safety. This report also very clearly signals the new more inclusive, upstream, closer to the problem approach that NHS Resolution is now taking to its work.

Facts, figures and trends Continue reading