“Marlise’s Law”: Protecting the Autonomy and Dignity of Brain-Dead Pregnant Women

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

On March 12, 2015, Texas Representative Elliot Naishtat (Austin) filed HB 3183, which would repeal the Texas law that currently prohibits pregnant women from exercising their advance directives.  The existing statute includes the following language:  “I understand that under Texas law this directive has no effect if I have been diagnosed as pregnant.” The bill strikes this sentence and would allow health care providers and medical institutions to honor a woman’s wishes about end-of-life care.

The bill is known as “Marlise’s Law,” named for Marlise Muñoz of Fort Worth, Texas, who was kept on mechanical support for two months after she was declared brain dead in 2013. Muñoz collapsed in her home in November 2013 when she was 14 weeks pregnant. She was declared brain dead two days later but John Peter Smith Hospital said it was legally prevented from removing life support because she was pregnant. Continue reading

Physician Aid In Dying: Whither Legalization After Brittany Maynard?

A new post by Charles Baron on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Brittany Maynard’s highly publicized decision to end her life under Oregon’s Death With Dignity law has given a new face to the American right to die movement. It is that of a young, attractive, athletic newlywed, who would not have considered herself as having a stake in the movement until the day she learned a brain tumor was the cause of her severe headaches. She was terminally ill and faced a future of six months of increasing pain, debilitation, and severe seizures before dying.

A video of Maynard’s story produced by the non-profit advocacy organization Compassion and Choices has reached many millions of viewers. Extended coverage of her decision-making process by People Magazine resulted in record numbers of hits to the publication’s website. During her illness, Maynard moved from California to Oregon and on November 1, 2014 took barbiturates to end her life. In her memory, her husband and mother have become prominent activists in the effort to legalize physician aid-in-dying (PAD). […]

See the full post here.

Dying: Closing the Gap between What We Know & What We Do

By Susan M. Wolf, JD (University of Minnesota), Nancy Berlinger, PhD (The Hastings Center), and Bruce Jennings, MA (Center for Humans and Nature)

Time is running out on fixing the way we die. As readers of this blog know, the courts first declared a right to refuse unwanted life-sustaining treatment in the 1976 Quinlan case. Nearly 4 decades later, too many people are still burdened with treatments they don’t want, can’t get support for care at home, and are dying without good relief of pain and suffering. So it was no surprise that the highest court in Canada finally threw in the towel. In its Feb. 6 opinion in Carter v. Canada, the court found people still “suffering intolerably as a result of a grievous and irremediable medical condition.” The court thus recognized a right to physician aid in dying. Canada now has a year to set up a system that will permit the practice while protecting the vulnerable from abuse.

Regardless of your views on physician aid in dying, too large a gap remains between what we know is high-quality care at the end of life and what we actually do to care for dying people. The Feb. 12 issue of the New England Journal of Medicine included four articles on the problem, including our analysis of “Forty Years of Work on End-of-Life Care: From Patients’ Rights to Systemic Reform.”  Continue reading

Last Year Was A Wild One For Health Law — What’s On The Docket For 2015?

A new blog post by Greg Curfman, Holly Fernandez Lynch and I. Glenn Cohen on the Health Affairs Blog:

Everywhere we look, we see the tremendous impact of new legal developments—whether regulatory or statutory, federal or state—on health and health care. These topics range from insurance to intellectual property to religion to professionalism to civil rights. They remain among the most important questions facing Americans today.

This post is the first in a series that will stem from the Third Annual Health Law Year in P/Review event to be held at Harvard Law School on Friday, January 30, 2015. The conference, which is free and open to the public, brings together leading experts to review major developments in health law over the previous year, and preview what is to come.

Read the full post here, and register for the Third Annual Health Law Year in P/Review for free here.

Book Review Review: Sunstein’s “Valuing Life”

A couple weeks ago the Financial Times ran a book review (behind a pay wall) by Mark Vandevelde of Cass Sunstein’s “Valuing Life: Humanizing the Regulatory State” (linked here). The book review carries the tagline “Beware the paternalist in libertarian garb.” I happen to have read the book and, since the Financial Times beat me to the job of reviewing, I thought I would use the holiday lull to review the review.

In short, for reasons I explain in perhaps too much detail below, the review misses the mark in a way foreshadowed by the tagline. The review takes issue with Sunstein the libertarian paternalist, the Sunstein who advocated a class of choice-respecting regulations in his book “Nudge.” But “Valuing Life” is not “Nudge”; it is about the nitty-gritty of how we quantify the costs and benefits of all sorts of regulations, not the desirability of any particular sort of regulation (or even regulation in general). On the latter topic Sunstein has much to say in his book, Vandevelde’s review not so much.

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The Right to Try Meets the Reality of Drug Approval

By Joan H. Krause

[Cross-posted at HealthLawProf Blog]

Whether it be a social media campaign to convince a company to provide an experimental anti-viral drug to a young cancer patient suffering from a life-threatening infection or the debate over appropriate treatment for high-profile Ebola cases, access to potentially life-saving but unapproved medications remains a controversial issue. Two recent articles, published on the same day, illustrate the difficulty of trying to balance desperate patients’ willingness to try unproven therapies with the very real concerns faced by manufacturers undergoing the drug approval process. The first was a Kaiser Health News article describing the passage of “Right to Try” laws in five states. The second was a brief note in the Los Angeles Business Journal that shares of CytRx Corporation, a biopharmaceutical R&D company, had fallen 9% after the company announced that the FDA had placed a partial clinical hold on its clinical trials after a patient’s death.

Right to Try laws are designed to give patients who have exhausted all other treatment options the right to access investigational medications, devices, and biological products that have met Phase I safety milestones. Right to Try legislation has been enacted in Colorado, Louisiana, Michigan and Missouri, and voters recently approved it by initiative in Arizona. The laws are based on model legislation drafted by the Goldwater Institute, which issued a detailed report on the issue in February 2014. While prohibiting states from blocking patient access to such medications, however, the model legislation does not require manufacturers to provide the products, nor does it require insurance companies to cover the costs. Continue reading

Death at 29 or 75: Are Manifestos Commitments to Die?

By Kelsey Berry

The news media has been reporting on the role and means of one’s own death more frequently recently, buoyed along by manifestos (Ezekiel Emanuel’s “Why I Hope to Die at 75”, Brittany Maynard’s “Compassion and Choices” Campaign) that have caught the attention of a diverse audience. These declarations are perhaps more connected to one another than we may think.

Just last week on this blog, Lauren Taylor authored an excellent post on new public figure Brittany Maynard – the terminally ill 29-year old woman who relocated to Oregon for access to its death with dignity law, and to end her life with a prescription for a fatal medication. Maynard’s story seems to have struck a chord in part due to her youth. She is the youngest advocate currently featured on the website of Compassion and Choices, the largest organization advocating for end-of-life options in the US (the next youngest is 57 years old). She is also a well-educated, well-traveled, well-spoken individual, supported in her choices by her immediate family and physician. When Maynard states that the remainder of her life, if allowed to come to a natural end as a result of her cancer and without the help of medical intervention, will not be of value (and will actually be of great disvalue) to her, we are inclined to believe her evaluation – and perhaps even the normative implications that Maynard claims should follow.

Another public figure recently claimed that a particular part of life is not of (sufficient) value to him in order to keep living it, either. In September, Dr. Ezekiel Emanuel, director of the Clinical Bioethics Department at the U.S. National Institutes of Health and head of the Department of Medical Ethics & Health Policy at the University of Pennsylvania, published his essay “Why I Hope to Die at 75” in The Atlantic. The part of life he wishes to avoid? An old age marred by disability, functional loss, and relinquishment of the values and expectations of a younger individual. He proposes to adopt (for himself only) active rejection of life-sustaining and life-prolonging heath care, beginning at age 75. The effect? Ideally, death from infection untreated by antibiotics — it’s “quick and painless.”  Continue reading

The Response to Brittany Maynard

By Lauren Taylor

29-year old Brittany Maynard has captured national headlines this week by publicly announcing her intention to end her own life on November 1st. She did so in an effort to raise funds for and awareness of the non-profit Compassion and Choices.

Maynard was diagnosed earlier this year with an aggressive brain cancer and has moved to Oregon for access to its death with dignity laws. Those laws have allowed her to be prescribed a fatal dose of medication by a physician to be taken at the time and place of her choosing. Maynard sees the prescription as a means of avoiding a potentially long, painful and de-humanizing decline in her health.

In light of Maynard’s case, virtually every major media outlet has featured a bit of medical ethics this week. Maynard’s own voice first appeared in People Magazine, announcing her intention to end her own life.  Therein, Maynard is clear that she does not consider herself to be planning for suicide.  Continue reading

HHS Issues Guidance on Same Sex Spouses and HIPAA

[Cross-posted at HealthLawProfs blog.]

Under HIPAA, patients’ spouses and other family members have certain rights to access health information. In an important guidance document in the wake of United States v. Windsor, the Office for Civil Rights (OCR) at HHS has clarified that “spouse” under HIPAA refers to legally married same-sex spouses, even if the individual is receiving services in a jurisdiction not recognizing same-sex marriage.  Continue reading

I. Glenn Cohen Discusses Ethics of Medical Personnel Involvement in Executions

cohen_talking_peoplePetrie-Flom Faculty Director I. Glenn Cohen appeared on The Rachel Maddow Show last night to discuss his recent opinion piece in JAMA, coauthored with Robert D. Truog and Mark A. Rockoff (both of Harvard Medical School), on “Physicians, Medical Ethics, and Execution by Lethal Injection.” In the piece, Cohen et al. argue that medical specialty boards should withdraw board certification from members who participate in executions.

From the interview:

…we think it [execution] is totally incompatible with the role of the doctor. A doctor is about healing. A doctor is about soothing pain. A doctor is not meant to be conscripted by the state to make what is the involuntary killing of another person look as though it’s a medical procedure, like getting your teeth pulled or putting your dog to sleep. It’s kabuki theater, Rachel, and we think doctors should stand up. Whatever your position is on capital punishment, it’s wrong to make this procedure look like medicine. That’s not what it is. […]

Watch the full interview.

Doctors, Lethal Injection, and Firing Squads

Yesterday JAMA published a new perspective I co-wrote with Bob Truog and Mark Rockoff  “Physicians, Medical Ethics, and Execution by Lethal Injection“. In that article we make the case that the recommendations coming out of the Oklahoma botched lethal injection executions to require physician involvement would force physicians into an untenable medical ethical position. We also argue that it supports a kind of kabuki theater of medicalization, where execution becomes normalized.

Now comes a news report of a Utah lawmaker pushing to give those set to be executed the option of firing squad which he views as more humane than lethal injection. Many people will no doubt recoil at this notion. But here is my intentionally provocative question (and this is on my behalf not my co-authors): If you are in favor of capital punishment, wouldn’t a single close range shot to the head as a form of execution be, in some ways, more defensible than lethal injection? If you recoil at the notion of this being a way of doing execution, have you perhaps fallen for the kabuki theater of medicalization? Why not choose a method of execution that is more honest about the gravity (and perhaps the horror) of what we are doing rather than present something as somewhere on a continuum with sedation?

New op-ed on doctors and the death penalty, coauthored by I. Glenn Cohen

Petrie-Flom Faculty Director I. Glenn Cohen has coauthored a new opinion piece now available through JAMA, “Physicians, Medical Ethics, and Execution by Lethal Injection.” From the article:

In the wake of the recent botched execution by lethal injection in Oklahoma, however, a group of eminent legal professionals known as the Death Penalty Committee of The Constitution Project has published a sweeping set of 39 recommendations that not only tinker with, but hope to fix, the multitude of problems that affect this method of capital punishment.

Many of the recommendations this committee makes with regard to legal and administrative reforms appear worthwhile and reasonable. Their final recommendation, however, concerns the role of the medical profession in performing lethal injection. It states: “Jurisdictions should ensure that qualified medical personnel are present at executions and responsible for all medically-related elements of executions.”

In particular, the recommendation specifies that “Execution team members…are licensed, practicing doctors, nurses or emergency medical technicians who are responsible for performing functions in their day-to-day practice that are similar to those they will perform at the execution.” Regardless of this committee’s recommendations, physician participation in capital punishment is an ethical dilemma that the profession of medicine must address.

Read the full article.

Art Caplan on “Pediatric Euthanasia in Belgium: Disturbing Developments”

Art Caplan has coauthored a new piece in JAMA on problems with Belgium’s new law allowing terminally-ill children and their families to choose euthanasia. From the article:

The Belgian pediatric euthanasia law seeks to respect the moral status of children as agents who possess the nascent capacity for self-determination. Specifically, the law requires the medical team to demonstrate a patient has the “capacity for discernment,” indicating that he or she understands the consequences of a choice for euthanasia.

What the law does not consider, however, is that adults choose euthanasia for reasons that go beyond pain. For adults, the decision to end their life can be based upon the fear of a loss of control, not wanting to burden others, or the desire not to spend their final days of life fully sedated. These desires might be supported by the experience they have had witnessing a loved one express a loss of dignity or because they understand what terminal sedation is and wish to refuse it. Children, however, lack the intellectual capacity to develop a sophisticated preference against palliative interventions of last resort. Instead, in the case of the new Belgian law, children seem to be asked to choose between unbearable suffering on the one hand and death on the other.

This possibility causes the Belgian euthanasia law to fall short of the standard required for valid assent. The criterion related to the “capacity for discernment” runs the risk of ignoring the fact that children and adolescents lack the experiential knowledge and sense of self that adults often invoke—rightly or wrongly—at the end of their lives.

Read the full article.

Advance Directives, Rights, and Brain Death Pregnancies

Dr. Jeffrey Ecker, a noted fetal medicine specialist, has an excellent piece on the Munoz case in Texas in a recent NEJM article (“Death in Pregnancy—An American Tragedy”).[1]   He shares the widespread view that brain dead pregnant women should not be maintained over the father or family’s objections.  He does, however, suggest that maintenance may occur with family consent to enable the fetus be born with the best chance of survival.

The burden of his comment is on legal issues and rights.  Because Texas recognizes brain death as legal death, the hospital had acted inappropriately when it relied on the Texas advance directive statute, which limits advance directives when a woman is pregnant, to maintain her over her husband’s wishes. The court ruled that since Ms Munoz was brain dead, the advance directive limitation which applies only to patients who are still alive, did not apply to a pregnant patient who was dead under cardiopulmonary or brain death criteria for death.  His comment deserves laurels for its clear presentation of the statutory conflict and its resolution.

Dr. Ecker, however, like many other commentators, runs into trouble when he says that the hospital’s actions in the Munoz case, even if supported by statute  are “a wrongful usurpation of the rights of individuals,  in this case  … women.”[2]  The problem is his the assumption that there is or should be a constitutional or legal right at Time 1 when competent to issue a legally binding directive at Time 2 when the maker is incompetent and indeed may have a different set of interests or none at all.

But there is no constitutional right to make a directive at Time 1 that binds at Time 2.  Justice Sandra O’Connor concurring in the outcome in Cruzan mentioned a possible 14th Amendment right to appoint a health care proxy to make a decision at Time 2, but no other justice joined her.[3]  Indeed, a constitutional right to make future directives that bind oneself directly or through an agent has no constitutional precedent and poses many problems.

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Quantifying Causes of Mortality and the Relative Burden of Disease

By Michael J. Young

“Mortis effare ordinem et serva vivos”

(State the facts of the death and serve the living)

It was with this incisive charge that Dr. Mark Flomenbaum concluded his lecture on forensic pathology to my medical school class on the final day of our first-year pathology course.

I was reminded of this teaching moment earlier this week when I came across a study recently published in the journal Neurology which found that the annual mortality rate from Alzheimer’s disease (AD) could be nearly six times greater than has previously been reported by the CDC from information gathered from death certificates.  “Deaths from AD,” the authors conclude, “far exceed the numbers reported by the CDC and may be closer in magnitude to the number of deaths reported for heart disease and cancer.”   Were the facts of death in the underreported cases simply misstated?

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American, Georgetown, and Hamline Law Offer Summer 2014 Health Law Courses

American University Washington College of Law’s seventh annual Health Law & Policy Summer Institute will run from June 16 to June 28. The Institute’s flexible schedule includes day, evening, and online courses focusing on: (1) pharmaceutical law, (2) bioethics, (3) health care fraud and compliance, and (4) the economics of health care reform.

The O’Neill Institute for National and Global Health Law at Georgetown University is pleased to present two programs this summer: (1) Emerging Issues in Food and Drug Law and (2) U.S. Health Reform – The Affordable Care Act.  Now in its third year, the Summer Programs will convene leading practitioners, policymakers, advocates and academics in global food and drug law and US health reform for a series of interactive lectures, panel discussions, and case studies.  Held during consecutive weeks, July 14-18 (Emerging Issues in Food and Drug Law) and July 21-25 (US Health Reform – The Affordable Care Act), interested participants may attend one or both programs.  Additional details, including schedule, speakers, online application, and program fees may be found here.  Questions may be directed to oneillsummer@law.georgetown.edu.

The Hamline University School of Law Health Law Institute is pleased to offer a variety of condensed health law courses taught by academic and industry experts in Saint Paul, MN. Courses include: (1) Health Care Compliance Institute, (2) Biotechnology Policy, (3) Elder Law, and (4) Health Care Fraud and Abuse. Courses will run from May 27th through June 28th. Additional information, including the application and course descriptions can be found here.

 

TOMORROW: Frances Kamm’s Bioethical Prescriptions: Book Talk and Panel Discussion

Please join us on February 27 at 2:00pm in Wasserstein 1019 at the Harvard Law School as we launch Professor Frances Kamm’s latest book, Bioethical Prescriptions: To Create, End, Choose, and Improve Lives (Oxford University Press, January 2014). The book showcases Professor Kamm’s articles on bioethics as parts of a coherent whole, with sections devoted to death and dying; early life (on conception and use of embryos, abortion, and childhood); genetics and other enhancements (on cloning and other genetic technologies); allocating scarce resources; and methodology (on the relation of moral theory and practical ethics).

Panelists include:

  • Frances Kamm, Littauer Professor of Philosophy & Public Policy, Harvard Kennedy School of Government; Professor of Philosophy, Faculty of Arts & Sciences, Harvard University; Former Senior Fellow, Petrie-Flom Center
  • Norman Daniels, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Thomas (Tim) Scanlon, Jr., Alford Professor of Natural Religion, Moral Philosophy, and Civil Polity, Faculty of Arts & Sciences, Harvard University
  • Moderator: Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Associate Professor, James E. Rogers College of Law, University of Arizona

This event is free and open to the public. For questions, please contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and BioethicsEdmond J. Safra Center for Ethics at Harvard University; and the Countway Library of Medicine at Harvard Medical School; with support from the Oswald DeN. Cammann Fund.

2/27: Frances Kamm’s Bioethical Prescriptions: Book Talk and Panel Discussion

Please join us on February 27 at 2:00pm in Wasserstein 1019 at the Harvard Law School as we launch Professor Frances Kamm’s latest book, Bioethical Prescriptions: To Create, End, Choose, and Improve Lives (Oxford University Press, January 2014). The book showcases Professor Kamm’s articles on bioethics as parts of a coherent whole, with sections devoted to death and dying; early life (on conception and use of embryos, abortion, and childhood); genetics and other enhancements (on cloning and other genetic technologies); allocating scarce resources; and methodology (on the relation of moral theory and practical ethics).

Panelists include:

  • Frances Kamm, Littauer Professor of Philosophy & Public Policy, Harvard Kennedy School of Government; Professor of Philosophy, Faculty of Arts & Sciences, Harvard University; Former Senior Fellow, Petrie-Flom Center
  • Norman Daniels, Mary B. Saltonstall Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Thomas (Tim) Scanlon, Jr., Alford Professor of Natural Religion, Moral Philosophy, and Civil Polity, Faculty of Arts & Sciences, Harvard University
  • Moderator: Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Associate Professor, James E. Rogers College of Law, University of Arizona

This event is free and open to the public. For questions, please contact petrie-flom@law.harvard.edu or 617-496-4662.

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; Edmond J. Safra Center for Ethics at Harvard University; and the Countway Library of Medicine at Harvard Medical School; with support from the Oswald DeN. Cammann Fund.

Are We Misusing the “Brain Death” Diagnosis to Hurry Along Families?

Cross-posted from HealthLawProf Blog. Originally posted January 20, 2014.

What are We Learning About Brain Death from the McMath and Munoz cases?

By Jennifer S. Bard, J.D., M.P.H., Ph.D.

With the understanding that this is one of those topics that health law professors are supposed to know something about, here is a quick update of what’s going on.  Along with my own views about the possible misuse by hospitals of declaring brain death in what are really medical futility cases.

Jahi McMath, age 12, in California who lost consciousness after a routine tonsillectomy and Marlize Munoz, age 32  in Texas who collapsed on her kitchen floor have both become involuntary public figures as their families struggle to make sense of both their medical conditions, which are complex, and of the laws which have declared them both legally dead based on a lack of brain activity.  In legal terms, a person declared “brain dead” has the same status as any other dead person.  Each state is entitled to make its own decision of whether or not to adopt a brain death statute.  California’s and Texas’ are similar in that they require the “complete cessation” of all brain activity.  The declaration of death is, in all states, a legal act.  Most hospitals have a policy similar to this one which set criteria and require the participation of at least two doctors.  A declaration of death cuts off any rights of the individual.  The family of someone declared dead is no longer a surrogate decision maker.  Rather, they have something like property rights to the disposal of the remains.    More pointedly, a declaration of death ends all eligibility for medical insurance, including Medicaid and Medicare.  If a family decides to release the organs for donation, their host becomes not a patient but rather a “heart beating organ donor.” 

When a family wants to donate their loved one’s organs, a declaration of brain death is helpful mechanism for doing so.  Indeed, a series of high profile cases involving anencephalic infants in the 1990s pointed out the frustrations of parents who wanted to donate their children’s organs but could not because they retained minimal brain function.  However, there is never any legal need  for a declaration of brain death in order for a family to withdraw life sustaining treatment.  In 1993 bioethicist Robert Veatch wrote an important article in the Hastings Center Report in which he pointed out that “no one really believes that literally all functions of the entire brain must be lost for an individual to be dead.”  And indeed, no one really believes that a piece of paper converts a warm, breathing body from alive to dead.

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Art Caplan on “Accepting Brain Death”

Art Caplan has a new piece, co-authored with David C. Magnus, Ph.D. and Benjamin S. Wilfond, M.D., in the NEJM, addressing the legal and medical reasons for accepting brain death as death. From the article:

Over the past several decades, brain death has become well entrenched as a legal and medical definition of death. It is clearly defined by the neurologic community […], standards for diagnosis are in place, and it is established in law. It has become the primary basis of organ-procurement policy for transplantation. Ironically, the other standard for defining death, irreversible cessation of circulation, lacks consensus about diagnosis.

The concept of brain death has periodically come under criticism.4  Continue reading