When Is An Emergency Not an Emergency?

By Nadia N. Sawicki

In 2010, Illinois issued an administrative rule requiring that pharmacies dispense all lawfully prescribed drugs, including emergency contraception, or face sanctions.  Last week, an Illinois appellate court in Morr-Fitz v. Quinn held that Illinois’ Conscience Act prohibits enforcement of the rule as applied to the plaintiffs, pharmacy owners with ethical convictions against distribution of emergency contraception.

The case was decided on state law grounds, and involved a rather thorough textual analysis of the Illinois Conscience Act and the administrative rule regarding pharmacies’ obligations to dispense.  The most interesting part of the court’s analysis, in my opinion, was its discussion of whether the need for emergency contraception qualifies as an emergency.

By its terms, the Illinois Conscience Act does not relieve medical providers from their legal obligations to provide “emergency medical care.”  The state defendants in this case argued that “because ‘every hour counts’ in the effectiveness of Plan B contraceptives, the provision of emergency contraceptives falls within this exception.”  The court, however, concluded that emergency medical care necessarily involves “an element of urgency and the need for immediate action,” and that a woman’s need for emergency contraception does not fall within this definition.  According to the court, unlike a ruptured appendix or surgical shock, “unprotected sex does not place a woman in imminent danger requiring an urgent response.”

What do you think?

More (or less) on Male Circumcision

Thanks to Pablo de Lora for pointing us to a new article from Bijan Fateh-Moghadam on the Cologne decision regarding male circumcision.

From the article’s conclusion:

Summing up, the Cologne Judgment misjudges the constitutional framework of the criminal law defense of proxy consent. Male circumcision in children, if performed lege artis and with the consent of the parents, is lawful, because it does not exceed the general legal limits of parental consent. Parents who circumcise their sons following Jewish or Muslim tradition do not claim for a legal privilege or “reasonable accommodation”, they rather utilize the parental right to the care and custody of the child and freedom of religion as guaranteed by the general law. The justification of male circumcision therefore does not follow from a religious or cultural defense but from the well-established principles of parental proxy consent. Hence, also the – circular – argument of the Cologne Judgment with reference to Art. 140 GG in conjunction with Art. 136(1) of the Weimar Constitution is misleading, because male circumcision does not exceed the limits of the general law in the first place.

 

Infrastructural Law: The Lesser-Known Cousin

by Jennifer Ibrahim, PhD, MPH

An article by Julia Costich, MPA, JD, PhD, and Dana Patton, PhD, in the October 2012 edition of the American Journal of Public Health reveals the tip of the iceberg on a highly discussed and yet insufficiently researched topic: the legal infrastructure. While the team reports a significant impact of the legal infrastructure of local health departments on population health outcomes, the paper also raises questions regarding the role of law more generally in the functioning of health departments.

While we “see” law all the time in action, we rarely “see” law as an important factor influencing the way health agencies operate. Sure, we understand law as a way to drive the behavior of individuals by regulating sugar-sweetened beverages or prohibiting texting while driving or preventing smoking in indoor spaces — this is called interventional law — but there is a lesser-known cousin, infrastructural law, that desperately needs our attention.

While public health officials, policy-makers, advocates and academics regularly discuss the funding and organization of health departments at both the state and local levels, they less often step back to think about what is driving the process — law. As states are facing significant fiscal crisis, funds are a major concern, but it is important to remember that appropriations are made through law. Additionally, in recent years, during natural disasters such as hurricanes in the south and major floods in New England, there were questions in the news about which agencies should be doing what and when. The authority for a health department to act and/or to act in concert with another agency is derived from law.

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ONC Backs Off Rule-making For Governance of Health Information Exchange

By Leslie Francis

Establishment of the infrastructure needed for the efficient, accurate, and secure exchange of health information is a crucial piece of improving care in the US.  Exchange fosters the ready availability of information, reducing redundancy and hopefully improving care quality.  To this end, proposals for a National Health Information Network were highly touted during the Bush Administration and continue to be supported by the Obama Administration, the Office of the National Coordinator for Health Information Technology (ONC) was established in 2004, and several federal advisory committees (the ONC Policy Committee and the ONC Standards Committee) were established by Congress in the HITECH Act in 2009.  Yet progress towards health information exchange remains halting at best–some hypothesize because of resistance within the private sector itself.  Recent developments at ONC are not encouraging.

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New Book on Conscientious Objection in Health Care

Related to the conversations we’ve been having lately on conscience, I wanted to point you to a relatively new book on the topic by Mark WicclairConscientious Objection in Health Care: An Ethical Analysis, Cambridge University Press, 2011.

From Amazon: “Historically associated with military service, conscientious objection has become a significant phenomenon in health care. Mark Wicclair offers a comprehensive ethical analysis of conscientious objection in three representative health care professions: medicine, nursing and pharmacy. He critically examines two extreme positions: the ‘incompatibility thesis’, that it is contrary to the professional obligations of practitioners to refuse provision of any service within the scope of their professional competence; and ‘conscience absolutism’, that they should be exempted from performing any action contrary to their conscience. He argues for a compromise approach that accommodates conscience-based refusals within the limits of specified ethical constraints. He also explores conscientious objection by students in each of the three professions, discusses conscience protection legislation and conscience-based refusals by pharmacies and hospitals, and analyzes several cases. His book is a valuable resource for scholars, professionals, trainees, students, and anyone interested in this increasingly important aspect of health care.”

Larry McCullough writes a glowing review over at Notre Dame Philosophical Reviews.

Mark’s book is broader than mine (Conflicts of Conscience in Health Care: An Institutional Compromise) in that he addresses conscientious objection as it arises in a variety of health care professions, as well as institutional objections, whereas I focus exclusively on objection by individual physicians.  However, Mark focuses on the ethics and ethical limits of conscientious objection, and does not consider means to enforce those limits or ensure patient access.  Such practical details are a major focus of my book.  So check them both out!

[H/T Glenn Cohen, via John Goldberg]

Reminder, TODAY – Health Care Reform: A View from Both Sides

Today’s the day!
12:00-1:30pm
Austin Hall, Classroom 111
Harvard Law School

Please join us for a special off-the-record debate on American health care reform, moderated by the Petrie-Flom Center’s Founding Faculty Director,  Einer Elhauge.  John McDonough, official surrogate of the Obama campaign and director of the Center for Public Health Leadership at the Harvard School of Public Health, and Oren Cass, domestic policy director for the Romney campaign, will discuss what each candidate would mean for the future of US health policy.

This event is free and open to the public.  No reporting will be permitted without the express permission of the speakers. Lunch and refreshments will be served.

Co-sponsored by the Petrie-Flom Center, HLS Democrats, HLS Republicans, and HLS American Constitution Society.

TODAY – Deceased Organ Donation and Allocation: 3 Experiments in Market Design

Sorry for the late notice, but we just learned that Al Roth will be giving a talk with this title TODAY @ 3:30 at Stanford.  More info here.

Al has also pointed us to two relevant posts over at his Market Design blog:

Allocating deceased donor kidneys for transplant: problems, some proposed changes, and how can we get more donors?

Two recent NY Times stories discuss the allocation of deceased donor kidneys:

A few different things are intertwined here: the long waiting lists, the congested process of offering kidneys and having them accepted or rejected and offered to the next person on the list, and the ordering of the list, which in turn might influence how often people need a second transplant, which comes back to how long the waiting lists are…There are lots of interesting and important questions about how to most efficiently allocate the scarce supply (see e.g. Zenios et al.)But organ allocation has an unusual aspect: how organs are allocated may also influence the supply, by changing donation behavior. [And this is the topic of Al’s talk today.]

Older kidneys work fine (thank you for asking:)

Older Kidneys Work Fine for Transplants“Using data from more than 50,000 living donor transplants from 1998 through 2003, researchers at the University of British Columbia concluded that the age of the donor made no difference to the eventual success of the transplant — except for recipients ages 18 to 39, who were more likely to succeed with a donor their own age. Patients in this group accounted for about a quarter of all the patients studied. The scientists also analyzed lists of people waiting for a kidney from a deceased donor and found that the probability of becoming ineligible for donation within three years was high, varying from 21 percent to 66 percent, depending on age, blood group and severity of disease. Waiting can be fatal, the authors contend, and an offer of a kidney should not be rejected simply because of the donor’s age.”

Refusals and Reasons: Is the Best Interests Principle the Best Standard?

By Erin Talati

In my last post, I puzzled over the boundaries of the state’s right to step in to protect the interests of children over the religious wishes of their parents, prompted by the question of whether it would be appropriate to prophylactically transfuse the child of a Jehovah’s Witness in order to minimize the risk of future harm.   As I continue to think about this question, I remain convinced that the boundaries are exceedingly fuzzy and do not necessarily seem to distinguish circumstances in a way that favors action “in the best interests of the child.” Rather, in looking at another situation in which the interests of the child may come into conflict with the religious or other interests of the parent, on the whole, it seems that the decision to intervene rests more on the legal basis for intervention rather than overall promotion of the best interests principle.

Take, for example, the general approach to vaccine refusals by parents.  The rights of parents to refuse vaccines for their children, generally, can be grounded in medical, philosophical, or religious objections.  Medical exemptions, based on medical contraindications to vaccination, remain the most robust mechanism of parental refusal. All states permit exemption from mandatory vaccination on the basis of medical exemptions.  Exemption for medical contraindication is consistent with the best interests principle as vaccination in these cases arguably is not in the best interests of the child.  Fewer states permit vaccine refusal on the basis of moral or philosophical objections. In almost all states, excepting Mississippi and West Virginia, parents can refuse vaccines for religious reasons, with states requiring varying levels of support for refusals grounded in religious objection.  It seems reasonable that, from the standpoint of protection of individual liberties, states would preference religious beliefs of parents in allowing refusals. Still, when either a religious or philosophical objection are not concurrently accompanied by a medical contraindication to vaccination, neither justification for refusal promotes action in the best interests of the child.

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Research Exceptionalism Diminishes Individual Autonomy

by Suzanne M. Rivera, Ph.D.

One of the peculiar legacies of unethical human experimentation is an impulse to protect people from perceived research risks, even when that means interfering with the ability of potential participants to exercise their own wills.  Fears about the possibility of exploitation and other harms have resulted in a system of research oversight that in some cases prevents people from even having the option to enroll in certain studies because the research appears inherently risky.

Despite the fact that one of the central (some would say, the most important) principles of ethical human research is “respect for persons,” (shorthand: autonomy), our current regulations– and the institutions that enforce them– paradoxically promote an approach to research gate-keeping which emphasizes the prevention of potential harm at the expense of individual freedom.  As a result, research activities often are treated as perils from which unsuspecting recruits should be shielded, either because the recruits themselves are perceived as too vulnerable to make reasoned choices about participation, or based on the premise that no person of sound mind should want to do whatever is proposed.

One example of such liberty-diminishing overprotection is the notion that study participants should not be paid very much for their time or discomfort because to provide ample compensation might constitute undue inducement. Although there is no explicit regulatory prohibition against compensating research participants for their service, The Common Rule requires researchers to “seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”  This has been interpreted by many to mean that payment for study participation cannot be offered in amounts greater than a symbolic thank you gesture and bus fare. Read More

Call for Applications: Summer Ethics Fellowships at Auschwitz for the Study of Professional Ethics

The Fellowships at Auschwitz for the Study of Professional Ethics (FASPE) uses a unique historical lens to engage law students in an intensive course of study focused on contemporary legal ethics.  FASPE Fellows are granted an all-expenses paid 12-day trip to Germany and Poland to learn about the roles played by legal practitioners — lawyers and judges — in Nazi Germany, underscoring the reality that moral codes governing the legal profession can break down or be distorted with devastating consequences.  This historical perspective then becomes a launching point for discussions about ethical dilemmas facing lawyers in American today.  The program integrates historical, cultural, philosophical, and literary sources; survivor testimony; and on-site workshops in Berlin, Auschwitz, and Nuremberg.

FASPE Law was initially developed with the assistance of Professor Tony Kronman, former Dean of Yale Law School and other Yale Law School faculty members.  Since piloting the program in 2009, 43 Fellows have participated from law schools including Berkeley, Columbia, Georgetown, Harvard, Northwestern, the University of Arizona and Yale. The summer 2013 program will include 12-15 new Fellows chosen through a national application process.  The lead instructor for the 2013 program will be Eric Muller, the Dan K. Moore Distinguished Professor in Jurisprudence and Ethics at UNC School of Law. The Fellowships include all costs associated with the 12-day program, including international and European travel, lodging, and food.

FASPE Law Fellows examine such topics as:

  • Ethical approaches to truth and disclosure in the adversarial process.
  • The ethical challenges of ambition in professional development.
  • Ethics and government lawyering.
  • The Nuremberg Trials and post-war justice, in historic and modern contexts.
  • Ethics in the day-to-day practice of law.

The Fellows are provided with reading materials prior to meeting in New York; and the academic component of the program is intensive and interactive.  Daily Seminars are led by faculty and local experts who engage the Fellows in legal issues associated with the locations visited.

The tentative program dates for FASPE Law are May 26 – June 6, 2013.

Completed applications must be received by January 11, 2013.  Candidates of all religious, ethnic, and cultural backgrounds are encouraged to apply. To apply or to learn more about FASPE, please visit:  https://www.FASPE.info If you have any questions, please contact Thorin Tritter, Managing Director of FASPE, at ttritter@FASPE.info.