Suing Psychiatrists: Causation, Spoliation, Alternative Liability, and Lost Chance

By Alex Stein

Almonte v. Kurl, 46 A.3d 1 (R.I. 2012), is a must-read malpractice decision. This decision is about a patient who was brought to a psychiatrist for involuntary committal evaluation after undergoing an acute episode.  The psychiatrist examined the patient, but opened no committal process. As a result, the patient was released to commit suicide, apparently with the same gun that he threatened to use in the episode that triggered the evaluation.

The Rhode Island Supreme Court affirmed the trial judge’s determination that the psychiatrist’s failure to open the committal process amounted to malpractice. The psychiatrist was nonetheless able to summarily defeat the wrongful death action filed by the patient’s family.

How could that happen? Read More

Politics after a SCOTUS decision

Some SCOTUS opinions stir up politics and legislation (think: Roe v Wade). Others tend to end the process. When the Court is interpreting a federal statute, if they get it “wrong” it is of course possible for the elected branches to reverse them. But for some of these issues, political stalemate in Congress gives the Justices the last word, perhaps for decades.

Which makes the Roberts Court both activist and powerful.

For more, see “Political gridlock empowers US justices” in today’s Financial Times, quoting me.


Introducing Guest Blogger Seema Shah

Seema Shah is a faculty member in the Department of Bioethics in the NIH Clinical Center with a joint appointment in the Division of AIDS.  Her research focuses on the ethics of international research, the ethics of research with children, and the intersection of law and bioethics.  She currently serves as a consultant for the Division of AIDS on its clinical sciences review committee and as an ethics consultant for the Clinical Center.  She has published in the field of bioethics in peer-reviewed journals such as the Journal of the American Medical Association, the American Journal of Bioethics, and the Lancet.  More recently, she has focused on controversies surrounding the determination of death and organ transplantation, with an article on the topic in the American Journal of Law and Medicine.

Ms. Shah earned her bachelor’s and juris doctor degrees from Stanford University.  She previously served as a federal law clerk in the Eastern District of California and a predoctoral fellow in the NIH Department of Bioethics.  She has lectured on the ethics of human subjects research at conferences run by PRIM&R, ASBH, ASTMH, and internationally in such locations as Mali, South Africa, Singapore, and Vietnam.

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Non-Medical Exemptions: Weighing Public Health and Individual Rights

By Y. Tony Yang, ScD, LLM, MPH

More and more frequently, the media are reporting two potentially related and troubling developments: an alarming increase in outbreaks of deadly infectious vaccine-targeted diseases and the growing refusal by parents to allow their children to be vaccinated. (See this recent U.S. News & World Report article on cases in New York). Public health officials may therefore fairly ask whether their state vaccine exemption laws are unnecessarily and unintentionally sowing the seeds for a public health crisis and, if so, how their laws could be changed soon to head off avoidable epidemics.

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Too Young For Sex, But Old Enough For The Sex Offender Registry, Part III

By Michele Goodwin

I conclude Part III in this series from Uganda—a nation recovering from what one doctor describes as a “genocide” from HIV and AIDS. Parts I and II can be found here and here.

As a society, do we really care that teens and preteens have sex? On the one hand we care too much—so much so that the criminal law is the central form of regulating teen sex. This form of regulation is derived from statutes that treat all sexual behavior alike, even though consent and context may drastically vary.  In Law’s Limits: Regulating Statutory Rape Law, found here, I articulate why the criminal law approach, filtered through the judiciary, leads to absurd results. These absurd results include the extralegal punishments inflicted on youth who are punished for participating in consensual sexual activity, such as lifelong registration as a sex offender. These types of consequences and outcomes are problematic because they are morally wrong and foster significant harms across a series of areas, including creating social status harms, by reifying racial and homosexual stereotypes. The criminal law approach also leads to cruel and unusual punishments in an era where sex offender registries are increasingly the norm and a condition of release from prison.  On inspection, such punishments are disproportionate and unjustified.

On the other hand, maybe we care too little about teen sexuality. The notorious Steubenville, Ohio rape case bears this out (where the rape victim suffered backlash and threats), as do the high rates of HIV, sexually transmitted diseases, and syphilis infections among teens, and teens’ relatively high use of alcohol and drugs prior to sex. Parents fail to talk to their children about sexuality when children most need to understand it: prior to commencing sexual experimentation. Empirical data shows that fathers barely speak to their daughters about sex and these omissions may impact their daughters’ sexual attitudes and behaviors. Governors and prosecutors sometimes demonstrate selective interest in teen sexuality—when it involves specific ethnic populations or the poor. This failure to care enough is manifested in the criminal law approach to shaping teen sex norms, rather than the public health where it is most justified.

So, how might we move forward? Read More

Reactions to Myriad, two weeks later

By Nicholson Price

Two weeks after the Supreme Court held isolated naturally occurring DNA unpatentable in Association for Molecular Pathology v. Myriad Genetics, Inc., there’s been quite a lot of commentary about the case’s implications for the biotech industry and medical science.  I’ll just mention a few here, with the certainty that there will be more to come.  On the practical side, Quest Diagnostics has already announced plans to offer testing for BRCA1 and BRCA2.

Paul Cole wrote about how Myriad lines up with international views on gene patenting, and concluded it doesn’t, at least not well – in the E.U. and Australia isolated DNA is patentable.  On the other hand, at least the Federal Court of Australia opinion (also against Myriad Genetics), the court relied in part on its conclusion that “in the absence of human intervention, naturally occurring nucleic acid does not exist outside the cell, and ‘isolated’ nucleic acid does not exist inside the cell. Isolated nucleic acid is the product of human intervention involving the extraction and purification of the nucleic acid found in the cell.”  The amicus brief filed by Dr. Eric Lander on behalf of neither party, and co-authored by Glenn Cohen here at the Petrie-Flom Center, points out the error of this conclusion, noting that there is a tremendous amount of isolated DNA present in the human body outside of cells.  Glenn posted extensively on this, and the importance of the brief in the Supreme Court’s reasoning, here.

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Special Issue of Jurimetrics on Law and Public Health

By Christopher Robertson

Arizona State University hosted a symposium on “The Intersection of Law, Science, and Policy to Protect the Public’s Health,” published in Jurimetrics, with excellent contributions by Wendy Parmet, David Hymen, Bernie Black, Vickie Williams, and many others.   Here is part of the abstract for the foreward by James Hodge:

Revitalization, revolution, renaissance. In the modern era, these three words depict the foundational changes in the role of law to protect, promote, and preserve the public’s health. Since the early 1990s, public health law has transformed into a distinct, identifiable field through the coupling of phenomenal scholarly vision (including from several scholars in this symposium issue) and public health practitioners’ bold experimentation in novel, applied uses of law to improve public health outcomes. After decades of sheer decline, reluctance, and even reversal of known, effective applications, law and policy have emerged as primary tools for making change in public health. Whether via constitutional interpretation, statutory or regulatory enactments, judicial interventions, or policy adjustments within legal systems, the notion that law can effectively contribute to the public’s health in areas as diverse as tobacco control, obesity prevention, and product safety is now relatively well accepted.

Decrease in the patient’s chances to survive held actionable as a standalone damage in Minnesota

By Alex Stein

On May 31, 2013, the Supreme Court of Minnesota has delivered an immensely important decision: it recognized as actionable a patient’s increased risk of dying resulting from her doctor’s negligent failure to secure timely diagnosis and treatment of cancer. Dickhoff v. Green, — N.W.2d —, 2013 WL 2363550 (Minn. 2013)

This case involved a family physician (the defendant) and her baby patient (the plaintiff). The baby had a lump on her buttock, which the defendant allegedly considered a non-issue for nearly a year. At the 1–year well-baby check, the defendant referred the baby to a specialist, who diagnosed her with alveolar rhabdomyosarcoma (ARS)—a rare and aggressive childhood cancer. The baby subsequently underwent a tumor-removal surgery, chemotherapy and radiotherapy, but remained dangerously ill. Read More

OHRP Announces Details of August 28 Public Meeting About SUPPORT and Similar Trials

By Michelle Meyer

Update: In other SUPPORT news today, a second group of bioethicists has written to the NEJM in, ahem, support of OHRP’s original criticisms of the SUPPORT trial. Readers may recall that another group of prominent bioethicists had previously published a letter in the NEJM in support of SUPPORT.

OHRP today announced details of the public meeting it previously said it would convene to address the SUPPORT trial and similar trials comparing two or more standard-of-care interventions in which subjects are randomized.

From an OHRP email:

On June 26, 2013, the Department of Health and Human Services (HHS) announced in the Federal Register an August 28, 2013 public meeting to seek public input and comment on how certain provisions of the Federal policy for the protection of human subjects should be applied to research studying one or more interventions which are used as standard of care treatment in the non-research context.

HHS specifically requests input regarding how an institutional review board (IRB) should assess the risks of research involving randomization to one or more treatments within the standard of care for particular interventions, and what reasonably foreseeable risks of the research should be disclosed to research subjects in the informed consent process.

HHS is seeking participation in the meeting and written comments from all interested parties, including, but not limited to, IRB members, IRB staff, institutional officials, research institutions, investigators, research subject advocacy groups, ethicists, and the regulated community at large.  The meeting and the written comments are intended to assist HHS, through the Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), in developing guidance regarding what constitutes reasonably foreseeable risk in research involving standard of care interventions such that the risk is required to be disclosed to research subjects.  HHS is seeking input on a number of specific questions but is interested in any other pertinent information participants in the public meeting would like to share.

More details and deadlines after the jump.

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Fetal Pain Laws: Scientific and Constitutional Controversy

By John A. Robertson, University of Texas Law School

A new front has opened in the abortion wars with laws that ban abortion at 20 weeks on the ground that the fetus is then capable of feeling pain.  Led by Nebraska in 2011, ten states have passed such laws, and Texas is now considering such a ban. Although affecting less than 1% of the 1.2 million abortions occurring annually in the United States, abortion between 20-24 weeks may be hugely important for women whose fetus has a lethal or severe genetic anomaly or who otherwise find that they cannot continue the pregnancy. If this challenge to Roe v. Wade ‘s viability line (24 weeks) is upheld, it would be an important victory for anti-abortion groups, spur more states to enact such laws, and signal that the Supreme Court is ready to reconsider other aspects of the abortion right.

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