Defendants’ Motion for Summary Judgment Granted in Looney v. Moore (SUPPORT trial lawsuit)

The district court has granted summary judgment (opinion pdf) for all remaining defendants as to all of plaintiffs’ remaining claims in Looney v. Moore, the lawsuit arising out of the controversial SUPPORT trial, which I last discussed here. This therefore ends the lawsuit, pending possible appeal by the plaintiffs.

Plaintiff infants include two who were randomized to the low oxygen group and survived, but suffer from “neurological issues,” and one who was randomized to the high oxygen group who developed ROP, but not permanent vision loss. In their Fifth Amended Complaint (pdf), plaintiffs alleged negligence, lack of informed consent, breach of fiduciary duty, and product liability claims against, variously, individual IRB members, the P.I., and the pulse oximeter manufacturer. What unites all of these claims is the burden on plaintiffs to show (among other things) that their injuries were caused by their participation in the trial. Continue reading

Fetal Personhood and the Constitution

By John A. Robertson

The Rubio-Huckabee claim that actual and legal personhood start at conception has drawn trenchant responses from Art Caplan on the medical uncertainty of such a claim and David Orentlicher, drawing on Judith Thomson’s famous article, that even if a fetus is a person, woman would not necessarily have a duty to keep it in her body.

Their debate claim that the fetus is already a legal person under the constitution also deserves a response, for it has no basis in positive law.  In Roe v. Wade all nine justices agreed that the use of “person” in the Constitution always assumed a born person, and therefore that the 14th Amendment’s mention of person did not confer constitutional rights until after a live birth.  In the years since Roe, when the make-up of the court has changed, no justice has ever disagreed with that conclusion, including those who would overturn Roe and Casey. Continue reading

Bioethicist Art Caplan: Marco Rubio And The GOP’s Dangerous Misconception On When Life Begins

Bill of Health Contributor Art Caplan has a new piece up on Forbes:

Does human life begin at conception? For Marco Rubio and some other politicians now running for the presidential nomination in the GOP herd, the answer is yes. There is no doubt in their mind about when life begins. Amazingly despite indifference to science regarding other matters like evolution and climate change, they invoke science on behalf of their advocacy of what might best be called “conceptionalism.” And given what science shows the law must protect every new life.

Those lobbying for conceptionalism aim to outlaw all abortions, no matter how an embryo is conceived. Even if a mentally ill 12-year-old woman is raped by her predatory father, killing an embryo, if one results, ought not be a legal option in their view. When life begins at conception murder is never an option, Rubio and his fellow-travelers aver. [..]

Read the full article here.

Bioethicist Art Caplan: All Hat, No Cattle—The False Hope of Right-to-Try Laws

Bill of Health contributor Arthur Caplan and Alison Bateman-House have a new piece up in Harvard Health Policy Review:

Are right-to-try laws a good idea? In 2014, they began appearing throughout the United States, first in Colorado and now in 23 states, with several more considering passing versions of this popular legislation.

At first glance these bills may seem worth enacting. Right-to-try (RTT) laws promise terminally ill patients that they can obtain experimental drugs or medical devices in their quests to save or extend their lives. These investigational medical products are still in development and have not yet met the requirements set by the Food and Drug Administration (FDA) in order to be approved for sale or use in the United States. In some cases, the products are still being tested and patient access would primarily be by enrolling in a clinical trial – something terminally ill people may be too unwell to do. Less commonly, the products have completed clinical testing and are waiting for an approval verdict from the FDA. In either case, RTT laws are about providing terminally ill patients access to unapproved drugs or devices. […]

Read the full article here.

Journal of Law and the Biosciences: Call for Harvard Student Submissions

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 Notes & Developments section, comprised  of  brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie­Flom Center is responsible for providing the Notes & Developments for one issue per annual volume.

We are currently seeking Harvard graduate students to contribute papers to be published in JLB’s Notes & Developments section in early 2016. In previous years, Notes & Developments have been generated from scratch specifically for JLB, based on selection from submitted proposals. This year, we are taking a different approach by publishing already complete (or to-be-completed by the deadline) original student papers (such as student notes, course papers, etc.) written by graduate students from any Harvard school.  Notes & Developments are limited to 5000 words, including footnotes and references,  and  should  be  on  a  topic  of  relevance  to  law  and  the  biosciences,  in particular a topic of relatively recent concern, controversy, or change. They should focus on  describing  the  issue  at  hand,  explaining  why  it  is  relevant to scholars and practitioners, and providing analysis and questions for further consideration.

Interested students should submit their papers and CVs for consideration no later than September 7, 2015 (earlier  is  welcome). Up to four papers will be selected for publication in the New Developments section of JLB. Applicants will be notified by the end of September. Selected students will receive comments on their papers by the end of October, and will also be responsible for providing comments to the other selected students. Revisions will be due by the end of November, and final submissions to JLB will be due by the end of December 2015.

Please send all application materials, and direct all questions, to Holly Fernandez Lynch, hlynch@law.harvard.edu.

Affective Forecasting and Genetics

by Zachary Shapiro

Psychological research on “affective forecasting,” studying individuals’ ability to predict their future emotional states, consistently shows that people are terrible at predicting their ability to adapt to future adversity. This finding has particular significance for medical decision-making, as so many serious health decisions hinge on quality-of-life judgments, generally made by an individual balancing risks and benefits they perceive of a future state that is likely to result from a given therapeutic regime.

Much of the research on affective forecasting has focused on high-stakes events, restricting study participation to those likely to find the study event particularly significant, such as tenure-track faculty, registered voters, or sports enthusiasts. Despite a growing body of research on forecasting biases in the medical domain, little work has previously systematically considered such biases in clinical genetics. However, as the prevalence of genetic testing has increased, scholars have noticed forecasting deficiencies with increasing regularity.[1]

While evidence suggests that those who receive genetic testing, whether they are non-carriers or carriers of specific genes, differ in terms of short-term general psychological distress, their long-term distress levels do not differ significantly. Results of research into the affective reactions of patients undergoing predictive genetic testing suggest that, in general, psychological outcomes are not as negative as one may expect.

Continue reading

Interpreting Fiorina’s Comments on Vaccination Law

I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.

Abortion and the Fetal Personhood Fallacy

By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

Marco Rubio, Mike Huckabee, and other politicians continue to assert a common fallacy about abortion—because human life begins at conception, fetuses are persons, and abortion must be prohibited. Indeed, Huckabee and Rubio claim that the U.S. Constitution requires such a result.

But they are wrong. And not just because people disagree about the beginning of personhood. The flaw in the Rubio/Huckabee logic was pointed out more than 40 years ago, even before the U.S. Supreme Court recognized a constitutional right to abortion in Roe v. Wade. In “A Defense of Abortion,” Professor Judith Jarvis Thomson correctly observed that even if we assume that personhood begins at conception, it does not follow that abortion must be banned before the fetus is viable. Indeed, as she wrote, a ban on abortion before fetal viability would be inconsistent with basic principles of law. Continue reading

Bioethicist Arthur Caplan: Euthanasia in Belgium and the Netherlands: On a Slippery Slope?

Bill of Health Contributor Art Caplan and Barron Lerner have a new piece up in JAMA Internal Medicine:

The slippery slope is an argument frequently invoked in the world of bioethics. It connotes the notion that a particular course of action will lead inevitably to undesirable and unintended consequences. Saying no to the original action, even if that act is moral in itself, may, in light of the slope that looms, be the ethical thing to do.

Slippery slope arguments have been especially pervasive in discussions of euthanasia, in which physicians actively end patients’ lives, and physician-assisted dying (or physician-assisted suicide), in which physicians supply medications to patients that enable them to end their own lives. The concern, fueled by the German experience with racially motivated euthanasia in the last century, has been that approving either of these procedures for a few individuals will inevitably lead to overuse and abuse. […]

Read the full article here.

GOP Confusion Over Stem Cell Research

Bill of Health Contributor Dov Fox has a new article up on the Huffington Post:

Republican candidates convened last night for the first debates of the 2016 campaign. The presidential hopefuls disagreed on every topic they faced — immigration, health care, foreign policy, gay rights, the economy — all but one, that is. Their differences of opinion disappeared each time they were asked about the controversy over the recent release of an undercover video with Planned Parenthood. On the issue raised by that edited film clip, the candidates came together in a rare consensus.

All 17 — from Ted Cruz to Carly Fiorina — staunchly opposed research that uses tissue cells from aborted or miscarried fetuses. The candidates unanimously called for Congress to end its support of Planned Parenthood over its contribution to that research, with some like Louisiana Gov. Bobby Jindal joining party leaders who would force a government shutdown over that issue. This, after Senate Republicans earlier this week failed to clear a procedural vote to defund. […]

Read the full article here.

Planned Parenthood Did Nothing Wrong – But there is a darker side to the human tissue trade

Our blogger Michelle Goodwin has a piece up on Politico:

Republicans on Capitol Hill, and now GOP presidential candidates like Donald Trump and Jeb Bush, are jumping over each other to defund Planned Parenthood because it transfers fetal tissues to researchers at cost. But if Americans want the benefits of biotechnology—helpful surgeries, cosmetics, vaccines, Alzheimer’s treatment and pharmaceutical drugs—they and their elected representatives need to learn a few basic facts about how these social services and products are derived from human tissue research.

The latest assault on Planned Parenthood comes after graphic video clips were released over the past three weeks purporting to show the non-profit organization nefariously trading fetal body parts for profit. Despite a move by Senate Democrats to block the defunding bill on Monday, Sen. Ted Cruz and Donald Trump are joining together to try to shut down the government if Planned Parenthood gets federal money. Just yesterday, Jeb Bush railed against “the hard-to-fathom $500 million in federal funding that goes to Planned Parenthood—an organization that was callously participating in the unthinkable practice of selling fetal organs.” […]

Read the full article here.

Mourning the Loss of Professor Bo Burt

By Abbe Gluck

Yale Law School and so many others in the medical-legal community mourn the sudden passing of our colleague and friend, Robert (“Bo”) Burt.  As many readers of this blog know, Bo was an early pioneer in thinking about doctor-patient relationships and the hardest questions about the end of life. He worked for years on the Soros Project, Death in America, and authored numerous books, including In the Whirlwind: God and Humanity in Conflict (Harvard Univ. Press, 2012); Death is That Man Taking Names: Intersections of American Medicine, Law and Culture (Univ. of California Press and the Milbank Memorial Fund, 2002); and Taking Care of Strangers: The Rule of Law in Doctor-Patient Relations (Free Press, 1979). His YLS obituary is here.  He will be sorely missed and always remembered.

The 21st Century Cures Act, HIPAA, Big Data, and Medical Research

By Nicholson Price

The 21st Century Cures Act is a big deal; the House passed it handily, and we’re still waiting to see what the Senate does.  A lot has been written about what it does in terms of changing FDA review processes, and a fair bit about the lovely increase in funding for NIH (see Rachel Sachs’ blog posts here, here, and here).  These are tremendously important.

But another provision in the bill has been getting much less play: the way it changes HIPAA to enable large-scale research, which is also a big deal all by itself. Continue reading

Pinker on the “moral imperative” for bioethics

In his stunning Op-Ed in today’s Boston Globe, Steven Pinker seems to suggest that bioethicists come in only one flavor: conservative. I certainly don’t fit that bill. But there’s a lot I think he gets right in this critically important piece. Why not change the default rules: what if new scientific advances were welcome, unless we had strong reason to worry, rather than the other way around?

Take a look, this is really important.

Update, 8/6/15: Many people have voiced strong objections to Pinker’s piece, taking his admonition that “the primary moral goal for today’s bioethics” should be to “[g]et out of the way” as squarely directed at IRBs.  His statement was definitely overbroad, but I didn’t take him to mean that we don’t need IRBs or human subjects protection at all.  In fact, he explicitly acknowledges that “individuals must be protected from identifiable harms” and recognizes the importance of existing safeguards for subject safety and informed consent. Instead, I read his piece not just with human subjects research in mind, but all of science. At the most basic level, I think he is making a very reasonable call for us to be aware of the risks of overprotection, of trying to imagine everything that could ever go wrong, with blinders on to the consequences of what will happen if we sit still, worrying for too long.

Some other reactions from around the web:

http://alicedreger.com/node/210

 http://www.bostonglobe.com/opinion/lette…

Neuroimaging as Evidence of Pain: It’s Time to Prepare

By Henry T. Greely, Edelman Johnson Professor of Law, Stanford Law School; Professor (by courtesy) of Genetics, Stanford Medical School; Director, Program in Neuroscience & Society, Stanford University

The recent meeting at Harvard on neuroimaging, pain, and the law demonstrated powerfully that the offering of neuroimaging as evidence of pain, in court and in administrative hearings, is growing closer. The science for identifying a likely pattern of neuroimaging results strongly associated with the subjective sensation of pain keeps improving. Two companies (and here) recently were founded to provide electro-encephalography (EEG) evidence of the existence of pain. And at least one neuroscientist has been providing expert testimony that a particular neuroimaging signal detected using functional magnetic resonance imaging (fMRI) is useful evidence of the existence of pain, as discussed recently in Nature.

If nothing more is done, neuroimaging evidence of pain will be offered, accepted, rejected, relied upon, and discounted in the normal, chaotic course of the law’s evolution. A “good” result, permitting appropriate use of some valid neuroimaging evidence and rejecting inappropriate use of other such evidence, might come about. Or it might not.

We can do better than this existing non-system. And the time to start planning a better approach is now. (Read on for more on how)

Continue reading

Of Algorithms, Algometry, and Others: Pain Measurement & The Quantification of Distrust

By Frank Pasquale, Professor of Law, University of Maryland Carey School of Law

Many thanks to Amanda for the opportunity to post as a guest in this symposium. I was thinking more about neuroethics half a decade ago, and my scholarly agenda has, since then, focused mainly on algorithms, automation, and health IT. But there is an important common thread: The unintended consequences of technology. With that in mind, I want to discuss a context where the measurement of pain (algometry?) might be further algorithmatized or systematized, and if so, who will be helped, who will be harmed, and what individual and social phenomena we may miss as we focus on new and compelling pictures.

Some hope that better pain measurement will make legal disability or damages determinations more scientific. Identifying a brain-based correlate for pain that otherwise lacks a clearly medically-determinable cause might help deserving claimants win recognition for their suffering as disabling. But the history of “rationalizing” disability and welfare determinations is not encouraging. Such steps have often been used to exclude individuals from entitlements, on flimsy grounds of widespread shirking. In other words, a push toward measurement is more often a cover for putting a suspect class through additional hurdles than it is toward finding and helping those viewed as deserving.

Of Disability, Malingering, and Interpersonal Comparisons of Disutility (read on for more)

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An ELSI Program for Pain Research: A Call to Action

By Diane Hoffmann, Director, Law & Health Care Program; Professor of Law; University of Maryland School of Law

As someone who has been greatly concerned about and devoted much of my scholarship to legal obstacles to the treatment of pain, I applaud Professor Pustilnik for increasing attention to the role of neuroimaging in our efforts to understand our experience of pain and how the law does or does not adequately take into account such experience. Pustilnik has written eloquently about this issue in several published articles but her efforts to bring together scientists, medical experts, legal academics, and judges (see also here) deserves high praise as a method for illuminating what we know and do not know about pain and the brain and to what extent brain imaging can serve as a diagnostic tool or an external validator of pain experience.

In this post, I discuss how DNA testing serves as a precedent for how to develop responsible uses of new technologies in law, including, potentially, brain imaging for pain detection. The ethical, legal, and social implications (ELSI) of DNA research and testing were integral to developing national protocols and rules about DNA. Brain imaging of pain needs its own ELSI initiative, before zealous adoption outpaces both the technology and the thinking about the right guiding principles and limitations.

The idea of brain images serving as a “pain-o-meter” to prove or disprove pain in legal cases is clearly a premature use of this information and likely an over simplification of the mechanisms of pain expression. However, the potential for an objective diagnostic tool or indicator of the pain experience is something that lawyers representing clients in criminal, personal injury, workers comp or disability cases may find too attractive to resist and attempt to have admitted in the courtroom. This state of affairs brings to mind the ways in which lawyers have attempted to use genetic test results, initially obtained for medical purposes, in litigation.  (Read on for more about ELSI in DNA and several national pain initiatives that could adopt the Human Genome Project and DNA ELSI model).

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The Right to Die and Informed Consent: New Ruling by the Supreme Court of Argentina

By Martín Hevia

In “D.M.A. s/ declaración de incapacidad” decided early this month, the Supreme Court of Argentina upheld the right to decide about one´s own death (“muerte digna”). As I had explained in a previous comment written when the ruling of the case was pending, the case involved a patient, M.A.D., that had been in a permanent, irreversible, vegetative state for 20 years due to a car accident. His sisters requested the discontinuation of the vital supportive measures which maintained M.A.D alive in an artificial way. Although this was not the first time that the Court discussed the right to die, it was a different case in that there was not a patient’s written statement on whether it was appropriate for him to continue or not certain medical treatment to keep him alive.

The Argentine National Congress had already passed legislation stating that, whenever a patient is unable to give informed consent, her relatives can do so in her name. On that basis, following the opinion of the sisters of M.A.D., the Supreme Court ordered the discontinuation of the vital supportive measures which maintained M.D alive in an artificial way. Continue reading