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

Emotional Harm as “Bodily Injury” in the Law – and in the Brain

By Francis X. Shen, Professor of Law, University of Minnesota Law School

Earlier this month the Supreme Court of New South Wales ruled that an individual who experienced post-traumatic stress disorder (PTSD) as the result of an airplane crash could recover damages under the Montreal Convention. The case was important because many courts have previously ruled that PTSD, absent any other “bodily injury,” was not covered by the bodily injury provisions of the international agreement.

The case is illustrative of the way in which courts across the world continue to find a meaningful distinction between “physical” (or “bodily”) injury/pain and “mental” (or “emotional”) injury/pain. If you want an example closer to home, pull out your auto insurance policy and scan for the phrase “bodily injury.” Auto insurance cases sometimes include disagreement about whether mental injuries are considered bodily.

I’m on the record as saying this traditional physical/emotional distinction no longer holds up because substance dualism is no longer a viable theory. If neurons and glia cells are physical (and last I checked they were), then emotions and emotional pain must be physical too.  But that doesn’t mean that the law has to treat all pain the same. Even if everything is physical, law may – for a variety of good reasons – choose to differentiate amongst them. For instance, do we want to understand assault (which is the infliction of “bodily injury”) to include the infliction of emotional pain? Maybe, but it’s not so cut and dry.

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Emotion and Pain – Beyond “All in Your Head”

By David Seminowicz, Principal Investigator, Seminowicz Pain Imaging Lab, Department of Neural and Pain Sciences, University of Maryland

A potential difficulty, but also an opportunity, relating to using neuroimaging evidence in legal cases arises from the difficulty brain researchers have in separating emotional and physical pain. We know that pain and emotion are tightly linked. In fact, “emotion” is in the very definition of pain. The IASP definition of pain is: “An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.”  Yet, the legal system deals with “physical” versus “psychiatric” versus “emotional” pain in different ways.

Chronic pain is associated with anxiety, depression, and stress. These factors can exacerbate the pain, and pain can exacerbate them. Pain’s sensory and emotional components connect in a “feed-forward” cycle. It may not be possible to entirely separate the sensory and emotional components of pain, biologically or experientially. But it might be necessary for the purposes of legal cases, as important areas of law create sharp distinctions between physical and emotional, or body and mind.

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Some Optimism on Brains, Pain, & Law – Let’s See What We Can Achieve

By Martha Farah, Director, University of Pennsylvania Center for Neuroscience & Society

Neurolaw includes some fascinating issues that lack any practical legal significance – for example whether we should consider anyone responsible for anything they do, given that all behavior is physically caused by brain processes.  It also includes some legally important issues that lack intellectual juiciness – like regulatory issues surrounding neurotechnology.

Thank goodness there are also some issues that combine intellectual fascination with practical legal importance. The Petrie-Flom Center at Harvard Law School and the Center for Law, Brain & Behavior at Massachusetts General Hospital recently focused on just such an issue when they convened a meeting of neuroscientists and legal scholars on the brain imaging of pain.

Pain, I learned at this meeting, is at the heart of many legal proceedings. A major problem to be solved in these proceedings is the determination of whether someone is truly in pain. Chronic pain in particular may not have physically obvious causes. There may be clinical and circumstantial evidence of pain – like adhering to a medication regime, seeking surgeries or other interventional procedures, and avoiding pleasurable activities – but often the major evidence of pain is just what someone says that it is. However, the motivation exists to lie about pain – to sue for more money, to obtain disability benefits – and so an objective measure of pain, a “pain-o-meter,” would be helpful.

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Pain-o-meters: How – and Why – Should We Develop Them?

By Karen Davis

The prevalence of chronic pain is staggering.  The Institute of Medicine reported in 2011 that 100 million Americans suffer from chronic pain – more than those with heart disease, cancer and diabetes combined.  The report also highlights that the annual costs for medical care, lost wages and productivity is more than $600B.  These enormous personal and societal costs of chronic pain has driven an effort to “prove” if and how much pain an individual is suffering from for health care providers, insurance companies and legal actors.  This is challenging because pain is a personal and subjective experience.  Ideally, self report would be sufficient to establish the “ground truth” of the pain experience.

However, some are not able to provide self reports accurately, and the potential financial gain associated with claims of pain has tarnished the perceived authenticity of subjective reports.  This has led some to develop brain imaging-based tests of pain – a so-called “painometer.”  Yet, current technologies are simply not able to determine whether or not someone has chronic pain.  Here, I consider specifically how we could develop a brain-imaging based painometer – and whether we would want to do so.  As we ask: “Can we do it?,” we should always ask, “Is this the right thing to do?”

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Pain on the Brain: A Week of Guest Posts on Pain Neuroimaging & Law

By Amanda C. Pustilnik

This week, the Petrie-Flom Center of Harvard Law School and the Center for Law, Brain & Behavior (CLBB) at Massachusetts General Hospital are hosting a series of posts on how brain imaging can help the law address issues of physical and emotional pain. Our contributors are world leaders in their fields, who participated on June 30, 2015, in the CLBB/Petrie-Flom conference Visible Solutions: How Brain Imaging Can Help Law Reenvision Pain.  They addressed questions including:

  • Can brain imaging can be a “painometer” to prove pain in legal cases?
  • Can neuroimaging help law do better at understanding what pain is?
  • How do emotion and pain relate to each other?
  • Does brain imaging showing emotional pain prompt us to reconsider law’s mind/body divide?

Professor Irene Tracey, D.Phil., a pioneer in pain neuroimaging and director of the Oxford Centre for Functional Magnetic Resonance Imaging of the Brain, opened the conference with a keynote explaining what happens when the brain is in pain.

Professor Hank T. Greely, Edelman Johnson Professor of Law and Director of the Program in Neuroscience and Society at Stanford Law School, provided a keynote explaining the many implications of brain imaging for the law.

This conference was the culmination of CLBB’s year of work on pain neuroimaging and law. As the first CLBB-Petrie-Flom Center Senior Fellow on Law & Applied Neuroscience, I focused on pain because it is one of the largest social, economic, and legal problems that can be addressed through new insights into the brain. Pain imaging can be a test case for how neuroscience can contribute positively to law and culture.  (Full conference video proceedings are available here.)  Please read on below! Continue reading

Payments to Egg “Donors”

By David Orentlicher

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

Interesting article in today’s Wall Street Journal about a lawsuit over limits on payments by fertility clinics to women who supply eggs for infertile couples. Under influential, though not mandatory, guidelines issued by the American Society for Reproductive Medicine, payments to egg “donors” above $5,000 “require justification,” and payments greater than $10,000 “are not appropriate.” (When I was in the Indiana legislature, a statute was passed limiting payments to $4,000, plus out-of-pocket expenses.)

In one view, payment caps are needed to “prevent coercion and exploitation in the egg-donation process.” But one also can view the guidelines as an “illegal conspiracy to set prices in violation of antitrust laws.” More to come in a case that could go to trial next year.

In the meantime, there are other important concerns about payments for eggs and the costs to infertile persons. As with other assisted reproductive treatments, insurers generally do not cover those costs. This encourages the infertile to seek multiple births in one treatment cycle rather than single births over multiple treatment cycles, which puts mothers and their infants at greater risks to health. In addition, lack of coverage leaves treatment unaffordable for many of the infertile. As I have argued elsewhere (here and here), social policy treats infertile persons unfairly when coverage is denied for assisted reproductive services,

HIPAA and the Physician-Patient Privilege: Can Doctors Defending Against Medical Malpractice Suit Carry Out Ex Parte Interviews with the Plaintiff’s Treating Physicians?

By Alex Stein

Whether a litigant’s right to conduct informal ex parte interviews with fact witnesses extends to the plaintiffs’ treating physicians, given the confidentiality provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), is a question of considerable practical importance. This question has recently received a positive answer from the Kentucky Supreme Court in Caldwell v. Chauvin, — S.W.3d —-, 2015 WL 3653447, (Ky. 2015), after “percolating through state courts, federal district courts, and academic circles for a decade.” Id. at *5. Continue reading

Bioethicist Art Caplan: Planned Parenthood’s awkward clash

A new opinion piece by contributor Art Caplan in The Chicago Tribune (free registration required):

Planned Parenthood finds itself under attack by anti-abortion activists. Not much new about that. But the terrain of the battle has shifted. The way in which fetal tissue for research is obtained at Planned Parenthood clinics is now center stage.

Planned Parenthood stands accused, as a result of a sting operation launched by anti-abortion political operatives, of selling “baby parts” for profit. Edited videos show individuals pretending to be tissue brokers discussing with Planned Parenthood doctors how to get fetal tissue, the cost for tissues, techniques for increasing the chance of obtaining particular tissues and other related issues. The doctors do not come across well. Discussions are in restaurants, there is wine on the table, the attitudes are cavalier and the doctors don’t seem to pick up on the cues that they are getting set up. […]

Read the full article here.

Check out the latest news from the Petrie-Flom Center!

Check out the July 24th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

November 4, 2015 1:00 – 5:30 PM  
Harvard Law School

Please join us for an afternoon of reflection on the life, work, and enduring influence of Professor Alan Wertheimer (1942-2015). Professor Wertheimer was a leading philosopher of law and bioethics, making critical contributions to clinical research ethics; theories of coercion, undue influence, and exploitation; consent in a variety of contexts, and much more. This tribute event will feature leading scholars discussing and engaging with Professor Wertheimer’s many contributions, and exploring how he influenced their own work.

At the time of his death in 2015, Alan Wertheimer was Senior Research Scholar in the Department of Bioethics at the National Institutes of Health. He was Professor Emeritus of Political Science at the University of Vermont, where he taught from 1968 to 2005 and was honored as University Scholar in 1995-1996. Before retiring from UVM, he was also John G. McCullough Professor of Political Science. He authored  Coercion (Princeton University Press, 1987), Exploitation (Princeton University Press, 1996), Consent to Sexual Relations (Cambridge University Press, 2003) and Rethinking the Ethics of Clinical Research: Widening the Lens (Oxford University Press, 2011). He was twice a Visiting Professor at the Harvard Kennedy School of Government, and held fellowships at the Institute of Advanced Study, Princeton (1984-85) and the Program in Ethics and the Professions, Harvard University (1989-90).

This event is free and open to the public but seating is limited and registration is required. Register now online

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14

This week we discussed Fraud & Abuse Laws and the “Two-Midnight” Rule with Elizabeth Weeks Leonard from the Georgia Law faculty. You can find many of Professor Leonard’s publications here.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Worth Reading This Week

By Nicolas Terry

Another Opinion Upholding the Contraceptives Coverage Accommodation

Today, the 10th Circuit issued its opinion in the Little Sisters of the Poor case, holding that the accommodation offered to religious nonprofits – and now also to certain closely-held for-profits – is legally acceptable under the standard imposed by the Religious Freedom Restoration Act (RFRA).  The accommodation, just recently finalized in its current form, allows eligible employers to avoid covering contraceptives for their employees so long as they notify their insurer or the government of their religious objection to doing so. Importantly, employees are still legally guaranteed access to free contraceptives through alternate mechanisms, usually the via insurer directly.

The 10th Circuit’s opinion represents the fifth win for the administration on the accommodation issue following Hobby Lobby. (Note that Hobby Lobby was about an employer who was not previously eligible for the accommodation.)  The RFRA standard provides that the government “may substantially burden a person’s exercise of religion only if it demonstrates that application of the burden to the person—(1) is in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest.”

In Little Sisters, the 10th Circuit dispensed with the RFRA claim by holding that there was no substantial burden, one of the threshold questions in the RFRA analysis.  It explained that the fact of the employer’s opt-out does not *cause* contraceptives coverage (i.e., by requiring another party to provide coverage in their stead), which instead is mandated by federal law.  It also determined that there is no substantial burden from complicity in the overall scheme to deliver contraceptive coverage, i.e., by delivering notice of objection, because their only involvement in the scheme is the act of opting out.  Thus, RFRA’s protections were not implicated, and the accommodation can stand.

I fully agree with the result in this case, but would have gotten there another way.

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Patent Law, Expertise, and the Court of Appeals for the Federal Circuit

by Zachary Shapiro

Since its creation in 1982, the Court of Appeals for the Federal Circuit (CAFC) has been a magnet for controversy and criticism. While I do not align myself with those critics, it would be foolish to not acknowledge the problems that are present with the CAFC. For instance, for the vast majority of federal law, when law develops differently in different circuits, the Supreme Court is able to observe those developments, and decide which interpretation is most desirable. Because the CAFC has sole jurisdiction over patent law appeals, patent law is not subject to these circuit splits. While splits temporarily hamper uniform justice, they do allow for experimentation, enabling different legal interpretations to be tested in real life. In this way, splits can allow an appellate body to make a more informed decision regarding which interpretation should be followed.

The lack of circuit splits in patent law can be problematic, given accusations that the CAFC has succumbed to a form of institutional capture by the patent lobby.[1] Critics highlight the CAFC’s decision in Amazon[2] and eBay[3] as evidence of this capture. In Amazon, the CAFC found a broad presumption of irreparable harm, allowing for broad extension of preliminary injunctions in future cases of patent infringement (even though they overturned the injunction at issue in the case). This patent-holder-friendly standard was ultimately overruled in eBay,[4] after the CAFC applied its nearly automatic injunction standard. The Supreme Court overturned this decision, and dialed back the presumption, in large part because it was seen as too favorable to patent holders.

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House Passes 21st Century Cures Act, Including a New NIH Innovation Prize Fund

This morning, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77, achieving a truly bipartisan result in a difficult political environment.  (I’ve blogged about the Act several times now, and the House Energy & Commerce Committee has a clear section-by-section summary here.)  There is much to like in the bill (such as the increased NIH funding), much to be concerned about (such as some of the provisions abbreviating FDA review of drugs and devices), and much whose value will depend on implementation.  It’s also not certain that any of these provisions will ultimately become law – the Senate has yet to even introduce its own draft bill, let alone vote on it or achieve a consensus with the House.  But I wanted to use this post to draw attention to a new amendment to the Act that was introduced a few days ago and approved by the House this morning prior to the vote on the full bill.

Representatives Todd Young (R-IN) and Andy Harris (R-MD) introduced an amendment creating an Innovation Prize Program within the NIH.  As the text stood on Wednesday (speakers on the floor of the House today suggested that some of this language is likely to change, if it has not already changed), it instructed the Director of the NIH to create the fund in service of one or both of these two goals: 1) “Identifying and funding areas of biomedical science that could realize significant advancements through the creation of a prize competition” and 2) “Improving health outcomes, particularly with respect to human diseases and conditions for which public and private investment in research is disproportionately small relative to Federal Government expenditures on prevention and treatment activities, thereby reducing Federal expenditures on health programs.”  The Director is also given wide discretion to design prize competitions, including whether they involve a lump-sum award at the end or are parceled out in milestone payments along the way.

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New HHS Rules on Contraceptive Coverage

Today, HHS released new final regulations further clarifying the contraceptives coverage mandate.  I have not had the chance to fully digest these, but you can read them here.

Key nuggets, pulled straight from the text:

  • These final regulations continue to allow eligible organizations to choose between using EBSA Form 700 or the alternative process consistent with the Wheaton interim order. The alternative process provides that an eligible organization may notify HHS in writing of its religious objection to covering all or a subset of contraceptive services. The notice must include the name of the eligible organization and the basis on which it qualifies for an accommodation; its objection based on sincerely held religious beliefs to covering some or all contraceptive services, as applicable (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable); the plan name and type (that is, whether it is a student health insurance plan within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of ERISA section 3(33)); and the name and contact information for any of the plan’s third party administrators and health insurance issuers.
  • [T]hese final regulations extend the [existing] accommodation to a for-profit entity that is not publicly traded, is majority-owned by a relatively small number of individuals, and objects to providing contraceptive coverage based on its owners’ religious beliefs. This definition includes for-profit entities that are controlled and operated by individual owners who are likely to have associational ties, are personally identified with the entity, and can be regarded as conducting personal business affairs through the entity. . . . Based on the information available, it appears that the definition of closely held for-profit entity set forth in these final regulations includes all the for-profit corporations that have filed lawsuits alleging that the contraceptive coverage requirement, absent an accommodation, violates RFRA.

The upshot(s):

  • The extended accommodation allowing eligible objecting employers to notify the government rather than their insurer directly has simply been changed from an interim to a final rule.  This won’t make the pending non-profit litigation go away because these employers still object to two things: (1) having to provide their insurer’s contact information to the government so the government can notify the insurers of their obligations to provide free contraceptives; and (2) having to continue to maintain relationships with insurers who will provide contraceptives.
  • The extension of the accommodation’s eligibility criteria to include closely-held for-profit employers has now been made official following proposed regulation in the wake of Hobby Lobby. In the interim period after Hobby Lobby, objecting for-profits could simply object and avoid the mandate – and their insurers did not have to step in because the accommodation did not yet apply. Now it does, and these employers will likely raise similar objections to the accommodation as have already been raised by their non-profit counterparts.

Let’s just face it – litigation stemming from the ACA will never go away…

Worth Reading This Week

By Nicolas Terry

Check out the latest news from the Petrie-Flom Center!

Check out the July 10th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:
AGENDA NOW AVAILABLE!
Specimen Science: Ethics and Policy Implications

November 16, 2015
8:00 AM – 5:00 PM

Harvard Law School
Room TBD 

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data. However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.

Please join us for a symposium to discuss the key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery. The experts at this day-long event will cover key topics, such as historical, legal, and international perspectives; donor attitudes, researcher perspectives, and institutional considerations; broad vs. specific informed consent; privacy, ownership, and control; use of specimens collected through mandatory newborn screening; research with discrete and insular populations; and others. Conference papers eventually will be published as an edited volume with a major academic press.

For a full agenda and to register for this event, visit our website

This event is a collaboration between Case Western Reserve University, the Petrie-Flom Center at Harvard Law School, and the Multi-Regional Clinical Trials Center at Harvard. It is supported by funding from the National Human Genome Research Institute.

For more on news and events at Petrie-Flom, see the full newsletter.

Medical Device Tax: Back in the News Post-King

By Gregory Curfman

Just when the Affordable Care Act (ACA) has won a second major Supreme Court victory in King v. Burwell, conservative critics of the ACA are back on the attack, this time directing their ire towards the medical device tax. Having lost the battle on subsidies, they are now focusing on the device tax as the prime target in their attempt to overturn parts of the ACA. This 2.3% excise tax levied on the medical device industry is stipulated as one of the tax provisions in the ACA. The rationale is that since the ACA provides coverage for many more people, thus bringing more business to the industry, it is reasonable to ask the industry to pay something back to support the programmatic mission of the ACA.

From the beginning, the medical device industry has strongly objected to the excise tax, claiming it will stifle innovation by taking away funds that would otherwise be used for new product research and development. For example, Dr. Thomas Stossel of Harvard Medical School, a conservative voice on health issues, recently wrote: “A 2.3 percent tax on sales can easily mean the difference between commercial success and bankruptcy: borderline profits become losses and investors flee to less risky ventures. Brute force taxes destabilize the fragile innovation ecosystem.” Continue reading