On July 30, the White House announced the updated 2020 HIV/AIDS strategy. The admirable vision of the strategy is that “The United States will become a place where new HIV infections are rare, and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity, or socio-economic circumstance, will have unfettered access to high quality, life-extending care, free from stigma and discrimination.”
This said, the strategy reflects continuing concerns about the numbers of people who do not know their HIV status, who do not have access to effective treatment, and who do not take advantage of preventive strategies. Demographic groups especially at risk include men having sex with men, African American men and women, Latino men and women, people who inject drugs, youth age 13-24, people in the Southern United States, and transgender women. The strategy emphasizes care coordination, coordination between health care and other social services such as housing, treatment as prevention, and pre-exposure prophylaxis. Notable initiatives since the 2010 HIV/AIDS strategy include interagency efforts to address the intersection of HIV and violence against women, a DOJ and CDC collaboration to publish a comprehensive examination and best practices guide on the intersection between HIV and criminal laws, and demonstration projects funded through the HHS Minority AIDS Initiative Fund. Continue reading →
If you are familiar with about a thousand medical malpractice decisions and can’t think of an accident that might surprise you, read Stayton v. Delaware Health Corporation, — A.3d —- 2015 WL 3654325 (Del. 2015). Another reason for reading this new decision of the Delaware Supreme Court is that it has delivered an important precedent: the Court decided that the collateral source rule does not cover medical costs written off by Medicare. Continue reading →
What should the future look like for brain-based pain measurement in the law? This is the question tackled by our concluding three contributors: Diane Hoffmann, Henry (“Hank”) T. Greely, and Frank Pasquale. Professors Hoffmann and Greely are among the founders of the fields of health law and law & biosciences. Both discuss parallels to the development of DNA evidence in court and the need for similar standards, practices, and ethical frameworks in the brain imaging area. Professor Pasquale is an innovative younger scholar who brings great theoretical depth, as well as technological savvy, to these fields. Their perspectives on the use of brain imaging in legal settings, particularly for pain measurement, illuminate different facets of this issue.
This post describes their provocative contributions – which stake out different visions but also reinforce each other. The post also highlights the forthcoming conference-based book with Oxford University Press and introduces future directions for the use of the brain imaging of pain – in areas as diverse as the law of torture, the death penalty, drug policy, criminal law, and animal rights and suffering. Please read on!
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)
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)
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).
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 →
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.
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.
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.
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.
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?”
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 →
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 →
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. […]
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!
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. Critics highlight the CAFC’s decision in Amazon and eBay 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, 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.
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 severaltimesnow, 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.