The problem is pain. Patients and their families tell the story:He is your son. You love him. You want to help him in every way you can, but when he is in that kind of pain, you are helpless in a sense. Im his daddy. It was-what was I supposed to do for him? I felt, you know, helpless.It terrifies you. You want to run away from it. Pain is something you wish would kill you but does not. Agony results (...) from the pain that does not have the decency to knock you out.[W]e had a good family, but how much can you watch? How much suffering can you watch from your child, your 7-year-old child, and still keep your mind?I am a forty-six-year-old registered nurse who specializes in oncology care and education. I am also a patient who suffers from chronic nonmalignant pain, and this malady has been the most frightening, the most humiliating, and the most difficult ordeal of my life. (shrink)

The problem is pain. Patients and their families tell the story:He is your son. You love him. You want to help him in every way you can, but when he is in that kind of pain, you are helpless in a sense. Im his daddy. It was-what was I supposed to do for him? I felt, you know, helpless.It terrifies you. You want to run away from it. Pain is something you wish would kill you but does not. Agony results (...) from the pain that does not have the decency to knock you out.[W]e had a good family, but how much can you watch? How much suffering can you watch from your child, your 7-year-old child, and still keep your mind?I am a forty-six-year-old registered nurse who specializes in oncology care and education. I am also a patient who suffers from chronic nonmalignant pain, and this malady has been the most frightening, the most humiliating, and the most difficult ordeal of my life. (shrink)

Law wrangles with setting and applying standards for the practice of medicine in many different arenas. One of the most prominent is medical malpractice litigation in which the trial process examines a physician's performance and measures it against the standard of care. The profession's prevailing custom, with some substantial tolerance for “respectable minority” views, has been the gold standard for scrutinizing physician practice and treatment decisions in the malpractice context. Using the profession's custom as the measure against which a physician's (...) performance is judged defers to the expertise of medicine. Deference to the medical profession is attractive as a tool for reining in law. Reliance on customary practice is criticized, however, for driving physicians to the relative safety of the middle of the herd. Creating such a strong incentive for compliance with customary practice can dampen medical innovation and the diffusion of new clinical knowledge. The safety of the herd can also deprive individual patients of the best care in their particular circumstances.Several current trends are strengthening claims that professional practice patterns are an inappropriate tool for distinguishing between high‐quality and substandard care. In particular, advocacy for evidence‐based medicine aggressively asserts that the traditional way of making medical treatment decisions is largely untethered from scientific method or data, rendering professional judgment, even in the aggregate, suspect. (shrink)

The capacity to treat pain has never been greater; but, as you will read in the articles that follow, the problem of undertreated and neglected pain in the United States persists. Deep-seated perceptions and practices undergird this strong and well-documented pattern of neglect. Among the reasons frequently noted for the inadequacy of treatment for pain, however, is that the legal system actually penalizes effective interventions to relieve pain while it leaves neglect of pain unthreatened. It is the mission of the (...) American Society of Law, Medicine & Ethics to explore areas, such as this one, where developments in medicine directly encounter the law and, in turn, create ethical issues for clinicians, regulators, patients, and lawyers.This special issue of the Journal of Law, Medicine & Ethics is part of a multi-year project in which ASLME, with the wonderful support of the Mayday Fund, has worked to address legal and regulatory barriers to effective pain relief. (shrink)

The capacity to treat pain has never been greater; but, as you will read in the articles that follow, the problem of undertreated and neglected pain in the United States persists. Deep-seated perceptions and practices undergird this strong and well-documented pattern of neglect. Among the reasons frequently noted for the inadequacy of treatment for pain, however, is that the legal system actually penalizes effective interventions to relieve pain while it leaves neglect of pain unthreatened. It is the mission of the (...) American Society of Law, Medicine & Ethics to explore areas, such as this one, where developments in medicine directly encounter the law and, in turn, create ethical issues for clinicians, regulators, patients, and lawyers.This special issue of the Journal of Law, Medicine & Ethics is part of a multi-year project in which ASLME, with the wonderful support of the Mayday Fund, has worked to address legal and regulatory barriers to effective pain relief. (shrink)

State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team’s larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious (...) wrongdoing by physicians. (shrink)

Scholarship has intrinsic value, of course; but when good scholarship can stimulate change for the better in an area as fundamental to human dignity as health care and the relief of suffering, there is a special satisfaction. This has been our experience since 1996, when the first of now four special issues of this journal focused on legal, regulatory, ethical, professional, and financial issues in medical treatment for pain.With the generous and steadfast support of the Mayday Fund, the American Society (...) of Law, Medicine & Ethics has generated a significant body of scholarship published in the Journal of Law, Medicine & Ethics. This research has proven absolutely essential in changing public policy to support better care for those who suffer pain.Over these years, the Mayday Project at ASLME has tackled many of the real and perceived barriers to effective pain relief. In pain management, both real and perceived obstacles can have a powerful negative effect. (shrink)

Scholarship has intrinsic value, of course; but when good scholarship can stimulate change for the better in an area as fundamental to human dignity as health care and the relief of suffering, there is a special satisfaction. This has been our experience since 1996, when the first of now four special issues of this journal focused on legal, regulatory, ethical, professional, and financial issues in medical treatment for pain.With the generous and steadfast support of the Mayday Fund, the American Society (...) of Law, Medicine & Ethics has generated a significant body of scholarship published in the Journal of Law, Medicine & Ethics. This research has proven absolutely essential in changing public policy to support better care for those who suffer pain.Over these years, the Mayday Project at ASLME has tackled many of the real and perceived barriers to effective pain relief. In pain management, both real and perceived obstacles can have a powerful negative effect. (shrink)

In establishing a new Conscience and Religious Freedom Division within the Office of Civil Rights of the Department of Health and Human Services and issuing new proposed regulations, the Trump administration has significantly expanded the power of health care providers over the medical choices of patients and has privileged the moral agency of health care providers over that of individual patients. When finalized, these regulations will replace those promulgated during the Obama administration, just as those regulations replaced those promulgated in (...) 2008 by the Bush administration. The 2018 proposed regulations interpret the federal conscience statutes more broadly than either of these predecessors. Among the many significant provisions in the proposed rules are definitional terms that reach a broader range of individuals and activities, the absence of balancing interests, and a powerful enforcement structure. (shrink)

Issues in bioethics often turn, at least in part, on the law and regulatory requirements. Consisting of chapters that address particular bioethics topics from the law’s perspective, this fascinating book includes: an introduction to the American legal system papers identifying the principal ways in which the law influences discussions and decisions concerning each of the topics highlighted supplemental papers on certain areas that address the influence and status of the law in countries other than the United States. Covering traditional topics (...) in bioethics, such as determinations of death and health care decisions for vulnerable groups, this study also explores emerging areas such as conflicts of interest in research, genetics, and privacy and confidentiality in the electronic age. Incisive and thought-provoking, this volume provides readers with a rich context for understanding the intersection between the law on bioethics and the central issues in bioethics. (shrink)

The Wall Street Journal article “Putting a Price on a Human Egg” triggered extensive media coverage of a rather unusual challenge to payments made to women providing ova for use in assisted reproduction. In Kamakahi v. American Society for Reproductive Medicine and Society for Assisted Reproductive Technologies, plaintiffs claim that ASRM and SART policies adopting limits on such payments violate the federal antitrust prohibition against price fixing.In 2007, an ASRM Ethics Committee Report, confirming a 2000 report, asserted that, “[a]lthough there (...) is no consensus on the precise payment that oocyte donors should receive, at this time sums of $5,000 or more require justification and sums above $10,000 are not appropriate.” SART is an affiliate organization of ASRM and counts as its members 90 percent of the clinics providing assisted reproductive technologies in the United States. SART requires that its members “[adhere] to all ASRM/SART Guidelines including ethical, practice, advertising, and laboratory.” The plaintiffs in Kamakahi claim that the agreement among SART members to abide by the ASRM policy restricts competition among agencies procuring oocytes and produces lower payments than women would otherwise be able to negotiate. It is through the requirement that SART members adhere to ASRM ethical guidelines that ethics goes to market and encounters antitrust law. Ethicists continue to debate whether payment for oocytes inappropriately commodifies the human body, and ASRM policy consistently refers to their procurement as the “donation process” and to women who participate as “donors.” Nevertheless, in the context of antitrust law, the procurement of oocytes is a business and clearly falls within the reach of antitrust restrictions on business conduct. (shrink)

In January 2018, the Trump administration established the Conscience and Religious Freedom Division within the Department of Health and Human Services’ Office of Civil Rights with the explicit goal of intensifying legal protection of religious and conscience objections in health care. The establishment of OCR’s new division illustrates the significant powers of administrative agencies to mold the substance of law without seeking legislative action. The mere formation of a division dedicated to protecting conscience rights is already having a significant impact; (...) it is causing health care entities, including hospitals, research organizations, and clinics, to change policies and practices to comply with the declared enforcement strategy. Administrative agencies also shape the law in what they decide not to pursue. For example, OCR has suspended enforcement of the Affordable Care Act prohibition against gender‐identity discrimination. (shrink)

Two cases in 2012 involved employment discrimination claims. In one, a Catholic diocese had refused to renew the contract of a teacher who had sought in vitro fertilization. In another, earlier case, a Lutheran elementary school had terminated the contract of a teacher for “damaging her working relationship” with the school by “threatening to take legal action” when she was not permitted to return to work after disability leave related to narcolepsy. In both cases, the employers have argued that the (...) employee's discrimination claims should be dismissed solely because of the religious character of the employer organization. The specific legal defenses in each suit differ somewhat, but ultimately they both rely on the First Amendment to exempt religious employers from civic responsibilities imposed by law on other private employers. (shrink)

Although bioethicists do not always recognize it, death is not defined uniformly in the United States. It is defined primarily in state law, and as with any legislative effort that proceeds state by state, results may vary.

Analysis in bioethics has relied primarily on the identification and application of general principles and on the examination of particular paradigmatic cases. Principalism and casuistry depend on an assumption of generalizability; that is, that learning and insights gained from an understanding of the principles or the case may be effectively applied to other similar situations. For the most part, the particular characteristics of the institutional setting have not played a central role in these approaches. It would appear, then, that what (...) has been learned in the context of one health care setting is transferable, with some few adjustments, to another. The institutional context does make both a practical and a substantive difference, however, and shifting ethical analyses from one context to another has sometimes proven difficult. This has been so, for example, in the context of nursing home care. (shrink)

Analysis in bioethics has relied primarily on the identification and application of general principles and on the examination of particular paradigmatic cases. Principalism and casuistry depend on an assumption of generalizability; that is, that learning and insights gained from an understanding of the principles or the case may be effectively applied to other similar situations. For the most part, the particular characteristics of the institutional setting have not played a central role in these approaches. It would appear, then, that what (...) has been learned in the context of one health care setting is transferable, with some few adjustments, to another.The institutional context does make both a practical and a substantive difference, however, and shifting ethical analyses from one context to another has sometimes proven difficult. This has been so, for example, in the context of nursing home care. (shrink)

Lois Shepherd's book If That Ever Happens to Me: Making Life and Death Decisions after Terri Schiavo demonstrates a great appreciation for the unresolved conflicts over end-of-life care revealed by the Schiavo case. Through detailed analysis, this book debunks the claim that the controversy defied an established consensus concerning the appropriateness of withdrawing medically administered nutrition and hydration. Arguments that settled legal standards provided a stalwart framework for that consensus failed to appreciate the variations and limitations of those norms. Shepherd (...) challenges the notion that we professionals—doctors, lawyers, judges, and bioethicists—had authoritatively resolved the moral and social .. (shrink)

The Department of Health and Human Services has issued far-reaching regulations to implement the nondiscrimination requirement of the Affordable Care Act. Now commonly called “Section 1557,” this ACA provision prohibits discrimination by “any health program or activity, any part of which is receiving Federal financial assistance,” on grounds prohibited under previously enacted federal antidiscrimination statutes. The DHHS Office of Civil Rights enforces Section 1557. These new regulations and accompanying commentary give warning of the standards the agency will use in its (...) enforcement efforts. Courts will also give some deference to the DHHS regulations in interpreting the statute in lawsuits by individuals claiming damages against covered health care providers for illegal discrimination under Section 1557. Three central issues are the nature of the rights created in Section 1557 and their relation to the listed federal antidiscrimination statutes, the sorts of health care programs and activities that are covered by Section 1557, and the definition of the personal characteristics, including sexual orientation and gender identity, against which discrimination is prohibited. (shrink)

The problem of harmful, unnecessary and neglected pain has been studied extensively in many health care settings over the past decade. Research has documented the incidence of untreated pain, and scholars and advocates have given the problem several names: “public health crisis,” “oligoanalgesia, and “moral failing,” among them. Articles have identified a litany of now familiar “obstacles” or “barriers” to effective pain relief. Each of these individual obstacles or barriers has been the subject of targeted remedial action in at least (...) some context.The checklist approach to improving care for patients in pain, however, is likely to have only limited effect. What really appears to be operating is a complex ecosystem that supports ambivalence, denial, and even suspicion of the circumstance of patients in pain and efforts to treat them. Pain relief in emergency medicine, a relatively new setting for the study of challenges to treating pain, provides a revealing context for viewing discrete obstacles to effective pain management in medicine as part of an integrated environment into which patients with pain enter for treatment. (shrink)

The problem of harmful, unnecessary and neglected pain has been studied extensively in many health care settings over the past decade. Research has documented the incidence of untreated pain, and scholars and advocates have given the problem several names: “public health crisis,” “oligoanalgesia, and “moral failing,” among them. Articles have identified a litany of now familiar “obstacles” or “barriers” to effective pain relief. Each of these individual obstacles or barriers has been the subject of targeted remedial action in at least (...) some context.The checklist approach to improving care for patients in pain, however, is likely to have only limited effect. What really appears to be operating is a complex ecosystem that supports ambivalence, denial, and even suspicion of the circumstance of patients in pain and efforts to treat them. Pain relief in emergency medicine, a relatively new setting for the study of challenges to treating pain, provides a revealing context for viewing discrete obstacles to effective pain management in medicine as part of an integrated environment into which patients with pain enter for treatment. (shrink)

Most health reform efforts focus on devising legal norms and procedures that will push the practice of health care professionals in the desired direction. In fact, although the law is a powerful influence on health care delivery and treatment decision‐making, many health reform efforts that rely on changes in the law fail to produce the expected good effect. Experience teaches that there are many reasons a legal requirement can fail to work as expected. In health care, one occasion for slippage (...) between good intentions and good outcomes for law reform is the transformation of legal standards through the formal and informal standards and procedures established within health care organizations. (shrink)

Assisted suicide is a tragic issue, one of those for which the tools of mere logic are inadequate and in which the power of the individual case is compelling and seductive but not necessarily clarifying. Meaningful dialogue is difficult. Persuasion is limited because the resolution of the issue, on a moral level, must be founded upon fundamental notions of what it means to be human, especially in the midst of suffering or disability or at the point of death.