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Full-Text Articles in Law
Medical Violence, Obstetric Racism, And The Limits Of Informed Consent For Black Women, Colleen Campbell
Medical Violence, Obstetric Racism, And The Limits Of Informed Consent For Black Women, Colleen Campbell
Michigan Journal of Race and Law
This Essay critically examines how medicine actively engages in the reproductive subordination of Black women. In obstetrics, particularly, Black women must contend with both gender and race subordination. Early American gynecology treated Black women as expendable clinical material for its institutional needs. This medical violence was animated by biological racism and the legal and economic exigencies of the antebellum era. Medical racism continues to animate Black women’s navigation of and their dehumanization within obstetrics. Today, the racial disparities in cesarean sections illustrate that Black women are simultaneously overmedicalized and medically neglected—an extension of historical medical practices rooted in the logic …
21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen
21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen
University of Michigan Journal of Law Reform
The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Michigan Telecommunications & Technology Law Review
Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …
Regulating Black-Box Medicine, W. Nicholson Price Ii
Regulating Black-Box Medicine, W. Nicholson Price Ii
Michigan Law Review
Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …
Piercing The Veil: The Limits Of Brain Death As A Legal Fiction, Seema K. Shah
Piercing The Veil: The Limits Of Brain Death As A Legal Fiction, Seema K. Shah
University of Michigan Journal of Law Reform
Brain death is different from the traditional, biological conception of death. Although there is no possibility of a meaningful recovery, considerable scientific evidence shows that neurological and other functions persist in patients accurately diagnosed as brain dead. Elsewhere with others, I have argued that brain death should be understood as an unacknowledged status legal fiction. A legal fiction arises when the law treats something as true, though it is known to be false or not known to be true, for a particular legal purpose (like the fiction that corporations are persons). Moving towards greater transparency, it is legally and ethically …
Long-Term Financial Burden Of Breast Cancer: Experiences Of A Diverse Cohort Of Survivors Identified Through Population-Based Registries, Reshma Jagsi, John A.E. Pottow, Kent A. Griffith, Cathy Bradley, Ann S. Hamilton, John Graff Rutgers University, Steven J. Katz, Sarah T. Hawley
Long-Term Financial Burden Of Breast Cancer: Experiences Of A Diverse Cohort Of Survivors Identified Through Population-Based Registries, Reshma Jagsi, John A.E. Pottow, Kent A. Griffith, Cathy Bradley, Ann S. Hamilton, John Graff Rutgers University, Steven J. Katz, Sarah T. Hawley
Articles
Purpose: To evaluate the financial experiences of a racially and ethnically diverse cohort of long-term breast cancer survivors (17% African American, 40% Latina) identified through population-based registries. Methods: Longitudinal study of women diagnosed with nonmetastatic breast cancer in 2005 to 2007 and reported to the SEER registries of metropolitan Los Angeles and Detroit. We surveyed 3,133 women approximately 9 months after diagnosis and 4 years later. Multivariable models evaluated correlates of self-reported decline in financial status attributed to breast cancer and of experiencing at least one type of privation (economically motivated treatment nonadherence and broader hardships related to medical expenses). …
Can Consumers Control Health-Care Costs?, Mark A. Hall, Carl E. Schneider
Can Consumers Control Health-Care Costs?, Mark A. Hall, Carl E. Schneider
Articles
The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today’s health policy watchword. This article evaluates consumerism and the regulatory mechanism …
Constitutional Flaw?, Carl E. Schneider
Constitutional Flaw?, Carl E. Schneider
Articles
Do terminally ill patients have a constitutional right "to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational drugs that the FDA has yet to approve for commercial marketing, but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing"? In Abigail Alliance for Better Access to Developmental Drugs v. McClellan, the United States District Court for the District of Columbia said "no." In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, a panel (three judges) of the United States Court of Appeals …
When Patients Say No (To Save Money): An Essay On The Tectonics Of Health Law., Mark A. Hall, Carl E. Schneider
When Patients Say No (To Save Money): An Essay On The Tectonics Of Health Law., Mark A. Hall, Carl E. Schneider
Articles
The ultimate aim of health care public policy is good care at good prices. Managed care stalled at achieving this goal by trying to influence providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy are now pressuring patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's watchword. This Article evaluates this ideal type …
The Patient Life: Can Consumers Direct Health Care?, Carl E. Schneider, Mark A. Hall
The Patient Life: Can Consumers Direct Health Care?, Carl E. Schneider, Mark A. Hall
Articles
The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's health policy watchword. This article evaluates consumerism and the regulatory mechanism …
The Professional Ethics Of Billing And Collections, Mark A. Hall, Carl E. Schneider
The Professional Ethics Of Billing And Collections, Mark A. Hall, Carl E. Schneider
Articles
Medicine is a Profession on which physicians rely for their livelihood and patients for their lives. If physicians do not charge for services, they cannot survive. If patients cannot afford those services, they cannot survive. No wonder many physicians have long agreed that fees are “one of the most difficult problems . . . between patient and physician.” For years comprehensive insurance subdued this problem, but currently widespread underinsurance and consumer-directed health care are reviving it. Even as the ranks of the uninsured continue to increase,the latest hope for controlling medical costs requires insured patients to pay for much more …
The Failure Of Breast Cancer Informed Consent Statuses, Rachael Anderson-Watts
The Failure Of Breast Cancer Informed Consent Statuses, Rachael Anderson-Watts
Michigan Journal of Gender & Law
Breast cancer informed consent legislation was introduced in response to breast cancer patient discontent with doctor-patient relationships. Physicians do not always believe that explaining treatment alternatives is important, and in this respect, legislation promoting the discussion of alternative treatment could be positive for breast cancer patients, many of whom do in fact have several viable medical options. Studies have found, however, that these statutes have no lasting impact on patient decision-making. Why aren't these patient-driven statutes affecting patient decision-making? And why is medical advice coming from the law at all? This Article argues that this legislation is a poor tool …
Principal Investigator Views Of The Irb System, Simon N. Whitney, Kirsten Alcser, Carl E. Schneider, Laurence B. Mccullough, Amy L. Mcguire, Robert J. Volk
Principal Investigator Views Of The Irb System, Simon N. Whitney, Kirsten Alcser, Carl E. Schneider, Laurence B. Mccullough, Amy L. Mcguire, Robert J. Volk
Articles
We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations. There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the …
Physician-Assisted Suicide In Oregon: A Medical Perspective, Herbert Hendin, Kathleen Foley
Physician-Assisted Suicide In Oregon: A Medical Perspective, Herbert Hendin, Kathleen Foley
Michigan Law Review
This Article examines the Oregon Death with Dignity Act from a medical perspective. Drawing on case studies and information provided by doctors, families, and other care givers, it finds that seemingly reasonable safeguards for the care and protection of terminally ill patients written into the Oregon law are being circumvented. The problem lies primarily with the Oregon Public Health Division ("OPHD"), which is charged with monitoring the law. OPHD does not collect the information it would need to effectively monitor the law and in its actions and publications acts as the defender of the law rather than as the protector …
The Cash Nexus, Carl E. Schneider
The Cash Nexus, Carl E. Schneider
Articles
Courts and legislatures have labored for decades to protect patients' choice of medical treatments, even though patients seize that gift less eagerly than lawmakers expect. Yet while courts have rushed to build the whited sepulchre of informed consent, they have fled from a related problem that patients actually yearn to solve and that actually can be ameliorated the plight of patients who perforce agree to a treatment before they know its costs and who receive a bill both unrelated to the treatment's value and several times what an insured patient would pay. Increasingly, patients must be consumers in the medical …
Void For Vagueness, Carl E. Schneider
Void For Vagueness, Carl E. Schneider
Articles
When law regulates a profession, where does it get its standards? Largely from the profession. Members of professions acquire esoteric and abstract knowledge through formal education and the experience of practice. They use professional judgment in applying this knowledge to each case. Because legislatures and courts lack this expertise, they adopt the standards of the experts. Thus in a malpractice suit, juries are instructed to determine whether the doctor met medicine's standard of care. Furthermore, physicians must be called as expert witnesses to guide juries in that work. Even when lawmakers contemplated intensifying their regulation of medicine by creating the …
Drugged, Carl E. Schneider
Drugged, Carl E. Schneider
Articles
The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …
After Autonomy, Carl E. Schneider
After Autonomy, Carl E. Schneider
Articles
Bioethicists today are like Bolsheviks on the death of Lenin. They have, rather to their surprise, won the day. Their principle of autonomy is dogma. Their era of charismatic leadership is over. Their work of Weberian rationalization, of institutionalizing principle and party, has begun. The liturgy is reverently recited, but the vitality of Lenin's "What Is To Be Done?" has yielded to the vacuity of Stalin's "The Foundations of Leninism." Effort once lavished on expounding ideology is now devoted to establishing associations, organizing degree programs, installing bioethicist commissars in every hospital, and staffing IRB soviets. Not-so-secret police prowl the libraries …
Hard Cases And The Politics Of Righteousness, Carl E. Schneider
Hard Cases And The Politics Of Righteousness, Carl E. Schneider
Articles
The law of bioethics has been the law of cases. Interpreting the common law and the Constitution, judges have written the law of informed consent, abortion, and assisted suicide. Reacting to causes célèbres, legislatures have written the law of advance directives and end of life decisions. The long, sad death of Terri Schiavo eclipsed even the long, sad deaths of Karen Ann Quinlan and Nancy Beth Cruzan in the duration and strength of the attention and passions it evoked. What are Schiavo’s lessons? Hard cases, lawyers say, make bad law. Why? First, hard cases are atypical cases. They present abnormal …
Liability For Life, Carl E. Schneider
Liability For Life, Carl E. Schneider
Articles
Marshall Klavan headed the Obstetrics and Gynecology Department of the Crozer-Chester Medical Center. He deeply feared strokes, perhaps because his father had been savaged by one. In 1993, Dr. Klavan wrote an advance directive which said that (as a court later put it) "he 'absolutely did not want any extraordinary care measures utilized by health care providers.'" On April29, 1997, Dr. Klavan tried to kill himsel£ He left suicide notes and a note refusing resuscitation. The next morning, medical center employees found him unconscious and took him to the emergency room, where he was resuscitated. By May 2, Dr. Klavan …
Enough: The Failure Of The Living Will, Angela Fagerlin, Carl E. Schneider
Enough: The Failure Of The Living Will, Angela Fagerlin, Carl E. Schneider
Articles
Enough. The living will has failed, and it is time to say so. We should have known it would fail: A notable but neglected psychological literature always provided arresting reasons to expect the policy of living wills to misfire. Given their alluring potential, perhaps they were worth trying. But a crescendoing empirical literature and persistent clinical disappointments reveal that the rewards of the campaign to promote living wills do not justify its costs. Nor can any degree of tinkering ever make the living will an effective instrument of social policy. As the evidence of failure has mounted, living wills have …
Advocacy In Whispers: The Impact Of The Unsaid Global Gag Rule Upon Free Speech And Free Association In The Context Of Abortion Law Reform In Three East African Countries, Patty Skuster
Michigan Journal of Gender & Law
In 2001, President George W. Bush restricted the participation in democratic processes for non-governmental organizations (NGOs) abroad by reinstating a policy restricting family planning funding granted by the United States Agency for International Development (USAID). The restriction sharply curtailed the ability to speak and to associate freely for organizations working to preserve women's health and lives. For this reason, I refer to the restriction as the Global Gag Rule (GGR). Organizations in Uganda, Ethiopia, and Kenya had begun to identify the problems associated with their countries' restrictive abortion laws. In these three countries, as elsewhere in the world, illegal abortions …
Benumbed, Carl E. Schneider
Benumbed, Carl E. Schneider
Articles
I originally intended to write a column on tort liability and research ethics, and I still plan to do so. But this column is a cri de coeur as I finish another semester teaching law and bioethics. This year, I asked with growing frequency, urgency, and exasperation, "Must law's reverence for autonomy squeeze out the impulse to kindness? Where is the beneficence in bioethics?" These questions assail me every term. Why? Consider Steele v. Hamilton County Community Mental Health Board. Mr. Steele was involuntarily "hospitalized after his family reported that he was 'seeing things and trying to fight imaginary …
Going To Pot, Carl E. Schneider
Going To Pot, Carl E. Schneider
Articles
In several earlier columns, I suggested that judges are usually poorly placed to make good biomedical policy, not least because the law so rarely offers them direct and cogent guidance. Recently, the U.S. Court of Appeals for the Ninth Circuit proffered a new example of this old problem. In 1996, California's voters approved Proposition 215. Its "Compassionate Use Act of 1996" provided -that a patient "who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician" committed no crime.
How Underlying Patient Beliefs Can Affect Physician-Patient Communicaion About Prostate-Specific Antigen Testing, Michael H. Farrell, Margaret Ann Murphy, Carl E. Schneider
How Underlying Patient Beliefs Can Affect Physician-Patient Communicaion About Prostate-Specific Antigen Testing, Michael H. Farrell, Margaret Ann Murphy, Carl E. Schneider
Articles
Routine cancer screening with prostate-specific antigen (PSA) is controversial, and practice guidelines recommend that men be counseled about its risks and benefits. OBJECTIVE. To evaluate the process of decision making as men react to and use information after PSA counseling. DESIGN. Written surveys and semistructured qualitative interviews before and after a neutral PSA counseling intervention. PARTICIPANTS. Men 40 to 65 years of age in southeastern Michigan were recruited until thematic saturation—that is, the point at which no new themes emerged in interviews (n = 40). RESULTS. In a paper survey, 37 of 40 participants (93%) said that they interpreted the …
The Bill For Rights, Carl E. Schneider
The Bill For Rights, Carl E. Schneider
Articles
Where today is legislative ingenuity lavished more bountiully than on the titles of statutes? And where has that ingenuity been better exercised than in the name "patients' bill of rights"? Do not our dearest liberties flow from the Bill of Rights? And who more deserves similar protection than patients in the hands of an angry Managed Care Organization? And behold, both Democrats and Republicans, both President Clinton and President Bush, have summoned us to arms. The patients' bill of rights is an idea whose time has seemed to have come for several years, and only conflicts among the numerous proposals …
Gang Aft Agley, Carl E. Schneider
Gang Aft Agley, Carl E. Schneider
Articles
In my last contribution to this column (HCR, July-August 2000), I argued that the law of bioethics has repeatedly failed to achieve the hopes cherished for it. I presented evidence, for example, that most doctors breach the duty of informed consent, that advance directives do not direct patients' care, and that repeated legal attempts to increase organ donation have failed to find the success predicted for them. I closed that column by promising to try to explain this chastening experience. It would, of course, take a lifetime of columns to capture all the reasons the law of bioethics …
The Best-Laid Plans, Carl E. Schneider
The Best-Laid Plans, Carl E. Schneider
Articles
It is natural to suppose law is like the centurion and can do as it will: "I say to this man, Go, and he goeth; and to another, Come, and he cometh; and to my servant, Do this, and he doeth it." But a thousand years ago, King Canute tried to disillusion his courtiers about his efficacy by commanding the waves to stop beating. And fifty years ago, Harry Truman predicted of Dwight Eisenhower, "He'll sit here, and he'll say, 'Do this! Do that!' And nothing will happen. Poor Ike-it won't be a bit like the Army. He'll find it …
Minors As Medical Decision Makers: The Pretextual Reasoning Of The Court In The Abortion Cases, J. Shoshanna Ehrlich
Minors As Medical Decision Makers: The Pretextual Reasoning Of The Court In The Abortion Cases, J. Shoshanna Ehrlich
Michigan Journal of Gender & Law
By examining the Court's failure to consider the allocation of authority between parents and children in the critical realm of medical decision making, this article exposes the irrationality of the Court's acceptance of limitations on the abortion rights of minors and reveals the pronatalist thrust of the parental involvement decisions. The article begins by looking at how the Roe Court characterized abortion as a medical decision, followed by a discussion about the medical decision-making rights of minors. Rooted in this medical paradigm, the article then turns to the parental involvement cases to examine the Court's failure to consider the medical …
An Emerging Ethical And Medical Dilemma: Should Physicians Perform Sex Assignment Surgery On Infants With Ambiguous Genitalia?, Hazel Glenn Beh, Milton Diamond
An Emerging Ethical And Medical Dilemma: Should Physicians Perform Sex Assignment Surgery On Infants With Ambiguous Genitalia?, Hazel Glenn Beh, Milton Diamond
Michigan Journal of Gender & Law
This article discusses the development of a surgical approach to treating intersex infants and others with genital anomalies that began in the late 1950s and 1960s and became standard in the 1970s. Although professional literature has recently questioned the surgical approach to the treatment of infants, controversy surrounding treatment persists and the medical community now is divided. How sex reassignment surgery for intersex infants became a routine recommendation of practitioners and how parents were persuaded to consent to such radical surgeries provide a cautionary tale that is relevant to both medicine and law.