Law Commons^™

How Liability Insurers Protect Patients And Improve Safety, Tom Baker, Charles Silver

All Faculty Scholarship

Forty years after the publication of the first systematic study of adverse medical events, there is greater access to information about adverse medical events and increasingly widespread acceptance of the view that patient safety requires more than vigilance by well-intentioned medical professionals. In this essay, we describe some of the ways that medical liability insurance organizations contributed to this transformation, and we catalog the roles that those organizations play in promoting patient safety today. Whether liability insurance in fact discourages providers from improving safety or encourages them to protect patients from avoidable harms is an empirical question that a survey …

Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar

Articles

In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful data …

Bedside Bureaucrats: Why Medicare Reform Hasn't Worked, Nicholas Bagley

Articles

Notwithstanding its obvious importance, Medicare is almost invisible in the legal literature. Part of the reason is that administrative law scholars typically train their attention on the sources of external control over agencies’ exercise of the vast discretion that Congress so often delegates to them. Medicare’s administrators, however, wield considerably less policy discretion than the agencies that feature prominently in the legal commentary. Traditional administrative law thus yields slim insight into Medicare’s operation. But questions about external control do not—or at least they should not—exhaust the field. An old and often disregarded tradition in administrative law focuses not on external …

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 …

Malpractice Suits And Physician Apologies In Cancer Care, Eugene Chung, Jill R. Horwitz, John A.E. Pottow, Reshma Jagsi

Articles

Conside the following case: The patient is a 44-year-old woman who presents for radiation treatment of an isolated locoregional recurrence of breat cancer in her chest wall, 3 years after undergoing masectomy. At the time of diagnosis, she had T2N2M0 disease, with four of 15 lymph nodes involved with tumor. She received a masectomy with negative margins and appropriate chemotherapy, but none of her physicians talked to her about postmasectomy radiation therapy, which would clearly have been indicated to reduce her risk of locoregional failure and would have been expected to improve her likelihood of survival. She asks the radiation …

Prosecuting Doctors For Trusting Patients, Deborah Hellman

Faculty Scholarship

In an escalating phase of our country’s war on drugs, doctors treating patients in pain are being prosecuted for drug trafficking under the Controlled Substances Act. While doctors surely can be guilty of drug trafficking when they sell drugs for money, lately some doctors have been prosecuted for violations of a statute that requires knowingly distributing or dispensing controlled substances in an unauthorized manner for simply being willfully blind to the fact that their patients were reselling the drugs. While willful blindness may be an apt substitute for knowledge in the traditional drug courier scenario, doctors in these cases are …

Social Factoring The Numbers With Assisted Reproduction, Bridget J. Crawford, Lolita Buckner Inniss

Publications

In early 2009 the airwaves came alive with sensational stories about Nadya Suleman, the California mother who gave birth to octuplets conceived via assisted reproductive technology. Nadya Suleman and her octuplets are vehicles through which Americans express their anxiety about race, class and gender. Expressions of concern for the health of children, the mother's well-being, the future of reproductive medicine or the financial drain on taxpayers barely conceal deep impulses towards racism, sexism and classism. It is true that the public has had a longstanding fascination with multiple births and with large families. This is evidenced by a long history …

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 Virtues Of Medicare, Jill R. Horwitz

Reviews

Most of us look forward to a heaven where people don't get sick. But if they do, health care would be traded among fully informed patients and providers in perfectly competitive and frictionless markets. In that perfect world, sick citizens simply shop for doctors the way they shop for other consumer goods. The better doctors, like the most elegant hotel rooms and fanciest cars, would cost more than inferior doctors. Patients would consult their utility meters and, with appropriate attention to discounting over an infinite lifetime, choose accordingly. After each treatment, the patients would know the quality of their outcome …

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 …

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

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

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

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

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

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

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 …

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 …

Licensing Health Care Professionals: Has The United States Outlived The Need For Medical Licensure?, Gregory Dolin

All Faculty Scholarship

With an expanding market for what is now known as "complimentary and alternative" medicine (CAM), states are increasingly facing the issue of who can and who should be allowed to practice medicine. Of necessity, this question also concerns whom patients may see to treat their ailments.

This paper will argue that the struggle to define who is and who is not licensed to practice medicine is rather fruitless and will always leave patients with less choice than they desire. Part II will review the history of licensure in the United States. Parts III and IV will focus on benefits and …

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

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

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 …

Exploitation Of The Elite: A Case For Physician Unionization, Dionne L. Koller

All Faculty Scholarship

Our intuition tells us that physicians are elites, and therefore they cannot be exploited. Relying on this intuition, we adopt policies which attempt to provide a health care system that gives first-quality care, at the lowest prices, delivered through a “free-market” system. As the key gatekeepers to health care, physicians are thus caught in the middle. Top-notch American health care costs money and for-profit MCOs must watch their bottom line. Rationing, therefore, is key. The issue is, assuming we have decided that free-market health care is the solution, how much should physicians have to sacrifice in the name of the …

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 Limits Of Law At The Limits Of Life: Lessons From Cannibalism, Euthanasia, Abortion, And The Court-Ordered Killing Of One Conjoined Twin To Save The Other, George J. Annas

Faculty Scholarship

The subject is law at the beginning and end of life. Most of my work is in the area of general health law: law and medicine, public health law, and health and human rights. But this is my favorite subject area, and I expect you to ask me the hardest questions you can. I am not saying I can answer them, but if I cannot that is my fault, not yours. I am going to make a pretty broad argument today about law and medicine; specifically about how new medical technology and medical practice standards have eclipsed religion (and sometimes …

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 …

Information, Decisions, And The Limits Of Informed Consent, Carl E. Scheider, Michael H. Farrell

Book Chapters

For many years, the heart's wish of bioethics has been to confide medical decisions to patients and not to doctors. The favoured key to doing so has been the doctrine of informed consent. The theory of and hopes for that doctrine are well captured in the influential case of Caterbury v. Spence: '[t]rue consent to what happens to one's self is the informed exercise of a choice, and that entails an opportunity to evaluate knoledgeably the options available and the risks attendant upon each'.

Government As God: An Update On Federal Intervention In The Treatment Of Critically Ill Newborns, Dionne L. Koller

All Faculty Scholarship

Whether a severely impaired or critically ill infant should receive lifesaving, and sometimes extraordinary, medical treatment, or be allowed to die, is hotly debated. The issue initially garnered public attention in 1982, when an infant who was born with Down's Syndrome, “Baby Doe,” was allowed to die from a correctable birth defect. Following this, the federal government took a lead role in determining the fate of critically ill newborns. In the meantime, doctors, philosophers, and others have debated whether federal interference in this area is appropriate.

This essay will bring the reader up to date on the “Baby Doe” issue …

Regulating Doctors, Carl E. Schneider

Articles

Alawyer today can hardly speak to a doctor--or even be treated by one-without being assailed by lawyer jokes. These jokes go well beyond good-humored badinage and pass the line into venom and gall. They reflect, I think, the sense many doctors today have that they are embattled and endangered, cruelly subject to pervasive and perverse controls. This is puzzling, almost to the point of mystery. Doctors have long been the American profession with the greatest social prestige, the greatest wealth, and the greatest control over its work. Indeed, what other profession has been as all-conquering? One may need to go …

Managed Care And Managed Sentencing — A Tale Of Two Systems, Ronald Weich

All Faculty Scholarship

The daily injustices mount. The front line professionals who administer the system cry out for more discretion to depart from the rigid rules that bind them, Congress finally hears their call, and is poised to enact sweeping reforms.

Are improvements in federal sentencing law on the way? Probably not in the near future. But the new Congress will surely take up proposals to regulate the managed health care industry, and the impending debate over a proposed "Patients' Bill of Rights" law offers important lessons for federal sentencing policy.

At first blush, sentencing reform and health care reform have about as …