David Orentlicher

Medical malpractice: treating the causes instead of the symptoms.

debate and legislative activity in the past 20 years, some things have not changed very much with medical malpractice and the law. Eighteen years after landmark Califoria data and 8 years after equally important New York data, malpractice occurrence and malpractice claims data from Colorado and Utah in 1992 paint essentially the same picture as the earlier results: a small percentage of injured patients actually sue, and when claims are brought, a high percentage of them do not involve malpractice. In other words, the tort system includes many false-positives (patients who sue in the absence of negligence) and even more falsenegatives (patients who do not sue despite having been harmed by negligence).3 As a result, the law often subjects the wrong physicians to legal process, it generally does not hold physicians accountable for their negligence, and it fails to ensure adequate compensation for injured patients.l

Making Research a Requirement of Treatment: Why We Should Sometimes Let Doctors Pressure Patients to Participate in Research

When a patient could be offered one of multiple established treatments, doctors should be able to offer treatment only if the patient agrees to participate in research aimed at determining which of the treatments is most effective. Making treatment conditional on research participation will help researchers complete badly needed studies.

Psychosocial assessment of organ transplant candidates and the Americans with disabilities act

The use of psychosocial criteria to assess candidates for organ transplantation may violate the Americans with Disabilities Act (ADA). The ADA prohibits discrimination on the basis of disability or on the basis of eligibility criteria that disproportionately affect persons with disabilities. When organ programs deny access to a person because of schizophrenia, they are denying an organ on the basis of disability. When organ programs deny access to a noncompliant person, they are denying an organ on the basis of an eligibility criterion that is more common in persons with coexisting disabilities like mental illness. Accordingly, both of these denials may violate the ADA. However, the ADA recognizes that it often is appropriate to take a persons disability into account when allocating organs for transplantation. There is a legitimate social interest in allocating organs in a way that maximizes medical benefit, and a persons disability may compromise the benefit that the person will receive from a transplant. It is likely that courts will interpret the ADA to permit denials of organs or lower waiting list priorities for persons with disabilities as long as predictions of diminished benefit are based on scientifically valid criteria, the assessment of candidates is individualized and not based entirely on generalized predictors, and the transplant program undertakes reasonable steps like psychological counseling to compensate for an organ candidates coexisting disability.

Universality and its limits: when research ethics can reflect local circumstances.

In recent years, many research trials in developing countries have been criticized because they would have been unethical in developed countries. For example, studies of therapy to prevent HIV-transmission from mother to child were criticized for employing a placebo control when a similar study in the United States would have required an active treatment control. In the view of many commentators, researchers may not employ a double standard in which studies that would be unacceptable in their own country are conducted instead in developing countries. I argue in this paper that researchers can take into account local circumstances in applying universal principles of research ethics, with the result that studies may be ethical in some countries even though they are unethical in other countries. I further argue that while strong safeguards must be adopted to prevent exploitation of citizens of developing countries when local circumstances are taken into account, the guidelines of the Council for International Organizations of Medical Sciences (CIOMS) are unduly strict. CIOMS requires that the therapy studied be made reasonably available in the host country after the clinical trial. By analogizing to non-research settings, I conclude that exploitation can be avoided by the provision of other kinds of benefit to the host country, such as royalty payments from sales of the therapy in developed countries.

Clinical Criteria for Physician Aid in Dying.

Abstract More than 20 years ago, even before voters in Oregon had enacted the first aid in dying (AID) statute in the United States, Timothy Quill and colleagues proposed clinical criteria AID. Their proposal was carefully considered and temperate, but there were little data on the practice of AID at the time. (With AID, a physician writes a prescription for life-ending medication for a terminally ill, mentally capacitated adult.) With the passage of time, a substantial body of data on AID has developed from the states of Oregon and Washington. For more than 17 years, physicians in Oregon have been authorized to provide a prescription for AID. Accordingly, we have updated the clinical criteria of Quill, et al., based on the many years of experience with AID. With more jurisdictions authorizing AID, it is critical that physicians can turn to reliable clinical criteria. As with any medical practice, AID must be provided in a safe and effective manner. Physicians need to know (1) how to respond to a patients inquiry about AID, (2) how to assess patient decision making capacity, and (3) how to address a range of other issues that may arise. To ensure that physicians have the guidance they need, Compassion & Choices convened the Physician Aid-in-Dying Clinical Criteria Committee, in July 2012, to create clinical criteria for physicians who are willing to provide AID to patients who request it. The committee includes experts in medicine, law, bioethics, hospice, nursing, social work, and pharmacy. Using an iterative consensus process, the Committee drafted the criteria over a one-year period.

Toward acceptance of uterus transplants.

Should surgeons offer uterus transplants to women who want to become pregnant but do not have a functioning uterus? The debate reminds us that society often neglects the interests of the infertile. Only a handful of uterus transplants have been reported worldwide—including two this past September—but advances in technique may make the transplants available more widely. Some women are born without a functioning uterus; others have hysterectomies for cancer, postpartum hemorrhage, or other reasons. Many of these women want to become mothers and carry their own pregnancies. However, the prospect of uterus transplantation has elicited sharp criticism. According to ethics professor Rebecca Kukla, the surgery is not, “in any traditional sense, therapeutic.”

The FDA's Graphic Tobacco Warnings and the First Amendment

As the Supreme Court has broadened corporate freedom to advertise, it has narrowed governmental power to preserve the publics health. The fate of the FDA-mandated graphic cigarette warnings is illustrative.

Computerized Patient-Flow Analysis Of Local Family Planning Clinics

The Center for Disease Control, in cooperation with the Illinois Family Planning Council and the Tennessee Department of Public Health, has created a computerized method of patient flow analysis (PFA) to meet the need for a simply operated, easily understood and inexpensively performed technique. PFA is a self administered time and motion study performed during 1 clinic session, relating characteristics of the clinic setting, staff, and patient population to the amount of time each staff member spends with each patient. Output consists of an easily read flowchart and a detailed statistical report showing how patient and staff time is used, and presents a brief cost analysis of services provided. Using these data, clinic managers can compare staff activity with patient movement and spot probable causes of inefficiency and bottle necks in patient flow. The operation of PFA is described fully, together with its use in a 5 step problem solving process. Its use in a publicly funded family planning clinic is described, where patient waiting time was reduced nearly an hour and costs per visit reduced by 1 dollar.

The Commercial Speech Doctrine in Health Regulation: The Clash between the Public Interest in a Robust First Amendment and the Public Interest in Effective Protection from Harm

Historically, government has been given more leeway when invoking its interests in safeguarding the public health than when asserting other state interests. For example, when considering a constitutional challenge to mandatory small pox immunization in Jacobson v. Massachusetts, the Supreme Court employed its highly deferential, rational basis review rather than the stricter level of scrutiny that it normally employs when individuals assert interests in bodily integrity. In recent years, however, it appears that a trend is developing toward applying the same level of constitutional scrutiny to health regulation. In Abigail Alliance, a three-judge panel in the U.S. Court of Appeals for the D.C. Circuit overrode FDA regulations to recognize a short-lived constitutional right of access for patients to experimental chemotherapy. In Western States, the U.S. Supreme Court struck down advertising restrictions imposed on pharmacies by Congress. To some extent, it makes sense to treat health regulation more like other kinds of regulation. Government may be too quick to sacrifice individual liberty when threats to health loom. However, courts may be overcompensating in their efforts to right the balance between individual liberties and the public’s interest in good health. In this paper, I will explore the clash between the interest in freedom of speech and the interest in public health in the context of the commercial speech doctrine and suggest how the balance should be drawn between two very important societal interests. In particular, I will argue that there are two important doctrines for retaining some special treatment of public health concerns. First, rather than following the Jacobson principle of deference to legislative judgment, courts should follow the principle of deference to the judgment of public health officials that was enunciated in School Board of Nassau County v. Arline. Second, courts should invoke the principle of trust and its concomitant duty of loyalty to adequately recognize the interests of individuals in not having their relationships with physicians, pharmacists and other health care providers exploited for the providers’ personal gain.

The implementation of Oregon's Death with Dignity Act: reassuring, but more data are needed.

Undoubtedly, empirical data from Oregon will play a key role for academics, legislators, judges, and the public as debate over the legalization of physician-assisted suicide continues. A central issue in the debate is whether a right to assisted suicide can be limited to only the truly compelling cases, or whether it will in practice be provided to patients who choose it out of depression, coercion, or misunderstanding. Empirical research can provide critical insights into this questions.