Johnson identifies three responses to physicians’ “bad law” claims. Each of these is aimed at “relieving [physicians’] fears and reducing or managing the legal risk, real or perceived, so that doctors can freely engage in the socially desirable behaviors threatened by the operation of the putative bad law.” First, to the extent that physicians’ fears of the law are based on misinformation or misunderstanding, it might seem that they could be educated about the actual (often low or virtually non-existent) legal risk. Second, if physicians perceive a particular desirable course of action as too risky, asymmetrical incentives might be eliminated by making inappropriate alternatives equally risky. But Johnson explains that these two responses are typically unlikely to be effective.

The third response to “bad law” claims is safe harbor legal immunity. Johnson observes that this is one of “the more familiar legislative responses to physician-reported fears of legal risks.” Indeed, it would seem to be the strongest legal weapon in quelling physicians’ fears of legal risk. Immunity, after all, is a classic mechanism for encouraging legally fearful individuals to do their job.9 But Johnson concludes that “the evidence seems to indicate otherwise.”

When does legal safe harbor immunity work to dispel physicians’ legal fears? When does it fail? What are the essential attributes of an effective safe harbor? What are the limitations? These are the question that I will address in this Article. In Section I, I provide a brief taxonomy of medical safe harbors. In Section II, I outline the essential attributes of an effective safe harbor. Finally, in Section III, I discuss three key limitations of medical safe harbors. Notwithstanding these limitations, I conclude that safe harbors can be an efficacious mechanism for addressing physicians’ “bad law” claims.

The 2010 Widener University Law Review Symposium, Health Law and the Elderly: Managing Risk at the End of Life, was held on March 26, 2010 at the Widener University School of Law’s Ruby R. Vale Moot Courtroom in Wilmington, Delaware. It was co-sponsored by the Widener University School of Nursing, the Medical Society of Delaware, the Delaware End-of-Life Coalition, and Delaware Hospice.

The Symposium brought together a group of thoughtful and accomplished scholars and practitioners to assess and improve how consumers and professionals plan for the end of life. Local and national experts addressed topics such as advance care planning, MOLST, decision-making capacity, end of-life communication, fraud and abuse laws impacting hospice, professional ethics, and aid-in-dying.

End-of-life healthcare has been getting more attention than ever. However, there are serious ongoing problems. Many are due to the fact that lawyers lack a sufficient appreciation of the clinical reality and how decisionmaking standards are actually implemented. Analogously, healthcare providers lack a sufficient understanding of the governing legal standards.

To address both these shortcomings, the Symposium was directed not only to lawyers but also to physicians, hospital administrators, hospital ethics committee members, nurses, social workers, other health professionals, health policy experts, and academics involved in these disciplines. To enhance its value and interest to these professionals, the Symposium was approved for CLE credits (including ethics credits), CE credits for nursing, and CME credits for medicine.

This Symposium brought these various disciplines together to identify problems, challenges, strategies, and solutions. Both the Symposium, and the articles published in this issue of the Widener Law Review that stemmed from presentations at that event, make significant contributions to a critical and topical concern for contemporary society.

I contend that we should not reassign the BIS’s limiting function to the harm principle. In this article I make two arguments to support my position. First, the BIS has effectively served, and can serve, both guiding and limiting functions. Second, the harm principle would be an inadequate substitute. It cannot serve the limiting function as well as the more robust BIS.

There seem to be at least three distinct missions of this special issue of the Health Law Journal. First, several articles have an empirical focus. They describe how the FHCDA has been implemented in hospitals and nursing homes. Second, several articles have a normative focus. They describe how the FHCDA can and should be extended to health care settings (e.g. hospice, home care) to which it does not now apply. Third, several articles take a broader normative focus. They explain how the FHCDA might be better implemented (e.g. by training ethics committees).

This article serves the third mission. It focuses on those provisions at the heart of the FHCDA: the authorization of surrogates to make health care decisions on the patient’s behalf. Specifically, this Article compares the surrogate rules in the FHCDA to the “default” surrogate rules in other states’ health care decisions statutes. These comparisons can be usefully grouped into three categories: (1) the surrogate list, (2) the scope of surrogate decision making authority, and (3) the resolution of conflicts between and among surrogates.

This Chapter has four primary aims. First, it describes the traditional neglect of public health law. Second, it describes a built-in bias of the common law toward treatment over prevention. Third, this Chapter describes many of the most notable recent legal developments that increasingly emphasize the prevention, rather than the medical treatment, of health problems. Fourth, this Chapter examines normative problems raised both by these new, more paternalistic public health laws and by others that are likely to follow.

Nevertheless, these patients have another right, another option to avoid suffering at the end of life. Patients with decision-making capacity may choose (through contemporaneous instructions) to voluntarily stop oral eating and drinking to accelerate the dying process. Moreover, patients without capacity often have the same option. Voluntarily stopping eating and drinking (VSED) is a clinically validated “exit option” that enables a good quality death. Significant and growing evidence supports VSED as a means of accelerating the dying process. Nevertheless, VSED is widely resisted by healthcare practitioners either because they think that it is illegal or because they are uncertain of its legality.

There has been little legal analysis of a right to VSED. In this Article, we aim to fill this gap and to clarify the legal status of VSED. Specifically, we argue that both contemporaneous and (most) non-contemporaneous decisions for VSED are legally permissible. Individuals may refuse nutrition and hydration just as they may refuse other intrusions on their personal autonomy. This right is grounded in the common law of battery, statutes, state constitutions, and even the U.S. Constitution. Moreover, VSED does not, as many believe, constitute abuse, neglect, or assisted suicide. Even ex ante decisions for VSED (exercised through an advance directive or a surrogate decision maker) are legal in most United States jurisdictions.

Currently, in the United States, more than 100,000 persons are waiting for organ transplantation. In China more than 1.5 million people are waiting. Given the chronic shortage of available organs (especially kidneys and livers) relative to demand, the primary focus of most legal developments has been on increasing the rate of donation.

These and related developments are usefully divided into the following thirteen topical categories: (1) Revised Uniform Anatomical Gift Act, (2) Presumed Consent and Opt-Out, (3) Mandated Choice, (4) Donation after Cardiac Death, (5) Payment and Compensation, (6) Donation by Prisoners, (7) Donor Registries, (8) Public Education, (9) Other Procurement Initiatives, (10) Lawsuits and Liability, (11) Trafficking and Tourism, and (13) Allocation and Distribution.

Healthcare providers’ own moral beliefs have been obstructing and are expected to increasingly obstruct patients’ access to medical services. For example, some providers, on ethical or moral grounds, have denied: (1) sterilization procedures to pregnant patients, (2) pain medications in end-of-life situations, and (3) information about emergency contraception to rape victims. On the other hand, many healthcare providers have been forced to provide medical treatment that is inconsistent with their moral beliefs.

There are two fundamental types of conscientious objection laws. First, there are laws that permit healthcare workers to refuse providing — on ethical, moral, or religious grounds — healthcare services that they might otherwise have a legal or employer-mandated obligation to provide. Second, there are laws directed at forcing healthcare workers to provide services to which they might have ethical, moral, or religious objections. Both types of laws are rarely comprehensive, but instead target: (1) certain types of healthcare providers, (2) specific categories of healthcare services, (3) specific patient circumstances, and (4) certain conditions under which a right or obligation is triggered. For the sake of clarity, I have grouped recent legal developments concerning conscientious refusal into eight categories:

1. Abortion: right to refuse 2. Abortion: duty to provide 3. Contraception: right to refuse 4. Contraception: duty to provide 5. Sterilization: right to refuse 6. Fertility, HIV, vaccines, counseling 7. End-of-life measures: right to refuse 8. Comprehensive laws: right to refuse.

In this paper, I address this question: Under what circumstances should policymakers usurp consumer autonomy instead of fostering it? First, I will discuss the scope and nature of a recent and growing shift in attitude toward autonomy. Then, I will use therapeutic drug law policy (i.e. the regulation of pharmaceuticals) as a vehicle for exploring the implications of this shift in attitude toward autonomy on the communication of scientific health information.

On the front cover of Field’s new book, Health Care Regulation in America: Complexity, Confrontation, and Compromise, is a picture of a giant three-dimensional labyrinth. Rarely is cover art so perfectly appropriate. A maze is surely the image that best symbolizes the core objective of Field’s book: to provide readers a map and guidebook to the many interacting and overlapping private institutions and government agencies that regulate health care in America.

Like all primers, the book has its limitations, but it fulfills its mission most admirably. Health Care Regulation in America provides a thorough overview of the federal, state, and local government agencies as well of as the large assortment of private organizations that develop and enforce health care regulations against hospitals, insurers, pharmaceutical companies, and other industry players. This array of oversight bodies, as Field reminds us many times, can be bewildering. But Health Care Regulation in America not only untangles this twisted web, it also clarifies the logic behind the regulatory complexity.

Both legal and health professional readers can profit by using the matrix offered by this book to get the “big picture” of the history, structure, rationale, and challenges of health care regulation in the United States.