by Barry R. Schaller. Foreword by Todd Brewster. Westport, CT: Praeger, 2008. 264pp. Cloth. $49.95/£27.95. ISBN: 9780275999186. eBook format. $54.95. ISBN: 9780275999193.

Reviewed by Lynne S. Viti, The Writing Program, Wellesley College. Email: lviti[at] wellesley.edu.


Connecticut Supreme Court Justice Barry R. Schaller teaches bioethics at Trinity College and participates in several working groups at Yale’s Bioethics Center. In this book, he brings his extensive experience as an advocate, a trial judge, and an appellate judge to bear on this complex, emerging discipline. Standing at the intersection of philosophy, law, science, medicine and in some cases, theology, bioethics encompasses some of the most troubling questions of the past two decades. Here, Schaller addresses and analyzes in depth a range of bioethical issues: the use of human subjects in scientific research; wrongful birth and wrongful life claims; in vitro fertilization and use of embryos; genetic diagnostic techniques; embryonic stem cell research; organ transplants; and end-of-life issues, including withdrawal of artificial nutrition and hydration.

Schaller combines a practical sense of how the law works, with a reflective approach to all these contemporary legal and ethical issues. His basic premise, to which he returns repeatedly, is that recent developments in medicine and biomedical technology have far outpaced the written law developed by state legislatures and, on the federal level, by the US Congress. As a result, a full and open debate on bioethical issues has thus far been stifled. Disputes arise in the aforementioned areas, and courts seem compelled to use traditional means – jury trials, protracted litigation, the adversarial system – to resolve a particular dispute, and at the same time, to address the lacunae in public policy on bioethical issues. Schaller deplores this; as he sees it, courts are making policy rather than ruling narrowly on the disputes before them. Judges, often appointed, not elected, and often unschooled in bioethics, resort to the traditional tools of their profession in these cutting edge cases, with mixed results. Schaller is outspoken in his opposition to judges who intrude on the territory of legislatures, while at the same time, he finds such judges blameless, since they cannot be expected to cite or rely on statutes that do not yet exist. He is deeply concerned about the many ways in which litigation is inadequate to address fundamental ethical issues in twenty-first century America. To support his thesis and to explore the intricacies of contemporary bioethics and the law, he includes extensive analysis of the factual background, the bioethical context, litigation, and the outcome of a half dozen high profile cases from the past two decades.

In keeping with his teaching of undergraduates with no background in the law, ethics, or public policy, Schaller [*714] assumes little previous knowledge of these disciplines on the part of his readers. For this reason, the text will appeal to novices. Schaller begins with what he identifies as the touchstone documents of bioethics: the Nuremberg Code (1947), the Helsinki Declaration (1964), and the Belmont Report (1974). In subsequent chapters, Schaller reiterates the principles set forth in these, particularly on the question of informed consent in research using human subjects. It is therefore perplexing why, often, Schaller assumes a certain amount of sophistication on the part of readers. In the Introduction, “Bioethics on Trial,” he refers in passing to Tuskegee, Willowbrook, and Jewish Chronic Disease Hospital, assuming that his audience is familiar with these cases of “human experimentation abuse” (p.6), or perhaps expecting the inexperienced to consult general reference sources to gain historical context. He sprinkles his prose liberally with a confusing array of acronyms and abbreviations for federal statutes, governmental departments and institutes, for example: The Office of Human Research Protection (OHRP), the Institute of Medicine (IOM) of the National Institute of Health (NIH), the Health Resources and Services Administration (HRSA) of the Department of Health and Human Services (HHS), the Organ Procurement and Transplantation Network (PRTN), the National Organ Transplant Act (NOTA). Thus, some readers will find themselves all too often flipping back and forth within the text, or in the Index, to navigate through a chapter. A glossary would have been useful, particularly since Schaller explicitly contemplated “undergraduate, graduate and law students” in his intended audience (p.xvii).

Apart from the introduction, a second chapter on the context of bioethics, law and society, and the conclusion, five middle chapters constitute the meat of Schaller’s foray into contemporary bioethics. The first of these, on using human subjects for scientific and medical experimentation, begins with the case of Jesse Gelsinger, a young man who suffered from a rare genetic disorder. Gelsinger died in 1999 as the result of an immunological response to an injection of genetically altered virus, in a clinical trial at the University of Pennsylvania‘s Institute for Gene Therapy. Schaller provides details of the study itself, the issue of parental consent for their minor children’s participation in the study, the lawsuit filed by Jesse’s parents against the University and individual researchers, and University of Pennsylvania bioethicist Arthur Caplan, who was later dropped from the lawsuit. Schaller uses a companion focus case, that of Ellen Roche, who died in a 2001 asthma study at Johns Hopkins, to show how litigation (or in the case of Roche, a formal inquiry by the federal government into Hopkins’ research protocol) inspired two immediate results. The Maryland legislature passed a law extending federal protections to all human research subjects in Maryland, and both the University of Pennsylvania and Hopkins instituted improved self-regulatory measures.

Schaller discusses the ways in which bioethical issues fit, or fit poorly, into traditional forms of litigation that are based on theories of medical malpractice, assault and battery, breach of fiduciary duty, product liability, strict tort liability, intentional infliction of emotional distress, and even Fourteenth Amendment claims. Because the [*715] relationship between medical researcher and human subject differs considerably from that of doctor and patient, Schaller argues, courts are not well suited to be arbiters of such claims. And when courts do make policy in the act of resolving a claim by a human subject who claims an injury, this discourages legislatures from conducting the sort of open debate and exchange of ideas that makes for good public policy and progressive, effective legislation by elected representatives of the people, as opposed to judges, who are often appointed and isolated from citizens’ input.

Schaller sees litigation as a poor method of resolving bioethical controversies like these because “judicial decisions, once made, become precedent and thus have normative effect on the actions and conduct of citizens other than those before the court in the present controversy. . . Decisions will have far-reaching impact on decision making in the ethical context” (p.65). Setting norms ought to be the business of legislatures, not courts; the public interest in setting standards for human subject research – as well as for embryonic stem cell production, use and ownership of human embryos, organ transplants, and end-of-life protocols and treatment decisions – is paramount, and deserving of a robust and thorough public debate, and corresponding debate, negotiation and consensus among legislators.

Schaller’s chapter on organ transplantation issues is particularly detailed and thought-provoking. He poses and explores a range of perplexing questions: Which would-be organ recipients ought to have priority? How is the waiting list of potential recipients affected by delay, or by inadequacy in the supply of organs? How should negligence on the part of physicians and hospitals be addressed – by traditional litigation, or by new measures? What risks exist for living organ donors? As well, Schaller points to disparate ethical issues arising for different kinds of organ transplants – liver, kidney, heart, even facial transplants. And while Schaller sees litigation as a way of revealing flaws in the organ transplant system currently in place, he believes lawsuits fail to challenge the way the current system works, in setting priorities for recipients finding sources, and controlling access to organs. Instead, plaintiffs claim only that those entities involved in the collection, distribution, and transplanting of human organs have violated the basic principles of the system.

Above all, whether presenting a disquisition on organ transplantation, embryonic stem cell research, or end-of-life issues ( Chapter 7, “Boundaries at the End of Life,” is an extended analysis of the Schiavo debacle), Schaller consistently rejects the retrospective view of bioethical controversies embodied in traditional litigation: “In bioethical issues, legal standards and concepts are poor substitutes for the values and standards used in ethical decision-making by individuals and communities. The retrospective outlook of judicial decision-making has no place in the ethical decision-making process” (p.130).

Schaller proposes a radical restructuring of our medical, political and legal culture’s approach to bioethical issues. He advocates ethical decision making as a process – one that depends on reasoned [*716] and pragmatic negotiation or mediation, is based on clearly stated principles, and is always open to revision as science develops new technologies, or, in end-of-life decisions, as the patient’s medical status and prognosis shifts. He asserts that legislative decisions should consider public opinion and the most recent scientific or medical information, and promulgate broad guidelines for behavior, based on commonly accepted ethical standards. The public policy debate he sees as essential in this context would address the tension between our wish to improve our quality of life, and the desire to respect all life, particularly, as Schaller repeatedly emphasizes, in the early stages of development. Competing values and limited resources, he writes, make this debate essential.

Schaller asserts that judges and courts have a role to play in this bioethical debate, but “a methodology ought to exist that will enable participants (medical professionals and interested participants) to resolve most of their problems without turning to courts” (p.201). He believes judges must be better trained to handle cases turning on bioethics or biotechnology; they must understand the nuances and complications present in this new discipline. They must be aware of the clinical consequences of their decisions in particular cases, as well as the effects on parties to the litigation. They must exercise judicial restraint, taking care not to get ahead of “the leading edge of social change” (p.202). Judges ought to turn more to experts to guide them through the bioethical minefield. As well, Schaller makes a case for changes in the way bioethical litigation is conducted. Participation in a lawsuit involving organ transplantation, end-of-life decisions, cloning, and other issues arising from new biotechnology should be expanded beyond the traditional roles of plaintiff and defendant; the more views on controversial topics represented, Schaller suggests, the better. Judges ought to take the lead in encouraging legislatures to take up and enact better laws to address bioethical quandaries. Both trial and appellate judges can utilize judicial notice more frequently, and if local rules permit, retain jurisdiction over some cases so that parties can return when necessary – a proposal clearly designed to avoid the protracted litigation seen in SCHIAVO. Court-appointed counsel should be made more available in these civil disputes to widen access to the law for those who cannot afford attorneys’ and court fees.

Schaller closes on a somewhat pessimistic note, reminding readers of the “boundary –defining function” (p.206) of courts: “Courts tend to place themselves at the center of the controversy and the decision process” (p.206). This phenomenon stymies legislative action and results in a proliferation of new cases, each of which resolves a single dispute but does nothing to clarify the particular bioethical question at the heart of a case, or create a comprehensive policy that prevents future litigation on the same bioethical issue.

Despite clearly identified chapter topics and useful headings within chapters, the text can often be dense, circular, and replete with judicial jargon. Although this book is a useful analysis of bioethics and the law from an experienced and thoughtful jurist, Schaller’s prose style makes for slow going at times, even for readers well versed in law, politics, and [*717] bioethics. Schaller’s work would fit best in a bioethics and law course as purely supplementary reading, with judicial opinions in Schaller’s focus cases as required reading for class discussion and analysis.

BUSH v. SCHIAVO, 2004 WL 980028 (2004).

©Copyright 2008 by the author, Lynne S. Viti.