ABA Health eSource
 July 2005 Volume 1 Number 11

Bioethics Testimony in Adjudication: Established Reliability
by Bethany Spielman, Southern Illinois University School of Medicine, Southern Illinois University School of Law, Springfield, IL

Attorneys have begun to use bioethics testimony in a variety of health law cases, and will need to understand how the reliability of such testimony can be established and challenged. Thirty years ago, bioethics testimony was used almost exclusively in end-of-life medical treatment cases. Today, it is used in toxic torts, actions against managed care plans and pharmaceutical companies, and even in criminal cases against physicians who prescribe for pain management. Three challenges in establishing the reliability of such testimony under Daubert, Foot NoteKumho Tire Foot Noteand progeny are highlighted below.

I. Establishing Reliability is a Step-by-Step Affair, Even with Ethics Testimony

The first challenge in establishing or challenging the reliability of bioethics testimony is approaching the “ethics” in the testimony in a step-by-step fashion. For ethics testimony as well as testimony from other fields, "any step that renders the analysis unreliable . . . renders the expert's testimony inadmissible. This is true whether the step completely changes a reliable methodology or merely misapplies that methodology.” Foot Note

Several steps comprise the two dominant types of bioethics reasoning. Principlism, the most well known approach to bioethical reasoning, is built upon four ethical principles: autonomy, beneficence, nonmaleficence, and justice. Beauchamp and Childress, who developed the principlist approach, characterize the four principles as “only a framework for identifying and reflecting on moral problems.” Foot NoteIn their view, “specification” is also required before addressing a particular ethical problem. Specification is a process of providing abstract norms with action-guiding content. Foot NoteAssuming that the field of bioethics can pass the “astronomy test,” the first step in establishing reliability of principlist testimony is at the level of principles, a second is at the level of specification, and another is at the level of application.

Testimony in Izidor v. Knight, Foot Notea wrongful death case, consisted of principles, specification, and application. The question at issue was whether the Dr. Knight had a duty to revoke a sports authorization form he had completed for Mr. Izidor (a college student) when Dr. Knight learned from a specialist’s report that Izidor had been diagnosed with hypertrophic cardiomyopathy. The student died of hypoertrophic cardiomyopathy shortly after playing basketball at college.

The expert analyzed the ethical problem from within a principlist framework, specifically relying on the principles of autonomy and nonmaleficence. Respecting autonomy would suggest protecting Mr. Izidor’s confidentiality, but could result in significant harm to Mr. Izidor. Permitting breaches of the medical confidentiality of decisionally capable adults in cases involving significant and imminent physical harm to an identifiable third party is, within the field of bioethics, a well-accepted specification of the rule of confidentiality. But there is no such specification based on harm to the patient himself. Foot NoteThe expert reasoned that since there was no risk of significant third party harm in this case, Dr. Knight had no duty to revoke Mr. Izidor’s sports authorization; instead he had an obligation to protect confidentiality. Both the principles and the specification tracked generally accepted and peer reviewed steps in principlist ethical reasoning. Each could be considered reliable under Frye or peer review standards.

Casuistry, along with principlism , is a well accepted and multi-step mode of ethical reasoning in bioethics. It is much like common law reasoning. The casuist bioethicist reasons analogically from a familiar case about which there is widespread agreement in the field to a case about which there is no such agreement. Although varieties of casuistry are used in bioethics, each requires at least these steps: identify the paradigm case, articulate the rule that is associated with the paradigm case, and connect the paradigm case to the new case by means of the rule.

The standard “child of a Jehovah’s Witness” case is often identified as the paradigm case when parents refuse medical treatment for their child, and health care providers or the state consider overriding the parent’s decision in order to save the child’ life. In the much publicized Baby K case, Foot Notefor example, casuist testimony on each side was based on the “child of a Jehovah’s Witness” case. Foot NoteThe infant’s mother wanted emergency respiratory treatment for her anencephalic infant; the physicians and hospital believed doing so was futile. A bioethics expert for the mother used the “child of a Jehovah’s Witness” case to address the question of when the state may override parental medical decision-making. The rule by which he connected the paradigm case to the Baby K case was that overriding parental decision-making in health care is permissible only when the parent’s decision may result in life-threatening harm to the child.

A bioethics expert for the hospital began with the same paradigm case. Thereafter, however, his reasoning diverged from that of the mother’s bioethics expert. The hospital’s expert used a different, newly invented rule: that the state may override parental medical decision making even if the parent’s decision would prolong the child’s life, if significant “moral harm” would ensue. The point at which this bioethics expert’s reasoning became unreliable can be identified: he misstated the rule.

II. Establishing the Reliability of Other Bioethics Testimony

The second challenge in establishing reliability is recognizing that bioethics testimony will rarely, if ever, be “pure” ethics. Bioethicists often draw from a variety of sources, methods, theories, and fields, and combine them in ways that are alternately multidisciplinary and nondisciplinary. Comparing medical ethics (just one area of bioethics) to Wallace Stevens’ thirteen “ways of looking at a blackbird,” the editors of a recent volume included the following among its “methods”: philosophy; religion and theology; professional codes; legal methods; casuistry; history; qualitative methods; ethnographic methods; quantitative surveys; experimental methods; and economics and decision science. Foot NoteFinding one’s way through bioethics reasoning to determine what methods, theories, principles, and modes of reasoning a bioethics expert uses requires familiarity with many fields other than ethics.

Bioethics experts must establish the reliability of key steps in their non-ethics testimony as well as ethics testimony. In Heinrich v. Sweet, a class action brought against health care providers in 1995 for conducting radiation experiments in 1961, a bioethics expert concluded that the risks of the research had outweighed its benefits and therefore the research should never have been approved by an institutional review board or conducted by researchers. Foot NoteUnfortunately, the expert’s historical method was flawed. He had based his opinions on knowledge of what the review committees’ duties were, what the state of medical knowledge was, and what research standards were after, rather than before, the experiment was conducted. Foot NoteTestimony about the history of research ethics, like testimony about the history of anything else, must be based on reliable historical methods.

III. Establishing the Reliability of Experience Based Bioethics Testimony

Bioethicists’ experiences are diverse: commissions inquiring into new technologies or social problems; review boards to regulate research or access to technologies; consulting with public and private bodies, teaching health care professionals and students, consulting on clinical cases, and drafting policies for hospitals, professional bodies or industrial organizations. Foot NoteDespite the wide range of experiences that even a highly qualified bioethics expert might have accumulated, he or she still must “explain how th[e] experience leads to the conclusion reached, why that experience is a sufficient basis for the opinion, and how that experience is reliably applied to the facts.” Foot Note

The field of bioethics has barely begun to identify the bioethics skills that are developed from these experiences. The American Society of Bioethics and Humanities report “Core Competencies of Health Care Ethics Consultation” includes a list of competencies that clinical bioethicists should possess. Foot NoteAmong them, for example, is the skill of applying professional ethics codes--a skill claimed by a bioethics expert testifying in Diet Drugs, a suit against the manufacturer of diet drugs Pondimin and Redux. Foot NoteUnfortunately for that expert, the field of bioethics has not developed, and during a Daubert hearing he did not articulate, procedures for establishing the quality of ethics code interpretation or other bioethics skills .

Bioethicists and the attorneys who work with them can, however, draw upon procedures developed by qualitative researchers to demonstrate the reliability of bioethics skills. An expert applying the ethics code of a group to which he or she does not belong, such as the bioethicist in Diet Drugs, could use a technique such as triangulation, by discussing the codes’ interpretation with the promulgators of the codes and members of the organizations adopting the codes.

These three challenges--approaching the “ethics” in the testimony in a step-by-step fashion; ensuring that various non-ethics approaches are used reliably; and identifying and documenting skills that bioethicists develop from experience – will continue to challenge health lawyers as litigation over medicine and biotechnology expand in the post-Daubert era.

Foot NoteDaubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
Foot NoteKumho Tire Co. v. Carmichael, 526 U.S. 137 (1999).
Foot NoteFed. R. Evid. Advisory Committee Notes, Rule 702.
Foot NoteTom L. Beauchamp & James F. Childress, Principles of Biomedical Ethics 15 (5th ed. 2001).
Foot NoteId at 16.
Foot NoteIzidor v. Knight , 117 Wn. App. 1070 (2003).
Foot NoteBeachamp and Childress, supra note 4, at 308; Albert R. Jonsen, Mark Siegler & William J. Winslade, Clinical Ethics: A Practical Approach to Ethical Decisions in Clinical Medicine166-168 (4 th ed. 1998).
Foot NoteIn re Baby K, 832 F. Supp. 2d 1022 (1993).
Foot NoteRaanon Gillon, Four Scenarios, 29 J Med. Ethics 267, 267-8 (2003).
Foot NoteMethods of Medical Ethics (Jeremy Sugarman & Daniel P. Sulmasy eds., 2001).
Foot NoteHeinrich v. Sweet, 308 F. 3d 48 at 66 (2002).
Foot NoteId.
Foot NoteRichard E. Ashcroft, Bioethics and Conflicts of Interest, 35 Stud. Histo. Phil. Biol. & Biomed. Sci. 155-65, 156 (2004).
Foot NoteFed. R. Evid. Advisory Committee Notes, Rule 702.
Foot NoteRobert M. Arnold & Stuart J. Youngner, Core Competencies for Health Care Ethics Consultation 20-21 (1998).
Foot NoteIn re Diet Drugs Prods. Liab. Litig., MDL Docket No. 1203, 2000 U.S. Dist. LEXIS 9037.