Genetic Test Results and the Duty to Disclose: Can Medical Researchers Control Liability?

• Publication year: 1999
• Citation: Vol. 23 No. 01

SEATTLE UNIVERSITY LAW REVIEWVolume 23, No. 2FALL 1999

COMMENTS

Genetic Test Results and the Duty to Disclose: Can Medical Researchers Control Liability?

Richard L. Furman, Jr. (fn*)

Increased knowledge of heredity means increased power of control over the living thing, and as we come to understand more and more the architecture of the plant or animal we realize what can and what cannot be done towards modification or improvement. . . .

It is not, however, in the economic field, important as this may be, that Mendel's discovery is likely to have most meaning for us: rather it is in the new light in which man will come to view himself and his fellow creatures. . . . The little that we know today offers the hope of a great extension in our knowledge at no very distant time. If this hope is borne out. . . and if also man decides that his life shall be ordered in the light of this knowledge, it is obvious that the social system will have to undergo considerable changes.(fn1)

I. Introduction

Increasingly, medical clinicians and researchers use human genes to identify and predict specific traits that are inherited from parents and passed on to children. As ninety-nine percent of human beings' DNA molecules are identical, each person shares with every other more biological similarities than differences. Our individuality or personal genetic past and future resides in that one percent of our DNA molecules that is unique.(fn2) Thus, a genetic test is a way to learn about oneself. Reliable genetic tests for inherited diseases have made the early detection and treatment of inherited diseases possible.(fn3) For example, prenatal and perinatal genetic screening aids parents in making reproductive decisions.(fn4) Today, physicians routinely screen fetuses and nearly four million newborns for known genetic defects.(fn5) Prenatal genetic screening also gives parents an opportunity to choose the characteristics of their child. Collecting and storing blood from the umbilical cord allows doctors to establish the health of the newborn, to perform autologous blood transfusions in premature infants, and, most recently, to perform hematopoietic stem cell transplants in newborns with abnormal bone marrow stem cells.(fn6)

Yet, not all genetic test results bring good news. Although your physician may have the means to diagnose your genetic conditions, he or she may not be able to offer an effective treatment. As a result, many people at risk for a genetic disorder choose not to undergo genetic testing.(fn7)

The value of genetic information in predicting the present and future health of specific individuals has not gone unnoticed by third parties. Today, insurers, employers, schools, the military, courts, and families often request access to an individual's genetic test results.(fn8) The debate over who should have access to genetic information intensifies as the list of genetically identifiable and potentially harmful diseases and traits continues to grow. Courts and legislatures are now in the center of this controversy.

This Comment examines research on the human genome and explores the existence of a duty to disclose genetic test results in clinical and research settings. Part II begins with a hypothetical describing how such a duty to disclose can arise. Part III (A-C) describes advances in the sequencing of the human genome, the development of reliable tests for genetic disorders, and issues regarding access and control of genetic test samples and results. Part III (D) looks at the tort law basis for a general duty of physicians to disclose medical information, the specific duty of clinical physicians to disclose the presence of genetic disease, and the specific duty of the nonphysician medical researcher to disclose genetic test results. Part III (E) explores justification based on a tort-contract hybrid for an expectation interest, on the part of a research subject and a third party, in the disclosure of genetic test results, as defined by informed consent. Part III (F) examines a tort-contract-property hybrid basis for invoking an affirmative duty to disclose genetic test results that combines a negligence standard of tort law with a tort-contract based duty of informed consent to form an individual property interest in genetic information.

This Comment concludes that whether a duty to disclose genetic test results exists depends on whether the court recognizes the plaintiffs claim as based in tort, contract, or property. If the court recognizes the claim as based in tort, then the status of the researcher will determine whether a special relationship exists. If the court recognizes the claim as based in tort-contract, then the status of the sample, informed consent, and the subject's expectation interest will determine the existence and scope of a duty to disclose. If the court bases the claim on the property right of the research subject in his or her genetic information, the court's analysis will be a hybrid of negligence and contract law that emphasizes the recognized property interest in informed consent. As a result, medical researchers may best protect themselves from liability surrounding the duty to disclose genetic test results by making the principal investigator a nonphysician and carefully drafting the informed consent document. The following hypothetical is useful in illustrating these issues.

II. Hypothetical

Physician Doe routinely conducts breast biopsies on suspicious masses found in the breasts of her patients. Before each surgery, Dr. Doe explains the procedure and the attendant risks and obtains informed consent from her patients. A pathology lab examines the breast biopsies collected by Dr. Doe and catalogues and stores the samples. After reviewing the pathology report, Dr. Doe contacts her patients with the biopsy test results.

Geneticist Roe develops a genetic test designed to predict an increased risk of breast cancer in women. Geneticist Roe and a team of epidemiologists hope to confirm the validity and reliability of the new genetic breast cancer test. Their proposed research protocol requires the analysis of breast tissue samples. The researchers expect to reduce their data collection costs by analyzing previously collected breast tissue samples. Geneticist Roe realizes that pathology labs throughout the country routinely store tissue samples sent to them for analysis. The Roe research team contacts the pathology lab used by Dr. Doe and requests access to the repository of breast tissue samples stored in their freezers.

Attorney Black is retained by Ms. Jones, a patient of Dr. Doe, after she learns that her breast tissue, removed by Dr. Doe during a breast biopsy procedure, is being used for research purposes. Attorney Black reviews the informed consent document signed by Ms. Jones prior to surgery and fails to find a clause stating that tissue samples removed from Ms. Jones would be used in current or future research projects. Furthermore, the informed consent document did not notify Ms. Jones of the existence of a genetic test that could determine whether she was at an increased risk for breast cancer or the fact that this genetic test would be performed on her tissue sample. Attorney Black files a claim against Dr. Doe and the Roe research team asserting the following ten causes of action: (1) conversion, (2) lack of informed consent, (3) breach of fiduciary duty, (4) fraud and deceit, (5) quasi-contract, (6) bad faith breach of the implied covenant of good faith and fair dealing, (7) intentional infliction of emotional distress, (8) negligent misrepresentation, (9) slander of title, and (10) declaratory relief.

Attorney White is retained as defense counsel by the Roe research team and Dr. Doe. Attorney White's defense centers on whether the Roe research team or Dr. Doe had an affirmative duty to disclose genetic test results to Ms. Jones.

The issues raised by this hypothetical fact pattern will be the subject matter of the background and analysis sections that follow.

III. Background

A. The Human Genome

The human genome(fn9) consists of approximately 70,000 to 100,000 pairs of genes(fn10) found in twenty-three equivalent pairs of chromosomes.(fn11) All nucleated somatic cells(fn12) in the human body contain two sets of chromosomes.(fn13) The individual genes within each chromosome are strung together in a double helix(fn14) form of deoxyribonucleic acid (DNA). The DNA in each nucleated cell of the same body is identical.(fn15) Each DNA molecule contains about three billion nucleotides.(fn16) Nucleotides combine with one another in one of four possible base pairs.(fn17) A useful visual analogy describes the nucleotide combination as a spiral staircase. DNA is composed of a long double helix, which looks like a spiral staircase. The backbone of this molecule (i.e., the handrails and balustrade of the staircase) consists of repeated sequences of phosphate and deoxyribose sugar. Attached to the sugar links in the backbone are four types of organic bases: Adenine . . . , Guanine . . . , Cytosine . . . , and Thymine. . . . The steps of the staircase are formed by pairs of these bases. . . .(fn18)

DNA molecules encode a person's genes with a blueprint for the human organism. With the exception of identical twins, no two people have identical DNA.(fn19)

B. Genetic Disease and Testing

In 1988 Congress...