Duty to disclose in medical genetics: A legal perspective

American Journal of Medical Genetics 39:347-354 (1991)

Duty to Disclose in Medical Genetics: A Legal Perspective

Mary Z. Pelias Department of Biometry and Genetics, Louisiana State Uniuersity Medical Center, New Orleans, Louisiana

As technical knowledge and public information in medical genetics continue to expand, the geneticist may expect to be held responsible for informing patients and clients about new developments in research and diagnosis. The long legal evolution of the physician’s duty to disclose, and more recent findings of a physician’s duty to recall former patients to inform them about newly discovered risks of treatment, indicate that medical geneticists may have a duty to disclose both current and future information about conditions that are or could be inherited. Recent case law supports findings of professional liability for both present and future disclosure, even in the absence of an active physician-patient relationship. The requirement of candid and complete disclosure will affect the counseling approach in testing for deleterious genes and in providing medical treatment for minors with hereditary diseases. Finding a duty to recall may impose further professional bur- dens on the geneticist to reach beyond the immediate counseling arena and to recontact patients, perhaps years after their initial visit to genetics clinic.

KEY WORDS: disclosure, duty to recall, informed consent, malpractice, liability, medical jurispru- dence

INTRODUCTION The rapid expansion of medical malpractice litigation

during the past 3 decades has underscored the individual’s right to competent delivery of medical care. Con- sumers of medical information and treatment have suc-

Received for publication, May 11, 1990; revision received Sep- tember 21, 1990.

Address reprint requests to Mary Z. Pelias, Ph.D., J.D., Depart- ment of Biometry and Genetics, L.S.U. Medical Center, 1901 Per- dido Street, New Orleans, LA 70112.

This paper is dedicated to the memory of Fred Zengel, LLB, patient friend and thoughtful counselor for many years.

0 1991 Wiley-Liss, Inc.

cessfully demanded extensive disclosure about proposed medical treatment, including information on possible, though unlikely, consequences of the treatment. The refusal of patients to accept anything less than a desired outcome has placed the medical profession in the position of practicing defensively and paying enormously increased insurance premiums [Reynolds et al., 19871. Physicians are now more inclined to order tests of ques- tionable necessity to avoid subsequent allegations of lack of thoroughness. Further, they are less inclined to practice in high-risk specialties, and they have been known to refuse to treat patients who are reputed to be contentious. Continuously expanding litigation has fo- mented suspicion and fear in physician-patient relation- ships that have been characterized traditionally by beneficence and, more recently, by a strengthening respect for patient autonomy [Faden and Beauchamp, 19861.

While the medical profession has endured the challenges of an increasingly litigious society, growing knowledge of the genetic nature of many human traits and disorders has matured into a recognized specialty of medical practice. From tenuous beginnings as an area of “genetic hygiene,” medical genetics and genetic counseling have been elevated to departmental status in many tertiary and secondary medical centers. The teaching of medical genetics to aspiring physicians and allied health care personnel has been supported by cur- riculum revisions in many medical schools. Clinical and laboratory refinements became a driving force in estab- lishing certification procedures for practitioners in var- ious areas of medical genetics. These changes have been promoted and guarded by those who practice medical genetics and who, in recent years, have begun to stress the responsibilities as well as the rewards of their newly founded area of practice [Fraser, 19791.

Allegations of medical malpractice in medical genetics and genetic counseling first attracted attention during the 1970’s in a flurry of suits in tort for wrongful birth and wrongful life [Pelias, 19863. This litigation has alerted medical geneticists to the liabilities associated with providing information about an individual’s genetic status and about the possible outcomes of pregnancy. Further, successful lawsuits against practitioners in reproductive medicine have defined the physician’s duty to recall patients when new information about risks and consequences of earlier treatment is amassed [Tresemer v. Barke, 19781.

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This paper reviews the evolution of the physician’s duty to disclose and considers the implications of this duty in the future practice of medical genetics and genetic counseling.

HISTORICAL BACKGROUND O F INFORMED CONSENT

Moral Foundations of the Physician-Patient Relationship

The physician-patient relationship was long characterized by the moral principle of beneficence, which has the general goal of promoting the welfare of others. Physicians were guided by the notion that first they should “do no harm,” and that they should always act for the benefit of the patient [Jones, 19231. The practice of beneficence was typified by paternalism toward the patient and by a dim view of the patient’s ability to compre- hend his condition, its treatment, and the prognosis. Gradually, however, the practice of medicine has wit- nessed a major shift in orientation from the principle of beneficence to the principle of personal autonomy, which supports the patient’s right to make his own decisions about his own medical treatment [Katz, 19841. Early recognition of the right to personal autonomy empha- sized a moral obligation to obtain a patient’s consent to treatment, but only in the sense of compliance with the physician’s recommendations. More recently, as the courts have sought to support the concept of informed consent, the physician’s obligation has been expanded to include the duty to inform the patient about the diagnosis, the nature and risks of proposed treatment, and any reasonable options to the proposed treatment. The source of decisional authority has shifted from the physician care-giver to the patient, the ultimate consumer of health care services. This shift has been incorporated from moral thought into medical practice and into legal theory and practice as well.

Legal Concepts in Informed Consent A legally recognized relationship between a provider

and a consumer of health care services is the prerequi- site to addressing questions of medical negligence. Tech- nically, the creation of the physician-patient relationship is contractual, although the contract is an implied one, based on mutual agreement and expectations between the 2 parties [Hankerson v. Thomas, 19591. Once the relationship is established, duties attach to both parties: the physician owes a duty of due care, and the patient assumes the duty to participate and to cooperate in further evaluation and treatment [Rigelhaupt, 19821.

Although the physician-patient relationship is tech- nically an implied contract, patients who sue physicians rarely sue for breach of contract. Rather, most suits against health care providers are actions in tort. A tort is a private injury to person or property for which damages may be claimed in a court of law. The elements of a tort are the existence of a duty owed by the defendant to the plaintiff, a breach of that duty, and causation between the breach and the damage or injury to the plaintiff (Black’s Law Dictionary, [Black, 197911. Most com- monly, the plaintiff bears the burden of proving the elements of the tort, although in exceptional circum-

stances the law may presume the defendant’s liability and shift the burden to the defendant of proving that one or more of the elements of the tort have not been real- ized.

Early litigation in questions of consent to treatment were based on a theory of intentional, unconsented touching [Mohr v. Williams, 19051, but this approach has largely given way to malpractice actions based on a theory of negligence. When applied to questions of informed consent, medical malpractice, or a tort of medical negligence, occurs when the health care provider fails to impart sufficient information for the patient to be able to make a truly informed decision. As the tort is considered in each of its elements, the health care provider has a duty to inform the patient, and he breaches that duty when he fails to make adequate disclosure. If this breach causes the patient to choose a course of action that results in unanticipated injury to the patient, the patient may recover damages for his injury from the health care provider.

In the context of medical genetics, plaintiffs have suc- cessfully defined the tort of wrongful birth as a specific version of medical negligence. The plaintiffs in wrongful birth actions allege 1) that the health care provider, usually an obstetrician or a geneticist, had the duty to inform them about pre-conception andlor prenatal tests that would determine either their own genetic status or that of their fetus; 2) that the failure to inform deprived them of the opportunity to avoid the birth of a child with defects; and 3) that this event constituted injury to the parents, who would have taken measures to avoid the birth of such a child if they had been properly informed either before conceiving or while carrying the defective fetus. Usually the parents claim damages that include costs of raising and caring for the defective child [Pelias, 19861.

The extent of the duty to inform and, consequently, what constitutes a breach of that duty, is determined in court by the plaintiff, who presents evidence of the standard of care that the health care provider must meet to avoid malpractice liability. Depending on the statutes and the courts of the state where the case is tried, the standard of care may be measured from one of 2 points of view. In the majority of American jurisdictions, the conduct of the health care provider is measured from the perspective ofthe professional, and such conduct must a t least equal what the average practitioner would do in a similar situation. Defining this professional standard of care depends on the testimony of expert medical witnesses about the prevailing practice in the medical profession [Green v. Hussey, 19701. In a minority of Ameri- can jurisdictions, the conduct of the health care provider is measured from the perspective of the health care consumer, and the information imparted must be material to the decision reached by a reasonably prudent patient. Depending on the court, the prudent patient standard of care may be based either on expert testimony [Cobbs v. Grant, 19721, or on the jury’s determina- tion of the materiality of undisclosed information [Can- terbury v. Spence, 19721. In any event, deciding the legal standard of care is hazardous for the defendant health care provider because both judges and juries, as

Duty to Disclose 349

well as expert witnesses, have the benefit of hindsight when they consider how the professional should have acted.

Current Status of the Law The current legal guidelines for the duty to inform

start with disclosure of the patient’s condition or diagnosis. The “condition” includes fully manifest disease as well as any signs of incipient risk or danger [Keogan v. Holy Family Hospital, 19801. Diagnosis includes the results of any diagnostic tests that the physician has ordered and a description of any alternative diagnostic procedures. Complete disclosure further includes a description of the proposed treatment and available alter- natives to the proposed treatment [Scott v. Bradford, 19791. Finally, the health care provider is obligated to disclose both the risks and the benefits of proposed procedures for diagnosis and treatment [Gates v. Jensen, 19791 and the risks of refusing treatment [Truman v. Thomas, 19801. If these criteria for disclosure are not met and an untoward outcome occurs, the health care provider risks costly litigation and an adverse judgment of negligence.

A difficult question has arisen in defining the magni- tude of a risk that may give rise to legal liability. If a given procedure has 99% chance of a completely favorable outcome and a 1% chance of a drastic adverse outcome, must the adverse outcome and its risk be disclosed? Or, if a given procedure has a 98% chance of a completely favorable outcome, a 1% risk of a slightly imperfect outcome, and a 1% risk of a drastic adverse outcome, must the risk ofthe slightly imperfect outcome be disclosed? The courts have attempted to inject some logic into this quagmire of probabilities and relative detriment by holding that the health care provider is obliged to disclose any risk that would be material to the patient’s making an informed decision. Material information is generally any information that could cause the patient to decline the proposed procedure [Canter- bury v. Spence, 19721. Thus, a small risk of a drastic adverse outcome is material, and a small risk of a slightly imperfect outcome could well be material under the facts and circumstances of a given case. The wise practitioner in today’s health care environment will err, if a t all, on the side of caution and thoroughness rather than risk the wrath of a damaged or dissatisfied patient.

IMPLICATIONS IN MEDICAL GENETICS Testing and Counseling for Deleterious Genes The power of geneticists to detect the presence of dele-

terious genes has increased rapidly with progressive refinements in the use of DNA markers. As technical knowledge expands, so does the power of the geneticist to influence the lives of clients who seek counseling about their own genetic status or the status of their children. In this developing context, the geneticist may experi- ence most vividly the contrast between the beneficent care-giver and the client whose autonomy must be re- spected. Here, depending on the law of the state where a lawsuit arises, the geneticist may appreciate the full impact of the judicial mandate to impart all information

that is material to a patient’s decision-making process [Canterbury v. Spence, 19721.

Nowhere has the power of the medical geneticist been expressed more clearly than in recent suggestions about predictive testing for the gene that causes Huntington disease. Several authors have recommended that predictive testing should be unavailable both for minor children and for couples who seek prenatal testing but equivocate about terminating a high risk pregnancy [Bloch and Hayden, 1990; Committee of IHA and WFN, 19901. Parents of minor children would be classified as third parties, whose interests in their own minor children are equated with interests of “adoption agencies, educational institutions, insurance companies, and other third parties.” Limiting the interests of parents by classifying them as third parties is proposed as a means of protecting the privacy and autonomy of the minor child. Genetic counseling would be directed toward dis- couraging parents and at-risk couples from seeking information. Since no immediate advantage can be predicted for minor children whose genetic status is investigated, the refusal by professionals to test children or at-risk couples is viewed as a policy that supports the best interests of family life and the emotional and psychological security of children who may harbor the gene. These arguments against disclosure rest on the facts that Hungtington disease is a late-onset disorder and that no treatment is presently available.

These suggestions must have resulted from consider- able deliberation, and they are unquestionably sincere. However, they raise serious questions about paternalism in genetic counseling and about the duty of a counselor to his client. They also challenge the principles of parental autonomy and of the privacy of the family unit in our culture. The fundamental issue is neither the nature of the specific genetic disease nor the availability of any treatment but, rather, a renewed tension between the beneficence model of patient care and the rights of parents to their own autonomy and to the protection of their family units.

Although references to constitutional history may have only peripheral interest in suits of professional negligence, the holdings of the Supreme Court are none- theless regarded as reflections of the values of our society. On several occasions the Supreme Court has affirmed the sanctity of the family unit, so that courts and legislatures are now loathe to interfere with this most basic social group. The scope of “liberty” guaranteed to every American by the fourteenth amendment was ad- dressed in a frequently quoted case involving the role of parents in making educational decisions for their children:

Without doubt, [liberty] denotes not merely free- dom from bodily restraint but also the right of the individual to contract, to engage in any of the common occupations of life, to acquire useful knowledge, to marry, establish a home and bring up children, to worship God according to the dictates of his own conscience, and generally to enjoy those privileges long recognized at common law as essential to the orderly pursuit of happiness by free men [Meyer v. Nebraska, 19231.

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This holding was reinforced when the Court later affirmed “the liberty of parents and guardians to direct the upbringing and education of children under their control” [Pierce v. Society of Sisters, 19251. More recently, in the context of making medical decisions for minor children, the Court noted that “[sltate law vests decisional responsibility in the parents, in the first in- stance” [Bowen v. American Hosp. Ass’n, 19861. This judicial thrust was supported by the President’s Com- mission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research when it noted that

[Tlhere is a presumption, strong but rebuttable, that parents are the appropriate decisionmakers for their infants. Traditional law concerning the family, buttressed by the emerging right of privacy, protects a substantial range of discretion for parents [President’s Commission, 19831.

Considerations by both the judicial and administrative branches of federal government have thus affirmed the role of parents as the primary decision makers in the lives of their children. Any attempt to usurp the parental role contradicts this clearly expressed public policy, and justification of such an effort would indeed have to be compelling in order to survive a constitutional challenge. The geneticist who defines parents as “third parties” in relation to their own children and assumes the right to make parental decisions acts without regard to our history of protecting the parental prerogative.

A more realistic hazard for the medical geneticist lies in the possibility of being sued in tort for failure to disclose all information material to the plaintiffs decision-making process. When a practicing geneticist assumes the role of guardian of the privacy and autonomy of children who may have deleterious genes, he assumes the role of the parents of these children. If the geneticist then fails to disclose complete information to the parents of these children, he risks allegations of injury to both the parents and the child. Parents deprived of complete information about the genetic status of their children will assert that their parental autonomy was compro- mised when they were deprived of the chance to explore every available opportunity for their child with a deleterious gene. Children will also claim injury resulting from these diminished opportunities. Parents denied prenatal testing when they refuse to commit to aborting an affected, or high risk, fetus, will have actions in wrongful birth, and children born to these parents may have actions in wrongful life.’ The plaintiffs may demonstrate that these lost opportunities should be compen- sable and may well recover substantial damages.

Beyond the practical aspects of litigation may lie a far

‘Wrongful life actions are brought by children who are born with defects that could have been predicted or detected prenatally. These children claim that it would be better not to be born at all than to be born to a life of suffering and pain. The success of wrongful life actions is considerably more dubious than the success of wrongful birth actions because the courts have demonstrated a reluctance to make judgments about the value of a diminished life in relation to not being born a t all [Pelias, 19861.

greater hazard to the profession of medical genetics. Most medical geneticists have adopted a policy of non- directive counseling aimed a t communicating information and helping clients understand and cope with their situations [Fraser, 1974; Ad Hoc Committee on Genetic Counseling, 19751. If medical geneticists now adopt a policy of limiting the information available for disclosure, or if counseling becomes so directive as to solicit an agreement to terminate an affected pregnancy in return for prenatal testing, it can only be a matter of time before these situations are exposed in court and exploited in the media. Such exposure and exploitation could severely damage the credibility of the profession. This risk can be avoided, however, by respecting the autonomy of clients and adopting a policy and a practice of full, unconditional disclosure.

Another question of disclosure that arises in the context of testing for deleterious genes is whether the geneticist has any obligation, or right, to disclose genetic information to third parties, including collateral relatives who participate in a study, or schools, employers, or insurance companies. With respect to disclosure to participating collateral relatives, 3 facts must be considered. First, both the client and the relative are protected by their rights to privacy and to personal autonomy. Second, any exchange between a physician and his patient is confidential. The only legal precedent for break- ing this confidence is knowledge by the physician that the patient poses a foreseeable danger to an identifiable third party, in particular, a psychiatrist’s knowledge of a patient’s threats of bodily harm to his former girlfriend [Tarasoff v. Regents of the Univ. of Cal., 1976; Davis v. Lhim, 19831. Third, while the geneticist may not dis- cover information that is immediately life-threatening, as in Tarasoff or Davis, the information may well have a significant influence on a relative’s family planning decisions and on the children who are born to that relative. With these facts in mind, then, the geneticist should have the consent of both his client and the participating collateral relative before revealing any information to the relative. Any fortuitous information about non-participating relatives should ideally be kept in confidence until an inquiry is initiated by that relative himself. Certainly the geneticist is in a position to encourage communication among family members, but he is obliged to respect the privacy, autonomy, and confiden- tiality of those with whom he has direct contact.

Disclosure of genetic information to institutional or commercial third parties should ideally be a matter of contractual agreement between the counseling client and his school, employer, or insurance company. Unfor- tunately, these contractual agreements may not shield the geneticist from being named a party to litigation initiated by the third party against the client for failure to disclose his own genetic status. However, the cautious geneticist will carefully document all counseling with the client, noting whether the client understands the necessity or obligation to inform any third party about potential hazards. Such documentation might protect the geneticist from allegations of violation of the client’s privacy and further justify the geneticist’s responding to inquiries from third parties if such responses are war-


ranted. Questions of genetic privacy and the legal rights of third parties are areas of legal development that are likely to remain unsettled for some time, and these questions will merit careful study as our knowledge of the human genome becomes more refined.

The core of testing and counseling for deleterious genes is information. Laboratory geneticists develop new techniques for detecting the presence of deleterious genes, and they compile information that must be made available those who carry the genes. Clinical geneticists and genetic counselors impart this information to clients who inquire about their own genetic status or that of their children. The geneticist may hope that genetic information he imparts will improve the quality of life of his clients and their families, but it remains the prerogative of clients themselves to decide what to do with that information-a prerogative that is strongly protected by the constitutional right to privacy and the common law right to personal autonomy.

Treating Minors With Genetic Diseases While the primary function of genetic counseling is

dissemination of information, decisions about treating active genetic disease go beyond conveying information to the heart of medical practice. Because the common law has long regarded the parents of minor children as the decision-makers for their children, early discussions about disclosure and consent to treatment focused on dialogue between physicians and parents about the best course of treatment to select for the sick child lEwald, 19821. Parental consent has been mandatory in all situations except when the patient is an emancipated minor or when an emergency makes immediate treatment crit- ical. Thus, treatment without parental consent gives the parent an action in assault and battery on behalf of his child. In nearly all circumstances the consent of persons other than the parents, such as babysitters or school teachers, is invalid and invites allegations of negligent medical practice as well as battery [Holder, 19881.

In addition to the rights of parents to decidC for their minor children, and in response to the increased drug abuse and increased sexual activity among adolescents, a number of legislatures and courts have begun to recognize the increasing independence of adolescents in our society. Many states, for example, have passed legisla- tion that recognizes the capacity of these minors, under some circumstances, to seek and to consent to treatment without parental notification or approval. These statutes have been enacted in an effort to encourage minors to seek treatment for substance abuse or for venereal disease without the fear of parental retribution [Wilkins, 19751. In addition to a legislative approach to these problems, the courts have also supported the increasing autonomy of teenagers by developing a body of case law that supports the “mature minor rule.” Judicial guidelines stress the importance of the parental participation but nevertheless support the adolescent who is independently seeking reasonable medical treatment that is to his own benefit [Wadlington, 19731. Even the most recent decisions of the Supreme Court give support to the minor who is seeking an abortion without paren-

tal consent: state laws that require parental consent have been ruled constitutional provided that the law also allows a judicial bypass, or judicial consent, for a mature minor who does not wish to notify her parents [Hodgson v. Minnesota, 1990; Ohio v. Akron Center for Reproductive Health, 19901.

Although treatment questions usually focus on seeking treatment and accepting what is offered, an impor- tant related consideration is the question of the right to refuse a treatment that is offered by the care-giver. The legal guidelines in this area support the right of parents to refuse treatments for their minor children, with the provisos that the children are not denied medical help because of the religious convictions of the parents [Jehovah’s Witnesses of Washington v. King County Hosp., 19681, and that children are not subjected to negligent care that violates child abuse statutes. Be- yond these specific exceptions, however, decisions about accepting or refusing treatment for young children rest with their parents. On the other hand, if the minor being treated is an adolescent, his wish to refuse treatment may be honored if he can convince a court that his reasons are his own and not the product of coercion by his parents [In the Interests of E.G., 19871.

A particularly troublesome area in the question of disclosure and consent to treatment is the use of experi- mental therapies that may or may not benefit the child. Assuming that there is full disclosure of the uncertainty of a proposed course of treatment, there remain grave concerns about whether the parents of a seriously ill child may give valid consent to unproven therapy that may even be detrimental to the child. Parents of children with serious genetic problems may be willing to consent to unproven regimens of treatment in the hopes of keep- ing their child alive. These dilemmas must be ap- proached with great caution, for both ethical and practical reasons: on the one hand, distraught parents may be bound by their own convictions to treat at all costs, even when a child’s condition is uniformly fatal; and, on the other hand, the physician is bound to “do no harm,” while he has a practical and professional interests in avoiding malpractice suits. In any event, the most hu- mane approach to such difficult scenarios must start with full disclosure of the treatment plan and a clear explanation of the possibility that no benefit may be derived from participation in the treatment regimen. Further, a child who has some appreciation of the circumstances may be consulted about his own wishes to participate in something that might not do him any good and, indeed, might even hurt [Levine, 19861.

The medical geneticist who participates in the treatment of minors with severe hereditary disorders is thus confronted with a long legal history that supports the right of parents to decide for their children. Not only are parents entitled to complete disclosure when they are considering treatment options for their own children, but, as the law continues to recognize the competence of minors in some circumstances, these younger persons will also be entitled to the benefits of full disclosure if they are going to be able to give truly informed consent. In either situation, the geneticist is obligated to impart information to the client, or patient, and it will be the

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clients, or patients, whether parents or their sick children, who decide how the information will be used.

Duty to &-Contact Patients In addition to having a duty to disclose known facts

and information to genetic counseling clients, the geneticist may also find that he has a continuing obligation to re-contact former clients when he receives new information that could be material in their lives. The geneticist’s prospective duty to disclose future knowledge is likely to find support in the courts, based on 2 lines of reasoning. First, the geneticist is likely to be viewed as the “knowledgeable professional” who is responsible for dissemination of new information in genetics to clients who are dependent on his expertise. Second, case law precedents on similar questions will be argued as analogies to the delivery of genetic services.

The concept of the health care provider as a “knowledgeable professional,” or “learned intermediary,” arose in the context of dispensing and prescribing drugs for patients. Drug manufacturers are responsible for sup- plying warnings about the drugs, but the prescribing physician is usually responsible for translating technical package inserts into language that can be under- stood by the average patient [Calfee, 19821. Just as the physician explains the information in package inserts, so does the geneticist explain the complicated results that are generated in the laboratory to persons who are dependent on him for understandable information. The unanswered question in this area is how far the geneticist, as the knowledgeable professional, must go to fulfill his duty to patients when he learns new information that may have a bearing on the lives of clients who were last seen in clinic years before.

The law on the duty to re-contact patients includes 3 cases that may be used as precedents to guide the courts when questions arise in medical genetics. In 1964 a federal court found that the federal government had been negligent in treating a patient who suffered severe injury from a radioactive dye used to diagnose his sinus conditions during World War 11. The court noted that “the government had a duty to follow up those cases in which the drug had been installed, even if the patients never returned to a government physician” [Schwartz v. United States, 19641. Two later cases involving negligence in the practice of gynecology may have more direct application to medical genetics. In 197 1 the University of Chicago became aware of the dangers of the drug diethylstilbesterol (DES) given to a group of women in the 1950’s, but the university delayed notification of these women until 4 and 5 years later. In finding the university negligent for delaying to notify, the court noted that the duty to notify arose when the hospital became aware ofthe dangers of DES, and that “[tlhe fact that knowledge of the risk was obtained after the patient was treated does not alter the obligation. . . ” [Mink v. University of Chicago, 19781. In the third case, a woman visited a gynecologist once, in 1972, for inser- tion of a Dalkon shield intrauterine devise. She later sued the physician for failing to notify her of the newly discovered dangers of the IUD. This court allowed the plaintiffs case to proceed and commented that the plain-

tiff s malpractice action arose “from the imposed continuing status of physician-patient where the danger arose from that relationship,” because the physician had a “separate duty to act” [Tresemer v. Barke, 19781. These cases indicate that the physician-patient relationship is likely to be viewed by a court as continuing, or on-going, especially when future injury to a client can be attributed to the relationship. In addition to stressing the concept of a continuing relationship, the Tresemer court held that the physician’s duty is a separate duty, not subject to extinction under the statute of limitations. Either way, the practical outcome for a geneticist, who offers his clients information rather than drugs or birth control devices, is the possibility of being sued for failure to keep former patients informed about new developments.

Because the duty to disclose may be expanded to include complete disclosure of new information, a cautious geneticist will anticipate the possibility of such allegations and will involve the client in the on-going process. The client should be informed of the expanding nature of genetic knowledge and should be urged to keep the clinic informed of changes in status and address. This theme should be recorded in clinic notes and reiterated in follow-up letters to the client and to referring and consult- ing physicians. With a showing of due diligence the courts will probably not unduly burden a physician or genetic counselor who includes this information in his counseling protocol and who can demonstrate a good faith effort to notify former clients when new information is discovered. Thus, complete disclosure and thor- ough counseling and documentation again become the geneticist’s best defense in any litigation.

SUMMARY AND CONCLUSIONS During the past century the physician-patient rela-

tionship has evolved from the beneficent approach to providing health care to an approach that gives great deference to the patient’s moral and legal right to personal autonomy. Decisions formerly made by health care providers for the benefit of their patients are now made by patients themselves. This shift in decision-making prerogative has been accompanied by the evolution of the legal doctrine of informed consent. Care-givers are now required to impart information that meets either the standard of care practiced among professionals or the standard of care determined to include all information material to a patient’s decision. Professional conduct that fails to meet the applicable standard of care constitutes a breach of duty owed to the patient. If the patient is injured as a result ofthis breach, he may sue in tort for medical negligence to recover his damages.

Full disclosure and communication of genetic information often involves information that is unpleasant, even devastating, to counseling clients. The hard reality of genetic counseling is that clients must often learn of poor prognoses, limited if any treatment options, and diminished life expectancy of loved ones. This reality applies equally to chromosomal problems and to single gene disorders, whether dominant or recessive, across the full range of hereditary problems that affect human beings. Geneticists who intentionally restrict informa-


tion that is sought by clients place themselves a t risk of being sued for inadequate disclosure under the doctrine of informed consent. Geneticists who make decisions on behalf of minor children also disregard the constitutional status of parents as the primary decision-makers for their own children. Beyond the detriment to the immediate parties in genetic counseling, however, lies a grave risk to the profession of medical genetics of allegations of directive counseling aimed a t controlling the lives and the reproductive decisions of genetic counseling clients. These dangers must be avoided. They will be best avoided by recognizing a policy of full disclosure to clients who seek information about any hereditary prob- lem.

Respect for patient autonomy and the need for full disclosure in the treatment of genetic disease has also acquired new facets as medical and surgical therapies have become more refined. While parents are usually regarded as the sole decision-makers for their children in questions about treatment, there has recently been a growing recognition in the legislatures and courts of the ability of mature minors to understand and to participate in these decisions. This ability is recognized both in accepting and in refusing a proposed course of treatment. Full disclosure is also mandated when experimen- tal treatment regimens are proposed, with the addi- tional caveat that this is a controversial area, with no professional consensus about ethical standards. Such tenuous treatment situations demand utmost sensi- tivity to the needs and expectations of all persons in- volved. Failure of the geneticist to disclose all available information to clients, or patients, who must make criti- cal decisions will be an invitation for allegations of malpractice.

The doctrine of informed consent may eventually be extended to include a duty of the medical geneticist to re-contact counseling clients when new information is amassed that could be material in decisions made by these persons. Based on relevant case law, the geneticist, as the knowledgeable professional, may be required to disclose new information, but he can mitigate the chances of litigation by including his clients in the counseling process, by stressing the importance of communicating changes of address and status, and by making good faith efforts to re-contact patients who seem to have disappeared.

The history of medical genetics acknowledges the difficult aspects of genetic counseling, but it also supports the need for candid and complete disclosure of information to counseling clients. For many years one thrust of counseling has been to help families “make the best possible adjustment to the disorder in an affected family member” [Committee on Genetic Counseling, 19751. How one family deals with genetic information may differ greatly from the way another family deals with the same information, and these decisions are appro- priately made within the privacy of each family. The geneticist should continue to serve as the trustee of genetic information. Counseling clients and patients, as the beneficiaries of this trust, are morally and legally entitled to full disclosure and to the right to give truly informed consent.

ACKNOWLEDGMENTS The author thanks Drs. Margery W. Shaw and

Stephen P. Daiger for encouraging discussions and comments during the development of this paper. Addi- tional thanks are extended to Drs. Bronya J.B. Keats and Richard Alan Lewis far reviewing the manuscript and suggesting numerous improvements.

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Documents

Duty to disclose in medical genetics: A legal perspective