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Mapping Public Policy for Genetic TechnologiesAppendix C Case Law
Information Contained in this Chapter
The progress in genetics technology has been rapid and expansive in the last several years, posing a number of potentially complex legal issues concerning privacy, confidentiality, familial obligations, health care professionals' duties to the family of patients, and discrimination. The case law in this area is years behind the technology. Very few cases deal specifically with genetics testing, with the exception of wrongful birth and wrongful life actions. Thus, any attempt to consider how courts might think about genetics-related issues requires an examination of analogous case law. The following discussion of case law focuses on questions concerning standards of care in genetic testing (wrongful birth life actions and informed consent), as well as privacy and confidentiality of medical information. It also includes a discussion of mandatory testing, professional guidelines, testing of minors, and employment and insurance discrimination. Because so little case law deals specifically with genetics, much of the discussion draws upon analogous areas to conjecture how courts might respond to questions concerning genetics.
Malpractice in Prenatal Genetic TestingWrongful birth and life claims are among the few areas where courts have examined legal questions concerning genetic testing per se. These cases address whether genetics professionals or doctors breach the standard of care by failing to offer genetic testing, interpreting test results inappropriately, or by failing to inform patients of the test results in time for them to decide whether to continue or terminate a pregnancy. Wrongful birthParents bring wrongful birth claims for damages suffered from having a child born with birth defects or genetic diseases. These claims are based on the physician's or genetic counselor's failure to inform couples of an appropriate prenatal test, failure to diagnose a condition through, for example, misinterpretation of results, or failure to deliver test results in time for couples to make decisions about whether to continue the pregnancy. The vast majority of jurisdictions recognize these claims, although a handful fail to recognize such claims on the grounds that claims should not be based on the failure of a physician to give parents the opportunity to prevent the existence of another. A few states-including Idaho, Minnesota, Missouri, and Pennsylvania-have enacted statutes prohibiting actions based on a "claim that, but for an act or omission of another, a person would not have been permitted to be born alive, but would have been aborted." Challenges to the constitutionality of these statutes have been upheld (for example, Campbell vs. U.S., 962 F.2d 1579 (11th Cir. 1992)). Wrongful lifeWrongful life claims are similar to wrongful birth claims except that the plaintiff is the child, not the parents. The child's claim is based upon the theory that, but for the negligence of the health care provider, the child's birth defects would have been detected and the parents would have terminated the pregnancy, preventing the plaintiff from being born and suffering from the illness. Most courts offer the following reasons for rejecting these causes of action:
Only a few jurisdictions-California, Louisiana, New Jersey and Washington-have recognized such claims. The theory in allowing these claims is that the plaintiff is burdened with extraordinary costs of care for which she or he should be compensated. As a result, the only recoverable damages are the extraordinary costs associated with the illness. Wrongful birth and life claims present awkward political and moral positions for courts because an inescapable aspect of these claims is that the parents were denied the opportunity to abort their child. To avoid the political controversy surrounding abortion, some courts make distinctions between pre- and post-conception claims in their definitions of what constitutes a wrongful birth action. North Carolina, for example, prohibits wrongful birth actions-which it defines more narrowly than many jurisdictions-and distinguishes them from wrongful conception actions. In North Carolina, wrongful birth applies to post-conception claims, whereas wrongful conception claims apply to a failure to advise a couple of their genetic risks prior to conception. Most states do not make such distinctions. Lost opportunity claimsIn some cases, genetic counselors fail to offer tests that have only limited predictive value, such as MSAFP screening. In a few jurisdictions, plaintiffs have successfully brought lost opportunity claims. These are claims that someone was denied an opportunity to prevent a particular harm, when the lost chance was substantial, although less than 50 percent. They originally arose when the alleged negligence resulted in a lost opportunity to prevent death. A minority of courts do not recognize these claims under any circumstances, even with regard to death (see Dumas vs. Cooney, 235 Cal. App. 3d 1593 (1992)). In fact, some legislatures have prohibited any form of lost opportunity claims. Other courts are not willing to extend lost opportunity cases to include harms other than death. Some jurisdictions, however, have applied the theory to harms other than just death, including wrongful birth. For example, in a Michigan case (Blair vs. Hutzel Hospital, 552 N.W.2d 507 (Mi. Ct. App. 1996)), parents of a child with Down syndrome were not offered MSAFP screening, which has only a 25 percent to 30 percent success rate in identifying the condition prenatally. The court allowed the claim to stand, reasoning that lost opportunity claims apply to all medical malpractice actions, including wrongful birth actions. The fact that lost opportunity claims have been recognized in some jurisdictions with respect to wrongful birth actions suggests that some courts might recognize similar claims for failure to offer genetic tests for susceptibility to diseases. No case law exists with regard to such cases, but the logic of such causes of actions would be consistent with general lost opportunity claims. Informed consentDuring the last several decades, courts have increasingly protected patients' rights in medical decision making by recognizing informed consent actions. To bring such a claim, a patient must show that she underwent medical treatment, that she was not informed of a material risk of the treatment, and that she was injured from the risk that was not disclosed (causation). Most courts require disclosure of information such as a description of the patient's physical condition; the purpose and advantages of the proposed treatment; the material risks of the proposed treatment; and the material risks of alternatives, including no treatment. Plaintiffs are increasingly asking courts to expand the scope of information that should be disclosed, with differing outcomes. A few courts have held that some physician-specific risk information is material information. The Wisconsin Supreme Court held that, when different physicians have "substantially different success rates with the same procedure and a reasonable person in the patient's position would consider such information material," this evidence may be admitted at trial (Johnson vs. Kokemoor, 546 N.W.2d 495 (Wis. 1996)). Another court reasoned that a physician's HIV-positive status is a material risk when a physician performs invasive procedures (Estate of Behringer vs. Medical Center, 592 A.2d 1251 (N.J. Super. 1991)). Finally, the California Supreme Court has held that a physician must disclose personal interests (whether research or economic) that are unrelated to the patient's health and that may affect the physician's professional judgment. Thus, in Moore vs. Regents of the University of California, 793 P.2d 479 (Cal. 1990), the court found that a leukemia patient had a claim when the patient's physician failed to disclose his commercial and research interest in the patient's spleen cells at the time when he sought consent for the patient's splenectomy. Courts, however, have not found statistical mortality information to be material. In Arato vs. Avedon, 858 P.2d 598 (Cal. 1993), the California Supreme Court upheld a trial court's decision in favor of the defendant physician, who failed to disclose the statistical life expectancy associated with a particular cancer treatment. The court reasoned that the information was outside the scope of material risks and that, even if the information were material to the patient's nonmedical interest-such as pending business affairs-the scope of information to be disclosed under the informed consent doctrine should be limited to therapeutic information. Increasingly, genetics professionals are discussing the need to inform patients of nonmedical risks associated with genetic testing, such as the possibility of insurance or employment discrimination or adverse psychological reactions to the test results. It is not clear whether claims brought for failure to disclose information related to discrimination would be legally cognizable. Under the rationale of Arato, this sort of information might not be considered "therapeutic" and therefore would not be material. Risks related to psychological reactions, however, might be deemed therapeutic information and therefore within the scope of information that must be disclosed. Cases requiring physicians to disclose their HIV status or success rates raise the question of whether physicians known to have a gene for Alzheimer's, Huntington's, or other neurological or disabling disorders might be required to disclose such information to their patients. If such a case arose, a court probably would consider whether the physician's genetic status posed a risk to the patient at the time the procedure was contemplated; otherwise, it could not be said that the genetic status was material information. A concern might be that some courts would not understand that merely carrying the gene for Huntington's, for example, does not mean someone is affected. What is relevant is whether neurological symptoms have begun to develop; thus, the importance of educating courts about genetics.
Disclosure of Medical InformationTwo separate questions arise concerning the disclosure of medical information:
The first question concerns the confidentiality of medical information and exceptions to the standard rule that medical information must be protected against unauthorized disclosure. Although legislatures are becoming increasingly concerned with protecting the confidentiality of genetic information, the courts have yet to examine this question in the context of genetics. The second question concerns whether the interest in revealing medical information to protect others is so great as to create a legal duty to disclose the relevant information. As discussed in more detail below, a few courts have considered this issue with respect to inherited diseases. Confidentiality of medical informationCourts handle issues of privacy and confidentiality of medical records and information in several different ways, sometimes blurring the distinctions among the various approaches. Courts have relied on constitutional privacy rights, common law privacy rights, privacy or confidentiality statutes, statutorily created testimonial privileges, implied contract, fiduciary duty, and physician licensing statutes as bases for protecting confidentiality of medical information. Under any of these theories, courts analyze the issues on a case-by-case basis, considering the nature and content of disclosure, the person to whom disclosure is made, and the context in which the disclosure is made. Generally, courts presume that medical information is confidential and should not be disclosed to third parties without the patient's consent. In Whalen vs. Roe, 428 U.S. 589 (1977), the Supreme Court noted the existence of two types of constitutionally protected privacy interests, including an "interest in avoiding disclosure of personal matters." Several courts have recognized a federal or state constitutional right of privacy with respect to medical records and information. A great many jurisdictions recognize that unauthorized disclosure of confidential medical information may constitute an actionable claim for invasion of privacy. In Horne vs. Patton, 287 So.2d, 824 (Ma. 1973), the Massachusetts Supreme Court noted that unauthorized disclosure of a personal medical record constitutes an invasion of the patient's right of privacy, since patients often disclose information that is intended to be private and that might be embarrassing, disgraceful or incriminating. Often, these are not common law claims, but are based on statutorily created privacy rights. Quite frequently, the confidentiality of medical information is grounded in testimonial privilege statutes, which shield information from disclosure in discovery or as evidence at trial. These statutes are intended to encourage patients to disclose information that might be necessary for treatment, regardless of how embarrassing or humiliating it may be. In virtually all jurisdictions, the privilege does not exist as common law. As a result, most courts are reluctant to find such a privilege where no statute exists. One problem in basing claims for unauthorized disclosure on testimonial privilege is that a few courts have reasoned that the privilege applies only to matters of evidence to be used in court but not to communications to third parties (Quarles vs. Sutherland, 389 S.W.2d 249 (Tenn. 1965)). Thus, if a physician disclosed genetic information to an insurer, a claim based on the privilege might not be recognized in such jurisdictions. Most jurisdictions adopt the theory that a physician's disclosure of confidential information constitutes a breach of the confidential or privileged relationship between doctor and patient. A few jurisdictions, however, have refused to recognize such a cause of action. (see Collins vs. Howard, 156 F. Supp. 322 (D.C. Ga. 1957)). Courts will either treat this type of claim as a tort action based on a fiduciary duty to maintain patient confidentiality or as an implied breach of contract. Damages in a breach of contract case may not include emotional distress, unless it can be shown that emotional security was the object of the promised confidentiality. In some cases, statutory requirements for licensing of physicians are the basis for claims of unauthorized disclosure of confidential information. For example, in Simonsen vs. Swenson, 177 N.W. 831 (14 Neb. 1920), the court relied on a statute permitting a physician's license to be revoked if the physician was found guilty of unprofessional or dishonorable conduct, such as "betrayal of a professional secret to the detriment of a patient." A few courts, however, view the statutes as "merely [creating] administrative provisions" concerning physician licensing that cannot be the basis for a patient's claim for wrongful disclosure of a medical report (Quarles vs. Sutherland, 389 S.W.2d 249 (Tenn. 1965)). Exceptions to the general rule of confidentialityIn spite of the general presumption that medical information is confidential, courts have found a number of exceptions to the standard protections against disclosure of confidential information. Regardless of the legal theory protecting medical information, courts do not treat privacy or confidentiality interests as absolute, particularly when "supervening interests of society or the private interests of the patient intervene" (Horne vs. Patton, 287 So.2d 824 (Ma. 1973)). Courts have concluded that physicians may disclose medical information without liability under a number of different circumstances.
In child custody disputes, however, some courts continue to uphold the physician-patient privilege, while noting that the state's interest in correctly determining who is the proper caretaker is weighty enough to allow the court and other interested parties to examine the parents' records privately (D. vs. D., 260 A.2d 255 (N.J. Super. Ct. 1969). In contrast, however, a number of courts find that the medical records of parents are protected from disclosure by the physician-patient privilege, period (Best Koshman vs. Superior Court of Sacramento County, 168 Cal Rptr. 558 (Cal. Ct. App. 1980); Wing vs. Wing, 393 So. 2d 285 (La. Ct. App. 1980); Bond vs. Pecaut, 561 F. Supp. 1037 (N.D. Ill. 1983)).
A few of these cases have involved the military's need for information regarding employees' use of drugs or alcohol. In those cases, the courts usually find that the military's security needs may require knowledge of the employee's health status. For example, courts have found no cause of action when physicians informed the military of a patient's alcoholism when the patient was a military employee (Clark vs. Geraci, 208 N.Y.S.2d 564 (N.Y. 1960)), or of a patient's husband's use of alcohol and illegal drugs because the husband held a high-level security clearance position (Howes vs. United States, 887 F.2d 729 (6th Cir. 1989)).
A number of courts do, however, consider medical information privileged or protected by privacy rights even with respect to the other spouse (Khairzdah vs. Khairzdah, 464 So. 2d 1311 (La. Dist. Ct. App. 1985)). Indeed, one court reasoned that a more stringent standard should apply with regard to psychiatric information, since a spouse often seeks counseling for problems that could affect the spousal relationship (MacDonald vs. Clinger, 446 N.Y.S.2d 801 (N.Y. App. Div. 1982)).
The vast number of exceptions to the general rule against disclosure of medical information demonstrates the great leeway one has in arguing for or against a cause of action for unauthorized disclosure of medical information. A few common themes emerge, however. First, information communicated or obtained in the course of treatment is presumed to be protected against unauthorized disclosure unless the interest in disclosing the information is weightier than the patient's interest in avoiding disclosure. The competing interests most likely to supersede the patient's interest in confidentiality or privacy are the interests in 1) protecting parties, 2) justice and prosecuting crimes, and 3) protecting the integrity of the medical profession. A point of key importance in the area of genetics is that, even when statutes prohibit unauthorized disclosure of medical information, employers and insurers might nevertheless have legitimate access to genetic information in some circumstances. Thus, in the often - cited hypothetical case of an airline pilot who tests positive for Huntington's, a court might reason that it is in both the employer's and the public's interest to disclose the information to the employer so that it can monitor the pilot for neurological decline. The legality of such disclosure is even more likely if the employer is the United States military because of national security interests. The willingness of many courts to disclose confidential information to spouses might influence the legality of genetic counselors' disclosing genetic information to spouses. Courts might conclude that disclosure would not be actionable because this information affects reproductive decision making and therefore could benefit the spouse, especially if they rely on cases presuming that medical information should be shared between spouses. Courts might be more reluctant to allow disclosure to siblings, since one presumes less intimacy exists among siblings. The sibling cases, however, usually involve disclosure only for the benefit of litigation, which might be deemed a less pressing interest than disclosure for the benefit of making reproductive decisions. Thus, even in those instances, a court might theoretically decide that a sibling's interests are sufficiently weighty to overcome the patient's interest in nondisclosure.
Duty to WarnThe second aspect regarding the disclosure of medical information concerns whether physicians or health care professionals have an obligation to disclose otherwise confidential medical information or to warn of risks that patients present to third parties. The courts have found a number of instances in which physicians are legally obligated to protect a third party from a patient's medical or psychological condition. In some of the early cases, the information a physician was obligated to share did not concern confidential information. For example, the family might already have known that the patient was sick but not that the illness was infectious. More recently, the issue of confidentiality is avoided when physicians fulfill the duty to protect third parties by informing the patient of the infectiousness of the disease. For example, physicians may fulfill the duty to their patients' sexual partners by informing the patients of the sexually transmissible nature of their disease (Reisner vs. Regents of University of California, 37 Cal. Rptr. 2d 518 (1995) (HIV); DiMarco vs. Lynch Homes-Chester County, 525 A.2d 422 (Pa. 1990) (hepatitis B)). Courts often will impose the duty to protect or disclose information to third parties on the person who actually poses the risk. Several jurisdictions require those who know they are infected with a venereal disease to protect their partners by refraining from sexual intercourse or by informing their partners of their infection (see Meany vs. Meany, 639 So.2d 229 (La. 1994)). Some courts have found that a person infected with a venereal disease may be liable not only to his sexual partner for failing to warn of the disease, but also to foreseeable partners, such as the spouse of his sexual partner (Mussivand vs. David, 544 N.E.2d 265 (Ohio 1989)). In addition to duties imposed by tort law, some states make it a crime to intentionally infect another with HIV (Idaho Code, § 39-608 (1995); Mo. Ann. Stat. § 191.677.1(2) (Vernon 1995)). The duty to warn is particularly interesting when it requires health professionals to disclose medical information that otherwise would be confidential. In the famous case of Tarasoff vs. Regents of University of California, 551 P.2d 334 (Cal. 1976), the California Supreme Court held that psychotherapists may have a duty to warn third parties of the danger of the psychotherapist's patient, even though it would require disclosure of confidential information. Most courts restrict this duty to cases in which the victim is known or identifiable, although a few jurisdictions apply the duty even when there is no specifically identifiable victim. Not all jurisdictions, however, follow the Tarasoff approach. (see, for example, Nasser vs. Parker, 455 S.E.2d 502 (Va. 1995)). A number of courts also have imposed a duty on physicians to warn third parties or take steps to protect them from patients who take medications that might result in dangerous side effects, such as impaired driving abilities (Welke vs. Kuzilla, 375 N.W.2d 403 (Mich. Ct. App. 1985)). Duty to warn in the context of geneticsJust recently, the courts have begun to consider whether physicians or others have a duty to warn in the context of genetics. Two courts have found that physicians have a duty to the families of their patients, although they differ about who should be warned of the risks of heritable illnesses. In Pate vs. Threlkel, 661 So.2d 278 (Fla. 1995), a patient was treated for medullary thyroid carcinoma. Her daughter, who developed the same cancer, alleged that the physician was liable for failing to warn her mother of the risk to her children they could prevent the cancer from developing. The court recognized the claim and held that any duty to warn a patient of a genetic risk extends to the patient's family. Such a duty may not require warning the family directly, however; merely informing the patient of the risk to her family may satisfy it. As the court reasoned, "to require the physician to seek out and warn various members of the patient's family would often be difficult or impractical and would place too heavy a burden upon the physician." In Safer vs. Pack, 677 A.2d 1188 (N.J. Super. 1996), the plaintiff's father died of colon cancer and the plaintiff herself developed colon cancer. She claimed that the father's physician never warned the family of the risk to his children. The court held that the physician had a duty to warn the patient and his family of the heritability of the cancer. It was reluctant, however, to decide "how precisely that duty is to be discharged ... except to require that reasonable steps be taken to assure that the information reaches those likely to be affected or is made available for their benefit." The court reasoned that the duty to warn might not always be satisfied merely by warning the patient; it may require a breach of confidentiality. As the court stated, "[i]t may be necessary ... to resolve a conflict between the physician's broader duty to warn and his fidelity to an expressed preference of the patient that nothing be said to family members about the details of the disease." In a third related case, Olson vs. Children's Home Society of California, 204 Cal App. 3d 1362 (1988), the court found no duty on the part of an adoption agency to warn biological parents that a genetic disease was identified in the child they placed for adoption. After they gave up their first child for adoption, the Olsons gave birth to a son who died of combined severe immune deficiency (CSID). Mrs. Olson later learned she was a carrier. The Olsons contacted CHS and learned that their first son was alive with CSID. They alleged that CHS knew or should have known of the medical diagnosis and that it breached a duty to warn them of this diagnosis. Because the Olsons did not allege "any conduct on the part of CHS during the adoption process ... which would justify Mrs. Olson's alleged permanent condition of dependency or reliance with respect to her future health or that of any children ... she might have," the court found no special relationship between CHS and Mrs. Olson and therefore no duty to warn. These cases suggest that the duty to protect third parties in the context of genetics require, at a minimum, that the genetic counselor warn the patient of the family members' risk of inheriting a disease that afflicts the patient. In some instances the duty to protect third parties might require the physician to warn third parties directly, even if this potentially breaches confidentiality. Whether a court would rule in favor of a duty to warn the relative directly depends on the balance of interests at stake. Courts would likely consider such factors as:
Mandatory TestingThe courts have not considered cases dealing specifically with mandatory genetic testing. A primary question in this area is whether mandatory testing would violate the constitutionally protected, though nonabsolute, right to liberty. An analogous area is mandatory testing is mandatory treatment. As a general rule, the common law has long recognized an individual's right to refuse unwanted medical treatment. In addition, the Supreme Court has stated that one can infer that "a competent person has a constitutionally protected liberty interest in refusing unwanted medical treatment" Cruzan vs. Director, Missouri Department of Health, 497 U.S. 261(1990). Moreover, the vast majority of states have statutes that allow competent individuals to refuse life-sustaining medical treatment. Thus, medical treatment generally cannot be mandated. For example, Jehovah's Witnesses usually may refuse medical treatment, even if the results are fatal. The right to refuse medical treatment, however, is not absolute and must be balanced against relevant state interests. In a few cases, courts have found mandatory treatment constitutional based on the theory that the state interest in protecting the public health and safety outweighed the individual's liberty interests. In a well-known case, Jacobson vs. Massachusetts, 197 U.S. 11 (1905), the Supreme Court upheld a Massachusetts regulation requiring Cambridge residents to be vaccinated against smallpox. The Court was persuaded by the fact that smallpox was a prevalent and growing problem and that liberty interests are not absolute and subject to restrictions for "the common good." In another case, Reynolds vs. McNichols, 488 F.2d 1378 (l0th Cir. 1973), a plaintiff challenged a city ordinance requiring the detention, examination and treatment of people reasonably suspected of having a venereal disease. The court upheld the ordinance as constitutional because the legislative intent was to control the incidence of venereal disease, which was reaching "virtually epidemic proportions." The balancing of interests becomes particularly complex when there are fetal-maternal conflicts. Some courts will order medical procedures to save an "unborn child" over the mother's objections (in re Application of Jamaica Hospital, 491 N.Y.S.2d 898 (N.Y. Sup. Ct. 1985) (blood transfusion); Jefferson vs. Griffin Spalding County Hospital Authority, 274 S.E.2d 457 (Ga. 1981)(C-section)). Other courts reason that the mother's right to refuse medical treatment should prevail (in re Baby Boy Doe a Fetus, 632 N.E.2d 326 (Ill. Ct. App. 1994)). Mandatory genetic testingCurrently, mandatory genetic testing is primarily limited to newborn screening (NBS) and testing certain criminal offenders in some states. Newborn screening is widely accepted, largely because the goal is to detect and treat or ameliorate illness in newborns. Every state has newborn screening legislation for phenylketonuria (PKU) and different combinations of other diseases, such as hypothyroidism, galactosemia, maple syrup urine disease, homocystinuria, biotinidase deficiency, cystic fibrosis, adrenal hyperplasia, tyrosinemia, toxoplasmosis, hemoglobinopathy and sickle cell anemia. NBS generally is mandatory. In at least three states-including Michigan, Montana, and West Virginia-screening is mandatory without exception. Many states, however, have provisions for parental objections on religious or other grounds. Parents, however, rarely are told of their right to refuse; thus NBS is virtually mandatory in many states. In other jurisdictions, statutes state explicitly that NBS is voluntary. In two states-Missouri and South Carolina-parents who refuse to allow their children to undergo NBS are at risk of criminal penalties. Although many support newborn screening, there is growing concern regarding some of the approaches. Some worry about the propriety of testing for conditions like cystic fibrosis, for which there is no therapeutic benefit. Several commentators also are concerned about the lack of voluntariness, especially if the goal is to screen as many newborns as possible. Some evidence suggests that the voluntariness of testing may lead to higher rates of actual screening. For example, in states that screen the highest percentage of newborns, testing is voluntary, whereas states with the lowest yield have mandatory testing with exceptions for religious objections. California has in place something related to mandatory genetic screening. It requires that physicians offer MSAFP screening to all pregnant women. Although the testing is not mandatory per se, in practice it is akin to mandatory: physicians are so concerned about liability for failure to offer the test that they are either highly directive or, in many cases, fail to obtain consent at all. As a result, many patients do not realize that testing is voluntary. Although only a few groups currently are subject to mandatory genetic testing, a number are required to be tested for HIV or sexually transmitted diseases (STDs). For example, the federal government requires HIV testing for all active duty military personnel as well as State Department and Peace Corps personnel stationed outside the United States. In addition, Louisiana requires HIV testing for a marriage license. In some states, prostitutes are screened for sexually transmitted diseases. Many states require HIV testing for prisoners or criminal offenders. And in February, New York became the first state to require newborns to be screened for HIV and mothers to be notified of the test results. In effect, New York requires indirect testing of mothers. The above discussion suggest that courts would most likely uphold mandatory genetic testing if a demonstrated public health risk could be reduced through testing. Such a justification often is used for HIV and STD screening and has long been the rationale for newborn screening. Given the strongly protected right to avoid treatment and the fact that genetic diseases are not contagious-and therefore do not present threats of "epidemics,"-mandatory genetic testing for groups other than newborns and criminals would be unlikely to survive constitutional challenges. Two conditions probably are necessary for mandatory genetic testing to survive constitutional challenges: 1) the disease is sufficiently prevalent and severe to constitute a public health problem, and 2) effective treatment is available. This situation is most likely to arise as the gap between diagnosis and treatment closes, as we discover genes for diseases that are more prevalent than most "traditional" genetic diseases, and as treatments become available to prevent or slow the development of genetic diseases. As the concept of genetic disease expands to include conditions such as heart disease or diabetes, genetic illness may become a more widespread public health concern and, theoretically, more susceptible to mandatory testing. With a national history of ill-conceived mandatory testing schemes, however, legislatures would be wary of enacting such statutes and courts would be reluctant to find that mandatory testing served the public interest.
Testing MinorsAlthough much case law addresses parental medical decision making on behalf of minors, no cases deal with parental decisions concerning genetic testing per se. Traditionally, the law has held that parents or legal guardians should make treatment decisions for minors because minors are considered incapable of giving legal consent to medical procedures. This tradition stems in large part from the presumption that parents know what is best for their children and that the state should not interfere with the parent-child relationship without a compelling need. Parents, however, generally do not have unbounded discretion to make medical decisions for their children. In Parham vs. J. R., 442 U.S. 584 (1979), a case concerning the institutionalization of children in mental hospitals, the United States Supreme Court stated that "parents cannot always have absolute and unreviewable discretion to decide whether to have a child institutionalized." Several exceptions exist with respect to a parent's general right to make medical decisions for minors. In an emergency situation, health care professionals can treat minors without parental consent. "Emancipated minors" statutes also allow certain minors to be treated without parental consent if the minors are married, have children or are financially independent and living away from home. In addition, a few states recognize the "mature minors" exception, which holds that a minor who is sufficiently mature is legally competent to assess the risks and benefits of a proposed treatment and to make reasoned medical decisions. Finally, minors have been allowed to make independent decisions with respect to treatment for venereal disease, drug and alcohol abuse, pregnancy-related care, mental health, and contraception. Parental refusal to consent to treatment of childrenCourts have addressed cases in which parents, usually on religious grounds, refused to consent to medical treatment that a physician deemed appropriate for the child. For example, Jehovah's Witnesses may refuse to consent to blood transfusions for their children. In these cases, courts analyze whether treatment should be ordered based on the "best interests" of the child. Courts will consider whether the condition is life threatening and whether the proposed treatment subjects the child to great risk. Thus, courts generally order blood transfusions when parents refuse to consent. When the minor's condition is not life threatening, however, courts generally will not order treatment. Parental insistence on treatmentMost cases concerning parental decision making involve parental refusal of treatment and hospital or physician challenges to their decision. Rarely do cases arise in which parents request treatment that a hospital refuses. One exception concerns parents who decide to have one child serve as an organ or bone marrow donor for another child. These cases are particularly interesting because the medical procedure offers no medical benefit to the potential donor child. As a result, hospitals often seek court determinations as to whether the donation is appropriate. Courts analyze the problem in a few different ways:
Genetic testing of minorsAlthough some controversy surrounds the approaches to newborn screening, most support this type of "testing," even when mandatory. Similarly, testing minors for diagnostic purposes is not controversial, since it is clearly within the child's best interests. The genetics professional community, however, generally disfavors presymptomatic testing for conditions that have no treatment. Several professional organizations recommend that "timely medical benefits to children should be the primary justification for genetic testing in children and adolescents" and that, if medical benefits are uncertain or unavailable, genetic testing should be deferred. Commentators cite a number of potential dangers posed by nontherapeutic, presymptomatic testing of minors:
A number of different possible scenarios might lead to conflicts surrounding testing for minors. A case could be made that this information is relevant to reproductive decision making, and therefore teens should be able to consent to genetic testing. On the other hand, if the teenager is not pregnant or planning a pregnancy, courts may view the matter differently. Even if a test is within the standard of care, a physician who is morally opposed to or concerned about the propriety of a test is not legally bound to perform the test, as long as she informs the patient of the test and, possibly, as long as she refers or directs the patient to those who would provide the test. Even if the physician supports genetic testing, courts might require the minor's assent, especially if the failure to test will not result in serious harm to the child. A few have tried to argue that parents have a constitutional right to insist on genetic testing based on cases granting parental authority with respect to educational decision making (see, for example, Wisconsin vs. Yoder, 406 U.S. 205 (1972)). These arguments are not particularly persuasive given the Supreme Court's hesitation to expand constitutional rights and because the medical profession has a great deal of discretion in establishing the appropriate standard of care. In abortion cases, for example, the Supreme Court describes the constitutionally protected interest not as just the woman's right to decide, but as the right of the woman and doctor to decide together. Thus, if a physician found no therapeutic benefit in testing, a court would be unlikely to find a constitutionally protected parental right to have his or her child tested.
Legal Basis for Genetic Counseling Professional StandardsMost of the case law dealing with professional standards focuses on wrongful birth or life claims. However, statutes in three states-Colorado, California and Maryland-require nondirective genetic counseling. The statutes offer little guidance as to what exactly this entails. There also are no cases interpreting this statutory requirement. The best source of professional standards comes from accreditation criteria and professional codes as discussed below.
Professional GuidelinesFew formal guidelines define professional standards for health care professionals who work in the field of genetics. The accreditation criteria and the code of ethics for genetic counselors, however, define some key requirements for quality genetic counseling. Graduate programs in genetic counseling that seek accreditation by the American Board of Genetic Counselors must show that they train genetic counselors to develop:
The code of ethics makes similar demands. Under the code, genetic counselors must:
In addition, some consensus has developed over the years with regard to appropriate approaches to difficult genetic counseling issues. For example, professional groups have given a great deal of attention to the appropriate approach to testing for late-onset conditions, such as Huntington's disease (HD), and testing of minors. Many centers follow a number of the recommendations issued by the International Huntington Association and the World Federation of Neurology Research Group on Huntington's Chorea. Several of the recommendations are notable.
It is interesting to note how different these approaches to counseling are from the traditional recommendations for genetic counseling. In particular, the recommended counseling is highly directive with respect to certain decisions. For example, prenatal testing should not be done without an intention to terminate affected pregnancies. The recommendations also are highly directive as to whether and how testing is done: one must be free of "serious psychiatric conditions," one must wait at least one month before deciding whether to be tested, and one should have a companion through all stages of testing. Legal enforcement of professional guidelinesIt is not clear whether the accreditation criteria, the code of ethics, and the development of a professional consensus would be legally enforceable. In some states, legal protection against noncompliance is unlikely. Courts might be guided by case law addressing whether the model rules of professional conduct for attorneys may be used as evidence in legal malpractice suits. One approach is to exclude the model rules from evidence, particularly since the rules state explicitly that they "should not give rise to a cause of action," should not "create any presumption that a legal duty has been breached," and they "are not designed to be a basis for civil liability" (Rizey vs. Carpenter, 830 P.2d 646 (Wash. 1992)). At the other extreme, courts treat the rules as conclusive evidence to establish ethical duties that an attorney owes a client (Rizzo vs. Haines, 555 A.2d 58 (Pa. 1989)). Finally, there is the middle approach, where the rules may be admitted into evidence, but violating them neither constitutes negligence per se nor creates a legal duty (Pressley vs. Farley, 579 So.2d 160 (Fla. Dist. Ct. App. 1991)). Courts have sometimes created legal duties for medical professionals, in part on the basis of medical ethics. For example, some courts have relied on the AMA's principles of medical ethics to find a legal duty to maintain patient confidentiality (Horne vs. Patton, 287 So.2d 824 (Ala. 1973)). Finally, the standard of care in medical malpractice cases is based primarily on medical testimony as to what the custom is within the profession. The accreditation criteria, code of ethics, and professional consensus on various issues provide some evidence of what this may be in genetics. Although the code of ethics, accreditation criteria, and professional consensus might provide evidence of the legal standard of care for genetics professionals, some questions remain as to whether they really create new legal obligations. Medical professionals are already held to a duty to have appropriate knowledge of the field in which they practice, to preserve patient confidentiality, and to obtain informed consent. The professional codes of behavior may impose some "new" kinds of obligations, such as duties to counsel nondirectively or to counsel with cultural sensitivity. Claims based on a breach of these duties are not likely to succeed, however, for a few reasons. First, it is not fully clear what kinds of actions or omissions would constitute a breach of either duty. In addition, there are problems of causation. If a counselor were directive, for example, but fully informed the client of her alternatives, could the client succeed in saying that she would have made different decisions had the counselor been neutral? Probably not, since informed consent law does not require that information be presented in a particular manner, so long as it is clearly communicated. Moreover, courts are unlikely to assume that patients cannot make their own decisions in the face of different points of view as long as all the options have been disclosed.
Employment DiscriminationVery little case law deals specifically with discrimination on the basis of genetic information, although the area of disability discrimination provides some guidance. Disability discrimination legislation exists at the federal and state levels. The federal Rehabilitation Act of 1973 (29 U.S.C. § 794 (1988)) protects "otherwise qualified handicapped individuals" from being excluded from participation in, ... denied benefits of, or ... subjected to discrimination under any program or activity receiving Federal financial assistance." A handicapped person is defined as one who "has a physical or medical impairment which substantially limits one or more of such person's major life activities, has a record of such impairment, or is regarded as having such an impairment." The Americans with Disabilities Act (ADA) of 1990 (42 U.S.C. §§ 12101-12213 (1988)) broadened the scope of disability protection by prohibiting discrimination in public and private employment. Much of the defining language remains the same. A number of states have disability laws that protect individuals with specific diseases, including HIV infection and, sometimes, genetic conditions. A seminal case in this area is School Board vs. Arline, 480 U.S. 273 (1987), in which the Supreme Court ruled that an individual afflicted with an infectious disease (tuberculosis) was protected by the Rehabilitation Act of 1973. In Estate of Behringer vs. Medical Center, 592 A.2d 1251 (N.J. Super. 1991), a New Jersey court considered whether curtailment of an HIV-infected physician's surgical privileges was unlawful discrimination under New Jersey law. Although the court recognized that AIDS is a handicap under federal and state discrimination legislation, the court concluded that the hospital's policy served an "evident public health purpose," since there was a "reasonable probability of substantial harm" if the physician continued to perform invasive procedures. As a result, the policy was sustained, even if its effect was discriminatory. Application of legislation to geneticsRecently, commentators have considered whether the ADA affords protections to individuals with genetic predispositions. A court has yet to rule on this question. In 1995, however, the Equal Employment Opportunity Commission (EEOC) issued an official interpretation of the applicability of ADA to genetic discrimination: "'[D]isability' applies to individuals who are subjected to discrimination on the basis of genetic information related to illness, disease, or other disorders. Covered entities that discriminate against individuals on the basis of such genetic information are regarding the individuals as having impairments that substantially limit a major life activity. Those individuals, therefore, are covered by the third part of the definition of 'disability"' (EEOC Compliance Manual, Volume 2, EEOC Order 915.002). In addition, the manual's example of someone who would be covered under the ADA is an individual with a genetic susceptibility to colon cancer. Commentators suggest that whether the ADA applies to genetics testing probably depend on the nature of the condition.
Many of the theories that would protect against genetics discrimination require that the employer have a particular viewpoint-such as regarding the individual as having an impairment. This might present difficult evidentiary problems: How does the plaintiff prove that she was "so regarded?" In addition, although the EEOC ruling offers some persuasive evidence that the ADA covers genetics discrimination, it is not binding. Moreover, simply being considered handicapped under the ADA or other such legislation is not sufficient to succeed in a claim of discrimination. The plaintiff must demonstrate that she is "otherwise qualified." To do so, the plaintiff must show that she is able to perform the essential functions of the position, either without any assistance or with "reasonable accommodation," which raises additional issues regarding the reasonableness of the assistance she requires.
Insurance DiscriminationA great deal of legislation prohibiting insurance discrimination based on genetic status has recently been enacted or is pending at the state and federal levels. Once again, very little case law exists with respect to the interpretation of these statutes. This area is made more complex by the fact that many employers self-insure. Although states regulate health insurance, self-insured employer plans are covered by ERISA, and therefore are exempt from state insurance laws and regulations. Thus, many employers may be able to avoid anti-discrimination state law with respect to their insurance plans. Cases involving employer self-insured plansIn McGann vs. H & H Music Co., 946 F.2d 401 (5th Cir. 1991), cert. denied, 506 U.S. 981 (1992), an employment group insurance plan had a $1 million policy limit for all medical benefits. When the employer learned that the employee was diagnosed with AIDS, however, the employer reduced the lifetime limit to $5,000 for AIDS-related conditions, although it retained the $1 million maximum for all other conditions. The Fifth Circuit held that, under ERISA, the employer was free to modify or exclude the coverage of certain conditions. Although the ADA did not apply in McGann, it may offer protection against McGann-type discrimination. The EEOC's "Interim Guidance," issued in 1993, states that, under the ADA, employers can make distinctions in health benefits that are not disability based-such as preexisting condition clauses, lifetime or other universal limitations, experimental drugs and treatment, and elective surgeries and certain medical procedures-as long as they are not used exclusively for a particular disability. The employer also must demonstrate that the limitation is not a "subterfuge for discrimination." Thus, group insurance plans that reduce benefits with respect to particular conditions have been found to violate the ADA (Carparts Distribution Center, Inc. vs. Automotive wholesaler's Association of New England, Inc., 37 F.3d 12 (1st Cir. 1994) (claim for reducing maximum AIDS-related benefits from $1 million to $25,000); (Henderson vs. Bodine Aluminum, Inc., 70 F.3d 953(8th Cir. 1995) (claim for failing to pay for high dose chemotherapy with autologous bone marrow transplant for the treatment of breast cancer). Some categories of conditions are not so protected, however. Fertility treatments may be excluded from health plans under the ADA, since some courts do not consider infertility an impairment that substantially affects a major life activity (Kraul vs. Iowa Methodist Medical Center, 95 F.3d 674 (8th Cir. 1996)). In addition, mental conditions may be treated differently from physical illness under disability leave and health benefit programs (Parker vs. Metropolitan Life Insurance Co., 1997 WL 431351(6th Cir. 1997)). Although courts have not considered these issues with respect to genetic conditions, it seems plausible that courts would treat genetic conditions more like AIDS or cancer than infertility. Genetic conditions fall more clearly within the scope of medical conditions, whereas commentators differ as to whether infertility constitutes a medical condition. If courts treat genetic predisposition like AIDS or cancer, employers would be prohibited from offering limited benefits for particular genetic diseases.
ConclusionThe recent advancements in genetics pose a number of challenges to medical professionals and society, as well as possible conflicts of interest among family members and other individuals. One can only begin to conjecture as to how courts may address these challenges and conflicts. In many ways, the problems are not new: genetics information is much like other medical information in that it can reveal deeply personal information that may, in some cases, be of value to third parties. When analyzing legal issues that arise in the context of genetics, courts would do well to draw from the well-established legal doctrine whenever the analogies are appropriate. Yet because genetic information can be predictive and because it often reveals something about health risks to family members, some of the issues may be more complex than those involving traditional medical information. As a result, in sorting out the legal problem before them, courts should always keep in mind whether these differences are relevant. Attentiveness to nuances in this area is crucial so that courts and legislatures avoid assuming too quickly that genetics issues are completely similar to or completely different from those in other areas of medicine. Given the complexities of this emerging field, courts and legislatures should move forward with care and caution.
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