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Reaping the Full Health Benefits of the Human Genome: The Duty to Warn and The Need to Establish a Comprehensive Federal Regulatory Structure for Genetic Testing

Margaret Harrison

April 30, 2002

Class of 2002

Third Year Written Requirement

& Food and Drug Law

Course RequirementReaping the Full Health Benefits of the Human Genome: The Duty to Warn and the Need to Establish a Comprehensive Federal Regulatory Structure for Genetic Testing

TABLE OF CONTENTS

Reaping the Full Health Benefits of the Human Genome: The Duty to Warn and the Need to Establish a Comprehensive Federal Regulatory Structure for Genetic Testing

By Margaret Harrison[1]

“Although researchers are providing the map to the human genome, it will be up to lawyers and other policymakers to determine where that map will lead.” [2]

I. Abstract

This paper discusses the need for a comprehensive federal regulatory structure governing genetic testing. Particularly, the article proposes a legal standard to govern physicians’ duty to warn their patients about the implications that their genetic test results hold for relatives. The article advocates that this legal standard be tied to clinical guidelines developed by a national legislatively authorized commission. The author also suggests that a limited privilege exist for physicians or genetic counselors to warn family members directly when serious, imminent harm could be avoided thereby. The article also notes that such a legal standard is only justifiable if genetic tests’ safety and efficacy are assured by adequate regulatory oversight by the Food and Drug Administration (FDA) and other relevant federal agencies. The article concludes by discussing policy and legal arguments against greater FDA oversight of genetic testing and asserting that the FDA does have jurisdiction and should exercise it to regulate in-house genetic tests, – the so-called “home brews” – which constitute the majority of genetic tests provided.

II. Introduction

The Human Genome Project[3] and associated research [4] has been heralded as the beginning of a revolution in medicine [5] and raised new ethical and legal quandaries for physicians and policymakers. [6] Genetic information partially breaks down the barriers between public health and traditional health care in several ways. First, genetic information is neither entirely private nor entirely public but is rather a hybrid between the two, opening up the possibility of potential external benefits beyond those of the individual patient. [7] Second, genetic information promises to open up a whole new opportunity for preventative health care, which has traditionally been the focus of the public health system rather than the private health care system.[8] Anticipating that many ethical and other complications would arise from the Human Genome Project, 5% of its funds were designated to the Ethical, Legal and Social Implications of the Human Genome Project Commission (ELSI) for research on the ethical, legal and social impacts of the new and evolving technology.[9]

The ethical quandaries created by the genetic testing industry’s recent and anticipated growth highlight the most important of the ethical, legal and social complications. Genetic tests reveal information about a patient’s family members, who share the patient’s genes, as well as the patient. Some unfortunate situations arise where an individual’s privacy right conflicts with her relatives’ desire to have full information about their health risks.[10] Unfortunately, despite the prescience of the founders of ELSI, the common law on patient confidentiality of genetic test results has evolved before ELSI reached any meaningful, concrete consensus on that issue. Two courts have already held that a doctor has a legal duty to warn her patient’s relatives when her patient’s diagnosis reveals that the patient’s relatives have a high probability of developing a serious, but treatable, genetically-linked disease.[11] As genetic knowledge increases, more such cases will arise. [12]

These legal developments have occurred amidst an environment of uncertainty regarding the true clinical and analytical validity of these tests. As Bernard Schwetz D.V.M, Ph.D. , Acting Principal Deputy Commissioner of the Food and Drug Administration (FDA) observed: “There are hundreds of genetic tests in development and available in the United States. Only six have been submitted to and approved by [the] FDA.”[13] Thus, both doctors and patients lack adequate knowledge on the safety and efficacy of genetic testing as well as an understanding of the relevant legal duties of disclosure and confidentiality. [14] This general uncertainty about both the science and the accompanying ethical, legal and social implications of genetic testing hampers this industry’s growth – in particular, its application to a wider audience and its promise of increasing preventative measures and eventually lowering health care costs. A coherent, practical legal framework is essential to realize the full potential of genomics in an efficient and socially responsible manner. [15]

Several articles have advocated for and against a duty to warn patients’ relatives when genetic test results reveal that the relatives may be at risk of a serious, but preventable, disease . [16] They have discussed the relative lack of knowledge about genetics within both the medical community and the public, and the limitations of many existing genetic tests. However, few, if any, of these articles have addressed the need to link the legal guidelines governing the confidentiality of genetic test results to explicit clinical guidelines and federal regulation of the quality and efficacy of genetic testing. This failure is another example of the unfortunate lack of dialogue between the legal and scientific and medical communities.[17] This article attempts to bridge that gap by addressing the legal as well as the clinical viewpoints in developing and supporting its recommendations.

III. The Proposed Standard

The author proposes that the following legal standard should govern the confidentiality of genetic test results across the United States and that health care providers should inform a patient of this legal standard before conducting a genetic testing service as part of the informed consent process. Doctors or genetic counselors generally should not disclose the results of genetic tests to anyone other than the patient without the patient's consent (presuming the patient is a competent adult[18] ). However, a doctor or genetic counselor will have a legal duty to warn her patients when their genetic test results reveal that:

  1. their immediate family members’ health may be at significant risk from a serious (e.g. life threatening or severely debilitating) disease that is
  2. preventable[19] if detected early or whose progress/symptoms can be significantly slowed/reduced,[20] and where
  3. the expense of screening and/or preventative measures is relatively high so that universal screening and treatment do not make sense.[21]

In very narrow circumstances, a physician will have a privilege to warn the immediate family members directly – even against the wishes of the patient. However, this privilege will only exist when the harm is significant, imminent and preventable, though not curable if caught too late, and when the benefits of a warning outweigh any psychological or other harm caused by notification. In addition, before exercising the privilege the physician or genetic counselor must have reason to believe that the patient will not warn the relevant family member[s] herself. Finally, the disclosure should be “limited to the information necessary for diagnosis or treatment of the relative.”[22]

The following limitations will apply to both the duty and the privilege. First, the privilege and duty will only exist for those genetic tests that have been approved by the FDA as safe and efficacious and where a national commission (described below) has recommended that such a duty be found.[23] Second, the physician or genetic counselor must inform the patient of the privilege as part of the informed consent process and before exercising it. Finally, a physician or genetic counselor should only be responsible for following the clinical guidelines that prevailed for the duration of the physician-patient relationship. [24]

The complex medical issues involved moves the author to propose that the legal duty should be closely tied to explicit clinical guidelines developed by a national, congressionally authorized commission rather than tied to the “national medical standard of care,” which is often murky and difficult for courts to define. [25] It may be difficult for this commission to keep up with rapid advances in genetic testing, however, privacy concerns merit a more conservative approach regarding disclosure of potential risks to family members than that applied to the genetic testing of individuals for diagnostic or therapeutic purposes.[26] In addition, a national, public approach will also help to expand the public’s and the medical community’s trust in and knowledge of evolving genetics technologies. [27]

The content of the legal duty defined by this commission must be closely tied to the process of approving genetic tests as safe and efficacious to maximize efficiency and coordination within the legal framework governing genetic testing.[28] Thus, the aforementioned national commission should serve as an advisory panel to the FDA to help develop the content of the required informed consent that should accompany specific genetic tests using material submitted by the test developer in the FDA approval process. [29] A condition of FDA approval could be that these informed consent guidelines accompany genetic tests as the “adequate instructions for use” of this evolving diagnostic technology.[30] In cases, where the chartered commission determines that genetic counseling[31] is necessary, the genetic counselor should inform the patient of the aforementioned standard’s application to the patient’s case and the counselor’s limited privilege to warn the patient’s family members directly when appropriate.

In 1999 the Secretary of the Department of Health and Human Services (DHHS) chartered a committee, the Secretary’s Advisory Committee on Genetic Testing (SACGT) and asked it to evaluate the current oversight of genetic testing and propose recommendations regarding alternatives. As part of this task, the SACGT has already begun to consider the possible connections between FDA regulation of the quality and efficacy of genetic testing and greater oversight of the informed consent process.[32] This experience and its broad-based membership make the SACGT a good candidate to serve as the commission charged with collaborating with the FDA to flesh out the application of the aforementioned legal standard to particular genetic tests. If the SACGT members do not wish to serve this function, the FDA commissioner could charter another commission and/or use the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee that it established in 1999. However, regardless, it is essential that the commission constituted include both clinical and legal experts to address the full range of issues implicated by the standard and to help ensure that the standard is accepted and applied by both the legal and medical communities.

IV. Details of the Proposed Standard That Should Be Guided By Clinical Knowledge

Clinical knowledge should be used to define the proposed standard’s ambiguous terms, such as: A) what is a “genetic test;” B) how “serious” does the disease need to be to trigger the duty; C) who qualifies as an “immediate” family member and D) how “significant” must their risk be.

Obviously our current genetic and general clinical knowledge is imperfect. While we have decoded the human genome and have identified approximately 4000 rare diseases that are tied to a single mutation in a single gene, only a fraction of these diseases can be detected using commercially available genetic tests. [33] Indeed, even where tests exist, geneticists often do not yet understand the full implications of genetic test results, nor do they know why diseases manifest themselves at varying levels of severity in different individuals. [34]

This uncertainty around genetic testing makes it even more important for physicians and patients to understand their limits and benefits. [35] If the committee finds that the uncertainty inherent in genetic tests warrants imposing very few duties to warn, the standard may have limited impact initially. However, as genetics knowledge develops, the standard can create a fluid mechanism whereby the law evolves in line with medical advances rather than behind them. A clear public standard tied to clinical guidelines that determine when warnings are warranted, and the warnings’ appropriate scope, will minimize confidentiality breaches and the number of potential law suits as well as help to disseminate information on genetic testing and genetic diseases to clinicians and the public. Finally, the knowledge and certainty provided by a public, explicit standard could also hopefully enhance patients’ and physicians’ comfort in using genetic testing.[36]

A. Defining Genetic Tests

For the purposes of the proposed standard, genetic tests are defined using the Genetic Task Force definition as:

The analysis of human DNA, RNA, chromosomes, proteins, and certain metabolites in order to detect heritable disease-related genotypes, mutations, phenotypes, or karyotypes for clinical purposes....Tests for metabolites are covered only when they are undertaken with high probability that an excess or deficiency of the metabolite indicates the presence of heritable mutations in single genes. Tests conducted purely for research are excluded from the definition, as are tests for somatic (as opposed to heritable) mutations, and testing for forensic purposes.[37]

The Commission’s clinical guidelines will define for which genetic tests a legal duty to warn exists under the proposed standard.[38]

B. Defining Serious: Fleshing Out What Diseases Are Covered

The notion of “serious”- i.e. what diseases warrant a warning - is highly subjective. In the early 1990’s, various national genetic boards around the world surveyed the certified geneticists in their respective regions regarding the definition of “serious.” [39] A majority (72%) of U.S. and Canadian respondents asserted that individual patients should define “serious.”[40] 24% of U.S, 18% of Canadian, 37% of European, and 65% of Latin American respondents suggested that professional associations develop lists of serious disorders.[41] In addition, eight percent of respondents favored a legal definition of serious. (4% in the U.S.) 16% asserted that a national ethics committee should develop the definition. Finally, 14% opined that hospital ethics committees should define serious, and 28% stated that individual practitioners should define serious.[42] Despite this apparent lack of unanimity in the medical genetics community, as noted below, it is not impossible to include patient input in developing the recommendations regarding what diseases are “serious” enough to warrant a warning. Indeed, the proposed legal standard respects the majority’s (within the U.S.) view that patients should decide on the seriousness, and hence the import, of their test results by defining the duty as a duty to warn the patient of the genetic test’s implications for the patient’s family members. The proposed standard also responds to the other respondents’ apparent desire for certainty and consensus within the medical and legal communities.

As noted, it is possible and desirable to integrate patients’ and physicians’ input in developing the clinical guidelines. In 1997, the Massachusetts Medical Society voted to “conduct a public survey of Massachusetts residents to measure public opinion regarding legislation affecting the confidentiality and privacy of medical records.”[43] They plan to use the survey results “to educate legislators and to inform the media about public opinion regarding privacy and confidentiality legislation.”[44] While the commission may decide that a public survey is not the most-efficient way of gathering public input, some public input should be included in the commission’s deliberations. The notice and comment requirements that govern the agency rulemaking process arguably help to ensure that some public input is included in the agency’s deliberations.[45] The fairly broad-based response to the SACGT’s recommendations regarding oversight mechanisms for genetic testing, which included genetic testing consumers, laboratories, geneticists, academics, genetic counselors, trade and professional groups, and consumer groups[46] , indicate that public participation could well be greater than that of the public in most rulemaking activities. Thus, the commission should make use of this form of garnering public input as well as others they may decide upon.[47]

In general, the rough outlines of the proposed standard – “life threatening or severely debilitating” and high screening and prevention costs– should guide the commission in developing their guidelines. The commission should include physicians, genetic counselors, representatives from consumer groups, and other relevant individuals to ensure that the clinical guidelines are usable and make legal, ethical, and social, as well as clinical, sense.[48]

C. Defining Immediate Family Members

The legal duty’s potential beneficiaries should be limited to minimize both the physicians’ burden and confidentiality concerns. Generally the duty will only extend to immediate family members, which includes sisters, brothers, children, and parents. However, the clinical guidelines will indicate in which cases a relative’s risks are likely to be significant enough to warrant a warning and can decide that certain diseases warrant warning other first degree relatives, such as cousins, aunts and uncles.[49]

D. Defining Significant Risk

In general, genetic tests should have a very high analytic and clinical validity[50] and the disease should have fairly high penetrance[51] before a legal duty to warn should be imposed. However, the degree of risk deemed “significant” may vary depending on the severity of the harm that could be avoided as decided by the commission. The standards governing presymptomatic genetic testing and mere susceptibility testing should vary, because the predictive value of the latter is usually uncertain. [52] As noted above during the discussion of the appropriate interpretation of “serious,” however, broad-based input should be included in the decisions on what risks are deemed significant so that the specific applications of the standard make legal, ethical, and social, as well as clinical, sense.

V. Details of the Standard That Should Be Guided by Legal Doctrine

There are additional details of this rule that should be informed by legal doctrine, for example: the informed consent process, the disclosure process, liability and enforcement issues, and source of law considerations.

A. The Disclosure Procedure

The disclosure procedure should be threefold. First, before undertaking genetic tests as part of the informed consent process, physicians should notify their patients of the potential relevance of the results for family members and of their legal duties and privileges.[53] Second, particularly given positive test results, if the physician does not have the time or expertise to explain the results and their implications for the patient’s family members, she should refer her patient to a certified genetic counselor.[54] Finally, the physician or genetic counselor should encourage the patient to inform the affected family members, or their primary care providers if possible, in a manner similar to the AIDS partner notification model described below. Only after all efforts to elicit voluntary disclosure by the patient have failed may the physician consider whether it is appropriate to exercise her limited privilege to warn her patient’s relatives directly.[55]

Generally, there are two models for AIDS partner notification programs: the “provider notification model” and the “partner notification model.”[56] In the provider notification model health care providers are responsible for notifying the patient’s sexual partners directly.[57] Meanwhile, in the partner notification model, providers tell patients to warn at-risk sexual partners, and the patient is responsible for the actual notification.[58] Most proponents of AIDS partner notification systems prefer the provider notification model because it ensures that the partners are actually and effectively notified of their risks.[59]

However, the partner notification model is preferable to the provider notification model in the genetic disease context for several reasons. First, as the patient is not the cause of the family members’ disease risk and as many genetic diseases do not have the strong public stigma associated with AIDS, there is a greater likelihood that the patient will indeed inform the relevant family members than in the AIDS case.[60] Second, in the genetic disease case there is less ethical and legal justification for violating the patient’s confidentiality since the patient is not the cause of the third parties’ disease risk. Third, the model better accommodates the relatives’ right not to know. [61] Knowledge of one’s genetic status may involve many psychological costs, as well as risk of employment and insurance discrimination and even domestic violence in some cases.[62] Patient are more likely to be aware of their family members’ proclivities and so are less likely to violate their family members’ “right not to know.” Also, the patient is more likely to know about extenuating circumstances that make notifying family members inadvisable. Finally, there is no public health crisis related to genetically linked diseases, which could justify the high relative and actual costs of creating a provider notification system.[63]

B. Liability and Enforcement Issues.

Perhaps the most controversial issue is whether this legal duty should in fact be a legal duty or a legal privilege.[64] A legal duty is defined as an action required by law, which can be enforced by the duty’s beneficiary. For example, almost all states require physicians to report suspected cases of child abuse.[65] In contrast, when a party has a legal privilege, the party may, but is not required to, carry out the privileged action. Thus, the privilege holder is immune from suit both for exercising and failing to exercise the privilege.[66] For example, while a doctor may help a stranger in an emergency, the doctor is not required to do so under the so-called “Good Samaritan” laws of most states.[67]

The proposed standard recommends that the physician have a duty to warn the patient for the benefit of the family members, which shall be tied to clinical guidelines. The legal duty will ensure the proper scope of enforcement. Also, unlike the current duty established by the courts, the clinical guidelines will be public, explicit and limited in scope so that doctors will not have any “unfair” surprises or undue burdens, making enforcing the duty more justifiable.[68] So long as doctors follow the clinical guidelines, they will not be exposed to any liability. Thus, the huge liability costs of requiring a legal duty touted by duty-to-warn opponents,[69] and the subsequent large increases in the cost of genetic testing services, should not arise.

In contrast, a physician should only have a legal privilege to warn family members directly when genetic test results reveal serious, but preventable, and imminent risks to the family members. A legal duty to directly warn the patient’s family members would be unduly burdensome, given the mobility of American society and the fact that some family members are estranged and have lost touch. In addition, the proposed standard advocating only a narrowly limited privilege to warn family members directly is more consistent with current public attitudes about the importance of privacy and confidentiality relative to more communal values.[70] The intermediate solution is also appropriate given the quasi-public and quasi-private nature of the information,[71] the fact that the regulation of the practice of medicine traditionally has been an area of state control,[72] and general sentiments within the medical profession.[73] If, at some point, American values shift, the legislature or the national commission could reconsider the scope of the physician’s duty to warn.

  1. Source of Law Considerations

A national legislatively authorized commission should develop the standard’s clinical guidelines in cooperation with relevant medical societies and the Food and Drug Administration, which approves the safety and efficacy of genetic tests. Discussing the resolution of ethical issues related to genetics research, the Court in Diamond v. Chakrabarty stated: “ [the] process involves the balancing of competing values and interests, which in our democratic system is the business of elected representatives. Whatever their validity, the contentions now pressed on us should be addressed to the political branches of the Government, the Congress and the Executive, and not to the courts.”[74] The decision as to what general policy should govern how to balance the privacy interests of patients with the interests of their at-risk relatives in accessing information about their disease risks also involves balancing conflicting societal values – that of privacy and confidentiality against disease prevention and efficient health care utilization.[75] Thus, this decision should likewise be decided by the legislature and the executive rather than made on the ad hoc basis by the courts as has been done thus far.[76] Also, at least as regards test-specific factors, there is a certain amount of evidence that is universal; thus fairness, notice and other rule of law considerations[77] support establishing a clear rule that courts can apply to ensure that there truly is a “national standard of care” in genetic testing. In addition, as mentioned previously, the public national standard will have the positive externality of communicating information about evolving genetic technology to physicians throughout the country. Given the current poor state of physician knowledge about this new field and the dearth of certified genetic counselors, this externality is extremely valuable.[78]

In contrast, as the correct application of the physician’s limited privilege to warn family members directly depends on diverse, case-specific factors, the court’s more flexible approach should determine the privilege’s scope. As the choice of whether to exercise a legal privilege is voluntary, advance warning is less essential to preserve our fundamental notions of fairness in the law. Also, where harm is imminent, the flexibility of a court-developed standard is preferable so physicians will be free to apply the latest clinical developments of which they are aware. Finally, the current public discomfort with genetic testing, makes it preferable that doctors err on the side of confidentiality rather than disclosure so that patients are not dissuaded by privacy concerns from using evolving genetic technology.[79]

VI. The Legal Perspective: Review of the Relevant Case Law

A. Introduction

Many critics of a duty to warn emphasize the importance of doctor-patient confidentiality and argue that establishing a legal duty to warn would be an unprecedented legal development. Yet numerous cases have held that a patient’s right to confidentiality is not absolute and can be overcome by a strong public interest in disclosure.[80] In the last twenty-five years, a public policy exception to the doctor-patient confidentiality requirement has been developed in a string of cases regarding psychiatric disorders and communicable diseases (especially sexually transmitted diseases).[81] More recent case law has expanded this exception to other circumstances where the patient is not the cause of the at-risk relative’s disease risk.[82] The only two cases specifically dealing with genetically transferable diseases have held that a doctor does have a duty to warn his or her patient’s at-risk relatives.[83]

B. Early Case Law

In 1958, a Utah court recognized that a physician’s duty of confidentiality could be trumped when a physician felt that it was necessary to protect a third party’s compelling interest.[84] In Barry v Moench ,[85] the Utah court held that: “the responsibility of the doctor to keep confidence may be outweighed by a higher duty to give out information, even though defamatory, if there is a sufficiently important interest to protect.”[86] In that case the interest to be protected was the happiness of a young woman whose parents were considering betrothing her to the physician’s patient. Admittedly the case is anachronistic as regards the grounds justifying the breach of the physician’s confidentiality duty. However, the principle that physician-patient confidentiality is not absolute but rather must give way to “the rule of good sense and customary conduct of people motivated by good will and proper consideration for others”[87] reappears in later case law establishing a duty to warn. In modern parlance, the rhetoric of a “proper consideration for others” has often been recast as “the strong public interest in promoting public health.” [88]

C. Psychiatric Case Law

The duty to warn those at risk from a psychotherapist’s patient was first clearly established in Tarasoff v. Regents of the University of California .[89] In Tarasoff, a psychotherapist’s patient threatened the life of a young woman whom the patient later killed. The woman’s family sued stating that the psychotherapist had a duty to warn her and the police of his patient’s threat and dangerous tendencies. The California Supreme Court upheld the existence of a legal duty, stating:

[T]he public policy favoring protection of the confidential character of patient-psychotherapist communications must yield to the extent to which disclosure is essential to avert danger to others. The protective privilege ends where the public peril begins. Our current crowded and computerized society compels the interdependence of its members. In this risk-infested society we can hardly tolerate the further exposure to danger that would result from a concealed knowledge.[90]

An analogy can clearly be drawn between the highly personal nature of psychiatric disorders and genetic disease status. Thus, a standard in which the well being of at-risk individuals trumps the patient’s interest in even very personal information has precedent.

D. Infectious Disease Case Law: AIDS

Using similar reasoning in Reisner v. Regents of the University of California ,[91] a California court held that a doctor’s duty to warn third parties includes those who are foreseeably at risk of contracting a serious communicable disease due to the patient’s contagious status. In Reisner a man sued his girlfriend’s doctor for failing to inform her that she had contracted HIV from a contaminated blood transfusion. Due to the doctor’s failure to warn the patient of her HIV status, she subsequently became intimately involved with the plaintiff. The plaintiff then contracted AIDS as a result of his unprotected sexual activity with the doctor’s patient. The California Supreme Court rejected the physician’s argument that he did not owe a duty to the plaintiff. The court stated “California law already imposes a duty to third persons and the only arguably new issue in this case is whether that duty is the same when the third person's identity is unknown to the physician and not readily ascertainable."[92] However, the court added that "[o]nce the physician warns the patient of the risk to others and advises the patient how to prevent the spread of the disease, the physician has fulfilled his duty--and no more (but no less) is required." Thus, while the Court did expand the physician’s duty to third parties to include those not specifically identifiable, it also held that the doctor could fulfill the duty by notifying his or her own patient of their status and the risks of transmission. The doctor did not need to notify the third parties directly, an important limitation.[93]

E. Expansion of Duty to Warn To Cases where the Patient is Not the Agent of Disease Transmission

In a 1993 Tennessee case, Bradshaw v. Daniel [94] a court expanded the physician’s duty to warn to cover a case where the doctor’s patient was not the cause of the third party’s disease risk. In Bradshaw , the court held that the physician-patient relationship imposed an affirmative duty on a physician to warn identifiable third persons in the patient's immediate family of risks that are foreseeable as a result of his patient's illness.[95] Similar to what happens in the case of genetic diseases, the diseased status of the patient in Bradshaw merely revealed information relevant to another party’s – in this case his spouse’s - disease risks.

The Bradshaw court based its holding on several common law principles. First, the court stated that “duty is not sacrosanct in itself, but is only an expression of the sum total of those considerations of policy which lead the law to say that the plaintiff is entitled to protection.”[96] Second, the court cited the infectious disease cases, which held that a physician’s legal duties – particularly as regards negligence - are not confined to his patients, but include foreseeable beneficiaries of the doctor-patient relationship.[97] Finally, they observed that the magnitude of the foreseeability and the severity of the harm that could be averted with the help of a warning warranted imposing a duty to warn on the physician.[98]

F. Genetic Disease Case Law

In Pate v. Threlkel [99] the duty to warn was first extended to the genetic disease context. In Pate a woman sued her mother’s physician for failing to warn her mother that the disease he was treating her for, medullary thyroid carcinoma, was genetically linked. The daughter alleged that Dr. Threlkel knew, or should have known, that his patient’s children were at risk of developing the disease and that he should have warned his patient to have her children tested. She further asserted that his failure to do so resulted in the plaintiff developing the disease herself, which, if diagnosed and treated early, could have been cured. The doctor moved to dismiss the complaint alleging that his duty did not extend to third parties beyond his patient. The state trial and district courts granted his motion. The Florida Supreme Court reversed and remanded, holding that the physician did owe a duty to his patient’s children; they were beneficiaries of the established medical standard of care and fell “within the zone of foreseeable risk” created by the doctor-patient relationship.[100]

Nevertheless, consistent with Reisner, the court held that the doctor could fulfill the duty by notifying the patient of the risks to her children. There was no need to warn the patient’s children directly as: “[t]o 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.”[101] Thus, this case went no further than Reisner in defining the duty’s scope; the patient’s right to confidentiality still trumped the doctor’s duty toward third parties.

The second case addressing whether a doctor had a duty to warn his or her patient’s relatives of their risk of having a genetically-linked disease, Safer v. Estate of Pack ,[102] broadened the scope of the physician’s duty to warn. In Safer, a woman sued a surgeon who had treated her father for colon and multiple polyposis for failing to warn of the risk to her health. In her complaint, the plaintiff alleged that the disease’s hereditary nature was known when the physician was treating her father. She further argued that prevailing standards of care required the physician to warn those at risk of developing the disease since “early examination, monitoring, detection and treatment ... would provide opportunity to avoid the most baneful consequences of the condition.”[103] The New Jersey Supreme Court endorsed the Florida Supreme Court’s holding in Pate that a physician had a duty to warn of “avertible risk from genetic causes.”[104] The court also went further than the Florida Supreme Court stating, “We decline to hold as the Florida Supreme Court did in Pate v. Threlkel ... that, in all circumstances, the duty to warn will be satisfied by informing the patient. It may be necessary, at some stage, 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.”[105] Unlike the Florida Supreme Court, the New Jersey Supreme Court did not feel this was an undue burden. It opined:

Although an overly broad and general application of the physician’s duty to warn might lead to confusion, conflict or unfairness in many types of circumstances, we are confident that a duty to warn of avertible risk from genetic causes, by definition a matter of familial concern, is sufficiently narrow to serve the interests of justice. Further, it is appropriate... that the duty be seen as owed not only to the patient himself but that it also “extend[s] beyond the interests of a patient to members of the immediate family of the patient who may be adversely affected by a breach of that duty.”[106]

Thus, the Safer Court recognized that genetic information is not fully private information and so the physician’s duty should expand to cover relevant family members. Yet, although the holding is arguably consistent with the apparent legal trend towards gradual expansion of the physician’s duty to warn, some found this ruling to be a disturbing and unprecedented extension of the law. [107] Unfortunately, the case’s facts were not developed enough for the court to define the scope of the duty with any specificity, which may exacerbate some commentators’ concerns.

VII. The Medical Perspective: Physician Attitudes Towards a Duty to Warn in the Genetic Disease Context

There is profound ambivalence within the medical community on whether there should be a legal, or even an ethical, duty to warn a patient’s relatives of their risk of having a genetic disease. Generally, physician organizations and government bodies composed of physician experts supporting an ethical duty to warn at-risk relatives call for a standard similar to that proposed by the author.

A. The Massachusetts Medical Society’s Policy Statement

An example of a state medical society policy expressing a position similar to the author’s is the Massachusetts Medical Society’s policy, which states:

The possibility that genetic information derived about a patient might be of clinical importance to relatives or other third persons does not alter the physician’s duty of confidentiality to his or her patients. The physician should , however, inform patients who are considering a genetic test about the potential importance of the data that could be derived therefrom to relatives. On very rare occasions, a physician may reveal otherwise confidential genetic information to a third person if withholding the genetic information derived from the patient will likely cause imminent and serious harm, injury or danger to that particular third person. [108]

The Society’s statement does not give specific examples of when a physician should reveal private genetic information to third parties, implying that the Massachusetts Medical Society would support having the proposed privilege’s scope determined on a case-specific basis.

B. The American Society of Human Geneticists’ Policy Statement

The American Society of Human Geneticists (ASHG) advocates a policy similar to the Massachusetts Medical Society’s.[109] In their policy statement on the confidentiality of genetic testing results they argue:

At a minimum, health-care professionals should be obliged to inform patients about the implications of their genetic test results and about the potential risks to their family members. This duty to inform the patient about familial implications, both prior to genetic testing and again if the patient refuses to communicate results, is paramount. It is presumed that most patients, provided with the proper information, will inform their relatives of potential risks so that early monitoring, detection, and treatment are available to them.[110]

However, the ASHG recommendations are more detailed about their proposed limited disclosure privilege; the ASHG policy outlines various issues that a physician, geneticist, or other relevant health care professional should consider in deciding whether to exercise the disclosure privilege. They state: “[d]isclosure should be permissible where attempts to encourage disclosure on the part of the patient have failed; where the harm is likely to occur and is serious and foreseeable; where the at-risk relative(s) is identifiable; and where either the disease is preventable/treatable or medically accepted standards indicate that early monitoring will reduce the genetic risk.”[111] They add, “[t]he harm that may result from failure to disclose should outweigh the harm that may result from disclosure. Failure to warn may lead to irreparable harm if opportunities for avoidance, treatment, or prevention of the genetic condition are thereby limited. The harm that may arise from nondisclosure should outweigh the potential psychological, social, financial, and discriminatory harm that may arise from disclosure.”[112]

In developing its policy the ASGH reviewed the relevant ethical and legal opinions both within the U.S. and abroad.[113] The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1983) [114] and the Institute of Medicine Committee (1994) reached the similar conclusion that there should be a limited privilege to disclose confidential genetic information in certain circumstances.[115] The ASGH also observed that: “the majority [of foreign legal standards] are ... in favor of a limited disclosure of genetic test results (without the consent of the patient) in cases where the harm to at-risk relatives is grave and imminent and where the disclosure of information could result in effective medical intervention.”[116]

C. The ELSI Task Force on Genetic Testing Recommendation

The Task Force on Genetic Testing created by the NIH and Department of Energy made a similar recommendation regarding the confidentiality of genetic testing information:

Health care providers have an obligation to the person being tested not to inform other family members without the permission of the person tested except in extreme circumstances. Disclosure by providers to other family members is appropriate only when the person tested refuses to communicate information despite reasonable attempts to persuade him or her to do so, and when failure to give that information has a high probability of resulting in irreversible or fatal harm to the relative . When test results have serious implications for relatives, it is incumbent on providers to explain to people who are tested why they should communicate the information to their relatives.[117]

D. Example of Non-US Professional Position: The Canadian Clinical Perspective

Likewise, a prominent group of Canadian genetics counselors advocated for a limitation on the otherwise strict standard of confidentiality when information is available that family members could use to avoid harm.[118] They discussed the standard that should govern the confidentiality of BC gene testing results as follows:

It should be an explicit policy that any person who comes in for testing should be told that any female siblings will be informed that they should be tested if the proband [one already tested] has the BC gene, or if there is a significant probability that her mother had the BC gene....The reason for adopting this policy is that it will not discourage many people from coming in for testing, because, if a woman suspected that she might have the BC gene, it would be irrational not to be tested. It will also allow the testing facility to avoid the moral dilemma that might arise in the unusual case in which the proband does not want any of her female siblings informed.... Having the explicit public policy just outlined avoids this moral dilemma by making it clear from the start that, in coming in to be tested, one waives confidentiality to the extent necessary to help prevent preventable death and disability. Apart from this explicit exclusion, the standard policy of confidentiality would be maintained.[119]

E. The World Health Organization’s Policy Statement

Finally, the World Health Organization recommends that “[t]he implications of the test results for the individual and family must be clarified beforehand,” and that at-risk relatives be contacted when individual patients refuse to communicate the relevance of results to their relatives, especially when effective remedies and/or preventative measures are available.[120]

In sum, most relevant bodies support a standard like the proposed standard, which requires doctors to warn their patients when genetic test results reveal information relevant to their family members. Most also support a limited privilege to warn family members directly, similar to that proposed by the author. This relatively broad consensus will hopefully ensure the acceptance and effectiveness of the proposed standard.

VIII. The Need for Regulation of Genetic Testing

“In order to achieve widespread adoption of genetic screening, every member of the health care chain must understand and believe in its value, both clinically and financially.” [121]

“Where experiment or research is necessary to determine the presence or the degree of danger, the product must not be tried out on the public, nor must the public be expected to possess the facilities or the technical knowledge to learn for itself of inherent but latent dangers.” [122]

Despite the general consensus noted above, establishing a legal duty and a limited privilege to warn is only justifiable if the underlying genetic tests that doctors and patients are relying on provide accurate and clinically useful information. Otherwise, many unnecessary lawsuits, costly prophylactic health care interventions, and needless psychological and other harms will result.[123] Indeed, the potential positive results from genetic testing – early detection and intervention and, hopefully, an ultimate reduction in overall health care costs – will only be possible if physicians and patients trust and understand genetic testing results.

A. The Genetic Testing Market

The genetic testing industry has been growing at a dramatic rate and this dramatic growth is expected to continue as researchers continue to mine the human genome for clinically useful applications.[124] Currently, the genetic testing industry generates close to $319 million in revenues and the market is expected to grow to $779 by 2005 and perhaps to $1 billion by 2006.[125] Market concentration is low in the genetic testing industry, and most of the competition occurs at the lab level.[126] There are about 523 registered labs that engage in genetic testing and 907 diseases for which genetic testing is available (531 available clinically, 376 on a research basis).[127]

B. The Current Legal Regime Governing Genetic Testing

Despite the rapid expansion of the genetic testing market, there is little specific genetic testing-related regulation. The Institute of Medicine Committee on Assessing Genetic Risks found “that although adequate [federal] legislative authority exists to oversee the quality of genetic testing, this authority is not in fact being implemented for genetic testing.”[128] They also noted the limitations of state regulation of genetic testing in their 1994 report. “Rigorous state licensing provides protections to the citizens of that state, but continued reliance on the states will not afford equal protection to citizens of all states. Separate programs in each state could result in duplication of effort or in competing and, in some instances, conflicting laboratory standards.”[129] One main reason for inadequate federal oversight is that most genetic tests are created within the same laboratory where they are used and marketed as in-house laboratory testing services, (so-called “home brews”) and, so far, the FDA has chosen not to regulate these in-house genetic tests directly.[130] Another reason is that thus far the CMS and CDC entities regulating clinical laboratories have not established requirements specific to genetic testing, although this may change soon.[131]

1. FDA Regulation of Genetic Testing

The Food and Drug Administration (FDA) has authority under the Medical Devices Amendments of 1976)[132] and the Safe Medical Devices Act of 1990[133] , to regulate genetic testing kits that are marketed in interstate commerce.[134] Lab tests sold as test kits to multiple labs require FDA approval of a pre-market application (PMA), which substantiates the test’s safety, and analytical and clinical validity.[135] The Division of Clinical Lab Devices in FDA’s Office of Device Evaluation is in charge of regulating the clinical sensitivity and clinical specificity requirements governing diagnostic testing kits.[136] However, the Assessing Genetic Risks Committee of the Institute of Medicine found that "[o]nly a small proportion of genetic tests in widespread use have been reviewed by the FDA.”[137] To create the infrastructure to allow it to do so, in 1999, the FDA established the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to advise the FDA in the area of DNA-based diagnostics.[138]

One of the reasons for inadequate FDA oversight stems from the FDA’s failure thus far to regulate “home brews.”[139] While the FDA has stated that it has authority to regulate in-house genetic tests, it has principally elected not to exercise this authority.[140] The only regulation of home-brews is the FDA’s limited regulation of their active ingredients, analyte-specific reagents (ASRs), which are subject to general controls such as Good Manufacturing Practice requirements (GMPs).[141] With few exceptions, current regulations of ASRs do not require PMA, although regulations do prohibit direct-to-consumer marketing of most “home brew” tests, which are classified as restrictive devices, thereby limiting their broad application.[142]

2. CLIA Regulation by the CMS Division of Laboratories and Acute Care Services and the CDC Division of Laboratory Systems

Under the Clinical Laboratory Improvement Amendments (CLIA)[143] , the CMS and CDC were delegated authority to develop standards for laboratory certification.[144] A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.[145] CLIA is user fee funded; therefore, all costs of administering the program must be covered by the regulated facilities.[146]

CLIA regulations govern the analytical validity of lab tests, which are either denoted of “moderate” or “high” complexity.[147] Labs conducting moderate or high complexity tests must comply with general quality control standards and “specialty-specific” quality control standards, including proficiency testing.[148] A laboratory test that has not been categorized by complexity “is considered to be a test of high complexity until PHS (Public Health Service), upon request, reviews the matter and notifies the applicant of its decision.”[149] Furthermore, CLIA regulations require that the laboratory directors have certain qualifications and provide for on-site inspections every two years by the CMS to evaluate the adequacy of CLIA-certified laboratories' quality control and internal proficiency testing systems.[150] However, CLIA-certification depends on relevant laboratories filing a request for certification,[151] and studies have found that many laboratories conducting genetic testing services are not aware of the CLIA-certification requirement and/or have not submitted CLIA-applications. [152]

Currently, the CLIA doesn’t address the analytical or clinical validity and utility of genetic tests[153] or issues related to informed consent and genetic counseling, although there are some plans to address some of these key issues.[154] For example, the Clinical Laboratory Improvement Advisory Committee (CLIAC) has recommended that specific requirements for laboratories performing genetic testing be developed and promulgated. [155] In addition, the CLIAC is trying to develop a Quality Institute responsible for ongoing monitoring of lab quality, including those performing genetic testing.[156] Generally, CLIA activities focus on the analytic, not the clinical, validity of laboratory tests.[157] However, the CDC is leading an interagency effort to examine how a public-private partnership can be formed to collect, review, and disseminate data on the clinical validity of genetic tests.[158]

3. Activities of Other DHHS Agencies[159]

a. National Institutes of Health (NIH)

NIH helps to fund genetics research and also has produced consensus statements and technical assessment reports including one on the development and assessment of newborn screening for sickle cell disease, one on genetic testing for cystic fibrosis, and one on the screening for and management of PKU.[160]

b. AHRQ (Agency for Healthcare Research and Quality)

The AHRQ’s Technical Assessment Program evaluates the pros and cons associated with health care interventions (both diagnostic and therapeutic) to inform consumers, health care providers, and payers.[161] The AHRQ also supports the US Preventive Services Task Force, which evaluates more than 100 interventions that prevent illnesses and conditions, including screening tests for genetically determined conditions, and recommends which interventions should be used.[162]

4. Other Actors: State Governments, Professional Organizations, and Patient Advocacy Groups

a. States Governments

The state governments also exercise oversight over genetic testing by controlling the licensing of the personnel and facilities that perform genetic tests.[163] In addition to enforcing their own regulations and operating state public health laboratories, state-operated lab licensure programs are often deemed equivalent to the federal CLIA program, and so are responsible for many federal quality assurance activities. Some states, such as NY and CA, have promulgated regulations that are more stringent then federal CLIA requirements.[164] Appendix B contains a table summarizing some of the key state legislative activity in the genetic testing area. Only recently have a few states, such as Nebraska and South Dakota passed statutes that establish specific requirements for genetic testing and/or genetic testing laboratories.[165]

b. Professional Organizations[166]

Professional Organizations, such as the National Committee on Clinical Laboratory Standards, (NCCLS), the American College of Medical Genetics (ACMG) and the College of American Pathologists (CAP), also provide oversight in voluntary partnership with the CMS and CDC by developing laboratory standards and clinical guidelines governing genetic testing. For example, the ACMG has drafted guidelines regarding recommended uses of particular tests and methodologies and has collaborated with CAP to develop proficiency tests for certain genetic tests. Other professional organizations involved in creating guidelines and recommendations include the American Society of Human Geneticists (ASHG), the National Society of Genetic Counselors [NSGC], the American Academy of Pediatrics, and the American College of Obstetrics/Gynecology. However, the IOM Assessing Genetic Risks Committee noted that “[m]any diagnostic laboratories do not now participate in voluntary quality assurance and proficiency testing in genetics.”[167] The Committee recommended that compliance with voluntary quality evaluations should be published to encourage participation in these programs.[168]

c. Patient Advocacy Groups

Patient Advocacy groups also participate in the development of standards and guidelines through advocacy and monitoring of health care practices.[169] For example, the Genetics Alliance “is a non-profit tax-exempt organization founded in 1986 as an international coalition of genetic lay advocacy groups and health organizations.”[170] The Genetics Alliance has submitted comments to the SACGT regarding the adequacy of oversight over genetic testing.[171] In addition, Genetic Alliance board members serve on the SACGT and the NIH’s Council on Public Representatives (COPR), which reviews and advises on NIH priorities and mechanisms for public input to NIH decisions.[172]

5. The Secretary’s Advisory Committee on Genetic Testing (SACGT)

In June 1998, following the recommendation of the NIH-DOE Task Force on Genetic Testing and the ELSI, the SACGT was chartered to advise the Department of Health and Human Services (DHHS) on the medical, scientific, ethical, legal, and social issues around genetic testing. [173] In June 1999, David Satcher, the Assistant Secretary for Health and Surgeon General, asked the SACGT to evaluate the adequacy of the oversight of genetic testing and to recommend options for additional oversight.[174] Among the charges that the Secretary of DHHS gave to the SACGT was to develop a list of clinical guidelines for selecting and administering a genetic test.[175] SAGCT is considering the tests’ purposes, collection procedures, accuracy, reliability and clinical utility in developing the guidelines, and it also plans to propose guidelines on standardizing the terminology used by labs for reporting test results.[176]

C. Gaps in Current Regulation of Genetic Testing

1. The Information Asymmetry Problem Generally in the Health Care Industry

In 1962, Kenneth Arrow first articulated his theory that the asymmetry of information between patients and doctors creates market imperfections. He asserted that, as patients cannot adequately judge the technical quality of the health care they receive, market prices do not adequately reflect health care quality and so there is often a “race to the bottom.” [177] Some empirical evidence supports these assertions.[178] Arrow concluded that certain non-market mechanisms subsequently arose to address these imperfections and to protect patients, such as credentialing and professionalism.[179]

Some academics have asserted that the effect of asymmetric information on the health care market has been exaggerated and is diminishing as more and more medical information becomes available on the Internet.[180] However, Arrow and others question whether the Internet fully eliminates the true source of asymmetry of information.[181] There are insufficient controls over the quality of Internet information, and patients generally still lack the professional training and judgment of professionals.[182]

2. The Significant Information Asymmetry Problem in the Genetic Testing Industry and SACGT Recommended Responses.

The problem of information asymmetry is especially relevant in the complex area of genetic testing. Genetic tests are very difficult to interpret and both physicians and the public lack adequate knowledge and expertise to evaluate this new and evolving technology.[183] It is unlikely that the market alone will produce full and adequate information in the near future, and some government oversight seems advisable.[184] As one SACGT member supporting FDA regulation of the informed consent requirements in genetic testing stated, “We ... have to understand that the test developers do not have a natural incentive to make this information available, not in the way in which people need to make rational decisions.” [185]

The SACGT identified a number of gaps in the availability of information regarding genetic testing, which impede the genetic testing market’s development and which could be corrected by developing adequate oversight mechanisms.[186] For example, there is no systemic mechanism to review evidence and determine the safety and efficacy of genetic tests before they’re introduced into clinical practice.[187] Once tests become part of standard clinical practice, it is difficult, mainly because of privacy concerns and the federal government’s inability to regulate individual practitioners, to retrieve data on their use and outcomes.[188] The SACGT recommended that FDA oversight be extended to all genetic tests – “home brews” as well as testing kits and that a multidisciplinary body be constituted to review currently marketed genetic tests for clinical efficacy and to develop and publish guidelines for their appropriate use.[189]

A second problem is that only some data on the safety, clinical validity and utility of genetic tests is publicly available.[190] The SACGT recommended that an interagency body directed by the CDC, in collaboration with the FDA, other federal agencies, and private sector organizations should develop a publicly available database of all evolving post-market information on the validity and utility of clinical tests.[191]

Thirdly, under current CLIA regulations, a lab decides when it has met the CLIA requirement for analytical validity, which is only later evaluated for accuracy during a CLIA inspection.[192] SACGT believes that this ex-post validation of the analytical validity of genetic tests is inadequate given the complexity of the information they generate and the fact that they often indicate risk information for otherwise healthy individuals.[193] Even the genetic testing industry is concerned over the quality gaps in genetic testing services.[194]

Fourth, the current inadequate system of CLIA inspection can not ensure the continuing validity of genetic tests, which may alter when manufacturing methods and/or materials are changed. Thus, the SACGT recommended that stronger incentives are needed to re-qualify tests when manufacturing methods and materials change to demonstrate equivalent analytical validity performance.[195]

Fifth, currently government agencies have taken little enforcement action against false or deceptive claims involving genetic tests.[196] The SACGT therefore advised that current FDA and FTC regulations should be enforced in the area of genetic test promotion and marketing.[197] As one recent commentator observed, “while direct consumer marketing should be permissible, regulations mandating disclosure of pertinent information regarding predictive value and accuracy in testing, as well as the requirement that consumers seek physician referral to genetic counselors before testing, must be implemented.”[198]

Finally, there is currently no requirement for informed consent regarding a genetic test’s risks and benefits and written documentation thereof.[199] The current trend towards increasing the stringency of informed consent requirements and decreasing physicians’ therapeutic privilege,[200] and inadequate understanding of genetics by many physicians[201] necessitates greater information dissemination to both patients and physicians. Thus, many, including the SACGT, support using formally trained and licensed genetic counselors as the intermediaries in some cases and greater provider and public education regarding genetics and genetic testing.[202] In addition, the SACGT recommends that written informed consent be required for certain genetic tests and that some measure of informed consent be required for all genetic tests.[203]

3. Other Gaps in the Regulation of Genetic Testing Services

Most government bodies commissioned to evaluate the ethical, legal, and social implications of genetic testing have not fully addressed the issue of the appropriate scope of warnings to genetic testing recipients’ relatives.[204] In particular, these bodies have not confronted how the general lack of physician expertise in the area and the dearth of genetic counselors makes the traditional medical model, which presumes physician expertise, inadequate to govern the scope of the duty to warn a patient’s relatives.[205] For example, the SACGT simply noted the implications for family members and that the information provided about family members’ disease risks were some of the potential benefits and costs of genetic testing about which the testing recipient should be informed.[206] The SACGT, subsequently observed that family members may or may not wish to have access to this information, without commenting on whether there should be a duty or privilege to warn the family members in certain circumstances.[207] Meanwhile, the Genetic Task Force agreed with the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research and the Institute of Medicine regarding the narrow grounds justifying provider direct disclosures to relatives.[208] The Task Force also noted the need to inform the patient of familial implications “prior to genetic testing.” [209] However, the Task Force did not discuss the need for test-specific guidelines and/or explain how providers would determine the content of their legal duties regarding the confidentiality of genetic test results. This failure to address the specifics of the legal standard governing familial notification of genetic risks in part stems from the uncertainty surrounding current genetics knowledge and in part from the view dictated by existing medical paradigms, which exclusively focus on the physician-patient relationship, largely ignoring third parties.[210]

D. Explanations For The Reluctance to Regulate Genetic Tests Further

Several factors could explain why both state and federal government agencies have not fully tackled the need to regulate genetic testing further.[211] First, from the state’s perspective, it is unclear whether the FDA will step in preemptively and make state regulation unnecessary, or if in fact the Medical Device Amendments (MDA) to the FDCA actually already pre-empts state regulation in this area.[212] Second, from both the state and federal perspective, there is no consensus on the issue of “genetics exceptionalism” making this a difficult and controversial issue.[213] Third, many are reluctant to impose the costly and time consuming FDA regulatory structure that governs prescription drugs and medical devices on this exciting new technology, especially given concerns over rising medical costs.[214] Fourth, the most controversial issues involve the service rather than the “product” aspects of genetic testing,[215] and some question the FDA’s authority to regulate these service aspects and the “home brews” that make up the majority of genetic tests offered. [216] The FDA itself, although uncertain of the scope of its power to regulate informed consent,[217] has asserted that it has the power to regulate the “home brews” but has chosen not to exercise that power.[218] Given all of the aforementioned complications and its scarce resources,[219] the FDA has chosen to focus its resources on more traditional and less controversial areas. [220]

E. Policy Arguments Supporting Greater Federal, Especially FDA, Regulation of Genetic Testing

There are several policy reasons that support greater federal regulation of genetic testing generally. First, there are the efficiency gains that can be reaped through establishing “reasonable national public standards” governing genetic testing rather than relying on diverse state laws.[221] The healthy national development of the genetic testing industry would likely be served rather than harmed by facing a uniform set of laws and regulations.[222] Current differential treatment of genetic testing kits and in-house genetic tests hampers the development of the genetic test kit market[223] and makes it less desirable to pursue economies of scale through creating several regional centers. [224] Thus, genetic testing remains largely concentrated in a few states rather than widely available.[225]

In addition, the current regulatory vacuum does not adequately protect consumers against potentially false and misleading genetic tests, and the FDA seems the appropriate regulatory body to address this problem.[226] The FDA is experienced in monitoring the safety, efficacy, and labeling requirements of medical diagnostic tests in general and has some experience now in regulating genetic testing kits and certain active reagents used in in-house genetic tests.[227] Meanwhile, state departments of health and many other federal agencies lack this experience and expertise.[228] Some have argued that development of genetics-specific CLIA regulations is sufficient to protect the public against inadequate genetic tests.[229] However, as noted by the SACGT, the NIH-DOE Genetics Task Force and others, CLIA only governs the analytic validity of genetic tests [whether the test accurately measures the gene allele it alleges to], not the clinical utility or validity.[230] In addition, the agency primarily responsible for administering CLIA, CMS, does not have expertise in approving the clinical validity and utility of diagnostic tests.[231] Thus, it does not appear that expansion of CLIA regulations alone would be sufficient, though they would be a desirable complement to greater FDA regulation.[232]

F. Policy Arguments Supporting A Comprehensive FDA Regulatory Structure Linking Oversight of the Clinical Validity and Utility of Genetic Testing, and Informed Consent.

Policy arguments and legal doctrine support including informed consent requirements in FDA genetic testing regulation. First, in the area of genetic testing, safety and efficacy are inextricably bound as some of the main dangers that can arise from genetic testing are unnecessary and potentially dangerous prophylactic treatments due to false positive results and inappropriate complacency from false negative results.[233] One can argue that appropriate warnings are part of the “good manufacturing practice” of diagnostic testing. As one SACGT member noted: “The FDA is the only place that can assemble all of the information that is absolutely necessary for informed consent to occur. We also have to understand that the test developers do not have a natural incentive to make this information available, not in the way in which people need to make rational decisions.” The same policy considerations that gave rise to the Corporate Practice of Medicine Laws support government regulation to ensure that patients are protected - information asymmetry and the lack of altruistic commitment (on the part of commercial genetic test manufacturers in this case). [234] In addition, the recent trend toward a more rigorous informed consent doctrine, the lack of general physician expertise in this area, and the dearth of genetic counselors, suggest that regulation is needed to ensure that physicians and patients receive sufficient information to determine what is in the patients’ best interests.

The FDA, in collaboration with other federal bodies, appears to be the most efficient entity to regulate the above areas, as it already has the authority to collect information on the safety and efficacy of genetic tests from those creating them.[235] The FDA does not have the jurisdiction to regulate actual physician practice.[236] However, the FDA can regulate the reports of genetic test results to ensure they provide adequate warnings about the risks and limitations of the genetic test, and include information about the import of the genetic test results for relatives.[237] As noted, the proposed national committee charged with developing the clinical guidelines regarding a physician’s duty to warn her patients of the relevance of genetic test results for family members could advise the FDA on the appropriate content of informed consent requirements for particular genetic tests.[238] In addition, CLIA periodic inspections could examine whether the required written information on the risks, limitations, and implications of genetic testing is actually being given to physicians who order the tests and/or to patients along with their test results.

G. Analysis of Alleged Legal Barriers to Greater FDA Regulation of Genetic Testing

1. Arguments that the FDA Does Not Have Authority to Regulate In-House Genetic Tests

Many opponents of greater FDA regulation of genetic testing argue that FDA regulation of in-house genetic testing would constitute regulation of the practice of medicine, which the FDA does not have jurisdiction to do.[239] These opponents assert that there is substantial evidence in the FDCA legislative history that Congress did not intend to give the FDA the power to regulate the "practice of medicine."[240] They often add that, in general, the FDA itself has avoided taking activities that appear to be regulating the practice medicine and has implied that it doesn't have that authority.[241] Critics of the expansion of FDA authority may furthermore argue that even if Congress had purported to give the FDA such authority it would be an unwarranted intrusion on the states’ traditional prerogative to regulate the health and safety of their populations and so would be unconstitutional.[242] However, federal regulation of genetic tests as regards test-specific factors is both statutorily authorized and constitutional.

2. FDA Regulation of the Test-Specific Factors of In-House Genetic Tests is Not an Unwarranted Expansion of FDA Authority into the Practice of Medicine

It is not reasonable to argue that Congress meant to preclude any FDA oversight of the “practice of medicine” under the FDCA.[243] As several courts have recognized, the FDA does some things that influence the practice of medicine (e.g. requiring that medical devices and drugs get approved as safe and effective for at least some use before they may be legally marketed and used and requiring prescription package inserts).[244] When Congress added the Practice of Medicine Section to the FDCA in 1997, it stated:

Nothing in this Act shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are...established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices. [245]

The explanatory notes to the Joint Conference Report state: “The conference agreement includes a provision intended by the conferees to emphasize that the FDA should not interfere in the practice of medicine. Specifically, the conferees note that theoff-label uses of a medical device by a physician using his or her best medical judgment in determining how and when to use the medical productfor the care of a particular patient is not the province of the FDA.” [246] Thus, the crucial question is whether regulation of in-house genetic testing constitutes prohibited regulation of the practice of medicine as the term is conceived under the FDCA or whether it is within FDA jurisdiction over in-vitro diagnostic testing, as the FDA itself has held.[247]

a. In-House Genetic Testing Does Not Fall Under the FDCA’s Limited Practice of Medicine Exception

The determination of whether in-house genetic testing constitutes the practice of medicine under the FDCA is a matter of statutory interpretation, which the courts have not yet addressed. However, the case law governing whether the practice of medicine protects physician use of unapproved drugs and devices hints at how courts might treat the issue. In addition, the case law regarding state corporate practice of medicine prohibitions and HMO liability provides a useful analogy.[248]

Generally, courts have interpreted the practice of medicine prohibition in the FDCA as intended to ensure that the Act does not interfere with physicians’ unapproved uses of already approved drugs and devices – so-called “off-label” uses rather than as a general physician exemption to FDCA requirements.[249] As the Fifth Circuit observed in U.S. v Evers , [250] “[o]f course, while the Act was not intended to regulate the practice of medicine, it was obviously intended to control the availability of drugs for prescribing by physicians.”[251] The Third Circuit, cites Evers with approval, “Thus, the Court of Appeals for the Fifth Circuit, although acknowledging the existence of the practice of medicine exception, nevertheless characterized it in effect as the extra-label use of a lawfully acquired drug.[252] The Third Circuit further noted that the D.C. Circuit’s decision in Chaney v. Heckler ,[253] likewise supports this limited interpretation of the practice of medicine exception.[254]

b. The Trends in Corporate Practice of Medicine Law and HMO Liability Also Provide An Analog for Distinguishing Between Medical Services and Other Facets of Health Care

Corporate practice of medicine case law also sheds some light into whether courts would likely categorize in-house genetic tests as medical devices or as the practice of medicine. Generally, whether an HMO is found to be violating corporate practice of medicine prohibitions (CPMP) and/or is found liable depends on whether the HMO exercises control over physician decision-making.[255] Similar reasoning could be used to distinguish between genetic tests and genetic testing services. As one commentator notes:

By analogy to managed care, corporate entities offering diagnostic genetic testing might not be held to exercise medical judgment if they do not render advice based on test results.... Testing alone rests on one end of a continuum of potential activity, while on the other end rests offering highly technical advice about particular drugs to take or gene therapies to undergo given a patient’s genetic profile. The latter activity is much more likely to be considered the exercise of medical judgment that impacts the individual’s course of treatment substantially and directly, thus constituting prohibited medical practice.[256]

Thus, when one just considers the genetic test itself, rather than the full genetic testing service, in-house genetic tests do not seem to be very different from other diagnostic tests, which are regulated by the FDA.[257]

c. Courts Will Likely Uphold FDA Jurisdiction Under the FDCA to Regulate the Safety and Efficacy of Genetic Tests

Courts are likely to hold that FDA regulation requiring “substantial evidence” demonstrating an in-house genetic test’s safety and efficacy for some diagnostic purpose is consistent with the overall purpose of the FDCA of protecting consumers and the general broad interpretation given to the scope of FDA authority under the Act.[258] It seems clear that the FDA is authorized to protect the public from misinformation and that in the current context of genetic testing, there is a need for FDA oversight at least of the test itself. Indeed, SACGT members have already recognized the distinction between patient-specific information and test-specific information and suggested that the latter can and should be regulated by the FDA:

Now obviously FDA can’t deal with things that vary by patient. They could only deal with things that are test-specific. So, examples of test-specific factors would be the purpose of doing the test that was submitted by the sponsor, which is what FDA has to work from, and the second factor would be the robustness of the test, how secure the validity information is known, what kinds of limitations or what kinds of data you want to be sure is provided in the result returned. So there are test-specific things which can be very clearly delineated that FDA could monitor... I compare this simply with labeling for drugs and medicine. After all, FDA does tell us what is the appropriate use for particular medications.[259]

In fact, the FDA has taken a similar view and has already drafted “Instructions for Completing the Template for In-House Developed Genetic Tests; Draft Instructions for Clinical Laboratories.”[260]

In sum, while admittedly, regulating “home brews” would be "stretching the boundaries" of the FDA's authority - and to be safe, an amendment to the FDCA could be sought, good policy reasons and legal doctrine support a conclusion that regulating genetic testing is within the FDA’s statutory jurisdiction.[261] As the courts have been fairly deferential to agency interpretations of their so-called "enabling statutes," Courts would probably sustain FDA regulation of in-house genetic testing, especially if the regulation is developed through formal rulemaking.[262] Indeed, courts have generally been deferential to FDA interpretations, and generally will not overturn them unless “the FDA’s views about the needs of public health are arbitrary and capricious.”[263]

d. Courts Would Also Probably Uphold FDA Regulation of the Informed Consent Requirements that Accompany Genetic Tests

A final issue involves the scope of the FDA’s power to regulate genetic testing and whether it could adequately address the concerns that are raised by genetic testing. Case law surrounding the adequate directions for use requirement contained in 21 U.S.C.A. §352(f) has sustained their implementing regulations even where they have been applied to diagnostic or other devices sold only to licensed professionals. [264] However, a closer question is whether the FDA has the authority to regulate genetic tests’ informed consent requirements (i.e. whether informed consent should be required and if so what its content should be). This regulation would fall much closer to the practice of medicine prohibition, and the FDA is uncertain of its authority in this area. [265]

Case law regarding FDA requirements of adequate directions for use and prescription package inserts containing warnings of potential side effects suggests that the FDA could regulate the content of informed consent required for the safe and effective use of genetic tests, although not the actual process of informed consent. As noted, courts have not exempted devices from the adequate directions for use requirement contained in 21 U.S.C.A. §352(f) even where the devices are sold only to licensed medical practitioners.[266] Recommendations regarding what should be included in the informed consent process could arguably fall within the general rubric of adequate directions for use. In addition, FDA package insert requirements have been sustained as a valid exercise of FDA power. The informed consent requirements could also be deemed equivalent to package inserts. Overall, courts would probably sustain FDA regulation under the FDCA of the content of and need for informed.

3. Constitutional Analysis: The Constitution Does Not Bar Congress From Regulating Genetic Testing

While traditionally states have had the power to regulate health and safety[267] , constitutional jurisprudence suggests that Congress could use its power under the commerce clause to regulate in-house genetic tests as well as the informed consent requirements of all genetic tests.[268] First of all, the Courts have interpreted Congressional power under the Commerce Clause very broadly, particularly when economic matters are involved. Generally, if it can be argued that even intrastate activity (i.e. home brew genetic test) "substantially impacts" on interstate commerce [i.e. the genetic testing industry] then Congress has the power to regulate the intrastate activity.[269] Given that many have noted that the lack of regulation for home brews has reduced incentives to market the regulated genetic tests kits,[270] commercialized home brews can arguably be said to “substantially impact” on the national genetic testing market.

Second, technological advances have contributed to the “nationalization” of the health care industry and have subsequently changed the courts’ treatment of the relative scope of federal versus state powers in the area. As one commentator observed:

describing health care as a police power may have more to do with the historical practice of medicine as a local art than any inherent definition of the phrase. The advance of technology... weakens the presumption that there is something uniquely local about health care, although in most cases, care is still delivered locally. ...Technology has traditionally permitted proponents of an expansive Commerce Clause to identify a relationship to interstate and foreign commerce that permits federal regulation.[271]

For example, where advertising of a product [such as a genetic testing service] crosses state lines, then clear jurisdiction exists to regulate the product.[272] Also, where components that go into making a product cross state lines before manufacture, the court has upheld federal jurisdiction.[273] In addition, recognizing the increasing nationalization of health care, courts have given a very expansive reading of the effect of anti-trust law over in-state behavior of health care organizations, holding that so long as an organization has any business generally with interstate commerce even its non-interstate commerce activities can be regulated.[274] In general, courts would probably hold that FDA regulation over in-house genetic tests was constitutional, except perhaps for those provided in not-for-profit research organizations [arguably not commercial enterprises and so not affecting the national genetic testing industry]. However, the latter entities would instead be covered by IRB requirements if they receive any federal funding.

Finally, the expansion of individual rights indicated by the Slaughter House cases, shows that the importance of individual rights [e.g. right to medical privacy] is growing – often at the expense of states’ rights including state control over the “practice of medicine”.[275] Case law interpreting the scope of FDA’s authority under the FDCA and the PHA suggests that it is no longer true that “direct control of medical practice in the States is beyond the power of the federal government,” as a pre-New Deal Supreme Court stated.[276] At very least, the degree of federal control over the practice of medicine that is deemed suitably indirect has been substantially expanded in post-New Deal jurisprudence. For example, most courts addressing the issue have upheld the FDA’s power to regulate the use of unapproved drugs by physicians against challenges that it violates the FDCA or federalism principles.[277] In addition, Congress has allowed FDA to consider the practice of medicine in regulating radiopharmaceuticals, suggesting that Congress also thinks it is within its power to consider the practice of medicine in regulating drugs and devices.[278] Furthermore, cases upholding the constitutionality of requiring prescription package inserts indicate that the FDA can regulate – at least indirectly – the information that should accompany a diagnostic test.[279] In general, there does not seem to be any strong constitutional right to non-interference in the practice of medicine and – at least some federal regulation impinging on the practice of medicine seems constitutional.[280] Thus, so long as the FDA limits its regulations to the more “product” aspects of genetic testing, regulating them to a similar degree as it regulates other medical devices and drugs, the Supreme Court is not likely to support any statutory or constitutional challenge to the regulation.

IX. Conclusion

A purported goal of the Human Genome Project is to promote the "common good," which includes: “[the] understanding of genetic contributions to human disease and the development of rational strategies for minimizing or preventing disease phenotypes altogether.”[281] However, to accomplish this worthy goal, a coherent legal framework must be developed so that physicians and patients can feel comfortable and safe in using this new and evolving technology. This article outlines a clear legal standard governing when a physician should have a duty to warn her patient of risks to relatives revealed by the patient’s genetic test results. In addition, the standard advocates establishing a limited privilege to warn a patient’s family members directly in cases where a warning could prevent serious and imminent harm. The author further proposes that the legal duty to warn should be tied to evolving and public clinical guidelines developed by a national commission to ensure certainty and flexibility as genetics knowledge evolves. The national commission will serve as an advisory panel to the FDA, who will disburse the guidelines as part of the “adequate instructions for use” accompanying genetic testing documentation. Obviously establishing clinical guidelines cannot reduce the normal amount of discretion involved in interpreting genetic test and other clinical information. The national commission will no doubt be sensitive to this limitation on absolute certainty in drafting the clinical guidelines. Meanwhile, the scope of the limited privilege to warn a patient’s family members directly should be developed by the courts to ensure equitable flexibility and minimum harm to patient confidentiality.

In addition, the article proposes establishing a coherent regime for regulation of the accuracy, reliability and utility of genetic testing through controlling the approval process for new genetic tests and by monitoring laboratories engaged in genetic testing. If new duties and privileges are to be enforced and exercised, it is necessary that individuals be secure in the reliability and accuracy of the data upon which they are based. As noted, this approval and monitoring process will be linked to the duty to warn guidelines as part of the required instructions for use that should accompany genetic test kits and in-house genetic test results and as part of the content of the informed consent that will be required in genetic testing.

In sum, as part of a comprehensive legal framework governing genetic privacy,[282] the proposed standard offers a number of advantages over the current ad hoc system established through case law. The explicit public standard can help to prevent unnecessary legal suits, protect the doctor-patient relationship, and minimize the extent of confidentiality breaches. The proposed regulatory framework meanwhile can ensure that patients and doctors are able to utilize the evolving genetic technologies with security. Finally, as medical knowledge evolves, hopefully the standard will increase the dissemination of knowledge about genetic testing and related matters to the public and the medical community and help to reduce the number of people who develop serious, genetically linked diseases.


[1] The author is a third year law student at Harvard Law School. The author would like to thank all friends and family, but particularly William Kroll, Matilde Nobu Kamiya, Lauren Schwartz, James Campbell, and Carly Kelly for their comments, advice, and support.

[2] Andrews, Lori B., A Conceptual Framework For Genetic Policy: Comparing the Medical, Public Health, and Fundamental Rights Models, 79 WASH. U. L.Q . 221, 224 (2001).

[3] The Human Genome Project is an international, publicly funded research project whose main goal is to develop a complete DNA map for all twenty-four human chromosomes. THE NEW YORK STATE TASK FORCE ON LIFE AND THE LAW , GENETIC TESTING AND SCREENING IN THE AGE OF GENOMIC MEDICINE 23-24 (2000).

[4] There are about 800 genetic tests now available. See The Potential For Discrimination In Health Insurance Based On Predictive Genetic Tests: Hearing on H.R. 602 Before the Subcomm. on Commerce, Trade, and Consumer Protection of the House Comm. on Energy and Commerce , 107th Cong. 7 (2001) (statement of Hon. Louise M Slaughter, expressing her support for H.R. 602, The Genetic Nondiscrimination in Health Insurance and Employment Act, which she and Hon. Constance Morella (R-MD) have sponsored).

[5] See e.g. Michael J. Malinowski, Separating Predictive Genetic Testing from Snake Oil: Regulation, Liabilities, and Lost Opportunities , 41 JURIMETRICS 23- 52, 26 (2000) and id at 31: “Through genetics, the practice of medicine will shift from treatment to intervention and prevention.” Also id at 32-33 discusses how bioinformatics is speeding the pace of this revolution.

[6] See Denise K. Casey, Genes, Dreams and Reality: The Promises and Risks of the New Genetics 83 JUDICATURE 105 (NOVEMBER-DECEMBER 1999) . Layman interested in genetics may consult: Sonia M. Suter, Note, Whose Genes Are These Anyway? Familial Conflicts Over Access to Genetic Information , 91 MICH. L. REV . 1854 (1993); and Janet A. Kobrin, Confidentiality of Genetic Information, 30 UCLA L. REV . 1283 (1983) or The Genome Sequencing Consortium, Initial Sequencing and Analysis of the Human Genome , 409 NATURE 860-921 (2001) at http://www.nature.com/genomics/human/papers /409860a0_fs_5.html (visited on Mar. 7, 2001).

[7] See COMMITTEE ON ASSESSING GENETIC RISKS, INSTITUTE OF MEDICINE, ASSESSING GENETIC RISKS 256 (Lori B. Andrews et al. eds., Nat. Acad. Press 1994) [hereinafter IOM ASSESSING GENETIC RISKS ] (“However, individual rights are not without bound, and the area of genetics raises important questions of where individual rights end and where responsibilities to a group – such as one’s family or the larger society – begin.”)

[8] Id. (“there have been circumstances in which the medical model has been supplanted by the public health model, which encourages the prevention of disease – for example, by requiring that certain medical intervention (such as vaccinations) be undertaken and by warning individuals of health risks (e.g. through .... contact tracing with respect to venereal diseases.”). Some commentators have suggested that the public health model be applied to genetics.”)

[9] See COMMITTEE ON GOVERNMENT OPERATIONS, U.S. HOUSE OF REPRESENTATIVES, DESIGNING GENETIC INFORMATION POLICY: THE NEED FOR AN INDEPENDENT POLICY REVIEW OF THE ETHICAL, LEGAL AND SOCIAL IMPLICATIONS OF THE HUMAN GENOME PROJECT, H.R. REP. NO. 478-16 (102d Cong., 2d Sess. 1992); MARK A. ROTHSTEIN, REPORT OF THE JOINT NIH/DOE COMMITTEE TO EVALUATE THE ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS PROGRAM OF THE HUMAN GENOME PROJECT (1996); Eric Meslin et al., The Ethical, Legal, and Social Implications Research Program at the National Human Genome Research Institute , 7 KENNEDY INST. ETHICS J. 291 (1997). See generally <www.nhgri.nih.gov/elsi>. See also A Public Consultation on Oversight of Genetic Tests, 64 Fed. Reg. 67273 (Dec. 1, 1999) (published by the Secretary's Advisory Committee on Genetic Testing, which was created in 1998 to advise the government on issues raised by the development and use of genetic tests). From 1990 through 1997, the federal government expended more than $50 million for ELSI studies and projects. See Michael J. Malinowski, Separating Predictive Genetic Testing from Snake Oil: Regulation, Liabilities, and Lost Opportunities , 41 JURIMETRICS 23- 52, note 69 (2000) (citing D.H. Kaye, Respecting Genetic Privacy: The AS U-SB Conference on La w, Science, and Technology , 40 JURIMETRICS J. 1, 5 n.22 (1 999 )).

[10] See Casey, supra note 6.

[11] See Pate v Threlkel , 661 So.2d 278 (Fla. 1995); and Safer v Estate of Pack , 677 A.2d 1188 (N.J. Super. Ct. App. Div. 1996) .

[12] See AUBREY MILUNSKY, YOUR GENETIC DESTINY 344-348 ( Perseus Publishers 2001), which discusses the impact that medical genetics is having and will have on medical malpractice and predicts that “a bewildering array of lawsuits can be expected.” (Id. at 348).

[13] Report on FDA Accomplishments Before the Subcomm. on Agric., Rural Dev., and Related Agencies, House Comm. on Appropriations , 107th Cong. (March 8, 2001) (statement of Bernard Schwetz, Acting Principal Deputy Commissioner of the Food and Drug Administration)

[14] See SECRETARY’S ADVISORY COMMITTEE ON GENETIC TESTING, NIH, ENHANCING THE OVERSIGHT OF GENETIC TESTS: RECOMMENDATIONS OF THE SACGT (July 2000) [hereinafter SACGT RECOMMENDATIONS ]. See also Statement of Ms Schneider for the National Society of Genetic Counselors at the 12th Meeting of the SACGT (Day 2) p. 135, lns 14-18 (Feb 14, 2002) (available at http://www4.od.nih.gov/oba/sacgt.htm) [hereinafter SACGT 12th Meeting Transcript] (“clinical genetics researchers need clear guidance on how to protect each family member’s right to privacy.”).

[15] See Bernard Gert, Applying Morality to the Nine Huntington Disease Cases: An Alternative Model for Genetic Counseling in MORALITY AND THE NEW GENETICS: A GUIDE FOR STUDENTS AND HEALTH CARE PROVIDERS 97, 113 ( Jones & Bartlett Pub. 1996) (“An advantage of a confidentiality policy with explicit limitations is that it helps one avoid the moral dilemmas that may arise in the absence of those explicit limitations. Another advantage is that it makes it much more likely that the probands [people undergoing genetic testing] will have a better understanding of the nonmedical risks of genetic testing and so be able to provide a more informed consent to such testing.”). See also Michael J. Malinowski, supra note 5, at 27 (“predictive genetic testing, like other medical technologies, should be introduced in a regulatory framework that offers meaningful assurances of safety, efficacy, and market responsibility. Such an approach is essential to ensure that the technology will help build provider, public, and payer acceptance.”). See also Testimony of Dr. Kenkare SACGT 12th Meeting Transcript, supra note 14, at Day 1, p 122, lns 1-3 (“In order to achieve widespread adoption of genetic screening, every member of the health care chain must understand and believe in its value, both clinically and financially.”)

[16] For articles proposing a legal duty to warn see Jeffrey W. Burnett , A Physician's Duty To Warn A Patient's Relatives Of A Patient's Genetically Inheritable Disease 36 HOUS. L. REV . 559 (Summer 1999); and L.J. Deftos, Genomic torts: The law of the future--The duty of physicians to disclose the presence of a genetic disease to the relatives of their patients with the disease , 32 U.S.F.L. REV. 105 (1997) (after reviewing case law, advocates for a limited duty to warn in certain cases). But see Ellen Wright Clayton, Testing and Telling?: Implications for Genetic Privacy, Family Disclosure and the Law 1 J. HEALTH CARE L. & POL'Y 373 (1998) (arguing against imposing a legal duty on patients or physicians); Michelle R. King, Physician Duty To Warn A Patient's Offspring Of Hereditary Genetic Defects: Balancing The Patient's Right To Confidentiality Against The Family Member's Right To Know--Can Or Should Tarasoff Apply 4 QUINNIPIAC HEALTH L.J . 1 (2000); Angela Liang, Comment, Testing and Telling?: Implications for Genetic Privacy, Family Disclosure and the Law 1 J. HEALTH CARE L.& POL'Y 437 (1998); and Sonia M. Suter, Note, Whose Genes Are These Anyway? Familial Conflicts Over Access to Genetic Information , 91 MICH. L. REV. 1854 (1993), which advocate against a duty to warn.

[17] See Clark C. Havigurst, American Health Care and The Law – We Need to Talk! 19(4) HEALTH AFFAIRS 84 (2000) for a discussion of the failure in dialogue between the health care policy and medical communities and the resulting incoherence in much health care policy. See also Andrews, supra note 2 at 227 (who discusses the need for a comprehensive framework for genetics-related policy, and observes that “Little attempt has been made to create an overall conceptual framework to regulate genetics.”)

[18] This paper will not address the complex issues around the testing of minors and so only discusses the rule when the patient is an adult.

[19] The utility of predictive genetic testing is lower when a disease is readily curable. Evans, James P., The Complexities of Predictive Genetic Testing, BRITISH MEDICAL JOURNAL , April 28, 2001, available at http://www.findarticles.com (last visited Mar. 21, 2002).

[20] Thus, diseases such as Huntington’s, for which no known cures exist, would not require a legal duty to warn. A study of the attitudes of genetic counselors found that half would disclose information to relatives over a patient’s refusal. See IOM ASSESSING GENETIC RISKS , supra note 7, at 264. The study also discovered that about the same number would disclose to the relative even when the disorder was untreatable, such as Huntington disease. Id , at 264-5. Another study, however, found that most people at risk for Huntington disease would not want to be tested for the disease, suggesting that “geneticists may be overestimating the relative’s desire for genetic information and infringing upon the relative’s right not to know.” Id. at 265. The author feels that the best compromise between the patient’s right to confidentiality and the patient’s relatives right to know genetic risk information is to make the patient the intermediary and only to allow the health care provider to warn relatives directly where significant and imminent harm could be avoided thereby. The average rational person should want to know information that could be used to avert disease risk. However, not everyone would want to know risk information if nothing can be done. Finally, this limited duty and privilege is consistent with legal doctrine regarding instances where breaching confidentiality is warranted. See , discussion of the law, infra Section V.

[21] Where the costs of screening or preventative measures are very low, then universal screening and treatment should be implemented as a replacement for such duty. However, if such universal screening and/or prevention measures are not available then a duty would still exist. A rare disorder for which the utility of predictive information is clear and a duty should likely be found is multiple endocrine neoplasia type 2. Evans, James P., The Complexities of Predictive Genetic Testing, BRITISH MEDICAL JOURNAL , April 28, 2001, available at http://www.findarticles.com (last visited Mar. 21, 2002). In addition, predictive genetic testing information can help individuals whose family history indicates a heightened risk of developing colorectal cancer, where periodic colonoscopic surveillance has been found to reduce the development of colorectal cancer by 62% compared to unscreened controls. Id.

[22] See IOM ASSESSING GENETIC RISKS, supra note 7, at 267.

[23] In addition, if an application has been submitted to the FDA and approval is likely but FDA approval has not yet been garnered, a duty could also be found if the physician had actual knowledge of the reliable, independent evidence substantiating the test’s safety and efficacy. Likewise a privilege could be found if the physician notified the patient in advance of this knowledge and its implications for the patient’s family members and the physician’s privilege.

[24] L.J. Deftos, Genomic Torts: The Law of the Future--The duty of physicians to disclose the presence of a genetic disease to the relatives of their patients with the disease , 32 U.S.F.L. REV. 105, 134 (1997). Imposing a duty to warn past patients about newly apparent risks to their relatives would be too onerous in our highly mobile society.

[25] See Bradley v Empire Blue Cross , 562 N.Y.S.2d. 908 (1990) for an illustration of the fact that courts may reach a determination regarding appropriate medical treatment that later proves to be false, given courts’ lack of expertise in science and medicine and their subsequent overreliance on physician experts, who may be biased. Given that courts recognize a national standard of medical care, and that most physicians lack genetics expertise, this kind of notice is only fair. See HEALTH CARE LAW AND POLICY 992-1076, ( Clark C. Havighurst, et al., eds., 2nd ed. 1998) for a discussion on legal developments in the standard of medical care and how courts address the standard given uncertainty.

[26] See Testimony of Dr. Steve Gutman, SACGT’s 12th Meeting Transcript, supra note 14, at Day 2, p. 30, lns 1-8 (where he discusses the relative ease with which the FDA could update applications of a broad standard requiring more strict informed consent provisions for certain genetic tests.)

[27] The need for explicit, clear and public guidelines arises in large part because of inadequacies in provider knowledge regarding genetics and the death of certified genetics counselors. See SACGT RECOMMENDATIONS , supra note 14, at 16-17 discussing the risks and problems stemming from inadequate provider and public understanding of genetics; see also PROMOTING SAFE AND EFFECTIVE GENETIC TESTING IN THE UNITED STATES: FINAL REPORT OF THE TASK FORCE ON GENETIC TESTING (Neil A. Holtzman & Michael S. Watson, eds., Johns Hopkins Univ. Press 1997) [hereinafter : FINAL REPORT OF THE TASK FORCE ON GENETIC TESTING ]. The public guidelines thus serve educational functions as well as helping to control the uniformity of genetic testing provision.

[28] See IOM ASSESSING GENETIC RISKS, supra note 7, at 290-291.

[29] The FDA, CLIAC and professional groups have already developed a draft template for collecting information on in-house genetic tests that gathers information on the implications for family members as part of the information on the genetic test’s clinical utility. See FDA, et al, INSTRUCTIONS FOR COMPLETING THE TEMPLATE FOR IN-HOUSE DEVELOPED GENETIC TESTS; DRAFT INSTRUCTIONS FOR CLINICAL LABORATORIES , draft # 19 (07-21-01) (received on Apr. 12, 2002 from SACGT Exec. Sec. Sarah Carr and on file with author). These efforts can be tied to the FDA regulation regarding informed consent discussed below in section VII. The benefits from the proposed National Commission’s clinical guidelines – saved lives, reduced litigation and increased provider and patient education about genetics – warrant any costs of maintaining this national commission. See Paul Thagard, HOW SCIENTISTS EXPLAIN DISEASE 197-198 ( Princeton Univ. Press 1999) (“Consensus conferences are expensive, in that they require the transporting, housing, and feeding of numerous participants. But a three-day conference is a relatively rapid means of exchanging information, establishing recommendations, and providing the basis for spreading reliable conclusions to a broad audience...Physicians and hospitals can learn not only from the treatments recommended by consensus panels but also learn from the treatments not recommended: Consensus statements provide health care providers with reasons not to give ineffective treatments to people who may be requesting them based on weak information. Today’s patients may march into their physicians’ offices with a printout from the World Wide Web in their hands, but there is great variability in the quality of such information. Evidence-based and cost-effective medicine instituted through the recommendations of consensus conferences should improve patient care.”; see also Maliknowski, supra note 5, at 41: “Moreover, meaningful education, both for health care providers and the public, is more likely to be achieved through the experience of using the technology incrementally in a regulated manner as instances of clinical utility arise.”

[30] See the discussion infra Sec. VII, regarding the requirement under the Food, Drug and Cosmetic Act that certain medical devices be accompanied with such instructions in order not to be “misbranded.” See also IOM ASSESSING GENETIC RISKS, supra note 7, at 282 (“The committee recommends that careful consideration be given to the development of policies for the implementation of genetic testing and the handling of genetic test results.”)

[31] A comprehensive definition of genetic counseling was developed by the American Society of Human Genetics in 1975. “Genetic counseling is a communication process which deals with the human problems associated with the occurrence, or the risk of occurrence, of a genetic disorder in a family. This process involves an attempt by one or more appropriately trained persons to help the individual or family (1) comprehend the medical facts, including the diagnosis, the probable course of the disorder, and the available management; (2) appreciate the way heredity contributes to the disorder and the risk of recurrence in specified relatives; (3) understand the options for dealing with the risk of recurrence; (4) choose the course of action which seems appropriate to them in view of their risk and family goals, and act in accordance with that decision; and (5) make the best possible adjustment to the disorder in an affected family member and/or to the risk of recurrence of that disorder.” See KARL H. MUENCH, GENETIC MEDICINE 225 (Elsevier Science Publishing Co., Inc. 1988).

[32] SECRETARY’S ADVISORY COMMITTEE ON GENETIC TESTING , Transcript of Twelfth Meeting (Day Two) (Feb. 14, 2002).

[33] Giarelli, Ellen, A Legal Look at Genetic Testing , RN ( October, 2001).

[34] The American Society of Human Genetics Social Issues Subcommittee on Familial Disclosure, ASHG Statement: Professional Disclosure of Familial Genetic Information, 62 AM. J. HUMAN GEN.474, 474 (1998) [hereinafter ASGH Statement ] which discusses the limits of genetic tests’ ability to provide concrete predictions on whether and when and how severely a person will contract a given disease. See also Casey, supra note 4.

[35] See IOM ASSESSING GENETIC RISKS, supra note 7, at 37-39 (discussing the limitations of genetic testing); see esp. Id. at 39 (“Because of the imperfect nature of genetic tests and the implications of both true positive and false positive test results, as well as false negative results, the understanding of those who offer tests and of the recipients themselves is crucial to appropriate use of genetic testing.”); see also quotation from Thagard, supra note 27 and Thagard, supra note 27 (“By virtue of their use of expert testimony and impartial panels, medical consensus conferences can contribute to the reliability, fecundity, and practical benefit of medical beliefs.”)

[36] Of course, the concern expressed by many about the need for anti-genetic discrimination legislation is a necessary complement to enhance patient comfort in using genetic testing. See The Potential For Discrimination In Health Insurance Based On Predictive Genetic Tests: Hearing on H.R. 602 Before the Subcomm. on Commerce, Trade, and Consumer Protection of the House Comm. on Energy and Commerce , 107th Cong. 10-12 (2001) (statement of Hon. Constance Morella regarding the need to address the problem of genetics discrimination) (“However, in order to fulfill the promise that the mapping of the Human Genome holds, we do need to address the issue of genetic discrimination.”); see also Id. at 35-37 (statement of Craig Venter, Chief Science Officer of Celera Genomics on behalf of BIO, a trade organization representing 1000 biotechnology companies, academic institutions, state biotech centers, etc.) (“I, along with BIO, urge Congress to draft carefully worded legislation that would prohibit discrimination in health insurance based on genetic discoveries and testing.”)

[37] See FINAL REPORT OF THE TASK FORCE ON GENETIC TESTING , supra note 27, at 8. See also Evans, James P., The Complexities of Predictive Genetic Testing, BRITISH MEDICAL JOURNAL , April 28, 2001, for a discussion of various types of genetic testing. (available at http://www.findarticles.com ) (last visited Mar. 21, 2002)

[38] Id.

[39] ASGH Statement, supra note 34.

[40] Id.

[41] ASGH Statement, supra note 34, at n. 31.

[42] Id.

[43] Massachusetts Medical Society, GENERAL PRINCIPLES ON GENETIC INFORMATION AND PATIENT PRIVACY 2 (1998) (on file with author).

[44] Id.

[45] See The Administrative Procedure Act, 5 U.S.C.A. §553 (2002) for general agency rulemaking requirements.

[46] See SACGT, APPENDIX B: SUMMARY OF PUBLIC COMMENTS TO THE SACGT’S FINAL REPORT ON ENHANCING THE OVERSIGHT OF GENETIC TESTS , (available at http://www4.od. nih.gov./oba/sacgt.htm ). One religious entity, The First Church of Chesnut Hill, even submitted a public comment. Id.

[47] See IOM ASSESSING GENETIC RISKS, supra note 7, at 300, recommending that “research be undertaken to determine what people feel they need to know in order to decide whether or not to undergo a genetic test. Research is also needed on what constitutes informed consent.”

[48] See IOM ASSESSING GENETIC RISKS, supra note 7, at 292-294.

[49] See Br adshaw v. Da niel , 854 S.W.2d 865, 872 (Tenn. 1993), which restricts the duty to warn to immediate family members. Also see L.J. Deftos, supra note 24, at 135 for a general discussion of family relationship factors that should be considered in developing a legal duty to warn standard.

[50] Analytical validity is an indicator of how well a test measures the property or characteristic it is intended to measure (e.g. specific mutations). Clinical validity is an indicator of the ability of a test to distinguish affected and unaffected populations, including a determination of the probability of being affected, which is a measure of the clinical sensitivity, specificity, and predictive value of a test. See SACGT RECOMMENDATIONS , at 16 and the glossary of the INSTRUCTIONS FOR COMPLETING THE TEMPLATE FOR IN-HOUSE DEVELOPED GENETIC TESTS; DRAFT INSTRUCTIONS FOR CLINICAL LABORATORIES, supra note 29, which contains a technical definition of analytical and clinical validity, as well as clinical specificity, sensitivity and predictive value.

[51] Penetrance is the frequency with which a genotype manifests in a given phenotype – i.e. disease state. See Id. or see KARL H. MUENCH, GENETIC MEDICINE 252 (Elsevier Science Publishing Co., Inc. 1988).

[52] See Chantelle M. Wolpert, Human Genomics in Clinical Practice, CLINICIAN REVIEWS (July 2000), which notes the highly uncertain information provided by susceptibility testing.

[53] See IOM ASSESSING GENETIC RISKS, supra note 7, at 255 (“Health care providers should explain their policies for disclosure in advance, including for disclosure to relatives.”).

[54] See Wolpert, supra at note 52 for a list of reasons where referrals to genetic counselors are advisable. Wolpert also cites the 1997 Final Report of the NIH, DOE Working Group on Ethical, Legal, and Social Implications of Human Genome Research, which recommended that health care providers not specialized in genetics consider consulting a genetic counselor or geneticist when considering genetic testing. However, Andrews, supra note 2 at 253 observes “there are only approximately two thousand genetic counselors in the United States, most of whom are disproportionately located in certain geographic areas (i.e., New England, Chicago, and California).” Thus, physicians and other health care providers as well as patients must be educated regarding genetics to mitigate any negative effects from this shortage.

[55] Obviously there are differences between the AIDS context, where the patient is the agent through which the at-risk individual contracts the disease, and the genetic disease context, which will be discussed below. See ASGH and other opinions expressed in the medical perspectives section, infra , Section VI for a discussion of the need to first try to encourage voluntary patient disclosure before warning patients’ family members directly.

[56] See Lawrence O. Gostin & James Hodge, Jr., Piercing the Veil of Secrecy in HIV/AIDS and Other

Sexually Transmitted Diseases: Theories of Privacy in Partner Notification , 5 DUKE J. GENDER L. & POL'Y

9, 27 (1998) [hereinafter Gostin & Hodge], which notes the pros and cons of the partner and patient notification models.

[57] Id.

[58] Id.

[59] Id. The stigma associated with AIDS, as well as fear about the angry reaction of the at-risk partners may dissuade patients from notifying their partners and past partners. Thus, those particularly interested in stemming the AIDS public health “crisis” felt that the increased certainty of the provider notification model was worth its high costs. While some are concerned about the impact of this breach of confidentiality on HIV testing, others respond that the HIV infected patient owes a duty to warn past and present sexual partners of the health risk created by the patient and that the AIDS public health “crisis” warrants extreme measures.

[60] In cases where significant consequences and stigma are associated with a genetically transferable disease, the individual should probably be referred to a genetic counselor who can assist the individual in getting over any guilt and other feelings the individual may experience. The commission can decide in which cases this assistance is categorically required and in which cases the physician can – but is not required to- refer an individual to a genetics counselor.

[61] See ASGH Statement, supra note 34; Clayton, supra note 16, at 444, n. 63 discussing the right not to know; and Graeme T. Laurie, CHALLENGING MEDICAL-LEGAL NORMS: The Role Of Autonomy, Confidentiality, And Privacy In Protecting Individual And Familial Group Rights In Genetic Information , 22 J. LEGAL MED . 1 (March 2001), which discusses extensively the right NOT to know of one’s genetic risks. The genetic testing recipient’s family members’ situations are ethically distinguishable from the sexual partners of a patient known to have HIV, as unlike the latter individuals, they will not in danger of “infecting others.” Bearing children at risk is arguably not equivalent to passing on infectious diseases.

[62] See Clayton, supra note 16, at 443-445 discussing the psychological distress often caused by knowing that one has a genetic disease, particularly when it is not curable or treatable and the guilt associated with family members when their results reveal possible negative risks for relatives. Clayton also discusses the risks of employment and insurance discrimination and possible domestic violence that may result from disclosure at 448-452.

[63] See IOM ASSESSING GENETIC RISKS, supra note 7, at 256 (“In contrast to infectious disease, the transmission of genetic diseases does not present an immediate threat to society.”).

[64] See Clayton, supra note 16, at 472 – 475 (advocating privilege rather than duty).

[65] See , e.g., N.Y. Soc. Serv. Law § 413(1) (McKinney 1999).

[66] See Arthur Corbin, Jural Relations and Their Classification 30 Yale L.J 226, 226-229 (1921), reprinted in JOSEPH WILLIAM SINGER, PROPERTY LAW: RULES, POLICIES, AND PRACTICES 157-158 (2d ed.1997).

[67] See e.g. SC State Code 1976, § 15-1-310 (Good Samaritan law, which limits liability of those coming to a stranger’s aid); see also Hirpa v. IHC Hospitals, Inc. , 149 F.Supp.2d 1289, 1293 (D. Utah 2001) (“The Utah high court held that doctors are protected by the Good Samaritan Act when they respond to an in- hospital emergency, if they had no preexisting duty to do so. Hirpa v. IHC Hosp., Inc., 948 P.2d 785, 790 (S. Ct. Utah 1997).”)

[68] See Michael J. Malinowski, supra note 5, at 38-39 (“Too often, judicial determinations lack medical and scientific soundness, and innovative medical technologies are forced into use through litigation and legal liability only to be seriously questioned later. Legal liability is simply too crude an instrument for responsible integration of predictive genetic testing into health care, especially given that this technology is still emerging.”). Indeed, a fuzzier duty would likely have a “chilling effect” on genetic testing.

[69] See articles against a duty to warn cited supra , note 16.

[70] The Health Insurance Portability and Accountability Act of 1996, P.L. 104-191 (HIPAA) and the subsequent final rule on health information privacy promulgated by the Department of Health and Human Services (DHHS) illustrate the current public concern with the privacy and confidentiality of medical information. The HIPAA required DHHS to develop national standards governing health plans’ and health care providers’ common electronic health care transactions. The final regulations cover protected health information in any form or medium. See 65 Fed. Reg. 82461, § 164.501 (Dec. 28, 2000).

[71] Genetic information partially breaks down the barriers between public health and traditional health care. The information revealed in genetic tests is neither entirely private [i.e. it reveals information relevant to the patient’s family members] nor entirely public [it does not reveal information about the risk of a population at large, such as contagious disease information], but is rather a hybrid between the two extremes.

[72] See Section VII for a discussion of the scopes of the jurisdictions over health care of the federal and state governments. This intermediate solution is more likely to get broad-based endorsement throughout the states, who will be responsible for enforcing this standard on physicians through the tort system.

[73] See Section VI for a discussion of the medical perspectives on the duty to warn issue.

[74] Diamond v. Chakrabarty , 447 U.S. 303, 317 (1980).

[75] See Richard L. Furman, Jr, Genetic Test Results And The Duty To Disclose: Can Medical Researchers Control Liability?, 23 SEATTLE U. L. REV . 391, 397 (1999), which cites the majority opinion in Diamond v. Chakrabarty, 447 U.S. 303 (1980), as stating that the legislature rather than the courts should decide policies regarding genetic research and privacy.

[76] See Peter L Strauss, Revisiting Overton Park: Political and Judicial Controls Over Administrative Actions Affecting the Community , 39 UCLA L.REV. 1251, 1256-57 (1992) (“Politicians, not judges, should be responsible for setting the dimensions of social policy that may involve trades among the interest of broad groupings of citizens.”)

[77] See ROBERTO M. UNGER, KNOWLEDGE AND POLITICS 89-90 (1975) (“Only decisions ‘under a rule’ are consistent with freedom; others constitute arbitrary exercises of judicial power.”)

[78] There is a general concern about the general lack of physician understanding of genetics. See e.g. FINAL REPORT OF THE TASK FORCE ON GENETIC TESTING , supra note 27; see also IOM ASSESSING GENETIC RISKS , supra note 35, at 202-231, which discusses the personnel issues in human genetics and the summary recommendations at 18-20.

[79] Given that medical ethics stresses the importance of doctor-patient confidentiality, absent a clear legal duty to warn, doctors will probably continue to favor confidentiality when interpreting this privilege.

[80] See section B below.

[81] See sections C and D below.

[82] See e.g.Bradshaw v. Daniel, discussed in section E below.

[83] See Section F below.

[84] Barry v Moench, 331 P.2d 814, 818 (Utah 1958) .

[85] 331 P.2d 814 (Utah 1958) .

[86] Id . at 817.

[87] Id . at 818.

[88] For a discussion of the justifications for partner notification programs in the AIDS context see e.g. Lawrence O. Gostin & James Hodge, Jr., Piercing the Veil of Secrecy in HIV/AIDS and Other Sexually Transmitted Diseases: Theories of Privacy in Partner Notification , 5 DUKE J. GENDER L. & POL'Y 9, 18 (1998).

[89] 551 P.2d 334 (Cal. 1976) .

[90] Id. at 347.

[91] 37 Cal. Rptr. 2d 518 (Ct. App. 1995) .

[92] Id. at 523.

[93] Although in this case, the doctor did not know of the third party’s existence at the time he knew that his patient was at risk of HIV. Thus, it is possible that where the doctor knew the third party’s identity a direct duty might be found. For other duty to warn in HIV cases, see H of man v. B lackmo n, 241 So. 2d 752 (Fla. App. 1970); Skillings v. Allen , 173 N.W. 663 (Minn. 1919). AIDS partner notification laws, which do sometimes require the provider to warn the patient’s sexual partners directly, are discussed supra in section II.

[94] 854 S.W.2d 865 (Tenn. 1993) (the stepson of a doctor’s patient successfully sued the patient’s doctor for failing to warn his mother that she had a similar epidemiological risk of contracting Rocky Mountain Spotted Fever, a non-contagious disease).

[95] Id. at 872.

[96] Id. at 870.

[97] Id. at 871-872.

[98] See Id . at 872 (“foresee able risk of harm to an identifiable third party, and the reasons supporting the

recognition of the duty to warn are equally compelling here”). See also Carol McCrehan Parker, Camping Trips And Family Trees: Must Tennessee Physicians Warn Their Patients' Relatives Of Genetic Risks, 65 TENN. L. REV . 585, 600-602 (1998), which notes that the forsee ability and magnitude of the harm that could be averted were crucial criteria in the Bradshaw decision. Parker particularly observed that “treatability is the most significant in relation to a duty to warn.” Id. at 601.

[99] 661 So.2d 278 (Fla. 1995).

[100] Id . at 282.

[101] Id.

[102] 677 A.2d 1188 (N.J. Super. Ct. App. Div. 1996).

[103] Id. at 1190.

[104] Id. at 1192.

[105] Id. at 1192-93.

[106] Id. at 1192.

[107] See articles against a duty to warn cited supra , note 16.

[108] Massachusetts Medical Society, GENERAL PRINCIPLES ON GENETIC INFORMATION AND PATIENT PRIVACY (1998) (on file with author, emphasis added).

[109] See ASHG Statement, supra note 1.

[110] See ASGH Statement , supra note 1 (emphasis added).

[111] Id.

[112] Id.

[113] Id.

[114] See SCREENING AND COUNSELING FOR GENETIC CONDITIONS : A Report on the Ethical, Social, and Legal Implications of Genetic Screening, Counseling, and Education Programs, President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1983) [hereinafter SCREENING AND COUNSELING FOR GENETIC CONDITIONS].

[115] Id. The President’s Commission and the Institute of Medicine both required that “reasonable efforts to elicit voluntary consent to disclosure” be attempted before disclosing information against a patient’s wishes.

[116] Id.

[117] Proposed Recommendations of the Task Force on Genetic Testing , 62 FR 4539, 4541 (Sep. 1997) (emphasis added) (also included in the FINAL REPORT OF THE GENETIC TASK FORCE , supra , note 27)

[118] See Gert, supra note 15, at 112.

[119] Id.

[120] MILUNSKY , supra note 12, at 333-334.

[121] See Testimony of Dr. Kenkare, the SACGT 12th Meeting Transcript, supra note 14, at Day 1, p. 122, lns 1-3.

[122] See language from Justice Jackson’s dissenting opinion in the Dalehite case, cited in Hutt, Peter Barton, Philosophy of Regulation Under the Federal Food, Drug, and Cosmetic Act , 50 FOOD & DRUG L.J . 101, 101 (1995).

[123] See Michael J. Malinowski, supra note 5, 34-39 for a discussion of the dangers that emerging technologies will be bottled up and only used in defensive medicine given the lack of quality assurance mechanisms and recent judicial decisions regarding the duty to warn.

[124] Experts project a growth rate of around 27% in the genetic predisposition testing market and similarly high growth in the diagnostic kit manufacturing market. See Testimony of Dr. Kenkare, supra note 121, at p. 125.

[125] Id. at 121.

[126] Id.

[127] Id. , at 123, lns 10-13.

[128] See COMMITTEE ON ASSESSING GENETIC RISKS, INSTITUTE OF MEDICINE, ASSESSING GENETIC RISKS: IMPLICATIONS FOR HEALTH AND SOCIAL POLICY 11 ( Lori B Andrews et al, eds., 1994).

[129] Id. at 124.

[130] See FDA’s Final Rule re: Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents, 62 FR 62243-02 (November 21, 1997) (to be codified at 21 C.F.R. pts. 809 and 864).

[131] See discussion infra regarding the recommendations of the Clinical Laboratory Improvement Advisory Committee.

[132] P.L. No. 94-295, 90 Stat. 539 (codified as amended 21 U.S.C. § § 360c-k, 379 , 379a (1994) ; 42 U.S.C. § 3512 (1994) ).

[133] P.L. No. 101-629, 104 Stat. 4511 (codified as amended 21 U.S.C. § § 360l , 383 (1994) ).

[134] 21 U.S.C. § § 360s, l (1994) .

[135] 21 U.S.C. § 360c (1994), See also SACGT RECOMMENDATIONS , supra note 14, at 10.

[136] See id. at 10.

[137] IOM ASSESSING GENETIC RISKS , supra note 7, at 128.

[138] Id.

[139] See FUTURE PERFECT , supra note, at 18 (“The Food and Drug Administration regulates genetic tests sold as kits – which does not cover the vast majority of tests, which are sold as services by university, hospital, and biotechnology laboratories.”)

[140] See id. at 132, and SACGT RECOMMENDATIONS, supra note 14, at 10. See also Lori B. Andrews, A Conceptual Framework For Genetic Policy: Comparing The Medical, Public Health, And Fundamental Rights Models , 79 WASH.U.L.Q . 221, 255-257 (Spring 2001) (“a 1995 survey found that an alarming number of organizations developing or offering "home brew" genetic tests have never contacted the FDA regarding such services. Of the forty-three biotech companies and 215 not-for-profit organizations surveyed less than sixteen percent had contacted the FDA.”) Id. at 255.

[141] 21 CFR Parts 809 and 864 (2002).

[142] See Final Rule on Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents, 62 FR 62243-02, 62246, (Friday, November 21, 1997) (“FDA has added § 809.10(f) to restrict ordering in-house developed tests using ASR's to physicians or other health care practitioners authorized by the law of the State in which the test is being offered.”).

[143] 42 USCA § 263a et seq . (2002). Regulations regarding the Federal Policy for the Protection of Human Subjects also apply to the investigational phases of genetic testing research. See 45 C.F.R. 46, 21 C.F.R. 50, and 21 C.F.R. 56 (2002). Some relevant legislation that is currently under consideration includes: To amend title 35, USC, to provide for noninfringing uses of patents on genetic sequence information for purposes of research and genetic diagnostic testing, and to require public disclosure of such information in certain patent applications, H.R. 3967, 107th Cong (2d Sess. 2002), (Introduced in the House and Referenced to the Comm. On Judiciary Mar 14, 2002); and To amend the FDCA to make improvements in the regulation of medical devices, and for other purposes, HR 3580, 107th Cong. (1st Sess. 2001) (Introduced in the House, Amended Dec 20, 2001).

[144] 42 USCA §263a (2002). See also IOM ASSESSING GENETIC RISKS, supra note 7, at 124-5. However, CLIA does not preempt the FDA's authority to regulate clinical laboratory's devices used in testing; CLIA regulations require laboratories to comply with all applicable federal laws, including Federal Food, Drug, and Cosmetic Act (FDCA). See Clinical Reference Laboratory, Inc. v. Sullivan , 7 91 F.Supp. 1499 (D.Kan.1992), aff’d in part, rev’d in part, 21 F.3d 1026 .

[145] Id; see also The Clinical Laboratory Improvement Amendments, 42 USCA § 263a(a). (2002)

[146] IOM ASSESSING GENETIC RISKS , supra note 7, at 126.

[147] 42 CFR Parts 493 et seq . (2002); see also IOM ASSESSING GENETIC RISKS supra note 7, at 125; see also http://www.fda.gov/cdrh/clia/categorization.html (Updated 3/6/2001) –visited 4/5/02 (“HCFA [now CMS] assumes primary responsibility for financial management operations of the CLIA program. The categorization of commercially marketed in vitro diagnostic tests under CLIA are now the responsibility of the FDA. FDA has assumed primary responsibility for performing the CLIA complexity categorization functions that include the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories based on their potential risk to public health: waived tests, test of moderate complexity, and tests of high complexity. FDA will revise as necessary criteria for waivers, moderate and high complexities.”)

[148] Id.

[149] Id.

[150] See Id . at 125-126.

[151] Id.

[152] See Lori B. Andrews, FUTURE PERFECT: CONFRONTING DECISIONS ABOUT GENETICS 114 (Columbia University Press, 2001). [Hereafter FUTURE PERFECT ]. See also Lori B. Andrews, A Conceptual Framework For Genetic Policy: Comparing The Medical, Public Health, And Fundamental Rights Models , 79 WASH. U. L.Q . 221, 256-257 (Spring 2001).

[153] See SACGT RECOMMENDATIONS , supra note 14, at 9 (“Currently, according to HCFA [now CMS], CLIA does not address additional aspects of oversight that are critical to the appropriate use of genetic tests, such as clinical validity including clinical sensitivity and clinical specificity, clinical utility ..., and issues related to informed consent and genetic counseling.”)

[154] See id. at 9.

[155] See Notice of Intent; Genetic Testing Under the Clinical Laboratory Improvement Amendments, 65 FR 25928-25934 (May 4, 2000).

[156] See SACGT 12th Meeting Transcript, supra note 14, at Day 1, p. 151-6.

[157] See Proposed Recommendations of the Task Force on Genetic Testing, 62 FR 4539, 4554 (proposed January 30, 1997) (Final Report submitted September 1997) (“Under the CLIA, clinical laboratories must demonstrate analytical validity of their tests but there is no statutory or regulatory requirement for them to establish the clinical validity or utility of clinical laboratory tests.”)

[158] Id.

[159] In addition to the agencies noted below, the HRSA also performs actions relevant to genetic testing. SEE SACGT RECOMMENDATIONS , supra note 14, at 11-12 (“The Genetic Services Program of HRSA promotes support and leadership for assurance, assessment and policy development for utilization of genetic medicine and technology within health care and public health practice.”)

[160] Id. at 11.

[161] Id. at 11.

[162] Id. at 11

[163] Id. at 12.

[164] Id.

[165] See 2001 Nebraska Legislative Bill No. 432 (97th) and 2002 South Dakota Senate Bill No. 93 (77th Cong.)

[166] The following information comes from the SACGT RECOMMENDATIONS , supra note 14, at 12.

[167] IOM ASSESSING GENETIC RISKS , supra note 7, at 124.

[168] Id.

[169] Id.

[170] The Genetic Alliance, BYLAWS , available at http://www.geneticalliance.org/aboutus/bylaws.html.

[171] See Genetic Alliance, PUBLIC COMMENTS TO THE SACGT (submitted Jan. 31, 2000) available at http://www.geneticalliance.org/geneticissues/gaSACGTcomments.html. (last visited Apr. 29, 2002)

[172] See GENETIC ALLIANCE ALERT (March 2002) available at http://www.geneticalliance.org/alert.html#article16.

[173] See DRAFT INSTRUCTIONS FOR COMPLETING THE TEMPLATE FOR IN-HOUSE DEVELOPED GENETIC TESTS; DRAFT INSTRUCTIONS FOR CLINICAL LABORATORIES, supra note 29, at 4.

[174] Id.

[175] See Giarelli, supra note 33.

[176] Id.

[177] See Kenneth J. Arrow, Uncertainty and the Welfare Economics of Medical Care , 53(5) AMERICAN ECON. REV. 941 (1963); see also Uwe E. Reinhardt, Can Efficiency in Health Care Be Left to the Market? 26(5) J. HEALTH POL., POL’Y, & L . 974 (Oct. 2001) who discusses the differences between economists’ and laypersons’ views of efficiency and optimality and how health care market imperfections make it difficult to separate allocative and distributional procedures.

[178] See Deborah Haas-Wilson, Arrow and the Information Market Failure in Health Care: The Changing Content and Sources of Health Care Information, 26 (5) J. HEALTH POL., POL’Y, & L . 1031, 1033, 1037 (Oct. 2001) (noting that empirical evidence indicates, consistent with economic theory, that market-determined prices are not related to the more difficult to learn aspects of quality such as technical quality, but only related to the more obvious quality aspects, such as interpersonal quality).

[179] Id.

[180] See e.g. James C., Robinson, The End of Asymmetric Information , 26(5) J. HEALTH POL., POL’Y, & LAW 1045 (October 2001).

[181] See Haas-Wilson, supra note 177, at 1042 (“All the technological innovations in the world cannot make the informational asymmetry between physicians and patients go away... Data crunching will never eliminate the vast gray areas where technology, medical judgment, and patient preferences intersect.”) and Kenneth J. Arrow, Reflections on Reflections , 26(5) J. HEALTH POL., POL’Y, & L . 1197 (October 2001) (“The Internet is a source of information, but unlike refereed journals, there is no guarantee of accuracy.”).

[182] Id.

[183] See FUTURE PERFECT , supra note 152, at 108-110. (E.g. One study found that one-third of physicians erroneously interpreted results of a genetic tests for colorectal cancer), see also SACGT Recommendations at 16-17.

[184] See FUTURE PERFECT, supra note 152, at 124-128 for a discussion in the deficiencies in information provided to individuals undergoing genetic testing. Particular inadequacies were found in the information provided as part of informed consent by for-profit genetic testing laboratories. The only oversight of informational materials provided to genetic testing recipients and of genetic testing advertisements is done ex poste by the FDA and FTC prosecuting offenders under False Advertising regulations, or by the consumer product divisions of State AGs responding to filed complaints. Id , at 126.

[185] Dr. Tucksan, SACGT 12th Meeting Transcript, supra note 14, at Day 2, p. 41, lns 15-23. See also Allen C Nunnally, Commercialized Genetic Testing: the Role of Corporate Biotechnology in The New Genetic Age, 8 B.U.J. SCI.&TECH.L . 306, 343 (Winter 2002) discussing the fact that corporate genetic testing entities have no incentives to provide full, fair and accurate information on genetic testing and the subsequent need for FDA oversight to ensure the safety and efficacy of genetic testing. (“It is clear that the reliability of such tests cannot be judged by the corporate entities themselves, as they maintain a powerful interest in extolling the virtues of their own services. By holding for-profit entities accountable to a regulatory agency such as the FDA, the quality and integrity of their testing is better ensured.”)

[186] SACGT RECOMMENDATIONS , supra note 14, at 28-29.

[187] See id .

[188] See id. at 28 for a comment on the difficulty, in general. Note also that generally the FDA is not authorized and does not regulate the practice of individual physicians, as that is an area traditionally regulated by the states as part of their police powers.

[189] See SACGT RECOMMENDATIONS , supra note 14, at 27-31. The SACGT proposal is in some ways similar to the author’s proposal, minus the detail and the ongoing oversight.

[190] Id.

[191] Id. at 28.

[192] Id. at 28.

[193] The SACGT noted: “No federal standards guide how labs determine when enough is known about a genetic test for it to be used in clinical practice or the extent to which uncertainties about a test’s characteristics must be disclosed.” [Id. at.29]

[194] See Lori B. Andrews, A Conceptual Framework for Genetic Policy: Comparing the Medical, Public Health, and Fundamental Rights Models , 79 WASH. U. L.Q . 221, 256 (Spring 2001) (“The genetics industry itself has expressed widespread concern about the poor quality of genetic services. In one survey, sixty-seven percent of the 81 biotechnology companies and seventy-five percent of the 245 nonprofit organizations polled agreed that "FDA policies, or lack of policies, hinder the development of safe and effective genetic test kits or other products." The vast majority (over eighty-four percent) of both types of organizations indicated that there were genetic testing laboratories that lacked adequate quality assurance programs.”)

[195] Id.

[196] Id. at 31.

[197] Id. at 32.

[198] See Nunnally, supra note 185, at 343. See also id at 337 (“public image of genetic testing is critical in determining the operating climate for commercial genetic testing services.”)

[199] See SACGT RECOMMENDATIONS , supra note 14, at 14. See also the SACGT 12th Meeting Transcript, supra note 14 for a discussion on the importance of informed consent in genetic testing.

[200] See HEALTH CARE LAW AND POLICY 1087-1127( Clark C. Havighurst, et al., eds., 2nd ed. 1998) discussing physicians’ growing obligations to obtain patients’ informed consents. See also Protection of Human Subjects; Informed Consent , 46 FR 8942-01 (Jan. 27, 1981), 1981 WL 111289 (F.R.) (codified at 21 CFR Parts 50, 71, 171, 180, 310, 312, 314, 320, 330, 361, 430, 431, 601, 630, 812, 813, 1003, 1010) (“FDA believes that the regulation does not encroach upon the prerogatives of the medical community because a review of court decisions which have involved informed consent casts doubt on whether the so-called "therapeutic privilege" to dispense with informed consent has any continued viability even in the standard practice of medicine.”)

[201] See FINAL REPORT OF THE TASK FORCE ON GENETIC, supra note 27; see also IOM ASSESSING GENETIC RISKS , supra note 7, at 202-231, which discusses the personnel issues in human genetics and the summary recommendations at 18-20.

[202] Id . at 345; see also SACGT RECOMMENDATIONS , supra note 14.

[203] See SACGT RECOMMENDATIONS , supra note 14, at 14.

[204] See e.g. IOM ASSESSING GENETIC RISKS,supra note 7, at 247-280, which recommended a standard somewhat similar to the author’s. However, the IOM did not directly address the liability issues beyond recommending that physician/genetic counselor bear the burden of justifying any direct warning to a relative over a patient’s refusal to an ethics committee and possibly a court. See id. at 278. Also see following examples.

[205] See A ndrews, supra note 2, discussing the differences between the medical, public health and fundamental rights models.

[206] SACGT RECOMMENDATIONS , supra note 14, at 17-18

[207] Id. at 19.

[208] See FINAL REPORT OF THE TASK FORCE ON GENETIC, supra note 27, at 38 (emphasizing the need for providers to communicate clearly to patients that “they will not communicate results to relatives, except in extreme circumstances, which the provider should define.”)

[209] Id.

[210] See A ndrews, supra note 2, noting that most genetics regulation is governed by the medical model rather than the fundamental rights model, under which people are entitled to more information about medical services than under the medical model.

[211] Currently, there are no uniform procedures among the states for ensuring the quality of clinical testing.See Id at 28-30 for discussion of problems associated with state regulation, which he asserts “generally involve use-based, scientifically imprecise, and overly inclusive definitions, and some include awkward exceptions such as ‘all research uses.’” See also Andrews, Lori B., A Conceptual Framework for Genetic Policy: Comparing the Medical, Public Health, and Fundamental Rights Models, 79 WASH. U. L.Q. 221, 254-255 (2001) (“only a small minority of states have special licensing requirements for laboratories undertaking genetic tests. These requirements vary widely....Unfortunately, some state statutes impede, rather than encourage, quality in genetic services...Federal statutes address the quality of genetic services, but they are often not followed....[o]nly a small proportion of genetic tests in widespread use have been reviewed by FDA;”)

[212] See 21 U.S.C.A. § 360k (2002), which generally prohibits states from enacting any requirement “(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” See e.g. Martin v. Telect roni cs Pacing Systems, Inc., 105 F.3d 1090 (6th Cir. 1997), cert. den’d 118 S.Ct. 850, 522 U.S. 1075, 139 L.Ed.2d 751 (State law design defect claim asserted against manufacturer of pacemaker, which was investigational device under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (MDA), was preempted by MDA.) but see, e.g. Medtronic, Inc. v. Lohr , U.S.Fla.1996, 116 S.Ct. 2240, 518 U.S. 47 0, 135 L.Ed.2d 700, on remand 98 F.3d 618 .( Nothing in preemption provision of Medical Device Amendments (MDA) denies States right to provide traditional damages remedy for violations of common law duties when those duties parallel federal requirements, and MDA does not preempt state or local requirements that are equal to, or substantially identical to, requirements imposed by or under Food, Drug, and Cosmetic Act; presence of damages remedy does not amount to additional or different "requirement" under MDA, but merely provides another reason for manufacturers to comply with identical existing "requirements" under federal law. )

[213] See Michael J. Malinowski, supra note 5, at 28 for a discussion of the genetics exceptionalism debate’s impact on the regulation of genetic testing.

[214] See SACGT RECOMMENDATIONS , supra note 14, at 26 (where the SACGT notes that “a number of individuals from industry and professional organizations expressed concerns about the impact that additional oversight may have on the development, availability, and accessibility of genetic tests and expressed strong opposition to an increased role for FDA.”) See also id. at 26-27 (SACGT’s responsive recommendation for a streamlined process and a pilot test before actual implementation to determine the cost and effect on genetic testing, recognizing the validity of this concern and the chilling effect of an overly burdensome process. See also SACGT 12 th Meeting Transcript, supra note 14, at Day 2, p. 152, lns 17-25 where the SACGT discusses the FDA Modernization Act, which aims “to make all premarket review processes less burdensome). See also Final Rule on Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents , 62 FR 62243-02 (November 21, 1997) comments reported to FDA’s proposed rule regarding the regulation of ASRs. - e.g. Comment 14.

[215] See Michael S Watson, Regulation of Genetic Testing , in GENETIC TESTING 89, 96-101 (Clarissa Long, ed. AEI Press 1999)

[216] See id. at 26- 43, where the panel members debated whether FDA had the power and expertise to mandate certain informed consent requirements. See SACGT 12 th Meeting Transcript, supra note 14, at Day 2, p. 29, lns 4-8 (testimony of Dr. Steve Gutman of the FDA on whether FDA could regulate the degree of informed consent required for genetic tests: “you are very much at the edge of our legal framework in terms of where we have historically been. We do have precedent for pushing the envelope when we get worried about tests and all kinds of either traditional or untraditional ways, but we certainly haven’t visited this particular enterprise before and you’re correct, we don’t have any particular expertise. We’re growing expertise.”); See also Richard A. Merrill, Genetic Testing: A Role for FDA? , 41 JURIMETRICS J . 63-66 (2000) for a discussion of whether the FDA is the most appropriate entity to regulate genetic testing that questions the FDA’s institutional competence to regulate the areas that most need regulating, such as “autonomy, consent, and privacy that lie outside FDA’s statutory mandate and recognized expertise.” (Id. at 64). Merrill also notes that the “FDA has long embraced the proposition that it is not empowered to regulate ‘the practice of medicine,’” and he notes the “serious question of legal jurisdiction.”

[217] See SACGT 12 th Meeting Transcript, supra note 14, at 29, lines 4-22 (Testimony of Dr. Gutman).

[218] See Merrill, supra note 206, at 65, where Merrill notes that “the FDA might be able to assert jurisdiction over ‘home brew’ diagnostic tests to regulate certain reagents and other materials used by laboratories that perform genetic tests. Indeed, the agency has expressed the view that it could go further than it has gone, and Chevron U.S.A. v Natural Resources Defense Council indicates that an extension of jurisdiction might be upheld.”

[219] See Id. at 65-66, where Merrill discusses the FDA’s inadequate resources and asserts: “When all existing alternatives are considered, FDA may be the most appropriate repository of new regulatory responsibility. However, an expanded role should come from a suitably defined and structured statute accompanied by adequate resources.”

[220] See Neil A. Holtzman, FDA and the Regulation of Genetic Tests , 41 JURIMETRICS J 53-62, 61 (2000) (“Fearing that it will be deluged with new tests, FDA maintained that it lacks the resources to extend its full power to regulate devices to genetic tests marketed as services.”); see also Amy Huang, FDA Regulation Of Genetic Testing: Institutional Reluctance And Public Guardianship , 53 FOOD & DRUG L.J. 555, 571-2 (1998) discussing the FDA’s negative experience regulating testing in controversial areas, its difficult current environment and the fact that regulating genetics will likely be a “thankless task” because of the inherent controversies.

[221] Kevin Outterson, Health Care Symposium: E-Health: The Medical Frontier Health Care, Technology And Federalism , 103 W. VA. L. REV . 503, 527 (Summer 2001).

[222] See Andrews, FUTURE PERFECT , supra note152, at 113 (citing a survey of 81 biotechnology companies and 245 not-for-profit organizations (NFPs) that offer genetic testing, where 67% of the biotechnology companies and 75% of the NFPs agreed that “FDA policies, or lack of policies, hinder the development of safe and effective genetic test kits or other products.” The majority of both types of respondents (>84%) also noted that there were genetic testing laboratories that lacked adequate quality assurance programs.); see also Amy Huang, supra note 220, at 573 (“FDA's necessity has been demonstrated by experience, and despite complaints about the bureaucracy there is a certain efficiency to its existence. By having one national gatekeeper to monitor for potentially harmful drugs or devices, the independent review necessary to secure the public health takes places only once and is rendered in a methodical and dependable manner rather than duplicatively in offices and hospitals with inconsistent results depending on variations in time, access to information, and interest. The public benefits from consistency, standardization of review, avoidance of redundancy, and accumulation of institutional expertise generated by the existence of a central monitoring agency.”)

[223] See Id , n. 11 (“Dr. Neil A. Holtzman, chairman of the Task Force, observed, "Companies don't create kits so they can circumvent the FDA regulatory process”); but see id, note 68 (“See Weiss, supra note 22, at A1 ("But genetic tests are too new and complicated to be sold as kits."). Given low-cost multigene platforms such as the gene chip, however, the possibility of dramatic changes in the structure of testing is ever present.”); see also, id. at n. 183 (“Clive Cookson & Christopher Adams, Controls for Over-the-Counter Genetic Tests, FIN. TIMES, Sept. 24, 1997, at 12; see also Elizabeth Chang, Briefing #51: Doctor in the House, WASH. POST (Magazine), Sept. 7, 1997, at W 19 ("Home genetic tests might even be possible someday."). The success of at- home test kits in recent years further suggests that the market would probably be receptive to over the counter genetic tests. See A1 Heller, Do-It-Yourself Health Care Boosts Sales in Home Diagnostics Category, DRUG STORE NEWS, Oct. 6, 1997, at 21.”)

[224] See Amy Huang, FDA Regulation Of Genetic Testing: Institutional Reluctance And Public Guardianship , 53 FOOD & DRUG L.J. 555 (1998) for a discussion of the current problems, such as the patchwork of state and federal regulations, limiting the growth of the genetic testing industry and arguing of the need for increased regulatory oversight by the FDA.

[225] See IOM ASSESSING GENETIC RISKS, supra note 7, at 203 (“Currently, genetics professionals tend to be clustered in the Northeast and on the West Coast, as well as in the Chicago Area. A survey of genetic counselors and nurses working in genetics showed a heavy concentration of counselors in give states, with 43 percent of respondents located in California, Illinois, New Jersey, New York, and Pennsylvania. This uneven distribution of scarce genetic practitioners is even more limiting given the specialized expertise of many genetic centers in a relatively small number of genetics disorders.”)

[226] See Huang, supra note 214, which discusses the need for federal regulation and the fact that the FDA see ms to be best suited among the various DHHS agencies, given its expertise in regulating the safety and efficacy of other medical diagnostics, and the regulatory gaps (i.e. that it already currently regulates genetic test kits and it makes sense to create consistent regulation, rather than duplicate efforts).

[227] See Final Rule on Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents, 62 FR 62243-02 (Nov. 21, 1997).

[228] See Huang, supra note 224, at n. 216.

[229] See industry experts testifying at SACGT’s 12th Meeting. SACGT 12th Meeting Transcript, supra note 14.

[230] See e.g. Huang, supra note 216, at 588, and discussion supra Section VII(B)(2).

[231] See id.

[232] See SACGT RECOMMENDATIONS , supra note 14, at 27-28.

[233] See Neil A. Holtzman, FDA and the Regulation of Genetic Tests , 41 JURIMETRICS 53 (Fall 2000) (noting the particular dangers of lack of validation for predictive genetic tests, especially those predicting susceptibility to common, complex diseases in healthy people); see also Pilar N Ossorio, Product Liability for Predictive Genetic Tests , 4 JURIMETRICS 239, 248 (2000) (“Physical safety of the genetic test generally is not an issue. These tests often can be done using blood from a finger stick or cells from a cheek swab...Physical risks arise only when subsequent prophylactic or surveillance measures are taken in response to information produced by genetic tests results. The direct risks of genetic testing are primarily psychological and social and should be addressed through instructions, warnings and pre- and post-test counseling”); see also Amy Huang, FDA Regulation Of Genetic Testing: Institutional Reluctance And Public Guardianship , 53 FOOD & DRUG L.J . 555, 586 (1998) (“The information dynamics behind the distribution of genetic tests raise three concerns: misinformation, insufficient or unreliable information, and information with low predictive value.”)

[234] See Allen C Nunnally, Commercialized Genetic Testing: the Role of Corporate Biotechnology in The New Genetic Age, 8 B.U.J. SCI.&TECH.L. 306 (Winter 2002).

[235] See Huang, supra note 216, at 587-591.

[236] See Merrill, supra note 216, at 64.

[237] Written documentation of warnings is well within the FDA’s jurisdiction. See discussion, infra, of cases upholding regulation requiring prescription package inserts and adequate instructions for use for medical devices.

[238] This Committee –if it is not the SACGT itself – could build on the SACGT’s efforts to create a pamphlet for the general public explaining genetic testing, modifying the SACGT’s eventual template for specific genetic tests. See Request for Public Comment on a Draft Information Brochure on Genetic Tests for the General Public, 67 Fed. Reg. 13635 (Mar. 25, 2002).

[239] See William L. Christopher, Off-Label Drug Prescription: Filling the Regulatory Vacuum , 48 FOOD & DRUG L.J. 247, 250-56 (1993) (detailing the judicial indication that the FDA's oversight does not extend to regulation over

the practice of medicine); 142 Cong. Rec. S12,024 (daily ed. Sept. 30, 1996) (statement of Senator Frist) ("While the FDA regulates medical devices and pharmaceuticals, it has no authority to regulate the general practice of medicine.").

[240] See e.g. , Misuse of Prescription Drugs, Hearings Before the Subcomm. on Human Resources and Intergovernmental Relations of the House Comm. on Gov't Reform and Oversight (1996), available at 1996 WL 10830744 (statement of Michael Friedman, Deputy Commissioner for Operations, FDA) ("The history of the [FD&C] Act indicates that Congress did not intend FDA to interfere with the practice of medicine.");

[241] Jennifer L. Schenk , Rethinking FDA’s Draft Document On Cord Blood Stem Cell Products , 8 MD. J. CONTEMP. LEGAL ISSUES 151, 178 (1997) (“The FDA's policy with respect to bone marrow is that it falls within the practice of medicine and, thus, is not subject to FDA oversight unless the bone marrow has been manipulated to such an extent that it is rendered a somatic cell therapy.”

[242] Id. at 170. (The American Society of Clinical Oncology (ASCO) challenged the FDA's asserted authority to regulate the collection and storage of cord blood. ASCO took the position that the interstate commerce requirement limited the FDA's jurisdiction in the cord blood stem cell product arena.”)

[243] Notice the language in the statute, quoted below, which states that the FDA shall not interfere with the use by a practitioner of “any legally marketed device,” which presumes that the drug has at least been approved as safe and efficacious for some means and the general statutory purpose, which is to protect the public health against .

[244] See Southard v. Temple University Hospital , 1999 PA Super 95, 731 A.2d 603 [1999] (On the issue of FDA regulation of the practice of medicine, the Superior Court, stated that the "FDA at least minimally regulates the practice of medicine in several ways" by requiring that a device be FDA approved for some use before put to an off-label use.); see also Weaver v Reagen, 886 F.2d 194, 198 (8th Cir. 1989). (“Contrary to defendants' assertions, FDA approved indications were not intended to limit or interfere with the practice of medicine nor to preclude physicians from using their best judgment in the interest of the patient. Instead, the FDA new drug approval process is intended to ensure that drugs meet certain statutory standards for safety and effectiveness, manufacturing and controls, and labeling, 21 C.F.R. § 314.105(c) (1988), and to ensure that manufacturers market their drugs only for those indications for which the drug sponsor has demonstrated "substantial evidence" of effectiveness. Id. at § 314.126.”)

[245] Food and Drug Administration Modernization Act of 1997, Pub.L. 105-115, § 1(a), Nov. 21, 1997, 111 Stat. 2296, sec. 214 (emphasis added). Off-label use is usually defined as the unapproved uses of approved drugs.

[246] H.R. Conf. Rep. No. 399, 105th Cong., 1st Sess. 1997, Sec 214, at p. 97 (emphasis added).

[247] See Final Rule on Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents, 62 FR 62243-02 (Nov. 21, 1997).

[248] See id. at 327-331. See especially Id at 332. (“Beyond economic policy arguments, however, at least some of the reasoning for the non-application of CPMP doctrine to HMOs, and part of the rationale for not applying CPMP doctrine against genetic testing, stems from how medical practice is conceptualized.. . the question of whether diagnostic genetic testing functionally constitutes medical practice will be critical in assessing how the corporate prohibition may affect the genetic testing industry. Analysis of how CPMP doctrine impacts HMOs serves as an excellent predictive model for the genetic testing industry.”)

[249] See U.S. v Algon Chemical, Inc. , 879 F.2d 1154, 1160 (3d Cir. 1989). (“Congress intended to authorize compounding with legally acquired drugs and not to create an exception to the Act’s premarket approval process as explicated by the Supreme Court in United States v Rutherford. ...Rutherford involved the question of whether the FDA could prohibit the sale and distribution of the drug Laetrile for the treatment of terminally ill cancer patients. The Court held that, under the Act and the pre-approval process it established, the distribution of Laetrile was prohibited for any use until the FDA had approved it. In so holding, the Court did not except from the prohibition the sale ... to medical doctors and thus clearly upheld the FDA’s authority to restrict the flow of drugs to or by medical practitioners.”). Notice also the language in the statute, which states that the FDA shall not interfere with the use by a practitioner of “any legally marketed device,” which presumes that the drug has at least been approved as safe and efficacious for some means.

[250] 643 F.2d 1043 (5th Cir. 1981).

[251] Id. at 1048.

[252] U.S. v Algon Chemical, Inc . , 879 F.2d 1154, 1162 (3rd Cir. 1989) (emphasis added).

[253] Chaney v Heckler , 718 F.2d 1174 (D.C. Cir. 1983), rev’d on other grounds , 470 U.S. 821, 105 S Ct. 1649, 84 L.Ed. 2d. 714 (1985).

[254] U.S. v Algon Chemical, Inc. , 879 F.2d 1154, 1163 (3rd Cir. 1989)

[255] Id . at 333.

[256] Allen C Nunnally, Commercialized Genetic Testing: the Role of Corporate Biotechnology in The New Genetic Age, 8 B.U.J. SCI.& TECH.L. 306, 333-334 (Winter 2002).

[257] Note that the interstate commerce nexus is “presumed to exist” for medical devices under the FDCA. See 5 U.S.C.A. § 379a.

[258] The FDA already has regulated analyte specific reagents and so, in some way, has already begun to separate out some "product aspects" of genetic tests.

[259] See SACGT 12th Meeting Transcript, supra note 14, at Day 2, p. 32, ln 10 (statement by Dr. Charache, SACGT member).

[260] See INSTRUCTIONS FOR COMPLETING THE TEMPLATE FOR IN-HOUSE DEVELOPED GENETIC TESTS; DRAFT INSTRUCTIONS FOR CLINICAL LABORATORIES, supra note 29.

[261] Indeed, if genetic testing was instead found to be “the practice of medicine,” then in some states commercial entities might be barred from entering the genetic testing industry, which would limit the development of this burgeoning industry and hamper medical progress in general. See Nunnally, supra note 234, at 331 and id. at 341-2, which discusses the application of corporate practice of medicine prohibitions to the genetic testing industry.

[262] See Chevron, U.S.A, Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), and U.S. v Mead Corporation , 121 S. Ct. 2164 (2001).

[263] See e.g., U.S. v Algon, 879 F.2d 1154,1159 (3rd Cir 1989): (“With respect to this issue, however, we are not free to evaluate the FDA's position de novo. Courts must show substantial deference to the construction of a statute and regulations by an agency charged with their enforcement particularly where, as here, the agency is empowered not only to construe its governing statute, but additionally to make safety judgments delegated to it by Congress; accordingly, Algon can prevail only if it can show that "the FDA's views about the need of public health are arbitrary and capricious." Containers, 854 F.2d at 176.”); see also, Citizens to Preserve Overton Park v. Volpe, 401 U.S. at 416, 91 S.Ct. at 824 (citations omitted). (“When reviewing agency action under the arbitrary and capricious standard, the court must consider whether the decision was based on consideration of the relevant factors and whether there has been a clear error of judgment. Although this inquiry into the facts is to be searching and careful, the ultimate standard of review is a narrow one. The court is not empowered to substitute its judgment for that of the agency.”); see also U.S. v Loran Medical Systems, Inc ., 25 F. Supp.2d. 1082, 1086 (D.C.D. CA 1997) (upholding classification of a cell product as a drug under the FDA and citing a string of cases holding that "Congress fully intended that the [FD & C] Act's coverage be as broad as its literal language indicate."; see also Grand Laboratories, Inc. v. Harris, 660 F.2d 1288, 1291 (8th Cir.1981) (en banc) "[R]emedial legislation such as the Food, Drug and Cosmetic Act is to be given a liberal construction consistent with the Act's overriding purpose to protect the public health; and United States v. Western Serum, 666 F.2d 335, 341 (9th Cir.1982). (“In interpreting the FD & C Act, the court's duty is to "avoid any construction which would result in the free marketing of drugs which might well be unsafe." Classifying the Cell Product as a drug is consistent with Congress' intent to give the FDA broad authority in this important area.”)

[264] See e.g. Pharmaceutical Manufacturer’s Assoc. v FDA , 484 F.Supp. 1179, 1186 (D. Del. 1980).

[265] See SACGT 12th Meeting Transcript, supra note 14, at Day 2, p. 29 (Dr. Gutman’s testimony to SACGT).

[266] See 65 A.L.R. Fed. 725 (1983) (“The court in United States v Device Labeled "Cameron Spitler Amblyo-Syntonizer," etc. (1966, DC Neb) 261 F Supp 243, stated that the fact that the seized devices were only permitted to be sold to or used by licensed optometrists was not in itself a sufficient basis for an exemption from the adequate directions for use requirement contained in 21 U.S.C.A. § 352(f) Observing that licensed practitioners are not exempt from the terms of the Federal Food, Drug, and Cosmetic Act, the court stated that there was no reason why a device used solely by licensed practitioners should, for that reason alone, be exempt from the adequate directions or use requirement. Granting summary judgment to the government in an action to condemn two electric acupuncture devices, the court in United States v Articles of Device (Acuflex; Pro-Med) (1977, WD Pa) 426 F Supp 366, 65 ALR Fed 715, found that the devices were not exempt from the adequate directions for use requirement contained in 21 U.S.C.A. § 352(f) on the basis that the devices were intended to be sold only to licensed operators for use in their practices.”)

[267] Particularly, states have traditionally had the power to regulate the practice of medicine, which is usually delivered locally.

[268] See Huang, supra note 216, at 575-580 for a discussion of general Constitutional law on the extent of Congress’ authority under the interstate commerce clause, concluding that regulating most genetic tests would fall under Congress’ power.

[269] See Wickard v Fillburn , 317 U.S. at 118 (1942) (sustaining the Agricultural Adjustment Act of 1938, which imposed a wheat quota on a farmer whose wheat was intended entirely for home consumption); see also Huang, supra note 254.

[270] See Pilar N Ossorio, Product Liability for Predictive Genetic Tests , 4 JURIMETRICS 239, 241 (2000)

[271] Kevin Outterson, Health Care Symposium: E-Health: The Medical Frontier Health Care, Technology And Federalism , 103 W. VA. L. REV. 503, 527, 538-9 (Summer 2001)

[272] See Nunnally,supra note 234, at 326; see also Huang, supra note 216, at 576 (noting that where advertising, patients, or the components of genetic tests cross state lines there is clearly sufficient connection to interstate commerce. She adds that the case for regulating purely local provision in academic labs is tougher, however, the need there is also less.)

[273] Baker v. United States , 932 F.2d 813, 814 (9th Cir. 1991). ("Thus, the 'shipment in interstate commerce' requirement is satisfied even when only an ingredient is transported interstate.") ; see also Grand Labs. v. Harris , 660 F.2d 1288 (8th Cir. 1981) cert. denied sub nom . Grand Labs. v. Schweiker , 456 U.S. 927, 102 S. Ct. 1972, 72 L.Ed.2d 442 (1982) ; see also, Huang, supra note 224, at 578 (“In its argument for jurisdiction under this theory [materials received in interstate commerce] FDA would be assisted by the long-standing principle in food and drug law jurisprudence that the "high purpose of the Act to protect consumers who under present conditions are largely unable to protect themselves ... [should not] be easily defeated." Ensuring the public health is a prime example of national power and prerogative, especially where the circumstances are buttressed by other commercial and interstate elements. Thus, judicial interference in a decision by FDA to extend oversight [over genetic tests where the components were shipped in interstate commerce] is unlikely.”) (citing Kordel v. United States , 335 U.S. 345, 349 (1948).)

[274] See Hospital Building Co v Trustees of Rex Hospital, 425 U.S. 738 (1976)– where the Supreme Court found the Sherman Act’s interstate commerce requirement satisfied when hospital plaintiff, allegedly victim of “attempt to monopolize” made out-of-state purchases of medicines and supplies, derived revenues from out-of-state insurance companies, made payments to an out-of-state management company, and obtained financing for its expansion from out-of-state sources; see also McLain v Real Estate Board of New Orleans, Inc., 444 U.S. 232, 240 (1980) where the Supreme Court held that jurisdiction could be established even if challenged local activity was not “an essential, integral, part of the transaction and inseparable from its interstate aspects.” The Court stated “To establish federal jurisdiction in this case, there remains only the requirement that respondents’ activities, which allegedly have been infected by a price-fixing conspiracy be shown ‘as a matter of practical economics’ to have a not insubstantial effect on the interstate commerce involved.” Id at 246 (quoting Rex Hospital , 425 US at 745); see also Summit Health, Ltd. v. Pinhas , 500 US 322 (1991) (Held that plaintiff physician, did not have to allege or prove that unlawful action that caused his harm also had an actual effect on interstate commerce – would be sufficient if restraint alleged was potentially capable of affecting commerce.). Note that while some argue that U.S. v. Lopez signals a retrenchment in the expansion of Congress’ commerce power, Lopez dealt with regulation of arguably non-commercial behavior, which is distinguishable from regulating a commercial industry like genetic testing. Indeed, the Court majority in Lopez found it important that the activity being regulated (possession of guns in schools) was not itself a commercial activity. See U.S. v. Lopez , 514 US 549 (1995) (The Court found that the Congress exceeded its powers under the Commerce Clause, in passing a law making it a federal crime “for any individual knowingly to possess a firearm at a place that the individual knows, or has reasonable cause to believe, is a school zone.”).

[275] Id at 538-9.

[276] Linder v. United States , 268 U.S. 5, 18, 45 S. Ct. 446, 449, 69 L.Ed. 819 (1925)

[277] See e.g. , id. at 1188: (“The Federal Food, Drug & Cosmetic Act "rests upon the constitutional power resident in Congress to regulate interstate commerce," and its validity under that clause has been upheld. United States v. Walsh , 331 U.S. 432, 434, 67 S.Ct. 1283, 1284, 91 L.Ed. 1585 (1947). [FN13] The fact that the practice of medicine is an area traditionally regulated by the states does not invalidate those provisions of the Act which may at times impinge on some aspect of a doctor's practice.”); see also Cowan v U.S. DHHS and FDA , 5 F.Supp.2d 1235, 1242 (US D ND OK 1998) (“the law is very clear, and under the current statutes and regulations, Plaintiff's physician may not administer the goat neutralizing antibody drug absent prior approval of the FDA. In Court, Plaintiff argued that he should have the right to take whatever treatment he wishes due to his terminal condition regardless of whether the FDA approves the treatment as effective or safe, and that to prohibit him from taking the treatment he wishes violates his rights under the United States Constitution. [FN4] The United States Supreme Court previously addressed and rejected this argument in Rutherford. .”)

[278] See Federal Drug Administration Modernization Act of 1997 (Pub. L. 105-115), amending SEC. 122. REQUIREMENTS FOR RADIOPHARMACEUTICALS. (“Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services, after consultation with patient advocacy groups, associations, physicians licensed to use radiopharmaceuticals, and the regulated industry, shall issue proposed regulations governing the approval of radiopharmaceuticals. The regulations shall provide that the determination of the safety and effectiveness of such a radiopharmaceutical under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C.

262) shall include consideration of the proposed use of the radiopharmaceutical in the practice of medicine, the pharmacological and toxicological activity of the radiopharmaceutical (including any carrier or ligand component of the radiopharmaceutical), and the estimated absorbed radiation dose of the radiopharmaceutical.”)

[279] See e.g. Pharmaceutical Manufacturer’s Assoc. v FDA , 484 F.Supp. 1179 (D. Del. 1980) (upholding FDA’s authority to require mandatory prescription package inserts, against a challenge that the regulations were an unconstitutional interference with physicians’ right to practice medicine and the state’s historic power to regulate the practice of medicine); see especially id, at 1188, n. 13: “The misbranding provisions of the Act constitute a valid exercise of the power conferred by the commerce clause even though they apply to intrastate transfers and administrations following an interstate shipment of the drug. United States v. Sullivan , 332 U.S. 689, 68 S.Ct. 331, 92 L.Ed. 297 (1948).”; see also id. (“ There simply is no constitutional basis for recognition of a right on the part of physicians to control patient access to information concerning the possible side effects of prescription drugs. The cases cited by plaintiffs do contain language referring to a doctor's right to practice medicine, but the rights there recognized were only those necessary to facilitate the exercise of a right which patients were found to possess. The physician rights discussed are thus derivative of patient rights and do not exist independent of those rights. The Supreme Court pointed this out in Whalen v. Roe , 429 U.S. 589, 97 S.Ct. 869, 51 L.Ed.2d 64 (1977)”

[280] See Huang, supra note 224, at 579-580.

[281] See Francis S. Collins, Shattuck Lecture: Medical And Societal Consequences Of The Human Genome Project, 28 NEW ENG. J. OF MED . 341, 341 (1999).

[282] Complementary legal rules governing general medical privacy and prohibiting discrimination in employment and in insurance should be developed also so that patients and their relatives will not suffer undue financial and other harms from the physician’s limited privilege to warn.