Can I Be Sued for that? Liability risk and the Disclosure of Clinically Significant Genetic Research Findings

Genomic researchers increasingly are faced with difficult decisions about whether, under what circumstances, and how to return research results and significant incidental findings to study participants. Many have argued that there is an ethical—maybe even a legal—obligation to disclose significant findings under some circumstances. At the international level, over the last decade there has begun to emerge a clear legal obligation to return significant findings discovered during the course of research. However, there is no explicit legal duty to disclose in the United States. This creates legal uncertainty that may lead to unmanaged variation in practice and poor quality care. This article discusses liability risks associated with the disclosure of significant research findings for investigators in the United States

The Web of Relations: Thinking About Physicians and Patients

Like the other contributors to this symposium, I owe a profound debt to Jay Katz for his intellectual rigor, his gentle but firm Socratic pedagogy, and his unparalleled generosity of time and friendship. I first met Jay during my last year of law school when, at the urging of friends, I enrolled in his seminar on informed consent. By that time, he had collected most of the materials on which he based his important book. Not surprisingly, a single semester could not contain all of that material, so many of us continued on into the second semester. During that time I learned a number of things, but largely in the abstract mode that often characterizes the law school classroom. Fortunately, I had the opportunity after my first year in medical school to work on Jay\u27s book, The Silent World of Doctor and Patient. I am not sure that I contributed much. I have always viewed that summer as Jay\u27s effort to create a tutorial designed to make sure I got it. Even so, it required actually taking care of patients for the last twenty years to bring some of his lessons home. Over the years, I have come to see the physician-patient relationship not simply as a dyad of autonomous individuals, but as one part, albeit an important and complex part, of a web of dynamic interactions that influence both parties. This perspective has important implications. The work of Barabási and others has shown that networks are fluid, self-creating, and always changing. At the same time, networks tend to respond poorly or unexpectedly to deliberate attempts to induce change. Pressure at one point can lead to a countervailing response at another. This understanding provides additional insights into people\u27s actions and suggests both reasons for resistance as well as the possibility of support from unanticipated sources

Father and Mother Know Best: Defining the Liability of Physicians for Inadequate Genetic Counseling

Although genetic disorders have been recognized for centuries, recent advances in the study of human genetics often permit accurate determination of the risk that parents will have genetically defective children.\u27 When this information is available either before conception or during pregnancy, prospective parents may choose to prevent the birth of such defective children through contraception or abortion. Recently, courts have been called on to define the circumstances in which either the parents or the children should receive tort damages when parents are denied opportunities to prevent the birth of defective children because of their physicians\u27 negligent failure to detect or disclose risks of genetic disorder. Only eleven years ago, a court was unwilling to impose liability on physicians who had given inaccurate information about the risk of an environmentally induced birth defect. Yet many of the arguments that swayed that court are no longer persuasive to courts now deciding cases involving the birth of genetically defective children. This may be due in part to the growing public awareness of the economic and emotional burden of genetic disease. Moreover, with dramatic constitutional developments expanding the right to choose not to procreate, judicial reluctance to approve abortion undertaken to avoid the birth of defective children no longer seems justified. Thus, in Howard v. Lecher a physician had allegedly been negligent in failing to detect the parents\u27 risk that their child would be fatally afflicted with Tay-Sachs disease. Although the New York Court of Appeals denied the parents\u27 cause of action for emotional distress, the lower court\u27s recognition of their claim for medical and funeral expenses incurred in the child\u27s behalf was not even appealed. In Park v. Chessin, a later case based on allegations that the defendant physicians had given inaccurate genetic risk information, a New York appellate court refused to dismiss a cause of action for injuries and conscious pain and suffering brought on behalf of a child born with polycystic kidney disease, a degenerative genetic disorder that inevitably leads to early death. The child\u27s parents were allowed to assert a claim for their medical and support expenses. The new judicial willingness to recognize some physician liability for failure to give accurate genetic risk information has not produced consistent results. In some cases, courts have permitted only the parents to bring suit, while in others both parents and defective children have been allowed to sue. When courts have reached the question of defining the duty of physicians to detect and to disclose genetic risks, the standards promulgated have often limited inappropriately the scope of physicians\u27 liability. Finally, even cases in which liability has been imposed have recognized differing types and measures of damages for similar injuries.\u27 This Note provides a more coherent method for analyzing such cases. Part I discusses the process of identifying and advising prospective parents who risk having genetically defective children so that they may make better informed procreative choices. Part II argues that imposing tort liability on individual physicians can best vindicate the social interest in reducing the incidence of genetic defects; it also contends that only causes of action asserted by parents of children with such disorders should be sustained. Part III proposes a set of requirements, based largely on existing tort doctrines, for upholding such causes of action and sets forth principles for determining the measure of damages for negligent genetic counseling by physicians

Ten Fingers, Ten Toes: Newborn Screening for Untreatable Disorders

This movie makes two important points despite its admitted unreality. The first, which the screen writer probably did not fully appreciate at the time, is that genetic testing cannot now and probably will never be able to predict with complete certainty the occurrence and course of complex diseases. It is not true that Genes-R-Us. Rather, we are the products of complex interactions of our genes, the genomes of other organisms (many of which we live in relation with), and the environment, broadly understood to include the air we breathe, the water we drink, the food we eat, the drugs we take, our social structures, and our cultural practices. Moreover, the effects of these interactions can vary depending on when they occur in the lifecycle. For example, it appears that caloric deprivation during pregnancy may predispose children to a host of health problems later on, whereas the same deprivation during adulthood might be life prolonging. As a result, even the most sophisticated genetic analysis at birth is not going to reveal everything about a person\u27s future health. The other lesson of GATTACA, the ultimate of a genetic essentialist dystopia, is the importance of characteristics of the society in which the information is being used. Why might we want to screen newborns for untreatable disorders? Here the excellent paper by Bailey et al. in Pediatrics is particularly thoughtful. In this article, the authors discuss a number of arguments for newborn screening for these problems. These include avoiding delays in diagnosis often after numerous consultations, providing parents with information about their children\u27s health, allowing the earlier initiation of interventions, learning more about the natural history of these disorders, providing reproductive information to the family, and creating more opportunities to support these families

Patients and Biobanks

The question about the privacy of medical information can be stated simply: To what extent can and should patients control what the medical record contains and who has access to it and for what purposes? Patients often have apparently conflicting views on this subject. On the one hand, we, as patients, say that we prize privacy and that we fear that information will be used to harm us. On the other hand, we value the benefits that come from improved communication among providers, such as having our visits covered by third party payers and advances in medical science, which often come from researchers and providers having access to large data sets. These apparently contradictory desires are not unique to health care. In many other arenas of life, we sell information about ourselves incredibly cheaply, as the grocery and drug store discount tags on our key chains attest. But areas of discomfort remain, one of which I will explore: the use of the contents of the electronic record for medical research. Evolving practices in this area raise a host of questions

Through the Lens of the Sequence

The completion of the rough draft of the human genome is a scientific feat worthy of celebration. But the media attention that has been devoted to the Human Genome Project demonstrates that most people are not as interested in what the sequence is as in what it means for individuals and for society, for good or for ill. My purpose in writing this essay is to discuss how the project was conducted here in the United States, and some of the implications of knowing the sequence (or more aptly, a sequence)

Federal COVID-19 Response Unlawfully Blocks State Public Health Efforts

The federal government recently used preemption unlawfully to prevent state public health efforts to protect vulnerable people from COVID-19. As 1,000 current and former CDC epidemiologists noted in an open letter, the federal government has failed to use legal powers it does have to manage the crisis, leaving states to “invent their own differing systems” to manage COVID-19. We add that the federal government is now asserting emergency powers it does not have to disable state public health responses. Early this month, Nevada officials halted the use of two rapid coronavirus tests that produced high false-positive rates when used for screening vulnerable people in Nevada’s nursing homes, assisted-living, long-term care, and other congregate facilities. More than half the positive test results were false. On October 8, the U.S. Department of Health and Human Services (HHS) sent a letter threatening that the Nevada officials’ action was “inconsistent with and preempted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved.” Nevada yielded to this threat and, on October 9, removed its directive to stop using the tests

Deadly Delay: The FDA\u27s Role in America\u27s COVID-Testing Debacle

In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) published a series of 2020 guidance documents on how to seek Emergency Use Authorizations (EUAs) for new SARS-CoV-2 tests. These guidance documents suggest EUAs are needed for laboratory-developed tests (LDTs), a type of test created and used in-house by high-complexity clinical laboratories that already are regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These CLIA-regulated laboratories traditionally have provided a rapid response to emerging epidemics. Many laboratories viewed the FDA’s 2020 guidance documents as having a practical binding effect even though the FDA lacked clear statutory authority to require EUAs for LDTs developed at CLIA-compliant high-complexity laboratories. The FDA’s guidance documents led to decreased availability of testing, particularly in the early stages of the pandemic, which contributed to the catastrophic course of the COVID-19 pandemic in the United States. This Essay concludes that the FDA lacks authority to require EUAs for COVID-related LDTs and that the FDA’s intervention, in key respects, just replicates protections CLIA already provides. The Essay then discusses recently proposed legislation, known as the VALID Act of 2020, which would expand the FDA’s authority to regulate LDTs. While spurred by longstanding concerns about tests used in genomics and precision medicine, the VALID Act’s reach is much broader and would have harmful consequences for more traditional tests, including tests for emerging communicable diseases. Before Congress acts on specific legislative proposals, a much broader, more inclusive, nuanced, and evidence-informed dialogue about diagnostic-testing policy is needed