Abstract
This chapter is an overview of the current status of the law in the United States regarding prenatal genetic testing with an emphasis on issues related to professional liability and other challenges affecting patient access to prenatal genetic testing. The chapter discusses the roles that federal regulations, promulgated by the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), play in the regulation of prenatal genetic tests. The chapter discusses tort litigation based on allegations of malpractice in the provision of prenatal genetic testing and how courts have analyzed issues related to causation, damages and mitigation of damages. The chapter provides reference information regarding how individual states address causes of action under the tort theories of wrongful birth and wrongful life. The chapter concludes with a discussion of future legal issues that may affect clinical prenatal genetic testing services arising from the continued expansion of prenatal genetic testing, legal restrictions on access to abortion and the potential development of embryonic treatments.
Highlights
This chapter is a general overview of the current status of the law in the United States regarding prenatal genetic testing with an emphasis on issues related to professional liability and other challenges resulting from the current legal climate that affects patient access to prenatal genetic testing
The chapter includes a discussion based on a definition of prenatal testing that incorporates carrier screening, preimplantation genetic diagnosis (PGD), invasive testing and noninvasive prenatal testing (NIPT)
The New York requirements exceed the Clinical Laboratory Improvement Amendments of 1988 (CLIA) standards with the implementation of specific genetic testing standards, which laboratories seeking a genetic testing permit must satisfy. These requirements may serve as a model for amplification and refinement of the federal CLIA with regards to genetic testing
Summary
This chapter is a general overview of the current status of the law in the United States regarding prenatal genetic testing with an emphasis on issues related to professional liability and other challenges resulting from the current legal climate that affects patient access to prenatal genetic testing It includes a discussion of future legal issues that may arise from the continued expansion of prenatal genetic testing and the potential development of embryonic treatments and expansion of fetal surgical and other interventions. The practice and ethics guidelines promulgated by professional and scientific societies (e.g., the International Society for Prenatal Diagnosis, the National Society of Genetic Counselors, the American College of Obstetrics and Gynecology, the American College of Medical Genetics and Genomics) help structure clinical activities by providing guidelines and resources regarding best practices These guidelines may influence the development of regulatory requirements and may be cited in medical malpractice lawsuits but, they are merely advisory and have no binding legal authority. The clinical practices surrounding prenatal genetic testing may reflect both the anxieties that surround the possibility of civil litigation based on allegations of malpractice and the outcomes of such litigation
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