title: The Legal Past, Present and Future of Prenatal Genetic Testing: Professional Liability and Other Legal Challenges Affecting Patient Access to Services.
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.
authors.affiliation: Children's Law Group, Case Western Reserve University School of Law, LLC, 142 East Ontario, Suite 525 Chicago, IL 60611, USA. dpergament@childrenslawgroup.com.
authors.forename: Deborah
authors.initials: D
authors.lastname: Pergament
authors.affiliation: Children's Law Group, Case Western Reserve University School of Law, LLC, 142 East Ontario, Suite 525 Chicago, IL 60611, USA. dpergament@childrenslawgroup.com.
authors.forename: Katie
authors.initials: K
authors.lastname: Ilijic
keywords: cell-free fetal DNA testing; embryonic therapy; ethics of prenatal testing; fetal therapy; genetic counseling; informed consent; legal status of prenatal testing; noninvasive fetal  testing; preimplantation genetic diagnosis; professional liability; termination of pregnancy