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The Baby Doe Rules represent the first attempt by the US government to directly intervene in treatment options for neonates born with congenital defects. The name of the rule comes from the controversial 1982 case of a Bloomington, Indiana infant Baby Doe, a name coined by the media. The Baby Doe Rules mandate that, as a requirement for federal funding, hospitals and physicians must provide maximal care to any impaired infant, unless select exceptions are met. If a physician or parent chooses to withhold full treatment when the exceptions are not met, they are liable for medical neglect.
Thalidomide, a drug capable of causing fetal abnormalities (teratogen), has caused greater than ten thousand birth defects worldwide since its introduction to the market as a pharmaceutical agent. Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did. By 1962, approximately 20,000 patients in the US had taken thalidomide as part of an unregulated clinical trial before any actions were taken to stop thalidomide's distribution.
In the 1973 court case Doe v. Bolton, the US Supreme Court in Washington, D.C., ruled that a Georgia law regulating abortion was unconstitutional. The Georgia abortion law required women seeking abortions to get approval for the procedure from their personal physician, two consulting physicians, and from a committee at the admitting hospital. Furthermore, under the statutes, only women who had been raped, whose lives were in danger from the pregnancy, or who were carrying fetuses likely to be seriously, permanently malformed were permitted to receive abortions.