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US Regulatory Response to Thalidomide (1950-2000)
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.
Subject: Legal, Reproduction
United States v. Milan Vuitch (1971)
In the 1971 court case United States v. Milan Vuitch, hereafter US v. Vuitch, the US Supreme Court ruled that a Washington, DC law was constitutional by overturning a 1969 district court decision. Beginning in the early twentieth century, Washington, DC, prohibited abortions except for abortions performed to preserve the life or health of the pregnant woman. In 1969, Milan Vuitch, a physician in Washington, DC, was convicted of criminal abortion for providing an abortion when the woman’s life was not endangered.
Bowen v. American Hospital Association (1986)
The 1986 US Supreme Court decision Bowen v. American Hospital Association rejected the federal government's use of Section 504 of the Rehabilitation Act of 1973 to intervene in a hospital's treatment for neonates born with severe congenital defects. This case set a precedent for the role of government involvement in cases where parents refused consent for care of disabled newborns.
Subject: Legal, Reproduction
Uniform Anatomical Gift Act (1968)
The Uniform Anatomical Gift Act (UAGA or the Act) was passed in the US in 1968 and has since been revised in 1987 and in 2006. The Act sets a regulatory framework for the donation of organs, tissues, and other human body parts in the US. The UAGA helps regulate body donations to science, medicine, and education. The Act has been consulted in discussions about abortion , fetal tissue transplants , and Body Worlds , an anatomy exhibition.
Subject: Legal, Outreach, Reproduction
“Improving Women’s Health”: Section 3509 of the Affordable Care Act of 2010
In 2010, US Congress enacted section 3509 of the Patient Protection and Affordable Care Act or ACA, to target issues relating to women’s health. The ACA, signed into law by US President Barack Obama, aimed to increase people’s access to high-quality healthcare in the United States.
Human Fertilisation and Embryology Act (1990)
The Human Fertilisation and Embryology Act 1990 established the legal framework that governs infertility treatment, medical services ancillary to infertility treatment such as embryo storage, and all human embryological research performed in the UK. The law also defines a legal concept of the parent of a child conceived with assisted reproductive technologies.
Subject: Legal, Reproduction, Ethics
The US President's Council on Bioethics (2001-2009)
The US President's Council on Bioethics was an organization headquartered in Washington D.C. that was chartered to advise then US President George W. Bush on ethical issues related to biomedical science and technology. In November 2001, US President George W. Bush created the President's Council on Bioethics (PCB). Convened during a nationwide cloning and embryonic stem cell research debate, the Council stated that it worked to address arguments about ethics from many different perspectives.
Subject: Organizations, Legal, Ethics
Sindell v. Abbott Laboratories (1980)
Sindell v. Abbott Laboratories was a 1980 California case that established the doctrine of market share liability for personal injury cases. For such liability, when a drug causes personal injury and the manufacturer of the drug cannot be identified, each producer is responsible for paying the settlement in proportion to the percentage of the market they supplied. Judith Sindell and Maureen Rogers brought the case against the producers of diethylstilbestrol (DES), which their mothers had taken during pregnancy to prevent miscarriage and other complications.
The Baby Doe Rules (1984)
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.
Subject: Legal, Reproduction
California Proposition 71 (2004)
The California Stem Cell Research and Cures Act, also called Proposition 71, was a ballot
initiative proposed by California voters in 2004 to allocate three billion dollars of state
funds for stem cell research over ten years. Endorsed by California scientists and
patient-advocates, Prop 71 passed on 2 November 2004, amending the state constitution to make
stem cell research a constitutional right. In addition, Prop 71 led to the creation of the
California Institute for Regenerative Medicine (CIRM), in San Francisco, California to allocate
Stump v. Sparkman (1978)
On March 28, 1978, in Stump v. Sparkman, hereafter Stump, the United States Supreme Court held, in a five-to-three decision, that judges have absolute immunity from lawsuits involving any harm their judicial decisions cause. Linda Sparkman, who was unknowingly sterilized when she was fifteen years old in 1971, sued Harold Stump, the county circuit court judge who signed the petition to allow Sparkman’s mother to have her sterilized. Sparkman’s mother stated to Stump that she wanted her daughter sterilized because of Sparkman’s alleged mental deficiencies and sexual promiscuity.
Subject: Legal, Ethics, Reproduction
Beal v. Doe (1977)
In the case of Beal v. Doe, tried in 1977, the US Supreme Court ruled that states could constitutionally restrict money from Medicaid from funding elective abortions. After the 1973 case Roe v. Wade, in which the US Supreme Court had ruled women have the rights to terminate pregnancies within the first trimester, the state of Pennsylvania passed legislation that restricted the use of Medicaid funds for abortion procedures. In 1977, several Medicaid eligible women who were unable to receive coverage for a non-therapeutic abortion brought a case against Frank S.
Daubert v. Merrell Dow Pharmaceuticals, Inc. (1993)
In its 1993 decision Daubert v. Merrell Dow Pharmaceuticals, Inc., the US Supreme Court established the Daubert Standard for evaluating the admissibility of scientific knowledge as evidence in US federal courts. When it began in trial court, the case addressed whether or not Bendectin, an anti-nausea medication taken during pregnancy, caused birth defects. However, after the trial court dismissed the case for lack of admissible evidence, Daubert v. Merrell Dow Pharmaceuticals, Inc.
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