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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.

Format: Articles

Subject: Legal, Reproduction

Jeter v. Mayo Clinic Arizona [Brief] (2005)

In Arizona, statutes that protect persons, such as the wrongful death statute, will not be interpreted by the courts to grant personhood status to frozen embryos. The legislature may grant such protection in the statute if it chooses to do so by explicitly defining the word person to include frozen embryos.

Format: Articles

Subject: Legal, Reproduction

A. Z. v. B. Z. (2000)

In A.Z. v. B.Z. (2000), the Supreme Judicial Court of Massachusetts in Boston, Massachusetts, affirmed a lower courtÕs decision, ruling that contracts that require a party to become a parent against his or her will are unenforceable and contrary to public policy. The case centered around A.Z. and B.Z., a divorced couple who had previously used in vitro fertilization (IVF) to start a family together during their marriage and had several preembryos cryopreserved as part of the process.

Format: Articles

Subject: Legal

Frazer v. Schlegel (2007)

On 20 August 2007, in Frazer v. Schlegel, the United States Court of Appeals for the Federal Circuit decided that researchers Ian Frazer and Jian Zhou owned the rights to the vaccine patent for Human Papillomavirus, or HPV, instead of a research team led by Richard Schlegel. Frazer v. Schlegel reversed the decision that the Board of Patent Appeals and Interferences had previously made, awarding the patent to Schlegel on the basis that Frazer’s patent application contained inaccurate science.

Format: Articles

Subject: Legal, Technologies

NuvaRing

The NuvaRing is a self-administered hormonal contraceptive device in the form of a flexible plastic ring that is inserted into the vagina. It releases the hormones etonogestrel and ethinylestradiol, which are synthetic forms of the female reproductive hormones progesterone and estrogen, respectively. The pharmaceutical company Organon first made NuvaRing in the Netherlands in 1980s. The Netherlands first approved it for use in February of 2001, and the United States did the same in October of that year.

Format: Articles

Subject: Technologies, Reproduction, Legal

“Women’s Right to Know” Informed Consent Informational Materials

As of 2021, twenty-eight US states have informed consent laws for abortion, which is a medical procedure to terminate pregnancy, often called Women’s Right to Know laws. Those laws often require the state government to develop informational materials that healthcare providers must give to women before an abortion. Informational materials generally include information about the process of fetal development, accompanied by illustrations or pictures, risks and effects of abortion, and alternatives to abortion.

Format: Articles

Subject: Legal

Jeter v. Mayo (2005)

In Jeter v. Mayo, the Court of Appeals of Arizona in 2005 held that a cryopreserved, three-day-old pre-embryo is not a person for purposes of Arizona's wrongful death statutes, and that the Arizona Legislature was best suited to decide whether to expand the law to include cryopreserved pre-embryos. The Court of Appeals affirmed a decision by the Maricopa County Superior Court to dismiss a couple's wrongful death claim after the Mayo Clinic (Mayo) allegedly lost or destroyed several of their cryopreserved pre-embryos.

Format: Articles

Subject: Reproduction, Legal

Golden Rice

Golden Rice was engineered from normal rice by Ingo Potrykus and Peter Beyer in the 1990s to help improve human health. Golden Rice has an engineered multi-gene biochemical pathway in its genome. This pathway produces beta-carotene, a molecule that becomes vitamin A when metabolized by humans. Ingo Potrykus worked at the Swiss Federal Institute of Technology in Zurich, Switzerland, and Peter Beyer worked at University of Freiburg, in Freiburg, Germany. The US Rockefeller Foundation supported their collaboration.

Format: Articles

Subject: Organisms, Legal

Barry Morris Goldwater (1909–1998)

Barry Morris Goldwater was a Republican Arizona Senator and US presidential candidate in the twentieth-century whose policies supported the women's reproductive rights movement. Goldwater, a businessman and Air Force reservist, transitioned into politics in the 1950s. He helped align popular support for a conservative Republican Party in the 1960s. Throughout his life, he worked to maintain personal liberty and to limit governmental intrusion into citizens' private lives. Goldwater, influenced by his wife Margaret (Peggy) Goldwater, supported women's rights to abortions.

Format: Articles

Subject: People, Reproduction, Legal, Religion

Woman’s Right to Know Act in Texas (2003)

In 2003, the Texas state legislature passed the Woman’s Right to Know Act, hereafter the Act, as Chapter 171 of the state’s Health and Safety Code. The Act sets requirements that physicians must follow during the informed consent process for abortion, or a medical procedure to terminate pregnancy, in Texas. Lawmakers amended the Act and added several additional regulations that restrict access to abortion in 2011, 2013, 2015, and 2017.

Format: Articles

Subject: Legal

J. B. v. M. B. (2001)

In 2001, the Supreme Court of New Jersey decided a dispute between a divorced couple over cryopreserved preembryos created through in vitro fertilization (IVF) during the coupleÕs marriage. The former wife (J.B.) wanted the preembryos destroyed, while her former husband (M.B.) wanted them to be used for future implantation attempts, such as by an infertile couple. In J.B. v. M.B. (2001), the court declined to force J.B. to become a parent against her will, concluding that doing so would violate state public policy.

Format: Articles

Subject: Legal

Women’s Right to Know Act (2019) by Americans United for Life

In 2019, Americans United for Life, hereafter AUL, published a model legislation, called the Women’s Right to Know Act, in their annual publication Defending Life. The goal of the model legislation, which AUL annually updates, is to help state governments enact enhanced informed consent laws for abortion. The Women’s Right to Know Act requires physicians to provide specific information to women before they may consent to having an abortion.

Format: Articles

Subject: Legal, Publications, Reproduction

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.

Format: Articles

Subject: Legal

In re Agent Orange Product Liability Litigation (1979-1984)

In the legal case In re Agent Orange Product Liability Litigation of the early 1980s, US military veterans of the Vietnam War sued the US chemical companies that had produced the herbicide Agent Orange, and those companies settled with US veterans out of court. Agent Orange contains dioxin, a chemical later shown to disrupt the hormone system of the body and to cause cancer. As veterans returned to the US from Vietnam, scientists further confirmed that exposure to Agent Orange caused a variety of cancers in veterans and developmental problems in the veterans' children.

Format: Articles

Subject: Legal, Ethics

Title 1, Subtitle B, Parts I, II, and III of the “National Institutes of Health Revitalization Act of 1993” (1993)

In 1993, the NIH published the Revitalization Act that established guidelines for minorities’ and women’s participation in clinical research. Before the 1990s, investigators largely excluded women from their research based on the 1979 guidance from the US Food and Drug Administration, or FDA. The FDA urged investigators to exclude any woman who was or could become, pregnant to protect the woman and any developing fetuses from harm.

Format: Articles

Subject: Legal

Buck v. Bell (1927)

In 1927, the US Supreme Court case Buck v. Bell set the legal precedent that states may sterilize inmates of public institutions because the court argued that imbecility, epilepsy, and feeblemindedness are hereditary, and that the inmates should be prevented from passing these defects to the next generation. On 2 May 1927, in an eight to one decision, the US Supreme Court ordered that Carrie Buck, feebleminded daughter of a feebleminded mother and herself the mother of a feebleminded child, be sterilized under the 1924 Virginia Eugenical Sterilization Act. Buck v.

Format: Articles

Subject: Legal, Reproduction

Burwell v. Hobby Lobby (2014)

In the 2014 case Burwell v. Hobby Lobby, the US Supreme Court ruled that the contraceptive mandate promulgated under the Patient Protection and Affordable Care Act violated privately held, for-profit corporations’ right to religious freedom. The contraception mandate, issued in 2012 by the US Department of Health and Human Services, required that employer-provided health insurance plans offer their beneficiaries certain contraceptive methods free of charge.

Format: Articles

Subject: Legal, Reproduction

United States v. Georgia (2006)

In United States v. Georgia, the United States Supreme Court held, in a unanimous decision, that the rights protected under the Americans with Disabilities Act, or the ADA, extended to inmates held in state prisons. The Court also abolished sovereign immunity in cases where the Eighth Amendment is involved. The case came about as a result of Tony Goodman, a paraplegic man in a Georgia state prison, who attempted to sue the state under Title II of the ADA.

Format: Articles

Subject: Legal, Ethics, Disorders

Bonbrest v. Kotz [Brief] (1946)

This influential opinion was copied throughout the United States allowing civil actions and wrongful death claims on behalf of children who suffered injuries while a viable fetus. The case essentially overruled the opinion by Justice Oliver Wendell Holmes, Jr. in Dietrich v. Inhabitants of Northampton (1884). However, the ability to sue was usually limited in two ways: the fetus had to be viable, and a child had to be born alive to have a claim. These two restrictions have recently been removed in many jurisdictions.

Format: Articles

Subject: Legal, Reproduction

Physician Labeling Rule (2006)

In 2006, the United States Food and Drug Administration, or FDA, published the “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” also called the Physician Labeling Rule, to improve the safety and efficacy of prescription drugs and drug products. Within the Physician Labeling Rule, the FDA includes a section titled “Use in Specific Populations” or Section 8, which refers to drugs used by pregnant women, lactating women, and people of reproductive capacity.

Format: Articles

Subject: Legal

Individuals with Disabilities Education Act (1975)

In 1975, the United States Congress passed the Individuals with Disabilities Education Act, referred to as the IDEA, which codified the right of all American children to a free and appropriate public education regardless of disability status. The IDEA requires all public schools that accept federal funds to provide education that meets the needs of students with disabilities at the public expense. Prior to IDEA, many students with disabilities went without any educational opportunities, and many faced confinement in institutions.

Format: Articles

Subject: Legal, Disorders

Litowitz v. Litowitz (2002)

In a dispute over the allocation of cryopreserved preembryos, the Supreme Court of Washington resolved the case of David J. Litowitz v. Becky M. Litowitz (2002) by reaching a decision that neither party wanted. David Litowitz sought to find adoptive parents for two cryopreserved preembryos created during his marriage to Becky Litowitz when the couple was attempting to have children using in vitro fertilization (IVF). Becky sought to implant the preembryos in a surrogate in an effort to parent a child.

Format: Articles

Subject: Legal

Adolescent Family Life Act (1981)

The 1981 Adolescent Family Life Act, or AFLA, is a US federal law that provides federal funding to public and nonprofit private organizations to counsel adolescents to abstain from sex until marriage. AFLA was included under the Omnibus Reconciliation Act of 1981, which the US Congress signed into law that same year. Through the AFLA, the US Department of Health and Human Services, or HHS, funded a variety of sex education programs for adolescents to address the social and economic ramifications associated with pregnancy and childbirth among unmarried adolescents.

Format: Articles

Subject: Legal, Outreach, Ethics, Reproduction

“Abstinence Education: Assessing the Accuracy and Effectiveness of Federally Funded Programs” (2008), by Government Accountability Office

On 23 April 2008, the US Government Accountability Office, or GAO, released a report titled, “Abstinence Education: Assessing the Accuracy and Effectiveness of Federally Funded Programs,” hereafter “Abstinence Education,” in which it investigated the scientific accuracy and effectiveness of abstinence-only education programs sanctioned by individual states and the US Department of Health and Human Services, or HHS. GAO is a government agency whose role is to examine the use of public funds, evaluate federal programs and activities, and provide nonpartisan support to the US Congress.

Format: Articles

Subject: Legal, Reproduction, Publications

Davis v. Davis [Brief] (1992)

This case was the first of its kind to address questions of personhood in the context of in vitro fertilization of a human embryo. It laid a foundation for future cases to work from: specifically, this case established the importance of prior written agreements for disposition of frozen embryos. This was also the first court decision to borrow the word "pre-embryo" from bioethics to describe the in vitro embryo. This terminology has been copied by many states.

Format: Articles

Subject: Legal, Reproduction