Depo-Provera, known to most of us as an injectable birth control method that lasts for three months, was first approved in 1960 for treating endometriosis and recurring pregnancy loss. It did not turn out to be effective for those conditions; however, researchers discovered that it could prevent pregnancy in the long term. Its effectiveness at preventing pregnancy comes with risks, such as weight gain, heavy or irregular menstrual bleeding, bone loss, loss of libido, depression, and increased breast cancer risk. The fact that the drug can be administered simply by injection every three months has made it attractive for use in women who are thought to be unable to take a daily pill, notably, institutionalized women, disabled women, teenagers, poor women, and women of color. Depo-Provera has been approved by the Food and Drug Administration (FDA) as a contraceptive since 1992, but it was administered for decades before approval as an off-label medication in family planning clinics, doctors’ offices, research settings, and clinical trials, as well as being court ordered in probation or parole cases.
William Green’s Contraceptive Risk tells the story of how many different actors and institutions managed the risks of Depo-Provera for both women (who used it for birth control, primarily) and men (sex offenders who were injected for its chemical castration effect at high doses). Green argues that all of the primary actors—the FDA, the pharmaceutical company Upjohn (the manufacturer, since acquired by Pfizer), doctors who prescribed it off-label, and judges who ordered it for sex offenders—failed to properly and ethically manage the risks of Depo-Provera, and that it should be withdrawn or at least regulated much more tightly.
Green tells the Depo-Provera story through primary source analysis and legal methods across federal drug law, state civil law, and state criminal law, explaining the way in which the drug first came to be used in the United States, its early and lax testing in an Atlanta public hospital setting from 1967 to 1978, political and interagency disputes over contraceptive approval in the 1970s and 1980s and its eventual 1992 approval, the very limited personal injury litigation efforts against it, and its heyday in the 1990s as a probation condition for sex offenders. His approach focuses on the formal law and major institutions, drawing on the publicly available documents that track disputes about Depo-Provera (hearings, advisory committee meeting minutes, legal opinions and documents), but also contextualizing these data with interviews with a few major figures who are profiled and with references to women’s health advocacy organizations that were active in opposing the drug and documenting problems that women experienced.
The first half of the book takes place mostly in meeting rooms and courtrooms in the 1970s and into the 1980s in the context of Depo-Provera’s availability on the market for physician use by medical judgment but without FDA approval as a general contraceptive, covering expert disputes as well as one woman’s ultimately unsuccessful personal injury lawsuit against Upjohn (spanning 1978–90). At the point of the 1992 FDA approval, Green pivots to discussing the litigation landscape since 2004, in which the question has been whether Depo-Provera is responsible for harmful bone loss in the women who use it. There has been one large confidential settlement but also a string of plaintiffs’ losses because of the learned intermediary doctrine, which makes the treating physician the one who is responsible for interpreting the drug’s warnings for the patient (rather than the manufacturer).
The final part of the book switches to men’s use of Depo-Provera in the criminal justice system as part of a probation deal, describing how judges have ordered ongoing use of the drug to depress sexual urges in convicted sex offenders and arguing that these cases violate offenders’ constitutional rights under the First, Eighth, and Fourteenth Amendments. The periodization of this chapter is largely in the 1990s, which Green characterizes as a time of moral panic and punitiveness in response to sex crimes, though Depo-Provera’s use to treat sexual deviance dates back to 1966 work by medical researchers and clinicians at Johns Hopkins. The book concludes with normative, constitutional, and policy arguments criticizing the professional conduct of the wide array of actors discussed, and suggests reforms.
The main contributions of Contraceptive Risk are to be found in its carefully detailed descriptions of how civil law, expert government advising and regulation, and physician decision making came together to create the situation in which Depo-Provera could be prescribed for decades under conditions of disagreement and insufficient evidence, but whose harms are very difficult to represent as legal wrongs to any particular women. Green has combined accounts of lawsuits with the regulatory story very well, and scholars interested in law and courts, administrative agencies, and health and drug law will find this book to be a thoroughgoing scholarly discussion of the drug and its path through our governing institutions. The book shifts somewhat abruptly into the study of the drug’s use on men for control of sexual deviance, but this chapter is the only source I am aware of that covers the topic from a legal perspective that also weaves in the medical side of the story, for example, describing the clinic at Johns Hopkins that ran “an uncontrolled research study as the practice of medicine” (p. 177).
The closest subfield of political science that the book directly engages is the part of law and courts that focuses on policy aspects of constitutional law, and it would work best assigned in classes in which students could use it as a case study about how law can fail to grasp and manage risk. Scholars of health politics and policy will also find the book useful for advanced undergraduate courses or public health courses, and it is noteworthy that Green does not presume specialized knowledge of either law or drug policy and explains lucidly to all audiences.
The book is clearly written, though the level of detail may make it daunting to assign to undergraduates. Individual chapters could stand alone well in a syllabus, however.
I would compare Contraceptive Risk to books like Peter Schuck’s Agent Orange on Trial: Mass Toxic Disasters in the Courts (1987), an account of the class action lawsuits by Vietnam veterans against the chemical manufacturer. It is a mostly descriptive story, circumscribed around a substance and a few decades of events, driven by major legal and governmental actors, with some accounts of the people who were harmed included as well. It has a normative and policy aim. These books are often a great read and useful in teaching as a case study example. Contraceptive Risk accomplishes its goals of describing the ways that many people and institutions managed Depo-Provera’s risk and makes a quite convincing case that the drug’s use is problematic across several dimensions.
This is not a book that draws upon or discusses major theories or debates within political science, law and society, or gender studies of risk and pharmaceuticals, however. It lacks a theoretical framework or use of concepts from any of these fields. I would contrast it to works like Jeb Barnes’s Dust Up: Asbestos Litigation and the Failure of Commonsense Policy Reform (2011) and Barnes’s coauthored book with Thomas Burke, How Policy Shapes Politics: Rights, Courts, Litigation, and the Struggle over Injury Compensation (2015), both of which embed their case studies within theories of congressional policymaking and adversarial legalism, and thus more clearly engage other scholars in conversation about the themes and lessons from their case studies.
Feminist scholars will note that this is a book about contraception that mentions women’s health activism and the targeting of poor women of color for Depo-Provera at several points, but does not delve into this aspect of the story or engage legal scholars such as Dorothy Roberts, who has written extensively on race, gender, and drugs in health politics.
Following some of these threads could have added a helpful contextualization, especially as the story moves across time periods. The periodization I noted previously does not appear prominently in the book, and it can be hard to tell where in time the events are taking place because they are so thinly historicized. The debates over population growth in the 1970s and 1980s clearly played a role in enthusiasm for Depo-Provera, for instance, but these are not explained, and there is no discussion of the birth-control-for-welfare debates of the 1990s or ongoing sterilization campaigns that we now know were happening with these same targeted social groups in the 1970s and even later. The chapter on male sex offenders cites moral panic theory to explain why chemical castration seemed urgent and appealing in the 1990s, but it would have been interesting to make more in-depth use of the theory. (And why not apply it to the population control and minority fertility observations earlier in the book, which do not get an explanatory theory?) Of course, adding any of these discussions would have necessitated trade-offs in an already-tricky case study genre, but some of the detail could have been traded for more scholarly and theoretical connections that would have enhanced the book’s overall goals.
