Tort Liability and the Availability of Contraceptive Drugs and Devices in the United States


Almost sixty percent of all pregnancies in the United States are unintended. In addition, many sexually active Americans are at risk for sexually transmitted diseases and AIDS. Intrauterine devices are virtually unused in the U.S., even though they are widely utilized in Europe. So far in the 1990s, only three new contraceptive methods have been approved by the U.S. Food and Drug Administration (hereinafter FDA). One, Norplant, a hormonal implant, was quickly challenged by product liability lawsuits. The second, a female condom, has not been widely used. The third, Depo-Provera, an injectable hormone, won FDA approval twenty years after approval was first sought. RU 486, a medical abortifacient commonly used in Europe, is in clinical trials in the United States.

This paper summarizes recent information and analysis addressing the following questions: How does the risk of liability contribute to the development of new contraceptives and the continued availability of those now used? Is this cause for concern? If it is, what proposals have been made tochange liability processes and to make contraceptives more widely available? What are the strengths and weaknesses of these proposals? This article focuses on the availability of products, not on the organization and financing of family planning services. It seeks to present the facts and arguments, rather than to defend any particular approach. I do, of course, bring a large set of values to this project. These values support information, choice, the availability of products, the benefits of innovation, the provision of fair and effective mechanisms to assure that products are reasonably safe, and compensation for people who suffer injuries that could reasonably have been avoided.

Part II supplements Professor Mark Mildred’s discussion of the larger context of regulation and tort liability that explains many of the differences between the liability experience in the U.S. and Europe. It examines recent federal proposals to reform U.S. liability law and litigation processes. Although most tort law in the United States is defined at the state level, federal reform is more attractive to drug manufacturers because they operate in national markets. Nonetheless, proposals for radical change at the federal level have been rejected over the past two decades. Instead, reform in the United States has more often been implemented in a focused, incremental manner, usually at the state level.

Part III examines the liability history of particular contraceptive drugs and devices and other related products.

Part IV uses the histories of particular drugs and devices to highlight reform strategies that have not been discussed in prior sections.

Suggested Reading