Protecting Consumers, Prodding Companies, and Preventing Conception: Toward a Model Act for No Fault Liability for Contraceptives

Introduction

Nearly forty years after the “contraceptive revolution,” the demandfor safe, effective and practical contraception remains unmet. Indeed, the range of contraceptive choices has diminished in recent years, as technologies are taken off the market more frequently than new ones are introduced. While the scientific community reports on a number of promising new developments, such as male birth control methods, fertility-blocking vaccines, and vaginal preparations that would act as both contraceptives and barriers against sexually transmitted diseases. their eventual appearance on the market is not guaranteed. No government entity is likely to finance the testing and marketing of these methods, and it is increasingly unlikely that any private corporation will undertake that investment.

The inaction of both legislators and manufacturers in the face of an apparently impending contraceptive crisis is puzzling, given the significant public health implications of unwanted pregnancy and the vast global market for contraceptive products. Combined political and commercial forces have stalled initiatives in both the public and private sectors. These barriers to development must be examined separately and confronted systematically.

Historically, public investment in contraceptive development has been sparing. Controversy surrounding reproductive policy deters political initiatives. This is especially the case with post-coital technologies, defined by some as abortifacients. In addition, contraception has not yet been fully recognized as a public health need; rather, it is popularly considered a product for a discrete consumer group. The lack of public investment is reflected in the activities of the scientific community, for whom contraception has been a second-class area of study. While this disfavor may derive in part from a general disregard for applied research, it is also very likely due to the fact that contraceptive research receives less funding than research in areas like cancer, genetic diseases, and molecular biology.

More harmful to the progress of contraceptive technology in recent years has been the diminished activity of private industry, which is the real engine of development. Pharmaceutical companies, like politicians, steer away from bad publicity, and anti-choice factions have been remarkably successful in enmeshing contraceptives in controversy. A common rationale of private industry for not pursuing contraceptive development is the state of products liability law in the United States: pharmaceutical manufacturers uniformly claim that the huge costs associated with products liability lawsuits deter contraceptive research and development and have prompted the removal of some existing products from the market. Those costs include legal expenses, high products liability insurance prices, and large judgments awarded to injured consumers. In particular, manufacturers point to the lawsuits surrounding the Dalkon Shield and, more recently, Norplant.

A political climate that acknowledged contraceptive research and products as a public health priority could result in at least two constructive changes. First, more public money might go into contraceptive development. At the very least, more funds would increase the status of contraceptive development within the scientific community and more technological leads would emerge over time. Second, the liability concerns of private industry might be addressed legislatively. A no-fault compensation scheme could replace common law rules currently governing liability for injury resulting from use of new and existing contraceptive methods. Precedents for such a statutory scheme may be found among the several national and state laws replacing a tort scheme of recovery with a no-fault plan ensuring limited recovery from a compensation fund.

This paper focuses on the latter suggestion, the development of a contraceptive no-fault compensation scheme. Part II describes generally the features of a traditional tort compensation system and a statutory compensation scheme; explains why contraception should be treated differently from other drugs and devices; and, discusses the special challenges of developing legislation appropriate for contraceptive development. Part III reviews five legislative initiatives providing compensation to injured parties while shielding enterprises from excessive tort liability: the National Childhood Vaccine Injury Act of 1986 (NCVIA); the National Swine Flu Act; the Price-Anderson Act; the Virginia Birth-Related Neurological Injury Compensation Act; and the Longshore and Harbor Workers’ Compensation Act. Part IV reviews these five schemes in light of the challenges discussed in Part II and makes recommendations for legislation directed atcontraceptives. Part V summarizes the recommended features of a contra- ceptive compensation plan and evaluates the feasibility of each.

Suggested Reading