Regulation of Contraceptive Technologies

In addition to enhancing individual choice and restricting abuse, regulation of new technologies must ensure access and quality control. The development of new technologies is regulated formally by the approval process of the FDA, and informally by compensation awards under tort law for harm caused by defective products.

The FDA regulates the development of new drugs and contraceptive devices under the Federal Food, Drug and Cosmetic Act of1938. Under this law, a company interested in marketing new contraceptive drugs or devices must submit data, including results from various tests for safety, effectiveness, and dosage, as part of an extensive approval process. In addition to approving new drugs and devices, the FDA reviews labeling and assesses data in a postmarketing surveillance program. The FDA approval process has been criticized as expensive, time consuming, and a barrier to new techniques. It has also been praised for protecting consumers from the harm of untested substances.

The FDA approval process is not the sole factor dictating whether a reproductive technology reaches U.S. consumers, however. The American tort system is designed to compensate those injured, deter the marketing of dangerous and defective products, and resolve disputes between the injured person and the manufacturer.

A person may recover damages for dangerous or defective products, including contraceptive devices, if either negligence or a strict liability is established. Negligence requires proof that the manufacturer was at fault. However, sometimes the fault of a large company is difficult to establish, and therefore the interests of justice dictate that a victim should be allowed to recover damages without proving specific fault. According to the strict products-liability principle, if a product is sold in a defective condition, and is unreasonably dangerous to the consumer, there is liability regardless of the care taken, that is, regardless of negligence in any individual case. Strict liability may make manufacturers apprehensive about putting new contraceptive products on the market.

This is the case especially since the litigation experience of the A. H. Robins Company, developer and marketer of the Dalkon Shield, an intrauterine contraceptive device. In a series of court cases in the early 1980s, this device was proved to cause pelvic inflammatory disease, infertility, birth defects, perforated uterus, and spontaneous abortion. In a series of jury verdicts throughout the United States, A. H. Robins was forced to pay compensatory damages and punitive damages because plaintiffs proved that the company had understood the dangers of the device, withheld this knowledge from prospective users, and misrepresented the nature and safety of the device (Mintz). Despite this experience, cases brought by women seeking recovery for harm from contraceptive devices have usually found the manufacturer liable only under theories of negligence—for example, negligent failure to comply with the duty of care, negligent failure to warn of risks, or fraudulent misrepresentation (Hilliard v. A. H. Robins Co., Tetuan v. A. H. Robins Co.). In fact, even those courts purporting to apply strict liability seem to be applying a theory of negligent failure to warn under the rhetoric of strict liability (Henderson and Twerski; Fox and Traynor).

How tort law is interpreted is in a state of flux. Some judges and juries appear to view manufacturers as deep pockets (Reilly) and to see tort law as a vehicle for providing social insurance for injury victims. Many critics of large jury awards argue that the size of jury awards often bears no relationship to actual economic loss or to pain and suffering, and that awards of punitive damages are arbitrary and unfair. Supporters of the present pattern of trial awards argue that claims of a law crisis in this area are exaggerated because of manufacturers's dislike for how the law determines their liability (Fox and Traynor). However as long as manufacturers fear they will have to pay large financial penalties to women who suffer the consequences of their new products, many may be reluctant to market new products, a trend that may limit women's access to new contraceptive technologies.

Postcontraception, the morning-after pill, is widely dispensed on college campuses after unprotected intercourse and in emergency rooms for rape victims; it promises to be another barrier to unwanted pregnancy. The process generally entails two treatments of oral contraceptives within seventy-two hours of intercourse and is thought to prevent pregnancy either by blocking fertilization or by blocking implantation of the fertilized egg. An antihormone (mifepristone)

product called RU-486, discussed in the following section, has also shown promise as a morning-after pill.

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