[Suspension of IUD sales in the United States: what are the international implications?].

Abstract

The decisions by Ortho Pharmaceutical in 1985 to suspend manufacture and sale of the Lippes Loop IUD and by G.D. Searle and Co. to suspend sales of the copper 7 and copper T 200 IUDs in the US have virtually eliminated the IUD as a potential contraceptive method for American women. The only remaining IUD on the US market is the little used Progestasert hormone-releasing IUD, which accounted for only 3% of the US market at the time of Searle's decision. The decisions were made as a direct result of the liability insurance crisis and the high cost of lawsuits in the US. The US legal system, unlike those of many countries, permits individuals who believe they have been injured by actions, inactions, or products of individuals, companies, or governmental organizations to sue. The number of such lawsuits rose by 680% in US federal courts between 1974-84, and the average damages awarded now exceed US $1 million. The phenomenon of joint responsibility, in which the plaintiff can sue all parties who can be defined as having had responsibility for the alleged injury, is particularly worrisome for industry. In practice this often means that plaintiffs concentrate their efforts on the party able to pay the greatest amount in damages. As the volume of lawsuits and damages awarded have skyrocketed, so has the cost of liability insurance. Some insurance companies simply refuse to insure high risk ventures at any price. Causes of the insurance crisis in the US are multiple, but one important factor is the new unwillingness of much of the public to accept any risks in return for benefits such as control of fertility. The Lippes loop has been the object of about 200 lawsuits and the Searle IUDs of about 800, 400 of which have been dismissed or settled out of court. Of those going to court, Searle won 9 and lost 2. Legal fees in 4 recent cases won by Searle exceeded $1.5 million. Alza Corp., manufacturer of the Progestasert, is now making the device available to all physicians requesting it, but Alza urges physicians to obtain informed consent and includes a 7-page pamphlet with each device. Each unit costs $84 compared to the $25 or so for copper IUDs, and each must be replaced annually. Many satisfied users and family planning personnel in the US are dismayed by the disappearance of an effective method from the market. Although there is no objective reason for the termination of IUD use in the US to affect the availability of IUDs in other countries, the continued distribution of IUDs elsewhere has aroused suspicion. The International Planned Parenthood Federation, Family Health International, other family planning organizations, and the US Agency for International Development have examined the records of the IUD and have reiterated their conviction that the method is safe and effective for appropriately selected users. They emphasize that the IUD has the unqualified approval of the US Food and Drug Administration.