Two more Intrauterine Devices (IUDs) have become the focus of so many lawsuits in the U.S. that their makers have removed them from the American market. The CU-7 and the Tatum-T (two versions of an IUD called the Copper 7) are manufactured by the C. D. Searle Company. However, only one, the CU-7, is sold in Canada. Searle’s Canadian subsidiary has announced that the CU-7 will remain on sale in Canada since the decision to remove the product from the U.S. market was made for financial, rather than medical, reasons.
IUDs have an alarming history of causing Pelvic Inflammatory Disease (PID) in the user. Undetected, and untreated, PID can cause subsequent problems with fertility. Many women now suing the makers for damages have had to undergo hysterectomies, others who have become pregnant while wearing an IUD have suffered septic abortions or ectopic pregnancies, and some women have sued because the IUD has perforated the uterus.
The Copper 7 has been the largest selling IUD in the United States’ market since the Dalkon Shield was taken off the market in 1974. Annual sales in the U.S. are about $11-million, with between 300,000 and 400,000 sold each year. It was estimated that about 1 million American women were currently wearing the IUD shortly before it was withdrawn from the market. The CU-7 has been on the Canadian market since 1974, annual sales here are about 100,000.
Over 775 lawsuits have been launched against the Copper 7 in the last 14 years in the United States, nearly half of them have not yet been settled. Of the 470 suits which have been resolved, one-third were dismissed without any payment from the company. According to Searle, only two of 10 cases tried were won against the manufacturer. However, four recent trials in which the company paid no damages cost $1.5 million (U.S.) to defend.
It is the high cost of such litigation, and subsequent insurance problems, that is apparently behind the decision to remove the product from sale in the U.S. Searle vice president Tod Hullin told the Reuter news agency that “the escalating cost of defending unwarranted product litigation makes continuing in the IUD business in the United States no longer economically sensible for the company.” He added that future product liability insurance for its IUD had become “virtually unobtainable.” Searle’s Canadian general manager, James Rae, calls the Copper 7 “a safe and highly effective contraceptive method.” Adding that the Health Protection Branch of Health & Welfare Canada is quite satisfied with it.
“We have no evidence of any unusual side effects which would warrant its removal from the market,” Carol Peacock, spokesman for the federal Health Protection Branch, told Caitlin Kelly of The Globe and Mail.
While there have only been a couple of lawsuits in Canada, and they were defended successfully according to Searle, lack of litigation in Canadian courts does not mean that Canadian users have not been harmed medically by the IUD. Trish Polhill, president of the Birth Control Victims Association of Canada, knows of at least 100 Canadian cases now going through the American courts. She is concerned that many Canadian women do not realize that they can sue in the U.S. Mrs. Polhill also points out that many women are unaware that their fertility and other gynecological problems may well have been caused by an IUD in the first place. She is angry that the Health Department in Ottawa sees no reason to withdraw the IUD from the Canadian market. “For the many thousands of women like myself whose fertility has been permanently impaired by an IUD,” Mrs. Polhill pointed out, “it is far from reassuring to find out that Ottawa considers there is no evidence of unusual side effects.”
Mrs. Polhill started her organization in Toronto last year when the many claims against the Dalkon Shield IUD were coming to public attention. Although the Dalkon Shield has been off the market since 1974, lawsuits are still being brought against the manufacturer, the A.H. Robins Company. More than 14,000 lawsuits have been filed in the U.S. against Robins, and the company has paid $378-million to settle about 9,000 of the suits.
Some still unaware
Late last year Robins filed for bankruptcy in the U.S., although this does not mean the company is broke. It is, in effect, a complex legal manoeuvre to postpone payments of court-awarded damages. The bankruptcy has not yet been allowed and the court hearing the application has ordered that Robins give wide publicity to the dangers of the Dalkon Shield so that as many women as possible would be informed of their rights to initiate lawsuits if they had suffered damage from the Shield.
Trish Polhill warns that although the Shield was removed from the market 12 years ago, there is still a possibility that some women are still wearing one and unaware of the dangers. Women who have had the Shield removed some time ago are still suffering health problems caused by it and doctors are only now making the connection between a woman’s injuries and the IUD removed years earlier.
There is an April 30 deadline for filing lawsuits against the Dalkon Shield. Mrs. Polhill urges anyone who suspects she had health problems which could have been caused by an IUD (no matter how long ago they began) to contact her at the Birth Control Victims Association (address below). She will help women to make a claim in the U.S.
Birth Control Victims Association, 7 Four Winds Drive, Unit 14, Downsview, Ontario M3J 1K7. (416) 661-6935.