G. D. Searle

WHEN PHARMACEUTICAL giant Monsanto bought struggling rival G. D. Searle for its NutraSweet sugar-substitute patents, it did not expect to become responsible for millions of dollars in product liability related to the Cu-7 intrauterine device (IUD) marketed by Searle in the 1970s.

Due to scares over the long-term health effects of oral contraceptives, IUDs became both popular and profitable in the early 1970s. Although no one is quite sure how IUDs prevent conception—continuous irritation to the uterus preventing fertilized eggs from implanting, is one hypothesis—devices inserted into the uterus had been used since at least the mid-19th century. Each IUD innovation proved to cause serious fertility and health problems, culminating in the Dalkon Shield disaster, after which Searle competitor A. H. Robins declared bankruptcy to minimize product liability claims against it.

Initially, it seemed that Searle had learned from Robins' mistakes. The Cu-7 IUD, so named because it resembled a number 7 wrapped in copper (atomic symbol Cu), was the first IUD to receive premarketing approval from the U.S. Food and Drug Administration (FDA). The IUD was classified as a drug, rather than as a less-regulated device, because part of its contraceptive effectiveness was believed to come from leaching copper into the womb. Approved in 1974, the Cu-7 was, like the Dalkon Shield, marketed as a safe contraceptive for both multiparous women (those who had borne children) and nulliparous women (those who had never given birth and who therefore had smaller uteruses). During its 12 years on the U.S. market, the Cu-7 reputedly earned Searle more than $80 million in profits.

On January 31, 1986, Searle announced that it would halt Cu-7 sales in the United States. Planned Parenthood president Fay Wattleton told the Washington Post that she was “dismayed,” as her organization had recently reaffirmed its support for IUDs as a safe form of contraception. Women wearing the Cu-7 and another Searle IUD, the Tatum-T, were told there was no reason to have their IUDs removed before their scheduled replacement date. (Searle, unlike Robins, had recommended replacement every three years.)

Two years later, internal Searle documents unsealed at a Minneapolis, Minnesota, trial convinced a jury that company officials had known the Cu-7 was unsafe. Among the evidence was a proposed label that mentioned a “three-to-fivefold increased risk of pelvic inflammatory disease” (PID), particularly for nulliparous women and women under age 25.

PID is a known cause of infertility. By the time the label left the company for FDA approval, it no[Page 344] longer mentioned the risk level nor strongly recommended against using the IUD in younger women.

Additionally, testimony and documents suggested Searle had known there were defects in the IUD's monofilament string, allowing bacteria to travel up the string to the ordinarily sterile uterus, again causing PID. Although two-thirds of the previous 13,500 Cu-7 suits had been dismissed or settled for small amounts and Searle had won 15 of the 18 that went to court, this time a jury awarded $8.75 million to plaintiff Esther Kociemba, a nulliparous woman rendered infertile by her Cu-7. The first case to award punitive damages, this one was expected to start a torrent of successful claims against the company.

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