When G.D. Searle & Co. halted U.S. sales of its popular Cu-7 intrauterine contraceptive device two years ago, it said the decision was a matter of economics.

Although Searle announced that it had full confidence in the device -- then being worn by an estimated one million women -- the company said it no longer wanted to bear the costs of defending itself against a growing number of product liability lawsuits by women who blamed the product for infections that left them infertile.

Searle's assurances may soon face their severest test in the case of 29-year-old Esther Kociemba of Elk River, Minn., who says the Cu-7 left her unable to bear children. A lawsuit brought by Kociemba and her husband, Michael, is expected to go to trial in St. Paul, Minn., next month.

Thus far, the battle over the Cu-7's safety has gone Searle's way. Of 16 such damage cases that been tried thus far, the company has won 14, including 11 in a row. Although the product was removed from the U.S. market, it continues to be used by hundreds of thousands of women in this country and other nations, including Canada, where sales continue.

What sets the St. Paul case apart, according to the plaintiff's attorney, Michael J. Ciresi, are the documents from the files of Searle and its corporate parent, Monsanto Co., and related testimony that he intends to put before the jury.

Ciresi maintains that the material will show that the string attached to the Cu-7 to permit removal was capable of transmitting bacteria into the germ-free uterus; that the Cu-7 was too large for use by women such as Kociemba who have never had a child, thus increasing a risk of infection; and that Searle was aware of the product's risks but chose to conceal them.

The material from the companies' files has been sealed out of public view at Searle's request by U.S. District Judge Robert R. Renner. But an Oct. 23 court hearing provided a glimpse of what Ciresi says is some of most sensitive and potentially crucial information.

"Not one of the juries which have considered the safety of the Cu-7 has seen all of the pertinent medical evidence in Searle's files regarding the hazards of the Cu-7," said Ciresi. "Every national scientific and medical expert who has taken an objective look at the evidence Searle is hiding from the public has concluded that the Cu-7 is defective and hazardous," he says.

Paul F. Strain, Searle's lead defense attorney in the Cu-7 litigation, said in an interview that in each case that has been tried, the central issue was, "Did the Cu-7 injure a specific woman? Whenever we have been able to get a judge or jury to focus on that ... almost invariably the result is {a verdict} that the Cu-7 didn't hurt the woman. And the reason for that is that we believe the medical evidence is overwhelming that the Cu-7 is safe and does not hurt women."

Ciresi has tried to have the record disclosed to the public, and Searle has opposed him, saying, in Strain's words, that a "full and detailed review must necessarily await trial."

Kociemba had used a Cu-7 for nearly 18 months before having it removed because she and her husband wanted children. But she was unable to conceive afterward, and nearly four years went by before she was found to have "silent" or "subclinical" pelvic inflammatory disease (PID) and consequent blockage of her Fallopian tubes.

Silent PID may not be apparent for long periods, either to the woman or to a physician making a pelvic exam. Several operations to unblock Kociemba's tubes failed, leading the couple to adopt two children. The Kociembas sued Searle in October 1984, alleging negligence, fraud and other misconduct, and seeking unspecified compensatory and punitive damages.

The couple's complaint involving the Cu-7 echoes the tragic story of the Dalkon Shield, the defective IUD that A.H. Robins Co. sold in the first half of the 1970s and that is blamed for serious cases of PID in tens of thousands of women.

The Dalkon Shield string was made entirely of nylon, which rots under prolonged exposure to body fluids, and consisted of hundreds of tiny filaments encased in an open-ended sheath. Studies showed that as the sheath degraded with time, ruptures developed, providing the main ports of entry for vaginal bacteria. Once the bacteria had penetrated the spaces between the filaments, they could ascend into the womb, lifted by capillary action, or "wicking."

All other IUD strings but one were a single filament, or monofilament, made of polyethylene. The Cu-7 string was made of polypropylene.

In its information about the product, Searle had said the Cu-7 string was a monofilament. But at the St. Paul hearing, Renner said there "appears to be a significant dispute as to whether Searle represented to the Food and Drug Administration that the Cu-7 tail string was a monofilament."

Ciresi charged at the hearing that Cu-7 string frays, creating tiny fissures and interstices in which vaginal bacteria could lodge and multiply, and from which they could ascend into the uterus. Because of this, he said, the Cu-7 string has the same potential hazards as the shield multifilament, claiming that the Cu-7 string consists of "thousands of microfilaments which are adhered together ... When you touch them, they come apart."

An FDA spokesman, asked to comment on Ciresi's statement, said the FDA "has seen no studies showing a wicking action in any of the monofilaments."

Strain said that he believes "every reputable scientist ... would agree that this Cu-7 string is a true monofilament ... We have absolutely dramatic scanning electronic microscopy photographs that prove that. And there is zero evidence that any surface fraying ... is related in any way to human infection. The plaintiffs' want juries to believe that the Cu-7 string is like the Dalkon Shield string and causes infection. That is simply untrue."

Ciresi says that the string "is simply not a true monofilament ... Any statement to the contrary by Searle is unsupported by the evidence and indeed by their own consultants' notes and findings.

Another issue -- and potential tripwire for Searle in the lawsuit -- concerns a Food and Drug Administration rule called "Comment K," a legal doctrine for products said to be "unavoidably unsafe."

FDA rules did treat as prescription drugs those IUDs that contained metals that leached into the uterine cavity to enhance effectiveness. Because the Cu-7 contains copper, the FDA reviewed the Cu-7 for safety and efficacy and approved it in 1974. When Searle halted sales 12 years later, the agency said it "believes that the current professional and patient labeling is adequate to inform physicians and patients of the potential risks."

Searle argued in a pretrial motion that the Cu-7 was legally a prescription drug and consequently, as a matter of law, should be considered an "unavoidably unsafe product."

If this position prevails, Judge Renner told defense lawyer Madge S. Thorsen, "you are caught in a bind... . On the one hand, you'd have to introduce some evidence that it's unavoidably unsafe... . On the other hand, unless you do that, you can't claim credit for" application of Comment K as a legal defense.

Searle's position, Strain said, is that "the FDA has provided very clearly that the Cu-7 is safe and effective as labeled. The Cu-7, because it's a prescription drug like penicillin, is given the special legal category 'unavoidably unsafe' ... For plaintiffs' lawyers to suggest that doctors should have been told by Searle about that legal categorization is misleading. Doctors were told by Searle about ... the medical facts the FDA decided were appropriate ... Searle didn't tell doctors the Cu-7 was unsafe because the Cu-7 is safe."

And Ciresi responds: "It is false to state that the Cu-7, because it's a prescription drug, ... is given a special legal category called 'unavoidably unsafe.' The issue whether that category applies to any drug is made on a case-by-case basis.

"If there's a safer way to make the drug, then the clarification does not apply. Moreover, the burden is on the manufacturer to show that it is 'unavoidably unsafe,' and why that is so.

"In the case of the Cu-7, Searle would have to admit that the device unavoidably caused PID, but that its benefits outweighed that unsafe condition, and that the hazard couldn't be eliminated by a safer design. Searle ... has never admitted that."

But according to Ciresi, the issue of Cu-7's safety had arisen years before the halt in U.S. sales. The lawyer said at the Oct. 23 hearing that in 1980, Searle "put out a product-development proposal" for a "clean, safe method of attachment of a safer polyethylene string to the Cu-7." The executive summary of the proposal said that "the particular characteristics and properties of polypropylene have caused several medical problems."

Ciresi told the court: "And they go on to list them. And one of them is that the polypropylene has a tendency to fray, giving the string a low-quality appearance and perhaps increasing the likelihood of uterine infection."

Searle management rejected the proposal for a new string, said Ciresi, contending that reason was revealed in a statement he attributed to an unnamed Searle official: "The holdup on IUDs is the legal cases {Cu-7 lawsuits}. The legal department doesn't want us coming out with new and improved product design. Hurt our chances. FYI, this is holding everything down regarding IUDs," Ciresi said.

Strain said in the interview that Searle "considered whether there were changes to the Cu-7 which could make it even better. It called in ... one of the best design and testing laboratories ... it tried things out. The conclusion ... was that the Cu-7 was and is a safe product, and that to start making changes in it might create ... rather than solve problems ...

"The documents establish that Searle knew that safer strings were available, but failed to use them," said Ciresi, "because of the adverse impact that might have on the litigation ... they let the hazard remain, and let women be at risk, in the hopes that it might help them win a lawsuit or two."

Ciresi told the hearing that Canada's Health Protection Board said "these strings fray." Strain labeled the charge untrue.

At the hearing, Ciresi also referred to a Searle document which, he said, hinted at an effort to avoid a written record of sensitive information relating to PID. He quoted the paper as saying: "It does not look like we will be allowed to pursue the string change as desired by the Japanese. Keeping all of this out of writing is a difficult task." According to Strain, there never was a Searle policy to keep such information "out of writing."

In a document submitted to the FDA in 1972, Searle, in the judge's words, called PID "the second most common disorder associated with using the Cu-7." Yet, Ciresi said at the hearing, "PID was not mentioned in the Searle labeling or form letters to doctors." Instead, Searle's claim was, "uncommonly, pelvic infection has been reported."

Another contested issue is the promotion of the Cu-7 for women -- such as Esther Kociemba -- who have never had a child, and who are called nulliparous women, or nullips. They have smaller wombs than do women who have had babies, and run higher risks of PID. Warnings against use of IUDs in nullips are common in medical literature. The Population Council, the nonprofit developer of the Copper T 380A, which will enter the U.S. market in 1988, stresses that it's not for nullips.

At the hearing, Ciresi said that Searle's initial product monitor for the Cu-7 told the company in March 1971 -- three years before the market launch -- that it "was too large for the uterine cavities of nulliparous women, or indeed younger women who tend to have smaller uterine cavities." Yet in the same year,"The documents establish that Searle knew that safer strings were available, but failed to use them." -- Michael J. Ciresi, plaintiff's attorney Searle started to target nullips as being among the women for whom the device was "appropriate," he said.

In a proposal for making a smaller Cu-7 for nullips, Ciresi continued,"because some Searle officials argued that from both the business and medical standpoints, the standard Cu-7 "was too large for a significant number of women," and that its size accounts for a "higher than desirable" rate of adverse effects of the kind that indicate PID, such as bleeding and cramping. But the company failed to alert doctors and women to these risks, Ciresi said.

Dr. Timothy M. Scanlan testified that he inserted a Cu-7 in Kociemba in June 1977 after Searle salesmen, in Ciresi's words at the hearing, "specifically told him that the Cu-7 was appropriate for nulliparous women who had never had children, and that ... the Cu-7 tail string was a monofilament."

Strain commented that if the Cu-7 were unsafe for nullips, "the FDA would require doctors to tell women that. ... The FDA doesn't require that, and the reason is that nulliparous women can in fact be appropriate candidates for the Cu-7."

Ciresi said in the interview, "The documents establish that before Searle put the Cu-7 on the market, it knew that the device was too large for most nulliparous women, and that they would have to design a smaller device for nulliparous women.

"Despite that knowledge," he said, "Searle marketed specifically to nulliparous women, and at least 40 percent of Cu-7 users were nulliparous, and at least 70 percent were under the age of 25 by 1977."

On Feb. 3, 1986 -- three days after the sales halt -- O.B. Parrish, president of Searle's Pharmaceutical Group, wrote a memo on "media coverage" of the halt and sent a copy to Earle H. Harbison Jr., now Monsanto's president and chief operating officer, and chairman of Searle for a few months after Monsanto acquired Searle in October 1985.

Ciresi told the hearing that the memo said in part: "The defined objective was to focus the story on litigation insurance business aspects, and not focus on medical and safety aspects. To date, that objective has been achieved." Ciresi said he showed the memo to Harbison, who testified that safety issues hadn't triggered the halt.

Strain said that "the true reason that the Cu-7 was taken off the market was the costs of defending the product-liability lawsuits in terms of the dollars and time of {Searle's} key people. Searle decided that there were many better things to do in the field of medicine than have its doctors deal with lawyers day after day."

But Ciresi contends that Harbison's videotape deposition and related documents show that "Monsanto knew that the Cu-7 caused PID with all of its attendant problems, and their strategy was to withdraw it from the market and blame unwarranted lawsuits."