In January 1970, Dr. Hugh J. Davis of the Johns Hopkins School of Medicine sounded a much-publicized warning to a Senate subcommittee about the hazards of the birth-control pill. He said that "modern intrauterine devices" were at hand.
"You have no particular commercial interest in any of the intrauterine devices?" a staff member asked Davis, an assistant professor of obstetrics and gynecology.
"That is correct," Davis answered.
In fact, Davis was the developer of the Dalkon Shield and a year earlier had acquired a 35 percent interest in the company that made the device. He was not under oath.
Six months after Davis testified, A.H. Robins Co. purchased the Dalkon Shield. Davis' share was $240,000, plus a royalty on every Shield sold and a $20,000-a-year consulting contract with Robins.
Davis left Johns Hopkins in 1982. His attorney, Joseph G. Finnerty Jr., said Davis did not intend to mislead the subcommittee but believed at the time that the Shield, though distributed, was not yet commercially available. Said Finnerty: "You do have to look carefully at the words he said . . . . He's very precise."
An examination of court documents, congressional testimony, internal company records and dozens of interviews provide a detailed look at Robins' relationship with Davis and several other prominent university experts. Their academic affiliations and credentials were a cornerstone of Robins' promotion of the Shield and later in its defense against lawsuits and claims, which now number nearly 13,000.
The amounts these experts were paid by Robins or its attorneys varied widely, as did the extent of their contribution to the company. Some did not always disclose in books and journals their financial ties with Robins. Their position was that they were not being paid by Robins, but by the company's law firm. A spokesman for McGuire, Woods & Battle, the company's primary law firm, said that anyone the firm retains is paid by its client, in this case Robins. He also pointed out that it is common practice for both sides in litigation to retain outside experts as consultants and witnesses.
The potential hazards, as well as potential benefits, of financial ties between corporations and universities -- whether as sponsors of research or providers of consulting contracts to faculty members -- are a subject of public debate. Concerned over the possibility of conflicts of interest, some leading universities in recent years have required faculty members to disclose their financial ties with corporations. Developer and Tester
Few were more reluctant to acknowledge their outside financial links than Hugh Davis. On Feb. 20, 1974, he testified that he had been "offered" but declined some stock in the corporation that originally owned the device.
"I felt there would be a conflict of interest . . . ," he said. "I did not feel I should be in a position of testing and evaluating a device in which, on one side, I was functioning as an evaluator and on the other side I was in a capacity to, as a private individual, profit from participating in the corporation."
In November 1976, he was given an opportunity to reconsider his answer about his financial interest in the Shield. He said that at the time he testified 21 months earlier, he had already been paid more than $700,000 in connection with the Dalkon Shield -- much of it in royalties.
Davis later confirmed that, as part owner of rights to the Shield, he had received about a third of Robins' $750,000 purchase price for the device plus the same share of the royalty Robins paid -- though indirectly, through another investor in the Shield.
Davis was asked if he had ever owned stock in the Dalkon Corp. He said he did not know. Pressed further, he said he had "never received any stock certificates." Moments later, the attorney showed him an April 1970 document Davis had signed citing his interest in the corporation.
Finnerty, the attorney for Davis, said, "He never did categorically deny that he had an interest in the Dalkon Corp. He said he was uncertain whether he was actually a stock owner in Dalkon."
Davis also wrote a book for doctors that may have helped Shield sales and thereby his own royalties. The book, entitled "Intrauterine Devices for Contraception," was published in 1971, the year Robins began global Shield sales. Davis testified that one of the reasons he wrote the book was to promote Shield sales. Nowhere in the book did Davis disclose his own role in developing the Shield or his current financial interest in the device.
The book hailed the Shield as a "second generation" IUD that was superior to its rivals. By the time the book was published, Robins had paid Davis more than $240,000 and bought other copies mainly for foreign distribution. 'Must Reading'
In 1979, five years after the Shield was removed from the market and after Robins had become the subject of more than 3,000 Shield-related lawsuits and claims, three other experts wrote a book about intrauterine devices that mentioned the Shield repeatedly. What they did not mention were their ties to Robins or to the law firm representing Robins.
The book was "Intrauterine Devices and Their Complications." The authors were Drs. Gary S. Berger, Louis G. Keith and David A. Edelman. "Must reading for every physician who practices family planning or counsels women in that area," a reviewer said in the Journal of the American Medical Association.
Said a spokesman for Robins: "It is true that Berger, Keith and Edelman did not state in the preface to the book that they had consulted with Robins and the law firm. On the other hand it would have been unprecedented for them to have done that."
Alexander H. Slaughter, an attorney with a Richmond law firm representing Robins, said it is unfair to single out individuals for failing to disclose in scientific journals their financial ties.
"From an overall societal point of view, it might be the right thing to do, but to single them out would be unfair," he said. "It is endemic throughout the industry -- drugs, automobiles, absolutely every discipline that interacts with lawyers and products in the tort areas -- that people who write also consult and also testify, something they don't disclose in their learned journals."
Before the book was published, two of the three authors had received money for expenses and consulting on behalf of Robins: Edelman, a biostatistician and research director of the International Fertility Research Program, Research Triangle Park, N.C., had received more than $25,000; Berger, a University of North Carolina clinical professor of obstetrics and gynecology, more than $7,000.
According to Slaughter, the trio of authors has received to date $736,864 in witness and consultant fees on behalf of Robins: Berger has received $307,291; Edelman, $152,481; Keith, a Northwestern University obstetrics and gynecology professor, $277,092, all of it since 1980.
The firm for which Slaughter works had retained Berger and Edelman to review IUD literature and write a report, which was the genesis of the book.
In August 1984, Berger testified about Medical Research Consultants, a firm set up in 1976 or 1977 in which he, Edelman and Keith were principals. He told a jury in a Shield lawsuit that the firm had received money from Robins to conduct medical research. Berger said his share amounted to about $50,000.
In a recent interview, Edelman said that the research in the book "can be verified, based on the scientific information available at that time." He said there was no direct financing of the book by Robins and that it is not common practice to disclose private sources of research funds.
"I'm not sure how one can write a book about IUDs and not mention the Shield," Edelman said. "Parts of the book were not flattering to the Shield. If someone were paying me to write it, I might not have written it that way."
A Robins spokesman said he was confident that the work done by the three men was scientifically sound. Research done by Keith, while a consultant to Robins, received a scientific merit award at a conference where his results were presented, the spokesman said. 'Intractable Conflicts'
Keith has testified on behalf of Robins several times. One of those was during a trial in March 1983 in Tampa, Fla. Linda Harre had suffered from pelvic inflammatory disease and become sterile. She blamed it on the Dalkon Shield. Keith testified that in his opinion, the Dalkon Shield did not contribute to Linda Harre's illness, the Shield's design did not cause the infection and, finally, the Shield was not unreasonably dangerous.
The key to the case was whether the Shield's string, by which the device was to be located or removed, acted as a wick and drew bacteria up into the uterus. Keith's testimony struck at the heart of Harre's case. He told the jury that his statements exonerating the Shield were not merely opinion but findings based on scientific studies done under his direction. He said that a microbiologist had assisted him. He diagramed how the experiments were conducted.
Robins' attorney was critical of studies Harre's attorneys cited and said: "The best test that has been done on this subject was done under the auspices of Dr. Keith." The attorney spoke of "a series of tests" Keith had conducted. Harre lost her case in August 1983.
But a question arose about Keith's testimony. Eight months after his testimony in the Harre case, Keith testified that he had not conducted any tests on the Shield. He said that he had done no experimental work on the tail string, nor wicking experiments, had no one under his supervision working on such experiments and had not personally observed any such experiments.
Harre's lawyers appealed. Last Jan. 21, the 11th U.S. Circuit Court of Appeals said: "We find that the record supports appellant's [Harre's] argument that a material expert witness [Keith] testified falsely on the ultimate issue in the case, where the defense attorneys know or should have known of the falsity of the testimony."
The court cited what it called "intractable conflicts" in Keith's testimony and went on to say: "This court is deeply disturbed by the fact that a material witness, with complicity of counsel, would falsely testify on the ultimate issue of causation." The appellate court ordered a retrial for Harre.
An FBI spokesman in Tampa said yesterday that Keith was under investigation for alleged perjury.
Matthew F. Kennelly, an attorney for Keith, said in court papers that Keith's testimony "was not, except in one minor respect, inconsistent" and the "court's opinion does not take into account the nuances of language used by lawyers and Dr. Keith" in the two cases.
Said an attorney representing Robins: "Louis Keith did not lie. He did in fact give overall medical direction to the study. He did not supervise the microbiology work that was done. I cannot in my mind see the contradiction." ' "Our" Testimony'
Dr. Donald R. Ostergard, an obstetrician and gynecologist on the faculty at the University of California at Los Angeles told a House subcommittee in June 1973: "I am not a consultant to Robins at the present time, nor have I ever been."
He said that "Robins is paying my expenses, of course, to come to this particular hearing." Robins said later that by then, the company had paid $38,688 in fees and expenses to Ostergard and the hospital staff's professional association to which he belonged.
The day after the hearing, Ostergard billed Robins for "fees" and expenses. His check for $1,858.97 came with a note from a Robins physician, Ellen J. Preston, saying it was for "your expenses and fees in connection with 'our' testimony." By February 1975, the company had paid him $82,955.
In a recent interview, Ostergard said that he never considered himself a Robins consultant, that Robins was merely paying him for his time away from his practice and not for his opinions. "I was submitting information to the subcommittee but not to the A.H. Robins Co.," said Ostergard.
Ostergard said the money Robins paid him for research went to his hospital's professional association. "I derived no personal dollars into my bank account from that," he said. Studies and Statistics
In 1983 Robins reported that Dr. Max Elstein, a British physician, had received more than $100,000 from Robins and another $100,000 went to the University of Southampton when he was on its faculty. The money was to finance bacteriological studies.
Elstein's research focused on pelvic infections caused by bacteria invading the germ-free womb. He testified that he was unaware of "any evidence" from studies of "any increased hazard" with the Shield design.
A spokesman for Robins said Elstein conducted two studies, one in the laboratory, one in a clinic, and concluded that "the Shield tail string did not carry bacteria to the uterus in a manner than was different from other" strings used on other IUDs, that all IUD strings carry bacteria into the uterus.
A portion of the clinical study consisted of a bacteriological examination of the uterine lining of three women Shield users who had had hysterectomies for conditions Robins said were unrelated to the Shield.
Elstein testified in 1981 that he had been told by a statistician that the study showed "no statistically significant difference" between the Shield and other devices. He was asked if he thought such a study could produce a meaningful scientific conclusion. "The inference that we had was that there was not a difference between them and therefore we stopped the study," Elstein said. ". . . I am not a biostatistician."
In a recent interview Elstein said he considered the study involving only three Shield users to be inadequate and incomplete, but said that his observations were not based on that study alone. Robins Gets a Proposal
In 1981 Dr. Attila Toth, an assistant professor of obstetrics and gynecology at Cornell University Medical School, began noticing stories about lawsuits brought by women who had used the Shield and suffered pelvic infections. He sent a letter to Robins' medical services director, Fletcher B. Owen Jr.
Toth proposed to do a two-part study "that would be of paramount importance in explaining the IUD-related [pelvic infections] and at the same time relieve some of the blame from drug companies" in "our current litigation-conscious society."
He saw responsibility for the infections to be not with IUDs but with the sex partners of the users. Specifically, he linked the infections to infertile men or to men who have had genital-tract infections.
In part one of the study, Toth wrote, "we would like to show that infertile males and males with a past history of genital-tract infection have many more bacteria in their seminal fluid than men in a monogamous marriage situation and those who easily reproduce." In part two, Toth said he would look for "other diseases [that] can be associated with men who walk around with a lot of sperms and bacteria."
Robins sent $97,516 to Cornell's McLeod Laboratory for Infertility, which Toth had helped to set up. Toth testified he got $5,000 of it as a salary increase.
Toth finished part one of his study in October 1982. He told Robins that it "shows without doubt that it is not the intrauterine device per se but the infected seminal fluid that causes pelvic infections in women who use this type of birth control method."
Toth said in 1983 that he had ties with the law firm representing Robins, mainly McGuire, Woods, but had not been paid by Robins to testify. At the time Toth was listed by Robins' attorneys as a prospective witness in a St. Paul, Minn., trial.
A defense attorney said that Toth "has had no contact with" Robins but is "working for the lawyers." The attorney added, "We told him we represented the A.H. Robins Co." Toth was called to testify at trial.
"The lawyer that made the statement was in error," said Franklin M. Tatum III, an attorney representing Robins. Tatum said a Robins attorney corrected the record the next day, spelling out Toth's connection in a deposition.
Toth said in a recent interview that Robins' financing of his research had had no influence on its outcome and that he was already well along with the study before he sought Robins' support for it. He said the reports of a higher incidence of pelvic infections among women who used the Shield were the result of a campaign or bias against the device and that the figures had been distorted. Disputed Data
Last year, Robins' general counsel, William A. Forrest Jr., was asked by an opposing attorney why the company had not retained "renowned experts" to give independent opinions on whether the Shield caused pelvic infections. Robins had financed "experts independent of the . . . company," Forrest answered. He cited Robert Snowden, head of the Institute of Population Studies at the University of Exeter in Britain. Snowden is a sociologist.
Snowden has been a consultant to Robins since 1973. By mid-1983, he had received fees of $4,052 and the institute he heads had gotten "grants and payments" of $41,588. Part of that money, he testified, was a research grant from the Richmond law firm representing Robins.
Snowden figured in a 62-page article in the November 1982 issue of Current Problems in Obstetrics and Gynecology. The article was written by Keith, Berger and Edelman. They wrote that "unpublished data" suggested there were no differences in the risk of pelvic infection among users of various IUDs.
The data were Snowden's: he had referred to them -- while they were still preliminary -- at a meeting in Arizona of Shield defense experts. Snowden said he later discovered the article in Current Problems by chance.
He told attorney Tatum that a table in the article based on his data listed an erroneously low PID rate for the Shield and erroneously high rates for rival IUDs. "I certainly told Tatum that those rates were incorrect as they appeared in that table," he has testified. "And I expressed my dislike of the fact that this had been used and that the new draft I was producing would not be exactly the same."
Tatum said the information published by Berger, Keith and Edelman was "essentially the same as the data published by Snowden . . . . The conclusions didn't change. All that changed was nitpicks as the data was revised."
Snowden and a British economist wrote in the British Medical Journal last May that "fears that the Dalkon Shield may be associated with a higher incidence of pelvic infection than other intrauterine devices may have been unjustified."
In a final paragraph, the authors wrote: "A grant was also received from A.H. Robins Ltd, USA, for the subsequent more detailed analysis."
In a recent interview, Snowden said the grant came to about $30,000 over four years. He said he believed his research on the Dalkon Shield was thorough and accurate.