Tetuan v. A.H. Robins Co.

The opinion of the court was delivered by

Plaintiff Loretta L. Tetuan filed the present civil action against defendant A.H. Robins Co., Inc., on January 29, 1982. The plaintiffs suit concerned personal injuries allegedly resulting from her use of an intrauterine contraceptive device known as the “Daikon Shield,” and alleged negligence, civil conspiracy, strict liability in tort, breach of warranty of merchantability, breach of express warranty, fraud, and gross and wanton negligence. On May 3, 1985, a jury returned a verdict in the plaintiff s favor for $1.7 million in compensatory damages and $7.5 million in punitive damages. Defendant Robins appeals.

The factual background relating to the plaintiff can be summarized as follows. Loretta Tetuan was born on February 11, 1952. She married Michael Tetuan with whom she had attended school. Plaintiff testified there were no difficulties in the marriage prior to her health problems. The Tetuans had two children: Michael, d.o.b. 12/25/69, and Christina, d.o.b. 7/31/71. Plaintiff did not finish high school and worked in the Ramada *443 Inn laundry department in Topeka, Kansas. She had never had any serious illness other than appendicitis.

Because Christina was born with Down’s syndrome, Michael and Loretta decided not to have any more children for awhile, although they did plan to have more children eventually. Plaintiffs sister suggested that she try an intrauterine device (IUD). Plaintiff brought up the subject of an IUD with Dr. Robert Pfuetze on September 14, 1971.

On the same day, Dr. Pfuetze inserted plaintiff with a Daikon Shield but did not inform her of the brand of the IUD. Dr. Pfuetze had been detailed by Robins representatives on the Daikon Shield. Dr. Pfuetze did not tell her of any possible danger from infection and said only that her periods would be a little heavier.

Other than the heavier menstrual periods, plaintiff initially suffered no ill effects from the Daikon Shield. She resumed work at a new job at Josten’s Yearbook Company.

In 1974, Mr. Tetuan joined the United States Army and was stationed in Fort Carson, Colorado. Plaintiff accompanied her husband to Colorado. Because her menstrual flow increased, she went to the post clinic. She was told by an Army nurse that she should have her IUD removed to reduce the heavier flow. She was not told of any dangers from the Daikon Shield or of the possibility of infection. Her periods returned to normal after the firstvis.it. When Mr. Tetuan was discharged, the couple returned to Topeka.

In 1978, she went to Dr. Pfuetze for a Pap smear. She had not had any physical problems prior to this time. She inquired about having the IUD removed. According to plaintiff, Dr. Pfuetze told her, “You’ve worn it this long, I don’t think you’ll have any problem with it.”

On September 21, 1979, she went to another physician, Dr. Darrell Weber, after experiencing fever and severe pain in the pelvic area. She had missed a week or two of work because of the pain. Dr. Weber told her she had a pelvic infection and gave her some antibiotics. Dr. Weber did not mention her IUD as a possible source of the infection. Dr. Weber testified that he had received no warnings from Robins regarding the dangers of the Daikon Shield.

Because the antibiotics were ineffective in relieving the pain, *444 she was hospitalized, given additional antibiotics, and then released. In March 1980, Dr. Weber removed the Daikon Shield. No one had yet indicated to her that the Daikon Shield IUD might be dangerous.

Because the pain still did not subside, in May 1980 she saw Dr. Lucien Pyle, who referred her to Dr. Charles Joss. In order to remove all the diseased tissue, on June 25, 1980, Dr. Joss performed a “total abdominal hysterectomy with bilateral salpingo oopher” — the complete removal of plaintiff s uterus, Fallopian tubes, and ovaries.

After the operation, the Tetuans’ marriage disintegrated and they filed for divorce in March 1981. Plaintiff now works at the American Bindery Company where she makes $4.15 per hour. She testified the operation made her feel less of a woman. Dr. Joss testified that “many women who have lost their pelvic structures have a deep feeling that they’ve lost their femininity and desirability to their husbands and become depressed and mentally sick this way.” Otherwise, her physical prognosis was generally good. Because of the loss of her ovaries, plaintiff will have to take synthetic hormones for the rest of her life. Testimony at trial indicated that women taking these hormones over a long period of time can experience dangerous side effects which, though not common, include

“increased risk of developing cancer of the lining of the womb, endometrial cancer. They’re at increased risk of other cancers like breast cancers, they’re at increased risk of liver disorders, of gall bladder disease, of abnormal blood clotting with thrombosis and embolisms, some of which are pretty frightening conditions, like stroke, coronary disease, embolism to the vessels of the eye and so forth, very serious kinds of problems can occur.”

Of course, plaintiff will not have to worry about endometrial cancer (cancer of the uterus). She no longer has a uterus.

Loretta Tetuan sued defendants Robins and Dr. Weber. The jury apportioned fault as follows: Plaintiff: 16%; Robins: 84%; Dr. Weber: 0%. The jury found for the plaintiff on the fraud count.

In order to understand the issues raised by this appeal, it is necessary to also summarize the history of the Daikon Shield.

The Daikon Shield is a white piece of plastic less than two centimeters in diameter. Roughly oval in shape, it contains four *445 phalanges on either side which enable it to remain secure in the uterus and gives the shield a crab-like appearance. Attached to the shield is a black string 8-9 centimeters in length. As with all IUDs, no one knows exactly why the Daikon Shield inhibits conception.

The Daikon Shield IUD was originally developed by Irwin S. Lerner and Dr. Hugh Davis. The rights to the device were held by the Daikon Corporation. The Daikon Corporation was made up of Lerner, Davis, Dr. Thad J. Earl, and Robert E. Cohn. The Daikon Corporation began manufacturing Daikon Shields in late 1968.

On February 1, 1970, Dr. Davis published a study in the American Journal of Obstetrics and Gynecology entitled, The Shield Intrauterine Device: A Superior Modern Contraceptive. This article would soon become the core of Robins’ Daikon Shield promotional campaigns. In the article, Davis related his study of 640 Daikon Shield insertions, which he claimed established that the Shield had a 1.1% pregnancy rate per year on the life table method.

Later investigations and studies would raise serious questions about the original Davis study. Riostatistician Dr. Thomas D. Downs, in testimony, characterized the Davis study at trial as being of “very poor quality.” The Davis study did not identify the time frame in which the data was collected, the age structure of the subject population, or the method by which the population was selected. No information was given in the study on the length of time the women participated in the study. Downs testified that the Davis article “reads like an advertisement instead of a scientific piece of work.” Moreover, the Davis article improperly claimed superiority to the pregnancy rate for other IUDs, even though the data collected in the article dealt only with the Daikon Shield and used pregnancy rate figures from other sources for other IUDs. No control group was used by Davis in the 1970 article and Davis neglected to mention in his article the substantial financial interest he had in the Daikon Shield.

The 1.1% pregnancy rate asserted by Davis in his 1970 article aroused the interest of Robins. Prior to Robins’ purchase of the Daikon Shield rights, it sought to find out more about Davis’ *446 study. On June 9, 1970, Dr. Fred A. Clark, an employee of Robins, filed a memorandum on his visit to Raltimore to meet with Davis. Like the original 1970 Davis study, the information contained in the Clark memo did not provide sufficient information to establish a scientifically accurate pregnancy rate for the Daikon Shield. However, the minimum possible pregnancy rate for the data in the Clark memorandum was 5.3%. In other words, prior to its purchase of the Daikon Shield, Robins had information which indicated that the Daikon Shield’s rate of pregnancy was nearly five times worse than Davis’ purported 1.1% rate, at a minimum.

The Clark memo reported, “Davis stated that the company which takes the Daikon Shield must move fast and distribute much merchandise and really make an inroad in ‘the next 8 months.’ My feeling was that others may be working on similar improvements for IUDs.” Robins decided to move fast. On June 12, 1970, A.H. Robins Co., Inc., purchased the rights to the Daikon Shield. Under the terms of the agreement, the Daikon Corporation transferred its patents for the Shield to Robins in exchange for outright cash payments, royalties from the continued sale of Daikon Shields, and employment of Lerner and Earl by Robins as consultants. Robins began to prepare for distribution of the Shield in 1971. The Shield was to be sold for $4.35. In late 1970, the'total costs for labor, overhead, materials, and freight amounted to only $.30 for each Daikon Shield.

While Robins’ main competition, Ortho’s Lippes Loop IUD, was already widely marketed, the Daikon Shield had not been produced yet in significant quantities. Moreover, Ortho had four years’ prior testing and experience with its IUD. The Daikon Shield had no pre-marketing testing. A June 8, 1970, internal Robins memo recognized that: “The device has not been subjected to any formal stability testing.”

In November 1970, Robins recognized in an internal memo the need for some form of study of the Daikon Shield. After outlining the subjects to be studied in future clinical studies, the memo stated: “The need for long-term studies stems (1) from the dearth of publishable data on the Daikon Shield for marketing support and (2) from the anticipated need for information available for presentation at the time of implementation of expected *447 medical device legislation.” (Emphasis added.) Prominent by its absence from this list was the need to ensure product safety. At the time Robins began to market the Daikon Shield, there were no government requirements for pre-market testing for IUDs, but recommendations existed that all products be found to be effective and safe, and the 1969 World Health Organization Report recommended a two-year testing program prior to marketing.

In a 1970 memo marked “PERSONAL & CONFIDENTIAL” to W.L. Zimmer, president of Robins, one of Robins’ vice-presidents expressed concern over the new product line:

”1 worry that our line is limited, to say the least. Our competitors are generally able to offer several means of contraception, including that most widely-accepted sold and used, the O.C. pill. This could permit others to compete on the I.U.D. level on a low price basis, while they make their profits on the other more widely accepted and sold products.”

He expressed concern that Robins had

“no present or past R&D effort on contraception and contraceptive methods. . . .”

“I worry about the fact that we have no market knowledge or experience in our company and we are prepared to learn-on-the-job. Meanwhile our competitors have at least a certain amount of know-how and experiences available to them today.”

Robins was not only marketing an IUD without significant research experience, it had also instituted several “minor” changes in the size and shape of the Daikon Shield which had been produced by the Daikon Corporation. The internal Robins report announcing the design changes concluded: “Incidentally, we will not ‘announce’ the fact that these minor design changes have been made.”

At the time Robins began to produce the Daikon Shield, it had no evidence of the safety of the device; the only information it had on the efficacy of the device was the questionable Davis article, which was for a different design of the Shield. Another Robins memo discussed the Shield in December 1970: “Rob does not regard the DALKON SHIELD as an ‘established’ product. Perhaps in view of the design changes it is ‘less established’ or more vulnerable than it was.” The lack of knowledge about the Daikon Shield continued after Robins began *448 distribution of the Shield: “At present [June 10, 1971] we have no ‘tangible’ evidence, i.e. statistics, of the performance of the current production model of the Daikon Shield.”

Accompanied by an extensive promotional campaign, Robins began to market the Shield nationally in January 1971. The core of Robins’ promotion for the Daikon Shield was that its product was “safe and superior” to other forms of birth control. Robins obtained hundreds of thousands of reprints of Davis’ 1970 article and gave them to its detailmen to give to physicians. The reprint given to physicians, however, did not include the label of “Current Investigation” which had originally appeared on the Davis article. Dr. Emanuel Friedman, an expert witness for plaintiff, testified that “Current Investigation” would indicate a preliminary report, something not yet established as scientifically valid.

Product cards prepared in September 1970 to be given by Robins detailmen to physicians lauded the overall superiority of the Shield’s pregnancy rate to the pill’s and other IUDs’, and claimed it was safe and produced no side effects on the body. Other cards prepared in November 1971 also stressed the 1.1% rate.

Robins also prepared, in September 1970, Patient Information Sheets entitled, “Daikon Shield: Answers to your patients’ questions.” The answers included:

“Are the IUDs safe?

“Many leading authorities believe they are the safest method of effective contraception available today. Unlike the Pill, they do not produce generalized side effects, such as headaches, blood clots, depression, breast tenderness, hair loss, weight gain, decreased sexual desire, etc.

“Is the Shield as effective as the Pill in preventing pregnancies?

“The pregnancy rates with the modem pills and the modern IUD are similar. The Shield prevents 99% of pregnancies, as do most oral contraceptives.”

Although earlier Robins Daikon Shield literature recommended removal of the Shield within two years, this recommendation was eliminated by November 1971. Literature provided by Robins in 1971 also stated: “The Shield is made of a plastic material which is neither dissolved nor ‘used up’ by the body tissues. It will provide protection for a period of years. Some women have used the same I.U.D. for five years or longer.” The literature did not note that the string attached to the Daikon *449 Shield was made of nylon which does disintegrate within the body.

However, Robins’ promotion of the Daikon Shield was not limited to professionals. Even though the Daikon Shield was an “ethical product,” which means it could be dispensed only by licensed physicians, Robins apparently sought to create a market among consumers directly. A Robins memo dated October 1, 1971, stated that top priority had been given to a special promotion of the Daikon Shield in nonmedical and trade publications. The public relations firm of Wilcox & Williams was to be hired for this purpose.

Publications subject to the campaign included newspapers, Family Circle Magazine, Mademoiselle, Midwest Magazine, Ladies’ Home Journal, Time, Glamour, Parade, and Cosmopolitan. The intent of this “press coverage” may be found in the paper submitted by Wilcox & Williams to Robins on November 30, 1971, entitled “A Communications Program for A.H. Robins Company, Inc.” It outlined a program to obtain favorable reaction among the general public. Favorable reaction was defined in terms of increased sales of the Shield. A progress report on the promotional campaign defined the project as one “to obtain consumer coverage for the Daikon Shield.” (Emphasis added.)

The promotional campaign directed at doctors and consumers was apparently very effective. By September 1972, 80 percent of doctors inserting IUDs were inserting Daikon Shields. By February 13, 1973, over two million Daikon Shields had been sold.

Prior to its purchase of the Daikon Shield, Robins had only the questionable 1970 Davis article to substantiate the effectiveness of the Daikon Shield. However, the 1.1% rate was the basis for all of Robins’ promotion for the Daikon Shield because it allowed Robins to claim superiority over other IUDs and equality to oral contraceptives. Evidence at trial indicated that Robins knew the Daikon Shield was not as successful as advertised in preventing pregnancies.

In December 1972, Dr. T. Primrose of the Royal Victoria Hospital in Montreal wrote to Dr. Ellen J. Preston, of Robins:

“(B) My colleagues in other provinces have informed me that the pregnancy failure rate of the shield in their hands is up to 7-8 per 100 woman years which they find unacceptable.”

*450 Also in December 1972, Robins received the following letter from Major Russel J. Thomsen, M.D., of the United States Army Hospital at Fort Polk, Louisiana, which stated, in part:

“Other than pointing out the inadequacies of this advertisement I will add a few observations about clinical useage [sic] of the Daikon Shield. Like most obstetricians-gynecologists, I was impressed'with the logic of the early claims for the Shield. I used it widely. But I (about two years later) no longer use it. My experience and that of many of my colleagues suggests that the actual long term (2 to 4 year) pregnancy rate with the Daikon Shield is actually about 10 per cent when term pregnancies, miscarriages, and ectopic pregnancies are considered with their respective major morbidities. And the complications of menorrhagia, metrorrhagia, uterine cramping, and pelvic inflammatory disease also seem high.

“I am recommending that you seriously evaluate again the Daikon Shield and its place in the clinical practice of birth control measures.

“I am also suggesting that you correct your advertising and issue appropriate cautionary statements to physicians. In fact, I am suggesting that you withdraw the Daikon Shield from the market until its safety can be established.”

Dr. Preston replied to a 1973 inquiry to have Robins consider funding a possible study on the Daikon Shield. “As I indicated to you during our telephone conversation, I am not very amenable at this point to expending a great deal of money or personnel time to analyze Daikon Shield data which is anticipated to be unfavorable.”

In June 1972, Robins began to receive reports of women experiencing septic abortions while wearing the Daikon Shield. A septic abortion occurs when a woman, after becoming pregnant, experiences an infection of the reproductive system which causes the spontaneous abortion of the pregnancy. Dr. Thad J. Earl, one of the developers of the Daikon Shield, also reported in June 1972:

“The next situation I have found is with women becoming pregnant and if the Shield is left in place the women abort at 3V4 to 5 months and become septic. I am advising physicians that the device should be removed as soon as a diagnosis of pregnancy is made. Numerous physicians have noted this. In my six pregnancies, I removed one and she carried full term, the rest all aborted and became septic. I therefore feel it is hazardous to leave the device in and I advised that it be removed. I realize that this is a small statistic but I feel we should correlate this data with other investigators across the country, because most men are experiencing the same problem.”

Other reports of severe infections continued in 1972 and in *451 1973. In April 1973, Dr. Anne Roard, a Robins doctor, sent a memorandum to Dr. Ellen J. Preston, which stated:

“As well as I can determine, there is a feeling or rumor (based upon the fact that several individuals have each experienced one case) that if a patient becomes pregnant while having a Daikon Shield in place, therapeutic abortion should be carried out post-haste. The reason for this is that patients with Daikon Shields are more likely to experience septic abortion than either (1) patients using other IUDs or (2) patients without IUDs who happen to experience spontaneous abortions.”

Dr. Preston responded:

“I do not know what relationship, if any, exists between the incidence of sepsis in patients pregnant with the Daikon Shield and the incidence of PID in the nonpregnant patient with a Daikon Shield. It has been suggested by some, particularly from the West Coast, that there is an increased incidence of PID associated with the Daikon Shield over that seen with other IUDs. I see no reason that this should be so, and none of my requests to physicians holding this view have resulted in any sort of documentation supporting this allegation.”

Information letters collected by Robins in its Spontaneous Septic Abortion File indicated that the total number of septic abortions associated with other IUDs was 39. The total number of Daikon Shield septic abortions was 250.

In 1974, because of growing reports about septic abortion and Robins’ discovery that Dr. C.D. Christian of the University of Arizona was preparing an article on the Daikon Shield and septic abortions, Robins invited numerous physicians to a Robins-sponsored conference on septic abortion and IUDs in February 1974. (Dr. Christian’s article, published in June 1974, reported on seven cases of septic abortions and five further cases of maternal deaths.) At the February 1974 conference, Robins made no mention of the information it had concerning the wicking phenomenon of the Daikon Shield tail string, no mention that Robins was “desperately” looking for a replacement string, or Dr. Earl’s 1972 report of septic abortions. (In August 1974, an unsigned Robins report states: “Five cases were reported from Thad Earl in June, 1972. These cases were inadvertently overlooked until the other day. No information at all is available on them.”).

The consensus at the February 1974 conference was strong enough that, on May 8, 1974, Robins issued its first “Dear Doctor” letter. The letter recommended that physicians remove *452 Daikon Shields from women who became pregnant. Robins issued a press release stating that “insufficient information is available to establish any cause and effect relationship between the Daikon Shield and septic spontaneous abortion.”

On June 26, 1974, the FDA requested Robins suspend distribution of the Daikon Shield. Robins announced the suspension to its distributors: “This is NOT A RECALL, but a suspension of sale until further notice, which is expected during the latter part of August.” An accompanying press release stated, “neither A.H. Robins nor the FDA has any reason at this time to believe that women now using the Daikon Shield successfully should have the device removed.” In August 1974, Robins Public Affairs Vice-President Richard Velz reported in a memo: “You will note that the August 23 WASHINGTON POST article mentions the dangerous word ‘recall.’ However, that statement was in error and further coverage corrects that.” A Robins “Status Report for Daikon Shield” stated under the heading “Legal Implications,” the statement: “It is the opinion of [Robins attorney Roger L.] Tuttle that if this product is taken off the market it will be a ‘confession of liability’ and Robins would lose many of the pending lawsuits.”

After sales of the product were temporarily suspended by the FDA in June 1974, Robins continued its overseas distribution of Daikon Shields. A November 1974 Daikon Shield ad in the Australian and New Zealand Journal of Obstetrics and Gynaecology compared the Shield’s effectiveness to other IUDs. Its claim of superiority was based on Davis’ 1970 1.1% rate which a Robins memo had characterized as “not valid” in 1973.

In August 1975, Robins announced it was abandoning plans to re-market the Daikon Shield under new FDA regulations. The company announced that “A.H. Robins remains firm in its belief that the Daikon Shield, when properly used, is a safe and effective IUD.” The same assurance of safety and efficacy was made in Robins’ 1975 report to its stockholders.

On September 25, 1980, Robins issued a second “Dear Doctor” letter recommending removal of Daikon Shields from asymptomatic users:

“The medical literature does not establish a firm relationship between the *453 duration of use of inert IUDs and an increased risk of pelvic infection generally; but a relationship has been suggested by recent literature, particularly when the causative organism is Actinomyces israelii. Cases of pelvic actinomycosis which cannot be explained on the basis of direct extension from the gastrointestinal tract have been observed most commonly among long-term IUD users.”

Robins soon received several requests from physicians and women requesting payment for the removal, which Robins refused. Robins’ Director of Medical Services, Dr. Fletcher Owen, Jr., responded that the second “Dear Doctor” letter “was not intended to be construed as a ‘recall’ ” of a “defective and potentially life-threatening product.”

On October 26, 1984, Robins sent out its final “Dear Doctor” letter, in which Robins recommended removal of any Daikon Shields remaining in place and offered to pay for removal, noting that “[t]here is substantial medical opinion that the continued use of the Daikon Shield may pose a serious personal health hazard to users.” However, Robins has continued to state that the Daikon Shield is safe.

Shortly after the final “Dear Doctor” letter, Owen appeared on a National Public Radio program in which he characterized the wicking phenomenon as a “red herring.” At trial, Robins’ board of directors member and ex-president, W.L. Zimmer, III, testified that the Daikon Shield was “safe and effective.”

The Daikon Shield, like most IUDs, contains a string which descends from the uterus through the cervix and permits the user to ensure the device is in place. Unlike other IUDs, however, the Daikon Shield contains a string which is composed of 200 to 400 individual filaments enclosed within a nylon sheath. Other IUDs contain monofilament strings. The Daikon Shield string sheath does not enclose the ends of the string and the filaments are exposed.

The possibility that an IUD string might “wick”, i.e., transport fluid by capillary action, was raised prior to Robins’ purchase of the Daikon Shield. The string selected for the Daikon Shield was the nylon-encased multifilament string. On June 29, 1970, the Robins product management coordinator reported: “The string or ‘tail’ situation needs a careful review since the present ‘tail’ is reported (by Mr. Lerner) to have a ‘wicking’ tendency.”

E. Wayne Crowder was quality control supervisor at Chap *454 Stick, a subsidiary of Robins. Robins had transferred the responsibility for assembly of the final Daikon Shield device to Chap Stick to minimize costs. In March 1971, Crowder suggested to Lerner that melting the string ends would be more effective in eliminating moisture and bacteria. Lerner stated he would think about it.

Crowder testified that the multifilament string commonly broke during tying operations and that, in the summer of 1971, Crowder rejected some 10,000-12,000 strings for sheath breakage. The rejection was later overruled by Quality Control at Robins. Crowder testified that string breakage was a continual problem.

Crowder tried a simple experiment in June 1971. He placed one end of a Daikon Shield string in a beaker of water. Several hours later, he discovered he could squeeze water out of the other end of the string. Crowder reported this to his supervisor, Julian Ross, at Chap Stick and, in July 1971, Crowder met with Ross and Chap Stick president Daniel French and told him about his wicking theory and experiment. Crowder suggested the problem could be solved by heat-sealing the string’s ends and demonstrated with a cigarette lighter. French responded that heat-sealing would cost too much and that Robins would not accept any changes in production then. To ensure that Robins was informed of his concerns, Crowder included comments on wicking in his report to French on the problem of string stiffness.

On September 2, 1971, a Robins quality control supervisor wrote to Robins’ medical department about concerns he discovered after a visit to the Chap Stick plant, including “[wjicking and bacterial problems associated with a multifilament nylon suture versus a sheathed nylon suture.” The same report also stated that a heat sealing solution had been suggested for the string stiffness problem, but concluded: “Flame sealing . . . would create another production problem.” The significance of the wicking tendency of the tailstring of an IUD is that it provides an avenue for bacteria to travel from the vagina into the uterus, causing infection.

Beginning in 1972, Robins began a search for a replacement string. Robins tested several different types of string material, *455 including a more expensive teflon string. However, none of these strings was used outside of experiments.

In 1973, Robins received several reports of PID (pelvic inflammatory disease) associated with the Daikon Shield. In November of that year, a Robins pharmacist noted:

“Dr. Kitty [Ellen] Preston has received reports of the string breaking and/or having visible weak spots. She has requested that tests be run on the string as well as the shields. Her main interest lies with those strings that were in situ for two years or more.”

Robins had also received other reports about the Daikon Shield string. Dr. Stewart Templeton of the Robins subsidiary in Horsham, England, wrote to Robins to inquire about any possible information on the Daikon Shield and PID. Dr. Templeton wrote that he had received complaints from an English user of the Daikon Shield who discovered cases of severe PID among his patients, which he felt was caused by the string acting as a wick along which bacteria traveled from the vagina into the uterine cavity.

Throughout 1974, Robins conducted tests on the wicking nature of the Shield string. In October 1974, a memo by a Robins vice-president commented on the hearings of the FDA committee considering whether to lift or retain the ban on sales of the Daikon Shield. The memo noted:

“In summary, Dr. Clark stated that our critics are unable to prove that the string is the causative factor in the cases associated with septic spontaneous abortions. On the other hand, we are unable to prove conclusively that it is not the causative factor.”

Dr. Templeton telexed Robins in November 1974, raising the same solution Wayne Crowder had suggested in 1971. He asked, “WHY DON’T WE JUST HEAT-SEAL THE DISTAL AND/OR PROXIMAL ENDS OF THE PRESENT STRING[?]” A Robins interoffice memo by Dr. Ellen Preston to Robins’ medical department vice-president discussed the suggestion, stating:

“I agree. It is too late to ‘heat seal’ now. We need to abandon the ‘multi-filament’ string. Heat sealing would have been a good thing to have done 4 years ago.”

In February 1975, Dr. Howard J. Tatum of The Population Council, et al., published their study, “The Daikon Shield Controversy: Structural and Bacteriological Studies of IUD Tails,” in *456 the Journal of the American Medical Association. The study concluded:

“[T]he appendage of the Daikon Shield is patent to a liquid medium andean and does function as a wick for the passage of fluid throughout its entire length by capillary action.”

Among the witnesses at trial were Dr. Judith Haber, a clinical microbiologist. Working for Biskind Laboratories in Burlingame, California in 1974, Dr. Haber performed experiments requested by Robins. Dr. Haber testified that her experiments, the results of which were sent to Robins, involved examining Daikon Shield strings removed from human users. All of the strings showed some bacteriological growth; 45% showed significant bacterial growth. Haber also testified that, because of the extremely small size of bacteria, the knots in the Daikon Shield string did not prevent their passage.

In 1983, Dr. Harvey Bank produced similar results in a study of the Daikon Shield multifilament string. Bank examined used strings, finding bacteria present in every one. He found that fluid similar in viscosity to body fluids in the vagina could wick through the length of the tail string in about 90 minutes. No fluid motion existed for monofilament strings or for multifilament strings that had been heat sealed. Finally, Bank concluded that live bacteria could ascend and exist in the string.

Bank testified at trial that the experiments were simple and could have been performed by anyone with proper equipment. Also testifying was Dr. Daniel Roberts, who examined Daikon Shield strings removed from human users. Roberts found that all the nylon sheaths had undergone partial or complete disintegration. The deteriorated state of the nylon sheath provided an additional avenue for bacteria to escape from the string into the uterus. Moreover, while the cervical mucus plug normally prevented bacteria from ascending the external sides of the IUD strings, the nylon sheath of the Daikon Shield string prevented the bactericidal agents of the mucus plug from killing bacteria within the string.

Expert testimony was also introduced at trial comparing PID rates for the Daikon Shield and other IUDs. The 1976 Center for Disease Control (CDC) report by Cates, et dl., indicated the Daikon Shield produced a PID risk rate three times higher than other IUDs. The 1983 Lee-Ory study concluded the Daikon *457 Shield had a PID risk eight times higher than for women who do not use any IUD. Moreover, where the PID risk for other IUDs declined over time, the Daikon Shield PID rate increased with time, so that the risk eventually reached 15.6 times the non-user rate.

Although there were several other studies introduced by Robins to establish the lack of any relationship between the Daikon Shield and PID, there appears to be substantial evidence in the record questioning the quality of these studies, which were funded in part by Robins.

In 1971, Roger Tuttle, a member of Robins’ legal department, was placed in charge of Robins’ products liability cases. Beginning in 1972, cases involving the Daikon Shield, including PIDs, began to “trickle” in. However, after the first case to reach trial on the merits, Deemer v. A.H. Robins Co., Case No. C-26420 (Dist. Ct. Sedgwick County, Kan. filed Oct. 1974), Robins President W.L. Zimmer, III, on August 15, 1974, sent the following memo to fifteen Robins officers and employees:

“You are requested to immediately search your pertinent files for any letters, memos or notes on oral or written communications relating in any way to the thread utilized for the tail for the Daikon Shield and send them to Ken Moore. Of particular interest are any references to ‘wicking’ of the tail. To the extent that you have had any oral communications with third parties on this subject which are not memorialized in writing, please submit a memo on any such communication to Mr. Moore.

“This project is of utmost importance, and should be completed by Friday, August 16.”

Tuttle testified that Robins began a program to destroy documents relating to the wicking phenomenon. The destruction program was ordered on February 2 or 3, 1975. Although Tuttle did not personally observe the destruction of documents, pursuant to orders, he instructed Robins employees to destroy documents and was informed that it had been accomplished. Tuttle was ordered to search for and destroy documents by Robins’ chief counsel Forrest, who told Tuttle he had discussed the destruction program with Zimmer. Tuttle testified that hundreds of documents were destroyed in a draft furnace. Tuttle secretly saved copies of some of the documents, but the vast majority of the documents were completely destroyed.

Forrest told Tuttle that he blamed Tuttle for allowing the *458 Clark memorandum of June 9, 1970, to come to light in the Deemer case. Forrest said he did not ever want anything like that to happen again, and the only way to ensure that was if the documents no longer existed.

Additional facts will be set out and discussed as necessary to determine the issues in this appeal.

Robins first contends that “such a large volume of irrelevant, immaterial, and inflammatory evidence” was introduced at trial that “prejudice to Defendant permeated the entire trial.” Robins recites a long list of allegedly prejudicial evidence, or statements in closing by plaintiff s counsel upon that evidence, which it terms “error,” including the following: 1) Evidence of a different pregnancy rate for the Daikon Shield than the 1.1% Robins claimed; 2) evidence of perforations of .the uterus by the Daikon Shield; 3) evidence of spontaneous septic abortions associated with the Daikon Shield; 4) other miscellaneous evidence, including a suit filed by Dr. Earl against Robins; a medical journal dated April 11, 1985; Robins’ judgment in an antitrust case; references to suits against Robins; and references to medical studies in 1981 and 1982.

The plaintiff s action was grounded in part upon fraud: Robins’ deliberate misrepresentation and concealment of the defectiveness of the Daikon Shield. In Minx v. Mitchell, 42 Kan. 688, 692, 22 Pac. 709 (1889), this court stated: “[W]here fraud is alleged, it is always permissible to prove every act of the party charged, connected in any way with the subject-matter of the fraud.” Similarly, in Culp v. Bloss, 203 Kan. 714, 718, 457 P.2d 154 (1969), this court held that other actions of the defendant were “relevant and admissible for the purpose of showing defendant’s motive and intent to defraud the plaintiffs.”

A similar issue was raised in U.S.D. No. 490 v. Celotex Corp., 6 Kan. App. 2d 346, 629 P.2d 196, rev. denied 230 Kan. 819 (1981). The plaintiff sued defendant Celotex for fraud in the construction of a defective roof. Celotex argued on appeal that the trial court had erred by allowing the introduction of evidence of other Celotex roof failures around the country. The Court of Appeals rejected that argument:

“The evidence of prior roof failures was not introduced by plaintiff to show that the two-ply roof of the El Dorado High School was defective, nor was it used to *459 indicate that the causes of the problems on previous roofs were related to the causes of the problems on the El Dorado High School roof. The actual purpose of the introduction of these documents was to prove Celotex’s knowledge of the defect that gave rise to the duty to warn. As to USD 490’s breach of warranty and fraud theories of recovery, the evidence of prior complaints was also relevant to show Celotex’s state of mind insofar as its representation is concerned and to prove Celotex’s knowledge of its truth or falsity or its reckless disregard of its truth or falsity.” 6 Kan. App. 2d at 359.

Citing this court’s holding in Culp, the Celotex court concluded:

“Although Celotex makes much of the fact in its brief that the roofs and roofing problems in the other cases were dissimilar, all of the complaints introduced were about two-ply roofs. We also note that internal memoranda of Celotex made reference to the fault of the two-ply roof, regardless of how the problems were manifested.” 6 Kan. App. 2d at 360.

In this case, the evidence of Robins’ knowledge of the higher pregnancy rate, perforations, and septic abortions was directly relevant to show Robins’ consistent failure to reveal the true nature of its product, and its continuing failure to warn. The theme of Robins’ promotion of the Daikon Shield was that it was “safe and effective.” The great weight of evidence at trial was that it was neither, and that Robins was aware it was not.

“Fraud is normally a secretive act and must be concealed for success,” Chute v. Old American Ins. Co., 6 Kan. App. 2d 412, 422, 629 P.2d 734 (1981), and thus “considerable latitude should be granted in the introduction of evidence to prove the fraud.” 6 Kan. App. 2d at 422 (citing Brakefield v. Shelton, 76 Kan. 451, 453, 92 Pac. 709 [1907]). In the present case, the evidence complained of by Robins, the reports of spontaneous abortions, the reports of perforations, and the reports of a much higher pregnancy rate were all relevant to show Robins’ continuing concealment of information from doctors and from women.

In Craig v. A.H. Robins Co., Inc., 790 F.2d 1 (1st Cir. 1986), Robins made the same argument before the First Circuit. Robins attacked the relevancy of evidence relating to the Daikon Shield’s pregnancy rate. The Court of Appeals rejected the argument, stating that evidence of “the frequency of pregnancies experienced by Daikon Shied users . . . [helps to] form part of a pervasive picture of covering up a defective product and contin *460 uing to merchandise it by misrepresenting both its efficacy and its safety.” 790 F.2d at 4.

In Hilliard v. A.H. Robins Co., 148 Cal. App. 3d 374, 410-11, 196 Cal. Rptr. 117 (1983), the court rejected a similar argument by Robins, stating:

“The question remains, however, whether evidence of allegedly ‘false’ or inaccurate pregnancy rates is inadmissible as claimed by defendant Robins. Dr. Dekle, who fitted plaintiff Hilliard with the Robins’ IUD, testified he relied, in part, on what he was told by detailmen and what he had seen in Robins’ promotional material in using and recommending the Daikon Shield. He was dubious about the low pregnancy rate claimed for the Daikon Shield, yet he did not anticipate the rate would exceed two percent based on Robins’ promotional efforts and his experience. This evidence was clearly admissible and relevant. If the evidence showed that the rate was substantially higher than the adv