Roger L. Tuttle, a former senior attorney with A.H. Robins Co., said he was directed by the firm's general counsel in February 1975 to collect and destroy internal documents about the Dalkon Shield birth-control device that might be damaging to the company.
Tuttle, who left the company a year later and is a law professor at Oral Roberts University, said that as a "sop to my conscience" he asked others at Robins to get rid of the records for him. "I didn't have the heart to do it . . . but the responsibility is mine . . . . "
Several company employes, according to Tuttle, reported to him that the records were burned in the furnace used for contaminated products.
Robins general counsel William A. Forrest Jr. denies that Tuttle or anyone else at the firm was asked to destroy records pertaining to the Shield. He said Tuttle "bears a grudge" against the firm for prohibiting him, while he was on the company's legal staff, from defending more Shield cases.
The three employes Tuttle has said carried out the order to destroy the documents say they received no such instructions.
Tuttle's account is one of several that raise questions about the manner in which the multinational drug firm, based in Richmond, has defended itself from lawsuits concerning its IUD. Nearly 13,000 women have brought suits or claims against Robins for what they say are Shield-related injuries -- pelvic infections, miscarriages and congenital deformities among them. About 3,800 claims against Robins are pending.
Aside from the plaintiffs and their lawyers, several judges have been sharply critical of Robins' conduct. They have questioned whether the company or its attorneys complied with court orders, destroyed or withheld documents, and asked highly personal, irrelevant questions of women suing the company.
In a Feb. 21, 1985, report to the U.S. District Court in Minnesota, two specially appointed court personnel who were supervising Robins' compliance with court orders wrote: "We conclude that plaintiffs have established a strong prima facie case that A.H. Robins Co. Inc. has, with the knowledge and participation of in-house counsel, engaged in an ongoing fraud by knowingly misrepresenting the nature, quality, safety and efficacy of the Dalkon Shield. The ongoing fraud has also involved the destruction or withholding of relevent evidence."
Alexander H. Slaughter, an attorney representing Robins, said that the company has always acted in "good faith," and that Robins' record is good. Said Slaughter: "We are or have been in courts in all 50 states. If you count all of the state courts and federal courts, it runs into the thousands. We have done our best to comply with the court orders in thousands of cases over 10 years . . . . We have in a very few instances incurred the ire of a few judges. These judges get the notoriety, and then the cumulative effect of this is to erode the public's and the other courts' confidence in Robins and its attorneys."
As of last Dec. 31, Shield cases have cost Robins and its insurer $315 million. In one 1979 case, a Denver jury awarded $6.2 million in punitive damages -- the largest punitive award up to that time against a drug firm -- plus $600,000 in compensatory damages to a woman who nearly died from a pelvic infection and miscarriage.
In a 1983 case, Robins offered $15,000 to Brenda Strempke, who claimed that the Dalkon Shield caused a severe pelvic infection. Strempke had been willing to settle for $195,000. A jury later awarded her $1.75 million, all but $250,000 in punitive damages.
Now, 11 years since the Shield was taken off the market at the urging of the federal Food and Drug Administration, it appears that neither the women who complained of complications nor the company will be able to put the tragedy behind them soon. Last fall, Robins began an advertising campaign urging women still wearing the Shield to have it removed at the company's expense. It was only the most recent of many such efforts, noted a Robins spokesman. As a result, about 4,400 women have had the Shield removed.
Last week, the company announced that it had a net loss for 1984 of $461 million -- more than its net worth. The firm has estimated that the minimum it will have to pay in compensatory damages and expenses in connection with Shield litigation is $615 million and that pay-outs are expected to continue until 2002. Producing the Documents
In June 1976 and again in November 1982, U.S. District Judge Frank G. Theis in Wichita, Kan., took up the matter of production of Shield documents by the company. Theis presides over pretrial proceedings into which more than 1,000 federal cases were merged. Robins produced thousands of documents, and Theis was convinced the company had complied.
But the question was opened again last year by Minnesota's Chief U.S. District Judge Miles W. Lord, who presided over several Shield cases. On Feb. 7, 1984, an attorney for Robins assured Lord that only legally exempt documents or those excluded by agreement with counsel had been withheld. Lord was not convinced. The next day, he ordered all documents related to the safety of the Shield to be presented and, to assure compliance, he sent two "special masters" to Richmond.
A few days later, Magistrate Patrick J. McNulty concluded that "the court has corroborated its impression, of a deliberate attempt to conceal rather than reveal" and that "this court has been involved in a day-to-day and hour-by-hour process of definition, of redefinition, of defining and refining, further redefinition, and of discussion as to the propriety of production, the methods of production . . . . "
Special master Thomas C. Bartsch said after 16 days' work that Robins claimed "two to three truck loads" of papers were exempt. He suggested "that [Lord's] order required the production of thousands of documents not previously produced." Over the next several months, about 5,000 new pages surfaced, according to an estimate by Robins' lawyers.
"The bulk of it had not been asked for before," said a Robins attorney. "A minute portion in our view had been overlooked . . . we were not perfect in the original searches."
Judge Theis, who twice before had been confident that all materials subject to his orders had been produced, was taken aback by the volume of new material. In a July 3, 1984, affidavit he said: "While there may possibly be explanations and justifications . . . it would seem, in the light of the disclosures by the masters, that serious questions exist as to whether or not counsel who appeared before me, or their client, should be disciplined . . . . The frustrations and confusion which I have at times experienced in the eight years I have been shepherding this discovery process appear to have been part of a pattern of that which occurred before Judge Lord."
A Robins spokesman said "the company does not believe it has violated any of the orders of Judge Theis in a material way."
The remarks by the special masters, the magistrate and Theis, said attorneys for Robins, were written at a time when Judge Lord was the subject of a judicial disciplinary proceeding initiated by Robins. They said the affidavits and reports were written in an apparent effort to bolster Lord's position in the inquiry. An Appeal to the Soul
Early last year, Robins agreed to settle seven Shield cases pending before Judge Lord, who decided he would approve the settlement only after an open-court proceeding with three senior Robins executives before him on Feb. 29, 1984. The three were E. Claiborne Robins Jr., chief executive officer and president; Carl D. Lunsford, senior vice president for research and development; and vice president and general counsel Forrest.
Lord asked the officers to read in silence a speech he had given in 1981, "The Church's Claim on the Corporate Conscience." A Robins' lawyer objected and asked for a halt to the hearing. Instead, Lord read a reprimand into the record, saying he hoped it "burns its mark into your souls." Lord pleaded with them to "face up to your misdeeds." The officers were silent. Several women who were suing Robins wept.
Robins filed a complaint against Lord under a 1980 law aimed at serious acts of judicial misconduct such as alcoholism and senility. A biased judge, the complaint charged, had committed "a gross abuse of judicial discretion and power."
The 8th U.S. Circuit Court of Appeals' Judicial Council convened a five-judge investigative panel. Lord said Robins was using the 1980 law improperly. He was represented by former attorney general Ramsey Clark, who said the complaints threatened the independence of the federal judiciary. Robins was represented by former attorney general Griffin B. Bell, who argued that Lord had denied the company due process.
In November, after a two-day hearing, the 8th Circuit Court struck Lord's reprimand from the record, calling it an improper "governmental attack on the [officers'] good name, reputation, honor and community standing." A Question of Privacy
Robins' inquiries, say some plaintiff attorneys, delved into very private aspects of womens' lives that had no relation to their injuries or legal issues.
An Iowa mother of two suffered a pelvic infection and the loss of her ovaries and womb. After she sued, attorneys for Robins took depositions from her and her husband, each in the other's presence. An attorney for Robins asked about her sexual relations before their marriage in 1963 -- 10 years before she was fitted with a Shield, and 15 years before her pelvic infection. Her lawyer objected, calling such questions "disgusting . . . irrelevant."
Robins then submitted written questions to the couple. Among the questions: "Prior to your marriage in 1963, did you have sexual relations with anybody else other than [your husband]?" and, "Who were these sexual partners?" Their attorney said he was so upset with the questions that he discouraged his own daughter, a Shield-wearer who had had two episodes of pelvic infection -- one nearly fatal -- from suing Robins.
Another woman was asked what sort of pantyhose she wore and what kind of fabric was in the crotch. "I'll answer that," she said, "but this sounds more like an obscene phone call than anything else."
"It's a bad rap we get on these cases," said Robins' attorney Slaughter. "In order to determine the cause of pelvic inflammatory disease or infection, it is necessary to know facts relating to personal hygiene and sexual experience." Slaughter said a number of judges have held such questions to be "pertinent to the issue of causation." In a few instances, he said, Robins has offered "to seal personal records to save any personal embarrassment." Missing Records
On June 28, 1974, Robins halted domestic Shield sales at the request of the FDA. Six weeks later, Robins President William L. Zimmer III told company executives, in a directive of "utmost importance," to "immediately search your pertinent files for any letters, memos or notes on oral or written communications relating in any way to the thread used for the tail string for the Dalkon Shield . . . .
"Of particular interest are any references to 'wicking' which lets vaginal bacteria climb between the string's hundreds of filaments into the germ-free uterus . . . . " The string referred to was attached to the Shield and extended from the device into the vagina where it provided a means of removing the IUD.
Six days later, on Aug. 21, an FDA panel was scheduled to hold a hearing on whether the Shield was less safe or effective than other IUDs. What happened to some papers collected in response to Zimmer's directive is not known.
Forrest, Robins' general counsel, said that no more than eight documents or copies of those documents out of the 43 collected under Zimmer's order have been lost, and that all of the documents were described in a chronology that has been available to opposing attorneys for 10 years. None of the eight missing documents referred to "wicking," he said.
At the FDA hearing, Robins' medical director Dr. Frederick A. Clark Jr. testified that regarding the Shield as more perilous than other IUDs "cannot be justified."
After the hearing, Chairman E. Claiborne Robins Sr. sent a memo to his top executives commending them for their work in dealing with the FDA panel: "Against a very tough 'jury,' we have presented our case in such a manner that the very real threat of dire and precipitous action was avoided. It appears that we are in a stronger position now than prior to this hearing." Allegation of Destruction-
Former Robins attorney Tuttle testified between July 30 and Aug. 2, 1984 that he had been instructed by general counsel Forrest to arrange for the destruction of Shield documents. Tuttle said that he relayed the directive to others at Robins, and that "I have every reason to believe that the people who reported back to me that it had been done did it."
Tuttle testified that he believed he was told to get rid of the records as a result of an earlier episode in which documents were unintentionally disclosed to an attorney who was suing Robins.
Tuttle testified that Forrest blamed him for the inadvertent disclosure of the records. His "comments were . . . to the effect that he didn't ever want that to happen again, and that the only way it wouldn't happen would be if the documents were no longer in existence," Tuttle said.
"That's false," said Forrest in a recent interview. "We certainly discussed the case, but I never made any of the statements he attributes to me."
According to Tuttle, on Feb. 2 or 3, 1975, Forrest directed him to dispose of records in the files of top officers "that ought not to be retained." Tuttle said he interpreted that to mean records that would be adverse to the company's interest in the event of a lawsuit or public disclosure.
Tuttle said he was concerned that the documents "were evidence in cases . . . . I personally lacked the courage to throw down the gauntlet at that point in time." In the end, he said, "I selected out the most damaging of the documents, to soften my own conscience as an attorney." Tuttle said he hid some of the documents.
Company employes named by Tuttle have testified that they searched for documents but did not destroy any. The company gives a different account of the events described by Tuttle.
According to Robins' attorney Slaughter, when Tuttle left the company in 1976, he took with him about 13 Shield documents he considered sensitive with the idea that he might use them in some way against the company in the future. Eleven of those documents or copies of them, Slaughter said, were produced by Robins in the course of litigation. The remaining two, he said, he believes could not be produced because Tuttle took the only copies with him.
Harris W. Wagenseil had represented Robins -- and sometimes its insurer, Aetna -- in at least 100 Shield lawsuits during a five-year period. Over the course of litigation, he had collected about 20 boxes of Shield documents and other legal records in his San Francisco home. In June 1983 he left Shield litigation and in August took a new job. Wagenseil had the boxes of records shipped to his new home in Columbus, Ind., because, he said later, they were "a piece of my life." He stored them in the basement.
Six months later, on Feb. 29, 1984, Federal Judge Robert G. Renner in St. Paul signed an order directing Robins to notify promptly "all its attorneys . . . and other persons who now have access to" Shield documents not to "damage, mutilate or destroy"any that have "potential relevance" to litigation.
Wagenseil said he never got the message. Instead, Renner got a letter dated May 25, 1984, from Michael Berens, an attorney representing Robins: "On March 22 and 23, 1984, in ignorance of the nondestruct order, Mr. Wagenseil's wife, with his consent, discarded his Dalkon Shield papers, as a part of general spring cleaning." Robins "interprets the word 'attorneys' to mean current attorneys," so it "assumes that the order did not apply to Mr. Wagenseil."
A Robins attorney said Wagenseil's name did not appear on the mailing list of current attorneys.
Wagenseil testified last August that on the eve of the cleanup, his wife told him " 'I'm throwing out that stuff in the basement. Do you have any problem with that?' " He said he replied, "No, go ahead." The boxes were taken to the local dump.
The chief concern to lawyers suing Robins was whether Wagenseil's records included documents related to unpublished studies on behalf of Robins or its insurer. They particularly wanted to know about studies on the string, the prime suspect in pelvic infections.
On Nov. 23, 1983 State District Judge Jonathan Lebedoff in Minneapolis ordered Robins to disclose whatever it knew about such tests. On March 21, 1984 the judge refused Robins' request to reconsider his order. Later in March, Robins was required for the first time to produce documents relating to tests by university scientists on behalf of the firm and its insurer that were commissioned in 1976-83. The tests dealt with the string's potential to wick bacteria.
Wagenseil testified that he had been in contact with expert witnesses at the request of the Richmond law firm that represented Robins. The 20 boxes taken to the dump on March 22, 1984, may have contained notes and other papers that related to the tests, Wagenseil testified, but most of the material was thousands of pages of court depositions. None was of any value to Dalkon Shield litigation, he testified, and nearly all of it was available elsewhere -- a position held by Robins' attorneys today. 'I'll Be Angry Forever'
Lynn M. Schaeffer, a 33-year-old nursing student from Baltimore, was 21 when she was fitted with the Dalkon Shield. The device "sounded great" to her. But from the start, she experienced cramping and abdominal pain. Six months later she had the device removed. For a year she tried to have a child, but doctors told her that pelvic infection had damaged her reproductive organs. Her chances of conceiving were slim. She had corrective surgery, and later suffered a tubal pregnancy because of what she said was scarring from the infections. In July 1979 she had a hysterectomy. That month, a 10-week-old baby was placed with her, a girl she later adopted. But for Lynn Schaeffer, not even the joy of her now 5-year-old daughter and another daughter adopted later obscures the bitterness she says she feels about her experience with the Shield. She sued and accepted a sum of money to settle the case.
"It teaches us that we needed this kind of law [regulating medical devices] sooner. I sure wish a law had existed that would have protected me . . . . It wasn't enough because what I've lost, the ability to ever bear children, can never be replaced with money, although the money is the language that this drug company understands. It was an irreparable injury . . . . I'll be angry forever."