The A.H. Robins Co., moving to assure that no American women continue to wear its Dalkon Shield intrauterine contraceptive device, yesterday announced a program to pay for medical examinations and the removal of any Shields that are found.
The announcement came more than a decade after the Richmond pharmaceutical firm heeded a Food and Drug Administration request and halted domestic sales of the IUD.
E. Claiborne Robins Jr., the firm's president and chief executive officer, called the program "unprecedented in American medical history." He said in a statement that the company will pay for advertisements on prime-time and daytime television and in the print media urging women who may be using the device to see their physicians -- at company expense -- or make inquiries if they are unsure which IUD they are wearing.
U.S. wearers of the Shield have filed more than 11,300 lawsuits and claims blaming the device for life-threatening pelvic infections, loss of fertility and other injuries; 3,768 cases were pending as of Sept. 30.
By April 1976, when the FDA stopped counting, it knew of 15 Shield users in this country who had suffered fatal infected miscarriages. In the last three years, at least three non-pregnant wearers have died of pelvic infection and other maladies -- one eight months ago in Los Angeles, another in April 1983 in New Orleans and a third in November 1981 in Los Angeles.
Physicians inserted Shields in an estimated 2.2 million U.S. women in a 3 1/2-year span that ended in mid-1974. The company and the FDA say they do not know how many women still use the Shield; estimates vary widely.
The National Women's Health Network, a Washington-based nonprofit organization that petitioned the FDA 18 months ago to recall the device, suggested that 50,000 to 100,000 women could be involved. Bradley Post, a leading Shield plaintiffs' lawyer in Wichita, Kan., said he viewed that estimate as "a little high," but added that the number is "certainly in the thousands." Others offer both higher and lower figures.
About 1.7 million Shields were distributed in 79 foreign countries, including Canada. Robins continued to sell the IUD in some of these countries for up to nine months after suspending U.S. sales in mid-1974. Robins said yesterday that it is notifying other countries of its U.S. program and "will be guided by each government's view as to what specific actions should be taken . . . . "
The program grew "out of concern for the health" of remaining Shield wearers and out of "unwarranted" adverse publicity, Claiborne Robins said. "Our company has never viewed the Dalkon Shield as posing any risk higher than that associated with other IUDs," he added. Because current wearers will have had the device for at least a decade, "it is time, from a medical standpoint, to see that all Dalkon Shields are removed," he said.
Robins' statement and a company "Dear Doctor" letter mailed Friday to 185,000 physicians and clinics ignored plaintiffs' charges that, with prolonged use, the Shield's unique, sheathed, multifilamented nylon "tail string" deteriorates, allowing vaginal bacteria between the filaments and then into the normally sterile womb, where the device is implanted.
All other IUDs use deterioration-resistant plastic monofilaments that bacteria cannot enter.
Yesterday's action by Robins produced an unusual and bitter statement from Miles W. Lord, chief U.S. District Court judge for Minnesota, who earlier this year excoriated Claiborne Robins and two other top company executives in a courtroom speech in which he pleaded with them to seek out every woman wearing a Shield and to recall this "deadly depth charge in their wombs, ready to explode at any time."
The company, in a complaint pending in the 8th U.S. Circuit Court of Appeals, accused Lord of misconduct.
Observing that "14 years too late is better than never," Lord said yesterday that "it was not the power of the courts, but rather the power of the media that caused" the company to find it "in its interest to issue a carefully worded statement that avoids admitting wrongdoing but serves to help it in future litigations."
"On its surface it may appear that this company has belatedly developed a concern for the women whose health it purports to protect," Lord said. "I fear, however, that the eyes of the company executives have not lifted above the bottom line. Their action . . . is an attempt to save them money in the future."
Lord said that if his February recall plea had helped lead the company officers to the new program, "it was well worth the anxiety, discomfort or inconvenience" that the misconduct complaint "may have caused me or my family." He added, "I will await the apology" of the three executives.
The first appeal for a Shield recall was made to the company by attorney Post in 1975. When he got no response, he and another lawyer, Aaron M. Levine of Washington, appealed to the FDA in 1977 to order a recall. The agency declined.
In April 1983, the National Women's Health Network filed a still-pending petition for an FDA recall. Shortly afterward, the FDA urged wearers to have the IUD removed. Yesterday, Sybil Shainwald, head of the network, charged that the agency and the company "could have averted countless tragedies if they had acted when they knew that the product was defective."
Post pointed out that in many countries there has been no publicity to warn Shield wearers, and he faulted the company for not saying that the string was why many users had suffered serious pelvic infections.