The Dalkon Shield was a contraceptive intrauterine device (IUD) developed by the Dalkon Corporation and marketed by the A.H. Robins Company. The Dalkon Shield was found to cause severe injury to a disproportionately large percentage of its users, which eventually led to numerous lawsuits in which juries awarded millions of dollars in compensatory and punitive damages.
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In 1970 the A.H. Robins Company acquired the Dalkon Shield from the Dalkon Corporation, founded by Hugh J. Davis, M.D. The Dalkon Corporation had only four shareholders: the inventors Davis and Irwin Lerner, their attorney Robert Cohn, and Thad J. Earl, M.D., a medical practitioner in Defiance, Ohio. In 1971, Dalkon Shields went to the market, beginning in the United States and Puerto Rico, spearheaded by a large marketing campaign. At its peak, about 2.8 million women used the Dalkon Shield in the U.S. The aggressive marketing and defense of the Dalkon Shield intrauterine device—despite the manufacturer's knowledge of safety problems—resulted in a huge scandal.
According to a May 1996 article in the newsletter HealthFacts:[1]
Only one small study was performed on the Dalkon Shield, solely to determine the device's effectiveness in preventing pregnancy. To make matters worse, the study's chief investigator never revealed his conflict of interest. As a developer of the Dalkon Shield, Hugh Davis, M.D., a faculty member of the Johns Hopkins Medical School, was entitled to a percentage of the profits on its sales. He claimed to have studied 640 women using the Shield for a full year and found a failure rate of only 1.1%.
Before A.H. Robins purchased rights to the Dalkon Shield, the company was warned by scientists that Davis' research was full of holes. Ignoring the warnings, Robins marketed the Shield's design as a technological breakthrough, which would produce a lower rate of infection and expulsion than other intrauterine devices. Both claims were later proven false.
According to a 1997 ethics group project paper by four students in a University of Minnesota undergraduate History of Science course:[2]
A. H. Robins Company continued to use data from Davis' original studies in books and advertisements long after new data that put the Dalkon Shield in a more unfavorable light were available; while Davis received stock and a percentage of the profits of the A. H. Robins Company, his financial interests in the Dalkon Shield were never mentioned in their promotional information nor his numerous articles, books, and studies that supported the Dalkon Shield. The problems generated by the bias of researchers evaluating a product, from whose sales they would benefit were starkly apparent in Davis' work. During cross-examination in a court hearing, Davis admitted that there was 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" (Mintz, 176).
He did not disclose that he instructed women in the study to use spermicide with the Shield. He published a scholarly article entitled, "The Shield: a Superior Modern Contraceptive."
According to Ohio personal injury lawyer Jim Szaller:[3]
On June 12, 1970, Robins purchased the Dalkon Shield from the Dalkon Corporation. (fn. 13) Within weeks of the purchase, some 30 high-ranking Robins officials, including E. Claiborne Robins, Sr., were informed in a memorandum stamped "confidential" of the Dalkon Shield tailstring's "tendency" to wick. The vagina is a wet cavity, normally inhabited by pathogenic bacteria. The uterus, on the other hand, is a sterile organ. If bacteria by some means gain entrance to the uterus, pelvic infection results. The infection can spread from the uterus to the fallopian tubes and ovaries, causing pelvic inflammatory disease (PID). PID, often evidenced by scars and adhesions on and around the pelvic organs, can cause occlusion of the fallopian tubes, resulting in ectopic pregnancies or sterility. Because the string was open at both ends (fn. 14) -- one in the bacteria-laden vagina, the other in the sterile uterus -- the wicking propensities of the Dalkon Shield tailstring portended disease. Of course, that didn't dampen Robins' enthusiasm, and irrespective of the warning it continued to march hastily toward production and sale.
National marketing began in January 1971, and Robins aggressively promoted the device as safe and effective. Insupportable, laudable claims were made while contraindications, side effects and cautions, contained in fine print on the next to last page of the "filecard" (the official labeling which accompanied the product) were seldom repeated in advertisements, even in diluted form. No warning was made in any promotional materials that the Dalkon Shield could cause widespread fulminating pelvic inflammatory disease, spontaneous or septic abortion, ectopic pregnancy, or infertility. The only warning given -- "sepsis may result from unclean technique" -- implied the treating physician's conduct, rather than the product, could harm the user.
Almost immediately after marketing began, Robins received complaints of severe pelvic infection. The tailstring was beginning to take its toll on users. Bacteria wicked from the vagina to the uterus was resulting in pelvic infection that caused PID, which in turn resulted in ectopic pregnancies and, for some, infertility. The longer the device remained in the body, the more bacteria could potentially enter the uterus, for the wicking process persisted. Compounding the situation was that the outer sheath of the Dalkon Shield tailstring, made of Nylon-6, underwent hydrolysis in the body. Wherever it disintegrated, holes in the sheath were created for bacteria to enter and exit. Finally, "fins" surrounding the body of the device dug into and often became embedded in the endometrium (the inner layer of the uterus), thus promoting the infectious process since the traumatized tissue was especially susceptible to bacteria. There was eventually reported in the medical literature (fn. 15) a unique and dire medical condition being suffered by some women who conceived while the Dalkon Shield was in situ. The condition was known as "septic spontaneous abortion," and occurred when the Dalkon Shield tailstring, filled with bacteria, was pulled upward as the pregnant uterus expanded. The bacteria attacked the placenta and the woman, ending in death of the fetus and, in some cases, the woman. Prior to reports of septic abortion in wearers of the Dalkon Shield, physicians had only seen this life-threatening medical condition in situations of criminal abortion with subsequent serious pelvic infection. When it was first reported that some women wearing the Dalkon Shield had occasioned septic spontaneous abortions, no one, including Robins, offered any explanation of how and why it occurred in Dalkon Shield wearers. Indeed, no one but Robins could have offered any explanation, because Robins had never disclosed to anyone that the tailstring was multifilament, and that it wicked. A physician in New York, Howard J. Tatum, M.D., Ph.D., was the first person who, outside of Robins, learned that the Dalkon Shield tailstring was multifilament, and that it had a propensity to wick. It was he who, in 1975, performed simple laboratory tests to evidence wicking and explain how the Dalkon Shield was the causative factor in septic spontaneous abortion. His results were published in the medical literature in January and February 1975, (fn. 16) but the information came too late to be of help to women considering which IUD to use. The Robins Company had "voluntarily" withdrawn the product from the market in June 1974 under pressure from the FDA.
More than 300,000 lawsuits were filed against the A.H. Robins Company – the largest tort liability case since asbestos, and the federal judge, Miles W. Lord, made history with the judgments, personal liabilities and public rebukes of the company heads.[4] The cost of litigation and settlements (estimated at billions of dollars) led the company to file for Chapter 11 bankruptcy protection in 1985. As a result, the stock value of the company quadrupled, and Robins was able to sell the company for a hefty profit to American Home Products, (now Wyeth).
American Home Products took over responsibility for the liability, and contested victims' claims for the next 15 years. It is estimated that the interest on Dalkon Shield profits they collected during the case earned more than payments to the victims, 15 years later. The average claimant represented by a lawyer got $21,000. The largest single payment was more than $2.2 million, to the family of a severely deformed girl who was conceived while her mother was using a Dalkon Shield.
In 1976, the Medical Device Amendments to the Food, Drug, and Cosmetic Act mandated the U. S. Food and Drug Administration for the first time began to require testing and approval of "medical devices", including IUDs.
The Dalkon Shield became infamous for its serious design flaw: a porous, multifilament string up which bacteria could travel into the uterus of users, leading to sepsis, injury, miscarriage, and death. Modern Intrauterine devices (IUDs) use monofilament strings which do not pose this grave risk to users.
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