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Dalkon Shield was the name of a contraceptive intrauterine device (IUD) introduced by the Dalkon Corporation. Severe harm caused to women by this product led to numerous lawsuits in which juries awarded millions of dollars in compensatory and punitive damages, and then a very famous class action lawsuit, which resulted in a settlement providing a 2.5 billion dollar trust.

History

In 1970 the A.H. Robins Company acquired the Dalkon Shield from the Dalkon Corporation, founded by Hugh Davis, M.D. The Dalkon Corporation had only four shareholders: the inventors, Hugh J. Davis, M.D. and Irwin Lerner, their attorney, Robert Cohn, and a practitioner in Defiance, Ohio, Thad J. Earl, M.D. 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.

Only one small study was performed on the Dalkon Shield, solely to determine the device's effectiveness in preventing pregnancy. 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 600 women using the Shield for a full year and found a failure rate of only 1.1%. He did not disclose that he instructed women in the study to use spermicide with the the Shield. He published a scholarly article entitled, "The Shield: a Superior Modern Contraceptive."

Before A.H. Robins purchased rights to the Dalkon Shield, the company was warned by scientists that Davis' research questionable. Ignoring the warnings and cancelling scheduled further study, 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. --><ref="sobol"sobol,richard b. ""The Dalkon Shield Story: a Company Rewarded for its Faulty Product"". Healthfacts.</ref>

After purchasing the Dalkon Shield, Robins hired Hugh Davis as a consultant, and continued to use data from Davis' original studies in books and advertisements long after new data was available. Davis received stock and a percentage of the profits of the A. H. Robins Company, but 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. 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).

Design

Within weeks of the Dalkon purchase by Robins, approximately 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-- one in the bacteria-laden vagina, the other in the sterile uterus -- the wicking propensities of the Dalkon Shield tailstring portended disease. Despite the warning, Robins moved ahead with production and sales, and mailed 199,000 copies of "The Shield: a Superior Modern Contraceptive," to doctors.

National direct-to-consumer marketing began in January of 1971, and Robins promoted the device as safe and effective. False 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 pelvic inflammatory disease, spontaneous or septic abortion, ectopic pregnancy, or infertility. The only warning given -- "sepsis may result from unclean technique" -- implied only 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. 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, comprised 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.

Medical literature cited a rare 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. 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. The Robins Company "voluntarily" withdrew the product from the market in June 1974 under pressure from the FDA.

About 235,000 American women suffered injuries, most of which involved life-threatening pelvic infections. Many cases were severe enough to cause hospitalization, permanent infertility, complete hysterectomy, and/or chronic pelvic pain. There were over 200 documented cases of spontaneous septic abortion. Ultimately, 33 women died of complications associated with the Dalkon Shield--septic abortions or PID.

Dalkon Dumped in Third World

Soon after thousands of reports of serious harm to women began to pour into the US in 1972, A.H. Robins began to look elsewhere to sell the Shield, and made a deal with the US Government, through the population control organization US AID to "dump" millions of unsterilized Dalkon Shields in third world countries. http://www.motherjones.com/news/feature/1979/11/ehrenreich.html {{cite web}}: Empty citation (help) MotherJones The Charge: Gynocide By Barbara Ehrenreich, Mark Dowie and Stephen Minkin

November/December 1979 Issue

Aftermath

More than 300,000 lawsuits were filed against the A.H. Robins Company in the aftermath of the Dalkon Shield horror--the largest tort liability case since asbestos. The cost of litigation and settlements (estimated at billions of dollars) led the company to file for Chapter 11 bankruptcy protection in 1985, in order to preserve almost a billion dollars in profits for shareholders, from victims' claims. Chapter 11 bankruptcy is "debt reorganization," not liquidation of the company. Half of the Dalkon Shield victims were precluded from filing claims against Robins by their bankruptcy maneuver, and Robins was able to sell the company for a hefty profit to American Home Products, which is now Wyeth. American Home Products took over repsonsibility for the liabilty, and used a vast legal team to contest victims' claims, usually by making degrading personal attacks on their sexual history in the hopes of intimidating them from requesting claims. After the announcement of Robins' chapter 11 bankruptcy filing, the stock value of the company quadrupled, directly benefiting the Robins' family, who were major shareholders. Due to intentional delays by American Home Products' attorneys, 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 award to claimants in the class action was $725.00. The average claimant represented by a lawyer got about $21,000. The largest payment was more than $2.2 million to the family of a severely deformed girl born after being conceived while her mother was using a Dalkon Shield.

After the Dalkon Shield, in 1976, the U. S. Food and Drug Administration required testing and approval of medical devices. Prior to 1976, no safety testing was required of "devices." No significant reform regarding corporate product liability to protect consumers had been enacted--but large drug companies in the US like Wyeth have spent millions of dollars lobbying for "tort reform" which would prevent them from being sued for defective products and drugs.

Books About the Dalkon Shield

BENDING THE LAW: THE STORY OF THE DALKON SHIELD BANKRUPTCY by Richard B. Sobol. Chicago: The University of Chicago Press, 1991. 408 pp. Cloth $29.95.

Bacigal, Ronald J. 1990. THE LIMITS OF LITIGATION: THE DALKON SHIELD CONTROVERSY. Durham, N.C.: Carolina Academic Press.

Morton Mintz 1985. AT ANY COST: CORPORATE GREED, WOMEN, AND THE DALKON SHIELD. New York: Pantheon.

Perry, Susan and Jim Dawson. 1985. NIGHTMARE: WOMEN AND THE DALKON SHIELD. New York: Macmillan.

Stern, Gerald M. 1976. THE BUFFALO CREEK DISASTER. New York: Random House.

Hicks, Karen M. SURVIVING THE DALKON SHIELD IUD : WOMEN V. THE PHARMACEUTICAL INDUSTRY. New York: Teachers College Press, 1994.

Hawkins, Mary E 1997: UNSHIELDED: THE HUMAN COST OF THE DALKON SHIELD. Toronto: University of Toronto Press.

Grant, Nicole J. THE SELLING OF CONTRACEPTION : THE DALKON SHIELD CASE, SEXUALITY, and WOMEN'S AUTONOMY. Columbus: Ohio State University Press, 1992.

Trivia

A sketch on the TV show Saturday Night Live included a fake commercial featuring then-castmembers Robert Downey, Jr. and Joan Cusack in which Dalkon Shields were used as trout lures.

The Harvard Law School Library has acquired a voluminous collection of papers related to the Dalkon Shield class action.

References

• Jim Szaller (1999). "One Lawyer's 25 Year Journey: The Dalkon Shield Saga" (Reprint). Ohio Trial. 9 (4). Retrieved 2006-8-17. {{cite journal}}: Check date values in: |accessdate= (help); Unknown parameter |month= ignored (help) - Chronicles legal team of Brown & Szaller's involvement in the Dalkon Shield Litigation.
• Richard B. Sobol (May, 1996). "The Dalkon Shield story: a company rewarded for its faulty product - A.H. Robins Company Inc. lawsuit". Healthfacts. Retrieved 2006-8-17. {{cite web}}: Check date values in: |accessdate= and |date= (help) Sourced from: Bending the Law, Richard B. Sobol, University of Chicago Press, 1991
• "Actinomycosis of the Endometrium". A Tumor Atlas Information, Resources, Images and Forms. Frontiers in Bioscience. - Photo of Dalkon Shield in hysterectomy specimen
• Speroff L, Glass RH, Kase NG. (1999). Clinical Gynecological Endocrinology and Infertility (6th Edition ed.). Lippincott, Williams & Wilkins. pp. p976. {{cite book}}: |edition= has extra text (help); |pages= has extra text (help)CS1 maint: multiple names: authors list (link)
• Meryl Gordon (February 20, 1999). "A Cash Settlement, But No Apology". the New York Times. Retrieved 2006-08-17.
• "The Charge: Gynocide" by Barbara Ehrenreich, for Mother Jones
• "The Dalkon Shield" http://www1.umn.edu/scitech/dalkfina.htm
• "What Standards for Corporate Crime?" http://query.nytimes.com/gst/fullpage.html?res=9A0DE0D8103BF931A25752C0A960948260
• press release from Ohio State University Press for THE SELLING OF CONTRACEPTION http://www.ohiostatepress.org/index.htm?/books/book%20pages/grant%20selling.htm
• "Fatal Contraption: The Horrifying Story of the Dalkon Shield"http://www.findarticles.com/p/articles/mi_m1264/is_n3_v20/ai_7709447
• "The Dalkon Shield: A Deadly Product From A.H. Robins" http://multinationalmonitor.org/hyper/issues/1987/04/ahrobins.html
• "Women's response to reproductive trauma secondary to contraceptive iatrogenesis: A phenomenological approach to the Dalkon Shield case" http://repository.upenn.edu/dissertations/AAI9427493/
• "Robins Plan Approved"http://query.nytimes.com/gst/fullpage.html?res=950DE4DA1430F934A25755C0A96F948260
• "A Crime Against Women: A.H. Robins and the Dalkon Shield" (Includes full text of presiding judge Miles Lord's statement to Clairbone Robins, et al, at bottom.) http://multinationalmonitor.org/hyper/issues/1986/0115/index.html
• "Healthy Skepticism" http://www.healthyskepticism.org/library/ref.php?id=3727
• "How to Reward The Criminals". The Nation. Shereff, Ruth. 248 (0006). February 13, 1989.

• Intrauterine contraception