Dalkon Shield

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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.

Contents 1 History 2 Design 3 Dalkon Dumped in Third World 4 Aftermath 4.1 Books About the Dalkon Shield 5 Trivia 6 References 7 Footnotes

[edit] 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 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 was 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.^[1]

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).

[edit] 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 could conceivably cause bacterial infection. 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.

[edit] Dalkon Dumped in Third World

Soon after thousands of reports of serious harm to women began to pour into the US in 1972, some sources claim A.H. Robins began to look elsewhere to sell the Shield. Barbara Ehrenreich, Mark Dowie and Stephen Minkin, in an article published in Mother Jones, describe how the company made a deal with the U.S. Government, to "dump" millions of unsterilized Dalkon Shields in Third World countries through the auspices of the Population Control office of the U.S. Agency for International Development. ^[2]

[edit] Aftermath

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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, who was seen as an activist, made history with the judgements, personal liabilities and public rebukes of the company heads^[3]. 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 liabilty, 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^{[citation needed]}. The average award to claimants in the class action was $725.00, while the average claimant represented by a lawyer got $21,000^{[citation needed]}. 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^{[citation needed]}.

In 1976, the U. S. Food and Drug Administration for the first time began to require testing and approval of "medical devices", including IUDs, by enacting the Medical Device Amendments.

[edit] Books About the Dalkon Shield

• Sobol, Richard B. (1991). Bending The Law: The Story Of The Dalkon Shield Bankruptcy. Chicago: The University of Chicago Press. 
• Bacigal, Ronald J. (1990). The Limits Of Litigation: The Dalkon Shield Controversy. Durham, N.C.: Carolina Academic Press. 
• Mintz, Morton (1985). At Any Cost: Corporate Greed, Women, And The Dalkon Shield. New York: Pantheon. 

  • Abstract: Morton Mintz (January 15, 1986). "A Crime Against Women: A.H. Robins and the Dalkon Shield". Multimedia Monitor Volume 7 (Number 1).  - Includes full text of presiding judge Miles Lord's statement to Clairbone Robins, et al, at bottom.
  • Reviewed and summarised by: Tamar Lewin. "What Standards For Corporate Crime?", New York Times, January 12, 1986.

• Perry, Susan and Jim Dawson (1985). Nightmare: Women And The Dalkon Shield. New York: Macmillan. 
• Stern (1976). The Buffalo Creek Disaster. New York: Random House. 
• Hicks, Karen M. (1994). Surviving The Dalkon Shield Iud : Women v. The Pharmaceutical Industry. New York: Teachers College Press. 
• Hawkins, Mary E. (1997). Unshielded: The Human Cost Of The Dalkon Shield. Toronto: University of Toronto Press. 
• Grant, Nicole J. (1992). The Selling Of Contraception : The Dalkon Shield Case, Sexuality, And Women's Autonomy (Press release), Columbus: Ohio State University Press. ISBN 0-8142-0615-8. 
• Engelmayer, Sheldon D. (1985). Lord's Justice : One Judge's War Against the Infamous Dalkon Shield (New York Times Review), New York: Doubleday Publishing,. ISBN: 0385230516. 

[edit] 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.

An episode of The Simpson TV show referenced the Shield of Dalkon as a treasure in a Dungeons and Dragons style game.

[edit] References

• Jim Szaller (Winter 1999). "One Lawyer's 25 Year Journey: The Dalkon Shield Saga" (Reprint). Ohio Trial 9 (4). Retrieved on 2006-08-17.  - Chronicles legal team of Brown & Szaller's involvement in the Dalkon Shield Litigation.
• 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, Lippincott, Williams & Wilkins, p976. 
• Meryl Gordon. "A Cash Settlement, But No Apology", the New York Times, February 20, 1999. Retrieved on 2006-08-17.
• Roberta Bloss, Joseph Corneli, Chris Moon, Lucas Tomsich (December 8, 1997). The Dalkon Shield. History of Science. University of Minnesota. Retrieved on 2006-08-22. - Student essay
• Michele Kort (July, 1989). Fatal Contraption: The horrifying truth about the Dalkon Shield. Essence.
• Russell Mokhiber (April 1987). "The Dalkon Shield: A Deadly Product from A.H. Robins". Multinational Monitor. 
• Katherine Kaby Anselmi (1994). Women's response to reproductive trauma secondary to contraceptive iatrogenesis: A phenomenological approach to the Dalkon Shield case (Abstract). University of Pennsylvania. - Dissertation
• Associated Press. "Robins Plan Is Approved", Company News, New York Times, June 17, 1989.
• (February 13, 1989) "How to Reward The Criminals". The Nation. Shereff, Ruth 248 (0006). 

[edit] Footnotes

1. ^ Richard B. Sobol (May, 1996). The Dalkon Shield story: a company rewarded for its faulty product - A.H. Robins Company Inc. lawsuit. Healthfacts. Retrieved on 2006-08-17. - Sourced from: Richard B. Sobol (1991). Bending the Law. University of Chicago Press. 
2. ^ Barbara Ehrenreich, Mark Dowie and Stephen Minkin (November/December 1979). The Charge: Gynocide. MotherJones. Retrieved on 2006-08-17.
3. ^ Time Magazine, “A Panel Tries to Judge a Judge”, Jul. 23, 1984, By MICHAEL S. SERRILL