Dalkon Shield
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Dalkon Shield was the name of a contraceptive intrauterine device (IUD) introduced by the Dalkon Corporation. Accusations of malfunction of this product led to a very famous lawsuit.
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History
The first modern IUDs were produced by Dr. Jack Lippes in the 1960s. They were made of plastic with an attached monofilament plastic tail. This tail had two purposes: By inserting a finger into the vagina and feeling the tail, a woman could be assured the IUD was in place, and it could be removed by a medical doctor when desired by the patient. Popular IUDs of the era include the Lippes Loop and the Saf-T-Coil.
In 1970 the A.H.Robins Company acquired the Dalkon Shield product from the Dalkon Corporation. In 1971, Dalkon Shields went to the market 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.
Design
Unlike the other products, the Dalkon Shield came with a multifilament rather than a monofilament string that reached from the device in the uterine cavity, through the cervix into the vagina.
Soon after the product came into the market, the A.H.Robins Company began receiving complains of sick clients, who experienced pelvic inflammatory disease and tubal infertility. Some patients suffered ectopic pregnancies (indicating that the Dalkon Shield was not 100% effective against pregnancy). Other women underwent septic abortions and 12 died. In 1975 allegations that these complications were the results of sexual behavior were silenced when Dr. Howard J. Tatum showed that the multifilament of the Dalkon Shield acted as a wick facilitating the entry of bacteria into the uterus. In the same year the product was taken off the market. It took another five years for a call to remove all Dalkon Shields from women who still carried them.
Lawsuits
The A.H.Robins Company tried to blame its users for the malfunction of the contraceptive. Their defense became weaker and weaker as more cases appeared nationwide. Numerous lawsuits were filed in Minnesota and Ohio.
In 1985, losing money from litigation, the Robins Company filed for Chapter 11 protection. There were over 300,000 claims filed in bankruptcy court.
In the time since, most Dalkon Shield users have won their lawsuits against the A.H.Robins Company. The awards amount to billions of dollars.
Aftermath
The case dramatically led to reduced sales of all IUDs and increased awareness of toxic shock syndrome and pelvic inflammatory disease. The decline in the use of IUDs was especially pronounced in the USA. The Dalkon Shield experience led the American public to believe that all IUDs were dangerous. Companies found it expensive to defend other IUDs in the court system even if they had undergone extensive clinical trials. For some time no manufacturer made IUDs available.
Since 1988, newer designs of the IUD have become available in the USA and have not been found to have increased risks as seen with the Dalkon Shield.
References
- Story of Trial Lawyer [1] (http://lawandhelp.com/oatl.htm)
- Speroff L, Glass RH, Kase NG. Clinical Gynecological Endocrinology and Infertility. 6th Edition, Lippincott, Williams & Wilkins, 1999, page 976.