{"id":4558,"date":"2020-05-18T00:00:00","date_gmt":"2020-05-18T00:00:00","guid":{"rendered":""},"modified":"2025-07-30T08:24:05","modified_gmt":"2025-07-30T08:24:05","slug":"the-dalkon-shield-lawsuit","status":"publish","type":"post","link":"https:\/\/www.ukessays.com\/essays\/law\/the-dalkon-shield-lawsuit.php","title":{"rendered":"The Dalkon Shield Lawsuit"},"content":{"rendered":"

\n\t\t\t\tFacts: <\/u><\/strong>\n\t\t\t<\/p>\n

\n\t\t\t\tThe Dalkon Shield was the most famous Intrauterine Device available in the market between 1970s and 1980s. The 1960s were a time of speedy amendment within the field of birth prevention. The need of the hour was such a contraceptive which would work without the implementation of hormone or hormone-derivative in the device. Following the trend of the required demand Dr. Hugh Davis developed one such IUD which met the requirements of the customers. The Dalkon Shield was originally produced by the Dalkon Corporation which was founded by Davis (DA) alongside his accomplice Lerner (L) and attorney Cohn (KON).[1]<\/sup>\n\t\t\t<\/p>\n

\n\t\t\t\tIn 1971 A.H Robins Company who were producers of the cough medication Robitussin bought the device from Davis and started extensive promoting effort through the U.S out and Puerto Rico.\n\t\t\t<\/p>\n

\n\t\t\t\tIssue:<\/u><\/strong>\n\t\t\t<\/p>\n

\n\t\t\t\tThe Dalkon Shield was a plastic made device which had a crab-shaped structure with the claim of preventing uterus from expelling the device. Little amount of Copper was introduced in the device which acted as a Spermicide and hence prevented the sperm from fertilizing the egg. A string which was made of fiber was attached to the device at the base and it helped to remove the device [1]<\/sup>.\n\t\t\t<\/p>\n

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\n\t\t\t\tFig 1. The Dalkon Shield IUD [2]<\/sup>\n\t\t\t<\/p>\n

\n\t\t\t\tThe litigation against Dalkon Shield was that it induced pelvic inflammatory disease (PID) consequently resulting in infertility in women after it was marketed in 1971 by A.H. Robins and Company. The PID was characterized by a severe infection that can lead to damage to the reproductive organs (uterus, fallopian tubules and ovaries) when bacteria enter the uterus through sexual interaction via vagina. Sepsis, infertility or sterility, miscarriage (especially the potentially lethal mid-pregnancy septic abortion), even death within 48 hours of the first flu-like symptoms are the other forms of manifestation of PID.[3]<\/sup>\n\t\t\t<\/p>\n

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\n\t\t\t\t <\/sup>\n\t\t\t<\/p>\n

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\n\t\t\t\tFig 2. The Dalkon Shield tail string infused with bacteria (shown under TEM) [4]<\/sup>\n\t\t\t<\/p>\n

\n\t\t\t\tLegal Standard:<\/u>\n\t\t\t<\/p>\n

\n\t\t\t\tIn the early 1970s when Davis and Irwin started promoting the Dalkon Shield, the device was not subjected to any extensive testing by US Food and Drug Administration as drugs were tested in those days. The US Food Drug and Administration did not regulate medical devices in a stringent manner as drugs in the early 1970s.\n\t\t\t<\/p>\n

\n\t\t\t\tDr. Hugh J. Davis began experimenting with intrauterine devices on both his private Johns Hopkins\u2019 family practice patients and in the Planned Parenthood Clinic of the greater Baltimore area. [1] <\/sup>No animal trial was conducted and hence the research result was not fruitful.\n\t\t\t<\/p>\n

\n\t\t\t\tFlooded with lawsuits, A.H. Robins sought-after bankruptcy protection from legal proceeding in 1985. The Dalkon Shield Claimants Trust was established in 1989, paying out nearly $3 billion by the time it closed Apr 2000. [3]<\/sup>\n\t\t\t<\/p>\n

\n\t\t\t\tAccording to USFDA the identification of an intrauterine device can be done if it follows the following definition:\n\t\t\t<\/p>\n

\n\t\t\t\tDate premarket approval application (PMA) or notice of completion of a product development protocol (PDP) is required.<\/em> A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before August 4, 1986, for any IUD and introducer that was in commercial distribution before May 28, 1976, or that has on or before August 4, 1986, been found to be substantially equivalent to an IUD and introducer that was in commercial distribution before May 28, 1976. Any other IUD and introducer shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution. (CFR – Code of Federal Regulations Title 21) [5]<\/sup>
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\n\t\t\t\tThe historical significance of the Dalkon Shield was that it changed the quality and manufacturing procedure of making of Intrauterine device. In 1974 all the marketed IUDs (approx. 3.6 million units) were withdrawn from the market due to government pressure. Government regulations were made stringent considering the safety and health concerns of the patients specifically the women. 4% of Dalkon Shield users were injured due to the device related complication and 3% of the women population were pregnant adding to the agony [6]<\/sup>.\n\t\t\t<\/p>\n

\n\t\t\t\tAny successful study requires a long-time trial on enough participants which will accumulate enough data to support the marketing of any medical device. Dr. Davis although conducted a 12-month study it did not have enough participants, nor the duration of the study was long to be able to determine adverse event rates (in this case pregnancy). So, the IUD was brought to the market with superficial data in hand which was a tremendous threat to the life of the women throughout the country. The average duration of study was from 5-months to 12-months. During this study period a huge number of participating women left the study. They were not even in the worth-noting group of the study which could have provided the data that could have stopped the disaster and life-risk.\n\t\t\t<\/p>\n

\n\t\t\t\tAs a method of assistance Dr. Davis mentioned to use birth control for the first 3-months post insertion but they did not mention in the report which was a major infringement. Many critical information was not mentioned in the reports as provided by Dr. Davis to remove the hindrance of making enormous monetary profit.\n\t\t\t<\/p>\n

\n\t\t\t\tMany of the documents were not presented despite of severe discrepant practice which were followed while conducting the study on the women. The Dalkon Shield claimed themselves as the \u201cSuperior contraception\u201d which had only 1% failure rate.\n\t\t\t<\/p>\n

\n\t\t\t\tLater it came to light that Davis and his co-workers tested the Dalkon Shield from 1968 to 1969 that was manufactured but never brought to the market. The improved Shield which had thinner Shield membrane to facilitate ease of insertion by folding inti half was never tested before they were brought to the market. Hence the flaws remained unidentified.\n\t\t\t<\/p>\n

\n\t\t\t\tMAJOR CHANGES TO DEVICE:<\/u><\/strong>\n\t\t\t<\/p>\n