The Dalkon Shield was manufactured by A.H. Robins Inc. in the early and mid seventies, before it was withdrawn from sale because of the influx of lawsuits against the manufacturers. The case has become the largest tort case in history, with approximately 200,000 claimants worldwide and will not be wound up for years to come. Slater and Gordon is an Australian firm of solicitors with offices in three states. They have the largest Dalkon Shield practice in the world and represent almost 3,000 claimants. One of their most difficult tasks in preparing the cases is the gathering of medical evidence to substantiate claimants' assertions. This entails collecting relevant medical records from across the country and around the world going back almost twenty years for almost 2,000 women. The project has magnified the importance of accurate and complete documentation, kept intact and made accessible. The influence of medical record administrators is highlighted.
PIP: An Australian law firm represented 3000 Dalkon Shield claimants, the largest number in the world. The manufacturer, A.H. Robins, allegedly did not follow adequate methods of production and sterilization of the IUD, tested and evaluated the IUD in a too short time period, and submitted false claims about its efficiency and safety. A.H. Robins knew of the IUD's defects in March 1972 but physicians continued to insert 1 million Dalkon Shields after that date. Alleged side effects included pain, bleeding, uterine perforations, pelvic inflammatory disease (PID), sterility, septic abortion, ectopic pregnancies, and unplanned pregnancy. Many women who had had a Dalkon Shield had to undergo a hysterectomy and subsequent hormone replacement therapy. 17 US women had died by 1976. A.H Robins stopped making the IUD in the US in 1974 but continued to market them in Australia until 1975. It declared itself bankrupt in 1985. The law firm found it difficult to verify claims of injury caused by the IUD. Specifically the problem centered around poor medical records and policies for destruction of these records. The Dalkon Shield Project accentuated the need for accurate and complete documentation which is preserved unaltered and accessible. The project needed to prove not so much what occurred but what did not occur. Some of its clients could not understand why their records had been destroyed by professional people. The project has made recommendations for medical record administrators (MRAs) to retain medical records and facilitate their retrieval. They could be more cooperative in providing clients and law firms who have fulfilled all requirements with medical records. Sometimes they fear that they are violating client confidentiality. MRAs should be familiar with medical record laws and policies but they should use their professional judgment to make an informed and independent decision to direct the dissemination of information.