The Dalkon Shield was a faulty contraceptive, a stingray shaped intra-uterine device (IUD) sold by the A H Robins Corporation of Virginia.
Robins began marketing the Shield in the early 1970s and sold over two million units worldwide. Over 100,000 Australian women were fitted with the device.
The Shield’s greatest problem was that its knotted string tail often resulted in infection. The plastic head of the device also cracked within a few years of insertion, making for more ready penetration of bacteria. The shield was linked to a condition called Pelvic Inflammatory Disease (PID), which is a painful infection often resulting in infertility or requiring a hysterectomy.
Infections generated by the Shield were held responsible for spontaneous abortions and associated septicaemia. The spiky edges of the Shield could also perforate the uterine wall and there were reports of the device migrating to the intestinal and abdominal cavities and causing horrific damage. Some women fitted with Dalkon Shields died of these conditions.
Reports of these injuries began emerging in 1972, not long after the device was first placed on the market.
Documents obtained from Robins show that the company was aware of these problems, but it continued to publicly defend the Shield as a safe contraceptive device.
In 1973, the US Food and Drug Administration began investigating the device and Robins agreed to temporarily suspend its sale in the US.
The FDA Committee reported that there was no conclusive proof of any fault in the device. However, five members of the Committee strongly dissented and called for its removal from the market. The FDA did recommend that the Shield’s tail be changed and that a patient register be maintained to allow monitoring of the Shield’s performance. Robins saw the decision as a vindication, but elected not to re-market the device in the US because of continuing adverse publicity.
Nevertheless, Robins continued to heavily promote the device in the rest of the world. Company memos obtained by PIAC show that it informed its Australian sales representatives of FDA bulletins and reports of the criticisms made in the US, but advised that this information ‘was not to be used in doctor discussions’.
The Dalkon Shield continued to be sold in Australia after its withdrawal from the US market and there were reports of doctors fitting the device as late as 1980, contrary to the advice that even Robins was then giving. The Australian Department of Health knew of the problems reported in the US but it took no action against the device. Family Planning agencies were also aware of the serious doubts about the device’s safety but elected to continue fitting it.
Over 15,000 personal injury claims were filed in the US. After some initial wins by complainants, including a judgment in 1975 for $6.5 million, Robins successfully defended actions for a number of years, mainly because the complainants had difficulty proving causation.
PIAC’s involvement with the Shield dates from 1983. The Leichhardt Women’s Health Service, then fighting an uphill battle to publicise the ill effects of the device, requested PIAC’s assistance in giving legal advice.
PIAC staff helped publicise the US litigation and put individual women in contact with US lawyers. In late 1984, the TV program 60 Minutes aired a story about the Shield, and included an interview with Angela Nanson, who had just started work at PIAC.
PIAC was deluged with inquiries from women who had suffered injury and again assisted these women to contact US lawyers.
PIAC also saw its role as publicising the general issues of contraceptive safety.
In January 1985, PIAC organized a seminar on these issues in Sydney, which was attended by over 300 people. Amongst the speakers were US attorneys handling Dalkon Shield litigation and Emmilina Quintillan, a Philippines lawyer who spoke of the third world dumping of unsafe products. The general conclusion of the conference was that the pre-market testing of contraceptives should be much more stringent, and that any potential for risk was unacceptable in products administered to otherwise healthy people.
PIAC’s casework took off after Robins filed for bankruptcy under Chapter 11 of the US Bankruptcy Code in 1985, saying that the outstanding Shield litigation could financially swamp the company. Under these provisions, the continued existence of the company was assured by consolidating all present liabilities, including future actions arising out of past conduct of the company, and paying them out of a fund set aside by the company.
Robins’ profits were still topping $100 million per year when it filed for bankruptcy. Many victims and their lawyers were outraged by the company’s actions and argued that the bankruptcy proceedings were a device to avoid paying as much in damages as the victims deserved.
The US Court set a deadline of 30 April 1986 for foreigners to lodge claims and directed that the company spend $1 million worldwide on advertising that deadline. Both the time and the money were patently inadequate.
PIAC, and in particular Angela Nanson, undertook a heavy schedule of media appearances in an endeavour to inform women of the need to file claims before this ‘once-and-for-all’ deadline. PIAC undertook to file claims on their behalf.
The Legal Aid Commission of NSW provided considerable assistance to PIAC, with grants totalling $140,000. This money enabled PIAC to hire four lawyers and two support staff and to open a sub-office, known affectionately as ‘Dalkon House’.
PIAC also decided that its clients needed representation in the US. Peter Cashman and Angela Nanson travelled to the US on two occasions during 1986 to follow up these matters. The trips proved very useful. Mr Cashman and Ms Nanson met with the counsel assisting the bankruptcy court and the presiding judge to express concern about the treatment of foreign claimants. As a result, a lawyer in the counsel’s office was assigned to deal with foreign claims.
The trips also confirmed that the continued representation of the claimants would require a huge input of resources. PIAC decided that the interests of its clients would be best met by placing the files with a firm of private solicitors who had the financial resources to carry the litigation during the years until the payout of claims. Slater and Gordon were recommended to PIAC’s clients, most of whom agreed to transfer.
Over 1,700 claims were filed before the due date by PIAC alone, with the Australia-wide figure being close to 6,000, the largest of any foreign country. Much of this can be attributed to PIAC’s efforts and especially to the work of Angela Nanson.