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 passing and 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, a large Melbourne
personal injury firm, 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.
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Image: Recall the Dalkon Shield c.1980, Marla Guppy | Women’s Warehouse Screenprinters. Gift of the Canberra Contemporary
Art Space 1993 to National Gallery of Australia. Accession No: NGA 93.1693