Babies born disabled in Australian drug trial

Up to 12 mothers who had disabled children after an Australian drug trial could sue a hospital for millions of dollars after it agreed to pay more than $NZ886,000 to a woman whose child was born with cerebral palsy.

The mothers are among 50 worried about their involvement in the trial at Wagga Wagga Base Hospital of the drug misoprostol to induce labour at full term.

The trial has been shrouded in secrecy, but the manufacturer of misoprostol, marketed as Cytotec, had warned as early as 2000 that it should not be used by pregnant women because it could cause unwanted abortion and birth defects such as club foot, missing fingers and brain injury.

Kimberley Reid sued the hospital after her son, Joshua, was born in 2001 with severe cerebral palsy. She said she was told that misoprostol was the only available drug for induction at the time and that she was not informed of the associated risks.

Her lawyer, John Potter, said yesterday that Ms Reid was asked during labour if she wanted to take part in the trial.

The Greater Southern Area Health Service had fought the case for the past three years. It was due to go to a six-week hearing today, but the hospital settled late on Friday after local media published details of it. The area health service has refused to provide any information on the trial, believed to have taken place between 2000 and 2003.

Misoprostol is licensed in Australia for the treatment of gastrointestinal ulcers in men and non-pregnant women and to treat hemorrhage after normal delivery.

It can also be used for low-cost abortions or in the case of a stillbirth, but is not licensed here for those purposes.

Joshua's father, Tony Reid, is also suing, and is expected to settle today. All cases heard in the NSW Supreme Court are for more than $A750,000 ($NZ886,000) in damages.

Mr Potter said the terms of Ms Reid's settlement were confidential and should be finalised in court on Wednesday, but the hospital had already admitted negligence.

"They certainly admitted that they had breached some of their obligation to the plaintiff," Mr Potter said. "Whilst this lady signed a consent form she wasn't informed of the risks involved, so we say there was no informed consent. The allegation is that they said there was no other treatment available at the time."

The Sydney Morning Herald understands the hospital settled for more than what Ms Reid had offered to accept a year ago.

Mr Potter said 50 other mothers who had taken part in the trial had contacted him since the case was made public in July.

"Half-a-dozen of them have children with disabilities, but I can't yet sheet that home to the trial," he said. He was still investigating their cases.

Mr Potter said the manufacturers of the drug warned it should not be used for live births. "It [the warning] was certainly there at the time that the trial was conducted at Wagga Wagga," he said. "The only countries that I can find [using it for live births] are Egypt and Libya."

The Department of Health will not reveal how many women took part in the trial, nor who was responsible for it.

Mr Potter said misoprostol was a fraction of the price of other labour-inducing drugs.

Joshua is the Reids' first child and requires 24-hour care. "It's a very tragic case … it has been devastating," Mr Potter said.

Mr Reid told the Sydney Morning Herald yesterday that it had been a long and painful journey. "It's definitely not celebrations here," he said.

A spokeswoman for the area health service said she could not discuss the trial because the case was still before the courts.

- © Fairfax NZ News