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Pregnant Patients Did Not Consent to Drug Trials


Wagga Wagga Base Hospital doctors may not have obtained the official informed consent of all the mothers it tested a drug on. The doctors alleged went ahead without informing the watchdog company, Therapeutic Goods Administration.

A Birth Injury Lawyer based in Manhattan, NY, revealed that hundreds of women were given the stomach ulcer drug misoprostol to induce labor at full term, despite warnings by the drug’s manufacturer as early as 2000.

Recently, the family of a six-year-old boy born with cerebral palsy successfully sued the hospital, which has admitted negligence in the drug trial.

At the hearing, it was revealed that the boy’s mother suffered hyper stimulation of the uterus – a serious complication associated with misoprostol.

As a result of this suit and the amount of evidence, as many as 12 of the250 other women who were part of the trial are considering legal action against the hospital, which would mean that millions of dollars in compensation claims. The 12 who are considering action had not signed any consent form for the drug trial.

Those who did sign forms are determining whether they were given adequate information about the drug. Some of these ladies believe that had no choice but to allow the use of the drug. Doctors and Lawyers in Brooklyn and The Bronx are dealing with these issues on many occasions.

According to a Manhattan Birth Injury Law Specialist, in August of 2000 the manufacturer of misoprostol, Searle, which has since been acquired by Pfizer, warned against its use in pregnancy because it could cause unwanted abortion and birth defects. It also reported that the effects on the later growth and development of children had not been established.

A retired obstetrician said that it would be enormously difficult to tell whether a child’s cerebral palsy had been caused by the drug. He insisted that when used properly, it was highly unlikely it could have been a contributing factor.

The vice-chairman of the National Association of Specialist Obstetricians and Gynecologists, however, said that misoprostol was still a controversial drug because of the rare risk of adverse events.

Even with the possible great advantages, these women should have been more adequately given information to clearly decide on whether to take part in the clinical trial.

NYC Birth Injury Attorneys are available to support your case should you have been the victim of a forcible clinical trial. Contact an Attorney in New York who specializes in Birth Injuries to go over the details of your litigation needs.

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