Is it negligent to use Cytotec (misoprostol) for labor induction without adequate patient consent?

Negligence is the “failure to take proper care of doing something”. It is one of several parts constituting malpractice. To commit malpractice four legal elements must be proven: (1) a professional duty owed to the patient; (2) breach of such duty (eg negligence); (3) injury caused by the breach; and (4) resulting damages.

Items that can potentially constitute negligence on behalf of a hospital or doctor include:

  • Potentially dangerous drugs are given without first confirming that the mother was properly informed about all the risks (no informed consent).
  • There are no detailed protocols (instructions) in place for the drugs’ proper use.
  • Physicians and nurses are not properly trained to recognize and treat complications (eg excessive uterine activity and fetal heart rate changes when inducing labor).

Cytotec or misoprostol is a medication approved for treating stomach ulcers. Though it is not FDA approved for that purpose, obstetricians and hospitals often use Cytotec for inducing labor. There are potentially serious problems associated with Cytotec during pregnancy. When given early in pregnancy, Cytotec could act as an “abortifacient”, a drug to induce an abortion or termination of the pregnancy. Later in pregnancy Cytotec can induce contractions of the uterus and labor. Like with many other medications during pregnancy, all patients given Cytotec must be thoroughly informed about its benefits and risks (informed consent).

From the FDA: This Patient Information Sheet is for pregnant women who may receive misoprostol to soften their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. These uses are not approved by the FDA. No company has sent the FDA scientific proof that misoprostol is safe and effective for these uses. Read More….

From the FDA: Cytotec (misoprostol) Prescribing Information: “A major adverse effect of the obstetrical use of Cytotec is hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported.” Read More….

From the NIH website: “The cost in terms of human life and the resulting permanent damage that Cytotec can do cannot be measured, although the number of deaths represented on the Safe Motherhood Quilt Project, coordinated by Ina May Gaskin (2008), continues to rise.” Read More….

In Dec. 2001, Tatia Oden French entered a well-known and well-respected hospital to deliver her first child. She was 32 years old, in perfect health, and looking forward to a natural childbirth, without any interventions or drugs. There were no problems during the pregnancy. According to her doctor’s calculations, she was a little under 2 weeks overdue. She was given the drug Cytotec to induce her labor. Cytotec, also known as Misoprostol, is a drug manufactured to treat ulcers. It is NOT approved by the FDA, or the drug company, to induce labor. Ten hours after being administered Cytotec, Tatia suffered hyper-stimulation of her uterus, an amniotic fluid embolism (AFE) was released, an emergency C-Section was performed because the baby was also in distress. Both Tatia and her baby Zorah died in the operating room. Read More….

Cytotec: Dangerous experiment or panacea? Read More….

“$9.566 Million for Improper use of Cytotec to Induce Labor Leads to Brain Injury.” Read More….

“$70 million Birth Injury Case – Largest Arbitration Award in U.S. History (Cytotec Brain Injury).” Read More….

“Cerebral palsy after birth injury during VBAC.” Read More….

Misoprostol (Cytotec) can cause birth injuries or maternal death. Read More.

Malpractice suit for Cytotec. Read More….

“As a result of 9.5 hours of Cytotec-induced excessive contractions, the baby was born with severe hypoxic-ischemic encephalopathy and multiple brain bleeds, resulting in intellectual disability, cerebral palsy, and a need for 24-hour around-the-clock care.
Patients should be fully informed of the risks and benefits of any medications prescribed to them, as well as any treatment options they are offered. Patients can ask questions regarding the specific benefits and potential drawbacks of any interventions their medical staff suggest, but – ultimately – it is the doctor’s responsibility to notify their patients about potential risks.” Read More….

Adverse Events Following Misoprostol Induction of Labor (A list of 16 cases). Read More….

Klonaris-Robinson was 38 and a half weeks pregnant with her second child when she was given Cytotec, a medication used to induce labor. At first, everything seemed normal as she started to have contractions. About 10 hours later she was given a second dose. Her contractions were coming much faster and now she had a sharp pain in her left side. “It went on and on, and I just kept saying, ‘Please, this pain doesn’t feel right.’”
“Two hours later, they finally listened and it was too late,” she said.
Her uterus had hyper-stimulated and tore top to bottom, front and the back. She was bleeding out and her daughter Meah was dead.

The death of Sofia Figus three days after she was born was caused by a lack of oxygen to the brain during a difficult birth. Her mother Anne Willicombe, 39, a university lecturer, was 12 days overdue when she was prescribed Misoprostol – a drug widely used in abortion clinics – to bring on contractions. Read More….

Are mothers properly informed?

If there are “Cytotec attorneys” then there must be a market. Read More….

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