The patient has the right to:
- control his own body, and
- refuse any form of care that the patient considers to be unacceptably dangerous.
It is up to the patient, NOT THE DOCTOR, to make the final decision as to what risk to accept, and what risks to refuse.
It is the doctor's duty to explain, in words that are understandable to the patient, all the facts that would be explained by a reasonable medical practitioner, so that when the patient does, in fact, consent, that consent is given with an awareness of:
- the patient's existing physical condition;
- the purposes and advantages of the operation, procedure, or medication;
- the reasonably foreseeable risks to the patient's health or life which the operation, procedure, or medication may impose;
- the risks involved to the patient if there is no operation, procedure, or use of medication, and
- the available alternatives and the risks and advantages of those alternatives.
Mark R. Bower, an experienced malpractice lawyer who handles Cytotec cases, says:
"It is impossible for a woman to give a true informed consent to the use of Cytotec to induce labor. A 'reasonable medical practitioner' would have to inform the mother that Cytotec manufacturer writes on the package insert that Cytotec should not be used to induce labor, and it is absolutely contraindicated for any use in a pregnant woman. Searle (Cytotec's manufacturer) says:
"CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY."
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 even fetal and maternal death have been reported.
In fact, Searle considers its product to be so dangerous, that it sent a "Dear Doctor" letter to every doctor in the country, warning them NOT TO GIVE CYTOTEC to their pregnant patients! (Searle did this to insulate itself from liability. If a woman has problems due to Cytotec, you can't go back to the manufacturer and sue them. The manufacturer said: "Don't do it!"
If a doctor actually gave a patient this information - which is right there on the paper that is in every package of Cytotec - no woman would EVER consent to taking this drug. The only reason women can be given Cytotec, is that doctors routinely WITHHOLD this information. Then, when a disaster occurs, the doctors express shock and amazement, and claim they had no idea this could happen. But the warning that it can happen is published and printed with each bottle of Cytotec."
Thus, Mr. Bower concludes that any woman whose childbirth resulted in a Cytotec disaster (and her child), have a good case of malpractice for lack of informed consent.
To learn more about issues of informed consent and Cytotec, read these articles from the 2004 Fall issue of the LiNC, the newsletter of the Pittsburgh Chapter of the American Association of Legal Nurse Consultants, which features Cytotec. Two nurse midwives wrote about clinical considerations, a nurse attorney/ hospital risk manager wrote about Informed Consent from her perspective, and Mark Bower wrote about "Cytotec and (Lack of) Informed Consent."
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