Cytotec® is the trade name given by pharmaceutical company, Searle, for the drug, Misoprostol (prostaglandin E1.) Originally, Searle was the only manufacturer of Cytotec® in the U.S., but its patent expired recently and now there are several generic versions available using the generic name, Misoprostol.
Misoprostol (the generic name for Cytotec) is the main active ingredient in "the morning-after pill" - RU486 - because it induces contractions and aborts the pregnancy.
Cytotec was discovered and marketed as a drug for stomach ulcers. However, when pregnant women with ulcers took the drug, they unexpectedly went into labor! As a result, the drug came into use "off label" (for a purpose other than the manufacturer recommends) and gained great popularity in the obstetrics community because it is cheap, easy to use, and most of the time, it jump-starts labor quickly. Insurance companies love it, because it is inexpensive.
Cytotec® was not tested in the laboratory to determine its safety before doctors starting using "off label" it to induce labor, and its manufacturer recommended against its use in inducing labor.
Instead, it was tested in real life labor and delivery, with unwitting mothers as the guinea pigs.
In some cases, Cytotec® imposes risks that far outweigh the benefits of a delivery that takes place at a convenient time. What's worse, it is often impossible to predict whether or when those risks will be realized. Other medications that are used to induce labor, such as Pitocin or Cervadil, can rapidly be discontinued if problems develop. But unlike Pitocin or Cervadil, once Cytotec® is given, whether swallowed in a pill form by mouth, or inserted vaginally or rectally, there is no way to stop its action, even if trouble occurs. The reason Cytotec® is used instead of other, safer drugs, is simply that it is cheap and easy. [Click here to view the A.C.O.G statement.]
Cytotec® can cause abnormally strong uterine contractions ("hyperstimulation" or "tetany") so powerful that the uterus ruptures, resulting in severe injury or death to the mother and/or child. It can cause such heavy bleeding ("hemorrhage") the mother's uterus must be removed (hysterectomy) to save her from bleeding to death, leaving her incapable of bearing another child, and disrupting her natural hormones. The violent contractions it provokes also increase the risk of amniotic fluid embolism that can result in a stroke or death.
Unfortunately, there is no reliable way to predict whether these complications will occur in any particular pregnancy. The patient and her caregivers have to just take their chances, and hope for the best. The good news is that most of the time, nothing bad happens. The bad news is that once the Cytotec is given, it cannot be reversed. There is no antidote, and its action cannot be stopped.
Cytotec® is not approved by the U.S. Food and Drug Administration. nor by its developers and original manufacturer, for cervical ripening and labor induction.
Searle, the original manufacturer of Cytotec®, sent all physicians a Drug Alert (also called a "Dear Doctor letter") in August of 2001, warning that Cytotec® may cause uterine rupture, and recommending against its use for induction of labor.
The FDA then re-posted Searle's letter, using it as their own "Safety Alert" to interested parties.
Searle has placed warnings on the drug label "not to be used in women who are pregnant." The silhouette of the pregnant woman with the slash through it at the top of this page actually appears on every Cytotec® box. [Click here to view the entire label and read its warnings, written in unmistakable terms.]
The decision to induce labor is not something that should be accepted without careful consideration.
Just about every medical intervention carries risks, and you - the patient - have to decide if the risks outweigh the benefits. Inducing labor carries risks to both the mother and baby; however, there are situations where inductions are medically indicated for the safety of the mom and or the baby.
Examples of some of medical reasons for induction are:
The reasons for induction must be carefully weighed against the risks of allowing labor and deliver progress naturally, because induction can cause death or serious injury to the mother and/or baby.
Some of the known complications of induction are:
There are some medical situations where inductions should not be done, or should be done only after careful consideration and with excellent monitoring:
Elective induction is increasingly being done by more mothers and obstetricians, with little or no consideration that the convenience of having a timed delivery inevitably includes some significant risks. While there are medical situations in which induction is appropriate, the decision to induce should always be discussed and the benefit/risk ratio weighed. The final decision to induce or not to induce belongs to the mother.
Using Cytotec as the “ripening” or induction agent may heighten the risks for problems, but even Pitocin and the other induction agents carry significant risks.
You may have a lawsuit, if your induction resulted in an injury to either the mother or the baby. Problems we see frequently when inductions go wrong:
The patient has the right to:
- control his/her own body, and
- refuse any treatment 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.
The key word in "informed consent" is "informed." It is the doctor's duty to explain, in words and in a way that is understandable to the patient, the facts so that when the patient does, in fact, consent, that consent is given with an awareness of:
Mark R. Bower, an experienced Cytotec litigator, says:
"It is almost impossible for a woman to give a true informed consent to the use of Cytotec to induce labor. The doctor or midwife would have to inform the mother that Cytotec manufacturer wrote on the package insert, product box, and bottle, that Cytotec should not be used to induce labor, and it is absolutely contraindicated for any use in a pregnant woman.
"'In fact, Cytotec's developer, Searle, considered its product to be so dangerous, that it sent a "Dear Doctor" letter [re-printed below] 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 warned the doctor, "Don't do it!"
'If a doctor or midwife actually gave a patient this information, no sensible woman would EVER consent to taking this drug. The ONLY reason women get Cytotec, is that their 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 or baby whose childbirth resulted in a Cytotec disaster, 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."
Here is the verbatim text of Searle's "Dear Doctor letter". We added the highlighting and underlining of the key parts.
August 23, 2000
Re: Cytotec® (misoprostol)
Dear Health Care Provider:
The purpose of this letter is to remind you that Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion. Cytotec is not approved for the induction of labor or abortion.
Cytotec is indicated for the prevention of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin)-induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer.The uterotonic effect of Cytotec is an inherent property of prostaglandin E1(PGE1), of which Cytotec is stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy. Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.
Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established. Searle promotes the use of Cytotec only for its approved indication. Please read the enclosed updated complete Prescribing Information for Cytotec.
Further information may be obtained by calling 1-800-323-4204.Michael Cullen, MD Medical Director, U.S. Searle
The purpose of this "Dear Doctor Letter" is to protect Searle from liability from Cytotec lawsuits. By warning doctors not to use Cytotec to induce labor, Searle erected a defensive barrier to products liability lawsuits. A doctor's failure to heed Searle's warnings breaks the chain of connection between the manufacturer and the patient, insulating the manufacturer legally.
However, this insulation puts the liability for the misuse of Cytotec directly on the prescribing doctor or midwife, because it makes it clear that the prescriber disregarded the manufacturer's warnings and over-rode the manufacturer's cautions.
According to the American College of Obstetricians & Gynecologists ("A.C.O.G."), there is a significant cost difference between Cytotec (misoprostol) and the other drugs [dinoprostone - Cervidil, Prepidil] for induction of labor. The price of a 100-µg tablet of Cytotec/misoprostol ranges from $0.36 to $1.20 per pill, compared with a dinoprostone gel kit that ranges from $65 to $75 and the dinoprostone vaginal insert that costs approximately $165.
The A.C.O.G. committee notes that the costs of Cytotec use increases if oxytocin (Pitocin) augmentation [trade name = Pitocin] is also needed. (Often, these drugs are used in combination.) In addition, Cervadil/Prepadil is an unstable compound that requires refrigeration to maintain its potency, whereas misoprostol is stable at room temperature.
Hospitals, nurses, and particularly, health insurance companies love Cytotec, because it is inexpensive and easy to store and use. These are real benefits, but they have to be weighed against the real risks and dangers that come with it. Dollar-driven medicine, and the quest for profits, often is the enemy of quality health care. The use of Cytotec is a classic example of trading off quality care for profits.
You might expect the professional organization of obstetricians' (A.C.O.G.'s) priority would be to safeguard the safety and well-being of their patients, but A.C.O.G. clings to the inexpensive and easy intervention to expedite deliveries. Cytotec's low cost and convenience outweighs safety concerns by those in whom we entrust our health and well-being, but that seems to be the reality.
The FDA's Cytotec 2000 warning is re-printed in full above. In May 2005, the FDA issued a similar, follow-up warning.
IN SPITE OF THESE WARNINGS, THE PROFESSIONAL ORGANIZATION OF OBSTETRICIANS STILL CLINGS TO CYTOTEC! Here is ACOG's response to the FDA's "Dear Doctor" letter:
"For Release: October 27, 2000
"Janet Woodcock, MD, Director
"Food and Drug Administration
"Dear Dr. Woodcock:
"The American College of Obstetricians and Gynecologists Committee on Obstetric Practice has met regarding Cytotec (misoprostol). We are expediting the transmittal of the content of their review to the Food and Drug Administration so that the agency can consider it during its review of the labeling of misoprostol.
"On August 23, 2000, G.D. Searle & Co. issued a letter entitled "Important Drug Warning Concerning Unapproved Use of Intravaginal or Oral Misoprostol in Pregnant Women for Induction of Labor or Abortion." This letter cautions that Cytotec (misoprostol) is indicated for prevention of non-steroidal-antiinflammatory-drug-induced gastric ulcers and states, "…Cytotec administration by any route is contraindicated in women who are pregnant because it can cause abortion." The letter further states that Searle has become aware of the drug's use for induction of labor or as a cervical ripening agent prior to termination of pregnancy. Moreover, the letter notes serious adverse events, including uterine hyperstimulation and uterine rupture, which have resulted in fetal and maternal death. Finally, the company cautions, "In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development, and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established."
"The American College of Obstetricians and Gynecologists (ACOG) is concerned by the content, timing, and tone of this letter. Given that misoprostol is commonly employed in conjunction with mifepristone (RU 486) to achieve nonsurgical early pregnancy terminations, the arrival of the Searle letter within weeks of the U.S. Food and Drug Administration's (FDA) approval of mifepristone could limit the use of this new option for reproductive choice. Also, although the letter correctly points out the potentially serious, but relatively rare, risks of misoprostol when employed for cervical ripening and labor induction, it fails to comment on the extensive clinical experience with this agent and the large body of published reports supporting its safety and efficacy when used appropriately. A recent review of the Cochrane Pregnancy and Childbirth group trials registry identified 26 clinical trials of misoprostol for cervical ripening or induction of labor or both (1). These studies indicate misoprostol is more effective than prostaglandin E2 in achieving vaginal deliveries within 24 hours and reduces the need for and total amount of oxytocin augmentation. Although these studies do suggest misoprostol is associated with a higher incidence of uterine hyperstimulation and meconium-stained amniotic fluid, these complications were more common with higher doses (> 25 µg) of misoprostol. Other recent reviews and clinical trials support these conclusions (2-4). No studies indicate that intrapartum exposure to misoprostol (or other prostaglandin cervical ripening agents) has any long-term adverse health consequences to the fetus in the absence of fetal distress, nor is there a plausible biological basis for such a concern.
"A review of published reports and of MedWatch, the FDA medical products reporting program, indicates the vast majority of adverse maternal and fetal outcomes associated with misoprostol therapy resulted from the use of doses greater than 25 µg, dosing intervals more frequent than 3-6 hours, addition of oxytocin less than 4 hours after the last misoprostol dose, or use of the drug in women with prior cesarean delivery or major uterine surgery. Grand multiparity also appears to be a relative risk factor for uterine rupture.
Thus, based on recently published series and a detailed review of adverse outcomes reported to the FDA, the ACOG Committee on Obstetric Practice strongly endorses its previous conclusions, published in Committee Opinion Number 228 (November 1999), Induction of Labor with Misoprostol, which states, "Given the current evidence, intravaginal misoprostol tablets appear effective in inducing labor in pregnant women who have unfavorable cervices" (5). Nonetheless, the Committee would like to emphasize that the following clinical practices appear to minimize the risk of uterine hyperstimulation and rupture in patients undergoing cervical ripening or induction in the third trimester:
"The use of higher doses of misoprostol (e.g., 50 µg every 6 hours) to induce labor may be appropriate in some situations, although there are reports that such doses increase the risk of complications, including uterine hyperstimulation and uterine rupture (6). There is insufficient clinical evidence to address the safety or efficacy of misoprostol in patients with multifetal gestations or suspected fetal macrosomia.
In conclusion, the ACOG Committee on Obstetric Practice reaffirms that misoprostol is a safe and effective agent for cervical ripening and labor induction when used appropriately. Moreover, misoprostol also contributes to the obstetrician-gynecologist's resources as an effective treatment for serious postpartum hemorrhage in the presence of uterine atony (7-12)."
Stanley Zinberg, MD, MS, FACOG"
No! Let's look at it in the terms of a situation where you might have been involved in an accident.
If you ran your car through a red light because you were distracted and caused a collision, you would have committed a negligent act. But this one event would not make you a bad driver or a reckless person. Everyone makes mistakes. You just had a fleeting moment of inattention. You are responsible for the error, but that doesn't make you a bad person.
The same goes for the Delivery Room. Just because your obstetrician or midwife did not deliver your baby safely, this lapse does not make him a bad doctor or a bad person. It is not a statement about his personal integrity, or his general competence. It could be that he just had a fleeting moment of inattention - an ordinary human error.
Your physician or midwife or nurses have insurance to protect them, just as you have when you drive your car. Though many of us put medical people on a pedestal and expect superhuman feats, the reality is that neither "higher education" nor medical degrees or titles can always protect the against mistakes. It is not up for debate as to who should be accountable for a mistake. If someone made a mistake that resulted in a serious injury, s/he should be held accountable, and they have insurance to pay for injuries and the other costs that flow from those injuries. Civil litigation is not a process to vilify a medical provider. It is the only process we have allowing an injured party to be compensated for their injuries.
Sadly, some people who have been seriously injured, or have a loved one who has been injured by medical malpractice or negligence, fear that there will be negative consequences to society if they were to seek a legal remedy. We address those concerns below.
No! Malpractice premiums constitute only about 1% of the total costs of health care. While the medical and insurance lobbies are constantly pushing to limit liability and pass the costs of the malpractice onto the injured patients, actuarial studies have proved, time and again, that the costs of malpractice insurance are a very small part of health costs overall.
Malpractice insurance premiums rise and fall as a function of interest and stock market rates. When interest rates are high, or the stock market it good, insurers make great profits on their investments and premiums become a non-issue. When interest rates are low, or the stock market is suffering, insurers investments suffer, and so they try to make up the difference with rate hikes. Either way, litigation costs are only a tiny factor in a much larger picture.
* - https://www.onyxmd.com/about-onyx-md/blog/why-doctors-are-leaving-the-profession/; http://www.medicaleconomics.com/medical-economics-blog/fed-technology-physicians-leave-profession; https://www.forbes.com/sites/dandiamond/2015/06/02/why-doctors-really-quit/#79a4d7157621
independent assessments by state officials and the media have found that the number of doctors in many states has remained stable and in most, has actually increased.
The National Practitioner Data Base Data continues to show that:
- The annual number of malpractice payments is down.- Medical malpractice payments per populateion continues to decline
- Million-Dollar Judgments are less than 1 percent of the total payments....
... While at the same time:
- Some common preventable errors are increasing.
- Easily preventable errors show a marked increase since 2003 From: "the Great Medical Malpractice Hoax: NPDB Data Continue to Show Medical Liability System Produces Rational Outcomes." January 2007 http://www.citizen.org/publications/release.cfm?ID=7497
You and your child are entitled to fair compensation. The cards are stacked against plaintiffs in the current political climate. To have a fair chance for obtaining a just settlement, you need to find an attorney who is experienced and concentrates his practice on protecting and pursuing your rights.
The only way to find out if you have a case, is to have the medical records reviewed and analyzed by skilled and experienced Cytotec litigators. Cases rise or fall depending on what the medical records document. This is always the starting point to determine if a case is worthwhile pursuing or not.
Hiring just any attorney is easy. Hiring the best attorney for your case is a bit more difficult.
Cytotec and birth trauma litigation is a sophisticated sub-speciality of medical malpractice law, which is itself a difficult specialty. You should retain an attorney who has handled several such cases and has a proven record of good results. You don't want a beginner learning the ropes of complicated medical litigation using your case for their learning experience.
We know that legal action can sometimes be overwhelming. We are dedicated to providing you help in language that you can understand. If you don't feel like you understand your options, just ask, and we will work to find an explanation that works for you.
We have been prosecuting Cytotec and Birth Trauma cases for over 40 years, with a proven track record of great results.
Mark R. Bower has handled and tried Cytotec cases around the country, affiliating with quality local counsel and getting admitted in other states as needed, to bring our special expertise to any state and any jurisdiction.
Mark R. Bower has attained national prominence, lecturing on birth trauma and Cytotec for the American Association of Justice and the Academy of Trial Lawyers of the State of New York.
We welcome your inquiry about your possible case on a free, no-obligation consultation. You have nothing to lose by reaching out to us. All cases are handled on a contingency fee basis, meaning no fee unless we get a recovery for you. The fee will be a percentage of the recovery, which is set by state rules and customs.
Please visit our main website at www.MRBowerLaw.com.
We invite you to fill out the "contact us" form below, or email us at Mark@MRBowerLaw.com, or call (917) 304-3337.
New York office: 176 Broadway #10E, New York, NY 10038-2511; New Jersey Office: 15 Wimbledon Dr. #3, Vernon, NJ 07462-6601; Colorado Office: P.O. Box 5012, Breckenridge, CO 80424-5012.
Telephone (all offices) : (917) 304-3337