Medical Malpractice
Cervidil is a vaginal insert containing a synthetic hormone that is used to soften the cervix in preparation for childbirth. Cervidil is one of several popular synthetic hormone drugs. These drugs are widely used to induce or accelerate labor and delivery.
While generally safe and effective, Cervidil and other labor-inducing drugs have the potential to cause hyperstimulation. Most obstetricians and delivery nurses have the skill to manage these complications. If they do not meet the standard of care in identifying the problems that can be created by Cervidil, it is medical malpractice that can lead to birth injuries.
About Cervidil
Cervidil (often misspelled as cervadyl) is given to women at the end of a normal pregnancy to help prepare their body childbirth and induce labor and delivery. Cervidil is a vaginal insert (pessary) which a nurse or doctor manually inserts into a mother’s vagina. Once properly placed in the vagina the insert continuously releases a synthetic version of a hormone called dinoprostone (Prostaglandin E2 or PGE2).
Dinosprostone is a naturally occurring hormone in the mother’s body that plays a key role in preparing her body for the process of labor and vaginal delivery of her baby. The drug chemically identical to endogenous prostaglandin and is approved by FDA for cervical ripening. Cervidil is used as a vaginal insert but it can be used as a cervical gel as well (Prepidil made by Pfizer). There is at least some suggestion in the literature that the cevical gel works better in biringing about vaginal delivery.
So obstetricians use Cervidil to accelerate the process of cervical ripening or softening for the induction of labor. The cervix functions as the entrance to the top of a woman’s birth canal. In a vaginal delivery, the cervix must loosen and open up to allow the baby to pass through. This opening of the woman’s cervix occurs during the early stages of labor. When the cervix is not ripening fast enough or the baby needs to be delivered sooner doctors will administer a Cervidil insert to help soften the cervix. How long does it take Cervidil to work? It should begin loosen the cervix very quickly. But how long it takes to induce will depend on a variety of factors.
Like all drugs, this drug has potential side effects. Among the most common side effects are abdominal pain or stomach cramps, diarrhea, nausea, vomiting and fever. Cervidil induction is counterindicated if the baby’s heart rate suggests fetal distress if delivery is not imminent. The drug is also counterindicated in women with unexplained vaginal bleeding during her pregnancy.
Difference Between Cervidil and Pitocin
Pitocin is another synthetic hormone drug that is often used to speed up or induce labor. There are two primary differences between Cervidil and Pitocin. First, Pitocin works on the uterus, not the cervix. Pitocin works by stimulating the mother’s uterine muscles to contract. By contrast, Cervidil works by stimulating the cervix to expand and open. The second major difference between Pitocin and Cervidil is the way they are administered. Pitocin is administered intravenously through a drip bag while Cervidil is a vaginal insert.
The difference is important. Because Cervidil is put in the cervix, it cannot easily be reversed. Pitocin is an IV infusion that can be quickly reversed by turning off the IV.
Ultimately, labor induction with Cervidil is only indicated in the baseline fetal heart rate is normal. Why? Because Cervidil cannot be quickly reversed. So if there is any abnormality in the fetal heart rate, you know it is going to take longer to solve what might be bothering the baby.
Risks & Problems With Cervidil
The major safety issue with using labor-inducing agents like Cervidil and Pitocin is that they can potentially cause overstimulation. This occurs when the drugs work too well and the labor becomes too fast and too intense. This sort of overstimulation can put the baby at significant risk. Because if contractions are too strong and occur too frequently, they can disrupt the supply of oxygen. Although this reaction is less common with Cervidil than with Pitocin, Cervidil induction can cause uterine hyperstimulation.
If the baby does not have enough time to recover from the contraction. The baby needs at least 60 seconds. If the child does not get those 60 seconds because of uterine hyperstimulation brought on by Cervidil, it can suffer permanent hypoxic damage.
Verdicts & Settlements Involving Cervidil
There are not a lot of Cervidil-related birth injury malpractice cases. Why so few? There is a relatively small number of these lawsuits and confidental settlements have express provisions that lawyers like us cannot share the details of the settlement. But we still found a few. These are summaries of verdicts and reported settlements from birth injury malpractice cases in which the administration of Cervidil was involved throughout the United States:
- D.B. v St. Bernard Hosp (Illinois 2023) $19 million: Mother was admitted to defendant hospital for labor at 40 weeks. She had a prior history of C-section delivery but the doctor gave her Cervidil to induce labor despite the fact that Cervidil is contraindicated for patients with prior C-sections. Uterine rupture occurred and the baby suffered major brain damage and he eventually died at 10 months. The lawsuit alleged that the negligent use of Cervidil cause the uterine rupture.
- P.S. v Smith-Foy (New York 2020) $1.3 million: Cervidil was used to induce labor. The Cervidil drip was continued despite signs of fetal distress and the baby eventually suffered oxygen loss resulting in HIE brain injury and permanent developmental delays. The lawsuit alleged that the midwife was negligent in using Cervidil, continuing the Cervidil after non-reassuring fetal monitoring strips, and refusing to discontinue the Cervidil.
- I.E. v Univ of Chicago Hosp (Illinois 2016) $53 million: The hospital staff fail to discontinue Cervidil as suggested by drug manufacturer’s warning and fail to notify doctors of need for emergency c-section delivery when baby shows signs of distress suggesting lack of adequate blood and oxygen. Baby allegedly suffers severe hypoxic ischemic encephalopathy and metabolic acidosis as a result of delayed response. He is ultimately diagnosed with cerebral palsy and confined to wheelchair. Jury awards $53 million which includes $36 million for future medical expenses.
- Plaintiff v OB/GYN (Massachusetts 2013) $1 million: A 38-year-old mother with normal pregnancy is admitted for labor and induced with both Cervidil and Pitocin. Everything proceeds normally for the first 9 hours but then the electronic fetal monitoring devices suddenly start showing rapid heart rate decelerations that should have been concerning. Hospital staff fails to alert the doctor there is a 90 minute delay before an emergency C-section is eventually performed. The baby sustains an HIE brain injury and dies within 2 days. Defendants argue that the woman received quality medical attention but the baby actually had a rare genetic birth defect which largely contributed to his death. Case settles for $1 million.
- Crowe v Wheaton Franciscan (2013 Wisconsin) $8 million: 300-pound mother is admitted to hospital for delivery and Cervidil insert is used to accelerate cervical ripening. The following morning the Cervidil insert becomes displaced and Pitcoin is administered. Within 30 minutes of starting the Pitocin the EFM tracings are concerning and continue to get worse as the Pitocin is increased. Eventually a nurse becomes concerned and calls the doctor who
stops the Pitocin drip. That doctor goes home for the night and is replaced by another doctor who restarted the Pitocin and Cervidil. Soon after the EFM tracings signal level 3 to 4 warnings and an emergency C-section is performed. Baby suffers massive brain injury and is diagnosed with spastic cerebral palsy. The case is settled out of court for $8 million. - Xiao-Hua v NYHMC (New York 2009) $4.4 million: mother in 38th week of pregnancy is diagnosed with preeclampsia and sent to hospital for early labor and delivery. To induce she is given Pitocin and Cervidil. Over the next few days the fetal monitoring strips show increasingly concerning signs of distress but the induction drugs are continued. Eventually the EFM warnings prompt an emergency C-section to be ordered by it takes several hours and the baby is born with brain damage and diagnosed with cerebral palsy. A jury in Queens awards $4.4 million in damages.
Contact Miller & Zois About Cervidil Birth Injuries
The birth injury attorneys at Miller & Zois can help you investigate whether the misuse of Cervidil may have played a role in your baby’s birth injury. Call us as 800-553-8082 or get an online consultation.
Cervidil Studies and Research
Liu, Wenjie, et al. “Predictive Factors for the Success of Vaginal Dinoprostone for the Induction of Labour.” International Journal of Women’s Health (2024): 1093-1101.
Andrikopoulou, Maria, et al. “Maternal and neonatal outcomes in nulliparous participants undergoing labor induction by cervical ripening method.” American journal of perinatology 40.10 (2023): 1061-1070.
Skibinska, Katarzyna A., et al. “Comparison of labor duration of induced labor with dinoprostone insert vs spontaneous labor.” Ginekologia Polska= Polish Gynecology 94.12 (2023): 984-989.