Legally Speaking: Did induction cause this uterine rupture?

Andrew I Kaplan, Esq, is a partner at Aaronson, Rappaport, Feinstein & Deutsch, LLP in New York City, specializing in medical malpractice defense and healthcare litigation.

In September 2011, a woman learned she was pregnant with her first child and visited ob/gyn Dr A. At some point during the pregnancy, Dr A diagnosed fibroids and indicated that if they grew too large, the patient would need to deliver via cesarean. In the early morning of April 29, 2012, the patient’s water broke and her husband brought her to the hospital at approximately 4 a.m. The patient—the plaintiff in this case—was at 35 weeks’ gestation.

Dr A had an agreement with defendant ob Dr B to cover each other's patients, and it was Dr. B who was the attending physician managing the plaintiff’s care when she arrived at the hospital. At the time, Dr B was the director of ambulatory care as well. The plaintiff was examined by a resident upon arrival at 4 am and was next seen by Dr B at about 5:30 a.m. Because the plaintiff had tested positive for Group-B streptococcus (GBS), Dr B ordered prophylactic antibiotics and indicated that the plaintiff would need to be admitted. At approximately 11:00 a.m., Dr. B examined the womanand indicated she would be placing a dinoprostone to prepare the plaintiff’s nonfavorable cervix for oxytocin administration later. Dr. B then informed the residents of the examination and placement of the dinoprostone and said that the plaintiff could receive an epidural if she complained of pain. At around 2 p.m., the plaintiff complained of pain and an epidural was administered.

Throughout the day, the labor and delivery nurses monitored the plaintiff, checking the fetal heart rate (FHR) monitor and palpating as necessary at 2:30, 4:05, and 5:43. In addition, the residents periodically assessed the plaintiff, but did not perform a vaginal examination as they were directed not to do so by Dr. B because of the plaintiff’s GBS status. Specifically, to prevent exposing the plaintiff to any further infection, Dr B had instructed that she should be examined only if there was tachysystole, a FHR tracing abnormality, or active labor. From approximately 3 p.m. until 7 p.m., the plaintiff was having contractions every 2 to 4 minutes, the FHR tracings were reassuring, and she plaintiff was not experiencing pain. Thus, there was no need to conduct a vaginal examination.

When the plaintiff was examined by a resident later that evening, the dinoprostone was found “on the chux.” No other induction agent was used and by 8:30 p.m., plaintiff was fully dilated and began to push. At 9:16 p.m., the plaintiff vaginally delivered a healthy girl with Apgars of 9/9. Although no episiotomy was needed, some second-degree tears were immediately repaired.

The plaintiff experienced postpartum hemorrhage, which Dr B diagnosed as uterine atony because the uterus was boggy and soft. Oxytocin was administered at about 9:19 p.m. to treat the atony and hemorrhage. The plaintiff was given an injection of methylergonovine at about 9:45 p.m., also to treat the atony and hemorrhage. When the methylergonovine appeared ineffective, Dr B ordered 400 mg of misoprostol, half the usual dose, to be administered rectally.

The bleeding ceased and the plaintiff appeared to be recovering until approximately 10:55 p.m., when she experienced pain, dizziness, and vomiting. Dr B ordered fluids and attempted to determine the cause of the plaintiff's symptoms. A bedside ultrasound was inconclusive, but a second ultrasound revealed fluid around the uterus. Dr B took the plaintiff to the operating room to perform an exploratory laparotomy, where she discovered that the plaintiff had sustained a 10-cm posterior uterine rupture. She undertook the repair and saved the plaintiff’s uterus, although she would have to deliver any future children via cesarean. Following the successful surgery, Dr B informed the plaintiff that she had never heard of dinoprostone causing uterine rupture. Resident doctors likewise told the plaintiff that a uterine rupture is not a common occurrence.

Allegations

The plaintiff’s lawyer claimed that the defendants did not appropriately monitor the plaintiff after the insertion of the dinoprostone and negligently prescribed dinoprostone, misoprostil, and oxytocin to induce labor. They claimed that the dinoprostone caused the uterine rupture and that defendants deviated from the standard of care in failing to perform serial vaginal examinations of the patient and in ordering dinoprostone and oxytocin after the delivery in an to attempt to control bleeding. They also contended that misoprostol was not utilized for its Food and Drug Administration-approved purpose.

Discovery

Dr B testified that her plan was to use the dinoprostone to start induction and "prevent [the plaintiff] from getting chorioamniotis, sepsis, and ending up with a C-section,” she said. She further testified, “ … the plan is always with somebody who has such an unfavorable cervix and ruptured membranes is to use a cervical ripening agent in the hopes that we will be able to start Pitocin augmentation with a better outcome.” According to Dr B, in a patient such as the plaintiff, who tested positive for GBS and had ruptured membranes, the most pressing concern is to prevent infection, and that is why dinprostone was used. As for the perforation, despite such a rupture being, in her words, “a major adverse event, a really, really rare thing" often requiring hysterectomy, Dr B was able to successfully repair the rupture, and as she said, "save her life, save her uterus.”

The plaintiff recalled that Dr. B "told me that she didn't expect to check me until I got the Pitocin, unless I wanted an epidural." She claimed that “immediately” upon the insertion of dinoprostone she began experiencing lower abdominal pain and this precipitated the 2 pm request for an epidural. The plaintiff acknowledged that the doctors at the hospital all told her that she "almost died,” saying, “it's a miracle that you're still here.” The plaintiff's husband likewise thanked Dr B "so much,” saying, “I thought she was going to die. You saved her life.” The plaintiff performed Internet "research" and found that “a uterine rupture is an adverse effect of Cervidil, and that the patient should be monitored for pain, as pain is not really common with Cervidil and pain is an indication that something might be going wrong with the Cervidil.”

Resolution

Armed with expert support, we moved for summary judgment dismissing all claims. Our ob expert opined that the plaintiff’s assertions regarding use of misoprotsol and oxytocin “during labor” lacked merit and they were used after labor. She stated that the patient was an appropriate candidate for dinoprostone given that there was no cervical dilatation or active labor for 7 1/2 hours after her water broke. It was good practice to remove the dinoprostone only when the patient went into active labor and to avoid vaginal examinations given her GBS status. There was no evidence either of uterine hyperstimulation or of dinoprostone causing or contributing to uterine rupture in this prima gravida. In opposing the motion to dismiss, the plaintiff’s expert argued that the defendants departed from good practice in failing to remove the dinoprostone in the face of hyperstimulation and active labor. They claimed a failure to perform vaginal exams during 7 hours of labor and that dinoprostone “on rare occasions” can cause rupture in a “pristine” or unscarred uterus. 

In reply, we submitted literature on uterine rupture with concomitant dinoprostone use that did not recognize dinoprostone as a causal factor in rupture of a pristine uterus. We also challenged the opposing expert’s diagnosis of tachysystole as inconsistent with the record.

NEXT: The verdict >>

The verdict

The court granted our motion for dismissal, finding that although the plaintiff’s expert created a question of fact as to when the patient went into active labor, he was unable to meet his burden of proof with regard to the use of dinoprostone being a departure from good practice or causing the rupture at issue.