Legally Speaking: Did misoprostol cause this postpartum hemorrhage?

THE FACTS

At 2:00 PM, a first dose of misoprostol was administered. A second dose was administered at 6:10 PM, and the patient was started on prophylactic penicillin. A fetal monitor was attached, and the strips were reassuring. At 1:15 AM, oxytocin was initiated at 4 mU/min and was to be increased every 20 or 30 minutes until contractions were 2 to 3 minutes apart. At 3:00 AM, the patient's oxytocin was increased to 8 mU/min; she was contracting every 2 to 5 minutes, but her cervix was unchanged. Her blood pressure was 109/69 mmHg.

By 4:25 AM on May 10, a resident noted that the patient was not feeling contractions although she had been receiving 32 mU/min of oxytocin. Her blood pressure ranged from 114/65 mmHg to 129/87 mmHg, and she was not reporting symptoms of preeclampsia. Sixty mU/min of oxytocin was administered at a rate of 20 mL per hour.

By 8:14 AM, there was still no change. At 9:00 AM, attending "C" documented that a cesarean delivery was being called for because of lack of progress.

The operative report indicates that delivery was complicated by severe uterine atony, which was treated with oxytocin, carboprost tromethamine, misoprostol, and the use of B-Lynch sutures. The patient lost 1,500 cc to 2,000 cc of blood, which was replaced with 2 units of packed red blood cells. She developed "severe" uterine atony that did not respond to several doses of carboprost tromethamine and a dose of rectal misoprostol. The atony and postpartum hemorrhage responded to the use of B-Lynch sutures.

The infant was delivered with Apgars of 9, weighing 8 lbs 3 oz. No claim was made as to injury to the baby. Attending "C" noted that because of severe uterine atony, "the uterus was inadvertently inverted and then re-approximated and re-positioned correctly." A B-Lynch suture was placed, and then a second suture was placed for "even tighter control."

The attendings saw the patient in recovery because of continued bleeding. The patient was evaluated for low blood pressure (70/40 mmHg) and the passage of a large amount of blood (approximately 600 cc). Because she remained unstable in spite of aggressive IV fluids and several transfusions, she was taken back to the operating room. The patient was deemed unstable for uterine artery embolization, and the previously placed B-Lynch suture was found to be "broken." Bleeding was controlled with the placement of new figure-8 sutures, but the uterus was very thin and distended with no contractility. There was significant peritoneal bleeding, and in light of the "massive hemorrhage" and the patient's poor prior response to transfusion and medical therapy, a decision was made to perform a hysterectomy. The attendings at this time identified a uterine anomaly in the form of a rudimental left uterine horn (unicornuate uterus). The pathology report identified retained placental tissue characterized by focal placenta accreta and findings suspicious for placenta increta.

ALLEGATIONS

The plaintiff pursued several assertions with regard to the 36 hours of labor, the actual delivery, and the time leading up to her hysterectomy, including failure to timely induce labor, failure to perform a cesarean delivery, and administering misoprostol simultaneously with oxytocin and then failing to discontinue misoprostol, as well as failure to obtain informed consent. Plaintiff's expert witness suggested that the use of misoprostol and the physicians' actions contributed to uterine inversion, which caused the hemorrhage and the need for hysterectomy.

DISCOVERY

Depositions of the plaintiff and her husband revealed that the concept of induction was discussed with them fully by the physicians involved in the course of labor and delivery. Plaintiffs deposed a variety of physicians with regard to labor, delivery, and the 2 operative procedures without a clear theory other than the suggestion that a "diagnosis" of uterine atony should have been made before delivery.

We retained an expert in ob/gyn who had authored one of the seminal papers on the use of misoprostol as an inductive agentand for controlling postpartum hemorrhage. We also retained a pathologist to review the placental slides.

Our expert said that the physicians saved the patient's life and that she would have undoubtedly bled to death had a hysterectomy not been performed when it was. She was adamant that the uterine atony, the hemorrhage, and the need for hysterectomy were secondary to placenta accreta and perhaps increta. She agreed that this was a pathologic diagnosis that could only have been made with a microscope after the fact.

The expert said that the physicians used the correct medications in the face of uterine atony and that they appropriately applied B-Lynch sutures. She noted that ACOG has recognized that misoprostol is effective in controlling postpartum hemorrhage and is considered "state of the art." In her opinion, the placenta accreta, not the misoprostol caused the patient's problems. The pathology expert stated that the patient definitely suffered from placenta accreta and potentially placenta increta. Regardless, she did not believe an obstetrician would have been able to diagnose accreta/increta during the pregnancy because the patient was a nullipara with no prior uterine surgery, and in this setting, a focal accreta would only under rare circumstances be detectable on ultrasound.

OUTCOME

The trial attorney convinced plaintiff's counsel that the case lacked merit and that in spite of their investment of time and effort, the case was "going nowhere." Plaintiff's counsel revisited its expert with the arguments proposed by ours, and their expert agreed with the defense's experts. Plaintiff's counsel moved to be relieved as counsel in lieu of trying the case, and, unable to find another attorney to litigate the matter, the plaintiffs abandoned the action.

ANALYSIS

Excellent documentation by the physicians during the course of labor and delivery about their plans for induction, the consents obtained, and the rationale behind the induction made the case easier to defend. The operative reports explained the thought processes and findings to avoid credible allegations that they "caused or contributed" in any way to the uterine inversion or the subsequent hemorrhage or that appropriate maneuvers were not undertaken before the use of B-Lynch sutures and then hysterectomy. Regardless, it is rare that plaintiff's counsel invests as much time and effort into a case as this one did and then willingly abandon that action in the face of compelling defense expert opinions.

MR KAPLAN is a partner at Aaronson, Rappaport, Feinstein & Deutsch, LLP, specializing in medical malpractice defense and healthcare litigation. This case was handled and resolved by his partner, Philip D Lerner, Esq.