Were this infant’s delays secondary to misapplication of a vacuum extractor?

Facts:

The patient was 37 years old in 2006 when she became pregnant. She was also morbidly obese, weighing over 330 pounds. Starting on February 24, co-defendant Dr. A. managed her prenatal care. At first, the patient’s expected due date was set as October 6. Then at 34 weeks gestation, she developed oligohydramnios. An ultrasound on August 23 confirmed a low amniotic fluid index (AFI) of 5.6, and she was referred to Defendant Hospital for hydration.         

That same day she was admitted to Defendant Hospital where she received intravenous fluids. The next day, a repeat ultrasound revealed that her AFI had decreased to 4.8, despite the administration of fluids. At the same time, there was normal fetal growth and she was judged to be 34 weeks pregnant. Faced with the risks of oligohydramnios for the remainder of her pregnancy, including possibilities of restricted growth and labor complications, the decision was made to deliver.           

On August 24, the patient received Betamethasone and Cervidil. At 3:00 AM the following morning the Cervidil was removed. Next, Pitocin was commenced at 8:30 AM. A second dose of Betamethasone was given at 3:30 PM. At 4:15 PM there was a deceleration noted on the fetal tracing with good return to baseline. A fetal scalp electrode was applied at 4:30 PM when the mother was 4 centimeters (cm) dilated. At this point, the fetal monitoring strips were reassuring. There was a good fetal heart rate and accelerations that signified fetal wellbeing.     

The mother dilated quickly to anterior lip by 5:13 PM. At this time, she had a 90-second deceleration due to cord compression, followed by a good return to baseline and then at 5:46 PM some mild variable decelerations. After 2 more variable decelerations at 6:02 PM, defendant Dr. B. decided to perform a vacuum extraction. With 1 quick pull of the extractor, measured at an appropriately negative pressure of 60 millimeters of mercury, he delivered the infant from the +4 station.        

At birth the infant weighed 5 pounds and 6 ounces. His Apgars were 7 at 1 minute, and 8 at 5 minutes. Pediatricians were present during the birth because he was premature. He did not need to be intubated and was transferred to the NICU. When there, the infant had some decreased tone and elevated bilirubin levels. The bilirubin was treated with double phototherapy lights, which help lower bilirubin levels. The infant also required a CPAP while in the NICU.         

On September 1st, the 5th day of life, an ultrasound of the head was within normal limits. On September 5th, the 11th day of life, an MRI revealed a grade II intraventricular hemorrhage in the cortico-thalamic region.   

The infant was diagnosed with hypotonic cerebral palsy, static encephalopathy and developmental delays. Though at first he needed leg braces to walk, he has recovered to the point where he now walks and runs without assistance. He does so with a slight diplegic gait, with mildly increased tone in the lower extremities that affects his left side less than his right. He scored a 66 on an IQ test at 4.5 years old.    

NEXT: Allegations and Discovery

Allegations:

Plaintiff alleged that the infant’s injuries were caused by traumatic damage during delivery; specifically, from the vacuum extractor. The plaintiff’s argument was that when the vacuum extractor pulled on the infant’s head it caused damage, evidenced by the intraventricular bleed.      

Discovery:      

Defendant Dr. B testified that he, as the attending, performed the vacuum-assisted delivery in this case. The resident was present and may have also had his hands on the vacuum; however, it was Dr. B who did the delivery.

Dr. B. described his role in evaluating the patient for vacuum extraction as looking at the labor history, fetal status, pelvic and fetal assessments, station and presenting part in ongoing assessments throughout the labor.   

Immediately prior to applying the vacuum, he would perform a final assessment of the fetal head, decide whether to perform a vacuum, and obtain maternal oral consent.  In this matter, a Kiwi vacuum was utilized, which involves a soft (silicon) cup, and suction by a hand pump.    

He described the labor as early labor between 8:30 AM and 4:00 PM, which then turned to active labor where the patient progressed from 4 cm to full dilatation in approximately 1 and 1/2 hours.  He classified this as rapid, normal labor. By 5:45 PM the patient was fully dilated and pushing, and he applied the vacuum at the +4 station. Delivery occurred with 1 pull. He listed the indication as fetal bradycardia, with the fetal monitoring strips depicting repetitive decelerations immediately prior to birth.   

Regarding the informed consent discussion, Dr. B. explained that he would tell the mother that the baby’s heart rate was down and he could help her safely deliver the baby by applying a vacuum.  He specifically would tell the mother that she still needs to push and that the vacuum is only an assist. He advises that some swelling of the scalp may occur, but does not tell the mother of bleeding in the scalp or any intracranial bleeding.    

Pediatricians were present due to the prematurity itself, but would also have been called due to the vacuum-assist. He conceded that performing a vacuum-assisted delivery in a gestation less than 34 weeks is a “relative” contraindication. and that a general risk of vacuum extraction in a 34-week gestation is bleeding in the scalp from the suction. He testified that intracranial bleed is not a risk of vacuum extraction and he would only use a vacuum with a very small amount of traction to expedite the delivery if he thought this would be an “easy delivery.”

After performing a final examination of the fetal station and head, he would wait for the contraction to finish and then place the cup on the fetal scalp, 1 cm anterior to the posterior fontanelle over the midline suture.  He would check the edge of the vacuum cup and confirm the position.  He indicated that he placed the vacuum in the middle of the fetal skull, the most optimal position, at the “flexion point”. The vacuum suction would start after the push started and lasted for less than 1 minute.  As soon as the head crowned the suction was released, and the cup removed.  There was only 1 pull and he indicated that he applied the traction along the usual course of 45° downward, followed by an upward curve after the face appeared.

The ob/gyn expert opined that it was appropriate to induce this mother at 34 weeks. Over a month remained until her expected due date and there was normal fetal growth, and these compounded the risks posed by her deficient amniotic fluid levels. Oligohydramnios caused the decelerations due to cord compression because of the lack of amniotic fluid to cushion the fetus. As to the delivery itself, the expert opined that 1 pull on a vacuum is considered an easy delivery and that the infant’s Apgar scores were good for a 34-week gestation neonate. And finally, the expert highlighted the flaws inherent in the plaintiff’s fixation on the intraventricular hemorrhage as evidence of malpractice, as this kind of intraventricular hemorrhage can occur spontaneously, even secondary to a flawlessly performed vacuum extraction.

The pediatric neurology expert felt that any deficits exhibited by the infant were due to in-utero, second-trimester events that were beyond anyone’s control-and decisively unrelated to labor, delivery or vacuum extraction. He based this conclusion on the negative ultrasound of the infant’s head on September 1st, and the grade II intraventricular hemorrhage on the MRI performed on September 5th. Indeed, he explained that grade II hemorrhages are considered insignificant, and that grades I and II usually have normal outcomes. He reviewed the MRI taken on the 11th day of life and indicated that there might not have even been any bleed to begin with. He noted that any cognitive or cerebral palsy issues were more likely the result of prematurity and second-trimester issues, both of which caused the original oligohydramnios. As such, this expert opined that the damage to this child occurred at 28 or 30 weeks gestation, and had nothing to do with the labor and delivery. Lastly, he specifically stated that there was no vacuum extraction injury in this case.    

Resolution:

Given the question of induction at 34 weeks, the questionable use of vacuum extraction at 34 weeks and the indications for that use, combined with the infant’s significant delays and a sympathetic venue for trial, the decision was made to mediate the case in light of plaintiff’s seven-figure demand. After mediation, the case ultimately resolved before trial for $500,000.