Should suspicion of maternal/fetal infection have led to earlier delivery?

Factual Summary

The patient transferred her care to defendant hospital on June 3, 2011, when she was 36 weeks and 6 days pregnant. Nonparty ob/gyn followed her for her prenatal care through May 2011. During this time, the pregnancy had progressed normally, with the exception of gestational diabetes, which was controlled by diet. Other than the known gestational diabetes, the patient’s pregnancy continued to progress normally under the care of Defendant ob/gyn with weekly prenatal visits and fetal nonstress tests, all of which were reactive. Following her final prenatal visit on July 1, she was scheduled for induction of labor on July 5, 2011.

On July 3, 2011, the patient presented to the labor-and-delivery department at defendant hospital accompanied by her husband. She reported painful contractions since 10 am, now occurring 2 minutes apart. Her vitals at the time of triage included a temperature of 96.1 F, heart rate of 90 beats per minute (BPM), and blood pressure of 131/69. She denied leaking of fluid or vaginal bleeding and reported active fetal movement. Her last group strep B (GBS) test on May 26 was negative; she was not in distress, her membranes were intact, she was 3 to 4 cm dilated, 50% effaced, and was at –3 station. Defendant ob/gyn was present for the cervical exam. External fetal monitoring was established and the infant’s baseline heart rate was 145 BPM with moderate variability, spontaneous accelerations, and no decelerations. The patient was admitted for a nonurgent delivery and the resident ordered continuous external fetal monitoring, routine labs, penicillin for unknown GBS, and an intravenous line (IV) for fluids. Defendant ob/gyn’s first note was written at 5:28 pm, wherein he reiterated much of the resident’s findings and determined that prophylaxis for GBS was not necessary since the mother had no risk factors. The first documented deceleration occurred at 6:15 pm. At that time, the fetal heart rate (FHR) decreased with a contraction from 145 to 60 for 10 seconds and recovered. The fetal heart tracing was considered a category 1. The patient requested a spinal epidural, which was started shortly after 6:30 pm.

Defendant ob/gyn saw the patient for a second time at 7:03 pm. He noted that she was comfortable with the continuous lumbar epidural and contractions were every 2 minutes. The FHR was 155 BPM, with moderate long-term variability, and no decelerations. Cervical exam showed 2 to 3 cm dilated, 80% effaced, and –3 station. Her membranes were ruptured manually and meconium was noted. Defendant ob/gyn documented that the patient was in early labor and the FHR was reassuring, so labor was allowed to continue. At 8 pm, a second deceleration occurred following a contraction. The FHR decreased from 145 to 60 BPM for 100 seconds and made a variable, spontaneous recovery. The tracing was considered a category 2 and the nursing staff turned the patient on her left side. A nursing shift-change note at 9:01 pm noted a third deceleration where the FHR decreased from 145 to 80 BPM for 120 seconds following a contraction. The patient remained on her left side and the rate of the IV fluids was increased.

Defendant ob/gyn noted intermittent variable decelerations on the fetal monitoring at 9:13 pm. The patient was turned to her left side, oxygen was administered via a nonrebreather mask, and the FHR returned to 140 BPM with moderate variability. Defendant ob/gyn indicated that “overall,” the FHR was reassuring. However, at 9:41 pm, Defendant ob/gyn was called to the patient’s room for a deceleration to 60 BPM for 4 minutes. The patient was placed on all fours, which caused the loss of external monitoring, so Defendant ob/gyn placed an ion-sensitive electrode and the patient was repositioned to her left side. Defendant ob/gyn reported spontaneous resolution of the decelerations and baseline FHR “now” 155 BPM, with moderate variability. He discussed with the patient and her husband that she still was in latent labor, so immediate intervention was not necessary; however, the possibility of a cesarean delivery was discussed. He noted that prior to this deceleration several intermittent variable decelerations had occurred, so they would follow the fetal monitoring closely. At 9:54 pm, the patient’s temperature was 98.4 F, her heart rate was 87 BPM, and her blood pressure was 131/72. At 10:16 pm, Defendant ob/gyn ordered oxytocin injection (Pitocin); however, this was never administered.

On exam, the patient was 3 cm dilated, 80% effaced, and –2 station. The record indicates that she had a “spontaneous” rupture of membranes, which were meconium stained, and she was having 1 to 5 contractions every 10 minutes. The FHR was 110 to 160 BPM, with moderate variability with accelerations and intermittent variable decelerations. At 11:30 pm, a second prolonged deceleration was noted when the FHR decreased to 55 BPM for 3 minutes and 20 seconds. The patient was placed on her left side and then on her hands and knees, oxygen was given by mask, and IV fluids were opened wide. A third prolonged deceleration was noted at 12:45 am on July 4. The FHR decreased from 130 to 65 BPM for 5 minutes with a gradual recovery. Again, the patient was placed on her left side and then on her hands and knees, oxygen was given by mask, and IV fluids were opened wide. Defendant ob/gyn was notified.

On July 4, at 1:24 am, Defendant ob/gyn noted that there had been several decelerations lasting 2 to 4 minutes over the course of the evening, with the most recent decelerations at 11:30 pm and 12:45 am. He discussed with the patient and her husband the possibility of an emergent C-section if the FHR did not recover following a deceleration. At 4:02 am, an OB resident noted that the patient was in latent labor and the FHR was in the 140s with moderate variability, no accelerations, and 3 variable decelerations to the 130s in the past 10 minutes. Her tracing was still a category 2. At 4:30 am, the FHR decelerated from 150 to 115 BPM for 40 seconds with a variable recovery. Fifteen minutes later, another deceleration from 150 to 70 BPM for 140 seconds was observed.

Later, at 5:30 am, the FHR decelerated from 155 to 130 BPM for 2 minutes with a gradual recovery. The variability was minimal, no accelerations were noted, and the tracing remained a category 2.

At 6:55 am, Defendant ob/gyn indicated that there had been no change in the patient’s condition since the last exam, and he recommended a C-section. The patient’s heart rate was 105 BPM at 7:00 am and continued in the range of 100 to 113 BPM between 7:45 am until she was taken to the operating room (OR) at 8:40 am. She never became febrile, as her highest temperature reading was 99.6 F at 7:45 am.

During the roughly 2 hours between the call for a C-section and the patient being taken to the OR at 8:40 am, the fetal monitoring strips were interpreted by the nurses as showing a baseline heart rate of between 150 and 155 BPM until 7:45 am, and then between 160 to 165 BPM with moderate variability; 5 decelerations were noted at 7:15, 7:30, 7:45, 8:00, and 8:15 am.

According to the intraoperative nursing note, the patient was in the OR at 8:40 am and the incision was made at 8:54 am. A female infant was delivered at about 9:20 am. Defendant ob/gyn reported thick meconium upon entering the uterus. The infant was delivered and handed off to the waiting pediatricians. The placenta was sent to pathology. The pathology report dated July 7 indicated that the placenta was mature and that there were fetal membranes with meconium-filled macrophages.

Further, pathology confirmed acute chorioamnionitis involving the extraplacental membranes, chorionic plate, and chorionic plate vessels, as well as severe, acute funisitis involving umbilical vessels and extending into Wharton jelly. Finally, pathology noted meconium-filled macrophages in the umbilical cord. Initially, the infant had limp muscle tone and was blue/pale in color.

However, 10 minutes after birth, she had a strong cry, flexed her extremities, and was completely pink. The infant was 51 cm long and weighed 3.575 kg at the time of delivery. Upon delivery, it was reported that she cried for 30 seconds, but was then apneic for 2 minutes. She was bagged and masked for positive pressure ventilation (PPV) from about 2.5 minutes to 6 minutes. Her heart rate was above 60 BPM but dipped from the 100s to the 60s when she became apneic. Her oxygen saturation (SpO2) levels were in the 70s and did not increase with PPV, so she was placed on continuous positive airway pressure (CPAP) with 40% oxygen followed by 60% oxygen when her SpO2 remained at 88%, with increased saturations to the high 80s/low 90s by 10 minutes.

She began breathing independently around 8 minutes and was continued on CPAP. The infant’s APGAR scores were 4, 5, and 9 at 1, 5, and 10 minutes after delivery. Her initial venous cord gases, taken at 9:09 am, were pH 7.15, BE –11.1, pCO2 51, PO2 85. Initial white blood cell count was 15.3. She was transported to the neonatal intensive care unit (NICU) on CPAP. The infant was admitted to the NICU. Neonatology’s initial impression included a term female with hypoxic respiratory failure likely secondary to pulmonary arterial hypertension, presumed sepsis/pneumonia, and relative hypotension.

She was responsive to tactile stimulation and had a regular heartbeat, but had diminished breath sounds, a weak cry, weak grasp, and weak rooting and sucking. CPAP was increased to 100% due to increased oxygen requirements and, eventually, the infant required intubation along with hand-bagging to correct hypoxemia. Blood cultures were taken and she was started on ampicillin and gentamicin.

The next day, the infant was removed from the oscillator and placed on conventional ventilator support per neonatology’s order. Initial blood cultures (stain) confirmed gram-negative rods, and antibiotics were continued. She remained sedated on midazolam (Versed) and morphine. During the afternoon of July 6, she began to deteriorate.

During the evening of July 6, neonatology ordered that she be placed on extracorporeal membrane oxygenation (ECMO) and she was cannulated at bedside without difficulty. Blood cultures confirmed pan-sensitive Escherichia coli and antibiotics were continued for Escherichia coli meningitis. Blood cultures taken on July 7 grew out multidrug resistant (MDR) Klebsiella pneumoniae on July 9, both peripherally and from the ECMO circuit. Her antibiotic regime was then changed from cefotaxime to meropenem and tobramycin.

Over the next 4 days, the infant continued to have respiratory distress with desaturations into the mid- to low- 80s, hypotension, thrombocytopenia, leukopenia, neutropenia, E coli sepsis, pneumonia, MDR K pneumoniae septic shock, and persistent pulmonary hypertension, in addition to worsening renal failure, anemia, persistent metabolic acidosis, high blood lactate, and anuria. Her prognosis remained poor and, on July 11 at 7:45 am, the father elected to withdraw ECMO support and continuous venovenous hemodialysis. She died 5 minutes after support was withdrawn.

Mom’s urine cultures returned with gentamycin-resistant K pneumoniae, which, per the note, was the same as found in the infant; cefepime was started after consultation with the infectious disease department. The patient’s lochia culture revealed many Pseudomonas aeruginosa and few K pneumoniae; the blood culture was negative; and the urine culture showed >100,000 colony-forming units/mL K pneumoniae. On this date, the patient also requested a psychiatric consult.

Plaintiff provided a medical consultation report for an exam of the patient performed on September 28, 2016. The patient presented with dyspareunia. She reported that this has existed since “the ‘traumatic’ (complicated) delivery in 2011.”

The report further indicated that she had used medication, including oxycodone, paracetamol, and ibuprofen, postoperatively since the delivery in 2011, and that she had remained on medication, including tramadol and oxycodone, which she uses 1 hour before any sexual intercourse and during her ovulation, which occurs 4 days per month. She also complained of menorrhagia and dysmenorrhea.

Allegations

The plaintiffs alleged that the fetal monitoring strips showed signs of fetal distress on a number of occasions throughout the labor that warranted earlier delivery by C-section. They also claimed that as a result of the misinterpretation of the strips and/or the failure to appreciate signs of distress on the strips, Defendant ob/gyn and hospital failed to timely diagnose and properly treat the arrest of labor.

Further, they alleged that Defendant ob/gyn and hospital failed to appreciate signs of infection 2 hours before the delivery and, thus, caused a further delay of about 2 hours between the call for delivery and the actual delivery. Plaintiffs claimed that thereafter, the patient was untimely and improperly treated for the infection, causing her infection to be more severe. The injuries claimed to be suffered by the infant include pain and suffering, infection, mental anguish, emotional distress, anxiety, fear of dying, and death due to an HAI.

The alleged injuries suffered by the patient included pain and suffering, infection, infected surgical wound, administration of antibiotics, having to seek additional medical care, having to undergo extensive tests, being incapacitated from attending to her usual duties, painful sexual intercourse, menorrhagia, and dysmenorrhea. The mother’s emotional damages for the infant’s death were dismissed pursuant to the decision on our motion for summary judgment.

Discovery

The patient testified that she experienced no fevers, sweating, tachycardia, or other signs of an infection in the weeks and days leading up to her labor or during her labor. She and her husband both testified to Defendant ob/gyn’s presence throughout the labor. They also claimed that the neonatologist told them that he felt, because of the strong and prolonged decelerations, that the C-section should have been performed earlier; according to the plaintiffs, the neonatologist said that the delay in the performance of the C-section was malpractice and that he felt the infant’s outcome would have been different if the C-section had been performed earlier.

Defendant ob/gyn confirmed that the plaintiff was delivered by C-section because of failure to progress relating to an arrest in dilation. He advised that it is possible for an infection to be asymptomatic, which this one was, and that no sign or symptom suggested an infection during labor. He stated that chorioamnionitis is not an indication for surgery, nor is meconium.

The presence of meconium did not change his management of the labor. He advised that an increase in the maternal or fetal heart rate alone or together does not diagnose chorioamnionitis, but that maternal fever and fetal tachycardia together would raise the suspicion of chorioamnionitis. Defendant ob/gyn confirmed that a maternal temperature of 99.6 F was not a fever, and the mother’s temperature never rose above this until after the delivery in the recovery room. In regard to the fetal monitoring strips, he testified that overall the baseline heart rate ranged from 140 to 155 BPM; the strips were reactive with moderate variability and thus were reassuring. He confirmed that he was aware of the multiple prolonged decelerations, but that there was never any point in time that the strips suggested an urgent or emergent reason to deliver the infant.

He would read the strips in long segments rather than section by section and, therefore, he was looking at the big picture of the labor. Defendant ob/gyn testified that, as standard, obstetricians attempt to do a C-section within 30 minutes of the call for it; extending the labor unnecessarily risks bleeding for the mother and infection for both mother and baby. He confirmed that this was not an urgent or emergent delivery, and when confronted with the fact that this plaintiff was not in the OR until 8:40 am, almost 2 hours after the decision for the C-section was made, he testified that the delay could have been caused by the ORs being occupied.

The neonatologist confirmed that the baby had bacteremia at the time of birth and that this later became sepsis. He felt there was no reason to suspect an MDR K pneumoniae and that this is what ultimately caused the infant’s death.

Result

Based upon the fact that the strips were not consistently reactive and did, in hindsight, suggest that the baby was sick, we estimated that the likelihood of a defense verdict was essentially a 50/50 proposition. We would have to walk a fine line in presenting a defense that suggested the infection was present prior to plaintiff’s hospital presentation but was not detectable or diagnosable prior to the delivery of the child, as the infection presented with no symptoms. This argument would place Defendant ob/gyn in a precarious position, as he was the physician in charge of the patient’s prenatal care, as well as her 17-hour labor at the hospital. Nonetheless, given the plaintiff’s 7-figure demand and the support of our experts in ob/gyn and infectious diseases, the decision was made to proceed to trial.

In the process of trial preparation and the scheduling of witnesses, the patient’s attorney proposed further negotiations and the case ultimately settled as to the hospital, only, for a more reasonable 6-figure award.