By Damian D. Capozzola, Esq.
The Law Offices of Damian D. Capozzola
Jamie Terrence, RN
President and Founder, Healthcare Risk Services
Former Director of Risk Management Services (2004-2013)
California Hospital Medical Center
Morgan Lynch, 2018 JD Candidate
Pepperdine University School of Law
News: A woman presented to a hospital for the delivery of her baby. After returning to the hospital following a discharge, the patient went into labor. She underwent an artificial rupture of membranes and was in a state of tachysystole. The physician prescribed Pitocin to augment the progression of labor and contractions. The fetus’ vitals indicated signs of hypoxia, and the Pitocin continued. The infant was delivered via spontaneous vaginal delivery and was diagnosed with severe hypoxia.
The infant was transferred to a children’s hospital, where he was diagnosed with severe hypoxic ischemic encephalopathy, seizures, respiratory distress, and coagulopathy. He later was diagnosed with cerebral palsy, requiring 24-hour care. A jury determined the child’s injuries were caused by the negligence of the physician and hospital, and returned a verdict for $14.5 million.
Background: In anticipation of the delivery of her child, a woman was given an estimated due date of July 14, 2012. She received prenatal care at a hospital in Erie, PA, before she transferred to a Clearfield hospital roughly four days before the estimated delivery date. Throughout the pregnancy, tests revealed the fetus was in good health.
On the afternoon of July 19, 2012, the patient presented to the Clearfield hospital with contractions spaced every 2-3 minutes, dilation of three centimeters, and an 80% effaced cervix. Just after 1:00 p.m., the treating physician discharged the patient with instructions to return when her contractions strengthened or her membranes ruptured. The mother returned to the hospital approximately three hours later, reporting pain, similar contraction frequency, and showing 5-6 centimeters of dilation.
Her dilation increased after admission to the hospital’s labor and delivery ward. She underwent an artificial rupture of membranes, revealing thick meconium-stained fluid. It was reported that the patient was frequently in tachysystole throughout the laboring process, a condition categorized by six contractions in a 10-minute period. Despite this, and without any signs of complication, the physician prescribed the patient Pitocin at 6 mu/min to augment the progression of labor.
During the labor, fetal monitor tracing showed increasing decelerations and other findings indicating progressive fetal hypoxia, hypoxemia, and acidosis that should have required intrauterine resuscitation and emergency delivery. Instead, the physician proceeded with spontaneous vaginal delivery.
The child was delivered at six pounds, 14 ounces. He appeared physically normal but was severely depressed, requiring immediate advanced neonatal resuscitation and intubation. The child’s Apgar scores were 1, 2, 3, 4, 4, 4, and 5 at 1, 5, 10, 15, 20, 25, and 30 minutes, respectively. He had severe metabolic acidosis on cord PH, indicative of acute hypoxia during labor. The child was treated with therapeutic cooling the next day at a children’s hospital and diagnosed with severe hypoxic ischemic encephalopathy, seizures, respiratory distress, and coagulopathy. The child also was diagnosed with cerebral palsy, for which he will require 24-hour care.
The infant’s parents contended the physician negligently administered a high dosage of Pitocin, failed to properly monitor the pregnancy and observe that the mother’s contractions had been progressing, and failed to swiftly deliver the baby when the heart rate began to drop. In her complaint on behalf of her son, the plaintiff listed 27 distinct injuries. The complaint also alleged negligence by the Clearfield hospital for failure to monitor the labor and otherwise alleged similar contentions as those set forth against the physician.
The defendants contended the physician followed proper procedures and that the injuries were the result of other factors not within the hospital’s control, such as the mother’s obesity, fetal exposure to secondhand smoke, and other health problems. The defense expert opined that the placenta was abnormally small for the size of the fetus and might have been inadequate to sustain the needed oxygenation during the second stage of labor.
The jury found the physician 60% negligent, while the Clearfield hospital was found to be 40% negligent. The plaintiff was awarded $14.5 million for past and future medical expenses, future lost wages, and past and future pain and suffering.
What this means to you: The American College of Obstetricians and Gynecologists reported the number of induced labors has doubled since 1990. Considering this statistic, it is imperative that medical professionals use uterine stimulants, such as Pitocin, properly. These stimulants are used frequently to induce labor when it does not begin naturally. The stimulants also are used, as here, to augment the strength and frequency of contractions when labor is stalled, or otherwise progressing improperly.
When uterine stimulants are used, it is critical to establish baseline vital signs to determine the way in which the mother and child react to the drug. Furthermore, once the stimulant is administered, monitoring and documenting vital signs allows for faster detection of problematic changes in the mother’s or the fetus’ condition. Such documentation should include the dosage and timing of all medications administered, and any side effects. Changes in pulse and mother’s blood pressure also should be monitored closely. Some stimulants, when given intravenously, should be diluted in IV fluid, and should not be administered if there is any question about the condition of the fetus, such as nonreassuring fetal heart rate tracing. Methergine, in particular, is not to be given intravenously, and should not be administered to a woman with hypertension.
Against this background, it is clear that the physician here did not act within the standard of care. He did not act appropriately when the fetal monitoring strips were not reassuring. When a mother is in a state of tachysystole, administration of a uterine stimulant is inadvisable absent other indications necessitating such a medication. In fact, there were several indications that contraindicated the use of Pitocin, such as decreased heart rate and blood pressure. Note also that when the patient presented to the hospital the first time, she was already 80% effaced. Fetal monitoring should have started then, as this was a high-risk patient with three risk factors: hypertension, obesity, and a smoking history. When she returned a few hours later, monitoring showed a slowing of the fetal heart rate during and immediately after each contraction, indicating decelerations during contraction. These did not return to baseline following the contractions, possibly due to tachysystole or other issues. These, combined with the presence of thick meconium following artificial rupture of membranes, were clear indicators that the fetus was in severe distress. An immediate cesarean section should have been considered and offered to the patient.
Meconium is produced in utero when the fetus is stressed and the contents of the bowel empty into the amniotic sac. The meconium can enter the fetal lungs during the laboring process, further compromising the oxygen saturation of blood reaching the brain. Pitocin was contraindicated and well below the standard of care, as contractions needed to slow to allow the fetal heart to recover between contractions.
This case also illustrates the value in documenting and monitoring medication administration. This serves to prevent negative effects of improper medication dosage and helps develop a medical record. Patients can suffer allergic reactions to medications, adverse interactions with other unknown medications or alcohol, or side effects from medication. Not only is monitoring and documentation important, but responding promptly and correctly is equally imperative for the care of a patient. Medical professionals must be educated and familiar with hospital policies relating to specific medications and circumstances.
Considering physicians may overlook changes in patient vitals, it also is imperative that hospitals empower supporting medical staff to report and react to concerning changes. The creation of a chain of command for medical professionals is valuable in situations where physicians neglect to either monitor medications or respond to problematic changes. Nurses and physician assistants should feel confident in their ability to quickly consult with their head nurse, director of nursing, and chief nursing officer. Further, such personnel should be reminded that they act as patient advocates, and that asking for help does not equate to incompetence. Individuals in the chain of command must be sufficiently competent and confident to manage such requests, and, to avoid misunderstandings, the chain of command must be very clearly articulated to each employee.
A prudent practice in labor and delivery departments is validation of inter-rater reliability for all involved with interpretation of fetal monitoring strips. Confirmation of a standard language and parameters leaves little for debate when abnormalities are noticed. Nurses and physicians can engage in rapid and open decision-making discussions free of power struggles. In most OB emergencies, there is no time to ascend the chain of command.
Finally, physicians should be instructed to encourage medical professionals to communicate changes in patient vitals immediately to ensure they can act quickly and appropriately in all situations. In labor, the vitals of a fetus can change fast and, as in this case, the changes can cause devastating and irreparable harm. Therefore, communication among all staff members must be encouraged and reinforced.
Decided on Jan. 27, 2017, in the United States District Court, W.D. Pennsylvania; case No. 3:14CV00149.