WHAT’S THE VERDICT?
The medical care and the federal-court bench trial held in front of a judge (not a jury) occurred in Florida. The verdict suggests that the ObGyn breached the standard of care by not offering or proceeding with a cesarean delivery and this management resulted in the child’s injuries. The court awarded damages in the amount of $33,813,495.91, including $29,413,495.91 for the infant; $3,300,000.00 for the plaintiff; and $1,100,000.00 for her spouse.4
Medical considerations
Refusal of medical care
Although it appears that in this case the patient did not actually refuse medical care (cesarean delivery), the case does raise the question of refusal. Refusal of medical care has been addressed by the American College of Obstetricians and Gynecologists (ACOG) predicated upon care that supports maternal and fetal wellbeing.5 There may be a fine balance between safeguarding the pregnant woman’s autonomy and optimization of fetal wellbeing. “Forced compliance,” on the other hand, is the alternative to respecting refusal of treatment. Ethical issues come into play: patient rights; respect for autonomy; violations of bodily integrity; power differentials; and gender equality.5 The use of coercion is “not only ethically impermissible but also medically inadvisable secondary to the realities of prognostic uncertainty and the limitations of medical knowledge.”5 There is an obligation to elicit the patient’s reasoning and lived experience. Perhaps most importantly, as clinicians working to achieve a resolution, consideration of the following is appropriate5:
- reliability and validity of evidence-based medicine
- severity of the prospective outcome
- degree of risk or burden placed on the patient
- patient understanding of the gravity of the situation and risks
- degree of urgency.
Much of this boils down to the obligation to discuss “risks and benefits of treatment, alternatives and consequences of refusing treatment.”6
Complications from vacuum-assisted vaginal delivery
Ghidini and associates, in a multicenter retrospective study, evaluated complications relating to vacuum-assisted delivery. They listed major primary outcomes of subgaleal hemorrhage, skull fracture, and intracranial bleeding, and minor primary outcomes of cephalohematoma, scalp laceration, and extensive skin abrasions. Secondary outcomes included a 5-minute Apgar score of <7, umbilical artery pH of <7.10, shoulder dystocia, and NICU admission.7
A retrospective study from Sweden assessing all vacuum deliveries over a 2-year period compared the use of the Kiwi OmniCup (Clinical Innovations) to use of the Malmström metal cup (Medela). No statistical differences in maternal or neonatal outcomes as well as failure rates were noted. However, the duration of the procedure was longer and the requirement for fundal pressure was higher with the Malmström device.8
Subgaleal hemorrhage. Ghidini and colleagues reported a heightened incidence of head injury related to the duration of vacuum application and birth weight.7 Specifically, vacuum delivery devices increase the risk of subgaleal hemorrhage. Blood can accumulate between the scalp’s epicranial aponeurosis and the periosteum and potentially can extend forward to the orbital margins, backward to the nuchal ridge, and laterally to the temporal fascia. As much as 260 mL of blood can get into this subaponeurotic space in term babies.9 Up to one-quarter of babies who require NICU admission for this condition die.10 This injury seldom occurs with forceps.
Shoulder dystocia. In a meta-analysisfrom Italy, the vacuum extractor was associated with increased risk of shoulder dystocia compared with spontaneous vaginal delivery.11
Intrapartum hypoxia. In 2003, the ACOG Task Force on Neonatal Encephalopathy and Cerebral Palsy defined an acute intrapartum hypoxic event (TABLE).12
Cerebral palsy (CP) is defined as “a chronic neuromuscular disability characterized by aberrant control of movement or posture appearing early in life and not the result of recognized progressive disease.”13,14
The Collaborative Perinatal Project concluded that birth trauma plays a minimal role in development of CP.15 Arrested labor, use of oxytocin, or prolonged labor did not play a role. CP can develop following significant cerebral or posterior fossa hemorrhage in term infants.16
Perinatal asphyxia is a poor and imprecise term and use of the expression should be abandoned. Overall, 90% of children with CP do not have birth asphyxia as the underlying etiology.14
Prognostic assessment can be made, in part, by using the Sarnat classification system (classification scale for hypoxic-ischemic encephalopathy of the newborn) or an electroencephalogram to stratify the severity of neonatal encephalopathy.12 Such tests are not stand-alone but a segment of assessment. At this point “a better understanding of the processes leading to neonatal encephalopathy and associated outcomes” appear to be required to understand and associate outcomes.12 “More accurate and reliable tools (are required) for prognostic forecasting.”12
Hypoxic-ischemic encephalopathy involves multisystem organ failure including renal, hepatic, hematologic, cardiac, gastrointestinal, and metabolic abnormalities. There is no correlation between the degree of CNS injury and level of other organ abnormalities.12
Differential diagnosis
When events such as those described in this case occur, develop a differential diagnosis by considering the following12:
- uterine rupture
- severe placental abruption
- umbilical cord prolapse
- amniotic fluid embolus
- maternal cardiovascular collapse
- fetal exsanguination.