The defense lawyers acknowledged there was a breach, noting the dosage was “excessive.” However, they argued that this error didn’t matter because the drug was no longer active in the patient’s body. In other words, there was no causal connection between the inappropriately high dose and the resultant uterine tachysystole and fetal distress. This is a difficult road for several reasons.
First, the chief danger of using misoprostol is uterine hyperstimulation and fetal distress. The defense would have to argue the hyperstimulation and fetal distress were coincidental and unrelated to the misoprostol—which carries a black box warning for these very adverse effects. The plaintiff’s attorney is sure to make a big deal out of the black box warning in front of the jury—noting any reasonable clinician practicing obstetrics should be aware of the risks that come with misoprostol’s use. You can almost hear the argument in summation: “It is so important, they drew a warning box around it.”
Furthermore, making the argument that the misoprostol was not in the mother’s system at the time the fetal distress started would entail dueling expert testimony about pharmacokinetics and bioavailability—concepts that are difficult for lay jurors to understand. Misoprostol has a half-life of about 20 to 40 min when administered orally and about 60 min when administered vaginally.4 We know the mother received the overdose of misoprostol at 12:24 pm and a little over an hour later, fetal monitoring was discontinued, leaving the patient unmonitored for 3.5 hours. The agent would have been active or at least potentially active when the monitoring was discontinued—but, the defense argued, was the misoprostol biologically active at 5 pm when uterine tachysystole and late decelerations were noted?
The plaintiff’s team might counter with an expert’s explanation that misoprostol’s bioavailability is increased 2- to 3-fold with vaginal versus oral administration. It would also be observed that compared with oral administration, vaginal administration of misoprostol is associated with a slower increase in plasma concentrations but longer elevations (peaking about 1-2 hours after vaginal administration).5
At best, the defense expert would be able to argue that the serum level likely peaked 1 to 2 hours after administration (1:24-2:24 pm) and was on its way down when the uterine tachysystole and late decelerations started. During cross-examination, plaintiff’s counsel would secure key expert witness admissions that vaginal absorption is less studied and less certain than oral administration and that “there was no way to be sure” what the patient’s blood level was when the fetal distress was finally detected. The expert would have to acknowledge the black box warning—a concept that is quite easy for a jury to grasp.
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