Presentation and physician action
A 34-year-old woman came to an ob-gyn for prenatal care on May 25. This was the patient’s fifth pregnancy. An ultrasound was performed and the patient’s estimated delivery date was determined to be December 8. The patient reported that she was taking benazepril 10 mg for hypertension, prescribed by her primary care physician.
The patient’s next appointment was June 8. It appears from the record that her dosage of benazepril was increased to 20 mg on this visit. The patient was again seen on June 28 and July 13.
During a July 16 visit, the patient complained of a greenish vaginal discharge. The ob-gyn admitted the patient that day. Her assessment was a 32.5-week pregnancy with prolonged rupture of the membranes, meconium-stained fluid, and breech presentation. The ob-gyn performed a cesarean delivery, delivering a girl. The placenta was noted to be small and the umbilical cord was “very thin.”
The baby was diagnosed with renal failure with anuria, hyaline membrane disease, and pulmonary hypertension. She was transferred to a children’s hospital where it was determined that she could not regain renal function. The baby was taken off life support and she died on July 28.
According to the autopsy report, the primary diagnosis was ACE inhibitor fetopathy with anuria, along with poorly controlled hypotension; hemodynamic changes of fluid overload; acute and terminal brain hypoxic ischemic changes; and findings associated with prematurity.
The pathologist wrote, “In conclusion, it should be noted that not all women treated with ACEI during pregnancy have untoward effects and it is likely that a combination of dosage, duration of treatment as well as genetic variations in different populations influenced the eventual fetal outcome.”
Allegations
A lawsuit was filed against the ob-gyn. The plaintiffs alleged that benazepril is a dangerous drug for pregnant women and is known to be associated with significant morbidity and mortality to the fetus. This medication should have been discontinued and substituted for a safer ACE inhibitor.
Legal implications
An ob-gyn who reviewed this case for the defense was critical of the prescription and continuation of benazepril to the patient. The medication should have been discontinued immediately at the first prenatal visit. This ob-gyn referred to the failure to discontinue benazepril as a “serious error that allowed the fetus to be exposed to the dangerous medication for additional weeks prior to her birth.” Two other ob-gyns who were consulted on this case agreed. The defendant ob-gyn also agreed that she should have discontinued benazepril.
Disposition
This case was settled on behalf of the ob-gyn.
Risk management considerations
Being an educated prescriber of medications is vital for physicians. When a patient comes to her first prenatal visit with a list of medications, it is good risk management practice to review the list for patient and fetal safety. Some medications may be safely discontinued; but, if the patient has a condition that requires close monitoring, then prescribing a safe substitute is optimal.
Many electronic medical records come with prescribing programs that feature black box warnings for medical conditions, drug/drug interactions, and drug/food interactions.
At each visit, the patient should be asked about the medications she is taking and if there have been any changes since the last visit. If the physician prescribes a new medication, document that the patient was told about the side effects and potential adverse interactions.
