A recent malpractice case involved a cardiologist who prescribed amiodarone, a drug with a black box warning, to a patient with heart palpitations.
"The drug, at that time, was commonly being used for patients with heart palpitations, but there was a black box warning indicating that it could cause loss of vision," says Lizabeth Brott, JD, regional vice president of risk management at ProAssurance Companies in Okemos, MI.
Within 24 hours of starting the medication, the patient reported headaches and blurred vision. "The cardiologist explained to the patient that to effectively treat her, she would need to stay on the medication for a while, and the patient was left on the medication for five weeks," says Brott.
Subsequently, the patient saw an ophthalmologist who confirmed a decrease in visual acuity. "The patient returned to the ophthalmologist four months later complaining of blurred vision which had subsequently resolved. The patient was told to return immediately if it occurred again," says Brott.
The patient returned to the ophthalmologist two months later and was referred to a retinal specialist who noted elevated pressure in both optic nerves. The patient was referred to a neurologic ophthalmologist, who diagnosed optic neuritis and recommended the patient’s cardiologist switch her to another medication.
"The neurologic ophthalmologist’s notes concluded the patient, probably experienced ischemic optic neuropathy possibly complicated by the amiodarone,’" says Brott. "So we now had documentation potentially linking the drug to the blurred vision."
Plaintiff didn’t pursue claim
The patient subsequently had cataracts removed from both her eyes.
"This ultimately resulted in overall visual acuity of 20/30," says Brott.
The patient sued the cardiologist. The plaintiff’s cardiology expert produced several articles that suggested there was strong circumstantial evidence linking the drug to optic nerve injury.
"The plaintiff’s cardiologist expert maintained that amiodarone was an inappropriate choice, and an ophthalmologist was willing to testify that 98% of the patient’s visual defects were caused by amiodarone-induced optic neuropathy," says Brott.
The black box warning indicated that amiodarone should only be administered in a controlled hospital setting and that the patient should be strictly monitored during a limited course of treatment.
"It also indicated that baseline lab work should be obtained, which did not occur in this case," says Brott. "The PDR’ [Physicians’ Desk Reference’] also warned of possible optic neuropathy."
Despite this information, the case was dismissed prior to trial. Here are some reasons why the defense was successful:
• The defense cardiology expert witness was prepared to testify that amiodarone was appropriate to use as a first-line rhythm control agent for treatment of atrial fibrillation, given the patient’s medical problems and history.
• A neuro-ophthalmologist was prepared to testify there was no causal link between the amiodarone and the optic neuritis, and that given the patient’s medical history, it was likely the vision loss was associated with an ischemic event resulting in ischemic optic neuropathy.
• A National Institutes of Health researcher was prepared to testify that given the patient’s age, that amiodarone was an acceptable first-line rhythm control agent for treatment of atrial fibrillation, and that age, smoking, hypertension and drinking made the plaintiff a likely candidate for structural heart problems.
"All of these factors combined ultimately led the plaintiff to decide not to pursue the case," says Brott.