A Houston County jury has awarded more than $20.5 million in damages against a pharmaceutical company.
The award of $17.5 million in punitive damages and more than $3 million in compensatory damages to retiring kindergarten school teacher Ann Pope and her husband, Anthony, came after an eight-day trial in State Court. The trial ended earlier this week.
The jury sided with the Popes’ claim that Akorn Inc. failed to include in its prescription warning labeling that a drug — methylene blue — that it manufactures would react adversely with another drug — Effexor XR — that Ann Pope was already taking.
Pope alleged she was given methylene blue during a surgery Sept. 11, 2013, at Perry Hospital and suffers from permanent cognitive injuries from the effects from the interaction of the drugs. The interaction of the drugs allegedly created a toxic level of serotonin in the brain known as serotonin syndrome.
“Following the surgery, Mrs. Pope awoke highly agitated with seizures and labile vital signs, and was diagnosed with serotonin syndrome caused by the combination of methylene blue and effexor,” according to a pretrial order.
“This serotonin syndrome caused Mrs. Pope to suffer a coma, a lengthy hospitalization, transfer to the Emory Healthcare Neuro Intensive Care Unit in Atlanta, extensive medical treatment including heavy benzodiazepine therapy, narcotic drug therapy, mechanical ventilation, hospital bed restraints, physical therapy, speech therapy, and permanent cognitive and other injuries.”
Judge Jason Ashford said the $20.5 million is the highest civil award granted in Houston County State Court in at least the past 30 years.
The compensatory damage award was based on medical bills, lost wages and related expenses, said Paul G. Phillips of Albany, one of the attorneys representing Ann and Anthony Pope.
Ann Pope was in a coma and her injuries are forcing her early retirement, he said. The punitive damages penalize the company.
“What they did was really egregious,” Phillips said. “I mean, they had a couple of different FDA warnings that had gone out two years before this warning of this specific interaction and informing them that other manufacturers were having serious injuries due to this interaction.
“And a couple of other manufacturers had already changed their labels to warn about it, and Akorn just acknowledged the information, and just said, ‘No,’ we’re going to choose not to change it. It was a willful, intentional choice, and it really resulted in some very serious injuries to Ann,” Phillips said.
Michael P. Bruyere and Ryan W. Babcock, Atlanta attorneys representing Akorn, could not be reached for comment Friday.
In the court filings, Akorn argued that there was no FDA directive to change its prescription warning labeling and that no related complaints were found its database after FDA issued the “safety communications” in 2011.
Also, Akorn contended that a drug interaction involving the company’s methylene blue could not be proven to have caused Ann Pope’s alleged serotonin syndrome, and that there was no evidence that she has any permanent, recurrent injuries from serotonin syndrome.
Additionally, Akorn alleged that Effexor’s label did include a warning of potential interaction with methylene blue, but that the hospital computer system did not screen most medications taken at home with drugs given in the hospital for drug interactions. Also, Akorn claimed her surgeon knew she was taking Effexor when he ordered that the methylene blue be given, though he was not aware of the potential adverse interaction.
The Popes originally filed their case as a medical malpractice lawsuit against Houston Healthcare, which operates Perry Hospital, and against Pope’s surgeon, Dr. Horatio V. Cabasares. Akorn was later added to the complaint, according to State Court records. The Popes subsequently released Houston Healthcare and Cabasares from the complaint, Phillips said.
“Basically, we discovered as we got into that they didn’t do anything wrong, frankly,” Phillips said.
The case went to trial as a pharmaceutical product liability case.