Tuesday, January 17, 2017
Outbreak Doctor Breaks Down on Witness Stand
By Walter F. Roche Jr.
BOSTON, Mass. A doctor who suddenly found himself in the midst of a growing public health crisis broke down in tears as he told a jury about his first encounter with patients who had been sickened from injections he administered.
Testifying in U.S. District Court, Dr. John Culclasure said he and his colleagues had expected the patients to be angry and blame them for the fungal meningitis they were suffering from.
"Instead they were concerned about us. I was shocked," Culclasure said.
U.S. District Judge Richard G. Stearns called a short recess as Culclasure wiped tears from his eyes.
Culclasure was the medical director and chief physician at the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn., the clinic where 115 patients were sickened after being injected with fungus laden spinal steroids shipped from a now defunct Massachusetts drug compounder.
The testimony came at the beginning of the second week in the criminal trial of Barry J. Cadden, the president and part owner of the New England Compounding Center, the company blamed for the 2012 outbreak which sickened some 778 patients, killing 76 of them. Cadden is facing charges of racketeering and 25 counts of second degree murder.
Culclasure said that 13 patients from the Nashville clinic eventually died, including Thomas Rybinski, the first patient to be identified as a victim. He said they later learned that there was an even earlier Tennessee victim, Kentucky Judge Eddie Lovelace. The judge's body had to be exhumed to determine the cause.
The doctor described the first hints of the outbreak, including the news that Rybinski was under treatment for a fungal infection at the nearby Vanderbilt University Medical Center.
"I was trying to see what was common among the victims," Culclasure said. He said in addition to the methylprednisolone acetate from NECC, patients were treated with a numbing agent and a dye before the spinal injection.
He said they closed the clinic and then started calling all the patients recently injected to see if they were showing symptoms of meningitis.
"The patients kept coming," he said. "It didn't make sense to me. I've never seen anything like that in all my years of training."
Though at first there was concern that something at the clinic was to blame, he said that was eventually eliminated when outbreak cases began popping up across the country. That left the NECC steroid as the common denominator.
Once victims were identified, he said they were put on powerful anti-fungal medications. He said those medications were extremely toxic. "The cure was almost as bad as the disease itself," he said
He said that as the enormity of the crisis became more apparent Tennessee Department of Health officials stepped in and began directing the efforts. He said those state officials directed his staff not to use the word meningitis in talking with patients.
Under cross examination by Bruce Singal, Cadden's attorney, Culclasure was questioned about the clinic's decision to purchase drugs from NECC.
Asked if NECC filled an important need, Culclasure said yes. He said the clinic began sending NECC lists of patients after the company told them they were needed due to a Massachusetts law. But he acknowledged they couldn't really identify which patients would be injected ahead of time.
He also acknowledged that the fungus found in Rybinski, aspergillus, was different than the fungus found in other clinic victims.
Court records show the Nashville clinic reached a settlement in a civil suit brought by outbreak patients, but the terms of that settlement have not been made public.