Wednesday, January 25, 2017
Doctor Says Some Outbreak Victims Face Lifelong Battle
By Walter F. Roche Jr.
BOSTON, Mass. A physician who unknowingly injected dozens of his patients with a fungus tainted steroid says some of the victims will be fighting lingering infections for the rest of their lives.
Dr. Edward Washabaugh testified in U.S. District Court that federal officials concluded 17 patients at Michigan Pain Specialist clinics died as a result of being injected with methylprednisolone acetate contaminated with fungus.
His testimony came in the trial of Barry J. Cadden, who has been charged with racketeering and 25 counts of second degree murder for his role in the deadly 2012 outbreak. Cadden was president and part owner of the New England Compounding Center, the company that produced the deadly steroids.
The 15 juror also heard further testimony from a former NECC employee, Owen Finnegan, who described how he and other workers switched labels on drug products concealing the fact that components had expired.
He also described how completely unlabeled and undated drugs were stored in plastic bags within the NECC clean room for use when orders overwhelmed the staff.
Washabaugh, the Michigan physician, said he first learned of the outbreak on Oct. 3 from a message that had been left on the clinic's voice mail the night before.
At first, he said, he didn't grasp how serious the situation was. He learned fast.
"By Oct. 5 two of my patients had died," Washabaugh said.
Asked to describe his first telephone conversations with the victims and survivors of victims, the pain specialist turned away, paused and then, trying to collect himself poured a glass of water, before continuing his testimony.
He said his first call was to a patient who was indeed sickened and died two weeks later.
He said as the days passed the clinic went into triage mode, first, on instructions from state and federal regulators, calling all the patients who had received shots from the lot of drugs identified by those officials as the likely source. The clinic had been shipped one of three suspect lots of methylprednisolone acetate.
He said the clinic tried to reach NECC, but the calls went unanswered.
Washabaugh said that the apparent cases quickly began to multiply, ultimately some 230 clinic patients were sickened.
He said a special unit was set up at a nearby hospital, Saint Joseph's Medical Center. Doctors, he said were working double shifts performing spinal taps on patients to test for any traces of fungal meningitis. Some patients had to undergo multiple taps.
In addition to meningitis, Washabaugh said they were discovering patients who had injections in joints, such as hips and knees were suffering from abscesses caused by the NECC steroid.
"These were very painful," he said.
The infected patients were treated with powerful antifungal medicines which Washabaugh said were the equivalent of chemo.
"These drugs are very very harsh," he said.
In addition to Washabaugh, a clinic employee, Deborah Kushman, testified about how the clinic became an NECC customer. She said she saw a company display at a trade show in 2005 and saw a display describing NECC's state of the art facilities and its compliance with highest sterility standards set by a nation agency.
"I wanted to make it was what it said it was," she stated, adding that she contacted a sales representative who assured her that NECC drugs would only be shipped after they tested negative for the presence of endotoxins or micro-organisms.
The jury also heard testimony from Andrew Cordiale, a drug buyer from a Glens Falls, NY hospital, who said after the facility became an NECC customer they were instructed to include fake names of patients when submitting orders. He said they were instructed to make sure the names sounded legitimate.
"They just needed a name to fill it in," he said, "a name that sounded real enough."