Details Disclosed on 20 Fatal Outbreak Victims

By Walter F. Roche Jr.

BOSTON, Mass. - Case by case a health official today went through the names, causes of death and and other details of 20 of the patients from seven states who died in the 2012 fungal meningitis outbreak.
 Ann Burgess, who holds a Ph.D. in nursing, cited the deaths of victims from Michigan, Tennesseee, Indiana, Maryland, Virginia, North Carolina and Florida in testimony in U.S. District Court. Burgess was a prosecution witness in the case of Barry J. Cadden.
Cadden has been on trial for over a month on charges of racketeering and 25 counts of second degree murder, along with mail fraud.
In nearly all of the cases, Burgess cited fungal meningitis as the direct or secondary cause of the deaths.
The death certificate for Diana Reed, 56, of Nashville listed "fungal meningitis" as the cause. She had three injections in August and September of 2012, Burgess testified. She died on Oct. 3.
The death certificate for Thomas Rybinski of Smyrna listed "complications of aspergillus meningitis" as the cause.
As each case was detailed, jurors were shown a photo of that victim.
Pauline Burema, an Indiana victim, was 89 when she died  in 2012. "Injected with tainted steroid," records of her case state.
Godwin Mitchell, 88, died March 18, 2013 after being injected with "a tainted steroid" at a Virginia clinic, Burgess said.
Prosecutors have presented other evidence on the deaths in the indictment not included in Burgess testimony.
The jury also heard testimony from an investigator from the U.S. Food and Drug Administration about the shipment of three lots of fungus laden methylprednisolone from Cadden's company, the New England Compounding Center, to health facilities including the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn.
Joseph Ridgley said the Nashville clinic got four shipments between June and early September of 2012. The cost of the orders, all for 500 vials, ranged from $3,270 to $3,430 vials.
Similar details were provided for shipments to Michigan Pain Specialists and an Indiana clinic, two other sites where victims were injected.
Under questioning by prosecutors, Ridgley matched a list  NECC drugs with some of the charges that have been leveled against Cadden. The drugs included some that did not have the required potency and others in which the ingredients had gone past their expiration date.
He also testified about drugs compounded by co-defendant Scott Connolly who was not registered as a pharmacy technician, as required under Massachuetts law.
The FDA investgator said Connolly compounded a drug called cardioplegia which was shipped to a Las Vegas hospital before test results came back. He said Connolly signed company records using Cadden's initials.
Ridgley also testified about a long list of other NECC drugs that did not meet specifications but are not included in the indictment.
Asked if any of those drugs caused any harm, Ridgely responded "I'm not aware of any."
FBI Agent Philip Sliney presented a chart showing NECC drugs that did not contain the required ingredients including a drug used in eye surgery that was shipped to the Massachusetts Eye and Ear Infirmary.
Another drug that didn't meet specifcations was shipped to a Tavares, Fl clinic, he said. Both of those cases were included in the indictment, he testified.
Under cross examination, Bruce Singal, Cadden's lawyer questioned how Cadden could be charged with a felony because an NECC clean room worker didn't put enough ingredients in a drug. He also noted that the long list Sliney presented included multiple entries for the same drug, an antibiotic.
His cross examination will continue Tuesday.
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Named Victims and Dates of Death

Michigan: Karina Baxter (9/23/12), Paula Brent (11/17/12), Gayle Gipson (10/26/12), Donna Kruzich (10/8/12), Lynn Lapierre  10/17/12), Mary Pletti (8/23/12), Sally Roe (10/18/12), Emma Todd

Tennessee: Marie Hester (11/1/12), Eddie Lovelace (9/17/12), Donald McDavid (11/4/12), Diana Reed (10/3/12) , Thomas Rybinski (9/29/12), Carol Wetton (4/16/13), Earline Williams (10/15/12)

Indiana: Pauline Burema (10/10/12), Kathy Dillon (11/5/12), Alice Machowiak (12/10/12)

Maryland: Bahman Kashi (1/28/13), Brenda Rozek (9/16/12), Edna Young (12/31/12)

Virginia: Kathy Sinclair (1/19/13), Douglas Wingate (9/18/12)

Florida: Godwin Mitchell (3/18/13)

North Carolina: Elwina Shaw (10/19/12)