Emails Show NECC Skipped Tests

By Walter F. Roche Jr.

Just weeks before a deadly outbreak became public the head of the company that caused the national health crisis told his workers that it was time that they started performing the product tests they should have been doing all along.
The email from Barry Cadden to his staffers at the New England Compounding Center was one of dozens of company records entered into the record Tuesday in the trial of six former NECC employees charged with racketeering, conspiracy and mail fraud.
Cadden, who already is serving a nine-year jail term, wrote in a 2012 email that NECC should have been doing end product testing prior to shipping drugs to hospitals and other health care providers across the country.
In fact, Cadden warned his colleagues that without those tests "People can die."
In a matter of weeks, the warning came true as the outbreak of fungal meningitis began to take the lives of patients in Tennessee and 19 other states. Ultimately 76 would die among nearly 800 that were sickened after being injected with fungus laden spinal steroids produced by NECC at its Framingham, Mass. facilities.
The six on trial before U.S. District Judge Richard G. Stearns were among 14 indicted in late 2014 following a two year federal probe of the outbreak.
Sara Albert, an investigator from the U.S. Defense Department, presented the exhibits which she said were gathered in the federal probe.
"We can't do what you are doing anymore," Cadden wrote in one email. "We're way to big to be cutting corners."
"We can't be caught with our pants around our ankles," he wrote in another.
In an email just days before the outbreak became public Cadden wrote,"We should do fungal testing on every lot of the steroids in the future."
Nonetheless in other emails entered in the case Tuesday, Cadden instructed staffers to "just re-label the old stuff" to ship a pending order.
Asked whether an expired chemical should be used for another shipmen, Cadden said to go ahead.
"Chemicals rarely expire," he wrote in an email.
In other emails, Cadden and Gregory Conigliaro, a defendant and former NECC vice president and part owner, discussed efforts to get an employee who had been working illegally as an NECC pharmacy technician, back his state registration. The effort included contact with a member of the state Pharmacy Board, Sophia Pasedis, who was also a top official at a sister company, Ameridose.
Lawyers for the six defendants subsequently challenged Albert, charging that prosecutors only presented parts of email chains, omitting messages that showed their clients were trying to do the right thing.
Noting that many of the exhibits focused on the steroids contaminated with fungus, Paul Kelly the attorney for defendant Christopher Leary turned the focus to emails in which his client was simply seeking a decision from Cadden.
"None of these defendants had anything to do with the MPA (steroids)," Kelly added.
In other emails cited by the defense lawyers, Sharon Carter, another defendant, repeatedly called on NECC customers to provide real names for the patients who were to receive NECC products. Prosecutors previously cited NECC records showing obviously fictitious patient names.
Still other emails showed Carter refusing to ship drugs until the customers provided real names. Other emails showed it was Cadden who made the final decision on whether to fill orders without real patient names.
In another email Cadden told Carter and others that only NECC's sales representatives would deal with the patient names issue and Carter and her colleagues should have no contact with customers.
Following Albert as a prosecution witness was Kristina Donahue of the U.S. Food and Drug Administration who was questioned about the standards her agency uses to evaluate drug compounders like NECC.
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