Attorney: Expired Chemicals Not Meant for Drugs

By Walter F. Roche Jr.


Boston, Mass. An attorney for one of the defendants charged in the wake of a deadly meningitis outbreak today charged that some of the expired drugs seized by federal investigators and paraded before jurors in an ongoing criminal trial were never intended for use as active ingredients in medicines meant for human consumption.
Paul V. Kelly, the attorney for a former pharmacist at the New England Compounding Center, charged that the large vial of outdated formaldehyde along with containers of five other expired drugs seized from a now defunct drug compounding center and paraded before jurors was never intended as active ingredients for use in drugs for human consumption.
Kelly's statement came as he cross examined Michael Mangiacotti, a criminal investigator for the U.S. Food and Drug Administrator and one of more than a dozen federal agents who searched NECC's Framingham, Mass. headquarters in October of 2012.
Kelly represents Christopher Leary, one of six former NECC employees on trial for charges ranging from racketeering to mail fraud and conspiracy. They were among 14 indicted in 2014 following a two year probe of the 2012 outbreak that killed 76 patients across the country including 16 from Tennessee.
Federal regulators concluded that fungal contamination of an NECC steroid, methylprednisolone acetate, caused the outbreak which also sickened over 700 other patients in 20 states.
Asked by Kelly if the acetic acid or other expired drugs would have been used in the production of drugs for use in humans, Mangiacotti said he was not a pharmacist and couldn't answer the question. E
Mangiacotti did testify about other seized and expired drugs which went unchallenged by Kelly and the other defense attorneys. Those included long expired methotrexate, a drug used to treat cancer patients. In prior related trials prosecutors presented evidence showing NECC did ship the methotrexate to health care providers, despite its age.
Kelly and other defense attorneys also questioned Mangiacotti about the involvement of Sophia Pasedis in the operation of NECC and a sister drug firm, Ameridose. Pasedis was also a member of the state Board of Pharmacy, which licensed NECC.In the midst of the outbreak, Pasedis was asked to resign but refused. Her term later ran out and was not renewed.
Noting that Pasedis was never charged, Kelly asked if she also held a position at NECC at some point in time. Mangiacotti said he did not know.
Michael Pinneault, the attorney for defendant Sharon Carter, also questioned Mangiacotti about a document seized in 2012 showing Pasedis was among a group of NECC and Ameridose officials slated to attend a company strategy session prior to the raid.
Mangiacotti said he did not know whether the strategy session ever took place.
In addition to the seized and expired drugs Mangiacotti testified about hundreds of pages of other records seized from NECC during two raids in October of 2012. Those included emails and memos in which NECC officials discussed problems in complying with a requirement in Massachusetts and many other states for an patient specific prescription for every dose of a compounded drug.
One of those emails stated that in the future all new customers would have to provide patient names unless approved by then NECC President Barry Cadden or sales chief Robert Ronzio.
Cadden has already been convicted of racketeering and related charges and is serving a nine year prison term. Ronzio has entered a guilty plea to a single conspiracy charge and is awaiting sentencing. He is expected to appear as a prosecution witness.