State Official Backs Charges

By Walter F. Roche Jr.

BOSTON- A Massachusetts official gave damning testimony today as federal prosecutors indicated they may soon rest their case against two pharmacists charged with violating a federal drug law. The two were swept up in a two year probe of a deadly fungal meningitis outbreak caused by the company that employed them.
Samuel J. Penta, chief investigator for the Massachusetts Board of Pharmacy, said the practices at the New England Compounding Center violated state laws and regulations. He said that while licensed pharmacists were responsible for verifying that valid prescriptions had been issued for drugs being dispensed, some patient names on prescriptions issued by NECC were obviously fake.
U.S. District Judge Richard G. Stearns, meanwhile told jurors that they should be prepared for an extended session tomorrow and disclosed he was preparing final instructions that will be given to jurors before they begin deliberations. Initially lawyers involved in the case had predicted the trial, which began Monday, would go into a second week.
The trial is the fourth and last resulting from the indictment of 14 persons affiliated with NECC, the company blamed for the 2012 outbreak that sickened nearly 800 patients, killing over 100 of them
Chin and Thomas were not charged with compounding the specific drug blamed for the outbreak but for the preparation of other drugs in violation of the the federal Food Drug and Cosmetic Act.
Penta said the forms used by NECC did not comply with Massachusetts laws and regulations mandating that an individual patient-specific prescription be issued for every drug dispensed.
"A prescription has to be verified before dispensing," Penta said, adding that the pharmacist was responsible for ensuring that the prescription was written for a specific patient. And, he added, that responsibility could not be delegated.
Penta also testified about his involvement in the investigation of NECC when the outbreak first surfaced in late September and early October of 2012. He said he and other staffers from the state board visited NECC's facilities and he was immediately overwhelmed by the volume of NECC's business.
He said it appeared to be acting as a drug manufacturer, not a local pharmacy as it was licensed,
He said fork lifts were being used to move around supplies.
"They were compounding on a large scale" Penta said.
On cross examination Chin's lawyer, Joan M. Griffin, confronted Penta with a 2013 letter to her client from the state board informing her that an investigation of her had been closed with no action being taken. And, she noted, Chin still has a valid pharmacist license.
Assistant U.S. Attorney Amanda Strachan later asked Penta whether the state investigation had been closed at the request of the U.S. Attorney's office. He said that was the case.
Griffin also questioned Penta about a letter sent to the board by NECC President Barry J. Cadden describing a new NECC procedure to assure orders were placed for real patients.
Penta said that the letter was Cadden's response to a board inquiry and did not indicate the board approved the new procedure.
It was superseded, Penta said.
Also testifying for the prosecution was Scott Connelly, who already has entered a guilty plea to ten counts of mail fraud. He testified that drugs he compounded were distributed without being checked by a licensed pharmacist. Though jurors were not told the details, Connolly's charges stem from his working as a pharmacy technician when he had surrendered his certification due to an unrelated investigation.
Connolly said he signed in to the computer system using the ID of NECC President Barry J. Cadden. Cadden is serving a nine year federal prison term following his conviction on racketeering and mail fraud charges.
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