2012 meningitis outbreak: Pharmacists on trial for allegedly approving phony prescriptions

BOSTON - A criminal investigator detailed on Monday dozens of fake prescriptions seized at a now defunct drug compounding company when an investigation was opened into the cause of a 2012 fungal meningitis outbreak that eventually led to the death of more than 100 patients.

Testifying in U.S. District Court, Michael Mangiacotti, of the U.S. Food and Drug Administration, said the phony prescriptions seized included patient names including L.L. Bean, Filet O Fish, Cocoa Puff and Harry Potter.

He told jurors that the records showed the prescriptions were verified in 2012 by Kathy Chin and Michelle Thomas, two licensed pharmacists then employed by the New England Compounding Center, the company ultimately blamed for the outbreak.

The two are on trial on charges that they violated the federal Food Drug and Cosmetic Act (FDCA) by effectively issuing the prescriptions for fictitious patients.

Lawyers for the two defendants countered by arguing that other NECC employees, not Chin or Thomas were responsible for verifying the patient names and their clients merely verified the type of drug ordered and the health facility that placed the order.

The trial is the fourth and final one to result from a 2014 indictment that named 14 defendants, two of who are already serving terms in federal prison. One of those already jailed in Glenn Chin, Kathy Chin's husband, but that information was not provided to jurors.

The charges against Chin and Thomas do not involve the drug methylprednisolone acetate, which caused the outbreak, but other drugs shipped to health facilities in Nebraska and Indiana.

Under questioning by Assistant U.S. Attorney Christopher Looney, Mangiacotti said he was one of many federal investigators called in to investigate NECC as the outbreak worsened in the fall 2012.

He said the records seized from NECC's Framingham, Massachusetts, facility included dozens of order forms that had been faxed from health facilities across the country.

Focusing on orders verified by Thomas and Chin, he read the names of the purported patients including Bradd Pitt, Flash Gordon and Johnny Cash.

Under Looney's questioning Mangiacotti said the records showed Thomas and Chin were listed as the verifying pharmacist for the orders. Specifically the two are charged with a total of six violations of the FDCA.

Mangiacotti said other records seized from NECC included the personnel files for Chin and Thomas. Thomas had only joined the company in March 2012 and departed in August before the outbreak became public. Chin had joined NECC in 2010 but had left for two maternity leaves by the time the outbreak became public in late September 2012.

Joan Griffin, Chin's lawyer, in cross examination of Mangiacotti, challenged why he had not also investigated the health facilities that ordered the drugs from NECC and submitted orders with patently false patient names. The FDA investigator said he did not know whether other investigators had investigated the health facilities.

Griffin and Michael Bourbeau, Thomas' lawyer, also charged in opening statements that it was Barry Cadden, the now jailed NECC president and part owner, who was responsible for the prescriptions being processed with fake names.

Cadden was convicted of racketeering and mail fraud, but that information, like Glenn Chin's conviction, was not conveyed to the 14 jurors hearing the case. Chin is serving an eight year sentence while Cadden got a nine year sentence.

Bourbeau, in his presentation and questioning, noted that his client only worked for NECC for a short period of time and was gone even before the outbreak became public.
In questioning Mangiacotti, Bourbeau asked about an interview the agent held with his client in which she did raise questions about questionable practices at NECC.

Mangiacotti acknowledged that he had heard that Thomas had some concerns and that was why he interviewed her. But, he said, she made no mention of fake patient names.
He also cited an email exchange in which another NECC employee, not his client, gave the final go-ahead to ship a questionable prescription.

The two defense attorneys argued that it was the health facilities and their officials who balked at giving real patient names due to a federal law and privacy concerns.