Key Timing Data Challenged in Cadden Trial

By Walter F. Roche Jr.

BOSTON Mass.- Using an FBI agent as one of their witnesses, lawyers for a former drug company executive facing second degree murder charges today attacked key timing issues in the case presented by prosecutors.
Called as a witness by lawyers for Barry J. Cadden, FBI Agent Philip Sliney acknowledged that a key prosecution witness, the head of sales for the now defunct New England Compounding Center, wasn't sure just when Cadden said,"It's us. It's over."
Sliney said Rob Ronzio, who testified against Cadden under a plea agreement, wasn't sure whether Cadden made the comment on Sept. 26 or Sept. 27, 2012.
Cadden is facing charges of racketeering and 25 counts of second degree murder for his role in the 2012 fungal meningitis outbreak which took the lives of 77 patients. Cadden's lawyers have conceded that NECC steroids caused the outbreak.
The date Cadden first learned of the emerging outbreak is critical, as his lawyer Bruce Singal  pointed out today.
Prosecutors have pointed to an apparent five day delay between the time Cadden first learned there might be a serious problem with one of NECC's key products and the institution of a recall of thousands of vials that turned out to be contaminated with a deadly fungus.
Cadden's lawyers also presented evidence challenging the timing testimony of an employee of a South Bend, Ind. pain clinic.
Wendy Huffman testified that she spoke with  Cadden in a phone call on Sept. 21, 2012 and he told her there might be a problem with a shipment of vials of methylprednisolone acetate.
Communications company officials, who had gathered the clinic's phone records, testified today that there were no calls to or from the clinic to a number in the 508 area code on Sept. 21, 2012.
On cross examination, prosecutors questioned whether the telephone records were complete.
Sliney, the FBI agent, was asked to review notes he made from interviews with Ronzio before the Cadden trial began nearly ten weeks ago.
"He (Ronzio) was clearly struggling with the date," Sliney said. "He wasn't sure. I felt he wasn't sure of it."
Ronzio also stated under questioning that Cadden knew from the time of the first reports of a problem at a Nashville, Tenn. clinic that it was an NECC product that was to blame. Tennessee health officials at first thought there might be other causes for several patients being taken ill.
In addition to the phone records, Cadden's lawyers read extensively from the transcript of a 2012 congressional hearing in which then FDA Commissioner Margaret Hamburg was being questioned about her agency's regulation of compounding pharmacies like NECC.
The hearing was called in response to the fungal meningitis outbreak. Hamburg told members of a House committee that court rulings striking down a key statute had made regulation difficult.
"The law is not clear on this," Hamburg testified, adding that there were "significant gaps in our authority."
Cadden's lawyers also read to the jury emails, memos and correspondence from federal officials in which the difficulty in regulating compounders was detailed.
One of the charges against Cadden is that he defrauded the FDA.
Another witness for Cadden, Stephen O'Neill, head of an Ashland, Mass. testing company, said his twice a year tests of NECC's clean rooms found no evidence of excess particulates. He said rooms met and exceeded industry standards.
U.S. District Judge Richard G. Stearns told the 15 jurors hearing the case that final witnesses would be called Monday and final arguments, depending on the weather, will come on Tuesday.