Monday, March 6, 2017
Cadden Learned Sept. 21 of First Victims
By Walter F. Roche Jr.
The New England Compounding Center first learned of a possible problem with its steroid drugs at a Nashville, Tenn. clinic on Sept. 20, 2012 and the next day the news had been passed on to the company president, Barry J. Cadden.
A company notation of the formal complaint was displayed for jurors in U.S. District Court here today as Cadden's trial on second degree murder charges entered another week. Also displayed by Assistant U.S. Attorney George Varghese was an email dated Sept. 21 informing Cadden of the complaint from the Saint Thomas Outpatient Neurosurgical Center.
The timing of the complaint and Cadden's reaction to what became the first warning of an impending national public health crisis has quickly become a key issue in the ongoing trial.
The charges against Cadden stem from a federal probe of the 2012 fungal meningitis outbreak which ultimately sickened 778 patients in more than 20 states. Seventy-six of them died. State and federal regulators have concluded that fungus tainted steroids from NECC caused the outbreak.
Under cross examination by Michelle Peirce, Cadden's lawyer, NECC's former national sales director Rob Ronzio, was questioned repeatedly about the timing of a conversation he had with Cadden in which Cadden conceded NECC was to blame.
"It's us," Ronzio quoted Cadden as saying.
On Friday Ronzio also testified Cadden "knew from the first that it was us."
Citing Ronzio's statement to prosecutors before the trial, Peirce asked whether the conversation actually took place on Sept. 25 or Sept. 26.
"The time frame is very important," Peirce said, questioning whether prosecutors urged him to "move the needle back" on the timing of the conversation
She noted that Cadden himself began calling customers on Sept. 25, a task Ronzio joined when he arrived for work that day.
"He (Cadden) was up all night calling clinics," Peirce said.
Ronzio said the conversation took place "when it first happened. If it wasn't Friday, it was that week."
The complaint from the Saint Thomas clinic was relayed by Mario Giamei Jr., the salesman handling the clinic's account. He reported that "a few" patients had infections following injection with methylprednisolone acetate from NECC and a clinic employee, Cindy McClendon, had expressed concern.
Later, in a brief followup Varghese introduced another NECC email sent from Cadden to Ronzio also on Sept. 21 at 2:17 p.m. inquiring about the company's standard operating procedure for instituting a recall.
Asked if there were any other recalls in that time period, Ronzio said no.
Peirce questioned Ronzio closely about his plea agreement under which he pleaded guilty to a single count of defrauding the federal government. Additional charges were dropped.
Asked if he hoped to avoid jail time, Ronzio said yes.
Peirce also challenged Ronzio's testimony about a meeting of executives of NECC and a sister firm, Ameridose, at the same time the crisis was deepening. Ronzio had testified he was "disgusted" that the main topic of discussion at the meeting was how to separate and save Ameridose.
Ronzio conceded that although Cadden was at the meeting, he was not the one talking about saving Ameridose.
He also acknowledged that Cadden appeared to be in shock and devastated.
Ronzio repeated his Friday testimony that it was on Sept. 25 that NECC got word of a complaint from an Indiana clinic that foreign matter was observed in a vial of NECC drugs.
"Oh no," Cadden responded in an email.
As the questioning neared four hours, U.S. District Judge Richard Stearns told Peirce, "You seem to be running out of material."
Showing a sketch of NECC's Framingham, Mass. facilities, Peirce questioned how he and Cadden could have heard a fax machine spewing out another drug order when it was located a few offices away.
"Absolutely. It was quiet as a church mouse. We were alone," Ronzio said.
He testified last week that Cadden referred to the fax as his personal ATM.