Friday, March 3, 2017
Cadden "Knew Right Away It Was Us"
By Walter F. Roche Jr.
BOSTON, Mass. "He knew right away it was us."
That was the testimony Friday by the one time national sales director for the now defunct New England Compounding Center.
Referring to his boss, Barry J. Cadden, Rob Ronzio told jurors that as soon as they got word on Sept. 21, 2012 that a patient at the Saint Thomas Outpatient Neurosurgical Center in Nashville, Tenn. was ill after being injected with an NECC steroid Cadden knew his company was to blame.
Ronzio, who was testifying under the terms of a plea agreement, delivered the most damaging testimony yet in a trial that is nearing its 40th day. Cadden has been charged with racketeering and 25 counts of second degree murder. Ronzio pleaded guilty late last year to a single count of conspiring to defraud the federal government.
The charges against Cadden and 13 others stem from a lengthy grand jury investigation of the 2012 fungal meningitis outbreak which sickened 778 patients, killing 76 of them. State and federal regulators have concluded the outbreak was caused by fungus riddled spinal steroids shipped from NECC's Framingham facility.
Under questioning for more than three hours by Assistant U.S. Attorney George Varghese, Ronzio also detailed, through a series of emails, how NECC, under Cadden's direction, dodged and darted to get around state laws and regulations requiring patient specific prescriptions for all the drugs they were selling.
In states like Colorado and Oregon where regulators were closing in, Cadden instructed his sales staffers to "just walk away. We have nothing to gain and we have a lot to lose."
In testimony about the outbreak itself, Ronzio recalled Cadden was in Boston for a hearing on an unrelated matter when he got word that NECC was being forced to surrender its pharmacy license.
"It's over," Ronzio quoted Cadden as saying.
Ronzio said the statement shocked him because he had been led to believe that NECC did extensive product testing and held drugs for two weeks to ensure that they were not contaminated.
"It can't be us" Ronzio said was his first reaction at the time.
Ronzio also recalled that Cadden said, "Oh no," when he got word on Sept. 25, 2012 from a sales representative that an Indiana clinic was complaining about seeing a foreign object in a vial of NECC's methylprednisolone acetate.
Ronzio said he was upset when during the same period the crisis was heightening he attended a meeting of executives of NECC and a sister company Ameridose including Cadden
"It was all about Ameridose, They were trying to created a separation between NECC and Ameridose," Ronzio said, adding that a public relations firm representative was among those in attendance.
"It was all about Ameridose," Ronzio said. "I was disgusted."
Ronzio said until the license was actually surrendered NECC continued shipping other drugs even as they were voluntarily recalling the preservative free methylprednisolone acetate. A recall of all of NECC's products was later issued.
Ronzio said when he came into work on Sept. 26 Cadden was in his office contacting customers about the recall.
"I felt it was my duty to contact as many (customers) as possible," he said, adding that he took over the job of notifying clients. He said he also assembled a spread sheet showing the drugs and lot numbers for all customers.
He said Cadden instructed him not to talk with the clients about infections like the one reported in Nashville.
"I wasn't admitting anything," he said.
He said Cadden was upset when he learned that the sales representative for the Nashville clinic had gone to the clinic and talked to its managers.
He said later that week he issued a bold faced large type email to his staffers telling them not to go on any sales calls. "If you have a meeting do not go to it," the message read.
Much of Ronzio's testimony related to skirmishes with state regulators over a requirement that individual prescriptions had to be written for each patient receiving NECC products.
He described a process called "backfilling" in which clinics and other customers would provide the names of previous patients for subsequent orders to make it appear that the requirement was being met.
He said some customers, especially hospitals resisted providing names and Cadden authorized exemptions for customers with substantial orders, like Partners, the Boston health conglomerate, which he called "our stable".
Ronzio said NECC also was improperly selling at least three drugs that duplicated products by companies licensed as manufacturers by the FDA. They included a form of methylprednisolone acetate with a preservative.
He said Cadden did not want the company registered with the FDA because it could not comply with the agency's mandatory manufacturing standards.
He said the company also used a five percent rule in some states that allowed up to five percent of total sales to be delivered to providers without patient names.
Ronzio said he didn't agree with the five percent device because "I didn't think it was the right thing to do."
Varghese asked Ronzio if despite the assurances that NECC was properly testing its products for sterility and potency, he eventually learned that was not the case.
Ronzio said yes, adding that there were "multiple issues" when numbing drugs delivered to the Massachusetts Eye and Ear Infirmary for use in cataract surgery turned out to lack sufficient potency.