Wednesday, November 7, 2018

NECC Cancer Drug Expired Years Before Shipment


By Walter F. Roche Jr.

Boston - A chemical company executive testified today that the drug distributed to health facilities by a Massachusetts drug compounding company in 2012 had a 2007 expiration date and should not have been used beyond that date.
Testifying in U.S. District Court Tom Tyner of Spectrum Chemical, told jurors that his company would not have shipped the methotrexate beyond the Jan. 23, 2007 deadline set by the original producer of the chemical.
The testimony came on the 20th day in the trial of six former employees of that now defunct compounding firm blamed for the deaths of the deaths of at least 76 patients, including 16 in Tennessee.
Another prosecution witness, a pharmacist from an Illinois hospital, testified that her facility ended up unwittingly purchasing the expired drug for use on a patient suffering from cancer.
Also appearing before U.S. District Judge Richard G. Stearns was an FBI agent who investigated the deadly 2012 outbreak caused by the New England Compounding Center. The six defendants are charged with racketeering and mail fraud.
Tom Tyner of Spectrum Chemical identified one of the containers of methotrexate seized in a 2012 search of the New England CompCenter
Under questioning from Assistant U.S. Attorney George Varghese, Tyner said NECC had ordered two containers of the drug in February It was shipped with a label setting a Jan. 23, 2007 expiration date.
Asked if there had ever been a request to extend the 2007 date, Tyner said, "No."
He added that any extensions were rare and that Spectrum would not normally guarantee the strength or purity of the product beyond that date.
Under cross examination by Jerome Sternberg, representing defendant Gene Svirskiy, Tyner acknowleged that Spectrum got into trouble with federal officials because it sold excessive quantities of a pain medication. He said the company entered into a memorandum of understanding as a result.
Spectrum, Tyner acknowledged, was also cited for mislabeling a drug.
"We got a warning letter," he said.
"We're getting off track here," Stearns stated, following an objection by prosecutors.
Kandie Dino from the Decatur Memorial Hospital in Illinois told Assistant U.S. Attorney Amanda Strachan that her facility purchased methotrexate from NECC in 2017. Records and seized evidence showed it came from the same lot shipped by Spectrum to NECC in 2007.
Dino said the drug was never actually administered because of a change in the cancer patient's condition, but said she never would have purchased the drug had she known its history. She said it was eventually discarded. Records from the hospital showed NECC was paid $1,770 for the drugs.
Under cross examination Dino said that even though there was a shortage of methotrexate at the time, the hospital would not used an expired product.
Defense attorneys Wednesday also completed the cross examination of Philip Sliney, the lead FBI agent assigned to the case
The agent had testified earlier this week about an interview he conducted with Evanosky, a defendant who worked in the same clean room where contaminated spinal steroids were produced.
Asked by Evanosky's lawyer, Mark Pearlstein, if he had any information showing his client's involvement in producing the steroids. Sliney said there was none that he was aware of.
Sliney also acknowledged there was "not a single allegation" he could recall regarding the intrathecal pumps his client worked on.
Sliney previously testified that he interviewed Evanosky at his home on Nov. 8, 2012 and while the former NECC employee denied any wrongdoing, he acknowledged he was aware that NECC was sending out drugs before promised testing could be completed.
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