Monday, June 24, 2019
Prosecutors File Appeal Notice on Acquittals
By Walter F. Roche Jr.
Federal prosecutors have filed a notice of appeal of the ruling by a federal judge reversing the unanimous guilty verdicts reached late last year in the case against a part owner of the drug compounding company blamed for the 2012 fungal meningitis outbreak.
In a notice filed today in U.S. District Court in Boston, Mass. Assistant U.S. Attorneys George Varghese and Amanda Strachan said they intend to appeal the acquittal order issued on June 11 by U.S. District Judge Richard G. Stearns. The notice is a first step before formally filing an appeal.
Stearns granted acquittal motions filed in behalf of Gregory Conigliaro, who was vice president and part owner of the now defunct New England Compounding Center, and Sharon Carter, an NECC operations manager. The two were convicted of conspiring to defraud the U.S. Food and Drug Administration.
They were among five defendants found guilty late last year following an eight week trial.
In the appeals lawyers for Conigliaro and Carter had argued that defrauding the FDA was a legal impossibility because at the time the federal agency did not believe it had clear jurisdiction over NECC, which was licensed by the state of Massachusetts. In fact Stearns himself had suggested that argument when he set a hearing date for the acquittal motions in a Dec. 18 order.
Conigliaro was vice president for regulatory affairs at NECC and prosecutors pointed to a letter he wrote to regulators contending that NECC was a small family owned pharmacy and not a drug manufacturer subject to FDA regulation.
Government witnesses, including a top official from the FDA, testified that NECC was in fact a drug manufacturer and should have been subject to stricter federal regulation.
The appeal notice is not the first by prosecutors in the NECC case. A prior ruling to acquit NECC defendants of criminal charges was reversed by the First Circuit Court of Appeals.
Conigliaro and Carter were among 14 indicted in 2014 following a two-year probe of the deadly 2012 fungal meningitis outbreak. Only one of the 14 has been acquitted and two are already serving federal prison terms.
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Thanks !
ReplyDeleteI especially liked top fda official testified that NECC was in fact a drug manufacture. Therefore should have been subject to stricter federal regulations.
Ok that’s a statement!
To this day the stricter is not being stricter, so what a bunch of baloney.
Just shows no one cares until it’s them. If a couple Congress folk or Senate folks, received a Necc surprise, bet stricter would mean stricter, or maybe what’s there applied. Plenty of people in positions to stop the murders just looked away, or stayed home that day. I feel as though I’ve been lied to from 2013. I don’t believe anyone really tried to increase the penalties, I don’t think the settlement lawyer was given may outlets that existed to work with, including media. Heck the fact that no one outside the victims hardly or never heard of the lack of oversight.
Sorry I get carried away.
There is no question that FDA knew NECC was operating as a manufacturer rather than as a traditional pharmacy. The problem, however, is that the FDA did nothing to stop NECC from operating as such. Well, I shouldn't say nothing. FDA did send a warning letter to NECC years prior to the 2012 outbreak. Unfortunately, FDA did nothing beyond sending the letter, despite clear knowledge that the company was not properly following CGMP standards (which is required of manufacturers).
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