Tuesday, April 25, 2017

Citing "Pure Legal Impossibility," NECC Defendants Seek Dismissal

By Walter F. Roche Jr.

Citing a comment by the presiding judge himself, three of the remaining defendants in the fungal meningitis probe, are asking for dismissal of a key conspiracy charge.
In motions filed this week in U.S. District Court in Boston, Mass., the group, headed by a part-owner of a defunct drug compounding company, is asking for dismissal of a charge that they conspired to defraud the U.S. Food and Drug Administration by evading regulation by that agency.
Gregory Conigliaro, who was a vice president of the New England Compounding Center, filed an 11-page memorandum contending that it was impossible for his firm to defraud the FDA because FDA officials didn't even believe at the time that they had clear jurisdiction over drug compounders.
Conigliaro is one of seven defendants charged with the conspiracy and a trial is expected in late Fall. In fact the conspiracy count is the only one Conigliaro has been charged with. Joining him in the motion to dismiss were defendants Alla Stepanets and Sharon Carter, former NECC employees.
Conigliaro's motion cites comments made by presiding U.S. District Judge Richard G. Stearns during the recent trial of NECC's president, Barry Cadden. Cadden was convicted on racketeering charges but cleared of 25 counts of second degree murder.
As the 10-week trial inched toward conclusion Stearns said it was hard to see just what it was that the FDA was defrauded of.
His comment followed the introduction by Cadden's lawyers of testimony by then FDA Commissioner Margaret Hamburg who told a congressional committee in 2012 that her agency did not believe it had clear legal authority to regulate compounders like NECC. She testified as the deadly fungal meningitis outbreak was still unfolding.
Conigliaro's motion also cites testimony by Janet Woodcock, then director of the Center for Drug Evaluation and Research, who expressed similar views.
The two regulators told congress that the FDA's authority over drug compounders was limited, unclear and contested.
Citing their comments, the motion states, "Thus it was impossible for the FDA to be defrauded in the manner the government has alleged."
Filed for Conigliaro by his attorney, Dan Rabinowitz, the memo adds, "Pure legal impossibility exists when actions which the defendant performs or sets in  motion, even if fully carried out, would not constitute a crime."
In addition to the lack of legal authority, the motion contends that there was no clear legal distinction at the time between drug compounders and drug manufacturers.
Prosecutors have charged that NECC, while licensed as a compounding pharmacy, was acting as a drug manufacturer and drug manufacturers were subject to direct FDA regulation.
The motion concludes by charging that the conspiracy to defraud charge "is entirely predicated on the faulty premise that the law drew a clear distinction between a compounding pharmacy and a manufacturer."
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