Conigliaro Seeks Acquittal or New Trial

By Walter F. Roche Jr.

A part owner of the drug company blamed for a deadly 2012 outbreak is seeking an acquittal or a new trial charging that highly prejudicial evidence and even a comment from the presiding judge made it impossible for confused jurors to conclude he conspired to defraud the U.S. Food and Drug Administration.
In two filings in U.S. District Court in Boston, Mass. the attorney for Gregory Conigliaro argued that prosecutors never should have been allowed to state that their client "made millions of dollars" from the New England Compounding Center, the now defunct firm blamed for the fungal meningitis outbreak.
Conigliaro and four others were convicted late last year on racketeering, mail fraud and conspiracy charges following a more than two month trial. The charges stem from a two year probe of the outbreak that took the lives of more than 100 patients.
Daniel Rabinowitz, Conigliaro's lawyer, stated that among the prejudicial evidence unfairly allowed during the trial was testimony relating to a nearby recycling facility that Conigliaro owns. He wrote that evidence should not have been allowed should not have been allowed because prosecutors failed to present any evidence that the recycling business was the source of deadly fungi that made its way into drugs that NECC was selling.
The filing cites a comment made during the trial by U.S. District Judge Richard G. Stearns regarding the recycling evidence as "unduly prejudicial."
"I have a different view," Stearns said following a comment by Conigliaro's defense team challenging the relevance of the recycling business.
The two memoranda come as the date for a hearing on the acquittal motion is approaching. Another defendant, Sharon Carter last week filed a similar acquittal motion. A Feb. 26 hearing date has been set for oral arguments on the acquittal requests.
Conigliaro and Carter's lawyers, taking a cue from Stearns, centered their arguments on the claim that it was a legal impossibility for the two to conspire to defraud the FDA, because the government agency did not have clear legal authority to regulate drug compounders like NECC.
Citing trial and Congressional testimony along with FDA documents, Rabinowitz wrote that "the uncontroverted evidence at trial showed it was legally impossible to determine whether a business was a manufacturer or a compounding pharmacy.
Prosecutors and government witnesses charged that NECC was actually acting as a manufacturer but disguised itself as a compounding pharmacy to avoid stricter regulation by the FDA.
Noting that the U.S. Supreme Court struck down a law that did set a distinction between manufacturers and compounders, Rabinowitz argued it was not possible for the court to find the FDA had been defrauded of its regulatory ability and cited the testimony of Dr. Janet Woodcock of the FDA and former FDA Commissioner Margaret Hamburg.
The filing also states that Conigliaro should have been granted a separate trial because much of the evidence against the four co-defendants had nothing to do with the single conspiracy charge against Conigliaro.
The result, the filing continues was "weeks and weeks of testimony" that was completely irrelevant to the single charge against Conigliaro.
Rabinowitz also argued that Stearns should not have allowed testimony by pharmacy regulators from nine states, who were called as prosecution witnesses against Conigliaro.
"The evidence at trial was legally insufficient for any rational trier of fact to conclude that the government proved beyond a reasonable doubt that Mr. Conigliaro intended to defraud the FDA," the filing concludes.