Wednesday, March 8, 2017

Cadden Seeks Acquittal on All Charges

By Walter F. Roche Jr.

BOSTON, Mass.- The head of a drug compounding firm blamed for a deadly fungal meningitis outbreak is asking a federal judge to acquit him on all charges, including racketeering and 25 counts of second degree murder.
In a 38-page motion filed today in U.S. District Court, Cadden's attorneys are charging that federal prosecutors failed to present adequate evidence of second degree murder though they conceded the evidence might support "at most" a manslaughter charge.
The motion, which was not unexpected, comes as federal prosecutors are about to call their last witness in a trial that began in January.
In testimony today a former employee described how she and a colleague created dozens of phony prescriptions to present to state officials in response to a complaint that had been filed against Cadden's company, the New England Compounding Center.
Cadden has been charged in only 25 of the 76 deaths recorded in the 2012 fungal meningitis outbreak. He was one of 14 to be charged in late 2014 following a lengthy grand jury probe. Charges against two defendants have been dismissed, Two others pleaded guilty to reduced charges with the remaining facing trial later this year.
Cadden's motion states that federal investigators, despite spending years on the case, still could not explain how vials of methylprednisolone acetate became contaminated with fungus.
"The fact that 25 (people) died is not in dispute," the motion states, adding that federal investigators never found evidence at NECC of the specific fungus, exserohilum rostratum, that was found in the bodies of victims and unopened vials of NECC steroids.
"Despite calling over 50 witnesses over 41 days, the government has failed to prove what caused the contamination," the motion states, adding that Cadden did not compound the steroids that caused the outbreak.
The government, the motion continues, "has provided no evidence that Cadden acted with the requisite intent to commit second degree murder."
Calling the murder charges unprecedented for "a participant in a non-violent business," the motion concludes, "The court should exercise its extreme discretion to grant the motion for acquittal."
At the court session Beth Reynolds, who worked for NECC's sales arm, Medical Sales Management, said that one of her duties was to ensure that pharmacists and technicians were properly licensed and registered.
A hesitant witness who spoke at times in whisper soft tones, Reynolds said she and another worker were assigned in 2012 to take patient names from a list at the Mass. Eye and Ear Infirmary and insert them on prescription forms.
According to previous testimony, the drugs in question already had been delivered to Mass Eye and Ear without patient specific prescriptions as required under state law. In fact the drug, a numbing agent, already had been administered to patients.
Reynold's assignment followed a complaint the health facility had filed with the state Pharmacy Board against NECC. The complaint charged the drugs that didn't have the required potency, prompting complaints from patients and doctors.
The witness identified a series of emails relating to the project.
"The labels have all been created, printed and proofed," Reynolds wrote in one email.
She said that both she and her colleague, Michelle Rivers, thought the project was "out of the ordinary."
She said she didn't like another 2012 assignment from Cadden, which was to compile a list of states that allow prescriptions to be filled under certain circumstances without the name of a patient. Under so-called office use provisions set quantities of drugs can be dispensed for use in a hospital or doctor's office in situations where the patient's identity can't be determined in advance.
She said the assignment made her feel uncomfortable and she did not know what was going to be done with the information.
An official of the Massachusetts Pharmacy Board later testified that there is no such exemption from the patient specific requirement for pharmacies, like NECC, licensed in Massachusetts.
Other witnesses provided additional testimony and evidence about the Mass Eye and Ear Infirmary incident including an email from Cadden with instructions on the need to insert patient names in each prescription.

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