Judge Questions Charges In Cadden Case

By Walter F. Roche Jr.

BOSTON, Mass.- The federal judge presiding over the the first criminal trial stemming from a deadly fungal meningitis outbreak said today that he will let the jury have the "first pass," but he expressed strong doubts about some of the more serious charges against a former drug company president.
"It's hard for me to see what the FDA (U.S. Food and Drug Administration) was defrauded of," said U.S. District Judge Richard G. Stearns., adding "I'll let the jury have the first pass."
He also said he would let the jury decide on the 25 counts of second degree murder facing Barry J. Cadden, but noted that some court rulings have concluded that recklessness alone is "not sufficient" to establish a case of second degree murder.
"This case is going to the jury anyway," he said.
Stearns comments came after the 15 jurors hearing the case had been sent home until Wednesday, when they will hear final arguments. Stearns said each side will have a total of 90 minutes.
In questioning the charges that Cadden and other employees of the New England Compounding Center conspired to defraud the FDA, Stearns cited the congressional testimony of former FDA Commissioner Margaret Hamburg.
Her testimony was read into the record last week by one of the attorneys representing Cadden.
At a 2012 hearing called by a House committee in response to the fungal meningitis outbreak,  Hamburg said, "The law is not clear on this,"  adding that there were "significant gaps in our authority." She also cited a court ruling striking down a law related to compounding.
The charges against Cadden, which also include racketeering and mail fraud, stem from a two year grand jury probe of the 2012 fungal meningitis outbreak which sickened some 778 patients across the country, killing 77 of them. Of the 14 originally indicted, charges have been dismissed against two and two others pleaded guilty to vastly reduced charges.
Cadden, who did not testify in his own defense, was president and part owner of the New England Compounding Center, the company blamed for the outbreak. His lawyers have conceded that spinal steroids shipped from NECC caused the deaths and illnesses.
The judge's comments come more than two months after the jury was selected in early January. Since then dozens of witnesses have been called to give hours of testimony in daily sessions starting at 9 a.m. and ending at 1 p.m.
Prior to Stearns' comments Bruce Singal, Cadden's lawyer had argued for acquittal contending that the problems at NECC cited by prosecutors did "not rise to the level necessary" to prove second degree murder.
"Something went horribly, tragically wrong," Singal conceded but said prosecutors had failed to connect the deaths to any specific deficiency. He said NECC had previously shipped some 800,000 vials of the same type of steroids without incident.
Calling the second degree murder charges "a gross overreach and a gross miscarriage of justice," Singal said no reasonable prosecutor would have brought such charges in the seven states where the 25 victims died.
Assistant U.S. Attorney George Varghese, however, said Cadden had been "extraordinarily reckless" by shipping drugs that hadn't been tested and that he knew would be injected into the spinal columns of patients.
Stating that Cadden's actions were equivalent to shooting into a crowd, Varghese said, "That's murder."
He said Cadden "didn't do what he was supposed to do" and he knew there was a likelihood of harm to patients.
Prior to their dismissal, jurors also heard testimony from a former employee of NECC's
sales affiliate who said his review of telephone records showed there were no calls from NECC to an Indiana clinic on Sept. 21, 2012.
A prosecution witness earlier testified Cadden did call her that day and informed her there might be a problem with a recent shipment of spinal steroids. The recall of those spinal steroids was instituted five days later.
Contact: wfroche@gmail.com