NECC and the Future of Compounding Pharmacy
Compounding pharmacist's case hinged on whether he was "willfully indifferent."
In 2012, a fungal meningitis outbreak killed more than 60 and left 732 people sickened. Many of those who survived face constant pain related to the illness. The cause of infection was large contaminated batches of injectable methylprednisolone acetate.
Owner and head pharmacist at the New England Compounding Center (NECC), where the medication was made, was Barry Cadden, RPh. Cadden, charged with second degree murder, was found guilty of 50 counts of mail fraud and racketeering. He was ultimately acquitted of 25 counts of second-degree murder. Final sentencing is set for June 21, and Cadden will be free until then.
Inspectors looking into the case found unsanitary conditions at NECC. Infractions included dirty mats and hoods, a leaky boiler, and debris floating in vials of medicine, according to news reports. Contamination was detected in the center’s clean room and many batches of drugs were not autoclaved for the required times.
The FDA had warned Cadden about conditions at NECC. Prosecutors argued that he disregarded this information in favor of profits, putting patients at risk.
“This trial revealed that, among other things, Mr. Cadden participated in a massive fraud in which NECC masqueraded as a pharmacy when it was in fact manufacturing drugs,” said William D. Weinreb, Acting United States Attorney for Massachusetts in a New York Times report. “As a result, he managed to escape FDA oversight of his actions, and 65 people died. Hundreds of others were injured.”
The defense argued that the prosecutors did not show how the drugs had been contaminated or the role that Cadden played in the subsequent deaths. In a statement to the New York Times, Cadden’s lawyer, Bruce A. Singal, argued that, “It was a terrible lapse of judgment for the U.S. Attorney’s Office to accuse Mr. Cadden of murder in the first instance … For the prosecution to persist in trying to blame him for the deaths in the wake of acquittals on all 25 murders is irresponsible and reprehensible.”
Keith Hasson, a Managing Partner at Hasson Law Group, an Atlanta-based firm that advises and
represents compounding pharmacies, noted in an email to Drug Topics, that the defense’s argument was that it was the mistakes of other employees, not Cadden’s, that led to the problems and that Cadden had not demonstrated depraved indifference. This seemed to persuade at least some of the jurors.
As to whether the charges against Cadden were “a terrible lapse of judgement,” Hasson does “not believe this shows that the U.S. Attorney’s Office showed a lack of judgment in bringing the charges in the first place,” he said. “It is the prosecutor’s job to bring charges that he believes he can prove. It is the jury’s job to determine whether the prosecutor has met his burden.”
To convict Cadden, the prosecution would have had to prove to the jury that he had demonstrated depraved indifference, which means “that a perpetrator had an utter disregard for the potential damage to human life that their actions could cause.”
“When most people think of murder, they think of a deliberate and intentional killing,” said Hasson. “Causing death by ‘depraved indifference’ is not what comes immediately to the mind of most jurors. To prove second-degree murder on a theory of depraved indifference requires an air-tight case—one that not only meets the very high ‘beyond a reasonable doubt’ standard of proof, but gets jurors comfortable with the idea that the defendant’s conduct was so reckless, and the deaths so foreseeable as a result of that recklessness, that it justifies treating the crime as if it were a deliberate and intentional killing. From media reports of the trial, there was enough evidence that a jury could have gone the other way, but this jury didn’t see it as a murder.”
Cadden will still face prison time for the 52 counts of mail fraud. Each of those charges carries up to 20 years in prison. He will, according to Hasson, face “a substantial prison term under the federal guidelines. Once imposed, federal sentences cannot be reduced by more than 10%. There is no longer any possibility of parole.”
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