NECC and Future of Compounding Pharmacy

April 18, 2017

Article

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.

The Trial

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.

Keith HassonAs 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.”

Up next: The future of compounding pharmacy

NECC and the Future of Compounding Pharmacy

In the five years since the outbreak, compounding pharmacists have had to brace for a new normal of greater public scrutiny by government and the media.

In response to the case, the FDA has stepped up regulations and inspections of pharmacies, especially in light of embarrassment in its handling of the NECC case. It was later shown, through both media and Congressional investigation, that FDA was aware of the problems at the NECC, and many argued that it did not act strongly enough on those accusations.

John Voliva, RPh, Executive Vice President of the International Academy of Compounding Pharmacists (IACP), told Drug Topics that “The tragic results of the NECC situation undermined the fundamentals of pharmacy.”

John VolivaThe FDA and Massachusetts Board of Pharmacy, according to Voliva and many other members of the media, “had clear authority to investigate and take action that would have stopped the operations at New England Compounding Center, and both had been informed of problems there. Neither did.”

“The NECC tragedy provided more evidence that an increase in the communication and coordination between the FDA and the State Boards of Pharmacy was vital,” said Voliva.

This extra scrutiny and regulation came at a cost, however. The Drug Quality and Security Act (DQSA), enacted in 2013, uses language that shows, according to Voliva, “Congressional intent to increase communication between the State Boards of Pharmacy and FDA.” However, Voliva and the IACP believe that the DQSA “does not square with Congressional intent.” “In addition, the IACP believes some elements of DQSA have restricted compounding pharmacists’ ability to serve patients and prescribers.”

Voliva stressed that the IACP is working with lawmakers on several issues, including office-use compoundng and FDA inspections. It is important, he said, to remember that, while patient safety is of utmost importance, regulations also need to be respectful of patients’ ability to access medications. “With drug shortages continuing to increase and skyrocketing prescription drug prices,” said Voliva, “compounding of medications preserves access to vital medications that patients often cannot get elsewhere.”

It is hoped that the increased regulation and scrutiny will win back public trust by making compounding pharmacies and pharmacists safer. Hasson argues that in the future, there will likely be fewer of these kinds of cases, because stricter regulations are removing “bad actors,” since the risks of neglecting safety protocols will outweigh the rewards.

Additionally, pharmacists will now have a better defense against these kinds of cases, because increased regulation means an increased chance for pharmacists to demonstrate compliance or “good faith.”

“Our profession continues to work with leaders from across the federal and state governments to make sure that what happened at NECC never happens again,” Voliva said.