Dozens of people died and hundreds of others fell ill during the 2012 fungal meningitis outbreak that began in a Framingham compounding pharmacy.
But should jurors in the latest trial against former pharmacy employees hear the devastating details of what is considered one of the largest public health crises ever caused by a pharmaceutical product?
Prosecutors and defense lawyers for nine pharmacists, technicians, and executives sparred over that question Monday at a hearing in US District Court in Boston.
The nine defendants are the lesser-known actors charged in the tragedy involving the New England Compounding Center during the summer of 2012, when prosecutors say contaminated, expired, and untested drugs were mislabeled and shipped to doctors, clinics, and hospitals across the country.
They face charges that include mail fraud and racketeering in connection with the scandal and are scheduled to go on trial in October. But their lawyers contend they had no role in producing the batches of a contaminated steroid that caused the deadly outbreak. Some had worked for years at the company, while others had only been there a few months when federal officials launched their investigation.
“The outbreak has nothing to do with the charges against them,” said Dana McSherry, who is representing Joseph M. Evanosky, a pharmacist who worked at NECC from April 2011 to October 2012.
The nine defendants had filed a joint motion asking that US District Judge Richard G. Stearns bar testimony about the tainted vials of the steroid, methylprednisolone acetate, and the harm they caused.
The man responsible for compounding that drug, pharmacy supervisor Glenn Chin, was convicted last fall, defense lawyers argued. Chin began serving an eight-year sentence for racketeering and fraud in April. NECC’s former owner, Barry Cadden, was convicted of fraud and racketeering in March 2017 and was sentenced to nine years in prison.
“This is not Cadden-Chin, round three,” McSherry said. “These are different defendants, different charges.”
Cadden and Chin were both acquitted of second-degree murder charges.
Assistant US Attorney George P. Varghese said it’s critical that jurors know about the fallout of the steroid’s production so they can understand why the federal government launched a massive investigation into the pharmacy.
The remaining defendants may not have been responsible for production of the steroid, but Varghese said they used the same unsafe practices to produce and ship other drugs.
“We are not seeking to inflame the jury,” Varghese said. “We are trying to demonstrate the story of what happened in this case.”
Varghese said prosecutors plan to seek testimony from Centers for Disease Control and Prevention and Food and Drug Administration officials but will not call victims or their families as witnesses.
Prosecutors have described NECC as a “fraudulent criminal enterprise” that produced substandard drugs and marketed them as the safest in the country. They say many of the remaining defendants conspired with Cadden and Chin to carry out the scheme, but defense lawyers say the government went too far in charging their clients for what are essentially civil regulatory violations.
In 2012, investigators from the CDC and the FDA found that NECC sent out vials of mold-tainted steroids that were injected into the spines of patients, many of whom suffered strokes. Those who survived continue to be afflicted by pain, headaches, and memory loss. Many now rely on canes and wheelchairs.
In 2014, prosecutors indicted 14 people in connection with the outbreak, which authorities said caused the deaths of 64 people and infected about 800 patients.
Stearns seemed to agree with defense lawyers that it could be problematic to include evidence of the deaths and illnesses at a trial for defendants who were not accused of producing the deadly steroid.
But he said prosecutors have a strong argument for why the jury may need the context of the outbreak to understand why the pharmacy was investigated in the first place.
McSherry countered that it is not necessary to tell the jurors of the deaths and illnesses that occurred, since the defense does not plan to argue that there was no reason for federal agencies to investigate the pharmacy.
“That’s fair,” Stearns replied.
But Varghese said prosecutors need that background to counter the likely defense argument that they overreached in charging the defendants with racketeering or conspiracy.
He alluded to the second-degree murder acquittals of Cadden and Chin to show that jurors in those trials, who were shown photos of the victims and heard wrenching testimony about how they died, were still able to assess the evidence objectively.
The government is seeking almost $74 million from Cadden in restitution for the victims.
Besides Evanosky, the remaining defendants are Gregory A. Conigliaro, a former owner and director of NECC; Sharon P. Carter, former director of operations; Scott M. Connolly, a pharmacy technician; and five other pharmacists: Chin’s wife, Kathy; Gene Svirskiy; Christopher M. Leary; Alla V. Stepanets; and Michelle L. Thomas.