According to prosecutors, Barry J. Cadden ignored the warning signs that led to the 2012 fungal meningitis outbreak that killed more than 60 people across the country and sickened hundreds more. He was told that a clean room at the New England Compounding Center in Framingham was infested with bugs and mice and that oil had spilled on the floor. Tests confirmed the existence of mold. But he did nothing, prosecutors contend.
Instead, Cadden proceeded with the dangerous process to compound sterile drugs, including steroids, Assistant US Attorney Amanda Strachan told jurors in the first criminal trial related to the outbreak.
“You do something if you care about patient safety,” Strachan said in her closing arguments in the case. “He saw the warning signs, that the train was going off the rails, and he chose to do nothing about it.”
But a lawyer for Cadden, the former co-owner and head pharmacist at the New England Compounding Center, told jurors that Strachan has gone too far in trying to convince them that Cadden was criminally responsible for any of the deaths caused by the outbreak.
“This is indeed a tragic death case, but it’s not a murder case, and there is a big difference between the two,” Bruce Singal told jurors in his closing arguments.
That’s the line that lawyers in the case have sought to draw for jurors after nine weeks of testimony from more than 60 witnesses. Prosecutors allege Cadden was reckless and responsible for the illnesses and deaths caused by steroids made at his business, while his lawyers argue that none of his actions can be shown to have directly caused the deaths.
Cadden faces dozens of other charges, but the jury’s verdict on the counts related to the deaths could mean a life sentence. The case was handed over to the jury on Thursday.
Cadden, 50, of Wrentham, faces 100 counts including fraud, conspiracy, and racketeering. Prosecutors say he is responsible for at least 25 deaths in seven states. In deciding the counts related to the deaths, jurors must determine whether Cadden committed second-degree murder under the standards of the state where a death occurred.
Cadden worked in the high-risk field of compounding sterile drugs. But prosecutors say he ranhis business like a criminal enterprise by skirting regulations to boost profits. Prosecutors allege he claimed to be following industry standards – and directed salespeople to make that pitch to potential customers – while he was ignoring test results showing drugs were not sterile or shipping drugs that were never tested for sterility at all.
In the summer of 2012, three batches of a steroid used to treat back pain were contaminated with a fungus, and more than 14,000 vials were distributed across the country. Doctors started to report that patients were getting sick from a mysterious illness that was not identified until September 2012, when the Centers for Disease Control and Prevention determined there was a fungal meningitis outbreak. Investigators ultimately traced the outbreak to Cadden’s pharmacy.
For 90 minutes Thursday, Strachan outlined the allegations against Cadden.
“Barry Cadden knew what he was doing could kill patients,” Strachan told jurors. “NECC was a fungal zoo, and that is what caused the victims’ deaths.”
That recklessness, she said, and Cadden’s willingness to ship the steroids to customers when he knew the health risks, make him responsible for the deaths, she argued.
Singal argued to jurors that NECC had built a spotless safety record since 2006, the year, prosecutors allege, Cadden’s conspiracy began. In that time, the company had distributed more than 859,000 vials of four high-risk steroids without incident.
Singal did not contest that some batches of steroids had been contaminated with mold. But he argued to jurors that prosecutors have failed to show exactly how they were contaminated, what Cadden did to contaminate them, and how he caused the deaths.
Singal called the contamination of the batches an unfortunate tragedy.
“This is a dangerous business, no question about it,” he said.
Milton J. Valencia can be reached at email@example.com. Follow him on Twitter @miltonvalencia.