BOSTON — A long-awaited federal trial opened Monday in Boston for Barry Cadden, a Massachusetts pharmacist facing murder and racketeering charges in the deaths of 25 patients injected with steroids from his lab.
Cadden, who earned tens of millions as co-founder and head pharmacist at New England Compounding Center (NECC) in Framingham, could receive a maximum life-in-prison sentence for his alleged role in a nationwide fungal meningitis outbreak in 2012. According to the U.S. Centers for Diseases Control and Prevention, 751 patients in 20 states came down with meningitis infections after being injected with NECC steroids, and 64 of them died.
Cadden is charged with 131 counts, including 25 acts of second-degree murder. Dressed in a dark suit, white shirt and tie, Cadden sat between two of his attorneys and mostly looked straight ahead without much expression.
Prosecutor George Varghese, in his opening statement, portrayed Cadden as a callous fraud who brushed off environmental warnings, ignored expiration dates, fabricated false patient names and knowingly imperiled thousands of lives by shipping drugs from a flagrantly unsanitary lab.
“It’s a story of greed,” Varghese said. “But mostly, it’s a story of fraud.”
Jurors saw photos of two men – Douglas Wingate of Roanoke, Va. and Godwin Mitchell of Ocala, Fla. – who’d both received injections for back pain Sept. 6, 2012. Both suffered headaches, followed by strokes and died. The cause, Varghese alleged, was a hard-to-diagnose fungus that had been injected, reached the brain stem, ate through blood vessels and triggered deadly strokes.
“They both had injections in their backs of a drug made by this man,” Varghese said, pointing in Cadden’s direction. “This man is Barry Cadden.”
Defense lawyer Bruce Singal countered that “there’s no evidence” to hold Cadden responsible for any of the deaths. Singal pushed back against the government’s portrayal of NECC’s facilities as a place where unheeded sanitation standards gave rise to mold, bacteria, flies in the air and oil seeping up from the ground through the floor.
Singal said the contamination-free "clean room" had a long track record for safety as evidenced in more than 850,000 uncontaminated vials. He showed jurors video clips of clean room employees in protective suits sterilizing syringes first thing in the morning.
What happened in the tragic meningitis outbreak, he said, was an “isolated, aberrational” event that was by no means typical for NECC.
Cadden is the first defendant to be tried in the NECC case. Supervisory pharmacist Glenn A. Chin, who allegedly oversaw the room where tainted batches were compounded, also faces second-degree murder charges and is expected to be tried after Cadden.
Twelve others were initially charged with lesser crimes; some had their charges dropped. Others have pleaded guilty.
With a trail of deaths stretching from Indiana to Florida, the Cadden case is especially resonating in hard-hit states such as Michigan, which suffered 264 illnesses and 19 deaths in the episode.
Prosecutors say Cadden co-conspired in a scheme that involved misleading regulators, failing to test drugs for sterility and ignoring warnings that flagged mold and bacteria growing in clean rooms.
“This is a case of super-gross, negligent, willful, wanton activity,” said Robert Bloom, a professor of criminal procedure at Boston College Law School. “They should have known that the stuff they were going to produce was going to result in this kind of problem, but they didn’t intend to kill anybody.”
Victims include people like Alan Przydzial, a retired machine repairman from New Hudson, Mich. He sought out injections for back pain but ended up needing infection treatments so extreme that his liver and kidneys began to fail. Last week, he received his first check from a $139,000 settlement for all he’s been through: organ damage, skin falling off, sunlight intolerance and new chronic pain.
“It’s the unknown about what’s coming next that has really ruined me as a person,” Przydzial says. “Not knowing if the (fungal infection) is permanently cleared up or if it’s going to come back weighs on me every day.”
Przydzial says the trial “will lift my spirits” because he’s confident Cadden will pay a steep price, albeit not steep enough to satisfy him. He believes Cadden should either get the death penalty (not an option for second-degree murder) or be injected with the same fungus-tainted drugs he distributed (also not an option).
But legal experts say Cadden’s fate is far from sealed. Bloom says defense lawyers will try to raise doubts about whether the deaths can be traced, not only to tainted drugs from NECC, but also to Cadden’s personal decision-making.
“This is not an easy case for the government to prove,” Bloom said. “You’ve got a medical lab that’s making these drugs. You have to show that the particular drug caused the death, which is not so easy.”
Since the meningitis outbreak of 2012, federal and state regulations have tightened up for compounding pharmacies. If tougher state and federal rules represent two legs of a stool in the quest for more accountability, Rooney says, then Cadden’s trial represents the third leg.
“This is putting everybody on notice that the authorities are taking this seriously,” Rooney said. “It certainly sends a strong message to all the compounding facilities that they really need to be on their game and really be paying close attention.”
|© Stephan Savoia, AP Barry Cadden|
First criminal trial in deadly fungal meningitis outbreak begins Monday
Joan Peay of Nashville is 76 years old, but she'll tell you she feels 86 and looks 86 because of two bouts with meningitis in 2012 and 2013.
"The whole month of October 2013 my family thought I was going to die," she said. "And I was so sick I wish I would’ve. I thought heaven would have been a better place."
Peay was one of about 750 people nationwide sickened by fungal meningitis attributed to tainted steroid injections made by a Massachusetts pharmacy in 2012. Seventy-six people died in the outbreak, according to an investigation by the U.S. Food and Drug Administration.
Now, after a lengthy federal probe and two years of legal battling, Peay and other victims are anxiously watching as the first pharmacy executive goes to trial on criminal charges.
Facing a jury is Barry J. Cadden, the director of the New England Compounding Center who is charged with 25 counts of second-degree murder connected to deaths in seven states and other crimes. He and 13 other company executives and pharmacists were indicted in 2014.
Opening statements are scheduled to begin Monday in federal court in Boston. The trial is before U.S. District Judge Richard G. Stearns. Twelve jurors who were chosen last week will decide the case, and there are three alternates who also will hear the evidence. Cadden's lawyer and federal prosecutors declined to comment on the trial.
Federal prosecutors say Cadden and other pharmacy executives did not follow regulation and procedure in preparing the medicine methylprednisolone acetate, leading to more than 10,000 tainted doses.
Michigan was hardest hit by the outbreak, with 264 illnesses and 19 deaths, according to the Centers for Disease Control and Prevention. Tennessee was the second-hardest hit state, with 153 illnesses and 16 deaths. The CDC's data was last updated in October 2015.
Among the violations alleged by prosecutors that led to that toll: using expired ingredients, failing to sterilize the medicine and ignoring indications there was mold in the rooms where medicines were made. Prosecutors say the pharmacy executives knew the potential consequence of those actions was death.
Not surprisingly, Peay agrees.
"We just feel like they knew what they were doing, and they just went ahead and did it," she said. "They knew tainted shots would hurt people, if not kill them. They just turned their backs because they were in it for the money.
"We hope they go to jail for the rest of their lives."
If convicted on all counts, Cadden could face a life term, according to a 2014 news release announcing the indictment from the U.S. Department of Justice.
It's likely the defense will focus on Cadden's role in the outbreak, on his job as an administrator and distancing him from other executives facing charges. Court records show that Cadden does not dispute that the outbreak was caused by NECC's medications.
As recently as December, Cadden was supposed to go to trial with another defendant, Glenn Chin. Chin was the company's supervisory pharmacist who oversaw the rooms where the drugs were compounded, court documents say. The judge's Dec. 15 order says the joint trial could not happen because their defenses might infringe on the other's right to a fair trial, indicating perhaps they might try to blame the other person. Chin will now stand trial after Cadden.
While there have been delays in the criminal case, most of the flurry of civil cases filed against the pharmacy have been resolved as part of a $200 million settlement. A few cases against medical facilities that prescribed the tainted steroids also are pending.
"This is the deadliest catastrophe in the history of modern medicine," said Mark Chalos, a lawyer at Lieff, Cabraser, Heimann & Bernstein in Nashville who has represented the victims.
"The stricken patients and families who lost loved ones take some comfort in knowing that those responsible for making the contaminated medication will be held accountable by a jury," he said. "The criminal trials are an important step. There remains more work to be done to hold all the wrongdoers accountable, by juries in civil and criminal courts."
Peay suffered hearing loss as a result of the second infection, and still deals with the back pain that led her to seek medical treatment in the first place.
She considered attending the trial but will not because of her back, which she said cannot withstand the punishing hard courtroom benches for hours, let alone days or weeks.
In a grandmotherly soft tone, her voice shatters into sobs when she describes the lasting impact of the infections. Still, she also perkily describes how life has gotten back to normal after her illness: her involvement in church, volunteering as a chaplain and at a food bank and a gig answering phones for the American Red Cross' disaster assistance.
"I just feel that you should do what you can in life to help people," she said. "This fungal meningitis has curtailed that, but it hasn't stopped me."