Prosecutor: Meningitis deaths 'a story of greed'

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 97 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.”

Varghese called the meningitis outbreak a “national tragedy” that will require weeks of patience from jurors as they listen to the government’s case. He resolved to show how the episode stemmed from an operation fraudulent from “from soup to nuts.” In charge of it all, he said, was the defendant, who then displayed “shocking disregard for the lives of people who got those injections.”

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.

First criminal trial in deadly fungal meningitis outbreak begins Monday

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.”

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.”