Douglas Wingate was a father of two from Virginia who got a steroid shot on Sept. 6, 2012, to help relieve back inflammation. He had a stroke and within two weeks was dead.
Goodwin Mitchell, 88, was a retired medical technologist and grandfather from Florida who also received a shot of the drug, methylprednisolone acetate, the same day, and later suffered several strokes. He also died.
Federal prosecutors alleged Monday that the two men were among the more than 60 people from at least seven states who died after receiving a fungus-contaminated deadly drug prepared by the New England Compounding Center in Framingham. An additional 700 were sickened in the nationwide outbreak of fungal meningitis that followed.
In opening statements in the first criminal trial related to the contamination, federal prosecutors sought to place Barry Cadden, a former owner of New England Compounding Center and lead pharmacist, at the center of responsibility, saying he oversaw the compounding, packaging, and shipping of the drug.
“It’s a story of greed, it’s a story of cutting corners, it’s a story of fraud,” said prosecutor George Varghese.
Cadden skirted regulations in favor of profits while knowing the risks, prosecutors argued, making him responsible for at least 25 deaths.
“Barry Cadden was NECC,” said Varghese, adding that the company “was a fraudulent enterprise, through and through.”
Bruce Singal, an attorney for Cadden, argued to jurors, however, that Cadden could not be held responsible for the mistakes of a corporation.
“He did not commit murder, and he is not responsible for those deaths,” Singal told jurors, saying that there is no evidence that Cadden did something to contaminate the drugs. “What did Barry Cadden do to cause these people to die?” he said.
The trial could last two months and is being watched closely by the pharmaceutical industry.
The compounding center used nonsterile ingredients to produce sterile drugs, said Varghese, and investigators with the Centers for Disease Control and Prevention determined that at least three lots of medications were contaminated with fungus from unsanitary conditions around early summer 2012.
The meningitis outbreak began to spread in a matter of months, though it took more time to recognize what was happening.
Varghese described for jurors why it was difficult to identify and diagnose the fungal meningitis outbreak: It is rare for a fungus to attack the brain and cause strokes.
“There’s no real way for fungus to go to your brain, unless it’s put there,” he said.
Authorities eventually traced the outbreak to New England Compounding and alleged that Cadden and other pharmacists were responsible for skirting industry regulations and allowing the contamination to occur.
“He didn’t do enough to make sure these drugs were sterile,” Varghese said.
Cadden and 13 other people connected to New England Compounding were charged in a mammoth 2014 indictment with crimes including racketeering for allegedly running the pharmacy like a criminal enterprise for their own benefit. Two of the defendants were charged with unrelated financial crimes; they have pleaded guilty and were sentenced to probation. A former salesman pleaded guilty and is cooperating with authorities. Charges against two of the defendants were later dismissed.
Only Cadden and supervisory pharmacist Glenn A. Chin were charged with directly causing deaths. US District Judge Richard G. Stearns agreed to hold a separate trial for Chin after lawyers for Cadden suggested they would place the blame on him at trial.
In his opening statements Monday, Singal argued that Chin and other pharmacists were in charge of cleaning and that prosecutors will show no evidence that Cadden did anything to cause the contamination. Singal argued that Cadden actually hired cleaning companies and other companies to test for contamination and lashed out at them for poor performance.
“He’s not sitting back and ignoring it, he’s trying to do something about it, and very aggressively,” Singal said. He also described how Cadden and his wife built the company together after studying pharmacy in college in Rhode Island.
He played a voicemail for jurors, during which Cadden could be heard telling a client after the outbreak was discovered to quarantine the drug.
“We consider this an emergency,” Cadden told the client.
“That reflects the heart and mind of the individual at that time,” Singal said.
Before that, Singal said, New England Compounding had produced more than 850,000 vials of the drug over six years without any problem, selling them to doctors and clinics.
But Varghese told jurors that Cadden built an environment in which pharmacists skirted industry regulations to increase their profit. He described how Cadden allegedly classified the compounding center as a pharmacy, rather than a manufacturing center, to evade additional federal regulations. To do so, Varghese said, the center needed a list of patients, so Cadden made them up: Filet O’Fish; L.L. Bean; Jay Leno.
He also said Cadden prepared drugs with ingredients that he knew had been expired for years. In some cases, he failed to test drugs he sent out to the market.
And the cleaning rooms were unsanitary, he argued. Inspectors found evidence of mice, flies, and insects, and oil leaching through the floor.
“Finding mold in your cleaning room is like a fire alarm. You need to act. Barry Cadden didn’t act,” Varghese said. “You don’t need to be a microbiologist to know this was not a sanitary place.”
The trial is slated to resume with testimony Tuesday.